CHAPTER 1
THE MEANINGS OF “RESPECT” FOR HUMAN
RESEARCH SUBJECTS
“Three basic principles, among those generally accepted in our cultural
tradition, are particularly relevant to the ethics of research involving human
subjects: the principles of respect for persons, beneficence, and justice.”1
These three principles were set forth by the National Commission for the
Protection of Human Subjects of Biomedical and Behavioral Research
(National Commission) in its Belmont Report in 1979. The National
Commission held that these three basic principles should guide the ethical
practice of research involving human subjects. They are intentionally broad
and necessarily general. Yet a comprehensive understanding of the practical
and moral implications of these principles is essential for the ethical conduct of
human subjects research.
This dissertation will focus on respect for research subjects. Little
attention has been given in the field of research ethics to the concept of
respect. What is needed is a thoughtful analysis of the various dimensions of
the ethical duty to respect research subjects. This dissertation provides such
an analysis by exploring the history of the concept of respect for research
1
The National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research, The Belmont Report: Ethical
Principles and Guidelines for the Protection of Human Subjects of Research
(Washington, D.C.: U.S. Government Printing Office, 1979).
1
subjects and by using that historical analysis to ground a conceptual and
policy analysis of respect in human subjects research.
The purpose of this dissertation is to rehabilitate the concept of respect
in research ethics and policy and to begin a meaningful dialogue about the
ethics of respect for research subjects. It is my thesis that present
conceptions of the ethical duty to respect research subjects are impoverished.
I argue that respect for research subjects requires more than has typically
been written about in the bioethics literature, where the ethics of respect has
primarily been understood in the limited sense of respect for individual
autonomy. This dissertation calls for reflective dialogue about the ethical duty
of respect in the context of human subjects research and seeks to begin this
conversation by suggesting a broader conceptualization of respect for
research subjects.
General Thoughts, Definitions, and Distinctions
I begin this dissertation by exploring the history of research ethics. It is
my thesis that the history and ethics of research can be best understood as a
history of disrespect for research subjects on the one hand and a search for a
greater understanding and appreciation of the various dimensions of respect
on the other. The history of abuse in research can be more vividly and fully
told if it is viewed as a history of disrespect. Moreover, I will argue that the
history of disrespect for research subjects creates a moral foundation for the
ethical duty to respect research subjects and provides important historical
2
insight into why the National Commission identified respect as a fundamental
ethical principle for research.
I begin my conceptual analysis of respect by exploring the National
Commission’s identification of the principle of respect for persons as one of
three guiding ethical principles for research. I argue that while some of the
commissioners seem to have had a morally robust conception of respect for
research subjects, their conceptualization was limited by their focus on respect
for persons and by their identification of respect as one among several ethical
principles.
Principlism and the Principle of Respect
There is significant debate in bioethics about the practical value of
principles for moral analysis. I am using the term “principle” to mean an
independent action-guiding moral norm that is prima facie binding unless it
conflicts with some other moral obligation.2 Some question the practical utility
of abstract moral principles, arguing that general ethical principles lack a
certain “locus of certitude,” making it difficult for diverse individuals to deduce
“particular concrete moral judgments” from them.3 Others believe that
principles are essential for the effective resolution of complex moral issues.4 I
2
Tom L. Beauchamp and James F. Childress, Principles of
Biomedical Ethics, 5th ed. (New York: Oxford University Press, 2001).
3 Albert R. Jonsen and Stephen Toulmin, The Abuse of Casuistry: A
History of Moral Reasoning (Berkeley and Los Angeles: University of
California Press, 1988), 16-19.
4
Beauchamp and Childress, Principles of Biomedical Ethics, 5th ed.
3
do not attempt to resolve this debate here. The focus of my analysis is neither
a defense of nor an attack on principlism per se. Nor is it a treatise on
methodological approaches to bioethics. Rather, it is an examination of the
moral significance and practical implications of respecting research subjects.
I do suggest, however, that a more serious consideration of the various
dimensions of respect reveals that respect, broadly conceived, incorporates
many ethical principles, including but not limited to autonomy, beneficence,
nonmaleficence, and justice. By categorizing respect as one among several
ethical principles, by defining it in terms of respect for autonomy and protection
for those with diminished autonomy, and by linking it solely to the practical
application of informed consent, the National Commission failed to appreciate
all of the moral dimensions of respect and, by so doing, failed to fully capture
what is morally required by the phrase “respect for research subjects.” I
suggest that research ethics and policy will be greatly enriched if respect is
understood as a multidimensional and overarching normative category for the
ethics of research, rather than one of many prima facie ethical principles.5 I
use the term “overarching normative category” to indicate a broader
5
The National Commission never explicitly refers to the three
principles in The Belmont Report as prima facie binding principles, but as
Albert Jonsen points out, they look a whole lot like W. D. Ross’s prima facie
principles. Albert R. Jonsen, “The Weight and Weighing of Ethical
Principles,” in Harold Y. Vanderpool, ed., The Ethics of Research Involving
Human Subjects: Facing the 21st Century (Frederick, Md.: University
Publishing Group, 1996), 59-82.
Respect for persons, however, was never listed as one of W. D.
Ross’s prima facie principles and was never intended to be treated as one of
several ethical principles. W. D. Ross, The Right and the Good (Oxford:
Clarendon Press, 1930).
4
conceptualization of respect that incorporates many independent ethical
principles, rules, duties, virtues, emotions, and other moral considerations. At
several points in the following discussion I will show how the meanings of
respect transcend the conceptual confines of one prima facie principle.
The Subject of Our Respect: Personhood and Respect for
Research Subjects
The purpose of this dissertation is not to provide a philosophical
analysis of personhood. In fact, the preoccupation with defining “persons”
seems to have contributed to the conceptual confusion surrounding the
concept of respect in research. If the subject of our respect is “persons,” as
the language used by the National Commission suggests, then the crucial
question becomes, what is a person? How one defines “persons” will
influence not only which subjects deserve respect, but also the justification for
that respect. For example, if persons are defined as morally valuable human
beings, then one might say that we respect persons because of their intrinsic
moral worth as human beings. On the other hand, if persons are defined as
only those human beings who are rational, then one might say that we respect
persons because of the various dimensions of human rationality. 6
6
The Encyclopedia of Ethics explains that there are three definitions
of “person” that are typically discussed:
1. Persons are all and only human beings.
2. Persons are all and only those beings who possess moral standing
(or who possess the highest moral standing).
3. Persons are all and only those beings who display attribute F (where
F signifies some suitably elevated cognitive ability).
5
I argue that there is a long history in bioethics of equating personhood
with rationality and of confining the ethical duty of respect to respect for
individual autonomy, or even more narrowly to respect for an individual’s right
of self-determination. This suggests that we respect people because and only
insofar as we respect (in the sense of not interfering with) their autonomous
choices.7 I argue throughout this dissertation that, while it is imperative that
we respect the autonomous choices of individuals, there are other ways to
respect even autonomous research subjects beyond respecting their
autonomy. There are also nonautonomous research subjects who deserve
respect. Thus, I begin with the assumption that all human subjects of research
deserve respect. I justify this duty of respect for all research subjects by
appealing to the horrific consequences of disrespecting research subjects (as
can be seen throughout history), and by pointing to the distinctive social role of
research subjects, who are both needed and used by society.
The goal of this dissertation is to begin a meaningful dialogue about the
ethics of respect for all research subjects, regardless of their moral status or
Lawrence C. Becker and Charlotte B. Becker, eds., Encyclopedia of Ethics
(New York: Garland Publishing, 1992), s.v. “person, concept of,” 950-56;
Mary B. Mahowald, “Person,” in Encyclopedia of Bioethics, 2nd ed., ed.
Warren T. Reich (New York: Free Press, 1995), 1934-40.
7
Robert Grodin argues that this confusion between the principle of
respect for persons and respect for people’s choices has deep historical
roots. He claims that the principle of respect for autonomy derives from the
more fundamental principle of respect for persons, and that “[w]e respect
people’s choices because we respect people, not the other way around.”
Thus, the principle of respect for autonomy is not wrong, but it is incomplete.
Robert E. Grodin, Political Theory and Public Policy (Chicago: University of
Chicago Press, 1982), 80.
6
“personhood.” I argue in chapter 6 that in order to avoid the philosophical
debate about personhood and to clarify that the concept of respect applies to
all research subjects, the National Commission should have focused on the
concept of respect for research subjects, rather than the principle of respect
for persons. The language of respect for research subjects more appropriately
conveys the conviction that all human subjects of research deserve respect
and appreciation for the valuable contribution that they make to the medical
research enterprise, regardless of their capacity for autonomous decision
making. A more comprehensive understanding of respect indicates that within
the context of research both the concept of respect for autonomy and respect
for persons are limiting. I therefore refer to the principle of respect for persons
when discussing the history of respect in research ethics because that was the
terminology that was used by the National Commission and others. However,
whenever discussing my own thoughts I simply use the language of respect
for research subjects.
This topic becomes more complicated when the subject of research is a
human being who has died (a cadaver) or is a potential human being (an
embryo). Although there has been much debate about the moral status of
cadavers and embryos,8 I believe that both entities deserve respect as
8
Lori Andrews and Dorothy Nelkin, Body Bazaar: The Market for
Human Tissue in the Biotechnology Age (New York: Crown Publishers,
2001); E. Richard Gold, Body Parts: Property Rights and the Ownership of
Human Biological Materials (Washington, D.C.: Georgetown University
Press, 1996); Suzanne Holland, Karen Lebacqz, and Laurie Zoloth, eds.,
The Human Embryonic Stem Cell Debate: Science, Ethics, and Public Policy
(Cambridge, Mass.: MIT Press, 2001); Brent Waters and Ronald ColeTurner, eds., God and the Embryo: Religious Voices on Stem Cells and
Cloning (Washington, D.C.: Georgetown University Press, 2003).
7
research subjects.9 The kind of respect that they deserve, however, may
differ from the kind of respect owed to living and conscious human beings. 10
Some commentators have suggested that the term “subject” is itself
disrespectful.11 Being a subject of something, they argue, suggests an
9
Although similar arguments can be made for respect for
experimental animals, that is beyond the scope of this dissertation. I limit my
analysis to human, potentially human (e.g., embryos), and previously human
(e.g., cadaver) subjects of research.
It is important to note that, although I include cadavers and embryos
in my analysis, these entities are not considered “human subjects” under the
Code of Federal Regulations. The federal regulations define “human
subjects” as “living individuals about whom an investigator (whether
professional or student) conducting research obtains (1) data through
interaction with the individual, or (2) identifiable private information.”
Protection of Human Subjects, Code of Federal Regulations, Title 45, sec.
46.102(f) (1991).
10 Karen Lebacqz tries to capture the difference between respecting a
sentient human being and respecting an embryo when she says,
Researchers show respect towards autonomous persons by engaging in
careful practices of informed consent. They show respect toward
sentient beings by limiting pain and fear. They can show respect
toward early embryonic tissue by engaging in careful practices of
research ethics that involve weighing the necessity of using this tissue,
limiting the way it is to be handled and even spoken about, and
honoring its potential to become a human person by choosing life over
death where possible.
Karen Lebacqz, “On the Elusive Nature of Respect,” in The Human Embryonic
Stem Cell Debate: Science, Ethics, and Public Policy, ed. Suzanne Holland,
Karen Lebacqz, and Laurie Zoloth (Cambridge, Mass.: MIT Press, 2001),
149-62, 160.
11
The American Psychological Association complains that the term
“subject” is too impersonal and suggests that it be used only “when
discussing statistics … [and] when there has been no direct consent by the
individual involved in the study (e.g., infants or some individuals with severe
brain damage or dementia).” American Psychological Association,
Publication Manual of the American Psychological Association, 5th ed.
(Washington, D.C.: American Psychological Association, 2001), Guidelines
to Reduce Bias in Language, Guideline 3: Acknowledge participation, 65.
8
unequal relationship where one individual is being manipulated and used by
another. It objectifies the individual and denies the importance of his or her
active participation in research. In recognition of the important role that
subjects play in the research enterprise, some have suggested that they be
called research “volunteers” or research “participants” instead of research
“subjects.”12
While I believe that this semantic shift is symbolically important,
reflecting and encouraging an attitudinal change in the relationship between
the various participants in research, it is conceptually problematic for several
reasons. First, research subjects are not the only participants in a medical
experiment; the investigator is also an important participant. Thus, it is unclear
when one uses the language research “participant” exactly which participant
that person is referring to. Second, not all individuals who are involved in
research are active participants. Some play a very passive role, even when
they agree (or consent) to be part of the experiment. The term “participant”
seems most appropriate for subjects who are called upon for their expertise or
12
For example, the Institute of Medicine (IOM) in its report on
“Responsible Research” adopted the language of research participant,
explaining:
This committee has elected to use the term “participant” rather than
“subject” to reflect its belief that the optimal functioning of research
oversight programs necessitates the meaningful integration of research
participants and their perspectives.
Institute of Medicine (IOM), Responsible Research: A Systems Approach to
Protecting Research Participants (Washington, D.C.: National Academies
Press, 2003), 2n1.
9
knowledge and less appropriate for those whose bodies are simply
manipulated for an experimental purpose. Furthermore, using the term
“participant” to describe all research subjects may have the untoward effect of
subjugating moral responsibility on the assumption that subjects are more
empowered in the culture and institution of medical research than they actually
are.13 Third, nonautonomous research subjects cannot personally volunteer
and nonliving research subjects (e.g., cadavers and embryos) can neither
volunteer nor actively participate in research. Excluding these research
subjects would suggest that I do not believe that they deserve respect, which
as I explain above is not true. Finally, the terms research “participant” and
research “volunteer” are both relatively new to the field of research ethics. I
find the symbolic significance of adopting the language of research
“participant” important and am intrigued by its relationship to our cultural
beliefs and attitudes. However, I find it conceptually problematic as a general
representation. Since I am exploring respect for research subjects from a
13
Although the National Bioethics Advisory Commission (NBAC)
chose to adopt the term “human participant” rather than “subject,”
Commissioners Capron, Backlar, and Cassell all objected, stating:
Participant might be fine as a term of aspiration, but it is premature to
adopt the term, because today too many patients and volunteers who
are enrolled in research studies are still not free and equal participants
in the research; indeed, changing the term could send a false signal
that less vigilance is needed to protect human subjects or that
investigators and IRBs need not expend further effort to move to a
system in which the people being studied are truly research
participants.
National Bioethics Advisory Commission (NBAC), Ethical and Policy Issues in
Research Involving Human Participants (Bethesda, Md.: NBAC, 2001), 33n.
10
historical perspective and because I am making an explicit argument that all
research subjects deserve respect, I have chosen to use the term “subject”
throughout this dissertation. I believe that the term “subject” need not and
should not be identified with notions of subjection. Instead, like the subjects of
portraits, subjects of research can and should be appreciated and identified in
terms of their particularities.
The Meanings and Significance of Respect
Shifting to the language of respect for research subjects raises the
question, what does it mean to “respect” a subject of research? This is a topic
that has received relatively little direct attention. Perhaps that is because we
all take for granted that we know what respect and, conversely, disrespect
mean. For example, when we hear about a physician calling a patient a
worthless, drug-seeking loser or a resident calling a nurse a ditzy blond or a
medical student playing football with a cadaver’s liver in the anatomy lab, we
would probably agree that these are all acts of disrespect. Identifying
disrespectful conduct can give us some insight into what it means to respect.
Yet the concept of respect is more abstract and complex than a laundry list of
actions and behaviors can express. We thus need to understand what respect
means from both a theoretical and a practical perspective. This dissertation
searches for the various meanings of respect in research.
A Historical, Conceptual, and Policy Analysis of
Respect
11
I begin in chapter 2 with a historical analysis of disrespect for human
subjects of research. This history of disrespect gives insight into why the
National Commission identified respect for persons as a fundamental ethical
principle in research and what the commissioners meant by it. The National
Commission was responding not only to a history of disrespectful behaviors
(e.g., experimenting on individuals without their informed consent) but also to
a pervasive attitude of disrespect in the research context. For example, the
atrocities committed by the Nazi physicians during World War II were
motivated by a defective attitude, which led to their defective behavior. This
attitude was based on a false assumption that certain groups (i.e., Jews,
Gypsies, etc.) were nonpersons and, thus, had no moral status and were not
worthy or deserving of respect. A more subtle attitude of disrespect developed
in the United States, partly because, historically, the people who were
experimented on were those members of society who were the most
vulnerable and socially marginalized, including orphans, prisoners, the
mentally ill, and charity patients. Members of these groups were often viewed
as unworthy and expendable. Some researchers felt that these individuals, as
wards of the state, owed a debt to society, which was paid partly through their
participation in medical research. Because their role as research subjects was
expected, their participation in medical research was not appreciated. They
were used and abused. Disrespect thus captures the many degrees of
mistreatment, abuse, neglect, and denigration that characterize the history of
research ethics.
12
Of course, there were many researchers who did not use members of
vulnerable populations for research, and of those who did, not all treated their
subjects with disrespect. Yet the attitude that these individuals were inferior in
some way and undeserving of respect had an effect on the general attitude
toward research subjects and their role in the research enterprise. Although
the most egregious abuse of research subjects by Nazi physicians during
World War II raised international awareness and sensitivity to the mistreatment
of research subjects, in some respects the war actually reinforced this latent
attitude of disrespect for research subjects in the United States.14 The
development of penicillin and other “miracle drugs” during World War II
highlighted the importance of medical research in the United States. American
physician-scientists were heralded as heroes and were supported both socially
and financially. As I show in chapter 2, an attitude of entitlement ensued and
the most vulnerable populations were expected more than ever to sacrifice in
the name of science and for the good of society.
I trace the National Commission’s response to this history in chapter 3,
focusing exclusively on its identification of the ethical principle of respect for
persons. Using primary sources such as the transcripts from the National
Commission meetings, unpublished manuscripts from members of the
National Commission, and personal communications with several
commissioners and staff members, I explore the National Commission’s
14
See, e.g., In re Cincinnati Radiation Litigation, 874 F.Supp. 796
(S.D. Ohio, 1995); Advisory Committee on Human Radiation Experiments,
Final Report of the Advisory Committee on Human Radiation Experiments
(New York: Oxford University Press, 1996); Jonathan D. Moreno, Undue
Risk: Secret State Experiments on Humans (New York: Routledge, 2001).
13
definition and application of the principle of respect for persons. I argue that
the National Commission tried to build an attitudinal component into research
ethics by explicitly identifying the principle of respect for persons instead of the
principle of respect for autonomy as a guiding ethical principle. Respect for
autonomy, as it has been defined and used in bioethics, requires certain acts,
namely obtaining an individual’s informed consent prior to involving him or her
in a research trial. It does not matter what value one ascribes to that individual
or how one regards him or her (or even the manner in which one treats him or
her). As long as one explains the risks, benefits, and alternatives of enrolling
in the trial and ensures that the person has decision-making capacity,
understands the information provided, and voluntarily agrees to participate,
one has shown proper respect for his or her autonomy. By adopting the
principle of respect for persons, the National Commission was trying to say
that, while respect for autonomy is important and is one way of showing
respect, it is not sufficient for a fuller understanding of respect for persons.
However, for many of the reasons that I discuss in chapter 3 (e.g., the
disagreement among commissioners about the nature of the National
Commission as a political body charged with developing practical guidelines
rather than philosophical theory, the pressure to adopt a secular ethic, the
concern with identifying ethical principles rather than establishing or
developing them, and the conceptualization of respect for persons as one of
several ethical principles), the National Commission failed to provide a robust
account of respect for research subjects in its Belmont Report.
14
I argue in chapter 4 that the limited understanding of respect that the
National Commission introduced in The Belmont Report permeated
subsequent bioethics literature. Not only was respect for persons interpreted
as synonymous with respect for autonomy, but the concept of autonomy was
further truncated into a right of self-determination. I trace this devolution of the
principle of respect for persons through three major bioethics treatises:
Beauchamp and Childress’ Principles of Biomedical Ethics; the President’s
Commission for the Study of Ethical Problems in Medicine and Biomedical and
Behavioral Research’s Report Making Health Care Decisions: The Ethical and
Legal Implications of Informed Consent in the Patient-Practitioner
Relationship; and the Encyclopedia of Bioethics. I illustrate through these
texts how respect for persons became marginalized in bioethics, and I
conclude that this resulted in a morally deficient account of what respect for
research subjects should mean as a comprehensive moral obligation.
In chapter 5, I examine more fully the rhetoric of respect in bioethics. I
explore the work of several early bioethicists who struggled to appreciate the
various dimensions of respect and who attempted to find greater meaning in
the concept of respect for others. I trace the contours of the discourse on
respect in research over the past thirty-five years in order to delineate where
we have been and to orient us to where we are headed.
In chapter 6, I use this historical analysis as a catalyst for my
conceptualization of what respect for research subjects ought to entail. I
justify a duty of respect for all research subjects and then turn to the
fundamental question of what it means to respect research subjects. I develop
15
a more robust definition of respect than has been present in the bioethics
discourse over the past thirty-five years and defend it on theoretical grounds
and from a policy perspective. I focus on four elements of respect that I
believe are missing from the current account: respect as an attitude as well as
a set of behaviors, respect for research subjects outside the realm of decision
making, respect for the unique contribution that subjects make to medical
research, and respect for nonautonomous individuals.
Although I am an advocate for what I call a more robust definition of
respect, such a definition is really no more extraordinary than the meaning
ascribed to the word in ordinary English usage. Thus, what I am actually
suggesting is that we take the denotation of the word seriously and apply it
universally to all human subjects of research. To give a flavor of what I mean
by respect, I turn to its dictionary definition. The first definition of “respect” in
Webster’s dictionary is: “To feel or show deferential regard for.”15 This
suggests that we respect people in our attitude toward them as well as in our
behavior with them. “Respect” is defined as a negative obligation, “To avoid
violation of or interference with,”16 as well as a positive obligation, “To take
notice of; to regard with special attention; to regard as worthy of special
consideration; hence, to care for; to heed.”17 “Respect” is about our
perceptions of others as well as the ways in which we relate to them.
Webster’s II New Riverside University Dictionary (Boston: Riverside
Publishing, 1984), s.v. “respect.”
15
16
Ibid.
The American Heritage Dictionary of the English Language, 4th ed.
(Boston: Houghton Mifflin, 2000), s.v. “respect.”
17
16
In chapter 6, I specify in more detail what it means to respect research
subjects. I then acknowledge several obstacles to adopting a robust definition
of respect for research subjects. I offer policy recommendations about
implementing the ethical duty of respect in research. Respect for research
subjects is essential to biomedical and behavioral research as a moral
enterprise and deserves serious attention and thoughtful consideration as a
comprehensive normative concept. This dissertation strives to begin a more
reflective dialogue about the meaning and implication of the ethics of respect
in human subjects research.
17
CHAPTER 2
A HISTORY OF DISRESPECT
Historically, the National Commission’s identification of the principle of
respect for persons as a basic ethical principle in research is grounded in a
pervasive attitude of tolerance for the instrumental use of human subjects for
research purposes, which arose in the nineteenth century and gained
momentum as scientific research progressed and expanded over the next
hundred years. Although unethical research practices were challenged
periodically throughout this period, public scrutiny was limited and human
experimentation remained largely unregulated until the 1970s. In order to
adequately understand research ethics, and specifically, current
interpretations of the ethical duty of respect for research subjects, it is
necessary to examine the history of disrespect for research subjects. I will do
that in this chapter by exploring three important periods in history when social
criticism of unethical and disrespectful research practices was most
conspicuous: the late nineteenth century, when the scientific revolution raised
concerns that American medicine was being transformed from a healing art
into a science; the 1940s, when Nazi physicians tortured and killed World War
II concentration camp prisoners in the name of medical research; and the
1960s, when a pattern of unethical research practices was exposed in the
United States. It is my thesis that viewing this history as a history of
disrespect for research subjects will provide important insight into the
subsequent ethics and regulation of human subjects research.
18
Unregulated Research in the United States
Early efforts to control human subjects research with legal regulation
began in the late nineteenth century, when American antivivisectionists 18
fought to regulate the unrestricted use of animals and vulnerable human
beings for research purposes.19 The antivivisectionists resented what they
viewed to be an attitude of unreflective utilitarianism among many American
physicians about the instrumental use of human beings for research purposes.
In response, they launched a national campaign against the medical research
community. Much of the debate centered on concern for the welfare of
vulnerable subjects and the flagrant disregard of human rights. However, an
important component of the antivivisectionist movement of the late nineteenth
century and early twentieth century was anxiety over some physicians’ lack of
sympathy for and disrespectful treatment of experimental subjects. This
contributed in significant ways to early efforts to enact state and federal
legislation restricting the practice of animal and human experimentation.
Antivivisectionists’ suspicions about physicians’ moral sensibilities
during this period, however, cannot be adequately understood without a
The word “vivisection” means literally “cutting into a living organism,
animal or human.” In the late nineteenth century, however, the term was
used to describe any experimental manipulation. “Human vivisection”
referred to “only those experiments on human beings undertaken not to
benefit an individual subject but to promote medical information.” Susan E.
Lederer, Subjected to Science: Human Experimentation in America before
the Second World War (Baltimore: Johns Hopkins University Press, 1995),
xiv.
18
For a history of the American antivivisectionists’ campaign to
regulate human experimentation prior to World War II, see Lederer,
Subjected to Science.
19
19
careful consideration of the social and scientific environment at the time.
Modern American medicine was built on a tradition of human experimentation
that was stimulated during the scientific revolution of the late nineteenth
century. It was this increased interest in experimenting on man that
concerned American antivivisectionists. They responded by attacking what
they considered unethical research practices and by lobbying for the legal
protection of research subjects. Between 1860 and 1920, physicians actively
defended their research practices and fought vigorously to avoid regulation,
retain professional autonomy, and win public support. Their efforts seemed to
have worked because American physicians enjoyed unprecedented cultural
authority and academic independence for the next forty years.
From 1941 to 1945, physicians in Nazi Germany tortured and murdered
innocent people in the name of science. Their actions and subsequent legal
trial prompted an international discussion of research ethics. Because the
experimental subjects during World War II were imprisoned and forced to
endure unimaginable physical harm and suffering, the ethical debate that
followed the war focused on the necessity of obtaining the voluntary consent
of subjects to participate in research and the need to protect volunteers from
physical injury. The concept of respect for research subjects was implicit in
these discussions but it was never explicitly invoked or comprehensively
defined. As a result, an impoverished conception of what it means to respect
research subjects emerged. For various reasons, which will be explored
throughout the remainder of this dissertation, this incomplete perception of the
moral obligation to respect research subjects survived and was incorporated,
20
whether intentionally or not, into modern codes of research ethics as well as
the federal regulation of human experimentation.
Following World War II, the research enterprise exploded in the United
States. Federal funding for research reached an unprecedented level, and
public support strengthened with each new medical breakthrough. American
physicians were heralded as heroes. Even though the Nazi experiments
triggered an international discussion of research ethics, investigators in the
United States escaped any serious scrutiny until the 1960s, when a pattern of
unethical human experimentation in the United States was publicly exposed.
Suddenly, what had been an era of toleration and moral blindness came to an
end and was replaced with suspicion and distrust of American physicians
reminiscent of pre-World War I antivivisectionist sentiment. This time,
however, physicians were not the only ones being attacked. Federal funding
agencies were imputed and the pressure to win public support, avoid legal
liability, and promote ethical research practices ultimately led to the first
successful attempt to regulate human subjects research.
The Human Lab Rat?: Human Experimentation and the Nature
of American Medicine from 1860 to 1910
Physicians have been debating the ethics of human experimentation
since at least the twelfth century, when Jewish physician and philosopher
Moses Maimonides counseled his colleagues “always to treat patients as ends
21
in themselves, not as means for learning new truths.”20 Before the nineteenth
century, however, public concern about unethical human experimentation was
minimal, primarily because of the intimate environment in which it was
conducted. Research was often indistinguishable from medical practice in that
physicians regularly administered new agents to their patients in an effort to
heal them or to prevent disease and then waited to see what happened.
Based on their results with individual patients, physicians developed theories
of disease and preferred methods of treatment.21 The purpose of
experimentation, then, was to discover the most effective method of treatment
for patients. Nontherapeutic experiments were generally discouraged,22 and
when they were performed, they were usually conducted first on the
researcher himself, his family, or people that he knew well.23
The pace of human experimentation quickened in the eighteenth
century, when for the first time, knowledge gained from medical research
20
David J. Rothman, Strangers at the Bedside: A History of How Law
and Bioethics Transformed Medical Decision Making (New York: Basic
Books, 1991), 19.
21
John Harley Warner, The Therapeutic Perspective: Medical
Practice, Knowledge, and Identity in America 1820-1885 (Princeton:
Princeton University Press, 1998).
22
For example, Roger Bacon discouraged experiments on humans in
the thirteenth century because of “the nobility of the [human] material.”
Rothman, Strangers at the Bedside, 19.
23
Albert R. Jonsen, The Birth of Bioethics (New York: Oxford
University Press, 1998); Lawrence K. Altman, Who Goes First?: The Story of
Self-Experimentation in Medicine (New York: Random House, 1987).
22
contributed significantly to improvements in human health. Physicians,
however, remained cautious about experimenting on human beings. In 1884,
for instance, Louis Pasteur reluctantly vaccinated a nine-year-old boy with his
rabies vaccine, but did so only because the boy was sure to die without it.24
Nontherapeutic research, on the other hand, continued to be condemned
throughout the nineteenth century. As French physiologist Claude Bernard
admonished in 1865:
It is our duty and right to perform an experiment on man whenever it can
save his life, cure him or gain him some personal benefit. The principle of
medical and surgical morality, therefore, consists in never performing on
man an experiment which might be harmful to him to any extent, even
though the result might be highly advantageous to science, i.e., to the
health of others.25
Despite this caution, acknowledgement of the importance of
experimentation in medicine led to increased concern about the potential
abuse of patients. By the nineteenth century, the need for consent to
participate in a medical experiment had been legally recognized. 26 If consent
24
Rothman, Strangers at the Bedside, 22.
25
Bernard exempted dying patients and condemned prisoners from
this rule. He voiced no objection to performing nontherapeutic experiments
on dying individuals without their knowledge or consent. Claude Bernard, An
Introduction to the Study of Experimental Medicine (New York: Dover,
1957),101.
26
Ruth Faden and Tom Beauchamp argue that, although there was
isolated concern regarding obtaining subject’s consent to experimentation,
there was no broad interest in research ethics or consent to research prior to
World War II. Ruth R. Faden and Tom L. Beauchamp, A History and Theory
of Informed Consent (New York: Oxford University Press, 1986). Cf.
Lederer, who persuasively disputes the claim that there was no system of
ethics prior to the Second World War: “Although lacking enforcement policies
and far from perfect, ethical guidelines influenced the conduct of research
23
was not obtained, the researcher could theoretically be liable to his patient for
damages and could be subject to criminal charges. As one English
commentator noted in 1830:
If the practitioner performs his experiment without giving such information
to, and obtaining the consent of his patient, he is liable to compensate in
damages any injury which may arise from his adopting a new method of
treatment.27
However, before 1935, there were no appellate cases in which there was a
legal requirement for consent of the patient who was a subject of medical
experimentation.28 There is little evidence that written consent documents
were used by physicians or scientists before 1935. To the extent that
physicians did either inform their patients of new therapies or obtain their oral
with both human and animal subjects in the decades before World War II.”
Lederer, Subjected to Science, xv.
27
Quoted in Rothman, Strangers at the Bedside, 24.
28
For a discussion of pre-World War II appellate cases regarding the
law of informed consent to human experimentation, see George J. Annas,
Leonard H. Glantz, and Barbara F. Katz, Informed Consent to Human
Experimentation: The Subject’s Dilemma (Cambridge, Mass.: Ballinger,
1977), 2-25. As Annas and his colleagues point out, judicial recognition that
physicians must inform their patients when they stray from the standard of
care dates back to the eighteenth century (see, e.g., Slater v. Baker and
Stapleton, C.B. Eng. Rptr. 860 [Michelmas Term, 8 Geo III, 1767]), but the
first American appellate case to explicitly limit the autonomy of physicians to
perform experiments on their patients without the patient’s prior knowledge
and consent was in 1935 (Fortner v. Koch, 272 Mich. 273, 261 N.W. 762
[1935]).
24
agreement to participate in medical experiments, the nature of these
conversations was rarely documented or discussed in scholarly publications.
There are a few documented cases of nontherapeutic research where
written consent to participate was obtained from the subjects. Although the
attempt to obtain consent represents an enormous stride towards the
recognition of patients’ and subjects’ rights at the time, the consent documents
that were used would be unacceptable by today’s standards.
Two of the earliest and most famous examples we have of a subject’s
“consent” to participate in a medical experiment are usually described as
“contracts” with research “volunteers” and both have been criticized as being
deceptive and coercive. In 1833 U.S. Army physician William Beaumont
contracted with a French-Canadian trapper named Alexis St. Martin to do
experiments on his partly healed stomach. St. Martin agreed to “serve, abide,
and continue with the said William Beaumont” as “his covenant servant” in
exchange for food, lodging, and $150 per year.29 St. Martin attempted to run
away several times and was returned to Beaumont, which indicates that the
“contract” between them was regarded more as a binding contract than as a
documentation of St. Martin’s voluntary consent.
In 1900 Surgeon General George Sternberg created the Yellow Fever
Commission under the direction of Major Walter Reed. Reed and three of his
29
William Beaumont, Experiments and Observations on the Gastric
Juice and Physiology of Digestion (1833; repr., New York: Peter Smith,
1941), xii-xiii, cited in Rothman, Strangers at the Bedside, 22.
25
colleagues traveled to Cuba to test their hypothesis that yellow fever was
transmitted via mosquitoes. They began their experiments by subjecting
themselves to mosquito bites, but when two of the investigators contracted
yellow fever and one of them died, they decided that it would be better to
conduct the rest of the experiments on healthy volunteers. They sought to
recruit servicemen and Spanish workers and had each sign a contract that
stated:
The undersigned understands perfectly well that in the case of the
development of yellow fever in him, that he endangers his life to a
certain extent but it being entirely impossible for him to avoid the
infection during his stay on this island he prefers to take the chance of
contracting it intentionally in the belief that he will receive … the
greatest care and most skillful medical service. 30
According to today’s standards, this contract would be considered coercive
and misleading, especially in light of the monetary rewards that were offered
for participation in the experiment. In exchange for participation, the
volunteers received $100 in gold, and those that contracted yellow fever were
given an additional $100 that went to their heirs if they died. Viewed
historically, however, these early efforts to document consent to participate in
human experimentation and to compensate subjects for their participation and
their resulting injuries represent an important turning point in research ethics.
For the first time it was recognized (at least in theory) that the right to selfdetermination could not be violated and that consent for participation in
30
added).
Quoted in Rothman, Strangers at the Bedside, 26 (emphasis
26
research was necessary. Additionally, although the compensation offered to
potential subjects can be viewed as coercive and therefore unethical, it can
also be viewed as an act of respect for research subjects. It represents an
acknowledgement by the researchers of their need for and dependence on
human subjects for research and it signifies their appreciation for the risk that
their subjects were taking and the sacrifices that they were making.
Public condemnation of research conducted without consent was
experienced most vividly when, in 1901, Russian physician V. V. Smidovich
(publishing under the pseudonym Vikenty Versaeff) cited more than a dozen
disrespectful and abusive experiments (mostly in Germany) in which
physicians inoculated uninformed patients with microorganisms of syphilis and
gonorrhea.31 Although this created public outrage, it did little to deter some
future researchers from conducting unethical experiments. As William Bynum
points out, “ethical dilemmas [relating to human experimentation] are not
unique to modern medicine,” but “in the absence of formal public guidelines,
the relation between the experimenter and his subject varied according to the
nature of the experiment and the dictates of the doctor’s own conscience.”32
31
Vikenty Versaeff [V. Smidovich], The Memoirs of a Physician, trans.
Simeon Linden (London: Grant Richards, 1904), partially reprinted in Jay
Katz, Experimentation with Human Beings: The Authority of the Investigator,
Subject, Professions, and State in the Human Experimentation Process, with
the assistance of Alexander Morgan Capron and Eleanor Swift Glass (New
York: Russell Sage Foundation, 1972).
William Bynum, “Reflections on the History of Human
Experimentation,” in The Use of Human Beings in Research: With Special
Reference to Clinical Trials, ed. Stuart F. Spicker, Ilai Alon, Andre de Vries,
and H. Tristram Engelhardt, Jr. (Dordrecht, Netherlands: Kluwer Academic
Publishers, 1988), 35.
32
27
Efforts to create formal public guidelines began in the late nineteenth
century, when the nature of human experimentation shifted from isolated
instances of therapeutic alterations to the more organized, albeit still relatively
small-scale practice of clinical experimentation, which was grounded in new
theories of scientific medicine. As John Harley Warner notes, the principle of
specificity, which grounded medical therapy prior to 1860 and focused on
tailoring treatment to an individual patient with a specific presentation was
replaced with the idea of generalizable knowledge and disease diagnosis.33
This shift occurred because of advances in scientific knowledge that were
gained in the new disciplines of physiology, bacteriology, microbiology,
pharmacology, and immunology as well as the development of new
technology that enabled physicians to more accurately record bodily
functioning, such as the thermometer, stethoscope, x-ray machine, and
urinalysis. The introduction of Pasteur’s germ theory of disease and Lister’s
aseptic surgery emphasized the importance of sterility and the dangers of
infection, heralding the birth of modern medicine. This, together with the
difficulty of incorporating new technological advancements in home health
care, resulted in a shift to hospital-based medicine and transformed the
structure and meaning of the hospital as a cultural and medical institution.34
33
Warner, Therapeutic Perspective.
34 Charles E. Rosenberg, The Care of Strangers: The Rise of
America’s Hospital System (New York: Basic Books, 1987).
28
It is difficult to overestimate the effect that the germ theory of disease
had on modern medicine and the influence that it had on the nature of clinical
experimentation. As Charles Rosenberg noted, “the germ theory had
immediate and practical dimensions; it was no intellectual abstraction. In the
next half century it would not only reshape the hospital but help transform
every aspect of medicine.”35 Acceptance of the germ theory of disease not
only changed how medicine was practiced, but shifted cultural ideas about
individual responsibility and disease. Moral accountability for illness and
disease could no longer simply be attributed to human volition. Although the
role of individual responsibility continued (and still continues today) to
permeate medical practice and social sentiment, physicians began to look to
the environment and to focus on the manipulation of microorganisms within
the human body in order to restore health. Patients began to be viewed more
as systems of disease variables, which physicians alone could understand and
manipulate, rather than afflicted individuals who seemed to benefit from faith
healers as much as medical doctors. As Rosemary Stevens observed:
The assumption of professional control over these dangerous, unseen
beings [microorganisms] enhanced the authority and the mystique of the
doctor and encouraged the image of the hospital as a necessary, scientific
base for treatment.36
35
Ibid., 141.
36
Rosemary Stevens, In Sickness and in Wealth: American Hospitals
in the Twentieth Century (Baltimore: Johns Hopkins University Press, 1999),
25.
29
The shift from home health care to hospital-based medicine also
contributed to the increased specialization of medical practice, further
transforming the connection between doctor and patient into a more
depersonalized, objective relationship. The traditional role of doctors as
purveyors of holistic care, dependent on an extensive history and physical
examination followed by intensive counseling was gradually replaced by a
concentration on biologically discrete systems that enabled more objective
testing to identify organic pathology. As Francis Weld Peabody observed in
1926:
The most common criticism made at present by older practitioners is that
young graduates have been taught a great deal about the mechanism of
disease, but very little about the practice of medicine—or, to put it more
bluntly, they are too “scientific” and do not know how to take care of
patients.37
He went on to warn his medical students:
The essence of the practice of medicine is that it is an intensely
personal matter, and one of the chief differences between private
practice and hospital practice is that the latter always tends to become
impersonal.38
Peabody concluded that “time, sympathy, and understanding must be lavishly
dispensed [to patients] … One of the essential qualities of the clinician is
Francis W. Peabody, “Lecture to Medical Students About Patient
Care” Journal of the American Medical Association 88 (March 19, 1927):
877-82.
37
38
Ibid.
30
interest in humanity, for the secret of the care of the patient is in caring for the
patient.”39
Peabody’s teachings revealed the increased difficulty physicians faced
in balancing the art of medicine with the new science that was so prevalent in
the hospital setting. The concentration of numerous patients in one locale
enabled physicians to become more efficient and increasingly specialized,
while advances in molecular biology stimulated an increased interest in
quantifying and generalizing medical knowledge. By the twentieth century,
there was a steadily increasing base of verifiable scientific evidence, based on
animal and human experimentation that could be used by physicians to make
clinically informed judgments about how to treat their patients. This scientific
evidence was amassed by academic physicians who, as Susan Lederer points
out, had, by the late nineteenth century transformed the image of the ideal
American physician from “a practitioner, whose authority stemmed from the
exercise of clinically informed judgment, into a scientist, the possessor of
specialized knowledge gained from experiments on animals and human
beings.”40 Although the majority of physicians at this time were not scientists,
they relied heavily on the new scientific evidence to make clinical judgments
about patient care. They chose to honor the ideal of physician as scientist and
thus reinforced the need for human experimentation.
39
Ibid.
40
Lederer, Subjected to Science, 1.
31
The migration to hospital-based care provided the perfect environment
in which academic physicians could conduct the necessary scientific
experiments to enhance their knowledge base and ensure medical progress
and the perfect pool of human research subjects—namely, hospital patients.
However, the increased practice of human experimentation on hospital
patients created public distrust and suspicion of physicians’ morals and
motives.41 The prospect of being a subject of experimentation without one’s
knowledge or consent during a hospital stay concerned many Americans and
prompted hospital administrators to publicly denounce the use of hospital
patients as research subjects. For example, in 1910, the board of the
Rockefeller Institute announced:
It has been supposed that a hospital connected with an Institute for
Medical Research would be one in which the patients were to be
experimented upon, but the trustees wish it understood clearly that this is
not the case.42
Although these assurances lacked enforcement power and did little to deter
some physicians from experimenting on hospital patients, they improved
public morale and boosted confidence in the modern hospital system.
By the time Abraham Flexner published his landmark survey of
American medical schools in 1910 (the “Flexner Report”), the modern medical
university, which was often affiliated with local hospitals, had been born and
the ideal medical institution was defined as one which incorporated both
41
Rothman, Strangers at the Bedside.
42
Quoted in Lederer, Subjected to Science, 84.
32
clinical research and medical education. In his Report, Flexner described and
evaluated 125 medical schools that he had visited. He evaluated the schools
in terms of their entrance requirements, size and status of teaching staff,
funding and resources, lab facilities, and clinical facilities. To Flexner, only a
university school with large full-time faculties and a vigorous commitment to
research was acceptable.43 This reinforced the idea that modern medicine
was effective and that experimental research was important and deserved
public support. The rise of the modern medical school united medical
education with clinical care, legitimized nontherapeutic medical research, and
transformed the hospital system into a scientific institution, creating
institutionalized opportunities for a new breed of doctors—physician-scientists.
Although there were still only a small number of
academic clinicians who engaged in experimental
research with humans by the 1920s, the
antivivisectionists, who opposed not only human but
also animal experimentation, became particularly
concerned that bedside doctors were being
transformed into overzealous scientists who, without
proper regulation, would harm and exploit vulnerable
human beings in the name of science. Even while the
cultural authority of medical science was affirmed in
the late nineteenth century, the antivivisectionists
43 Abraham Flexner, Medical Education in the United States and
Canada (New York: Carnegie Foundation for the Advancement of Teaching,
1910). For an excellent analysis of how the Flexner Report influenced
American medical education, see Kenneth M. Ludmerer, Learning to Heal:
The Development of American Medical Education (Baltimore: Johns Hopkins
University Press, 1995).
33
supported legislation to restrict both animal and
human experimentation. As Susan Lederer points out,
The regulation of a practice as emotionally charged as animal
vivisection appealed to these Americans in light of a characteristically
Progressive optimism that the interests of all concerned could be best
served by a supervisory bureaucracy. The state, rather than an
individual medical school or investigator, was considered the
appropriate overseer of animal welfare.44
In the late 1800s, physicians themselves feared that the practice of
human experimentation would dehumanize the practice of medicine.
Reflecting on the use of hospital patients as experimental subjects by German
physicians, American surgeon J. M. T. Finney said:
They would attempt things that in most other countries would be
considered unjustifiable. Though the results were fairly satisfactory, the
human element was largely lacking. The patient was something to work
on, interesting experimental material, but little more.45
In 1871, Boston surgeon Henry Jacob Bieglow expressed concern about the
moral sensibility of young American physicians when he said in an address on
medical education:
Watch the students at a vivisection … It is the blood and suffering, not
the science, that rivets their breathless attention. If hospital service
makes young students less tender to suffering, vivisection deadens
their humanity and begets indifference to it.46
44
Lederer, Subjected to Science, 59.
J. M. T. Finney, A Surgeon’s Life (New York: G. P. Putman’s Sons,
1940), 127, quoted in Lederer, Subjected to Science, 7.
45
46 Quoted in Vivisection: Hearing Before the Senate Committee on the
District of Columbia, February 21, 1900, on the Bill (S. 34) For the Further
Prevention of Cruelty to Animals in the District of Columbia (Washington,
34
As scientific medicine progressed, however, American physicians
expressed less concern about the dehumanization of modern medicine;
instead they became increasingly defensive. Antivivisectionists vigorously
challenged the morality and humanity of physicians’ experimental practices,
but instead of directly addressing the ethical concerns that were raised,
physicians launched a defensive campaign. The American Medical
Association (AMA) organized a Council on the Defense of Medical Research,
which fought to defeat legislative efforts to regulate research on animals and
human beings. The AMA argued that the regulation of human experimentation
would retard medical progress and responded to ethical challenges by
disputing the accuracy of the claims against them and justifying
nontherapeutic experiments by arguing that no injury occurred.47
Yet, harm to research subjects was not the only concern of
antivivisectionists. As Susan Lederer observed: “Even more disturbing to
[antivivisectionists] was the researchers’ apparent lack of sympathy for the
experimental subjects” and the “clinical detachment with which physicians
described experiments on human beings.”48 The real crime of physicians,
Lederer argued, “was the instrumental use of an unsuspecting person for
research purposes.”49 Americans feared that physicians would employ human
D.C.: U.S. Government Printing Office, 1900), 145; Lederer, Subjected to
Science, 54.
47
Lederer, Subjected to Science.
48
Ibid., 70-71.
49
Ibid.
35
beings for nontherapeutic experimentation and treat them like laboratory rats.
This fear was fueled by reports in which researchers described their subjects
as “animals” and “victims.” For example, in 1931, W. Osler Abbott and T.
Grier Miller conducted intubation experiments on several volunteers. After
Abbott found a bullet in one of his subject’s stomachs, which was apparently
lodged there the previous night by a jealous girlfriend who found him with
another women, he reported, “this led me to wish at times I could keep my
animals in metabolism cages.”50
Instead of encouraging a dialogue among physicians about the ethical
treatment of experimental subjects, the antivivisectionist movement merely
prompted researchers to monitor the language used to describe their work in
professional publications. Whether or not subjects were treated disrespectfully
was not the AMA’s major concern. As long as researchers did not use
disrespectful language when talking about their subjects, the antivivisectionists
would not protest. Some researchers did, however, go further and
emphasized that subject consent and avoidance of risk were essential
conditions to human experimentation.51
Nonetheless, suspicion and distrust lingered, and researchers’ apparent
insensitivity to and disrespectful treatment of research subjects prompted
50
Quoted in Lederer, Subjected to Science, 122 (emphasis added).
51
Walter Reed is an example of a researcher who went to great
lengths to publicize the fact that he obtained the “consent” of his subjects
prior to experimenting on them. Ibid.
36
numerous efforts by antivivisectionists to regulate human experimentation.
These efforts continued, albeit unsuccessfully, until the First World War, when
patriotism replaced suspicion. After the war, research practices continued with
relatively little disturbance until World War II, when the world was abruptly
introduced to the atrocities that could be committed in the name of science by
Nazi physicians.
Beyond Disrespect: The Nazi Experiments and the Nuremberg
Medical Trial
During World War II, Nazi physicians behaved disrespectfully toward
concentration camp prisoners. Moreover, they tortured and murdered some
prisoners in the name of science. The profound disregard for human life that
underscored the design and execution of those experiments is frightful. The
victims were, among other things, forced to remain in tanks of ice water for
periods of up to three hours, were kept outdoors at temperatures below
freezing for hours at a time while their body parts froze, were deliberately
infected with malaria, epidemic jaundice, and spotted fever, were intentionally
inflicted with wounds, which were infected with bacteria and aggravated by
forcing wood shavings and ground glass into them, were secretly poisoned
and then murdered so that they could be studied by autopsy, and were
butchered without their consent in an effort to develop new mass sterilization
techniques.52
52
United States v. Karl Brandt et al., The Medical Case, Trials of War
Criminals before the Nuremberg Military Tribunals under Control Council
Law No. 10 vol. 1-2 (Washington D.C.: U.S. Government Printing Office,
1949), partially reprinted in Katz, Experimentation with Human Beings
37
Many of the victims died as a result of these experiments and others
suffered severe pain, serious injury, intense agony, and unbearable suffering.
Understandably, much of their torment was caused by the physical torture they
endured. But the victims on were not just harmed physically. They were
violated, mutilated, disrespected, and dehumanized. They were treated worse
than laboratory animals. They had no name, no identity, and no worth beyond
their instrumental value as experimental material. After interviewing several
concentration camp survivors who had been experimented on by Nazi
physicians during World War II, Robert Lifton observed, “The depth of these
experimental victims’ sense of violation and mutilation was evident during
interviews I had with some of them thirty-five years later.”53 When one victim
who was enrolled in a castration experiment asked the Nazi physician
operating on him, “Why are you operating on me? I am … not sick,” the
physician responded, “Stop barking like a dog. You will die anyway.” 54 And
when the experimental victims died, one prisoner nurse explains, the physician
who caused their death “showed absolutely no interest, no reaction, as though
the matter didn’t concern him at all.”55 After all, Lifton concluded, “their deaths
[hereafter Karl Brandt]; see also Robert Jay Lifton, The Nazi Doctors:
Medical Killing and the Psychology of Genocide (New York: Basic Books,
1986).
53
Lifton, Nazi Doctors, 282.
54
Ibid., 283.
55
Ibid., 277.
38
mattered little since these guinea pigs [had] already served the function
expected of them.”56
How could these gross violations of human dignity have occurred in the
twentieth century? Was their no law, no code of professional conduct, and no
individual sense of integrity strong enough to deflect the evil motivations
behind and justifications for the physical, mental, and emotional brutality that
was committed in the name of science? Ironically, the first clear statement of
research ethics came from the German government in 1900. The Prussian
Minister of Religious, Educational and Medical Affairs issued a directive that
“absolutely prohibited” nontherapeutic research on minors and incompetents
and demanded that a competent adult declare “unequivocally that he consents
to the intervention” and that the declaration be made on the basis of “a proper
explanation of the adverse consequences that may result from the
intervention.”57 The Reich Minister of the Interior issued even stronger
“Regulations on New Therapy and Human Experimentation” in 1931, two
years before Adolf Hitler became Chancellor of Germany. This document
reminded physicians that the freedom to advance medical science through
human experimentation must be “weighed against [the physician’s] special
duty to remain aware at all times of his major responsibility for the life and
56
Ibid., 282.
57 Prussian Ministry of Health, Centralblatt der gesamten
Unterrichtsverwaltung in Preussen (1901), 188-89, as quoted in Michael A.
Grodin, “Historical Origins of the Nuremberg Code,” in The Nazi Doctors and
the Nuremberg Code: Human Rights in Human Experimentation, ed. George
J. Annas and Michael A. Grodin (New York: Oxford University Press, 1992),
127.
39
health of any person on whom he undertakes innovative therapy or perform[s]
an experiment” and required prior animal testing for all innovative therapies,
the unambiguous consent of the subject, and forbade the exploitation of social
hardship in order to conduct human experimentation.58 This visionary effort to
regulate human subjects research nonetheless failed when Nazi physicians
blatantly violated the letter as well as the spirit of the law just ten years later.
On December 9, 1946 twenty Nazi physicians and three medical
administrators were charged with “murders, tortures and other atrocities
committed in the name of medical science.”59 With authorization from the
United Nations, the United States took sole responsibility for prosecuting and
trying the defendants. The trial, commonly known as the “Medical Trial” lasted
ten months and resulted in the conviction of sixteen men; seven were hanged
and the remaining nine received sentences that ranged from ten years to life in
prison.60 Specifically, the defendants were accused of conducting “medical
experiments without the subjects’ consent” and, in the course of such
experiments, committing “murders, brutalities, cruelties, tortures, atrocities,
58
Reichsgesundheitblatt 11, no. 10 (March 1931), as quoted in
Grodin, “Historical Origins,” 130.
Karl Brandt, “Indictment,” partially reprinted in Katz,
Experimentation with Human Beings, 292-94.
59
60 Karl Brandt, “Judgment,” partially reprinted in Katz, Experimentation
on Human Beings, 305-6.
40
and other inhuman acts.”61 Technically, this was a murder trial, but everyone
involved knew that it was no ordinary homicide case.
The defendants, unable to deny that the experiments were performed,
offered several justifications for their action. They denied responsibility,
arguing that the individual researchers were only “following orders” from the
state and that they would have been putting their own lives at risk if they did
not obey. Further, they contended, the researchers were not responsible for
selecting the experimental subjects; they were chosen by military leaders and
other concentration camp prisoners. Those who were selected were lucky,
they continued, because had they not been chosen to be experimental
subjects they would have been condemned to death. The defendants also
appealed to the war effort and claimed that in times of war, all members of
society must contribute to promote the greater good. They argued that the
experiments conducted provided information that was essential for winning the
war. Finally, the defendants justified their behavior by insisting that it did not
deviate from standard research practices. They disputed the claim that there
were any universal standards of research ethics, argued that human
experimentation is necessary to promote medical progress, and claimed that
the use of prisoners as research subjects is a universally accepted practice.
Even if one could argue that subject consent was required, they maintained,
61 Karl Brandt, “Indictment,” partially reprinted in Katz,
Experimentation on Human Beings, 292-94.
41
since there was no evidence that their subjects explicitly refused to participate,
consent should be assumed.62
The nature of these claims exhibit profound disrespect for the subjects
of the Nazi experiments. Some of the Nazi physicians may have been “just
following orders,” but they did so with complete disregard for their victims.
They were viewed as “lucky to have been spared from the gas chambers” and
necessary material for the war effort, like drafts of a rejected battle plan,
mindlessly crumpled and discarded on the floor. The allegation that this
attitude and the resulting behaviors was not in fact unique to the Nazis, but
that it was rather the standard of care, was particularly disturbing. There was
moral outrage over the Nazi experiments and any implication that they
represented standard research practice was alarming to say the least. The
world was watching and the prosecutors recognized that their task was not
only to punish the offenders but to assure the public that the profound
disrespect of human life exhibited by the Nazi physicians could not and would
not be tolerated or repeated. The prosecution acknowledged the moral
significance of the task before them in their opening statement,
We have still other responsibilities here. The defendants in the dock are
charged with murder, but this is no mere murder trial. We cannot rest
content when we have shown that crimes were committed and that certain
persons committed them … It is our deep obligation to all peoples of the
world to show why and how these things happened. It is incumbent upon
us to set forth with conspicuous clarity the ideas and motives which moved
these defendants to treat their fellow men as less than beasts. The
62
Karl Brandt, partially reprinted in Katz, Experimentation on Human
Beings, 292-306. See Grodin, “Historical Origins,” 132-33, for a summary of
the justifications offered by the defense in the Medical Trial.
42
perverse thoughts and distorted concepts which brought about these
savageries are not dead. They cannot be killed by force of arms. They
must not become a spreading cancer in the breast of humanity. They must
be cut out and exposed, for the reason so well stated by Mr. Justice
Jackson in this courtroom a year ago—“The wrongs which we seek to
condemn and punish have been so calculated, so malignant, and so
devastating, that civilization cannot tolerate their being ignored because it
cannot survive their being repeated.”63
The prosecution had to prove that the defendants were not only legally
culpable, but also morally responsible for their actions. They did this by first
arguing that there were certain ethical principles, derivable from the “natural
law” of all people that together, formed universally accepted guidelines for
human experimentation. The prosecution was surprised to find no regulatory
code that governed research practices and no clear statement of research
ethics published in the United States prior to 1946. Thus, they had to rely on
the testimony of two expert witnesses, Dr. Leo Alexander and Dr. Andrew Ivy,
who testified how the Nazi physicians violated the basic principles of medical
ethics. The American Medical Association (AMA), which had debated passing
guidelines for the ethical conduct of research since 1900 but never did, was
particularly concerned about the impact that the Medical Trial would have on
research practices in the United States. As discussed above, the AMA had
spent the previous sixty years fighting for their professional autonomy and
resisting legislative efforts to restrict human experimentation. Their defense
had always been that the best safeguard against unethical research practices
was the conscientious physician and that researchers could be trusted to
monitor and regulate their professional activities. The lack of any formal
63
Karl Brandt, partially reprinted in Katz, Experimentation on Human
Beings, 294-95.
43
guidelines, together with the atmosphere of outrage, suspicion and distrust
surrounding the Nazi Medical Trial, did not bode well for American
researchers. In an effort to distance themselves from the Nazi physicians on
trial, the AMA insisted that there was an implicit ethical code that all rational
researchers followed. They then asked Dr. Ivy to submit a report to them that
would articulate these basic ethical principles of human experimentation and
describe how the Nazi experiments violated them. The AMA used this report
to develop formal guidelines on research ethics, which were passed nineteen
days after the Medical Trial began. These “Principles of Ethics Concerning
Experimentation on Human Beings” included three requirements:
1.
2.
3.
The voluntary consent of the individual upon whom the
experiment is to be performed must be obtained.
The danger of each experiment must be previously investigated
by animal experiments.
The experiment must be performed under proper medical
protection and management.64
The prosecution dishonestly claimed that the defendants violated these
AMA guidelines, even though they were not written until after the trial began.
Towards the end of the trial on April 15, 1947, Dr. Alexander submitted a
memorandum entitled “Ethical and Non-Ethical Experimentation on Human
Beings” to the United States Chief of Counsel for War Crimes and the court.
This memo proposed six ethical requirements for human experimentation,65
64
Journal of the American Medical Association 132 (1946): 1090. For
an account of the historical origins of the Nuremberg Code, see Grodin,
“Historical Origins.”
Leo Alexander, “Ethics of Human Experimentation,” Psychiatric
Journal of the University of Ottawa 1 (1976): 40-46; Grodin, “Historical
Origins,” 135.
65
44
almost all of which were adopted by the court and published in their final
judgment, which included ten ethical provisions that are known to the world as
the “Nuremberg Code.”66
The Nuremberg Code is unyielding on the issue of subject consent. It
opens with the provision: “The voluntary consent of the human subject is
absolutely essential.”67 It goes on to specify that the subject must be
competent, must consent voluntarily (without force, fraud, duress, coercion, or
deceit), should be informed of the nature, duration, purpose, method,
inconveniences, risks, and possible side effects of the experiment, and should
understand this information sufficiently to make an “enlightened decision.”
Provision nine stipulates that the human subject has the right to withdraw from
the experiment at any time “if he has reached the physical or mental state
where continuation of the experiment seems to him to be impossible.”68
Likewise, the experimenter is required to terminate the experiment under
provision ten “if he has probable cause to believe, in the exercise of the good
faith, superior skill and careful judgment required of him that a continuation of
66
Germany (Territory under allied occupation, 1945-1955: U.S. zone)
Military Tribunals, ed. “Permissible Medical Experiments,” in Trials of War
Criminals before the Nuremberg Military Tribunals under Control Council
Law No. 10: Nuremberg October 1946-April 1949, vol. 2 (Washington, D.C.:
U.S. Government Printing Office,1949-1953), 181-82 [hereafter Nuremberg
Code]; The Nuremberg Code (1949), reprinted in The Ethics of Research
Involving Human Subjects, ed. Vanderpool, Appendix A, 431-32.
67
Nuremberg Code (emphasis added).
68
Ibid.
45
the experiment is likely to result in injury, disability, or death to the
experimental subject.”69 The remaining seven provisions deal with proper
experimental design so as to minimize risk and injury to the human subject.
Significantly, the Nuremberg Code vests responsibility for obtaining
subject consent and ensuring that proper protective measures are taken in the
individual investigator rather than the institution where he or she works. Like
all of the codes that would follow it, the Nuremberg Code promotes the moral
duty to respect research subjects but only tangentially. It focuses on the
principles of respect for individual autonomy (by requiring subject consent) and
nonmaleficence (by protecting subjects from ill-designed experiments and
incompetent investigators and minimizing risk to the subject), both of which
serve to advance the concept of respect for research subjects but neither of
which sufficiently defines it. Since the Nuremberg Code addresses the ethical
obligations of individual investigators and deals specifically with the
researcher-subject relationship, it represents a unique opportunity for a more
robust notion of respect for research subjects to have been developed.
Unfortunately, however, this opportunity was missed. Perhaps this is because
the Nuremberg Code was written by lawyers and an enhanced vision of
respect for research subjects proves more difficult to legislate than the
principles of respect for autonomy and nonmaleficence. Or perhaps it was
due to the fact that the mutilation and torture suffered by subjects of Nazi
experimentation far outweighed the deleterious effects of being treated
69
Ibid.
46
disrespectfully and not being given adequate recognition. Whatever the
reason, the Nuremberg Code set the stage for future codes of ethics and legal
regulations, none of which has adequately developed the concept of respect
for research subjects.
Although the Nuremberg Code provided a foundation for future
international ethical guidelines as well as the United States federal regulations,
it never had a significant impact on American researchers. As a legal
document, the Code is problematic. The Nuremberg judges created
guidelines that they claimed were derived from natural law and were
universally recognized and obeyed, but that had no formal precedent in law or
ethics. These supposedly implicit ethical principles were made explicit and
were used ex post facto to justify the defendants’ legal liability. Yet, the Code
was not legally necessary to convict the defendants. As Michael Grodin points
out, it is not clear whether the defendants at trial were even held to the
standards of the Nuremberg Code.70 Since they were convicted of murder
and other crimes against humanity “the subtler stipulations for ethical human
experimentation did not need to be invoked.”71 Perhaps the judges included
the Code in their legal opinion because they wanted to create legal precedent
and to send a message to researchers and to the public that anybody who
committed similar acts of violence in the name of science would be legally
accountable. Michael Grodin opines: “It was their hope and vision that, once
70
Grodin, “Historical Origins.”
71
Ibid., 138.
47
established in international criminal law, this Code would be widely
disseminated and, if followed, would guard against future atrocities.”72
The Nuremberg Code retains historical significance as the first clear
international statement of research ethics. It served as an impetus for serious
debate about the ethics of human experimentation and ultimately led to the
legal regulation of medical research in the United States. However, it never
had the impact on research practices or international law that the Nuremberg
judges envisioned. As George Annas persuasively argues, the Nuremberg
Code has never been taken seriously as a legal document.73 It is considered
by most to be a historically important ethical statement but with limited
practical applicability. Jay Katz argues, “The Nuremberg Code was relegated
to history almost as soon as it was born.” He explains, “The spirit of the
Nuremberg Code was not, and perhaps could not be, taken seriously. Its
language was too uncompromising and too inhospitable to the advancement
of science.”74 The Code was written in response to the atrocities committed
by Nazi scientists. American physicians were quick to distance themselves
from these scientists. They regarded the Code as irrelevant to themselves in
72
Ibid.
73 George J. Annas, “The Nuremberg Code in U.S. Courts: Ethics
versus Expediency,” in The Nazi Doctors and the Nuremberg Code: Human
Rights in Human Experimentation, ed. George J. Annas and Michael A.
Grodin (New York: Oxford University Press, 1992), 201-26.
Jay Katz, “The Consent Principle of the Nuremberg Code: Its
Significance Then and Now,” in The Nazi Doctors and the Nuremberg Code:
Human Rights in Human Experimentation, ed. George J. Annas and Michael
A. Grodin (New York: Oxford University Press, 1992), 227-39, 228, 235.
74
48
particular and to American science in general. As Bill Winslade and Todd
Krause emphasized,
The Code was never meant to be practical. It was a device to facilitate the
punishment of Nazi physicians. The Code was intractable, unyielding, and
definite. It was written this way because it was written for “them” not “us.”
The problem of course is that the Code was our creation.75
After World War II, scientific research in the United States continued to
grow exponentially. The development of new drugs and vaccines during the
war validated the importance of medical research and elevated the cultural
status of physician-scientists. With an unprecedented amount of public
support and federal funding76 human experimentation was transformed from
what David Rothman describes as a “cottage industry” into a “national
William J. Winslade and Todd L. Krause, “The Nuremberg Code
Turns Fifty,” in Ethics Codes in Medicine: Foundations and Achievements of
Codification Since 1947, ed. Ulrich Trohler and Stella Reita-Theil (Aldershot,
U.K.: Ashgate, 1997), 140-62.
75
76
In 1941, President Franklin Roosevelt created the Office of
Scientific Research and Development (OSRD) to oversee weapons research
and medical research during the war. The OSRD’s Committee on Medical
Research (CMR) recommended about 600 research proposals to the OSRD
for funding during World War II. The OSRD contracted with investigators at
universities, hospitals, research institutes, and industrial firms to conduct
these experiments. After World War II the National Institutes of Health
(NIH), which was created in 1930 as an outgrowth of the research lab of the
U.S. Public Health Service, was transformed into the peacetime version of
the CMR. The NIH received $700,000 from Congress in 1945 for its
research program. That support grew to $36 million by 1955, $436 million by
1965, and $1.5 billion by 1970. By 1970, the NIH was supporting more than
11,000 research grants across the country. See Rothman, Strangers at the
Bedside, chap. 2-3, for a history of American research during and after
World War II.
49
program.”77 American researchers had successfully disassociated themselves
from the Nazi atrocities and escaped any serious public opposition. They
enjoyed almost complete professional autonomy for the next twenty years. It
wasn’t until the 1960s, when a pattern of research abuse in the United States
was exposed, that the integrity of 20th century American scientists was
challenged. They were accused of exploiting vulnerable populations and
criticized for their disrespectful treatment of human subjects. The suggestion
that research abuse occurred and was professionally tolerated in the United
States terrified and outraged the American public. Individuals sought legal
compensation, politicians fought for governmental oversight of the profession,
federal funding agencies struggled to avoid legal liability, and the medical
profession struggled to maintain their professional autonomy. The ethics of
human experimentation was, for the first time in half a century, the focus of
serious public and political debate in the United States.
77
Ibid., 30.
50
In My Own Country?: Disrespect and Abuse in the United
States
In March 1965, Henry Beecher, Dorr Professor of Research in
Anesthesia at Harvard Medical School, delivered a paper on the ethics of
clinical research at a conference on drug research in Brook Lodge, Wisconsin.
In his talk, he cited several published reports that described questionable
research practices.78 His presentation was published in 1966 in a New
England Journal of Medicine article, where he cited 22 examples of published
research studies from “leading medical schools, university hospitals, private
hospitals, governmental military departments (the Army, the Navy, and the Air
Force), governmental institutes (the National Institutes of Health), Veterans
Administration hospitals and industry” in which subjects were used for
research purposes and their health and well-being was endangered without
their knowledge or informed consent.79 Beecher excluded all references
because his intention was not to indict individuals, “but rather, a wish to call
attention to widespread practices.”80 He recognized the difficulty of obtaining
subjects’ fully informed consent, but thought it “absolutely essential” that
researchers try. “Except, possibly, in the most trivial situations,” Beecher
See Ibid., chap. 4 for an interesting analysis of Beecher’s exposé
and its impact on the history of human experimentation in the United States.
78
Henry K. Beecher, “Ethics and Clinical Research,” New England
Journal of Medicine 274 (1966): 1354-60.
79
80
Ibid.
51
insisted, informed consent “remains a goal toward which one must strive for
sociological, ethical and clear-cut legal reasons.”81 Although Beecher’s
exposé focused on the ethical problem of not obtaining subjects’ consent to
participation in clinical research, he also argued that no experiment should be
conducted unless the expected benefit is commensurate with the risk involved.
He warned that “an experiment is ethical or not at its inception; it does not
become ethical post hoc—ends do not justify means.”82 Ultimately, Beecher
was skeptical of any formal regulation of research practices and, instead,
called on investigators to take moral responsibility for their work. “There is no
more reliable safeguard,” Beecher maintained, than “the presence of an
intelligent, informed, conscientious, compassionate, responsible
investigator.”83
Beecher’s exposé represents an important turning point in the ethics
and regulation of human subjects research in the United States. Although
there were isolated discussions of research ethics between 1945 and 1965, as
David Rothman persuasively argued, these discussions were “calm” and
“made the problems seem more conceptual than actual, more academically
interesting than pressing. There was no sense of crisis, of lives at stake, or of
trust violated, and no hint of scandal.”84 Periodically, a controversial research
81
Ibid., 1355.
82
Ibid., 1360.
83
Ibid.
84
Rothman, Strangers at the Bedside, 67.
52
project would be publicized and spark alarm for the safety and well-being of
research subjects, but criticism was limited to individual investigators who
transgressed what were thought to be the generally accepted ethical bounds
of the profession. For example, in 1958, the results of a research project at
New York’s Willowbrook State Hospital for retarded persons was published
and vehemently criticized for the investigators’ harmful and disrespectful
treatment of their human subjects. Drs. Saul Krugman and Joan Giles were
studying the natural history of infectious hepatitis, hoping to eventually develop
a vaccine. Hepatitis was endemic in populations of institutionalized children
who, when infected, presented with mild, flu-like symptoms. Krugman and
Giles sought to study the natural history of hepatitis by artificially infecting
newly admitted children at Willowbrook State Hospital, rationalizing that almost
all children who entered the institution eventually contracted the disease
anyway and that induced infection would immunize them from any subsequent
exposure. The ethics of their study was debated both within and outside of the
medical profession.85 Criticism focused on the nontherapeutic nature of the
experiments, the harm done to the subjects, and the inadequacies of the
informed consent process. The Journal of the American Medical Association,
which published the results of the Willowbrook study ultimately defended it on
85
Dr. Stephen Goldby harshly criticized Drs. Krugman and Giles for
their research and censured the Journal of the American Medical
Association for publishing their work. Lancet 1 (1971): 749, 966-67, 1126,
partially reprinted in Katz, Experimentation with Human Beings, 1007-11.
53
the grounds that a successful vaccine was developed,86 but as Beecher
reminds us, “an experiment is ethical or not at its inception; … ends do not
justify means.”87
The Willowbrook experiments raised public awareness and concern
about the potential for individual investigators to exploit vulnerable populations
for research purposes. It also generated academic interest in the various
ethical issues relating to the use of human subjects in research and
heightened curiosity about the actual practices of medical researchers and
research institutions. In 1960, the National Institutes of Health (NIH), a
division of the U.S. Public Health Service (PHS), made a grant of $97,000 to
Boston University’s Law-Medicine Research Institute “to study the ethical and
legal aspects of clinical investigations, with particular reference to use of
children, prisoners, and informed consent.”88 As part if its study, a survey was
sent to eighty-six departments of medicine to determine what efforts had been
made to establish policies for the ethical conduct of research involving human
subjects.89 Only fifty-two departments responded. Of those, only nine
“The Editors of the Journal of the American Medical Association
Prevention of Viral Hepatitis—Mission Impossible?,” Journal of the American
Medical Association 217 (1971): 70-71, partially reprinted in Katz,
Experimentation with Human Beings, 1010.
87 Beecher, “Ethics and Clinical Research,” 1360.
86
88
Jonsen, Birth of Bioethics, 142.
89
This survey expanded on a previous survey that was conducted by
Dr. Louis G. Welt of the University of North Carolina in 1961. Dr. Welt found
that only eight out of sixty-six of the medical departments that responded to
his survey had a procedural document dealing with clinical research and only
twenty-four favored the establishment of a committee to review research
proposals. Louis G. Welt, “Reflections on the Problems of Human
54
reported that they had established a written policy for conducting clinical
research, and only sixteen affirmed that they used written consent forms for
research.90 The results of this survey alarmed NIH officials. They were
concerned that the absence of institutional oversight would expose them (as
the funding agency) to legal liability for scientific misconduct.
Their fear intensified in 1964, according to Mark Frankel, when a
controversial cancer study at the Jewish Chronic Disease Hospital in Brooklyn,
New York “brought into focus the legal issues in which the PHS could become
involved and dramatized the PHS responsibilities as a public agency.” 91 In
1963, Dr. Chester Southam of the Sloan-Kettering Institute for Cancer
Research approached Dr. Emanuel Mandel, Medical Director of the Jewish
Chronic Disease Hospital, with a proposal to study the immunological effect of
injecting live cancer cells under the skin of elderly patients who did not have
cancer but who suffered from other chronic and debilitating diseases. 92 Dr.
Experimentation,” Connecticut Medicine 25 (1961): 75-79; William J. Curran,
“Governmental Regulation of the Use of Human Subjects in Medical
Research: The Approach of Two Federal Agencies,” Dædalus 98 (1969):
542-94.
90
Irving Ladimer and Roger W. Newman, eds., Clinical Investigation
in Medicine: Legal, Ethical and Moral Aspects (Boston: Boston University
Law-Medicine Research Institute, 1963); Mark S. Frankel, The Public Health
Service Guidelines Governing Research Involving Human Subjects: An
Analysis of the Policy-Making Process (Washington, D.C.: George
Washington University Program of Policy Studies in Science and
Technology, 1972).
91
Frankel, Public Health Service Guidelines, 23.
92 Letter from Chester M. Southam, M.D., to Emanuel Mandel, M.D.
(July 5, 1963), reprinted in Katz, Experimentation with Human Beings, 10-11.
55
Mandel asked Dr. Southam, who had conducted a similar experiment on
cancer patients at Memorial and James Ewing hospitals and on healthy
volunteers at the Ohio State Penitentiary, if he obtained consent from his
subjects prior to injecting them with the cancer cells. Dr. Southam replied that
it was not necessary “since we now regard it as a routine study, much less
dramatic and hazardous than other routine procedures such as bone marrow
aspiration and lumbar puncture,” but that consent was obtained for the
prisoners “because of the law-oriented personalities of these men, rather than
for medical reasons.”93 Dr. Mandel agreed to collaborate in the project. He
attempted to enlist the help of several other physicians at the Jewish Chronic
Disease Hospital, but they refused, arguing that it was immoral and illegal to
conduct the experiment without obtaining the consent of the research
subjects.94 When these physicians discovered that Dr. Mandel was
conducting the experiments without their knowledge and over their objections,
they resigned, stating that, “the entire matter was unethical and immoral.” If
they did not resign, they felt, their “silence or continued association with the
hospital might be construed as condoning the actions of Dr. Mandel and Dr.
Custodio [another physician involved in the experiments] and might be
tantamount to [their] being co-conspirators.”95 The experiments were brought
93
Ibid.
Barron H. Lerner, “Sins of Omission—Cancer Research without
Informed Consent,” New England Journal of Medicine 351, no. 7 (2004):
628-30.
94
95
See Katz, Experimentation with Human Beings, 13-16, for affidavits
of physicians.
56
to the attention of the hospital’s board of directors. Several were outraged and
compared the research to Nazi experiments. William Hyman, a member of the
board, was particularly disturbed and sued the hospital to obtain the patients’
records.96 Drs. Mandel and Southam were brought up on disciplinary charges
and judged to have acted fraudulently, deceitfully, and unprofessionally in
failing to obtain the informed consent of the research subjects by the New
York State medical disciplinary board. Their licenses were suspended for one
year, but the suspension was stayed and they were placed on probation.97
The details of the experiments at the Jewish Chronic Disease Hospital
were widely publicized in 1964. NIH officials worried not only about their own
legal liability for funding the project but also about their public image. They
recognized the ineffectiveness of their guidelines and began discussing
amendments that would legally protect them and increase their public support.
As Joseph S. Murtaugh, former Director of the Office of Program Planning at
the NIH recalls:
It made all of us aware of the inadequacy of our guidelines and procedures
and it clearly brought to the fore the basic issue that in the setting in which
the patient is involved in an experimental effort, the judgment of the
96 Hyman v. Jewish Chronic Disease Hospital, 15 N.Y.2d 317, 206
N.E.2d 338 (1965).
97
See Katz, Experimentation with Human Beings, 44-63, for the
grievance committee’s recommendations and the Board of Regents’
decision.
57
investigator is not sufficient as a basis for reaching a conclusion
concerning the ethical and moral set of questions in that relationship. 98
Although some of the physicians who were involved in the Jewish
Chronic Disease Hospital incident recognized the legal and ethical problem of
performing nontherapeutic and potentially hazardous research on patients
without their consent,99 it became evident that there were still some physicians
(such as Drs. Mandel and Southam) who did not find it problematic. The tides
were turning, but it remained unclear how pervasive the problem of unethical
research practices was.
Henry Beecher’s article verified that the events of the Jewish Chronic
Disease Hospital were not unique. By providing tangible evidence for his
ethical concerns, Beecher was able to substantiate what had for years been
theoretical speculation; he confirmed that unethical research practices existed
in even the most respectable research institutions in the United States. This
created speculation about the integrity of all physician-scientists and
intensified suspicions about their ability to self-regulate.
98
Quoted in Frankel, Public Health Service Guidelines, 23.
99
By 1963 at least some physicians were being educated about the
legal repercussions of not obtaining research subjects’ informed consent. As
Dr. David Leichter explained,
I had attended lectures given by Bryant L. Jones of the CCNSC (Cancer
Chemo-Therapy National Service Center) whereby we were informed
that it was illegal to administer experimental drugs to patients without
their prior informed consent and knowledge and approval.
See Leichter’s affidavit in the Jewish Chronic Disease Hospital investigation,
reprinted in Katz, Experimentation with Human Beings, 13-14.
58
Beecher’s exposé was published at a time when Americans were
particularly sensitive to the exploitation of vulnerable populations. There was
a social atmosphere in the 1960s of general suspicion and distrust of authority
and a political battle to protect the rights of racial minorities, women, and
children. Many of the studies that Beecher cited had used soldiers, charity
patients, mentally retarded and delinquent children, newborns, elderly
patients, terminally ill patients, and chronic alcoholics as research “material”
without their knowledge or consent. These were particularly vulnerable
populations and a combative American public demanded that they be
protected from overzealous clinical investigators.
Beecher, a respected Harvard professor, published his article in a
prominent medical journal. He challenged the medical profession to address
the ethics of human experimentation, and the profession had no choice but to
respond. In true exposé fashion, however, Beecher did not limit his audience
to professional colleagues. He notified the media of his forthcoming
publication, which he hoped would raise public awareness about the
widespread practice of unethical human experimentation. When his story
broke, the American public was surprised and angry to learn that innocent
people were being used as research subjects without their knowledge or
consent and that many experiments that exploited and harmed vulnerable
individuals had been funded, conducted, and published in professional
journals without any criticism or concern. Although the nature and degree of
the research abuse documented by Beecher did not compare to the atrocities
committed by the Nazi physicians during World War II, Americans were
59
reminded of the Nazi experiments and feared the worst; that similar abuses
were occurring in their own country.
Although Beecher appealed to the integrity of the compassionate
investigator to safeguard research subjects, it became clear, not only to NIH
officials but also to the American public, that physician-scientists could no
longer be exclusively trusted to protect the interests of their patient-subjects or
to regulate their own professional activities. Federal oversight was inevitable.
The only question was what form it would take and who would be responsible
for it.
The Federal Regulation of Human Subjects Research
On July 15, 1962 the Washington Post reported that the sleeping pill,
Thalidomide, which was commonly used in Europe by pregnant women for
morning sickness and was prescribed to many women in the United States as
an experimental drug pending FDA approval, was suspected of causing limb
deformities in human fetuses.100 Allegedly, many of the women taking the
drug were not aware that it was experimental. This led to public outrage and
the eventual Kefauver-Harris amendments to the Federal Food, Drug, and
Cosmetic Act in 1962.101 These amendments tightened government control
Morton Mints, “Heroine of FDA Keeps Bad Drug off Market,”
Washington Post, July 15, 1962, A1, A8.
100
101 Drug Amendments of 1962, Public Law 87-781, U.S. Statutes at
Large 76 (1962), sec. 780, codified at U.S. Code 21 (1962), sec. 355.
60
over the approval of new drugs, allowing the FDA to test drugs not only for
safety, but also for efficacy. The amendments also required that all subjects
be informed that they are participating in an experimental trial and that their
consent be obtained, unless it is not feasible or not in the best interest of the
subject.102
Although the Kefauver-Harris amendments did not directly affect the
NIH, they raised concern among NIH policy-makers about the adequacy of
NIH policies for protecting human subjects of research.103 In 1963, NIH
Director, James Shannon, appointed an internal committee, headed by Dr.
Robert B. Livingston, to investigate ethical issues in human experimentation.
The committee submitted its report on November 4, 1964, which explained
that at the time there was “no generally accepted professional code relating to
the conduct of clinical research” and that “the legal status of clinical research
[was] ambiguous.”104 The Livingston committee ultimately acknowledged the
need for “a statement of principles relating to the moral and ethical aspects of
clinical investigation,”105 but they believed that such a document should be
102 Federal Food, Drug and Cosmetic Act of 1962, U.S. Code 21
(1962), sec. 505(i).
103
Frankel, Public Health Service Guidelines, 19.
104
Ibid., 21.
105
Ibid., 25, quoting Robert B. Livingston, Memorandum to Director,
NIH, “Progress Report on Survey of Moral and Ethical Aspects of Clinical
Investigation,” November 4, 1964 [hereinafter “Livingston Report”].
61
developed by an appropriate professional group, rather than the NIH. 106
Shannon disagreed, and in 1966 the NIH (through the PHS) issued a Policy
and Procedure Order, which was sent to research institutions and required, for
the first time, prior institutional review of research protocols.107
The NIH’s requirement for institutional review was an attempt to provide
greater protection for research subjects and to protect the federal government
from legal liability while retaining some semblance of professional
autonomy.108 In 1971, the NIH guidelines were extended by the Department
106
The Livingston committee stated in its report:
NIH is not in a position to shape the educational foundations of medical
ethics … More than that, whatever the NIH might do by way of
designing a code or stipulating standards for acceptable clinical
research would be likely to inhibit, delay, or distort the carrying out of
clinical research … it would be advantageous to the national health
research program if any general guidelines or code of clinical research
behavior were developed by a nonfederal body … In our view, it would
add to existing insecurities if the NIH were to assume an exclusive or
authoritarian position concerning the definition of ethical boundaries or
conditions mandatory for clinical research.
The Livingston Report, quoted in Frankel, Public Health Service Guidelines,
24.
107
Frankel, Public Health Service Guidelines, 30-41; Curran,
“Governmental Regulation.”
108
Dr. Dael Wolfle, a member of the National Advisory Health
Council, the committee charged with considering the issue of a general
statement of principles for the conduct of human subjects research, recalls:
“We thought the Government should have more protection than the mere
statement by the principal investigator that his methods were sound and
appropriate.” Frankel, Public Health Service Guidelines, 32.
62
of Health, Education and Welfare (DHEW) into a formal policy statement.109
However, it soon became apparent that even this was not sufficient.
In 1972 another research scandal was publicly exposed. This time, the
New York Times reported:
For forty years, the United States Public Health Service has conducted
a study in which human beings with syphilis, who were induced to serve
as guinea pigs, have gone without treatment for the disease … the
study was conducted to determine from autopsies what the disease
does to the human body.110
The study was conducted on poor, uneducated, black men in Tuskegee,
Alabama. The story about the Tuskegee Syphilis Study, as it was to become
known, was met with public outrage and federal concern. Especially in light of
the social environment at the time—e.g., the civil rights movement, patients’
rights movement, and resulting skepticism against authority—news of such
blatant disregard for the poor black men in this study was enraging. It was
obvious that the DHEW guidelines did not provide sufficient ethical protection
for research subjects or legal protection for the PHS. Thus, in 1974, the
guidelines were codified into federal law111 and the National Commission for
109
U.S. Department of Health, Education, and Welfare, The
Institutional Guide to DHEW Policy on Protection of Human Subjects
(Washington, D.C.: U.S. Government Printing Office, 1971), commonly
called “The Yellow Book.”
110 Jean Heller, “Syphilis Victims in US Study Went Untreated for 40
Years,” New York Times, July 26, 1972, A1, A8, quoted in Jonsen, Birth of
Bioethics, 146-47.
111 Protection of Human Subjects, Code of Federal Regulations, Title
45, Part 46 (1974).
63
the Protection of Human Subjects of Biomedical and Behavioral Research
(National Commission) was established to study the ethics of human subjects
research and to make recommendations to the Secretary of the DHEW about
the regulation of research practices.112
112 National Research Act, Public Law 93-348, codified at U.S. Code
42 (July 12, 1974), sec. 2891.101.
64
CHAPTER 3
IDENTIFICATION OF “RESPECT FOR PERSONS” AS A
GUIDING ETHICAL PRINCIPLE
The National Commission was established in response to the extensive
history of disrespect for research subjects discussed in chapter 2 and to the
more proximate public concern with the disrespectful attitude toward and
mistreatment of human subjects of research. The National Commission was
mandated by Congress in 1974 to “identify the basic ethical principles which
should underlie the conduct of biomedical and behavioral research involving
human subjects” and “develop guidelines which should be followed in such
research to assure that it is conducted in accordance with such principles.”113
Four years later the National Commission published The Belmont Report,
which identified three basic ethical principles that are relevant to research
involving human beings: respect for persons, beneficence, and justice.114 The
Belmont Report defined each ethical principle and discussed its practical
application. It was intended to inspire ethical reflection and to guide the
formulation and interpretation of more specific rules prescribed in various
ethical and legal codes of conduct.115 Any ethical reflection that has resulted,
113 National Research Act, Public Law 93-348, codified at U.S. Code
42 (July 12, 1974) sec. 2891.202(A)(1)(A).
114
National Commission, Belmont Report.
115
Ibid.
65
however, has been compromised by a truncated interpretation of the principle
of respect for persons.
In this chapter I analyze how the National Commission identified
respect for persons as a guiding ethical principle and examine how they
defined it in The Belmont Report. I credit the National Commission for raising
the issue of what kind of respect is owed to human subjects of research. I
argue, however, that the National Commission’s focus on autonomy and
informed consent and its mandate to identify ethical principles and to make
practical recommendations for the regulation of research prevented it from
developing a more robust interpretation of the various moral dimensions of
respect for research subjects. The National Commission’s identification of the
principle of respect for persons and its limited definition and application of that
principle consequently perpetuated a reductionist view of the concept of
respect that was enshrined in previous codes of ethics and that has
permeated subsequent interpretations of what is morally required by the
ethical duty to respect research subjects. Respect for persons has become
synonymous with respect for autonomy, which has been equated with the right
of self-determination. This limited interpretation of respect has unintentionally
resulted in an overly burdensome regulatory system that not only diminishes
the opportunities of research subjects for meaningful choices but also fosters a
bureaucratic mentality among researchers that strips them of their moral
sensibilities. The policy implications of this development will be examined
further in chapter 6.
66
In an effort to reconstruct the history of The Belmont Report I rely
primarily on the transcripts from the National Commission meetings and the
text of The Belmont Report itself. However, to fill in some gaps in the story
and to gain a deeper understanding of the National Commission’s work, I
reviewed some recent publications, as well as unpublished manuscripts by
various members of the National Commission. I also include information that I
received from personal communications with some of the National
Commission members (including Commissioner and ethicist Karen Lebacqz,
Staff Director Michael Yesley, and Staffer and philosophical consultant Tom
Beauchamp). These more recent sources provide valuable insight into why
the National Commission identified respect for persons as a basic ethical
principle and what they meant by it. They have their limitations, however. All
of them represent one persons’ memory of events that took place thirty years
ago. As we can see from Tom Beauchamp and Albert Jonsen’s ongoing
disagreement about the history of The Belmont Report,116 individuals may
remember common historical events differently. Each has a particular
perspective on the experience and each has been influenced by his or her
own work as well as developments in the field during the past thirty years.
These recollections (and their inconsistencies), however, provide valuable
insight into the dynamics of the people working on The Belmont Report as well
Jonsen, Birth of Bioethics; Tom L. Beauchamp, “The Origins,
Goals, and Core Commitments of The Belmont Report and Principles of
Biomedical Ethics,” in The Story of Bioethics: From Seminal Works to
Contemporary Exploration, ed. Jennifer K. Walter and Eran P. Klein
(Washington, D.C.: Georgetown University Press, 2003), 17-46.
116
67
as their individual perspective on what they were trying to accomplish as a
group.
Identification of the Basic Ethical Principle of “Respect for
Persons”
The National Research Act
The National Research Act was signed into law on July 12, 1974. This
unique piece of legislation created the National Commission for the Protection
of Human Subjects of Biomedical and Behavioral Research (National
Commission).117 The National Commission was composed of eleven
members representing several disciplines, including: “medicine, law, ethics,
theology, the biological, physical, behavioral and social sciences, philosophy,
humanities, health administration, government, and public affairs.”118 There
were three physicians: Kenneth Ryan from the Boston Hospital for Woman
(who chaired the National Commission), Robert Cooke from the University of
Wisconsin, and Donald Seldin from the University of Texas; two biomedical
researchers: Joseph Brady from Johns Hopkins University, and Eliot Stellar
from the University of Pennsylvania; three lawyers: Patricia King from
117
National Research Act, Public Law 93-348, codified at U.S. Code
42 (July 12, 1974) sec. 2891.201(A): “There is established a commission to
be known as The National Commission for the Protection of Human Subjects
of Biomedical and Behavioral Research (hereinafter in this title referred to as
the ‘Commission’)”.
118 National Research Act, Public Law 93-348, codified at U.S. Code
42 (July 12, 1974) sec. 2891.201(B)(1).
68
Georgetown University Law Center, David Louisell from the University of
California Law School, and Robert Turtle, who was in private practice; one
public member: Dorothy Height, President of the National Council of Negro
Women, Inc.; and two ethicists: Karen Lebacqz, a theologian from the Pacific
School of Religion, and Albert Jonsen, a philosopher from the University of
California.119
On December 3, 1974, these eleven individuals were sworn into the
National Commission and began work on their mandate to, among other
things:
Conduct a comprehensive investigation and study to identify the basic
ethical principles which should underlie the conduct of biomedical and
behavioral research involving human subjects … [and to] develop
guidelines which should be followed in such research to assure that it is
conducted in accordance with such principles.120
The National Research Act was truly an exceptional piece of legislation in that
it created a political body that was charged with providing ethical analyses,
which the Secretary of the Department of Health, Education and Welfare
(DHEW) was required to respond to and translate into legal regulations.
Never before had the law been so deliberately and explicitly informed by
ethical analysis. As Albert Jonsen put it, “This was ethics with a bite.”121
119 The National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research, “Transcripts of the 27th Meeting
Proceedings,” PB-264 704 (February 11-13, 1977), University of Texas
Medical Branch Archives; Jonsen, Birth of Bioethics.
120
National Research Act, Public Law 93-348, codified at U.S. Code
42 (July 12, 1974) sec. 2891.202.
121
Jonsen, The Birth of Bioethics, 99.
69
The National Commission’s Methodology
The National Commission never explicitly described what
methodological approach it took in identifying the basic ethical principles that
should underlie human subjects research.122 Its mandate suggested that it
ought to adopt a deductive approach by first conducting a “study to identify the
basic ethical principles” and then to use those principles to “develop [practical]
guidelines.”123 Yet, the National Commission seems to have adopted a
partially inductive approach for at least two reasons. First, the commissioners
were mandated to consider at least five things when identifying the
fundamental guiding principles in research: the boundaries between research
and practice; the role of risk-benefit assessment in determining the
appropriateness of research; the appropriate selection of human subjects for
research; the nature and definition of informed consent; and mechanisms for
evaluating and monitoring IRBs.124 This set up a conceptual template that the
122
Al Jonsen and Stephen Toulmin have argued that the National
Commission’s general methodological approach was rooted in casuistry.
They claim that the commissioners appealed to specific kinds of cases,
rather than universal principles, to reach agreement on particular judgments.
Jonsen and Toulmin, The Abuse of Casuistry.
Tom Beauchamp, on the other hand, claims that the commissioners
were strongly committed to general principles and that “the Transcripts of the
commission’s deliberations show a constant movement from principle to
case, and from case to principle.” Beauchamp, “Origins, Goals, and Core
Commitments,” 30.
This section deals not with the National Commission’s general
methodology, but more specifically, with the method it employed to identify
the universal principles in the first place.
123
National Research Act, Public Law 93-348, codified at U.S. Code
42 (July 12, 1974) sec. 2891.202.
124 National Research Act, Public Law 93-348, codified at U.S. Code
42 (July 12, 1974) sec. 2891.202(B).
70
commissioners ultimately adopted when writing The Belmont Report. After
many drafts, they ended up writing a section on the boundaries between
research and practice and then identifying three ethical principles—respect for
persons, beneficence, and justice—whose application addressed the issues of
informed consent, risk-benefit assessment, and selection of subjects,
respectively.125
It is unclear whether the applications of the principles were deduced
from the principles themselves or whether the principles were induced from
the already established (and congressionally mandated) applications. Most
likely, the answer is both. The commissioners were looking to identify the
basic ethical principles that should underlie human subjects research, but at
the same time, they were cognizant of the problems that they were asked to
address—namely, informed consent, risk-benefit assessment, and selection of
subjects—and these issues were shaped by and shaped the principles that
they ultimately identified.126
125 National Commission, Belmont Report. The evaluation of
institutional review boards was studied and reported on separately. The
National Commission for the Protection of Human Subjects of Biomedical
and Behavioral Research, Report and Recommendations: Institutional
Review Boards (Washington, D.C.: U.S. Government Printing Office, 1978).
126
Tom Beauchamp gives credit to Michael Yesley, the staff director
for the National Commission, for creating the conceptual framework of The
Belmont Report:
Yesley said, as a way of summarizing our reflections, “What these
principles come to is really quite simple for our purposes: Respect for
persons applies to informed consent, beneficence applies to risk-benefit
assessment, and justice applies to the selection of subject.”
71
The methodological approach that the National Commission took in
identifying the ethical principles that should guide research on human subjects
was more broadly influenced by time-constraints placed on their agenda.
When the National Commission was created, it was instructed to immediately
begin studying the ethics of fetal research, which was relevant to an ongoing
debate in the Senate. This project was deemed time-sensitive, and the
commissioners were given four months to complete it.127 Thus, instead of
beginning their work by identifying the ethical principles that should underlie all
research in general and then using this basic ethical framework to guide their
deliberations on some of the more specific issues in their mandate (e.g.,
identifying the requirements for informed consent in special populations, fetal
research, and psychosurgery), the commissioners had to work through some
specific issues before they could step back and investigate the broader
principles that grounded their previous efforts.
Consequently, by the time the commissioners began to work on what
was to become known as The Belmont Report, they had already tentatively
identified some basic principles underlying human subjects research. For
example, in their report, Research on the Fetus, which was published in 1975,
Beauchamp, “Origins, Goals, and Core Commitments,” 21. Although this
exact schema did not exist prior to Yesley’s revelation, Beauchamp explains
that it was “already nascent in pre-existing drafts of the report and in the
Commission’s deliberations.” Ibid.
127
National Research Act, Public Law 93-348, codified at U.S. Code
42 (July 12, 1974) sec. 2891.202(3)(B). See also Jonsen, Birth of Bioethics,
for a discussion of the Senate debate on fetal research that preceded the
enactment of the National Research Act.
72
the National Commission included a section on the “Ethical Principles and
Requirements Governing Research on Human Subjects with Special
Reference to the Fetus and the Pregnant Woman.” The commissioners stated
that this was meant to be an interim statement until they had an opportunity to
discuss the topic more fully, which would not happen until the Belmont Retreat
more than a year later. This interim statement said:
Among the general principles for research on human subjects judged to
be valid and binding are: (1) to avoid harm whenever possible, or at
least to minimize harm; (2) to provide for fair treatment by avoiding
discrimination between classes or among members of the same class;
and (3) to respect the integrity of human subjects by requiring informed
consent. An additional principle pertinent to the issue at hand is to
respect the human character of the fetus.128
It is interesting to note that these three principles roughly correspond to the
three principles in The Belmont Report: beneficence, justice, and respect for
persons. Under subsection (3) the commissioners seem to have been saying
that one respects the integrity of human subjects simply by obtaining informed
consent. I argue that this is only one of the many important elements of
respect for research subjects. The commissioners did go on to state that in
relation to fetuses, the human character of the fetus must also be respected.
The commissioners refused to comment on the personhood of the fetus, but
insisted: “moral concern should extend to all who share genetic heritage, and
that the fetus, regardless of life prospects, should be treated respectfully and
128
The National Commission for the Protection of Subjects of
Biomedical and Behavioral Research, Research on the Fetus: Report and
Recommendations (Washington, D.C.: U.S. Government Printing Office,
1975), 63 (emphasis added).
73
with dignity.”129 This hints at a broader conception of respect, but absent any
further explication, we are left with a vague notion of a concept devoid of
content and any moral or practical meaning.
The tension between a reductionist view of respect for persons as
synonymous with autonomy and a more robust conception of the principle
pervaded the Belmont deliberations. In an attempt to deal with this tension the
commissioners adopted the appropriate language of respect but failed to
follow through by comprehensively defining this term.
The National Commission in Context
In order to understand why the National Commission failed to adopt a
more comprehensive conceptualization of respect for research subjects, we
have to contextualize its work. In this section I discuss five challenging
aspects of the National Commission’s mandate that contributed to its limited
understanding of the ethics of respect in research.
First, bioethics was still a relatively new field in the 1970s. While the
Nuremberg Trials after World War II highlighted the need for ethical reflection
about the use of human subjects in research, public discussion about and
serious philosophical analysis of research ethics in the United States was still
in its infancy when the National Commission was created. Academics had
begun thinking about these issues,130 but the scientific community remained
129
Ibid., 62.
130 See, for example, Paul Ramsey, The Patient as Person:
Explorations in Medical Ethics (New Haven: Yale University Press, 1970);
Katz, Experimentation with Human Beings; Richard A. McCormick, Notes on
74
hostile toward intrusions (governmental or otherwise) on its professional
autonomy and sought to keep philosophers and theologians high in the ivory
tower.131 The National Commission was intended not only to bring ethicists
onto the front lines of public policy deliberations but also to compel them to
join forces with lawyers, doctors, scientists, and politicians in order to consider
the ethics of research involving human subjects from a variety of perspectives.
This was no small task given the political environment at the time.
Second, because it was a relatively new field in the 1970s, the
discourse of research ethics was fairly undeveloped. The commissioners had
to consider not only the implications of their work from philosophical, moral,
scientific, and legal perspectives, but they were then expected to articulate
their position in a way that would make sense to a multidisciplinary group of
“players.” Although some of the commissioners seem to have had a deeper
understanding of what it means to respect research subjects, they failed to
articulate this in The Belmont Report. I may criticize the language used by the
National Commission to define the principle of respect for persons in The
Belmont Report, but I do this with thirty years’ hindsight and a real
appreciation of the difficulty of finding the right words to characterize such a
vague and elusive concept.
Moral Theology 1965 through 1980 (Washington, D.C.: University Press of
America, 1981).
131 Chap. 2 includes some discussion about the resistance of the
medical profession to the regulation of research practices.
75
Third, the commissioners were constrained by the political implications
and legal applications of their work. One of the purposes of the National
Commission’s work, after all, was to inform the law. Their recommendations
were expected to be not only moral, but also practical. In fact, there was
significant debate among the various members of the National Commission
about the nature of their assignment. Some felt that it was their duty to publish
philosophically robust documents, while others thought that it was
inappropriate for the National Commission, which was primarily a political
body, to write philosophical treatises.132 These tensions about the nature and
purpose of the National Commission’s work pervaded its deliberations. In a
way, they are what made the National Commission so extraordinary; it was
able to integrate ethical analysis into public policy in a way that had never
been done before (or, some would argue, since). Yet, it is precisely because
of these tensions that the National Commission Reports (especially The
Belmont Report) failed to inspire deep moral reflection. Whether or not they
were intended for this purpose will depend on who you ask.133
132 The National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research, “Transcripts of the 15th Meeting
Proceedings,” PB-251 730 (February 13-16, 1976), University of Texas
Medical Branch Archives; Karen Lebacqz, telephone conversation with the
author, June 10, 2004.
133
Tom Beauchamp claims that Donald Seldin and Michael Yesley
were in favor of making The Belmont Report a philosophically robust
document, but that most of the other commissioners (including Patricia King)
felt that this was inappropriate:
Seldin was my constant counsel, forever exhorting me to make the
document more philosophically credible, only to confront a majority of
Commissioners who wanted a simple and streamlined document. And
throughout it all, Patricia King taught me more about the Commission
76
Fourth, the National Commission’s conceptualization of research ethics
was limited by its Congressional mandate. I argue in chapter 6 that a robust
interpretation of respect for research subjects reveals that the concept of
respect is multidimensional and incorporates many ethical principles, including
respect for autonomy, beneficence, nonmaleficence, and justice. Thus, I
suggest that research ethics and policy will be greatly enriched if respect for
research subjects is viewed as an overarching normative concept as opposed
to one of several prima facie binding principles.134 This type of
conceptualization of research ethics was not, however, on the National
Commission’s radar. It was mandated specifically to identify those ethical
principles that should underlie human subjects research. By identifying
respect for persons as one of several ethical principles of research the
National Commission precluded the possibility of adopting the more robust
interpretation of respect for research subjects that I believe is needed now.
Finally, there are many challenges inherent in the nature of commission
work. The commissioners had to reach a consensus not only about the
purpose and scope of their mission, but also about the substantive issues that
than anyone else. It was she who helped me understand why a really
philosophical document was not the desired result.
Beauchamp, “Origins, Goals, and Core Commitments,” 40n13. According to
Beauchamp, the latter group ultimately prevailed: “Seldin, Yesley, and I
ultimately relented, and bolder philosophical defenses of the principles were
gradually stripped from the body of Belmont.” Ibid., 20.
134
As I mentioned in chap. 1, the National Commission never
explicitly referred to the three principles in The Belmont Report as prima
facie binding principles. See chap. 1, n4.
77
they were exploring. There were eleven commissioners, along with several
full-time staff members who were trying to co-author a document discussing a
topic about which some of them had fundamental disagreements. As Jay Katz
observed when discussing the work of the President’s Commission (the
National Commission’s successor), “inevitable obfuscations emerge whenever
commissioners strive for a consensus report about complex moral
problems.”135 When analyzing The Belmont Report it is important to
remember the complexities inherent in doing ethics publicly. This is not to say
that the National Commission ought to be excused entirely for its
shortcomings. Rather, we can be critical and at the same time sympathetic to
the challenges that the National Commission faced. Understanding these
obstacles helps contextualize the National Commission’s efforts and provides
some explanation for the inconsistencies in its arguments, conclusions, and
general tone.136
Jay Katz, “Limping Is No Sin: Reflections on Making Health Care
Decisions,” Cardozo Law Review 6 (1984): 243-65, 246.
135
136 Alan Weisbard and John Arras have pointed out the difficulty of
reading Commission documents without paying attention to these contextual
issues. They are discussing the President’s Commission’s Reports, but their
observations are equally relevant to the National Commission’s work:
Some commentators have read Commission documents as if they were
singly authored, and have held them to corresponding standards of
intellectual logic and coherence. These commentators rightly identify
disparities in the tone and approach of the Commission documents, and
more tellingly, identify logical inconsistencies between arguments and
conclusions. In particular, several observers have noted that the tenor
of the underlying arguments, in many instances, would imply broader
and more powerful conclusions than those acknowledged in the reports
themselves.
78
With regard to the duty of respect for research subjects, the
commissioners made a good faith effort in their deliberations to articulate the
idea that human beings who participate in research deserve to be treated
respectfully and to be recognized and valued, not only as autonomous
individuals, but also as “embodied” and “embedded” persons.137 Because of
some of the reasons mentioned above, however, some of the more
meaningful dimensions of respect that the commissioners were struggling to
develop (including references to the dignity and humanity of research
subjects) were left out of The Belmont Report. These important dimensions of
respect, therefore, did not influence the federal regulation of human subjects
research and did not inform and inspire individual researchers and institutional
review board members.
The Belmont Retreat
The National Commission held a closed retreat at the Belmont
Conference Center in Elkridge, Maryland from February 13–16, 1976 in order
to tackle the considerable task of identifying the basic ethical principles
underlying research involving human subjects. In preparation for this meeting,
Alan J. Weisbard and John D. Arras, “Commissioning Morality: An Introduction
to the Symposium,” Cardozo Law Review 6 (1984): 223-41.
137
Karen Lebacqz claims that this is what the National Commission
was trying to say when it identified respect for persons as a basic ethical
principle, but that the commissioners simply lacked the language to express
these ideas effectively in 1979. Karen Lebacqz, “Twenty Years Older but
Are We Wiser?” paper presented at conference “Belmont Revisited,”
University of Virginia, Charlottesville, April 16-18, 1999; Karen Lebacqz,
telephone conversation with the author, June 10, 2004.
79
the National Commission commissioned several papers from leading ethicists
and moral philosophers addressing the role of ethics in general and the ethical
principles underlying research in particular. At the meeting, Stephen Toulmin,
a philosophical consultant to the National Commission, provided a summary
and meta-analysis of the papers. He identified the problem of reconciling the
protection of individual rights with the pursuit of collective enterprise as the
central issue that the commissioners must face.138 Toulmin noted that
historically, the collective interest always won out, but that the American
political and philosophical tradition had been built on individual rights, and so
he suggested that the National Commission situate itself within that
longstanding American tradition. Karen Lebacqz, one of the two ethicists on
the Commission, responded that the issue was not simply about individual
rights versus the collective enterprise, but that the commissioners must
consider broader communities as well as cultures with different values.139
With this statement, Lebacqz planted a seed that would grow into a lengthy
debate among the commissioners at a later meeting about the tensions
between autonomy and a broader conception of the principle of respect for
persons.
It is worth noting that several members of the National Commission had
reservations about the propriety of the National Commission identifying
general ethical principles. They referred frequently to the legislative history of
National Commission, “Transcripts of the 15th Meeting
Proceedings,” 4-5.
138
139
Ibid., 10-11, 14.
80
the National Research Act and reminded the others that the reason they had
been assembled in the first place was because the Senate Committee was
concerned that much of the present research involved more risk than potential
benefit to subjects and that therefore they were expected to establish methods
to assure that informed consent was obtained and peer review was sought.140
As we will see, this concern with being practical and addressing the specific
issues identified by the Senate Committee as problematic (including informed
consent) helps to explain why the commissioners stopped short of providing a
philosophically robust definition of respect and why they applied the principle
of respect for persons exclusively to the requirement for informed consent.
Several commissioners were also concerned about the scope of the
National Commission’s activities. It was mentioned several times during their
deliberations that they were directed simply to identify the principles underlying
research, not to develop or establish them.141 To this end, the statutory
language is somewhat confusing because on its face it states that the National
Commission shall “conduct a comprehensive investigation and study to
identify the basic ethical principles which should underlie the conduct of
biomedical and behavioral research involving human subjects.”142 By using
the term “identify” Congress indicates a descriptive task, but the use of the
140
Ibid., 50-51.
141
Ibid., 11-13, 111.
142 National Research Act, Public Law 93-348, codified at U.S. Code
42 (July 12, 1974) sec. 2891.202(1)(A)(I) (emphasis added).
81
term “should” suggests a more normative assignment. Certainly, the
commissioners could have interpreted this ambiguous statement in several
ways, especially since they were given broad discretion to determine the
scope of their activities.143 However, they relied once again on the legislative
history of the act, which explained:
The [Senate] Committee does not believe it is the responsibility of the
Federal government to develop and establish moral principles. It does
believe that the Commission should identify those principles [which
underlie the conduct of human subjects research] and use them as the
basis of the rules and regulations that the Commission will
promulgate.144
Thus, the commissioners specifically sought to identify the principles that had
already been recognized in previous codes of ethics such as the Nuremberg
Code and the Declaration of Helsinki as well as in the Federal Regulations,
which, ironically, their deliberations were intended to inform and improve,
rather than simply describe or affirm.
That said, the commissioners’ deliberations often seemed to go beyond
mere description into normativity. This is especially apparent in their
discussion of whether the principle of respect for persons would be more
appropriate than the principle of autonomy as a guiding ethical principle.
However, as is evident in the final Report, the commissioners ultimately
143
Senate Committee on Labor and Public Welfare, National
Research Service Award Act of 1974, 93rd Cong., 2nd sess., August 3,
1973, S. Rep. 93-381, Title II, sec. B: Duties of the Commission: “It is the
intent of the Committee to give the Commission the broadest possible
mandate to determine the scope of its own activities.”
144
Ibid. (emphasis added)
82
identified the principle of respect for persons as fundamental, but failed to
adequately develop it in all of its ramifications and potential applications. This
may not have been an oversight on their part but rather a deliberate restraint
given this history and their narrow interpretation of the Congressional
mandate.
After the first day of discussion at the Belmont Retreat, the
commissioners split up into sub-committees to work on the various tasks on
their agenda. The sub-committee on ethical principles, led by Karen Lebacqz,
drafted a report, which the National Commission discussed the following day
and continued to amend and discuss throughout the year. This report in its
final form would become known as The Belmont Report. The original draft of
the report identified seven basic ethical principles: respect for selfdetermination of human beings, concern to benefit individual subjects, concern
to benefit other individuals and groups (i.e.: society at large), concern to
minimize harm to subjects, concern to minimize consequential harm to others,
concern for distributive justice (equal protection and equal access), and
concern for compensatory justice. All of these were said to rest on broad
considerations of freedom, justice, and beneficence.145 Thus, the first draft of
The Belmont Report identified freedom as a basic ethical principle, which the
sub-committee primarily defined as respect for subjects’ self-determination.
The practical application of the principle of self-determination was the
requirement for informed consent. Robert Levine (a consultant to the National
Commission who was responsible for writing the section in The Belmont
National Commission, “Transcripts of the 15th Meeting
Proceedings,” 99-100.
145
83
Report on the boundaries between research and practice) expressed concern
that if respect for individual freedom (or self-determination) was too strongly
emphasized, the informed consent process might become a script instead of a
dialogue between the researcher and the subject. He felt that subjects
needed to know not only that they had a right to refuse participation in a
research study, but that they were being respected as a reasonable person.146
This type of apprehension led to the expansion of the principle of selfdetermination into autonomy in the second draft of The Belmont Report and
finally into respect for persons in the final Report.
The National Commission’s mandate to consider certain specific issues
(including informed consent) and to identify the basic ethical principles in
research may have contributed to the conceptual confusion about the
difference between freedom, self-determination, autonomy, and respect for
persons. Most narrowly (and in the legal context), the theoretical foundation of
informed consent is the right of self-determination (defined as the freedom to
determine what shall be done with one’s own body).147 More broadly,
informed consent is grounded in the principle of respect for autonomy. Finally
and most fundamentally, informed consent is rooted in the concept of respect
146
Ibid., 276.
Robert Veatch, “Three Theories of Informed Consent:
Philosophical Foundations and Policy Implications,” in Appendix, vol. 2, The
Belmont Report (Washington, D.C., U.S. Government Printing Office, 1979),
chap. 26; Schloendorff v. Society of New York Hospitals, 211 N.Y. 125,
105 N.E. 92 (1914).
147
84
for persons. It is, thus, extremely confusing to try to determine inductively
what morally grounds the requirement for informed consent.
Respect for persons, the most fundamental of the concepts discussed
above, may give rise to an obligation to obtain informed consent, but it also
suggests that more is required of us than simply respecting an individual’s
right to make autonomous decisions (through the requirement for informed
consent). But as H. Tristram Engelhardt, Jr. emphasized in his commissioned
paper on the basic ethical principles in research, the principle of respect for
persons appeared as a fundamental principle in previous codes of ethics and
in the federal regulations only in the injunction to obtain informed consent.
Thus, Engelhardt concluded, obtaining informed consent represents a form of
respect in that subjects’ self-determination, or negative liberty right to make
free and rational choices, is preserved.148 Engelhardt went on in his paper to
provide a more robust definition of respect for persons, relying on Charles
Fried, Paul Ramsey, and others to invoke a vision of respect that takes
account of individuals’ dignity and “full human particularity.”149 This moves us
beyond the realm of decision making and suggests a more robust
interpretation of respect for research subjects. As Engelhardt demonstrated,
however, although some philosophers were struggling to understand and
H. Tristram Engelhardt, Jr., “Basic Ethical Principles in the
Conduct of Biomedical and Behavioral Research Involving Human Subjects,”
in Appendix, vol. 1, The Belmont Report (Washington, D.C., U.S.
Government Printing Office, 1979), chap. 8.
148
Engelhardt, “Basic Ethical Principles,” citing Charles Fried, Medical
Experimentation: Personal Integrity and Social Policy (Amsterdam: NorthHolland Publishing, 1974).
149
85
appreciate the various dimensions of respect in the 1970s,150 an ethically
robust account of the principle of respect for persons had not been developed
in any of the existing legal or ethical research codes.
It is possible that the commissioners in their effort simply to identify the
guiding principles for human subjects research chose to emphasize selfdetermination in the first draft of The Belmont Report as the most salient
principle in established codes of ethics. It is also possible that the National
Commission unintentionally reduced the principle of respect for persons as it
was articulated by Engelhardt into self-determination in the first draft of The
Belmont Report and into autonomy in the second. In fact, in the second draft
of The Belmont Report the commissioners spent an entire page talking about
“respect for persons” but then paraphrased it on the following page under the
term “autonomy.”151 It was not until Lebacqz raised the issue in February
1977 that they seem to consider, for the first time perhaps, the conceptual
distinctions between self-determination, autonomy, and respect for persons.
Engelhardt, “Basic Ethical Principles.” See also Ramsey, Patient
as Person; Fried, Medical Experimentation.
150
151
National Commission, “Transcripts of the 27th Meeting Proceeding,” 92.
86
The Debate: “Respect for Persons” versus “Autonomy”
Stephen Toulmin edited the first draft of The Belmont Report, which
was circulated in March 1976 but not formally discussed until the following
year.152 When the second draft was presented for discussion at the 27th
meeting on February 11, 1977, three underlying fundamental principles were
identified: autonomy, beneficence, and distributive justice.
It is not entirely clear how or why the principle of self-determination (or,
more broadly, freedom) was replaced with autonomy in the second draft of the
Report. It is possible that Robert Levine’s concern at the Belmont Retreat that
the principle of self-determination did not convey an appropriate attitude of
respect for the individual as a reasonable person may have had some
influence on the language used in the second draft. It is also likely that as
Toulmin and others worked on the Report, their thinking was influenced by
Tom Beauchamp (a consultant to the National Commission who later became
a staff member) and Jim Childress’ (also a consultant to the National
Commission) foundational Principles of Biomedical Ethics, in which they
grounded the requirement for informed consent in the principle of autonomy.153
After all, as Beauchamp recalls, Principles of Biomedical Ethics and The
National Commission, “Transcripts of the 15th Meeting
Proceeding,” 315-16.
152
153 Tom L. Beauchamp and James F. Childress, Principles of
Biomedical Ethics (New York: Oxford University Press, 1979).
87
Belmont Report were “drafted simultaneously, often side-by-side, the one
inevitably influencing the other.”154
Whatever the reasons, when Beauchamp joined the staff of the
National Commission in January 1977, the principle of self-determination had
been replaced with the principle of autonomy in The Belmont Report.
Beauchamp remembers reading the Belmont Draft on January 10, 1977 for
the first time. According to his recollection, the first principle in the Report was
the principle of respect for persons.155 As mentioned above, the second draft
of The Belmont Report did discuss the principle of respect for persons, but it
made no conceptual distinction between respect for persons and autonomy
and ultimately paraphrased its discussion of the principle under the term
autonomy. As Toulmin pointed out at the February 11, 1977 meeting, in the
second draft of The Belmont Report “respect for persons was simply
translated into autonomy.”156 The conceptual confusion that this created set
the stage for what was to become a lively debate about which of the two terms
was more appropriate as a fundamental ethical principle for research.
Commissioner Seldin began this discussion on February 11, 1977 by
expressing concern about the principle of autonomy. “Autonomy,” he
explained, “is the notion that an individual ought to be respected as an end in
Tom L. Beauchamp, “The Origins and Evolution of The Belmont
Report” (working paper, 2004).
154
155
Ibid.
156 National Commission, “Transcripts of the 27th Meeting
Proceedings,” 92.
88
itself, as a free-choosing, self-regarding person, without further justification.”157
Yet, he continued, “very often we try to intervene in what we conceive to be
the individual’s best interest.”158 This is justified, he argued, when, for
example, an individual is unable to “pursue his own future choices, … either
because he can’t postpone gratifications or he is incapable of acting in his own
best interests.”159 Commissioner Seldin expressed concern that the notion of
autonomy, as it was defined in The Belmont Draft, would be interpreted as a
moral mandate to respect an individual’s free choice with no limitations or
exceptions. What he ultimately wanted was for the commissioners “to clarify
what one means by the term ‘autonomy’ and what its limitations may be.” 160
Lebacqz agreed that all of the principles needed to be discussed more
fully and defined more carefully. She then suggested that “autonomy may not
be a broad enough term for the principle that Don [Seldin] really is talking
about.”161 Instead, she suggested that the principle of autonomy be replaced
with the principle of respect for persons, “which includes not only respecting
their autonomy, but also includes respecting them in the sense of protecting
157
Ibid. 12-13.
158
Ibid., 13.
159
Ibid., 15.
160
Ibid., 17.
161
Ibid., 19.
89
them from harm, promoting their welfare, and so on.”162 The conceptual
approach that Lebacqz recommended was to identify the broader term,
respect for persons, as the fundamental principle and then to specify some
interpretations of respect for persons, including respect for an individual’s
autonomy.163 The National Commission ultimately adopted the language of
respect for persons, but not without serious disagreement and debate.
The arguments in favor of adopting the principle of respect for persons
instead of autonomy tended to focus on four issues: the more fundamental
character of respect for persons, the limitations of the principle of autonomy,
the naturally social nature of human beings, and concern about
nonautonomous persons who deserve respect.164
Commissioners Lebacqz and Ryan suggested that respect for persons
is the more appropriate principle because it is a broader and more
fundamental principle than autonomy. Respect for persons includes, but is not
limited to, respect for individual autonomy. Therefore, Commissioner Lebacqz
argued, it should be identified as one of the basic ethical principles and then
defined as incorporating the principle of respect for autonomy.
162
Ibid.
163
Lebacqz was on the right track in suggesting a broad interpretation
of respect that incorporates other ethical principles, but because the National
Commission was focused exclusively on identifying several competing
principles for research, it failed to appreciate all of the various dimensions of
respect as an overarching normative category. For further discussion about
respect as a normative category, see chap. 6.
164 National Commission, “Transcripts of the 27th Meeting
Proceedings,” 17-125.
90
Commissioners Jonsen and Lebacqz raised issues that pointed to the
limits of autonomy. Commissioner Jonsen suggested that the principle of
autonomy does not account for the fact that research is a moral and a human
enterprise, not just a scientific enterprise, and so sometimes one must
override autonomy in order to protect the research enterprise from being
heinous, rash, demeaning, and dangerous. Commissioner Lebacqz pointed
out that autonomy does not account for issues of privacy in obtaining informed
consent for research, while respect for persons does.
Many of the arguments in favor of the principle of respect for persons
related to the ability of that principle to account for the naturally social nature
of human beings. Commissioners Cooke, Jonsen, and Ryan all felt that the
principle of respect for persons captured the social and spiritualconnectedness of people. They argued that we are all inextricably connected
to one another such that decisions that put one person at risk also imperil
others. Even more broadly, Commissioner Ryan contended, when one
degrades one’s own humanity, one degrades all humanity. So, for example, if
a man is trying to jump off a building, he may be making an autonomous
decision, but “we wouldn’t let him do it, because it would take too much from
us as human beings.”165 Commissioner Jonsen believed that because we all
live in relation to each other, there is no such thing as an autonomous
individual; autonomy (letting people do what they please) must always be
coupled with responsibility (holding them accountable for their actions).
165
Ibid.
91
Finally, Commissioner Cooke raised a concern that the principle of
autonomy ignores nonautonomous persons, such as infants, who deserve
respect. He felt that the principle of respect for persons was better able to
provide a justification for proxy consent for these individuals with impaired
autonomy.
The National Commission’s interest in these particular issues was
strongly influenced by the work of philosopher Tom Beauchamp and
theologian Richard McCormick. As I mentioned above, the commissioners
were working on The Belmont Report at the same time that Beauchamp and
Childress were writing Principles of Biomedical Ethics. Although Beauchamp
did not become a staff member for the National Commission until January
1977,166 the commissioners were well aware of his work. As Lebacqz recalls,
“there was mutual conversation going on” between the commissioners and
Beauchamp and Childress.167 There was also considerable disagreement
about the basic principles identified. As we can see from the debate at the
February 1977 meeting, some of the commissioners had real concerns with
the limits of autonomy as it was characterized by Beauchamp and Childress
and as it had been defined in the second draft of The Belmont Report.
Beauchamp, “Origins, Goals, and Core Commitments”;
Beauchamp, “Origins and Evolution of The Belmont Report”; Tom L.
Beauchamp, “The Belmont Report” (working paper, 2004). Beauchamp and
Jonsen continue to disagree about many details relating to the history of The
Belmont Report (including who was primarily responsible for its content and
conceptual organization). Idem.; cf. Jonsen, Birth of Bioethics.
166
167
2004.
Karen Lebacqz, telephone conversation with the author, June 10,
92
Similarly, Beauchamp, who takes primary responsibility for drafting the final
version of The Belmont Report,168 had serious concerns about the principle of
respect for persons:
I thought at the time, and still do, that the Commission was confused in
the way it delineated the principle of respect for persons. It seemed to
blend two independent principles: a principle of respect for autonomy
and a principle of protecting and avoiding the causation of harm to
incompetent persons. 169
The commissioners’ concern about the limits of autonomy was
intertwined with the Commission’s previous work on fetal research. As I
mentioned above, the Commission’s report on the ethics of fetal research was
deemed time-sensitive and was therefore published prior to the
commencement of their work on The Belmont Report. In preparation for the
report, Research on the Fetus, Richard McCormick was commissioned to write
a paper entitled, “Experimentation on the Fetus: Policy Proposals.”170 In his
168
Beauchamp relates:
On my first morning in the office, Yesley told me that he was assigning
me full time to writing this paper [The Belmont Report] … In the next
few weeks I threw away virtually everything in this draft … I spent many
weeks drafting material on principles and then revising the drafts in
response to feedback from both staff and Commissioners … In this
respect the writing of this document was a joint product of
Commissioner-Staff interactions. However, most of the changes by
Commissioners concerned small matters, and Commissioners were
rarely involved in making written changes.
Beauchamp, “Origins, Goals, and Core Commitments,” 18.
169
Beauchamp, “Origins and Evolution of The Belmont Report.”
Richard A. McCormick, “Experimentation on the Fetus: Policy
Proposals,” in Appendix: Research on the Fetus (Washington, D.C.: U.S.
Government Printing Office, 1974), chap. 5.
170
93
paper, McCormick discussed an ongoing moral disagreement between himself
and Paul Ramsey about the ethics of research on children.171 Ramsey
advocated the position that children can never be subjects of nontherapeutic
research because they are unjustifiably harmed whenever they are used as a
means only rather than also as an end in themselves.172 McCormick, on the
other hand, argued that experimentation on children can be justified “where
there is no discernible risk or undue discomfort.”173 He felt that since we are
all members of the human community (including children) we have certain
obligations to each other, including the obligation to participate in certain kinds
of research.174 Lebacqz recalls McCormick explaining, “The child would
consent if the child could consent because the child should consent to
participating in this research.”175 The commissioners were strongly influenced
by McCormick’s description of people as relational beings who have certain
171
This disagreement between Ramsey and McCormick was most
visible during the years while The Belmont Report was being written. See
Richard A. McCormick, “Experimentation in Children: Sharing in Sociality,”
Hastings Center Report (December 1976); Paul Ramsey, “Children as
Research Subjects: A Reply,” Hastings Center Report (April 1977).
172
Idem.; Ramsey, Patient as Person.
McCormick, “Experimentation on the Fetus,” 5-3; Richard A.
McCormick, “Genetic Medicine: Notes on the Moral Literature,” Current
Theology (1972), reprinted in McCormick, Notes on Moral Theology, 401-22.
173
2004.
174
McCormick, “Experimentation on the Fetus,” 5-4.
175
Karen Lebacqz, telephone conversation with the author, June 10,
94
moral obligations to each other.176 This notion transcended the
commissioners’ work on fetal research and children. As we can see from their
debate about autonomy versus respect for persons it influenced the way they
identified the basic ethical principles for human subjects research.
Although there was significant support among the commissioners for
the identification of respect for persons as a fundamental guiding principle,
several commentators raised objections. Ironically, the most serious objection
came from Commissioner Lebacqz, who initially suggested that the National
Commission adopt the principle of respect for persons. She pointed out that it
is difficult to extrapolate from the principle of respect for persons how we are
supposed to relate to others.177 This raised the problem of the practical
applications of the principle, which the commissioners were instructed by
Congress to address.178 As some of the commissioners noted, respect for
persons is much broader than the principle of autonomy, but it may be too
broad. It is also more vague and more elusive than the principle of autonomy.
As is evident from the commissioners’ discussion, it is difficult to articulate
176
Ibid.
177 National Commission, “Transcripts of the 27th Meeting
Proceedings,” 101-2.
178
As mentioned above, the Congressional mandate instructed the
National Commission not only to “identify the basic ethical principles which
should underlie the conduct of biomedical and behavioral research involving
human subjects” but also to “develop guidelines which should be followed in
such research to assure that it is conducted in accordance with such
principles.” National Research Act, Public Law 93-348, codified at U.S.
Code 42 (July 12, 1974) sec. 2891.202(A)(1)(A).
95
what it means to respect persons. Given the nature of the commissioners’
work (to identify ethical principles to inform the legal regulation of research
practice), identifying a principle as broad and vague as respect for persons
could be problematic. From a legal perspective, laws that are overly vague
may be unconstitutional.179 As the United States Supreme Court has opined:
An enactment is void for vagueness if its prohibitions are not clearly
defined. Vague laws offend several important values. First, because
we assume that man is free to steer between lawful and unlawful
conduct, we insist that laws give the person of ordinary intelligence a
reasonable opportunity to know what is prohibited, so that he may act
accordingly. Vague laws may trap the innocent by not providing fair
warning. Second, if arbitrary and discriminatory enforcement is to be
prevented, laws must provide explicit standards for those who apply
them.180
Thus, the commissioners had a legitimate interest in ensuring not only that the
basic principles were clearly defined, but also that they could specify
unambiguous practical applications of those principles. After all, the DHEW
would ultimately have to translate those specific applications of the principles
into constitutionally-valid legal regulations. It is much easier to regulate the
various elements of informed consent181 than to command the respectful
179
Grayned v. City of Rockford, 92 S.Ct. 2294 (1972); Krichmar v.
State Bd. Of Vehicle Manufacturers, Dealers and Sales, 2004 WL 1176148
(Pa. Cmwlth. 2004); Planned Parenthood Federation of America v. Ashcroft,
2004 WL 1192708 (N.D.Cal. 2004).
180
Grayned, 92 S.Ct. at 2298-99.
181 The difficulty in regulating informed consent arises when IRBs and
researchers attempt to fulfill their legal obligations by administering lengthy
and complex consent forms that contain the eight basic elements identified
in the Common Rule as boilerplate instead of focusing on the subject’s
understanding of the information presented. This problem, however, could
be mitigated by adopting language in the regulations that focuses on subject
understanding instead of only on what information needs to be provided.
96
treatment of research subjects such that due recognition is given to their “full
human particularity.”182 Prohibiting research on a human being without his or
her fully informed consent presumably provides a person “of ordinary
intelligence a reasonable opportunity to know what is prohibited” while much
more work would need to be done to specify what is required and what is
prohibited by the general injunction to respect persons.183 It would not be
impossible to articulate such specifications, but respect for persons presents a
much larger philosophical challenge.
There is no evidence to support the suggestion that Commissioner
Lebacqz or any of the commissioners were explicitly concerned with the
validity of laws flowing from the Commission’s work, but given the sensitivity of
some of the commissioners’ about their role as a political body, it is
understandable that there would be concern about the practical implications of
their work. Regardless, Commissioner Lebacqz’s observation that respect for
persons is problematic as an action-guiding principle is important because it
See Protection of Human Subjects, Code of Federal Regulations, Title 45,
Part 46 (1991); Harold Y. Vanderpool, “Unfulfilled Promise: How the Belmont
Report Can Amend the Code of Federal Regulations Title 45 Part 46-Protection of Human Subjects,” in Ethical and Policy Issues in Research
Involving Human Participants, ed. National Bioethics Advisory Commission
(Bethesda, Md.: NBAC, 2001), sec. O, 1-20 (arguing that the language in the
Common Rule gives the false impression that all that IRBs should be
concerned with is the information that is given to subjects).
Engelhardt, “Basic Ethical Principles,” citing Fried, Medical
Experimentation.
182
183 Protection of Human Subjects, Code of Federal Regulations, Title
45, sec. 46.116 (1991).
97
highlights at least one obstacle that the commissioners faced (and that
persists today) in developing a robust concept of respect for research
subjects.
A second concern with the principle of respect for persons raised by
Commissioner Lebacqz was that it would be (mis)interpreted by individual
researchers as allowing them to impose their own values onto others, resulting
in unwarranted intrusions on individual autonomy. For example, she argued,
no one should be able to prevent a woman from participating in research in
order to ensure that she is able to fulfill her moral obligations to others by, say,
cooking dinner.184 These types of concerns raised by Commissioner Lebacqz
suggest that she had thought seriously about the principle of respect for
persons. She ultimately favored the adoption of respect for persons because
it is better equipped as a moral principle to account for the social nature of
individuals, yet she struggled (and continues to struggle) over its practical
implications.185
National Commission, “Transcripts of the 27th Meeting
Proceedings,” 101-2.
184
185 This tension is something that Karen Lebacqz continues to
struggle with today. She consistently argues for a principle of respect for
persons that pays serious attention to individuals as “embodied” and
“embedded” within communities, yet struggles with the policy implications of
that.
If we take seriously our embeddedness in communities then does that
mean that communities should have certain kinds of rights over
individuals? Or does it mean that in addition to individual consent we
should also be seeking community consent? I don’t know the answer to
that.
Karen Lebacqz, telephone conversation with the author, June 10, 2004.
98
Stephen Toulmin was less concerned with the semantics around the
principle. He recognized that there would be unresolved disagreements about
what the appropriate principle was, but felt confident that if the commissioners
could focus on the practical application of the principles then they could
achieve consensus.186 He mentioned, however, another objection to the
principle of respect for persons, which is that it muddles the principles of
autonomy and beneficence.187 This is one of Tom Beauchamp’s strongest
186 National Commission, “Transcripts of the 27th Meeting
Proceedings.” Toulmin and Jonsen went on to write a book, in which they
describe this aspect of the National Commission’s work and cite it as an
example of the use of casuistry as an approach to ethical dilemmas:
So long as the debate stayed on the level of particular judgments, the
eleven commissioners saw things in much the same way. The moment
it soared to the level of “principles,” they went their separate ways.
Instead of securely established universal principles, in which they had
unqualified confidence, giving them intellectual grounding for particular
judgments about specific kinds of cases, it was the other way around …
The locus of certitude in the commissioners’ discussions did not lie in an
agreed set of intrinsically convincing general rules or principles, as they
shared no commitment to any such body of agreed principles. Rather,
it lay in a shared perception of what was specifically at stake in
particular kinds of human situations.
Jonsen and Toulmin, Abuse of Casuistry, 18.
National Commission, “Transcripts of the 27th Meeting
Proceedings,” 28. Note, however, that this is only a concern if one views
respect for persons as a fundamental principle that incorporates the principle
of autonomy and competes with the principle of beneficence. If one views
respect for research subjects as an overarching normative category (as I
suggest one ought to), then it can be viewed as incorporating both the
principle of respect for autonomy and the principle of beneficence without
“muddling” the two.
187
99
criticisms of respect for persons, which led him to abandon it in his own book,
Principles of Biomedical Ethics.188
Finally, Commissioner Brady raised a stylistic concern with adopting the
principle of respect for persons. He felt that respect for persons did not fit
grammatically as well with beneficence and justice; “autonomy, beneficence,
and justice” simply sounds better, he argued, than “beneficence, justice, and
respect for persons.”189 While this seems like a trivial complaint, it exemplifies
my very point. Many of the commissioners themselves thought these terms
were synonymous and interchangeable. Some of them recognized this
problem and attempted to correct it. As a result, they adopted the language of
respect for persons in the final version of The Belmont Report, but perpetuated
its conflation with autonomy by defining it primarily in those terms. This, then,
becomes the legacy of The Belmont Report. It impacts not only the field of
research ethics and policy, but it also influences the broader bioethics
discourse.
Definition and Application of the Principle of Respect
for Persons
Beauchamp, “Origins, Goals, and Core Commitments”;
Beauchamp and Childress, Principles of Biomedical Ethics (1979).
188
189 National Commission, “Transcripts of the 27th Meeting
Proceedings,” 91-92.
100
The final draft of The Belmont Report defined respect for persons as
“incorporat[ing] at least two basic ethical convictions: first, that individuals
should be treated as autonomous agents, and second, that persons with
diminished autonomy are entitled to protection.”190 There are at least three
problems with this definition of the principle of respect for persons. First, it
reduces the principle of respect for persons to respect for people’s autonomy.
Autonomy may be an element of a more fundamental notion of respect for
persons, but respect for persons must include more. Otherwise, our moral
obligation to treat people with respect is limited to non-interference with their
autonomous choices. This ignores other elements of respect that transcend
the realm of individual decision making and disregards nonautonomous
individuals completely.
The National Commission recognized this problem and attempted to
remedy it by doing two things. First, it included under the principle of respect
for persons the injunction to protect individuals with diminished autonomy from
harm. Second, it suggested that the principle of respect for persons includes
other elements as well. Both of these actions, while well-intentioned, proved
problematic.
By including an ethical obligation to protect nonautonomous individuals
from harm under the principle of respect for persons, the National Commission
acknowledged that these individuals deserve respect, but then failed to specify
what that entails beyond a beneficence-based obligation of protection. Thus,
190
National Commission, Belmont Report, 4.
101
the principle of respect for persons gets muddled, not only with the principle of
autonomy, but also with the principle of beneficence.191 While respecting an
individual’s considered choices, protecting an individual from harm, and
promoting an individual’s welfare may all be done out of respect for that
person, classifying respect as one of several competing ethical principles and
defining it solely in terms of two other principles (respect for autonomy and
beneficence) creates confusion and leaves an incomplete impression of what
is required to respect research subjects.192
The National Commission attempted to address this problem by
maintaining that the principle of respect for persons incorporates at least two
basic ethical convictions (autonomy and protection for nonautonomous
individuals). This implies that there could be other ethical convictions
subsumed under the principle of respect for persons, but the National
Commission did not address (or even suggest) what these might be. By
limiting its discussion to these two ethical convictions, the National
Commission gave the impression that they are the only defining characteristics
of respect for persons. This suspicion was affirmed by the statement: “The
principle of respect for persons thus divides into two [only two?] moral
191 This is a common criticism of the principle of respect for persons
as it is articulated in The Belmont Report. See Beauchamp, “Origins, Goals,
and Core Commitments”; Robert M. Veatch, “Resolving Conflicts among
Principles: Ranking, Balancing, and Specifying,” Kennedy Institute of Ethics
Journal 5, no. 3 (1995): 199-218.
Veatch argues that, while “autonomy may be an element of a more
fundamental notion of respect for persons, … it seems that the duty to serve
the welfare of the incompetent is straightforwardly a part of the duty of
beneficence.” Veatch, “Resolving Conflicts among Principles,” 204.
192
102
requirements: the requirement to acknowledge autonomy and the requirement
to protect those with diminished autonomy.”193
In the remaining four paragraphs under “respect for persons” in The
Belmont Report the National Commission defined respect for autonomy,
discussed how to deal with persons with diminished autonomy (i.e., protect
them), and explained what to do when competing claims arising out of the
principle of respect for persons itself emerge (i.e., balance them). Those that
accept the received view that protection of nonautonomous individuals is more
appropriately subsumed under the duty of beneficence are thus left with the
impression that autonomy is the only thing that needs to be respected in
people. This was validated by the National Commission’s exclusive
application of the principle of respect for persons to the requirement for
informed consent.
In the applications section of The Belmont Report, the National
Commission said,
Respect for persons requires that subjects, to the degree that they are
capable, be given the opportunity to choose what shall or shall not
happen to them. This opportunity is provided when adequate standards
for informed consent are satisfied.194
It went on to discuss three elements of the consent process: information,
comprehension, and voluntariness. The commissioners were careful to
explain that informed consent is not only about “a simple listing of items,” but
193
National Commission, Belmont Report, 4-5.
194
Ibid., 10.
103
also about “the manner and context in which the information is conveyed.” 195
By emphasizing the importance of subject comprehension and voluntariness
and by grounding the requirement for informed consent in the principle of
respect for persons instead of self-determination, the commissioners tried to
address the concern raised by Robert Levine that the informed consent
process could become a script instead of a dialogue between researcher and
subject.196
Rooting informed consent in the principle of respect for persons may
have conveyed a more embodied understanding of the process of informed
consent, but at the same time, it implied a narrow interpretation of respect for
persons. By applying the principle of respect for persons exclusively to
informed consent, the National Commission insinuated that this is the only
moral requirement that arises out of the ethical duty of respect for research
subjects (or at least the only one worthy of discussion, and thus worthy of our
attention).
Commissioner Lebacqz, in a recent unpublished article, claimed that
the commissioners did not intend for the principle of respect for persons to
become synonymous with respect for autonomy, but rather “left open the
possibility that there would be additional important ‘convictions’ covered by this
fundamental principle [of respect for persons].”197 She argued that since The
195
Ibid., 11-12.
National Commission, “Transcripts of the 15th Meeting
Proceedings,” 276.
196
197
Lebacqz, “Twenty Years Older but Are We Wiser?”
104
Belmont Report was published in 1979, two things have happened that
“truncate and diminish this fundamental principle. First, respect for persons
became interpreted solely in the language of respect for autonomy. Second,
autonomy itself became interpreted in truncated ways.” 198 Lebacqz is an
advocate for a more communal understanding of respect for persons that
emphasizes the importance of mutuality, community, solidarity, and empathy.
While I largely agree with Commissioner Lebacqz, I believe that The
Belmont Report actually facilitated the trend in bioethics to diminish the
meaning of respect for persons. By linking respect for persons with autonomy
and applying it exclusively to the requirement for informed consent, the
National Commission sent the message that respect for persons is
synonymous with respect for individual autonomy. If the National Commission
did in fact intend for the principle of respect for persons to be interpreted more
broadly (as Commissioner Lebacqz claims and the transcripts indicate they
did), then as Harold Vanderpool has pointed out, “a sentence or two could
have clarified some of the confusion.”199
198
Ibid.
199
Vanderpool, “Unfulfilled Promise,” 8.
105
CHAPTER 4
THE SHORT LIFE OF “RESPECT FOR PERSONS”
AS A GUIDING ETHICAL PRINCIPLE
The marginalization of respect as a guiding normative obligation in
bioethics can be seen most vividly by examining three influential publications
in the field of bioethics: Principles of Biomedical Ethics, by Beauchamp and
Childress; Making Health Care Decisions, the report of the President’s
Commission for the Study of Ethical Problems in Medicine and Biomedical and
Behavioral Research (President’s Commission); and the Encyclopedia of
Bioethics. The principle of respect for persons was explicitly reduced to the
principle of autonomy in Principles of Biomedical Ethics. Not
inconsequentially, this was done the same year that The Belmont Report was
published and by the very person who takes responsibility for writing the final
version of The Belmont Report (Tom Beauchamp). The principle of autonomy
was further reduced as synonymous with self-determination by the President’s
Commission, the advisory council that succeeded the National Commission.
Finally, the marginalization of respect for persons can be most acutely
observed in the Encyclopedia of Bioethics, the most comprehensive reference
book in bioethics.200 There have been three editions of the Encyclopedia of
200
The third edition of the Encyclopedia of Bioethics has 457 articles
by more than 500 experts from eighteen major disciplines. Stephen G. Post,
ed., Encyclopedia of Bioethics, 3rd ed. (New York: McMillan Reference,
2004).
106
Bioethics published since 1979 and none of them has contained a serious
discussion of the concept respect or the principle of respect for persons.
“Respect for Persons” and “Autonomy”: Principles of
Biomedical Ethics
The first edition of Principles of Biomedical Ethics (PBE) was published
in 1979, the same year as The Belmont Report was published. PBE is
currently in its fifth edition and is considered “one of the most important basic
texts for medical ethics.”201 It was written collaboratively by Tom Beauchamp,
a philosopher, and James Childress, a theologian. They began working on
PBE in 1976, the same year that the first draft of The Belmont Report was
written.202
PBE presents four prima facie moral principles: autonomy (which later
became respect for autonomy), beneficence, nonmaleficence, and justice.
These principles are nearly identical to those promulgated in The Belmont
Report, but, significantly, respect for persons is replaced with autonomy.
Beauchamp, who, as I mentioned above, joined the staff of the National
Commission in January 1977 and takes primary responsibility for writing the
final draft of The Belmont Report,203 has acknowledged the enormous overlap
between his work on the Report and his work on PBE. In fact, he has claimed
201
Bulletin of Medical Ethics, review of Principles of Biomedical
Ethics, 5th ed., by Tom L. Beauchamp and James F. Childress (2001), back
cover.
202
Beauchamp, “Origins, Goals, and Core Commitments.”
203
Ibid.
107
that much of the material that he wrote for The Belmont Report ultimately
wound up in PBE:
I wrote much more for the commission about respect for persons,
beneficence, and justice than eventually found its way into The Belmont
Report. As this material was eliminated, I would scoop up the reject
pile and fashion it for Principles of Biomedical Ethics, which at this point
(roughly the summer of 1977) was more than 75 percent complete.
One might say that various late-written chunks of this book were
fashioned from the more philosophical, but abjured parts of what I wrote
for the commission, the parts that never found the light of day.
Undoubtedly my work at the commission accounts for the significant
percentage of material on research ethics found in the first edition of
Principles.204
At the same time, however, Beauchamp has denied intellectual ownership of
The Belmont Report and has maintained that to the extent that there are
inconsistencies between The Belmont Report and PBE, his personal views are
those expressed in PBE:
Once I grasped the moral vision of the National Commission initiated at
Belmont, I could see that Childress and I had major substantive
disagreements with the Commission. The principles articulated in the
Belmont Report are three principles with names bearing notable
similarities to some of the names Childress and I were using and
continued to use, but the two schemas of principles are far from
constituting a uniform name, number, or conception. Indeed, the two
frameworks are not coherent … From this point forward, I attempted to
analyze principles for the Commission exclusively as I thought
Commissioners would find acceptable. Principles of Biomedical Ethics
became the only work that reflected my own deepest philosophical
convictions about principles.205
204
Ibid., 22.
205
Beauchamp, “Origins and Evolution of The Belmont Report.”
108
There are several aspects of The Belmont Report that Beauchamp and
Childress fundamentally disagreed with, including its adoption of the principle
of respect for persons. Beauchamp believed (and continues to believe) “that
the commission was confused in the way it delineated the principle of respect
for persons.”206 His primary objection was that “it seemed to blend two
independent principles: a principle of respect for autonomy and a principle of
protecting and avoiding the causation of harm to incompetent persons.”207
This led Beauchamp and Childress to abandon the principle of respect for
persons in PBE and to replace it with the principle of autonomy. This may
have reduced confusion about the distinction between the principle of
autonomy and the principle of beneficence, but it intensified the perception
that respect for persons means no more than respect for people’s autonomous
decisions.
The fact that two of the most influential writings on the fundamental
principles in bioethics were published the same year and identified virtually the
same principles (except that one identified autonomy as a fundamental
principle and the other identified respect for persons, which it then defined as
incorporating the principle of autonomy), contributed to the confusion about
the difference between respect for persons and autonomy. The fact that both
the principle of respect for persons and the principle of autonomy were
credited in these publications with giving rise to the obligation of informed
206
Ibid., 23.
207
Ibid.
109
consent did not help. Furthermore, Beauchamp and Childress explicitly
conflated these two principles in PBE when they said,
Respect for persons is commonly expressed in biomedical ethics
through the principle of autonomy. Not to solicit consent for treatment
from patients or for participation in research from subjects is to violate
their autonomy and to fail to respect them as persons. But consent
cannot express autonomy unless it is informed, and it therefore
depends on communication and ultimately on truth telling. Thus, a duty
of veracity can be derived from a principle of respect for persons or
autonomy.208
They continued to use these terms interchangeably throughout the second
edition of PBE. For example, when discussing nondisclosure of information,
or “benevolent deception,” Beauchamp and Childress said,
The more compelling objections to “benevolent deception” stress
violations of the principles of respect for persons and fidelity, as well as
the long-term threat to the relationship of trust between physicians and
patients …
Even if such cases do not seriously threaten the relationship of trust,
they involve violations of the principles of fidelity and autonomy.209
This passage suggests that respect for persons and autonomy are
indistinguishable.
This assertion was made explicit in the third edition of PBE (published
in 1989). Beauchamp and Childress acknowledged in the third edition that
one could interpret the principle of respect for persons as broader than respect
208
Tom L. Beauchamp and James F. Childress, Principles of
Biomedical Ethics, 2nd ed. (New York: Oxford University Press, 1983), 222
(emphasis added).
209
Ibid., 225 (emphasis added).
110
for autonomy, but they rejected this position, without any explanation or
justification.
An alternative (although not one that we pursue or defend here) is to
emphasize a broader view of respect for persons than respect for their
autonomy and to assign derivative rights of privacy to nonautonomous
persons through a general standard of respect for human dignity. 210
By the fourth edition of PBE, the principle of respect for persons all but
disappeared. It is mentioned at least ten times in the third edition, but only
four times in the fourth edition and twice in the fifth (once in a footnote and
once in a discussion of the problems associated with considering social worth
when making decisions about the allocation of scarce resources).211 By the
fifth edition, Beauchamp and Childress did not even bother to mention the
alternative of “a broader view of respect for persons than respect for their
autonomy.”212 Presumably, by 2001, this “alternative” view had become so
marginalized in bioethics that it was, in their opinion, irrelevant.
Childress recently referred to PBE as a “work in progress,”213 which it
most certainly is. Through its five editions, Beauchamp and Childress have
made substantial substantive changes in response to many of their critics. For
210
Tom L. Beauchamp and James F. Childress, Principles of
Biomedical Ethics, 3rd ed. (New York: Oxford University Press, 1989), 322.
211 These numbers are based on the number of pages listed under the
entry “respect, for persons” in the index of each edition.
212
Beauchamp and Childress, Principles of Biomedical Ethics, 5th ed.
James F. Childress, “Principles of Biomedical Ethics: Reflections
on a Work in Progress,” in The Story of Bioethics: From Seminal Works to
Contemporary Exploration, ed. Jennifer K. Walter and Eran P. Klein
(Washington, D.C.: Georgetown University Press, 2003), 47-66.
213
111
example, in the first two editions of PBE, the principle of autonomy was
defined rather narrowly as “a right of noninterference and correlatively an
obligation not to constrain autonomous actions—nothing more but also
nothing less.”214 In the third edition, however, the principle of autonomy was
expanded into the principle of respect for autonomy, and the negative
injunction to avoid controlling or interfering with a person’s autonomous
actions was enhanced with “a positive or affirmative obligation of respectful
treatment in disclosing information and fostering autonomous decision
making.”215
By the fifth edition, criticisms similar to those raised by the National
Commission in 1977 about the limits of autonomy resulted in an even broader
interpretation of the principle of respect for autonomy. Addressing their critics,
Beauchamp and Childress attempted to stretch the principle of respect for
autonomy to account for what commissioners Jonsen and Ryan referred to,
fourteen years earlier, as the social nature of human beings216 and to consider
the emotions and social practices of individuals. As Beauchamp and
Childress explained,
214
ed., 62.
215
ed., 73.
Beauchamp and Childress, Principles of Biomedical Ethics, 2nd
Beauchamp and Childress, Principles of Biomedical Ethics, 3rd
216 National Commission, “Transcripts of the 27th Meeting
Proceedings,” 57-58, 97-98.
112
We aim to construct a conception of respect for autonomy that is not
excessively individualistic (neglecting the social nature of individuals
and the impact of individual choices and actions on others), not
excessively focused on reason (neglecting the emotions), and not
unduly legalistic (highlighting legal rights and downplaying social
practices).217
Conceptualizing the principle of respect for autonomy in such broad terms
enabled Beauchamp and Childress to expand its application beyond a mere
requirement for informed consent. Respect for autonomy in this expanded
sense, was thus better able to support various moral rules that inform our
respectful treatment of individuals, including truth-telling, respect for the
privacy of others, protection of confidential information, and the obligation to
help others make important decisions when asked.218
Delineated in this manner, respect for autonomy is able to account for
at least some of the “ethical convictions” incorporated in a more robust
definition of respect for persons. However, replacing the language of respect
for persons with respect for autonomy has the unfortunate effect of defining
persons exclusively in terms of their autonomy. 219 It also suggests that we
ought to treat people respectfully (by respecting their privacy and telling them
the truth, for example) simply because they have autonomously chosen “not to
be observed, touched, or intruded upon” or because they need honest
217
ed., 57.
Beauchamp and Childress, Principles of Biomedical Ethics, 5th
218
Ibid., 65.
219
Lebacqz, “Twenty Years Older but Are We Wiser?”
113
disclosure in order to make autonomous decisions.220 Thus, we respect
people only insofar as they are capable of autonomous choice and only in
regard to their decision making activities. This continues to ignore
nonautonomous individuals and fails to justify our moral obligations of respect
outside the context of decision making.
The problems associated with a truncated conception of respect for
persons as synonymous with respect for autonomy become even more
troublesome when autonomy is defined narrowly as a negative right of
freedom from interference. While Beauchamp and Childress have attempted
in their later editions of PBE to avoid this, the reduction of the principle of
autonomy into a right of self-determination can be found elsewhere, most
notably in the President’s Commission’s report, Making Health Care
Decisions.
“Autonomy” and “Self-Determination”: Making Health
Care Decisions
In 1978, shortly before the National Commission was to expire, the
Senate passed a bill (S.2579) establishing the President’s Commission for the
Study of Ethical Problems in Medicine and Biomedical and Behavioral
Research (President’s Commission). The President’s Commission was similar
to the National Commission in that it was composed of eleven members with
“the same degree of diversity of expertise and background” as was
220
ed., 296.
Beauchamp and Childress, Principles of Biomedical Ethics, 5th
114
represented on the National Commission.221 Its members, however, would
serve limited terms of four years (with a maximum of two terms served), which
were staggered so that each year “new expertise” would be “infused” into the
Commission.222 In order to maintain some consistency between the
President’s Commission and the National Commission, two members of the
National Commission were asked to serve on the President’s Commission,
ethicist Albert Jonsen and lawyer Patricia King.223
The jurisdiction and scope of activities assigned to the President’s
Commission, however, was broader than that of the National Commission. Its
jurisdiction was “expanded to cover all subjects of biomedical and behavioral
research regardless of Federal funding source” and it was “upgraded and
made a Presidential Commission in order to reflect [its] important and
expanded mandate.”224 This meant that all of its members were appointed by
the President and the Chairman had to be approved by the Senate. Finally, its
mandate was broader in scope than the National Commission’s; in addition to
221
Senate Committee on Human Resources, President's Commission
for the Protection of Human Subjects of Biomedical and Behavioral
Research Act of 1978, 95th Cong., 2nd sess., May 15, 1978, S. Rep. 95852, 15.
222
Ibid., 16.
223
Jonsen, Birth of Bioethics, 108.
224
Senate Committee on Human Resources, President's Commission
for the Protection of Human Subjects of Biomedical and Behavioral
Research Act of 1978, 95th Cong., 2nd sess., May 15, 1978, S. Rep. 95852, 4.
115
conducting “studies on the ethical, social, and legal implications of advances in
biomedical and behavioral research” the President’s Commission was
instructed to study the implications of
technology and of resource allocation decisions concerning health care
research and delivery, … to conduct studies on the requirements for
informed consent by patients before they receive medical treatment; on
the matter of defining death; on the ethical, moral, social and legal
implications of voluntary testing, counseling, and information and
education programs with respect to genetic diseases and conditions;
and on the current procedures and mechanisms designed to safeguard
the privacy of research subjects, to ensure confidentiality of patient
records, and to ensure appropriate access to information contained in
such records by patients.225
Some of the members of the President’s Commission, including
Commissioner Jonsen, had hoped that it would begin its work on these various
topics with some “general statement of a moral stance” similar to The Belmont
Report.226 Jonsen suggested that, while the National Commission focused
primarily on individual rights, the President’s Commission ought to “explicitly
shift this focus and take as its theme and analytic framework the problem of
how the common good of society could be promoted, with the protection of
individual rights as a moral constraint on this goal.”227 It never formulated
such a statement. Commissioner Jonsen explained that the President’s
Commission’s staff took his suggestion seriously and wrote “an elegant essay
225
Ibid., 5.
226
Jonsen, Birth of Bioethics, 109.
227
Ibid.
116
running that theme through the various mandates of the Commission.” This
“stimulated a rich discussion” but never materialized into anything more.228
In its final report, Summing Up, 229 the President’s Commission
explained that it explicitly avoided developing its own general statement of
ethics similar to The Belmont Report because it did not believe that this was
part of its assignment. As the commissioners explained,
The Commission has made no attempt to develop a comprehensive
theory of bioethics: its assignment from Congress was not to develop
theories but, more practically, to consider the implications of particular
practices and developments in the life sciences.230
The President’s Commission quickly learned, however, that it could not
adequately consider these issues without appealing to more general ethical
principles. Having failed to develop its own moral perspective, the
Commission approached each topic that it was instructed to study armed only
with the general principles articulated in The Belmont Report and in Principles
of Biomedical Ethics. In its final report, the President’s Commission
acknowledged its appeal to the principles of well-being, respect, and justice,
citing The Belmont Report and Principles of Biomedical Ethics as evidence
that these principles are especially important “in evaluating the ethical
implications of decisions, actions, and policies in medicine and biomedical and
228
Ibid.
President’s Commission for the Study of Ethical Problems in
Medicine and Biomedical and Behavioral Research, Summing Up: Final
Report on Studies of the Ethical and Legal Problems in Medicine and
Biomedical and Behavioral Research (Washington, D.C.: U.S. Government
Printing Office, March 1983).
230 Ibid., 66.
229
117
behavioral research.”231 This helps to explain why, despite Commissioner
Jonsen’s suggested framework for the President’s Commission’s work, it has
been criticized for being overly focused on individualism and individual rights,
specifically rights of autonomy and self-determination.232 This emphasis on
individual rights is evident in the President’s Commission’s interpretation and
implementation of the principle of respect for persons.
The President’s Commission acknowledged its appeal to the principle
of respect for persons in its various reports. In its final report, Summing Up, it
specified several ways in which we show respect for people in the health care
setting:
[By ensuring that] patients be given information about the possible
courses of action and that their choices about health care be honored
whenever possible, that the legitimate expectations of privacy be
safeguarded (that is, that individuals retain control over use of private
information about them), and that health care professionals not be
required to act contrary to their consciences or their values.233
On the one hand, this definition of respect for persons is more expansive than
the National Commission’s. By including expectations of privacy and
expanding the notion of respect to health care professionals, the President’s
Commission seems to have moved us towards a more complete moral
231
Ibid., 67.
Jonsen, Birth of Bioethics, 117; Daniel Callahan, “Morality and
Contemporary Culture: The President’s Commission and Beyond,” Cardozo
Law Review 6 (1984): 347-55; Christine Cassel, “Deciding to Forego LifeSustaining Treatment: Implications for Policy in 1985,” Cardozo Law Review
6 (1984): 287-302.
233 President’s Commission, Summing Up, 68.
232
118
account of the principle of respect for persons. Yet, it failed to develop this
expansive notion of respect for persons in its other published reports. Instead,
the President’s Commission focused almost exclusively on the right of selfdetermination, which it described as one aspect of the broader principle of
respect for persons.
The President’s Commission defined the principle of self-determination
in its final report by turning to the National Commission’s definition of respect
for persons: “that individuals should be treated as autonomous agents, and …
that persons with diminished autonomy are entitled to protection.”234 Thus, the
President’s Commission seems to have taken a step forward by differentiating
the principle of self-determination from other aspects of the principle of respect
for persons. At the same time, by defining self-determination exactly as the
National Commission defined respect for persons, without any explanation or
qualification, the President’s Commission implicitly reduced the principle of
respect for persons as it was identified by the National Commission into a
negative right of self-determination or freedom from interference. Whereas
substituting the principle of respect for persons with the principle of autonomy
diminished the depth of our ethical deliberations, reducing the concept of
respect for persons to a right of self-determination significantly confounded our
ethical standards with what should remain minimum legal requirements.
The President’s Commission not only reduced the principle of respect
for persons to a right of self-determination, but also failed to distinguish self-
234
Ibid., quoting National Commission, Belmont Report.
119
determination from the principle of autonomy. In its report, Making Health
Care Decisions: The Ethical and Legal Implications of Informed Consent in the
Patient-Practitioner Relationship,235 the President’s Commission used the
terms self-determination and autonomy interchangeably. It discussed the
importance of respecting self-determination (which it says is sometimes
termed “autonomy”) in the context of medical decision making. It went on to
define self-determination (or autonomy, as it is sometimes called) as “an
individual’s exercise of the capacity to form, revise, and pursue personal plans
for life.”236 This reduced the definition of autonomy to “a right of individuals to
make decisions for themselves without interference from others.”237 This
freedom of choice grounds the legal requirement for informed consent,238 but
as Karen Lebacqz declared, the logical outcome of reducing the principle of
respect for persons into autonomy and autonomy into self-determination “is
235 President’s Commission for the Study of Ethical Problems in
Medicine and Biomedical and Behavioral Research, Making Health Care
Decisions: The Ethical and Legal Implications of Informed Consent in the
Patient-Practitioner Relationship, vols. 1-3 (Washington, D.C.: U.S.
Government Printing Office, October 1982).
236
Ibid., 44.
237 Jay Katz, The Silent World of Doctor and Patient (New York: Free
Press, 1984), 105.
238
The legal doctrine of informed consent is rooted in the right of selfdetermination. This was expressed most unequivocally by Justice Cardozo
in 1914: “Every human being of adult years and sound mind has a right to
determine what shall be done with his own body.” Schloendorff v. Society of
New York Hospitals, 211 N.Y. 125, 105 N.E. 92 (1914). See also Natanson
v. Kline, 186 Kan. 393, 350 P.2d 1093 (1960); Canterbury v. Spence, 464
F.2d 772 (1972).
120
that the broad-ranging principle of ‘respect for persons’ is then truncated into
the rule of ‘informed consent.’”239
The reduction of autonomy to a right of self-determination was
perpetuated by Ruth Faden and Tom Beauchamp in their legendary book, A
History and Theory of Informed Consent, published in 1986.240 Faden and
Beauchamp correctly identified the legal basis of informed consent as the
general right of self-determination. They went on, however, to equate this
common law right of self-determination with the ethical principle of
autonomy.241 This narrow conception of autonomy as a right of
noninterference is consistent with Beauchamp’s definition of autonomy in the
second edition of Principles of Biomedical Ethics. It took Beauchamp three
more years after A History and Theory of Informed Consent was published to
re-delineate the principle of autonomy as the principle of respect for autonomy,
and to incorporate a positive obligation of “respectful treatment in disclosing
information and fostering autonomous decision making.”242
There were some scholars, however, in the early 1980s that recognized
the problem of a truncated interpretation of autonomy as synonymous with
self-determination and argued against it. For example, Jay Katz distinguished
239
Lebacqz, “Twenty Years Older but Are We Wiser?”
240
Faden and Beauchamp, History and Theory of Informed Consent.
241
Ibid.
242
Beauchamp and Childress, Principles of Biomedical Ethics, 3rd
ed., 73.
121
autonomy (or “psychological autonomy” as he calls it) from self-determination
by defining autonomy as a person’s capacity to reflect about and make
choices. Self-determination, on the other hand, deals only with a person’s
right to choose, according to Katz. Thus, Katz concluded, “psychological
autonomy is a concept that ‘informs’ the right to self-determination by
explaining, refining, and pointing up human capacities and incapacities for the
exercise of such a right.”243 Gerald Dworkin argued this point in a paper
commissioned in 1982 for the President’s Commission’s study on Making
Health Care Decisions. He maintained:
Autonomy is a richer notion than liberty, which is conceived either as
mere absence of interference or as the presence of alternatives. It is
tied up with the idea of being a subject, of being more than a passive
spectator of one’s desires and feelings. … [Autonomy involves] the
capacity to reflect upon one’s motivational structure and to reflect
critically upon one’s first-order preferences and desires, and the ability
to either identify with these or to change them in light of higher order
preferences and values.244
The President’s Commission, however, did not adopt this distinction in its final
Report. By failing to take Dworkin’s suggestion seriously, the President’s
Commission perpetuated the reduction of autonomy into self-determination
and contributed to the marginalization of the principle of respect for persons in
bioethics.
243
Katz, Silent World, 105-6.
244 Gerald Dworkin, “Autonomy and Informed Consent,” in President’s
Commission for the Study of Ethical Problems in Medicine and Biomedical
and Behavioral Research, Making Health Care Decisions: The Ethical and
Legal Implications of Informed Consent in the Patient-Practitioner
Relationship (Washington, D.C.: U.S. Government Printing Office, October
1982), vol. 3, 63-81, 70-71.
122
The Marginalization of “Respect for Persons”:
Encyclopedia of Bioethics
The first edition of the Encyclopedia of Bioethics (EB1) was published in
1978. It was the first major reference book in what was (and still is) a
developing field of inquiry. Its compilation was ambitious; its achievement
astonishing. The EB1 was unique in that it was an encyclopedia, offering
comprehensive information about a particular subject, but since the field of
bioethics was still in its infancy in the 1970s, many of the issues that were
discussed were novel. Thus, unlike most encyclopedias, instead of simply
reflecting common themes in a particular field, the EB1 influenced the
development of the field of bioethics in important ways. As its editor-in-chief,
Warren T. Reich believed,
the first edition of the EB (Reich 1978) played a major role in
establishing the field of bioethics, formulated the most widely accepted
definition of bioethics, defined the scope of the field, provided the first
organization of knowledge for this field, and articulated standards for
bioethics scholarship.245
The second edition of the Encyclopedia of Bioethics (EB2) was
published in 1995. By that time, the field of bioethics had matured
significantly; many bioethics textbooks had been written, numerous large
“centers” for bioethics had opened, graduate programs in bioethics had been
established, and the practice of bioethics had permeated and influenced the
Warren T. Reich, “Shaping and Mirroring the Field: The
Encyclopedia of Bioethics,” in The Story of Bioethics: From Seminal Works
to Contemporary Exploration, ed. Jennifer K. Walter and Eran P. Klein
(Washington, D.C.: Georgetown University Press, 2003), 165-96, 165.
245
123
regulation, legislation, and practice of medicine and medical research. Many
of the issues that were novel or nonexistent in 1978 had been discussed and
debated at length by 1995. Of course, there are always new and unexplored
issues in bioethics and as social attitudes, behaviors, and circumstances shift
so too does the focus of bioethicists. Thus, the second edition of the EB
served a dual role; it reflected the current status of the field in 1995, but it also
contributed to its changing nature. Again, editor-in-chief Reich explained, “I
regard the first edition of the EB as having had the function of shaping the
field, while the second edition began the process of mirroring the field while
continuing the function of shaping it.”246
Finally, the third edition of the Encyclopedia of Bioethics (EB3) was
published just this year (2004). It was the most comprehensive edition of the
encyclopedia, with 457 articles, written by more than 500 experts from 18
major disciplines.247 There were 120 new articles and 200 revised articles,
reflecting the continued growth and changing nature of the field. EB3 had a
new editor-in-chief, Stephen G. Post, but retained the ambitious vision and
lofty goals set by Reich more than twenty-five years ago: “to prepare a work
that would be characterized by the comprehensiveness and accuracy that
speak to the specialist, coupled with the accessibility of style required for the
broad dissemination of knowledge.”248
246
Ibid.
247
The first edition of the Encyclopedia contained 315 articles by 285
contributors, while the second edition had 464 articles by 437 contributors.
Ibid., 171.
248
Ibid., 170.
124
As the most comprehensive reference guide in bioethics, the
Encyclopedia of Bioethics is a valuable tool for tracing developments, trends,
and changes in the field over the last twenty-five years. Through its three
editions, the history and development of any particular topic in bioethics can
be explored. The extensive index to all three editions (prepared by
professional encyclopedia indexers hired by the publisher, Macmillan
Reference) makes this task possible.
Exploring the topic of respect for persons in this manner reveals that
the evolution of the EB reflects the devolution of the concept of respect in
bioethics. There is no serious discussion of respect or the principle of respect
for persons in any of the editions of the EB. The first edition was published in
1978, the year before both The Belmont Report and Principles of Biomedical
Ethics were published. The concept “respect” was indexed in the EB1, but
“respect for persons” was not. The importance of respecting persons was
discussed in a few articles, most notably, the article on care. Reich recently
recalled that in 1978 “the notion of care was almost totally undeveloped” in the
health care context.249 Thus, he explained, this is one example of the way in
which the EB1 shaped the field of bioethics. The ethics of care had generated
some discussion in the early 1970s, particularly in response to Raymond Duff
and A.G.M. Campbell’s 1973 article “Moral and Ethical Dilemmas in the
Special-Care Nursery,” in which they reported on the practice of discontinuing
249
Ibid.
125
treatment for some premature infants and allowing them to die.250 This article,
along with the highly publicized case of an infant born with Down’s syndrome
at John’s Hopkins whose parents refused a relatively minor surgery to correct
duodenal atresia, generated much discussion and debate on the ethics of
caring for newborn patients.251 Stanley Hauerwas built on this dialogue and
discussed the concept of care more generally in the EB1. Relying on the work
of Paul Ramsey,252 Charles Fried,253 and Edmund Pellegrino,254 Hauerwas
called for an ethic of care and compassion in medical practice and
emphasized the importance of the ethical injunction to respect persons.255 To
provide compassionate care to a patient, he explained, “is to respect the
uniqueness of each patient by helping the patient to make those choices that
are best for him or her.”256 Hauerwas emphasized the importance of respect
Raymond S. Duff and A. G. M. Campbell, “Moral and Ethical
Dilemmas in the Special-Care Nursery,” New England Journal of Medicine
289 (1973): 890-94.
250
Richard A. McCormick, “To Save or Let Die: The Dilemma of
Modern Medicine,” Journal of the American Medical Association 229 (1974):
172-76.
251
252
Ramsey, Patient as Person.
253
Charles Fried, An Anatomy of Values: Problems of Personal and
Social Choice (Cambridge, Mass.: Harvard University Press, 1970).
254 Edmund D. Pellegrino, “Educating the Humanist Physician: An
Ancient Ideal Reconsidered,” Journal of the American Medical Association
227 (1974): 1288-94.
Stanley Hauerwas, “Care,” in Encyclopedia of Bioethics, ed.
Warren T. Reich (New York: Free Press, 1978), 146-50.
255
256
Ibid., 147.
126
for people’s choices, but tried to extend this notion of respect by referring to
Fried’s four requirements of lucidity, autonomy, fidelity, and humanity.
Hauerwas concluded by agreeing with Fried’s appeal to humanity: “simply
being treated honestly and with autonomy is not sufficient. We should also be
noticed.”257 This begins to get at the more robust interpretation of “respect”
that was beginning to percolate in the field of bioethics in the 1970s.258
Appeals to the concept of respect in the EB1 were rooted in concern
about the disrespectful treatment of patients and research subjects. In an
article on the humanization and dehumanization of health care, Jan Howard
explored the dehumanization and depersonalization of American medicine.
She did not explicitly refer to the principle of respect for persons, but her
discussion hit at the heart of what it means to respect and conversely to
disrespect others. Dehumanization, as Howard described it, sounds a lot like
what I mean by disrespect; “a loss of human attributes,” a “loss of dignity,” “the
feeling that one is isolated from others and regarded as a thing rather than a
person.”259 It “refers to exploitation in the medical setting,” Howard explained,
“it signifies that people are being used instrumentally without regard for their
257
Ibid., 149; Fried, Anatomy of Values.
258
See chap. 5, for a discussion of the development of a more robust
notion of respect in bioethics.
Jan Howard, “Health Care: Humanization and Dehumanization of
Health Care,” in Encyclopedia of Bioethics, ed. Warren T. Reich (New York:
Free Press, 1978), 619-23, 619 (citing David Vail, Charles Lewis, and
Howard Leventhal).
259
127
pain and suffering, as guinea pigs are used.”260 The most obvious example of
dehumanization or disrespect in medical care is when patients or research
subjects are lured into medical treatment or an experiment without their
informed consent. A more subtle example, Howard noted, “takes place when
patients and providers are degraded and humiliated as nonpersons or lesser
persons.”261 It is about loss of autonomy, but it is more than that. It is also
about “absence of warmth,” feelings of isolation, and perceptions of
abandonment.
This concern with dehumanization in American health care mirrored a
broader social concern in the 1970s. For some, this inspired an appeal to
peace and love and motivated support for community outreach and social
solidarity. For others, it aroused a revolt against authority (the
“dehumanizors”) and led to the demand that the rights of oppressed
populations be recognized and respected. Ultimately, this language of rights
prevailed and, as we can see from the EB2, pervaded all aspects of social
thought and expression, including those in bioethics.
The emphasis on individual rights and freedom from oppression in
health care was recognized legally and ethically through the requirement for
informed consent and the principle of autonomy. Interestingly, there was no
entry on autonomy in the EB1. Respect for individual autonomy was
discussed in at least sixteen separate articles, but given the fact that the
260
Ibid.
261
Ibid., 620.
128
principle of autonomy was to soon become the core concept in bioethics, it is
surprising that it was treated so tangentially in the EB1. There was a separate
entry on informed consent, but the philosophical foundation of informed
consent was said to be respect for persons, while the promotion of individual
autonomy was recognized only as a function of obtaining informed consent.262
Respect for persons was defined narrowly in this entry as the right to make
medical decisions, once again blurring the distinction between respect for
persons and autonomy. The authors, Karen Lebacqz, who, incidentally, was a
National Commission member and was instrumental in the identification of the
principle of respect for persons in The Belmont Report, and Robert Levine,
who was a National Commission staff member, defined respect for persons by
reference to the legal declaration that “every human being of adult years and
sound mind has a right to determine what shall be done with his own body,” 263
confusing the ethical principle of respect for persons with the legal right of selfdetermination. This conceptual confusion about the concept of respect, the
principle of respect for autonomy, and the right of self-determination was
evident in all three edition of the EB. It stems from the informed consent
literature, but it permeates and distorts how all ethical dilemmas are analyzed.
As marginal as respect for persons was in the EB1, it was completely
ignored in the EB2. There was not even an index entry for “respect”, let alone
262 Karen Lebacqz and Robert J. Levine, “Informed Consent in Human
Research: Ethical and Legal Aspects,” in Encyclopedia of Bioethics, ed.
Warren T. Reich (New York: Free Press, 1978), 754-62.
263 Ibid., 754, quoting Schloendorff v. Society of New York Hospitals,
211 N.Y. 125, 105 N.E. 92 (1914).
129
“respect for persons.” There was one article on ethical issues in the
professional-patient relationship, which actually discussed the principle of
respect for persons as distinct from the principle of autonomy. The one
paragraph that was devoted to the principle of respect for persons emphasized
“the dignity of the patient as a person” and explained that the principle of
respect for persons “assumes that persons have inherent or essential worth
simply because they are human beings.”264 It said nothing more, however,
about the philosophical dimensions or practical implications of respect for
persons, leaving us only with the illusion of a meaningful moral concept.
The absence of a more substantial discussion of respect in the EB2 is
especially surprising given the enormous rhetorical influence that The Belmont
Report had in the context of research ethics. By 1995, probably everyone
involved in human subjects research could identify the Belmont principles,
respect for persons, beneficence, and justice. Yet, in the EB2 there were
seven articles that mentioned The Belmont Report specifically and none of
them gave serious consideration to the principle of respect for persons. In
fact, in three of these entries The Belmont Report was credited with identifying
the principles of autonomy, beneficence, and justice!265
Ruth B. Purtilo, “Professional-Patient Relationship: Ethical Issues,”
in Encyclopedia of Bioethics, 2nd ed., ed. Warren T. Reich (New York: Free
Press, 1995), 2094-2103, 2096.
264
David J. Rothman, “Research, Human: Historical Aspects,” in
Encyclopedia of Bioethics, 2nd ed., ed. Warren T. Reich (New York: Free
Press, 1995), 2248-58, 2256 (recalling [incorrectly] that The Belmont Report
identified respect for autonomy as a fundamental ethical principle that should
govern research); Albert Jonsen and Andrew Jameton, “Medical Ethics,
History Of: The Americas,” in Encyclopedia of Bioethics, 2nd ed., ed. Warren
T. Reich (New York: Free Press, 1995), 1616-32, 1624 (crediting The
Belmont Report with “first enunciat[ing] the triad of bioethical principles:
265
130
The principle of respect for persons was mentioned in several other
articles in the EB2, including entries on research on prisoners and informed
consent, but only tangentially and never as anything more than the injunction
to respect individual autonomy. The principle of autonomy, on the other hand,
was rampant in the EB2. Autonomy was one of the biggest topics to be
indexed, with 67 sub-headings. It was discussed on 159 different pages of
text and in 87 separate articles. In fact, there was an entire entry devoted to
the topic of autonomy. This reflects the reality that, by 1995, autonomy had
become what Reich refers to as “THE mainstay of bioethics.”266 There was
also, however, some allusion in the EB2 to what was becoming a major
criticism of American bioethics in the mid-1990s: the exaggerated emphasis
on individual autonomy.267 The limits of autonomy were particularly apparent
in international ethics, where cultural values and beliefs did not always support
an unwavering commitment to individual autonomy.268 These concerns
autonomy, beneficence, and justice”); Dan W. Brock, “Public Policy and
Bioethics,” in Encyclopedia of Bioethics, 2nd ed., ed. Warren T. Reich (New
York: Free Press, 1995), 2181-88, 2184 (acknowledging that The Belmont
Report identified the principle of respect for persons but then stating that this
was the same principle identified by Beauchamp and Childress in Principles
of Biomedical Ethics, the principle of autonomy).
266
Warren T. Reich, e-mail message to the author, March 18, 2004.
Jonsen and Jameton, “Medical Ethics, History Of,” in Encyclopedia
of Bioethics, 2nd ed., 1627 (observing that “some have asserted that
bioethics, while it had its origins in the strong affirmation of autonomy for
patients, may have moved too far in this direction and thereby neglected
other aspects of health care, such as benevolence, community, and social
justice.”).
267
268 Rihito Kimura, “Medical Ethics, History of South and East Asia,” in
Encyclopedia of Bioethics, 2nd ed., ed. Warren T. Reich (New York: Free
Press, 1995), 1496-1505; Arthur Kleinman, “Medicine, Anthropology Of,” in
131
ultimately led to a minor retreat from the unbridled commitment to respecting
individual autonomy that characterized the field of bioethics in the last two
decades of the twentieth century.
The field of bioethics is currently shifting and the adjustments that are
being made are reflected in the EB3. The importance of autonomy is still
recognized, but it is appealed to a little less frequently than it was in the 1990s.
While the total number of entries grew in the EB3, the number of articles
discussing autonomy shrank.269 The entry devoted to autonomy was reprinted
from the EB2, without any substantive changes or additions.270 What was
added was an index entry for respect for persons! While this suggests that the
principle of respect for persons has finally been given its due, closer
examination of the indexed entries reveals nothing new in the treatment of the
principle of respect for persons. In fact, all of the articles that discussed
respect for persons were reprinted from the EB2, with no substantive changes
Encyclopedia of Bioethics, 2nd ed., ed. Warren T. Reich (New York: Free
Press, 1995), 1667-74.
In 2004, the index for “autonomy” had fifty sub-headings.
“Autonomy” was discussed on about eighty-eight pages of text in the EB3
and was referenced in about fifty-two separate articles. In 1978, there were
fourteen subheadings under “autonomy” and the concept was discussed on
thirty-three pages of text and mentioned in sixteen separate articles. As
discussed above, in 1995, there were sixty-seven subheadings under the
term “autonomy” in the index. “Autonomy” was discussed on 159 pages of
text and in eighty-seven separate articles.
269
270
Only the bibliography was updated from 1995 to 2004. Bruce L.
Miller, “Autonomy,” in Encyclopedia of Bioethics, 3rd ed., ed. Stephen G.
Post (New York: Macmillan Publishing, 2004), 246-51.
132
or additions.271 There was also an index entry for respect for life, but again,
with no serious discussion of what this means as a guiding moral obligation.272
The Belmont Report was discussed in two new entries in the EB3, but again it
was credited on at least three occasions with establishing the principle of
autonomy instead of respect for persons.273 This suggests that the National
Commission’s legacy of reducing the principle of respect for persons to a
principle of respect for people’s choices is alive and well.
Even Reich, the editor-in-chief of the first two editions of the
Encyclopedia of Bioethics, was surprised to realize that there was no serious
discussion of the principle of respect for persons in any of the EB editions. In
271 Ruth B. Purtilo, “Professional-Patient Relationship,” in
Encyclopedia of Bioethics, 3rd ed., ed. Stephen G. Post (New York:
Macmillan Publishing, 2004), 2152; Roy Branson, “Prisoners as Research
Subjects,” in Encyclopedia of Bioethics, 3rd ed., ed. Stephen G. Post (New
York: Macmillan Publishing, 2004), 2105-6; John McMillan, “Reproductive
Technologies,” in Encyclopedia of Bioethics, 3rd ed., ed. Stephen G. Post
(New York: Macmillan Publishing, 2004), 2269 (discussing respect for
children as persons).
272
The articles indexed under this heading deal primarily with the
issue of the status of embryos. The article on informed consent that was
published in the EB2 is also listed under this entry (though it discusses the
principle of respect for persons specifically, not respect for life more
generally). It describes respect for persons as a guiding ethical principle, but
its treatment of respect for persons reduces it to no more than respect for
individual autonomy or the right of self-determination. Robert J. Levine,
“Informed Consent,” in Encyclopedia of Bioethics, 3rd ed., ed. Stephen G.
Post (New York: Macmillan Publishing, 2004), 1281.
273
The articles from the EB2 that made this mistake are reprinted in
the EB3. There is also one new article in the EB3 on international health
that makes this same mistake, stating: “The Belmont Report emphasized the
notion that individual autonomy, beneficence, and justice were central to the
ethical conduct of research involving humans.” James Kazura, “International
Health,” in Encyclopedia of Bioethics, 3rd ed., ed. Stephen G. Post (New
York: Macmillan Publishing, 2004), 1327.
133
an e-mail correspondence, Reich admitted, “I am astounded to find no subentry for “Persons, respect for.”274 In fact, Reich recently wrote an article on
the state of the field of bioethics.275 In that article, he listed some major topics
that he thought were neglected in the first two editions of the Encyclopedia of
Bioethics and deserved attention in the next edition. “I’m afraid,” he
confessed, “’Respect for Persons’ was not one of my recommended topics!”276
Reich agreed that “what is needed is an explicit and rich treatment of the
principle of respect for persons.”277 While this has not yet occurred in the field
of bioethics, it appears from the EB3 that some bioethicists are trying to
capture the essence of a more robust conception of respect for persons by
exploring what it is about persons besides their autonomy that deserves
respect.
Part of the answer to that question is explored in the EB3 in an article
on human dignity. This reflects international concern about respect for human
dignity, “an ethical mandate to which both sides of many bioethical debates
appeal.”278 It is invoked, declared John Kilner, “as an attribute of all human
274
Warren T. Reich, e-mail message to the author, March 18, 2004
(emphasis added).
275
Reich, “Shaping and Mirroring the Field.”
276
Warren T. Reich, e-mail message to the author, March 18, 2004.
277
Ibid.
John F. Kilner, “Human Dignity,” in Encyclopedia of Bioethics, 3rd
ed., ed. Stephen G. Post (New York: Macmillan Publishing, 2004), 11931200.
278
134
beings that establishes their great significance and worth. … suggesting … a
standard by which people should be viewed and treated.”279 It is closely
related to the concept of respect for persons and its inclusion in the EB3 can
be viewed as an attempt in the field of bioethics to discover a deeper
significance to the basic moral obligation of respect for others. However,
reliance on the concept of human dignity for this purpose is problematic for
two reasons. First, although the notion of respecting human dignity suggests
that there is more about humans that deserve respect than their autonomy,
namely their dignity, it is unclear what the term “human dignity” means. This
concept is as vague as the concept of respect for persons without
specification, and there is much confusion and disagreement about its
meaning in the bioethics literature. Second, assuming we can agree on a
definition of human dignity, how do we respect it? Human dignity may give us
more insight into what we respect about persons besides their autonomy, but it
tells us very little about how we respect persons beyond noninterference with
their autonomous choices. It is this latter concern to which I will now turn,
focusing on respect in the context of human subjects research.
279
Ibid.
135
CHAPTER 5
“RESPECT” IN RESEARCH ETHICS: PAST AND
PRESENT
Although respect for persons has become largely synonymous with
respect for autonomy in bioethics, there have been and continue to be more
fundamental appeals to the concept of respect in research. The call for
respect can be heard in the voices of some of the most thoughtful bioethicists
we have known. Not surprisingly, many of these individuals are theologians.
As such, their profound understanding of the concept of respect is rooted in
deeply held religious convictions, but voiced in the context of secular bioethics
discourse. Their messages have been heard, but their significance has been
undervalued in the attempts to turn moral reflections into legal regulations and
procedural requirements.
In this chapter, I tune in to the often obscured conversations among
bioethicists about the importance of respect for research subjects, tracing the
contours of the dialogue. I analyze several of the perspectives that have been
expressed in an effort to orient us to what has been said and to delineate what
has yet to be articulated. By unearthing how the rhetoric of respect for
research subjects has developed over the past forty years, I hope to resurrect
lost cries for humanity and to use them to build a unique and meaningful vision
for the future. This chapter, then, creates a foundation for my conceptual and
policy analysis. It reminds us where we have been, acquaints us with where
we are now, and foreshadows where we are heading.
136
The Past: Sacrificing Humanity
Although physicians have been debating the ethics of human
experimentation for centuries, individuals outside of the profession did not
enter the debate in any serious way until the 1940s.280 Responding to the
atrocities committed during World War II, lawyers were the first to arrive on the
scene. They consulted with physicians to delineate the ethical standards for
human experimentation. The result was an ethical code (The Nuremberg
Code) that was incorporated into a legal document (the court opinion United
States v. Karl Brandt et al.).281 By the time concern about the ethics of human
experimentation had reached American researchers in the 1960s, theologians
and philosophers had joined the discussion. These individuals were equally
concerned about the harmful and disrespectful treatment of research subjects.
As Jay Katz recalls, many of them “came to the study of human
experimentation out of a newly acquired conviction that research subjects
deserved to be treated with greater respect.”282 They perceived an imminent
need to protect potential subjects from overzealous researchers and to
establish moral limits on what some had begun to assume was a social
necessity—medical research.
280
As I discussed in chap. 2, nonprofessionals expressed concern
about the ethics of human experimentation well before the 1940s (e.g., the
antivivisectionists), but they had relatively little influence on public policy until
after World War II.
281 Karl Brandt. See chap. 2 for a more detailed discussion of The
Nuremberg Code.
Jay Katz, “’Ethics and Clinical Research’ Revisited: A Tribute to
Henry K. Beecher,” Hastings Center Report 23, no. 5 (1993): 31-39.
282
137
While the policymakers and lawyers fought for procedural protections
such as federal regulations and external review, several thoughtful theologians
and philosophers took on the larger moral issues. Some of them recognized
that the disrespectful treatment of research subjects stemmed from a more
fundamental problem—a disrespectful attitude toward those individuals. In an
effort to change attitudes (and thereby affect behaviors), conversation began
about the nature of the researcher-subject relationship and the moral status of
both parties and questions were asked about what constitutes right action and
what represents good behavior in the context of human experimentation.
Throughout these discussions there was always an emphasis on the necessity
of informed consent and the moral obligation to respect individual autonomy.
After all, the exposé of medical research conducted on individuals without their
knowledge or consent was what, to a large extent, precipitated the newfound
interest in the ethics of human experimentation.283
Emphasis on the requirement of informed consent was appropriate
given the social and scientific environment at that time. However, the
importance of obtaining consent and the ethical obligation to respect an
individual’s right to refuse participation in an experiment often eclipsed equally
important, but less politicized and more abstract concerns about respect for
research subjects. In this section I examine the research ethics discourse as it
developed from 1960 - 1990. I focus on five influential voices in bioethics,
Paul Ramsey, Hans Jonas, Charles Fried, Jay Katz, and Robert Veatch. Each
283
Beecher, “Ethics and Clinical Research.”
138
of these remarkable men had a profound impact on the field of bioethics, and
all of them struggled, each in his own way, with the concept of respect for
research subjects.
Paul Ramsey: The Patient as Person
Paul Ramsey, one of the first theologians to enter the field of bioethics,
was deeply committed to the principle of respect as a guiding principle for
medical research. Ramsey, a Protestant theologian, was the Harrington
Spear Paine Professor of Religion at Princeton University. In 1969 he
delivered the Lyman Beecher lectures at Yale University. In preparation for
the Lectures, Ramsey spent two semesters as the Joseph P. Kennedy Jr.
Foundation Visiting Professor of Genetic Ethics at Georgetown University
Medical School. He submerged himself in the realities of medical life,
observing, discussing, and reflecting on the moral aspects of medical practice
and research. Ramsey’s Lectures were published the following year as The
Patient as Person: Explorations in Medical Ethics. 284 “Those lectures and the
book that resulted from them,” Albert Jonsen reflects, “can rightly be called the
founding preaching and scriptures of the field of bioethics.”285
Ramsey’s work may have been grounded in the realities of medical
practice and research, but it was informed by fundamental principles of
284
Ramsey, Patient as Person.
Albert R. Jonsen, “The Structure of an Ethical Revolution: Paul
Ramsey, the Beecher Lectures, and the Birth of Bioethics,” preface to The
Patient as Person: Explorations in Medical Ethics, by Paul Ramsey (New
Haven: Yale University Press, 2002), xvi.
285
139
Christian morality. For example, Ramsey rooted the duty to respect others in
“the Biblical norm of fidelity to covenant.”286 A covenant is a sacred bond that
stems from profound love and respect for the sacredness of every individual
as “an embodied soul or ensouled body.”287 As Ronald Carson explained,
Covenant characterizes a living relationship. To be bound by covenant
is to be related to others in a special way. Covenant connotes fidelity in
relationships, commitment that reaches beyond the spoken and the
spelled-out. A covenant is a relationship of trust in the sense that one
receives others as one receives a gift—without strings attached and “in
trust.”288
Ramsey believed that the “sacredness or inviolability of the individual”
was being trampled in the quest for scientific advancement. He began with
the basic conviction that all human life is sacred and deserves to be
respected. “It is of first importance that this be understood,” he explained,
since we live in an age in which hesed (steadfast love) has become
maybe and the “sanctity” of human life has been reduced to the ever
more reducible notion of the “dignity” of human life. The latter is a sliver
of a shield in comparison with the awesome respect required of men in
all their dealings with men if man has a touch of sanctity in this his fetal,
mortal, bodily, living and dying life.289
286
Ramsey, Patient as Person, xlv.
287
Ibid., xlvi.
288 Ronald A. Carson, “Paul Ramsey’s Ethic of Covenant Fidelity,” in
Covenants of Life: Contemporary Medical Ethics in Light of the Thought of
Paul Ramsey, ed. Kenneth L. Vaux, Sara Vaux and Mark Stenberg,
(Dordrecht, Netherlands: Kluwer Academic Publishers, 2002), 10.
289
Ramsey, Patient as Person, xlvi.
140
Ramsey believed that “the moral requirements governing the relations of
physician to patients and researcher to subjects are only a special case of the
moral requirements governing any relations between man and man.”290 All
human relations are governed by canons of loyalty, or covenants among
individuals, according to Ramsey. These covenants stem from the Biblical
covenant with God and are sustained through our interrelations with others.
By invoking the canon of loyalty, Ramsey attempted to redefine the physicianpatient and researcher-subject relationships. He was fundamentally
concerned about the morality of medical practice and research. The Patient
as Person was Ramsey’s “plea for fundamental dialogue about the urgent
moral issues arising in medical practice.”291 Through such dialogue he sought:
to explore the meaning of care, to find the actions and abstentions that
come from adherence to covenant, to ask the meaning of the sanctity of
life, to articulate the requirements of steadfast faithfulness to a fellow
man … [To ask] What are the moral claims upon us in crucial medical
situations and human relations in which some decision must be made
about how to show respect for, protect, preserve, and honor the life of
fellow man.292
Only by engaging in the act of ethical reflection, Ramsey believed, could our
moral compass be readjusted to recognize the claims of every individual to
honor and respect:
290
Ibid., xlv.
291
Ibid., li.
292
Ibid., xlvi.
141
To take up the questions of medical ethics for probing, to try to enter
into the heart of these problems with reasonable and compassionate
moral reflection, is to engage in the greatest of joint ventures: the moral
becoming of man. This is to see in the prism of medical cases the
claims of any man to be honored and respected.293
Ramsey articulated his conceptual framework for addressing specific
ethical issues (via the covenant between physician/researcher and
patient/subject) in the preface to his book, The Patient as Person. The text of
the book analyzed four specific ethical issues in light of his covenantal model:
medical research, death and dying, organ transplantation, and the allocation of
scarce resources. Ramsey was exceedingly practical in his analysis of
medical research, focusing on the requirement for a “reasonably free and
adequately informed consent” as the “chief canon of loyalty … between the
man who is patient/subject and the man who performs medical investigational
procedures.”294 For Ramsey, consent is important because it recognizes the
subject’s active participation as a “joint adventurer” in research; consent is
necessary because of “man’s propensity to overreach his joint adventurer
even in a good cause.”295 Thus, Ramsey’s characterization of the researcher
and subject as “joint adventurers” in a common enterprise gives rise to the
requirement for informed consent. That they are joint adventurers “is evident
from the fact that consent is a continuing and repeatable requirement.”296 The
293
294
Ibid., li.
Ibid., 2.
295
Ibid., 6.
296
Ibid.
142
nature of the researcher-subject relationship, then, makes consent possible,
while the necessity of consent validates the structure of that relationship. For
Ramsey,
[Consent] lies at the heart of man’s continuing search for cures to all
man’s diseases as a great human adventure this is carried forward
jointly by the investigator and his subject. Stripped of the requirement
of a reasonably free and an adequately informed consent,
experimentation and medicine itself would speedily become
inhumane.297
Ramsey’s emphasis on the importance of consent can be best
understood in light of his own anxiety about the morality of medical research.
He was deeply concerned about “the material and spiritual pressures upon
investigators … the collective bias in the direction of successful research,
[and] the propensities of the scientific mind toward the consequences
alone.”298 For all of these reasons, informed consent is essential; it provides
the ultimate protection for research subjects and represents the most
fundamental act of respect for the inviolability of human beings.
Ramsey’s commitment to the sanctity of all research subjects as human
beings and as valuable participants in the research enterprise is admirable.
His recognition of their claim to honor and respect is impressive. Yet, his
exclusive emphasis on the requirement for informed consent is misleading. It
suggests that Ramsey’s ethic of love and covenant-fidelity and his
commitment to the duty of respect for others requires no more than a
297
Ibid., 11.
298
Ibid., 10.
143
“reasonably free and adequately informed consent.” As William Winslade
concluded, “the broad scope and exaggerated significance which is given to
the principle of consent leads Ramsey to blur important distinctions between
consent and respect for persons.”299 Winslade has argued that consent is
neither a necessary nor a sufficient condition for “expressing, establishing, or
sustaining (Ramsey’s words) the principle of respect for persons.”300 It is not
necessary because the duty of respect extends to all patients and research
subjects, “even if they do not or cannot consent to treatment.”301 It is not
sufficient because:
Even if a patient has consented to treatment, a physician may treat the
patient in a disrespectful manner … It all depends upon the manner in
which the doctor behaves toward the person, whether the doctor shows
kindness, compassion, patience, concern, etc. Consent is only one
element of a complex set of attitudinal and behavioral factors which are
relevant to a person-oriented medical morality.302
Thus, on the one hand, Ramsey ought to be credited for engaging in
“fundamental dialogue” about the ethics of respect for research subjects. His
characterization of the research subject as a joint adventurer in a common
enterprise encouraged an attitudinal shift in the perception of and appreciation
299 William J. Winslade, “Outline of a Critical Discussion of Paul
Ramsey’s The Patient as Person,” in Report of the Institute Fellows 19731974, Institute on Human Values in Medicine (Philadelphia: Society for
Health and Human Values, 1974), 155-56.
300
Ibid., 163.
301
Ibid.
302
Ibid.
144
for subjects of human experimentation. Ramsey insisted that these individuals
be recognized, acknowledged, honored, and respected. He was particularly
concerned about the exploitation of the most vulnerable individuals (e.g.,
children, the institutionalized, and the mentally ill). It would no longer suffice to
justify the use of these individuals for medical research by calling on the debt
that they owe society or by appealing to the social good. If they cannot
consent, they should not be subjected to experiments that are not related to
their own recovery. This unwavering devotion to the principle of consent was
inspired by a visceral desire to protect vulnerable research subjects from
abuse. It is both understandable and appropriate given the research
environment at the time.
However, Ramsey’s exclusive and emphatic allegiance to the principle
of consent had the unintended effect of diverting the conversation away from
the development of a morally robust conception of the researcher-subject
relationship, which was based on mutual respect, trust, concern, care, and
appreciation. Instead, the focus was on consent as the ultimate (and only
morally required) expression of respect.
Hans Jonas: “Philosophical Reflections”
The same year that Ramsey gave his Beecher Lectures at Yale
University a German Jewish philosopher from the New School for Social
Research in New York, Hans Jonas, published an article in Dædulus, Journal
of the American Academy of Arts and Sciences, called “Philosophical
145
Reflections on Experimenting with Human Subjects.”303 While Ramsey was
cautious about the limits of scientific inquiry, Jonas was adamant that society
has no “right” to engage in human experimentation. Rather, a “moral claim” or
“emotional appeal” must be made in order to elicit genuine volunteers to serve
as subjects of medical research.304 Jonas’ skepticism about modern
technology and the erosion of collective values and individual responsibility 305
makes sense in light of his background. He was a German Jew born in 1903
who grew up in a world riddled with anti-Semitism. He was forced to leave his
home and his family after Hitler gained power in 1933. His mother was
murdered in the Auschwitz concentration camp during World War II, while
Jonas fought as an Israeli soldier.306 It is no wonder, looking back on the
violence committed by Nazi physicians during World War II, that Jonas had
reservations about the ethics of human experimentation and its influence on
the human morality. “What is wrong with making a person an experimental
subject,” Jonas argued,
Hans Jonas, “Philosophical Reflections on Experimenting with
Human Subjects,” Dædalus, Journal of the American Academy of Arts and
Sciences 98, no. 2 (1969), reprinted in Experimentation with Human
Subjects, ed. Paul A. Freund (New York: George Braziller, 1969), 1-31.
303
304
Ibid.
305
Hans Jonas, The Imperative of Responsibility: In Search for an
Ethics for the Technological Age (Chicago: University of Chicago Press,
1984).
Peter Sewitz, “Hans Jonas: The Philosopher of Life,” German
News: The Magazine (1997); Harvey Scodel, “An Interview of Professor
Hans Jonas,” Social Research (New York: New School for Social Research,
2003).
306
146
is not so much that we make him thereby a means (which happens in
social contexts of all kinds), as that we make him a thing—a passive
thing merely to be acted on, and passive not even for real action, but for
token action whose token object he is. His being is reduced to that of a
mere token or “sample.”307
Jonas thought that the plight of the research subject was worse than “even the
most exploitative situations of social life,” for at least in those situations “the
business is real, not fictitious.”308 For example, he compared the research
subject to a soldier, who even though he is:
Subject to most unilateral discipline, forced to risk mutilation and death,
conscripted without, perhaps against, his will—he is still conscripted
with his capacities to act, to hold his own or fail in situations, to meet
real challenges for real stakes. Though a mere “number” to the High
Command, he is not a token and not a thing.
“Imagine,” Jonas reflected, “what he would say if it turned out that the war was
a game staged to sample observations on his endurance, courage, or
cowardice.”309 What a despicable act of disrespect to treat another human
being as a thing, as a token object “who is acted upon for an extraneous end
without being engaged in a real relation where he would be the counterpoint to
the other or to circumstance”!310
307
Jonas, “Philosophical Reflections,” 3.
308
Ibid.
309
Ibid.
310
Ibid.
147
For Jonas, this objectification is so offensive that “mere ‘consent’” is not
sufficient to rectify it. “Only genuine authenticity of volunteering can possibly
redeem the condition of ‘thinghood’ to which the subject submits.”311 Jonas
did not oppose medical research per se; what he objected to is the attitude
that society has a “right” to conduct medical experiments on human beings,
even if that means that some individuals have to be sacrificed or have to
sacrifice their own freedom and power out of social obligation. Neither our
present society nor the future society that will inherit our successes and
failures has a right to the promise of medical progress: “Our descendants have
a right to be left an unplundered planet;” Jonas argued, “they do not have a
right to new medical cures.”312 The attitude that human experimentation is
necessary for the social good and therefore creates an obligation on
individuals to become subjects of medical research is unjustified and
fundamentally disrespectful, according to Jonas. Of course, “one should strive
to minimize the risk [to subjects] and to maximize the consent [of subjects],”313
but to truly respect subjects, Jonas argued, one must not use them unless
they can authentically volunteer their services.
The ‘wrong’ of reification can only be made ‘right’ by such authentic
identification with the cause that it is the subject’s as well as the
researcher’s cause—whereby his role in its service is not just permitted
by him, but willed. That sovereign will of his which embraces the end
311
Ibid., 3-4.
312
Ibid., 14.
313
Ibid., 24.
148
as his own restores his personhood to the otherwise depersonalizing
context.314
Although Jonas did not directly speak of respect for research subjects,
his call for the restoration of subjects’ personhood through “authentic
identification” with the ends of the research cause assumed a shift in attitude
toward research subjects. Instead of being viewed as “tokens” or “objects” to
be manipulated and used for the social good, he believed that human subjects
of experimentation should be appreciated for their role as “martyrs for
science.” After all, it is an extraordinary individual who exhibits “virtue with its
readiness for sacrifice beyond defined duty.”315 Society needs these
individuals for its existence, Jonas argued. Our dependence on people who
volunteer to be subjects of medical research, thus, ought to inspire in us an
attitude of admiration. At the very least, it establishes a claim on behalf of
research subjects to recognition and appreciation.
Charles Fried: Personal Integrity and Social Policy
Charles Fried, a lawyer and professor at Harvard Law School, also
acknowledged that research subjects have certain rights that arise from the
nature of the researcher-subject relationship. Fried takes seriously Ramsey’s
suggestion that patients are at the most fundamental level, persons. He
believes that one’s sense of personhood is inextricably linked to one’s
identification with his or her body. Thus, “the doctor stands in a special
314
Ibid., 19.
315
Ibid., 12.
149
relation to his patient because he ministers to the basic unit which is the
person … For the person is his body, and the body’s health is the integrity of
the person.”316 In his book, Medical Experimentation: Personal Integrity and
Social Policy, Fried argued that this special relationship between doctor and
patient gives rise to a right of the patient to personal care. Thus, physicians
have a duty to provide the best care possible to each patient they encounter.
Fried extended this right of personal care to the researcher-subject
relationship, but restricted his analysis to subjects who are also patients
(participating in what he called “therapeutic research” where the goals of the
research are twofold: first, to cure the patient, and second, to improve the
experimental treatment in order to help others who are similarly situated).317
In the context of non-therapeutic research, which involves healthy volunteers,
Fried argued simply for full disclosure and for the researcher himself or herself
to be the first individual to serve as a subject. He warned that this may slow
the progress of medicine, but believed that its consequences for the integrity
of the researcher-subject relationship (by building confidence in the profession
316
Fried, Medical Experimentation, 96.
Ibid., 27. Since Fried’s book was published, the distinction
between therapeutic and nontherapeutic research has gone out of favor.
Some argue that this is a false distinction because the goal of all research is
to improve the experimental treatment; it is never primarily intended to
benefit the individual subject. To give the impression that therapeutic benefit
is a goal of the research, some argue, is to create a “therapeutic
misconception,” which may compromise the subject’s ability to make an
autonomous decision about participation. Robert J. Levine, “Clarifying the
Concepts of Research Ethics,” Hastings Center Report 9, no. 3 (1979): 2126; Paul S. Appelbaum, Loren H. Roth, and Charles W. Lidz, “The
Therapeutic Misconception: Informed Consent in Psychiatric Research,”
International Journal of Law and Psychiatry 5 (1982): 319-29.
317
150
and encouraging respect for research subjects) outweighed that risk.318 In
recruiting healthy volunteers for non-therapeutic research, Fried rejected the
use of deceit and coercion, but instead declared, “what is needed first of all is
candor and respect.”319
For what he terms therapeutic research, Fried identified four categories
of rights that are inherent in medical care and that “converge in the notion of
the integrity of the relation of personal care”: lucidity, autonomy, fidelity, and
humanity.320 All four of these rights are essential elements of respect for
research subjects. By focusing on the importance of all four elements, Fried
moved beyond a vision of respect for research subjects as synonymous with
respect for autonomy. Together, these four elements give us a more robust
conception of the term “respect.”
Lucidity is the right to full disclosure. As Fried described it:
The patient has a right to know all relevant details about the situation he
finds himself in … It is crucial to a fully human process of choosing
one’s good and to the process of choosing what kind of person one will
be. To deny a patient an opportunity for lucidity is to treat him not as a
person but as a means to an end. And even if the ends are the
patient’s own ends, to treat him as a means to them is to undermine his
humanity insofar as humanity consists in choosing and being able to
judge one’s own ends, rather than being a machine which is used to
serve ends, even one’s own ends.321
318
Fried, Medical Experimentation, 168.
319
Ibid., 170.
320
Ibid., 101.
321
Ibid.
151
Autonomy is the right of a subject to freely decide whether or not to participate
in medical research: “A patient has a right not only to be free from fraud in the
relation of medical care, but free from force, violence as well. Thus, if a
patient, though fully informed, is subjected to treatment against his will, this too
violates his rights.”322 Fidelity is the right to have one’s justified expectations
met and to be told the truth. Humanity is described by Fried as “the vaguest of
the four concepts.” Perhaps because it is so vague and difficult to articulate,
the right to humanity has been regrettably overlooked in the research ethics
discourse. This has resulted in an incomplete perception of the ethics of
research practice and of what is required in order to fully respect research
subjects. Fried described humanity as consisting of “the notion that over and
above a right to be treated without deceit or violence, a person has a right to
have his full human particularity taken into account by those who do enter into
relations with him.” He went on to explain that, under normal circumstances,
an individual may not have a right
to any affirmative considerations at all, but once he has been drawn into
a significant nexus, his wants, needs and vulnerabilities may not be
ignored even if his right to autonomy is fully respected and he is treated
with complete candor.323
Thus, the very nature of the physician-patient and researcher-subject
relationship establishes the right, not only to participate in decision making, but
322
Ibid., 102.
323
Ibid., 103.
152
to be treated with respect—to be recognized and cared for as a person. While
the rights to lucidity and autonomy give rise to a duty of informed consent,
The imperatives of fidelity and humanity … go further … It is an offense
against [one’s] humanity to look through his concreteness and see in
him only a statistic, only a representative man. And so the professional
who undertakes to deal with a patient’s serious illness [either through
standard treatment or experimental therapy] by that undertaking is
obligated not only to acknowledge but to respect, to make provisions for
the peculiarities, the needs and values of that individual …
The very vulnerability of the patient to his doctor creates expectations,
expectations not just of truthfulness but of humane treatment. To
disappoint those expectations is a wrong that goes beyond the actual
harm that is done. For in disappointing those expectations the
possibility of a system of trust is itself undermined.324
The trouble with this claim is that it is difficult to regulate and almost
impossible to enforce. Thus, at a time when the focus was on regulating
research practices and creating procedural safeguards, the rhetoric of respect
and the concern for humanity got overshadowed. It did not disappear,
however. By the 1980s, the requirement for informed consent was wellestablished in both law and ethics. The imperative to respect subjects’ right to
refuse participation in a medical experiment was entrenched in the culture of
research. Acknowledging the progress that had been made, several
bioethicists pushed the envelope further and suggested that the right of selfdetermination was not enough. These individuals challenged the reductionist
view of respect for research subjects and sought to enrich the researchersubject relationship by encouraging a more balanced affiliation.
324
Ibid., 156.
153
Jay Katz: The Silent World
Like Hans Jonas, Jay Katz, Elizabeth K. Dollard Professor Emeritus of
Law, Medicine, and Psychiatry and Harvey L. Karp Professional Lecturer in
Law and Psychoanalysis at Yale University, is a German Jew, whose
experience with anti-Semitism in Germany as a young boy inspired and
shaped his subsequent work in research ethics.325 Also like Jonas, Katz
challenged the requirement for consent, arguing that “mere consent” is not
sufficient. While Jonas focused on the voluntariness of the subject’s consent,
however, Katz focused on the conversation that takes place between
researcher and subject and the adequacy of disclosure.
Katz began studying the ethics of human experimentation when he was
asked to teach a course at Yale Law School on the topic in 1966. In
preparation for the course, Katz reconnected with his medical school
professor, Henry Beecher, and the two of them spent many hours discussing
the disrespectful treatment of research subjects by many of their colleagues
whom, they believed, “had paid too little attention to an increasingly
325
Katz once said in an address given at the final plenary session of a
conference commemorating the fiftieth anniversary of the Nazi doctors’ trial
at Nuremberg:
It all began with reading about Auschwitz, which led me on a long
journey, during which I learned much about what human beings can do
to one another in less egregious though still painful ways. Without my
and my people’s past, I might never have embarked on that journey.
Jay Katz, “Human Sacrifice and Human Experimentation: Reflections at
Nuremberg,” Yale Law School, Yale Law School Occasional Papers
(October 25, 1996), working paper 5.
154
widespread dimension of modern medical practice.”326 From a legal
perspective (remember, this was a law school course), Katz was particularly
interested in the application of the legal doctrine of informed consent to
medical research:
The common law doctrine of informed consent, barely five years old,
loomed large in our deliberations. I thought then that it showed
considerable promise in providing greater protection to subjects of
research. Even though as early as 1947 the Allied Military Tribunal had
made “voluntary consent” the cornerstone of its Nuremberg Code, that
prescription had made little impact on the conduct of research.
Perhaps informed consent would fare better.327
He was also interested in the regulation of research. The course description in
1965-1966 stated:
EXPERIMENTATION ON PEOPLE 2 Units. An examination of the
variety of “therapeutic” and “experimental” medical procedures which
have been carried out on patients and normal volunteers. Central to
this exploration will be a detailed study of consent and the role of the
state in the supervision of medical experimentation.328
After teaching this course for several years, Katz compiled his class materials
into a casebook called Experimentation with Human Beings: The Authority of
the Investigator, Subject, Professions, and State in the Human
Experimentation Process, which was published in 1972.329 The book focused
326
Katz, “’Ethics and Clinical Research’ Revisited,” 32.
327
Ibid.
328
Ibid.
329
Katz, Experimentation with Human Beings.
155
on the same general issues that Katz covered in his law school curriculum,
namely,
The functions that informed consent could serve for the human
experimentation process … A more general analysis of the extent and
limits of a subject’s ability and authority to make decisions on his or her
behalf … [And] problems of regulation … [addressing the question]
“What persons and institutions should have the authority to formulate,
administer, and review the human experimentation process?”330
The book was intended to “encourage and facilitate an intensive study of
human experimentation and provide better protections for the subjects of
research.”331 It has been lauded as “the most thorough single collection of
materials on research ethics and law.”332 As such, it is an invaluable source
book. Yet, it contains very little theoretical analysis. As Katz himself
acknowledged,
Our initial explorations were not influenced by theoretical considerations
but by concerns that human beings were not being treated with the
respect they deserved … In short, we were primarily interested in
customary medical practices that eventually might call for theoretical
formulations.333
Katz did not fully articulate his theoretical convictions until the
publication of his renowned book, The Silent World of Doctor and Patient in
330
Katz, “’Ethics and Clinical Research’ Revisited,” 32-33.
331
Ibid., 33.
332
Beauchamp, “Origins, Goals, and Core Commitments,” 20.
333
Katz, “’Ethics and Clinical Research’ Revisited,” 33.
156
1984.334 While this book focused primarily on the doctor-patient relationship,
Katz’s commitment to the moral obligation of respect for others, which is at the
heart of his thinking, extends to the researcher-subject relationship as well.335
Katz has always been concerned primarily with decision making and the
primacy of respect for autonomy, but his conception of the principle of respect
for autonomy is significantly broader than the traditional bioethics
interpretation of autonomy as synonymous with the right of self-determination
or freedom from interference.336 Katz is an advocate for the “idea of informed
consent,” arguing that true informed consent, based on meaningful
conversation, is necessary in order to foster “mutual trust” between physician
and patient.337 He believes that the practice of medicine is rooted in a history
of silence between doctor and patient and that only by inviting patients to
participate in the decision-making process can that silence be broken. Katz
challenged what he perceived to be the attitude of physicians towards
patients—as children who are subordinate to the authority of physicians,
334
Katz, Silent World.
Katz, “’Ethics and Clinical Research’ Revisited,” 36 (explaining that
the theoretical position to which he is committed that “whenever we use
human subjects for the sake of others, using them as means for our ends,
the principle of [respect for] autonomy alone must guide such practices” was
articulated in his book, The Silent World of Doctor and Patient).
335
Katz, Silent World, 105-6 (acknowledging that “autonomy” is often
used interchangeably with” self-determination” and distinguishing his
definition of “autonomy” from the right to self-determination).
336
337
Ibid.
157
incapable of actively participating in medical decision making, and of
researchers towards subjects—as “’lives not worth living’ and therefore
expendable.”338 He objected to the authoritarianism of medical practice and
research, arguing that it inherently leads to the objectification of patients and
subjects and prevents the realization of respect for persons.339 Katz argued
that, not only do patients have the capacity to participate in medical decisions,
but that they have the moral authority to do so. This authority derives, not only
from the right to self-determination, but from the basic human need for
recognition and appreciation. Citing Isaiah Berlin’s essay, Two Concepts of
Liberty, Katz acknowledged the desire for recognition and argued that “to
recognize others fully requires not only an appreciation of their limitations but
their capacities as well.”340
By referencing Berlin, Katz exhibited a commitment, not only to
respecting patients’ and subjects’ autonomy, but to respecting them as
persons. Berlin, a contemporary philosopher and historian of ideas, was
338
339
Katz, “Human Sacrifice and Human Experimentation.”
Katz believed:
The combination of the relentless pursuit of science, with its inherent
dangers of objectifying subjects, became embedded in the ancient
tradition of medical authoritarianism, with its inherent objectification of
patients. Both dynamics make it difficult to respect patient-subjects as
persons with their own interests and rights.
Ibid.
340
Katz, Silent World, 87.
158
deeply concerned with the limits of liberty and the preservation of human
dignity. In his essay, Two Concepts of Liberty, Berlin distinguished negative
liberty—or freedom from interference—from positive liberty—or freedom to be
one’s own master and to make one’s decisions. Katz was understandably
attracted to this distinction; he himself was arguing against a conception of
informed consent as rooted in a right of self-determination (or negative liberty)
and for an “idea of informed consent” that is grounded in respect for autonomy
(or positive liberty). However, both Berlin and Katz went further by
acknowledging the limits of both negative and positive liberty and by appealing
to the human desire for reciprocal recognition and mutual understanding.
Berlin’s analysis began with the recognition that human beings are by nature
social begins; one’s interaction with others fundamentally shapes who they
are:
In so far as I live in society, everything that I do inevitably affects, and is
affected by, what others do … I am a social being in a deeper sense
than that of interaction with others. For am I not what I am, to some
degree, in virtue of what others think and feel me to be? … I am not
disembodied reason.341
Because we are naturally social beings, Berlin argued, we desire more than
either negative liberty or positive liberty can offer. We want additionally to
avoid:
Simply being ignored, or patronized, or despised, or being taken too
much for granted—in short, not being treated as an individual, having
[our] uniqueness insufficiently recognized, being classed as a member
341 Isaiah Berlin, Two Concepts of Liberty (London: Oxford University
Press, 1958), 39-40.
159
of some featureless amalgam, a statistical unit without identifiable,
specifically human features and purposes of [our] own.342
Berlin explained:
This is the degradation that I am fighting against—not equality of legal
rights, nor liberty to do as I wish (although I may want these too) … I
desire to be understood and recognized … What I demand is an
alteration of the attitude towards me of those whose opinions and
behaviour help to determine my own image of myself … What I want …
is simply recognition … For if I am not so recognized, then I may fail to
recognize, I may doubt, my own claim to be a fully independent human
being. For what I am is, in large part, determined by what I feel and
think; and what I feel and think is determined by the feeling and thought
prevailing in the society to which I belong, of which … I form not an
isolable atom, but an ingredient … in a social pattern …
Yet, it is not with liberty, in either the ‘negative’ or in the ‘positive’
senses of the word, that this desire for status and recognition can easily
be identified. It is something no less profoundly needed and
passionately fought for by human beings—it is something akin to, but
not itself, freedom: it is more closely related to solidarity, fraternity,
mutual understanding, need for association on equal terms, all of which
are sometimes—but misleadingly—called social freedom … The desire
for recognition is a desire … for union, closer understanding, integration
of interests, a life of common dependence and common sacrifice.343
Berlin called this fundamental human need for recognition “a hybrid form of
freedom … an ideal which is perhaps more prominent than any other in the
world today, yet which no existing term seems to fit.”344 I call it respect.
Katz acknowledged this desire for recognition and respect, but failed to
appreciate the full significance that it carries for the physician-patient and
342
Ibid., 40-41.
343
Ibid., 40-43.
344
Ibid., 45-46.
160
researcher-subject relationship. Katz called for a change in attitude toward
patients and appealed to conversation as a way to “pierce the isolation, to
eliminate the feelings of abandonment, and to reverse the lack of control that
patients now experience so often in their interactions with physicians.” 345 He
believed that the lack of conversation with patients is itself disrespectful
because it makes patients feel “disregarded, ignored, patronized, and
dismissed.”346 This may be true, but Katz assumed that by simply conversing
with patients and obtaining their informed consent these feelings will
disappear. He addressed the attitudinal component of respect but disregarded
the important behavioral aspects outside the realm of decision making. True
recognition requires not only an appreciation of one’s limitations or even an
appreciation of one’s capacities for decision making, but an appreciation of
one as a unique individual. Katz’s discussion of Berlin’s conception of the
need for recognition broaches the conversation about what it means to respect
others in bioethics, but like Ramsey, Katz’s preoccupation with decision
making and the need for consent limits his analysis of respect to respect for
autonomy (albeit broadly conceived). Thus, he moved the conversation
forward by discussing the need for recognition and mutual understanding and
suggests a solution through meaningful conversation, but failed to articulate
the broader implications of a commitment to respect for research subjects (as
more than respect for individual autonomy). Although Katz’s conception of
345
Ibid., 210.
346
Ibid.
161
autonomy is much more robust than autonomy as the right to non-interference,
he continued to confuse respect for others with respect for autonomy,
inhibiting more reflective interpretations of his work and its relationship to the
moral obligation of respect for research subjects.347
Robert Veatch: The Patient as Partner
Three years after Katz published The Silent World of Doctor and Patient
Robert Veatch, Professor of Medical Ethics at The Kennedy Institute of Ethics
at Georgetown University, published The Patient as Partner: A Theory of
Human Experimentation Ethics.348 Like Katz, Ramsey, and others before him,
Veatch was concerned about the way in which human subjects of medical
research were being viewed and treated. By 1987, medical research in the
United States was federally regulated and procedural protections had been
established in order to reduce the prevalence of research abuse. Yet, some
bioethicists, including Veatch, were not satisfied. The elimination of grossly
unethical practices was necessary, but it was not sufficient. The more
fundamental problem of disrespecting research subjects needed to be
addressed as well.
In 1993, Katz admitted, “Early in my work I did not appreciate the
primacy I now wish to assign to respect for persons.” Katz, “’Ethics and
Clinical Research’ Revisited,” 34. He goes on, however, to articulate his
theoretical position in terms of his unwavering commitment to the principle of
autonomy. He describes his work as a “plea for autonomy, or better, for
respect for persons,” but then frames his conversation about respect for
persons around the need for “a binding commitment” to “respect for
autonomy and self-determination in clinical research.” Ibid., 37, 38-39.
347
348
Robert M. Veatch, The Patient as Partner: A Theory of HumanExperimentation Ethics (Bloomington: Indiana University Press, 1987).
162
Veatch believed that there was a tendency to treat research subjects
“as passive ‘material’ suitable for providing additional data points … [which]
stems in part from the presumption that clinical research subjects are sick,
usually very sick, and thus not capable of autonomous decision-making or full,
active participation in research.”349 He sought to divest society of this belief,
arguing that most research subjects are “questioning, thinking, feeling, active
moral persons” who deserve to be treated “as human beings with dignity and
respect.”350 Veatch challenged the traditional view of research subjects as
either “research material” or as “passive patients” and insisted:
We need to think of the subject as neither research material nor passive
patient, but simply as a person, with all the moral overtones that that
word conveys. As such, it is appropriate to view the person as a
partner in the research enterprise.351
This vision of the researcher-subject relationship as a true partnership
is grounded in the realization that researchers need subjects and are
dependent on them in order to “complete their life mission.”352 Veatch found
the metaphor of partnership perfect to describe the researcher-subject
relationship because, like any other partnership, the researcher and subject
“come together … because there is some mutuality of interests, some
349
Ibid., 3.
350
Ibid., 4.
351
Ibid.
352
Ibid., 6.
163
common point of intersection where each can help the other.”353 This
metaphor of partnership, if it is accepted and taken seriously, has important
implications for clinical research. As Veatch explained:
If researcher and subject are seen as partners who are both
autonomous, responsible, dignified human agents coming together to
form a limited covenant for pursuit of mutual interest, virtually all
aspects of the ethics of clinical research are affected. It provides a new
foundation for ethically acceptable clinical research.354
For example, Veatch’s vision implied a kind of active collaboration on the part
of the subject not only in making the decision whether or not to participate in
the experiment, but also in deciding how the research project should be
designed. For if a subject is treated as a true partner in the research, his or
her unique needs, desires, preferences, and feelings will all have to be
considered when negotiating the terms of the relationship (including the
manner in which the research will be carried out, when, where, and under
what circumstances). To acknowledge the subject in this way, according to
Veatch, is to treat him or her with the respect and dignity he or she deserves.
Veatch, like Fried, attempted to move outside of the realm of decision
making. Unlike many bioethicists before (and after) him, Veatch’s emphasis
was not solely on informed consent or the various elements of informed
consent (disclosure/conversation, understanding, voluntariness, or capacity).
Instead, he considered all of the implications of viewing the researcher-subject
relationship as a partnership and argued that, within this framework, acting in
353
Ibid.
354
Ibid., 8.
164
the subject’s best interest and obtaining his or her informed consent were not
sufficient. Rather, the researcher must be committed to at least seven basic
ethical principles—autonomy, beneficence, nonmaleficence, justice, fidelity,
veracity, and avoiding killing—which need to be balanced and prioritized in
order to make appropriate moral judgments about the conduct of medical
research. Veatch believed that the nonconsequentialist principles of
autonomy, justice, fidelity, veracity, and avoiding killing ought to take
precedence over the consequentialist principles of beneficence and
nonmaleficence, but he gave no special priority to the principle of autonomy.
Presumably, the principle of autonomy must be balanced and weighed against
the other nonconsequentialist principles when making moral judgments.
Veatch hoped that involving patients as active partners in research will
actually improve the quality of science. “At the very least,” he believed,
it [will] further the long-term goals of science by involving patients more
directly and more enthusiastically as part of the research process rather
than leaving them to perceive themselves as outsiders, passive guinea
pigs, or even victims … The case for inviting patients and normal
subjects to participate routinely in the design of research is a strong one
once one recognizes the legitimacy of their claims as respected human
beings.355
Veatch acknowledged the controversies inherent in accepting the partnership
model for research, but also stressed its benefits. He discussed several
research ethics problems that are solved by adopting the partnership model,
the most serious of which is the “problem of the patient as material—as
research or teaching or clinical material to be manipulated as an object—either
355
Ibid., 212.
165
for its own good or the good of others.”356 This problem, Veatch argued,
represents a fundamental flaw of the traditional model of the
physician/researcher-patient/subject relationship, which is grounded in the
commitment to benefit the patient/subject at all costs.
The traditional model of the physician-patient relationship in which the
physician fulfills his Hippocratic obligation to benefit the patient
regardless of whether the patient’s integrity is respected has as its most
fundamental flaw the dehumanization of the persons who are patients.
The shift to the research context in which the welfare of the society is
added to the welfare of the patient/subject does nothing to rehumanize
the person who is the object of study. The model in which the patient is
an active partner in the process, a knowing intelligent human being with
his or her own agenda, preferences, and ideas has the most profound
advantage of overcoming the indignity of the manipulative mode of the
more traditional relationship …
The patient-as-partner model is a model of research with human
subjects, not research on human objects.357
Veatch’s partnership model has been criticized because it assumes an
equal status between physicians/researchers and patients/subjects such that
both parties are free to autonomously negotiate the terms of their relationship.
In this sense, it views the clinical encounter as similar to any other transaction
that takes place in a free market. However, some commentators object that
the research enterprise is not like a normal marketplace for several reasons.
First, there is a fundamental inequality between physicians/researchers and
patients/subjects because physicians and researchers possess greater
knowledge than patients do and when subjects are also patients, the
356
Ibid., 214.
357
Ibid.
166
circumstance of illness necessarily places the patient/subject in a vulnerable
relationship.358 Second, under normal market conditions, either partner may
persuade the other partner to waive their rights. However, ethical principles
should not be waivable except to give way to a higher moral obligation.359
Third, many subjects of research are also patients who are not free to shop
around and choose among various medical options either because of their
weakened health or because there are no other standard medical treatments
available for them to try. This puts them in a compromised position when it
comes to negotiating the terms of their relationship with the
physician/researcher. Finally, and perhaps most importantly, physicians have
fiduciary obligations to their patients, which do not exist in most market
transactions. Thus, while Veatch’s partnership model advocates for research
subjects to be respected as equal partners in a common enterprise, it
represents an unrealistic and inaccurate depiction of the researcher-subject
relationship.
It also risks having a negative effect on research findings. If subjects
are treated as equal partners in the research and consulted about things such
as research design and publication of results, there is a chance that the
scientific integrity of the research will be compromised. Issues of research
design and methodology require expert judgment, which the investigator in an
358 Edmund D. Pellegrino and David C. Thomasma, For the Patient’s
Good: The Restoration of Beneficence in Health Care (New York: Oxford
University Press, 1988).
359 William F. May, “Code, Covenant, Contract, or Philanthropy,”
Hastings Center Report 5 (1975): 29-38.
167
experiment possesses, not the subjects of that experiment. Inviting subjects
to participate in the research as equal partners, as Veatch suggested, denies
the importance of expert judgment and therefore poses a significant risk to the
integrity of the research.
Veatch’s intentions are good; he seeks to elevate the moral status of
research subjects, hoping that if they are viewed and treated as equal partners
in research then they will receive the respect they deserve. But by comparing
the researcher-subject relationship to any other market transaction, Veatch
denies the reality of that relationship, risks sacrificing the integrity of scientific
research, and depersonalizes both medical and research ethics.
All five of these distinguished bioethicists have made important
contributions to the discourse on respect. They all attempted to answer two
essential questions: Why should we respect research subjects? And how do
we respect research subjects? In answering the first question, Ramsey
offered a theological argument. He claimed that the sacred covenant between
researcher and subject gives rise to an obligation of respect. Ramsey
appealed to theological concepts (such as the sanctity of human life and
canons of loyalty) in order to justify the duty of respect for persons, but he then
secularized his interpretation of what it means to respect others. This may
have been necessary in order to reach a pluralistic population, but it has the
unfortunate effect of reducing the depth of his analysis.
Fried, Veatch, and Jonas all located the duty of respect, not in God’s
creation, but in the very nature of the physician/researcher-patient/subject
relationship. Fried argued that, as a minister to the “basic unit which is the
168
person”—his or her body—the physician owes a duty of personal care to the
patient. This relation of personal care, in turn, gives rise to certain rights,
including the right to have one’s “full human particularity” respected. It is not
clear, however, how Fried gets from a duty of personal care to the four rights
of lucidity, autonomy, fidelity, and humanity. His account also fails to
distinguish the researcher-subject relationship from the physician-patient
relationship. He spoke only of subjects who are also patients. Consequently,
the implications of his model are unclear for a variety of research settings
where the researcher-subject relationship is not also a physician-patient
relationship, including research on non-patients and research conducted by an
investigator who is not also the subject’s personal physician. In fact, given the
primary goal of research, which generally does not include personal care for
the subject, it is doubtful whether Fried’s justification for the moral duty of
respect (via the right of humanity) is valid at all in the research context.
Veatch, on the other hand, grounded the duty of respect specifically in
the researcher-subject relationship and argued that the equality and “mutuality
of interest” between researcher and subject gives rise to a duty of respect for
research subjects. He argued that the research subject’s role as equal partner
in a common cause commands a certain amount of recognition and respect.
His account of the researcher-subject relationship, however, is flawed. It fails
to consider the realities of the relationship and creates unrealistic expectations
for research subjects. It also undermines the importance of expert judgment
by arguing that subjects can and should participate as equal partners in the
research design, implementation, and dissemination of results.
169
Jonas, like Veatch, focused on the role of the research subject. He
argued that research subjects are “martyrs of science” who sacrifice for the
common good. This distinctive social role commands admiration and
recognition. Jonas also argued for respect for research subjects from a
consequentialist perspective. He contended that the practice of research
leads to the objectification of research subjects. This, in turn, denies the
reality of the unique individual that is the research subject, puts everyone at
risk of being treated as a “mere token,” and hardens and therefore injures the
one who performs the objectification (the researcher). Respect is thus
necessary, according to Jonas, to “right the wrong of reification.”
Katz similarly grounded the duty of respect for research subjects in
history and the consequences of past dehumanization. He argued that history
teaches us that there is a basic human need for reciprocal recognition and
mutual understanding (as articulated by Berlin). To ignore this need in the
context of research is to disrespect, and thus harm, research subjects. Thus,
Jonas and Katz both appealed to the consequences of dehumanizing other
humans (as we have learned from historical experience) in arguing for a duty
of respect.
Although the concept of respect and its moral foundation have not been
clearly articulated by any one individual, each of these five men contributed in
important ways to the conversation by attempting to ground the duty of respect
in something other than the capacity for autonomous decision making.
Although none of these arguments escapes criticism, Jonas and Katz (via
Berlin) provide the most theoretically sound secular foundation for the duty of
170
respect for research subjects, appealing to the unique contribution that
research subjects make to society and the horrible consequences of
disrespecting research subjects, or treating them as “mere tokens.”
Having established the origins of a commitment to respect for research
subjects, each of these five individuals sought to delineate the types of
behaviors required by a duty of respect. Whereas Ramsey, Jonas, and Katz
provided the most conceptually robust justifications for respecting research
subjects, they all restricted their analysis of its implications to autonomous
decision making (via the requirement for informed consent). Ramsey stressed
the importance of consent. Jonas argued that “mere consent” is not enough,
but rather, authentic volunteering is necessary. Katz agreed with Jonas that
“mere consent” does not suffice, but he focused on the depth of conversation
that must take place between researcher and subject. He moved beyond
consent when he talked about the need for recognition and due regard (via
Berlin), but he ultimately failed to develop this important idea. The
conversation that Katz called for may be an important aspect of respect for
autonomous individuals, but it failed to address respect for nonautonomous
subjects (at least those that are incapable of communicating). Thus, all three
of these accounts reduced the application of respect to a primary
consideration of respect for autonomy.
Fried and Veatch, on the other hand, explicitly differentiated respect
from respect for autonomy, enabling them to construct a more robust
interpretation of respect for research subjects that included but was not limited
to respect for subject’s choices. Fried believed that lucidity and autonomy
171
were important aspects of respect, but the principles of fidelity and humanity
must also be respected. Thus, researchers must obtain subjects’ informed
consent, but they must also recognize and respect the “full human
particularity” of every individual subject. Perhaps Veatch’s most important
contribution to the “respect” discourse came in an article he wrote in 1995 in
which he explicitly distinguished the principle of respect for persons from
respect for autonomy. Like Fried, Veatch argued that respect for persons
included other nonconsequentialist principles besides autonomy, such as
fidelity, veracity, avoiding killing, gratitude, and reparation for previous wrongs
inflicted.360 This moved well beyond a conception of respect as synonymous
with respect for people’s choices. It introduced the question of what it means
to respect research subjects beyond respecting their autonomy.
This question has been indirectly asked by many bioethicists in the past
decade, primarily in response to recognition of the limits of autonomy and to
criticism of the overemphasis that has been placed on non-interference with
autonomous choices. The prominence of the principle of respect for autonomy
may have been necessary thirty years ago in order to rectify the type of
unethical practices that Henry Beecher exposed in 1966. However, by the
1990s, some bioethicists felt that the pendulum had swung too far in the
direction of individual self-determination and that patients and subjects were
being morally abandoned in the quest for informed consent. These concerns
prompted a shift back towards a more care-oriented approach to bioethics.
360
Veatch, “Resolving Conflicts among Principle,” 199-218.
172
The result was, in some cases, the development of more robust interpretations
of the moral obligation to respect research subjects.
The Present: A Spectrum of Recognition
The nature of clinical research has changed dramatically in the past two
decades. There are an increasing number of clinical trials each year, as both
NIH funding and private industry funding continue to increase. These clinical
trials have become more complex; they often involve very large sample sizes
and are conducted at multiple sites, both nationally and internationally.
Additionally, new technology and advancements in the field of genetics have
opened the door to exciting possibilities for creating, enhancing, and
prolonging life. All of these changes, however, have prompted new concern
about the ethics of medical research.361 Several high profile research
“scandals” have also contributed to increased skepticism about the adequacy
of our regulatory system to protect human research subjects. Much of the
criticism has focused on the lack of institutional compliance and the
361
As the National Bioethics Advisory Commission pointed out:
Research involving human participants has become a vast academic and
commercial activity, but this country’s system for the protection of
human participants has not kept pace with that growth. On the one
hand, the system is too narrow in scope to protect all participants, while
on the other hand, it is often so unnecessarily bureaucratic that it stifles
responsible research.
National Bioethics Advisory Commission, Ethical and Policy Issues in
Research Involving Human Participants: Summary (Bethesda, Md.: NBAC,
August 2001), available at www.bioethics.gov.
173
insufficiency of federal enforcement mechanisms, with relatively little attention
given to the underlying ethical norms guiding human subjects research. That
said, however, some ethicists have recognized the limits of autonomy as a
guiding moral principle in research, which has led them to re-evaluate the
scope of what it means to respect research subjects.
The public discourse surrounding the concept “respect” is strikingly
reminiscent of the National Commission’s deliberations almost thirty years
ago. The National Commission’s expressed concern about the limits of
autonomy ultimately resulted in the identification of the principle of respect for
persons, rather than the principle of autonomy, as a guiding ethical principle
for research in The Belmont Report. These concerns subsequently got
overshadowed in the quest to regulate research and to institutionalize the
requirement of informed consent, but have re-emerged in recent years.
Three major criticisms about the limits of autonomy have indirectly
resulted in more fertile conversations about the broader ethical duty of respect:
its inability to address concerns about the ethical treatment of nonautonomous
individuals, its focus on the individual, and its grounding in American liberal
ideals. All three of these issues were raised by the National Commission, the
first two as problematic for the principle of respect for autonomy and the third
as an argument in favor of identifying the principle of respect for autonomy as
a fundamental ethical principle for research. Thus, the subject is not novel,
but the dialogue has matured.
Respect for Nonautonomous Entities
174
Respect for autonomy cannot be invoked for humans who are
nonautonomous and have never been autonomous. I believe that a more
robust concept of “respect” for research subjects can help us understand
research ethics for this population of subjects who cannot be participants or
partners in the research in any meaningful sense. The National Commission
was particularly concerned about the moral abandonment of nonautonomous
entities. Recall that its first task was to investigate the ethics of fetal research.
Through its investigation the commissioners became convinced that an
essential element of the ethics of fetal research was that the “human character
of the fetus” be respected.362 The commissioners never explained what they
meant by this, but the recognition that nonautonomous entities, such as
fetuses, deserve respect clearly contributed to their identification of respect for
persons as a basic ethical principle for research (rather than the more narrow
principle of respect for autonomy).
This issue was discussed more recently, first by the National Institute of
Health’s (NIH) Human Embryo Research Panel (HERP) and subsequently by
the National Bioethics Advisory Commission (NBAC). The HERP was
established in 1993 as ad hoc consultants to the Advisory Committee to the
Director of NIH and was asked “to make recommendations to assist the
development of guidelines for funding preimplantation human embryo
research.”363 In its Report, the HERP acknowledged that the human embryo is
362
National Commission, Research on the Fetus, 63.
363
National Institutes of Health, Report of the Human Embryo
Research Panel (Bethesda, Md.: U.S. Government Printing Office,
September 1994).
175
not yet considered a person with full moral status, but insisted that it
nonetheless “deserves special respect” and “serious moral consideration as a
developing form of human life.”364 Similarly, the NBAC, which was established
by President Clinton in 1995, invoked the rhetoric of respect when advising
about the ethics of embryonic stem cell research.365
These policy statements have led to debate about what exactly it
means to “respect” a nonautonomous entity, such as an embryo. Some have
suggested that when research on human embryos is restricted in the name of
respect for those embryos, what is being respected is not the embryo itself,
but “deeply held symbolic concerns.”366 Others have argued that it is
impossible to show respect for human embryos while using them for research
purposes without any criteria for determining how to weigh the research needs
against the respect due to the embryo. “If we look under the rhetoric of
respect,” Daniel Callahan has suggested, it seems that what the HERP
actually did was to “simply [strip] preimplantation embryos of any value at
all.”367 As Karen Lebacqz has declared, “to take away value is not to be
respectful, whatever the rhetoric.”368
364
Ibid.
365
The National Bioethics Advisory Commission, Ethical Issues in
Human Stem Cell Research (Bethesda, Md.: NBAC, September 1999).
366 John A. Robertson, “Symbolic Issues in Embryo Research,”
Hastings Center Report 25, no. 1 (1995): 37-38.
Daniel Callahan, “The Puzzle of Profound Respect,” Hastings
Center Report 25, no. 1 (1995): 39-40.
367
176
These objections raise the question of what it means to respect
embryos. The answer to this question carries important implications for the
broader analysis of respect for all nonautonomous individuals. Lebacqz has
taken on this crucial issue in a serious way. She has provided what I have
found to be the most thoughtful analysis of the principle of respect for persons
as it applies to persons, nonpersons, and potential persons. She began her
analysis by examining Downie and Telfer’s classical definition of respect for
persons and explained that it includes “both an attitude and a moral norm. As
an attitude,” she clarified,
It implies thinking that something is valuable or estimable. Having
respect implies that the thing should be cherished. As a moral norm, it
means treating a person as an end and not merely as a means or as
something useful for my own ends or purposes … Having respect
involves ways of thinking and feeling as well as ways of acting …
To have respect for a person is to make that person’s ends our own; it
here requires a kind of active sympathy, a practical concern for others
… Thus, the attitude of respect includes at least these two components:
active sympathy and readiness to hear the reasons of others and to
consider that their rules might be valid. We are to try to see the world
from the other’s point of view.369
This account of respect for persons is reminiscent of both Jonas and Berlin’s
positions. Jonas and Berlin both argued that we ought to respect research
subjects because of the horrible consequences that we have experienced by
not respecting them (i.e.: by objectifying them and treating them as “mere
tokens”) in the past. Downie and Telfer clarify that the process of
368
Lebacqz, “On the Elusive Nature of Respect,” 149-62, 150.
369
Ibid., 151; R. S. Downie and Elizabeth Telfer, Respect for Persons
(London: George Allen and Unwin, 1969).
177
objectification involves both an attitude and a set of certain behaviors. The
attitude they described involves the kind of reciprocal recognition and mutual
understanding that Berlin discussed. Downie and Telfer depart from both
Jonas and Berlin, however, in how they have defined persons. Downie and
Telfer restricted the application of the principle of respect for persons to
autonomous individuals.
Lebacqz understands the limitations of this definition and has
concluded that, even though embryos are not persons according to this
definition, they can still be respected in a meaningful way: “Respect is owed
not simply to persons, but very precisely to those who are always in danger of
being cast outside the system of protection that personhood brings.”370 She
explained:
To have respect is to take a second look, seeing below the surface to
find the hidden value … It connotes showing honor or esteem,
consideration or regard. This suggests that we can speak of respecting
a wide variety of things beyond persons.371
Lebacqz analyzed what it means to respect embryos by first discussing
the concept of respect in the context of other non-persons. Addressing the
ethics of embryonic stem cell research, she asked whether it is de facto
disrespectful to kill an entity. Explaining that there are many other non-person
sentient beings that are treated with profound respect, even while they are
killed, Lebacqz argued against the assumption that death and respect are
370
Lebacqz, “On the Elusive Nature of Respect,” 152-53.
371
Ibid., 153.
178
incompatible. By way of example, she discussed the Biblical laws that allow
humans to kill animals so long as they do not ingest their blood, which
represents the animal’s life. Similarly, many Native Americans show respect
for the animals they hunt by praying, chanting, and asking forgiveness from
the animal itself. Thus, Lebacqz concluded, “killing per se is not necessarily
disrespectful. It is a question of how animals are killed. Respect or disrespect
lies not alone in what acts are done, but in the attitude accompanying those
acts.”372 One can thus respect sentient creatures even while they are being
killed, according to Lebacqz, so long as efforts are made to minimize their
pain, fear and stress. This aspect of respect, however, Lebacqz found not to
be particularly relevant to the embryo since the embryo is presumably
incapable of feeling or emotion.
Next, Lebacqz considered what respect requires in the context of nonsentient entities, such as plants and the environment. She referred to Barbara
McClintock, who showed tremendous respect for her corn plants by “never
trying to force them into a mold … know[ing] them as individuals … expect[ing]
the unexpected … [being] open to the possibility that they operated out of
rules that were not known and understood by humans.”373 From McClintock’s
work, Lebacqz deduced several elements of what it means to respect:
First, it means attention to the concrete reality of the other. Rather than
imposing preconceived notions of who or what the other should be,
respect means trying to perceive the other in itself. Second, respect
372
Ibid., 155.
373
Ibid.
179
requires humility, in the sense that we acknowledge that we may need
to “work on ourselves” in order to perceive correctly. 374
To this, Lebacqz added two more “fundamental tenets” of respect, which she
abstracted from ecological ethics:
First is an affirmation of the independent value of other creatures and of
the ecosystem itself. There is a fundamental shift from seeing nature
as valuable for us to seeing it as valuable in and of itself. Thus, respect
implies valuing the other …
Second is understanding the interconnection and mutual
interdependence of all creation, including humans … The underlying
idea is that all are part of a whole, and that damage to any part of that
whole damages every part of it, directly or indirectly. This implies a
symbiotic relationship, and to disrespect another part of creation is to
harm ourselves, whether or not we realize it.375
Thus, respect becomes much more than simply not interfering with another’s
autonomous choices or not harming another individual, but rather it means
“standing in awe and making every effort to support the flourishing of the
system.”376
In the context of embryos, Lebacqz argued that the embryo must be
valued and that harm to the embryo must be minimized. “To value
something,” Lebacqz explained, “is to believe that it has moral worth in itself,
apart from [its] usefulness to us.”377 That does not mean that it cannot be
used, only that it not be used cavalierly:
374
Ibid., 156.
375
Ibid., 157.
376
Ibid., 158.
377
Ibid., 159.
180
An entity is treated cavalierly if it is demolished without any sense of
violation or loss; if it is treated as only one of many and easily
replaceable; if its existence is made the butt of jokes or disrespectful
stereotyping. Thus, to require that a blastocyst not be treated cavalierly
is to require that it be treated as an entity with incredible value; as
something precious that cannot be replaced by any other blastocyst,
whose existence is to be celebrated, and whose loss is to be grieved.378
In minimizing harm to the embryo, one should consider whether it is possible
to use the embryo without destroying it and “if it is possible to do good for the
embryo by giving it continuing life rather than destroying it, giving life should
take priority.”379
Lebacqz’s conception of respect as it applies to non-persons is thus
extremely broad and extraordinarily deep. Derived in part from Downie and
Telfer’s discussion about respect for persons, one would expect that this
robust definition of respect would apply also to “persons” who are research
subjects. However, surprisingly, Lebacqz restricted her application of this
robust conception of respect to embryonic tissue. She explicitly limited the
application of respect for autonomous persons to practices of informed
consent and respect for nonautonomous but sentient beings to the
minimization of pain and fear. She concluded her argument with the
statement:
Researchers show respect toward autonomous persons by engaging in
careful practices of informed consent. They show respect toward
sentient beings by limiting pain and fear. They can show respect
toward early embryonic tissue by engaging in careful practices of
378
Ibid.
379
Ibid., 160.
181
research ethics that involve weighing the necessity of using this tissue,
limiting the way it is to be handled and even spoken about, and
honoring its potential to become a human person by choosing life over
death where possible.380
This conclusion is puzzling, particularly in light of Lebacqz’s recently
expressed view that the principle of respect for persons involves more than
respect for autonomy, even for autonomous individuals.381 Limiting respect for
autonomous persons to practices of informed consent perpetuates an
impoverished interpretation of respect, which is inconsistent with the broad
definition of respect that Lebacqz herself advocates for. What is needed is an
analysis of how Lebacqz’s conception of respect for non-persons can apply to
and enhance our understanding of what it means to respect all research
subjects, regardless of their moral status.
380
Ibid.
381
Lebacqz, “Twenty Years Older but Are We Wiser?”
182
Respect for Communities
The second criticism concerning the limits of autonomy that was raised
by the National Commission and that has resurfaced in recent years is that the
concept of autonomy is too individualistic; it fails to account for the social
nature of human beings and our inherent interconnectedness and mutual
interdependence. The National Commission decided that the principle of
respect for persons was better able to address this issue than the principle of
autonomy and so identified it as a fundamental ethical principle for research.
More recently, the focus has been on restraining the moral authority of respect
for autonomy and on expanding the definition of autonomy to account for the
social nature of individuals.382 Autonomy, which literally means “self rule”
cannot easily be interpreted as a socially-constructed moral norm. To attempt
this is to distort the principle of respect for autonomy and to give lip service to
the importance of community. Additionally, sometimes a person’s individual
choices are in conflict with their community values or social obligations. This
has led some commentators to suggest that there is an independent moral
consideration of respect for community that needs to be contemplated when
making ethical judgments in research.383
382 In the fifth edition of Principles of Biomedical Ethics Beauchamp
and Childress attempt to construct a definition of “autonomy” that is “not
excessively individualistic (neglecting the social nature of individuals and the
impact of individual choices and actions on others).” Beauchamp and
Childress, Principles of Biomedical Ethics, 5th ed., 57.
Charles Weijer and Ezekiel J. Emanuel, “Protecting Communities
in Biomedical Research,” Science 289, no. 5482 (2000): 1142-44; T. M.
Wilkinson, “Individualism and the Ethics of Research on Humans,” HEC
Forum 16, no. 1 (2004): 6-26.
383
183
For example, Weijer and Emanuel have argued that in light of the
changing nature of medical research (particularly genetics research) it is
essential that the rights and welfare of communities be respected and
protected. As communities are targeted for genetic research, there is
increased concern about the implications for entire groups of people. In an
effort to address those concerns, Weijer and Emanuel have advocated for
active community participation in all aspects of biomedical research, from the
protocol development to the informed consent process and even through the
dissemination and publication of results.384 Respect for research subjects
requires, then, not just respect for individual subjects, but more broadly, it
requires respect for subjects as they exist within communities.
Nancy King, Gail Henderson, and Jane Stein have gone further and
argued that a principlist approach to ethical problems in research is insufficient
given the inherently social nature of human beings. They believe that we are
in the midst of a paradigm shift, “from the regulatory, principle-based
paradigm,” which is centered on the individual, “to a paradigm based on
relationships.”385 Ruth Macklin, on the other hand, supports the universal
application of principles, such as the principle of respect for persons, but has
argued that they must be interpreted and applied broadly enough to account
for social considerations. She believes that “principles are necessary but not
384 Weijer and Emanuel, “Protecting Communities in Biomedical
Research.”
385
Nancy P. King, Gail E. Henderson, and Jane Stein, eds., Beyond
Regulations: Ethics in Human Subjects Research (Chapel Hill: University of
North Carolina Press, 1999), 15.
184
sufficient for a rich ethical analysis of human subjects research.” They
“require interpretation and elaboration before they can be applied in
practice.”386 Thus, the regulatory application of the principle of respect for
persons may focus on autonomy and the requirement for informed consent,
“but that is not the only value embodied in the principle [of respect for
persons].”387 It may be that the more subtle and abstract aspects of respect
cannot and ought not to be regulated. But, Macklin reminds us, this “is not
entirely to be lamented. It is both necessary and inevitable.”388 The danger is
that these more nuanced ethical considerations will be abandoned in an effort
to simply comply with the more procedurally-oriented regulatory aspects of
research. In chapter 6 I propose three ways to safeguard against this moral
hazard (as it applies to the duty of respect in research): (1) by enhancing the
procedural mechanisms for analyzing the most difficult ethical aspects of every
research protocol, (2) by remediating the misconception that respect for
research subjects is synonymous with respect for subjects’ choices and
encouraging responsible public discourse about the broad ethical implications
of the moral obligation of respect for research subjects, and (3) by studying
current attitudes, perceptions, and obstacles to respect among researchers
Ruth Macklin, “Is Ethics Universal?: Gender, Science and Culture
in Reproductive Health Research,” in Beyond Regulations: Ethics in Human
Subjects Research, ed. Nancy P. King, Gail E. Henderson, and Jane Stein
(Chapel Hill: University of North Carolina Press, 1999), 25.
386
387
Ibid.
388
Ibid., 42.
185
and subjects of biomedical and behavioral research. This will not only
enhance our conceptual understanding of what it means to respect research
subjects, but it is my thesis that if we take the duty of respect for research
subjects seriously, then the entire human subjects protection system will be
improved.
Respect for Cultural Diversity
Finally, the third criticism about the limits of autonomy that has led to a
more robust understanding of the duty of respect for research subjects is that
the importance of autonomous decision making is a uniquely American value.
This is related to the concern for respect for communities. The argument is
that not all communities, particularly non-Western communities, value
autonomous decision making and that it is therefore disrespectful to impose
our American values on subjects from other cultures. This issue has become
increasingly controversial as more and more American investigators conduct
clinical trials overseas. In response, some of the international ethics codes
have attempted to incorporate broader interpretations of respect for research
subjects that are more culturally sensitive and consistent with non-Western
values.
For example, the Council for International Organizations of Medical
Sciences’(CIOMS) 2002 International Ethical Guidelines for Biomedical
Research Involving Human Subjects aims specifically to address ethical
concerns in multinational research. They have acknowledged the challenge of
applying universal ethical principles in a multicultural world. Although they set
186
forth the same three general ethical principles that were identified in The
Belmont Report in 1979, they make efforts to apply the principle of respect for
persons more broadly in order to account for cultural diversity in the context of
international research.
The first ethical guideline set forth by the CIOMS states that biomedical
research “can be ethically justifiable only if it is carried out in ways that respect
and protect, and are fair to, the subjects of that research and are morally
acceptable within the communities in which the research is carried out.”389
While the CIOMS insists on the moral authority of respect for autonomy and
argues for the universal application of the requirement for informed consent, it
maintains that informed consent can be obtained while respecting the values
and practices of the subject’s culture:
In some cultures an investigator may enter a community to conduct
research or approach prospective subjects for their individual consent
only after obtaining permission from a community leader, a council of
elders, or another designated authority. Such customs must be
respected. In no case, however, may the permission of a community
leader or other authority substitute for individual informed consent. …
Sponsors and investigators should develop culturally appropriate ways
to communicate information that is necessary for adherence to the
standard required in the informed consent process.390
This effectively expands the principle of respect for persons to include respect
for the cultural environment within which different persons live. Respecting
389
Council for International Organizations of Medical Sciences
(CIOMS), International Guidelines for Biomedical Research Involving Human
Subjects (Geneva: CIOMS, 2002).
390
Ibid.
187
different cultures requires a recognition and consideration of various cultural or
community customs as well as the active participation of communities in the
research design, execution, and implementation. The CIOMS specifically
requires that research undertaken in communities with limited resources
is responsive to the health needs and priorities of the population or
community in which it is to be carried out; and [that] any intervention or
product developed, or knowledge generated, will be made reasonably
available for the benefit of that population or community. 391
This requirement addresses issues of justice, but it also expresses a
commitment to the idea of respect. In this way, the CIOMS goes beyond an
interpretation of respect for research subjects as synonymous with respect for
individual autonomy.
The concept “respect” is like a prism. Some people look at it and just
see white light, which symbolizes the principle of respect for autonomy. It is
the most glaringly obvious aspect of respect for research subjects. Yet, if you
look more deeply, there exists a complex and multifaceted array of
interpretations and meanings. They are not as obvious and at first glance may
seem too disorienting. Yet, acknowledging these complex reflections is well
worth the effort for the most interesting and meaningful aspects of the prism
can only be discovered upon closer examination. This chapter represents an
effort to see inside the prism of respect for research subjects and to orient us
to some of its distinguishing characteristics. In chapter 6, I identify three
themes that have emerged in the respect discourse: respect as a moral
requirement grounded in the distinctive social role of the research subject and
391
Ibid.
188
the horrible consequences of disrespect for research subjects in the past,
respect as more than respect for autonomy, and respect as an attitude as well
as a set of behaviors. As I develop these three themes, I present ways to
transform the rhetoric of respect into public policy.
189
CHAPTER 6
THE FUTURE: RESPECT IN THEORY AND RESPECT
IN PRACTICE
In this dissertation I have argued that the National Commission’s
identification of respect for persons as a fundamental guiding principle in
research stems from a long history of disrespectful treatment of human
research subjects. The National Commission’s deliberations reveal
tremendous insight into the distinction between the concept of respect and
respect for people’s choices. By identifying respect for persons as a guiding
ethical principle in research, the commissioners sought to fundamentally
change the attitude toward and treatment of research subjects. As
Engelhardt’s commissioned paper demonstrated, they were trying to translate
the dialogue that had begun with Ramsey, Jonas, and Fried into public
policy.392 Their ultimate goal was protection—protection from harm and
exploitation, but also protection from isolation, dehumanization, and a lack of
recognition. The National Commission developed a multi-component account
of respect for persons but then pared it down in an effort to be practical and
concise. In its published report, The Belmont Report, the National
Commission reduced respect for persons to two essential components:
392 The National Commission relied heavily on Engelhardt’s paper
when writing The Belmont Report. In his paper, Engelhardt relied on the
work of Ramsey, Jonas, and Fried in order to develop and interpret the
principle of respect for persons. Engelhardt, “Basic Ethical Principles.” See
also chap. 3 for further discussion on the influence that Engelhardt’s paper
had on the National Commission.
190
respect for autonomy and protection for individuals with diminished autonomy.
Some bioethicists, including Tom Beauchamp, felt that protection for
individuals with diminished autonomy was more appropriately subsumed
under the principle of beneficence and that the principle of respect for persons,
as defined by the National Commission, was therefore confusing. Thus, in
subsequent bioethics treatises the concept of respect for persons was further
reduced to a principle of respect for autonomy. Autonomy was then truncated
into a right of non-interference. This development ignores nonautonomous
individuals and fails to account for the variety of ethical implications of a robust
definition of respect.
In this chapter, I join the dialogue about respect for research subjects
and give voice to my own thoughts and conceptualizations. This dissertation
has primarily been an examination of the discourse of respect in research
ethics. I have examined the historical origins of the concept of respect in
research and followed its development over the past thirty-five years. I begin
this chapter by making two important arguments about the principle of respect
for persons, as it was identified by the National Commission. First, I argue
that the language of respect for research subjects, rather than the language of
respect for persons, should have been used by the National Commission.
Respect is an essential element of research ethics. All research subjects
deserve respect. Limiting the duty of respect to “persons” focuses the
discussion on the relevant elements of “personhood” and obscures the most
important policy questions that relate to a more robust concept of the duty of
respect.
191
Second, I suggest that research ethics and policy will be enriched if
respect is elevated and conceived of as an overarching normative category for
research that includes, but is not limited to, the principles of respect for
autonomy, beneficence, nonmaleficence, and justice. Thinking about the duty
of respect for research subjects in this way will encourage broader
interpretations of what it means to “respect research subjects.” Before we
discuss the meanings of “respect,” however, we must provide a moral
foundation for the duty of respect for research subjects. I argue, like Jonas
and Berlin, that respect for research subjects is a moral requirement that can
be justified from an appeal to the distinctive social role of research subjects
and from a consequentialist perspective. The fact that society needs human
beings to participate in research and uses research subjects as a means
(even if not merely as a means) creates a moral obligation of respect for those
who fulfill our need and who are the subjects of our use. Additionally, history
teaches us about the consequences of disrespecting research subjects.
These consequences (including the harm, isolation, dehumanization, and
humiliation) are so horrific that they simply cannot be morally tolerated. What,
then, must we do to rectify previous wrongs? We must learn from the past
and not let history repeat itself; we must change institutional culture and
demand that research subjects be treated with the respect that they deserve.
After arguing for and justifying an overarching moral category of respect
for research subjects, I begin a conversation about what it means to “respect”
research subjects. This is a topic that deserves considerable attention. In this
chapter, I explore the meanings of respect for research subjects by first
192
clarifying that respect incorporates, but is not limited to, respect for autonomy.
Next, I distinguish two essential components of respect: an attitudinal
component and a behavioral component. Based on these two elements, I
outline what a robust understanding of respect for research subjects would
entail. I acknowledge some obstacles to taking respect seriously in the
context of human subjects research but suggest that it is vital to the moral
integrity of the research enterprise.
Finally, I propose three ways that a more robust conception of respect
for research subjects can inform the field of research ethics and policy. First, I
believe that the language of respect should be incorporated into the federal
regulation of research and that the procedural mechanisms for ensuring that
research projects are conducted in an ethical and respectful manner be
enhanced. Second, I encourage moral reflection and responsible public
discourse about the meanings and implications of respect for research
subjects. This dissertation is a first step in achieving this important goal.
Finally, I believe that policy changes in this area must be informed by careful
conceptual analysis as well as empirical research. I argue in this dissertation
that there exists considerable conceptual confusion about the duty of respect
in research. I try to locate the source of that confusion and to sort out some of
the misconceptions. I make no claims, however, about whether research
subjects generally feel respected, how investigators perceive and treat their
subjects, or what respect means from the perspective of participants in a
research study. These are empirical claims, which need to be explored
through qualitative or quantitative research. The conceptual analysis that I
193
have done in this dissertation sheds light on the empirical questions that can
and should be asked. The next step is to do the empirical work, which,
combined with the conceptual work that has been done, will support the policy
changes that need to come.
The Establishment of and Justification for an
Overarching Normative Duty of Respect for Research
Subjects
Respect for Whom?
The National Commission was established in large part to address
concern about the abuse and exploitation of vulnerable populations of
research subjects—fetuses, children, prisoners, and the mentally infirm. The
commissioners were simultaneously working on recommendations for the
regulation of research practices on these vulnerable populations and on
identifying the fundamental ethical principles for all biomedical and behavioral
research. Thus, not only did their work on The Belmont Report influence their
deliberations and conclusions regarding research on special populations, but
their considerations about research with fetuses, children, prisoners, and the
mentally infirm to a large extent preceded and inspired their work on The
Belmont Report.393
393
As I mention in chap. 3, the National Commission was established
in 1974 and given only four months to complete its report Research on the
Fetus (published 1975). Although the commissioners began working on The
Belmont Report in 1976, it was not published until September 1979. In the
meantime, the commissioners were working on their reports Research
Involving Prisoners (published 1976), Research Involving Children
(published 1977), and Research Involving Those Institutionalized as Mentally
Infirm (published February 1978).
194
In The Belmont Report, the commissioners struggled to identify, rather
than develop or establish, the fundamental ethical principles of research.
Their goal was to be practical in their application of what were philosophically
robust moral principles so as to protect and promote the rights, interests, and
integrity of all human subjects of research. The commissioners were
specifically mandated to address the practical issues of informed consent, riskbenefit analysis, and selection of subjects. Considering the requirement of
informed consent, the commissioners initially identified the right of selfdetermination as the guiding principle from which a duty of informed consent
emerged. They later expanded this to the ethical principle of respect for
autonomy. Some of the commissioners, however, expressed concern about
the treatment of nonautonomous individuals—precisely those populations that
they were commissioned to protect. Recognizing the limited rights afforded to
some of those groups (especially fetuses),394 the commissioners avoided an
appeal to rights and reached instead for the language of respect. Their
intentions were good, but it is my thesis that the National Commission made
two conceptual errors in identifying the principle of respect for persons as one
of the three basic guiding principles for research, errors that have
compromised research ethics and policy over the past thirty-five years.
394
The National Commission was established in the wake of Roe v.
Wade, 410 U.S. 113, 93 S.Ct. 705 (1973), in which the United States
Supreme Court refused to consider the fetus a “person” under the
Fourteenth Amendment, denying fetuses the constitutionally protected right
to “life, liberty and the pursuit of happiness.” The Court did rule, however,
that the state’s “legitimate interest in protecting the potentiality of human life”
could compel proscription of third trimester abortions. Ibid.
195
First, the National Commission should have adopted the language of
respect for research subjects, rather than respect for persons. There is
complex philosophical disagreement about the definition of personhood. The
National Commission explicitly refused to address the issue of personhood,395
but at the same time, it extended the principle of respect for persons to
individuals who are not yet autonomous (e.g., fetuses and children), to
individuals with diminished autonomy (e.g., some prisoners and mentally infirm
individuals), and even to nonautonomous entities that will never become
autonomous persons (e.g., fetuses designated for abortion).396 This suggests
that the National Commission was recognizing a duty to respect all research
subjects, irrespective of the subject’s moral or civil status. The language of
395
stated:
In its report, Research on the Fetus, the National Commission
Throughout the deliberations of the Commission, the belief has been
affirmed that the fetus as a human subject is deserving of care and
respect. Although the Commission has not addressed directly the
issues of the personhood and the civil status of the fetus, the members
of the Commission are convinced that moral concern should extend to
all who share human genetic heritage, and that the fetus, regardless of
life prospects, should be treated respectfully and with dignity.
National Commission, Research On the Fetus, 61-62 (emphasis added).
396
Ibid.; The National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research, Research Involving
Prisoners (Washington, D.C.: U.S. Government Printing Office, 1976), 6-7;
The National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research, Research Involving Children
(Washington, D.C.: U.S. Government Printing Office, 1977), 130-31; The
National Commission for the Protection of Human Subjects of Biomedical
and Behavioral Research, Research Involving Those Institutionalized as
Mentally Infirm (Washington, D.C.: U.S. Government Printing Office, 1978).
196
respect for persons, however, qualifies the group to whom respect is owed
based on moral status or personhood. The central issue then becomes, what
is the definition of a “person”? 397 If personhood is contingent on the capacity
for autonomous decision making, then only autonomous research subjects
deserve respect. Likewise, if we define persons in terms of their autonomy,
then what we respect about them is their capacity for autonomous choice.
This has been interpreted as suggesting that the principle of respect for
persons requires only that we respect autonomous individual’s choices.
This is not, however, what the National Commission intended. As I
have shown throughout this dissertation, at least some of the commissioners
on the National Commission had in mind a much more robust conception of
the principle of respect for persons. They envisioned a moral principle that
encompassed, not only respect for autonomy, but also, at least protection from
harm and exploitation, consideration for the time and inconvenience requested
of subjects, regard for subjects’ privacy, and attentiveness to the maintenance
of subjects’ confidentiality.398 These are all aspects of a more nuanced
397
Ironically, the principle of respect for persons may not have helped
to prevent many of the Nazi experiments. The Nazis, after all, did not
believe that the prisoners that they were experimenting on were persons.
While this conviction can easily be debated, the ambiguous definition of
personhood makes it more difficult to disprove. The language of respect for
research subjects, however, leaves no room for disagreement about which
research subjects deserve respect (other than dispute over what constitutes
a “human” research subject and whether a “potential human being,” such as
an embryo, counts). The only relevant interpretive question then becomes,
what does it mean to “respect” research subjects? Thoughtful consideration
of this question is necessary to move us beyond a definition of respect as
synonymous with respect for autonomy.
398
The commissioners defined respect for persons in The Belmont
Report as incorporating “at least two basic ethical convictions: first, that
individuals should be treated as autonomous agents, and second, that
persons with diminished autonomy are entitled to protection.” National
197
definition of respect, which gets lost in the struggle to identify which research
subjects are persons and therefore worthy of respect.
Commission, Belmont Report, 4 (emphasis added). In its report, Research
Involving Prisoners, the National Commission interpreted the principle of
respect for persons as requiring protection from exploitation, which was used
to justify placing limits on prisoners’ opportunity to volunteer for certain kinds
of research:
To respect a person is to allow that person to live in accord with his or
her deliberate choices. Since the choices of prisoners in all matters
except those explicitly withdrawn by law should be respected, as courts
increasingly affirm, it seems at first glance that the principle of respect
for persons requires that prisoners not be deprived of the opportunity to
volunteer for research …
However, the application of the principles of respect and justice allows
another interpretation, which the Commission favors. When persons
seem regularly to engage in activities which, were they stronger or in
better circumstances, they would avoid, respect dictates that they be
protected against those forces that appear to compel their choices. It
has become evident to the Commission that, although prisoners who
participate in research affirm that they do so freely, the conditions of
social and economic deprivation in which they live compromise their
freedom. The Commission believes, therefore, that the appropriate
expression of respect consists in protection from exploitation.
National Commission, Research Involving Prisoners, 6-7. In its report,
Research Involving Children, the application of the principle of respect for
persons led to recommendations for child assent and proxy consent, as well
as considerations of respect for time and inconvenience to the subject,
privacy, and confidentiality:
There are several additional conditions that respect for persons requires
in the conduct of research: e.g., that the time and inconvenience
requested of subjects be justified by the importance of the research and
by the soundness of its design, even if no more than minimal risk is
involved; that the privacy of the children and their families be protected;
and that the confidentiality of data be maintained.
National Commission, Research Involving Children, 131.
198
If the National Commission intended to establish a moral duty of
respect that extends to all research subjects, which I believe it did, then it
should have, at a minimum, adopted the language of respect for research
subjects, rather than respect for persons. This would have provided some
clarity about the National Commission’s intentions and would have had a
profound impact on future interpretations of the National Commissions’
Reports (including The Belmont Report).
Respect as What?
The National Commission was limited in its thinking about what it
means to respect research subjects because it was so focused on identifying
several competing ethical principles for research. Karen Lebacqz was correct
when she suggested that respect is more fundamental than the principle of
respect for autonomy and that it includes, but is not limited to, concerns about
respecting autonomy, protecting research subjects from harm, and promoting
their welfare.399 However, because of the National Commission’s exclusive
emphasis on identifying the most basic ethical principles to guide the practice
of research, it did not consider the possibility that respect could function as an
overarching normative category for research. Rather, it tried to fit respect into
its tripartite principlistic schema, which has resulted in conceptual confusion
about what the ethics of respect requires.
399 National Commission, “Transcripts of the 27th Meeting
Proceedings,” 19. See chap. 3 for further discussion.
199
By identifying the principle of respect for persons and then defining it in
terms of respect for autonomy, the National Commission gives the false
impression that respecting autonomy is the only, or at least the most
important, aspect of respect for research subjects. This insinuation is
substantiated by the National Commission’s exclusive emphasis on the
application of informed consent, which is grounded in the principle of respect
for autonomy. As a result, the more nuanced implications of respect for
research subjects are overshadowed and disregarded.
Thus, the National Commission should have, at a minimum, explicitly
distinguished respect for research subjects from the principle of respect for
autonomy. This would have allowed for more robust interpretations and
applications of respect for research subjects in research ethics and policy. It is
my thesis, however, that research ethics and policy will be greatly enriched if
we go further and think about respect for research subjects, not as one of
several competing ethical principles, but as an overarching normative category
for research ethics, which includes, but is not limited to the principles of
respect for autonomy, beneficence, nonmaleficence, and justice. Respect for
autonomy via the requirement for informed consent deals with one particular
set of behaviors required by a robust conception of respect for research
subjects. However, respectful conduct also requires that certain actions be
taken to benefit research subjects (beneficence), protect them from harm
(nonmaleficence), and treat them equitably (justice). Before we can
appreciate what respect would look like as an overarching normative category
200
for research we must explore all of the various components of respect for
research subjects.
Respect as an Attitude and Respect as a Set of Behaviors
The ethics of respect has not been given serious enough attention in
the field of bioethics. As Ronald Carson points out, the principle of respect
functions in contemporary biomedical ethics primarily as a reminder “to mind
our own business, to leave each other alone.”400 Although this is sometimes
necessary advice, as I have shown throughout this dissertation, it is not
sufficient. Carson agrees that “we have settled for too shallow an
understanding of respect.”401 He calls for a shift in the sensibility of doctors;
for “an imagination capable of recognition, of appreciating others as they
are.”402 The title of Carson’s article, “Beyond Respect to Recognition and Due
Regard,” suggests that this sort of appreciation or acknowledgement of others
is something other than, and more than, respect. Certainly it moves beyond
the shallow interpretation of respect as synonymous with the right of selfdetermination that has been adopted by many bioethicists, but rather than
transcending the concept of respect, it merely begins to capture the more
Ronald A. Carson, “Beyond Respect to Recognition and Due
Regard,” in Chronic Illness: From Experience to Policy, ed. S. Kay Toombs,
David Barnard, and Ronald A. Carson (Bloomington: Indiana University
Press, 1995), 105.
400
401
Ibid., 106.
402
Ibid., 125.
201
complex and multifaceted meanings of respect in ordinary discourse. What is
needed is not a substitute for respect, but a more comprehensive
understanding of what it means to respect research subjects.
The word respect comes from the Latin word respectus, which means
literally, to look back at, or to regard.403 There are various dictionary
definitions of respect, including “to feel or show deferential regard for;
esteem,”404 “to take notice of; to regard with special attention; to regard as
worthy of special consideration; hence, to care for; to heed,”405 “an attitude of
admiration or esteem,”406 and “a courteous expression (by word or deed) of
esteem or regard.”407 Robin Dillon synthesizes these various usages of the
word “respect” in the Encyclopedia of Philosophy and identifies four common
elements of respect: attention, deference, valuing, and appropriate conduct.408
Paying attention to something, regarding it in a particular way, and trying to
Merriam-Webster Online Dictionary, s.v. “Respect,” http://www.mw.com/cgi-bin/dictionary?book=Dictionary&va=respect.
403
404
The American Heritage Dictionary of Idioms, s.v. “Respect.”
405
Webster’s Revised Unabridged Dictionary, s.v. “Respect.”
On-line Medical Dictionary, s.v. “Respect,”
http://cancerweb.ncl.ac.uk/omd/.
406
407
Ibid.
408
Edward N. Aalta, ed., The Stanford Encyclopedia of Philosophy,
s.v. “Respect,” by Robin S. Dillon (Stanford, Calif.: Stanford University,
2004), http://plato.stanford.edu/entries/respect/.
202
see it for what it really is, is one aspect of respect. It involves a “particular
mode of apprehending the object: the person who respects something
perceives it differently from one who does not and responds to it in light of that
perception.”409 This attentiveness contrasts with “being oblivious or indifferent
to it, ignoring or quickly dismissing it, neglecting or disregarding it, or
carelessly or intentionally misidentifying it.”410 Sometimes we show respect by
being deferential to the object of our respect. In such instances, “selfabsorption and egocentric concerns give way to consideration of the object,
one’s motives and feelings submit to the object’s reality.”411 We acknowledge
the other’s claim to our attention and choose, willingly, to “heed its call” and
“accord it its due.”412 Sometimes respect for an object involves “experiencing
and acknowledging the intrinsic value or significance” of it, “appreciat[ing] it as
having worth or importance that is independent of our antecedent desires or
commitments.”413 It is valuing the object and not treating it as “worthless or
insignificant or disdaining or having contempt for it.”414 Finally, respect often
409
Ibid.
410
Ibid.
411
Ibid.
412
Ibid.
413
Ibid.
414
Ibid.
203
involves adopting appropriate conduct. It is the manner in which you treat an
object, which reflects the attitude that you have about that object. Respectful
behavior is essential, but it is not enough. As Dillon points out,
Respect is more than merely respectful behavior, however, for one can
show respect that one does not have … To be a form or expression of
respect, behavior has to be motivated by one’s acknowledgment of the
object as calling for that behavior, and it has to be motivated directly by
consideration that the object is what it is, without reference to one’s
interests and desires.415
Dillon’s four elements of respect can be further distilled down to two
essential categories: respect as an attitude and respect as a set of behaviors.
Having a respectful attitude toward an object can mean two things. First, it
can denote a feeling of admiration or positive appraisal. One can respect the
features of an object that manifest “excellences of character,” even while
possessing some negative assessment of that object.416 This type of respect
is usually reserved for moral exemplars. While not every individual is a moral
exemplar, one might admire research subjects as a group for the sacrifices
that they make to science. Hans Jonas suggests that as “martyrs to science”
research subjects deserve this type of appraisal respect.417 Perhaps they do,
but it is difficult to establish a moral duty of admiration. What or who one
415
Ibid.
416 Ibid. Darwall calls this “appraisal respect” and contrasts it with
“recognition respect.” S. L. Darwall, “Self-Deception, Autonomy, and Moral
Constitution,” in Perspectives on Self-Deception, ed. B. P. McLaughlin and
A. O. Rorty (Berkeley and Los Angeles: University of California Press, 1988).
417
Jonas, “Philosophical Reflections.”
204
admires is subjective and may differ from what or who others admire. Thus,
respect for research subjects may involve admiration for subjects, but it need
not.
The second thing that having a respectful attitude toward research
subjects can signify is appreciation for the contribution that research subjects
make to the biomedical and behavioral sciences. The contribution that all
human subjects of research make to society and to the biomedical research
enterprise is tremendous. Whether they volunteer to participate in research or
not (e.g., incapacitated adults, children, fetuses, cadavers) and regardless of
their motivations for participating (e.g., self-interest, altruism, money) they
often go beyond the call of duty and always fulfill an important social role,
namely, the need for research subjects in order to advance scientific
knowledge and to further the goals of medicine. Their contribution must at
least be recognized, appreciated, and respected, even if it is not admired.418
The moral integrity of the research enterprise depends on it.
418
Many researchers clearly respect their research subjects in this
manner. For example, William Bartholome consistently advocates for child
assent to participate in research and for greater respect and appreciation of
pediatric research subjects. Of children who participate in research,
Bartholome says:
It is essential that we continue to respond to the many ethical challenges
involved in pediatric research ethics in a manner that is more sensitive
to the experience of the child subject, a manner that reflects an
awareness of both child subjects’ vulnerability and developing
capacities, as well as honors the “second-mile behavior” of the young
heros and heroines who willingly place themselves in harm’s way so
that the next generation of children may benefit from biomedical and
behavioral research.
William G. Bartholome, “Ethical Issues in Pediatric Research,” in The Ethics of
Research Involving Human Subjects: Facing the 21st Century, ed.
Vanderpool, 339-70, 366. See also William G. Bartholome, “Informed
205
Without an attitude of respect, any respectful behaviors are empty acts
of etiquette or thoughtless attempts to comply with bureaucratic codes of
conduct. These may help protect research subjects from abuse, but they do
nothing to ensure that subjects are protected from the harm associated with
dehumanization, humiliation, and isolation. Obtaining informed consent from
subjects, minimizing the risks to them, and ensuring the equitable selection of
research subjects are all essential elements of respectful conduct. Yet, they
are not sufficient. As Karen Lebacqz once said, “you can give me all the
informed consent in the world … but if you are still calling me a bitch behind
my back, that’s not very respectful.”419 It indicates a lack of appreciation and
disregard for the research subject.
Research subjects must not only be appreciated, they must be treated
with appreciation. This means that they must be recognized as the unique
and valuable individuals that they are. Their wants, needs, and fears must be
considered and attended to. The inconveniences to them must be
acknowledged and minimized. They must be made to feel like the important
contributor that they are. They must not be treated with contempt or
arrogance. They must not be defamed, ridiculed, mocked, or humiliated. All
of these are general behavioral requirements, which can be further specified
into specific acts. For example, out of appreciation for research subjects,
Consent, Parental Permission, and Assent in Pediatric Practice,” letter to the
editor, Pediatrics 96, no. 5, pt. 1 (1995): 981-82.
419
2004.
Karen Lebacqz, telephone conversation with the author, June 10,
206
investigators may find it appropriate to thank their subjects, but unless this act
is motivated by honest, reflective feelings of appreciation, it will become
nothing more than an empty gesture. Insincerity is a form of deceit and is in
and of itself morally objectionable. Thus, both attitude and behavior are
necessary for a morally robust conception of the duty of respect. As Michael
Meyer and Lawrence Nelson put it: “An agent evinces moral respect … when
she sincerely considers and actually treats an entity as worthy of some degree
of deference, reverence, or regard.”420 Reflection on the appropriate attitude
of respect will lead to more insightful assessments of the corresponding
respectful conduct.
Conceptualizing Respect for Research Subjects
Respect for research subjects thus involves two major components: an
attitudinal component and a behavioral component. Under the attitudinal
component, what is required is an attitude of appreciation for research
subjects’ contribution to science and their essential moral worth as human
beings. The conduct required by the principles of respect for autonomy,
beneficence, and justice is part of the behavioral aspect of the moral duty of
respect. What is missing, however, is the element of respect that Fried,
Jonas, and Berlin allude to. It is the act of recognition. This duty of
recognition involves, among other things, acts of compassion, concern, care,
Michael J. Meyer and Lawrence J. Nelson, “Respecting What We
Destroy: Reflections on Human Embryo Research,” Hastings Center Report
31, no. 1 (2001): 16-23, 17.
420
207
kindness, and attentiveness to subjects’ needs, wants, and fears. It aims to
avoid the dehumanization, humiliation, and isolation of research subjects.
Although recognition addresses the manner in which you treat someone, it is
intimately connected with the attitudinal component of respect. Whereas one
can easily refrain from interfering with an autonomous individual’s choices
without having any feelings whatsoever about that individual, it is difficult to
treat someone with compassion if one does not feel compassion for that
individual.
Acknowledging the various facets of the moral duty of respect has
important implications for research ethics and policy. Rather than a tripartite
principlistic scheme, it may be more helpful to view research ethics as follows:
Respect for Research Subjects
Attitudinal
Component
Appreciatio
n
Behavioral
Compone
nt
Recognition
Respect
for
Autonomy
208
Beneficenc
e
Justice
Conceptualizing the ethics of human subjects research in this manner
allows for a more nuanced and dynamic approach to the analysis of research
ethics and policy.
Why Respect?: The Moral Foundation of the Duty to Respect
Research Subjects
The National Commission never explicitly identified the moral
foundation of the principle of respect for persons. Perhaps this was because
the commissioners did not think that it was their responsibility to do so. They
felt that Congress had intended for them to merely identify those ethical
principles that were already well-established and justified and then to apply
them to human subjects research.421
It may also have been that the commissioners did not justify the three
principles that they identified because they could not agree on the moral
foundation of those principles. In preparation for the Belmont Retreat, where
the commissioners would draft the document identifying the basic ethical
principle that should underlie human subjects research, the National
Commission commissioned five papers, three philosophical papers on “The
Identification of Ethical Principles” and two papers on “Ethical Principles Which
Should Underlie the Conduct of Biomedical and Behavioral Research Involving
Human Subjects.”422 Stephen Toulmin, philosophical consultant to the
See chap. 3, for a discussion of the commissioners’ interpretation
of their mandate.
421
422
National Commission, Belmont Report, vol. 1.
209
National Commission, was charged with summarizing these five papers. In his
summary, he noted that, according to the commissioned papers, “it is no
longer practicable to obtain any sort of general agreement, either about what
constitutes an ‘ethical’ or ‘moral’ reason or issue, consideration or principle, or
about what ethical principles have any claim to ‘validity.’”423 However, he
encouraged the commissioners to persevere with their charge. Toulmin
advised the commissioners to focus on the practice of identifying ethical
principles, even if they could not agree about the moral foundation of those
principles.
Ethics is itself a practical, not a theoretical art; and we commonly learn
to “identify ethical principles,” in practice, before – even, in some
respects, wholly without – being able to give a “reasoned account” of
the grounds for making the particular identifications we do. In real life,
“identifying ethical principles”, rather than being an abstract intellectual
exercise, is something like riding a bicycle: we can learn to do it—and
learn to do it all in much the same way—without our being able to arrive
at an agreed or exact explanation of what is involved in doing it.424
Stephen Toulmin and Albert Jonsen, a commissioner for the National
Commission, later wrote a book called The Abuse of Casuistry in which they
described the National Commission’s deliberations. They claimed that there
was considerable disagreement among the commissioners regarding the
identification of ethical principles.
The locus of certitude in the commissioners’ discussions did not lie in an
agreed set of intrinsically convincing general rules or principles, as they
Stephen Toulmin, Staff Summary, “Ethical Principles and Human
Experimentation” (January 19, 1976), Georgetown University Archives.
423
424
Ibid., 4-6.
210
shared no commitment to any such body of agreed principles. Rather,
it lay in a shared perception of what was specifically at stake in
particular kinds of human situations.425
However, it seems that the commissioners did not generally disagree about
the basic ethical principles.426 Rather, the focus of their disagreement was the
moral justification for those principles.
Ultimately, the commissioners grounded the principles of respect for
persons, beneficence, and justice in American cultural tradition. In the final
version of The Belmont Report the National Commission simply stated: “Three
basic principles, among those generally accepted in our cultural tradition, are
particularly relevant to the ethics of research involving human subjects: the
principles of respect for persons, beneficence, and justice.”427 In an earlier
draft, the commissioners went to great lengths to establish the validity of the
three principles from a pluralistic perspective. They concluded:
We believe that a reliance on these three fundamental underlying
principles is consonant with the major traditions of Western ethical,
political and theological thought represented in the pluralistic society of
the United States, as well as being compatible with the results of an
experimentally based scientific analysis of human behavior; and that
they will, accordingly, be acceptable to persons of highly diverse
philosophical and religious persuasions.428
425
Jonsen and Toulmin, Abuse of Casuistry, 18.
426
As I show in chap. 3, there was some disagreement about whether
to identify the principle of respect for persons or autonomy, but the
commissioners seem to generally agree that the guiding principles should be
respect (whether it is for autonomy, persons, or research subjects),
beneficence, and justice.
427
National Commission, Belmont Report, 4 (emphasis added).
428
National Commission, Draft of The Belmont Report, Book 16, Tab
4, 9 (March 1, 1976), Georgetown University Archives.
211
This appeal to the general acceptability of the principles, however, does not
provide sufficient moral justification for them. The question still remains, why
must we respect/benefit/not harm/treat equitably others? With regard to the
principle of respect for persons, the question is why must we respect persons?
Paul Ramsey attempted to answer this question by appealing to
theology. He grounded the principle of respect for persons in the sanctity of
human life and the Biblical notion of “fidelity to covenant.”429 He made an
explicit theological argument for the duty of respect for persons but then tried
to interpret its implications for the physician/researcher-patient/subject
relationship in secular terms. The problem, of course, is that while theological
convictions certainly have a place in democratic discourse, they cannot be
treated as controlling because they are not universally shared (even within a
particular religious community or tradition). Thus, one must search for a
secular account of the moral foundation of respect for persons. As the
National Commission quickly learned, this proved to be a much more difficult
task.430
429
Ramsey, Patient as Person.
430
Immanuel Kant argues that all rational beings must have esteem,
or “respect” for other rational beings because of the “unconditional and
incomparable” moral worth, or “dignity” of rational beings. Immanuel Kant,
Foundations of the Metaphysics of Morals, ed. Robert Paul Wolff, trans.
Lewis White Beck (New York: McMillan Publishing, 1985), 2nd sec., 60-61.
Although I am attracted to the idea of grounding a broader duty of respect for
others in the intrinsic moral worth of all human beings, since Kant limits
respect to rational beings, his analysis is too limited for my purposes.
Additionally, it is not necessary for me to identify a moral foundation of a
general duty of respect for others since I am only concerned in this
dissertation with the duty of respect for research subjects qua research
subjects.
212
The duty of respect for research subjects, however, is much easier to
justify in secular terms than the principle of respect for persons. There are at
least two secular justifications for the duty of respect for research subjects.
First, the duty of respect for research subjects can be justified by an appeal to
consequences. The most atrocious consequences of adopting a disrespectful
attitude toward research subjects can be seen in the Nazi experiments during
World War II. The Nazi physicians treated their subjects with complete
disregard. They brutalized, tortured, dehumanized, humiliated, and murdered
innocent human beings in the name of science. As the Nazi experiments
made evident, the consequence of not respecting research subjects is so
offensive that it cannot and must not be tolerated. What is necessary to
ensure that history does not repeat itself is a shift in the culture of medical
research. The integrity of the research enterprise depends on it. Out of
history and an appeal to consequences, then, we derive a duty of respect for
research subjects.
Second, human research subjects, regardless of their motives for
participating in research or their capacity to volunteer their services, make
sacrifices for and provide an important contribution to the research enterprise.
Their role as a research subject is important and ought to be respected.
Society may not have a right to medical progress, as Hans Jonas points out,431
but it has a real interest in scientific advancements. For this, it needs human
research subjects, who can be used to achieve the ends of others. The
431
Jonas, “Philosophical Reflections.”
213
fulfillment of this social need gives rise to a moral claim to respect for research
subjects.
Policy Considerations
There are several obstacles to adopting a morally robust definition of
respect for research subjects. In this section, I focus on three major obstacles:
the difficulty of regulating respect, the challenge of changing attitudes, and the
objection to the assumption that research subjects are not currently being
adequately respected. I acknowledge the validity of all three of these
concerns and offer policy considerations for how to appropriately address
them.
The Difficulty of Regulating Respect
The human subjects protection system in the United States has
become, for better or worse, heavily regulated. This has resulted in greater
consistency in institutional practice432 and has ensured that the most
egregious acts of disrespect and abuse of research subjects have been
432
The federal regulations ensure that every federally funded
institution follows the same basic rules. There remain, however, some
inconsistencies in how different institutions interpret and apply the more
general regulations. See, e.g., Seema Shah et al., “How Do Institutional
Review Boards Apply the Federal Risk and Benefit Standards for Pediatric
Research?” JAMA 291, no. 4 (2004): 476-82; Amy Whittle et al., “Institutional
Review Board Practices Regarding Assent in Pediatric Research,” Pediatrics
113, no. 6 (2004): 1747-52.
Also, institutions that do not receive federal funding are not required
to follow the rules set forth in the federal regulations. Protection of Human
Subjects, Code of Federal Regulations, Title 45, Part 46 (1991).
214
reduced.433 However, it has also resulted in what some think is an overly
bureaucratic system. There are so many rules to follow, forms to fill out, and
deadlines to comply with that some researchers and institutional review
boards have become more concerned with their administrative responsibilities
than with their ethical duties.434 This has resulted in confusion about the
difference between compliance and morality. Some researchers may assume
that as long as they satisfy the regulatory requirements, they will be acting in
an ethically satisfactory manner. Although this may sometimes be true, one
can be compliant without having the right moral attitude. Likewise, legal
regulations often demand that the minimum standards be met, while ethics
433 Although not all research abuse has been eliminated, federal
oversight of human subjects research ensures that those abuses that do
occur are more often identified and subject to public scrutiny. This exposure
helps to educate researchers as well as the public and affects cultural and
attitudinal changes in research.
434
Jonathan Moreno warns against this danger. He suggests that the
human subjects research protection system is moving in the direction of
“strong protectionism,” where reliance on the virtue of scientific investigators
to protect research subjects will be completely replaced with regulation and
oversight. He warns that if others are responsible for protecting subjects,
the clinical researcher might then feel justified in taking what Josiah
Royce called a “moral holiday,” focusing only on the science and
leaving the task of protecting human subjects to those whose charge it
is …
In this way strong protectionism might inadvertently result in undermining
physician investigators’ sense of personal moral responsibility in the
conduct of human experiments.
Jonathan D. Moreno, “Goodbye to All That: The End of Moderate
Protectionism in Human Subjects Research,” Hastings Center Report 31, no.
3 (2001): 9-17, 17. I would argue that, under our current system, this has
already started to happen.
215
requires more. Thus, an act may be legal and at the same time morally
insufficient. Even for the many researchers who want to act ethically, time
constraints and lack of institutional support make it difficult. In this
environment, ethical reflection can get replaced with bureaucratic checklists,
and researchers’ frustration at the system risks getting displaced onto their
subjects. As Jeffrey Kahn and Anna Mastroianni point out,
An emphasis on oversight and compliance misses the point. By overly
focusing on making sure that rules are followed, we push researchers
away from a real appreciation for issues and into doing what it takes to
expedite the oversight process. This approach can cause researchers
to quickly lose sight of the point of research protections—the rights and
interests of the subjects themselves—and the protection of subjects can
quickly be lost in the shuffle of paperwork necessary to satisfy the letter,
if not the spirit, of regulations.435
Given our current system and its emphasis on compliance, some may argue
that a robust conception of respect for research subjects would be impossible
to enforce. How, after all, can you legally require that research subjects be
treated with respect?
This is a very legitimate concern and raises a fundamental question
about the relationship between law and ethics. The federal regulation of
research was supposed to be informed by ethics. The purpose of the National
Commission, after all, was to identify ethical principles and to make
recommendations to the Department of Health, Education, and Welfare
(DHEW) to assure that research would be conducted in accordance with those
Jeffrey P. Kahn and Anna C. Mastroianni, “Moving from
Compliance to Conscience: Why We Can and Should Improve on the Ethics
of Clinical Research,” Archives of Internal Medicine 161, no. 7 (2001): 92528.
435
216
principles.436 However, as Harold Vanderpool points out, “the accent on the
importance and roles of ethics in the Belmont Report is virtually absent from
the Federal Regulations … The term ‘ethics’ is mentioned only once in the
main body of the Regulations.”437 Instead, what is emphasized in the federal
regulations is the application of the ethical principles. There are detailed rules
regarding informed consent, risk-benefit analysis and selection of subjects.
This reinforces an attitude of procedural compliance rather than ethical
reflection. Perhaps if the ethical principles themselves were mentioned in the
regulations, then more attention would be given to them. Specifically,
introducing the language of respect into the federal regulations would facilitate
moral deliberation and encourage more thoughtful interpretations of the
requirement to respect research subjects. The lack of specificity associated
with the concept “respect” would make it difficult to legislate every aspect of
respect, but this is not necessarily bad. It would force contemplation and
create an opportunity for dialogue, while affirming the moral imperative to
respect research subjects.
If the language of respect is introduced into the federal regulations and
the ethics of human subjects research is to be taken seriously then the
institutional mechanism for ensuring the ethical conduct of research must be
enhanced. The federal regulations confer responsibility on institutional review
436
National Research Act, Public Law 93-348, codified at U.S. Code
42 (July 12, 1974) sec. 2891.202(A)(1)(A).
437
Vanderpool, “Unfulfilled Promise,” sec. O, 9-10.
217
boards (IRBs) to ensure the ethical treatment of human research subjects.438
This does not mean that individual researchers do not have a moral
responsibility to their subjects. It simply creates a second level of ethical
review from what is supposed to be an impartial and diverse community-based
committee. The IRB system has been scrutinized and criticized by several
groups in recent years.439 Although most individual IRB members are
committed to ensuring the ethical conduct of research, critics have complained
that many IRBs are overworked and understaffed, leaving little time for them to
engage in necessary ethical reflection. The Institute of Medicine (IOM)
suggests in its 2003 report, Responsible Research, that too much is expected
of IRBs.440 Many IRBs are responsible not only for reviewing the ethical
438
Protection of Human Subjects, Code of Federal Regulations, Title
45, Part 46 (1991); National Institutes of Health, Guidelines for the Conduct
of Research Involving Human Subjects at the National Institutes of Health,
5th printing (Washington, D.C.: U.S. Government Printing Office, August
2004).
439 IOM, Responsible Research (citing the American Association of
Universities (AAU) Task Force on Research Accountability, Report on
Individual and Institutional Financial Conflict of Interest (Washington, D.C.:
AAU, 2001); General Accounting Office (GAO), Scientific Research:
Continued Vigilance Critical to Protecting Human Subjects, Report No.
GAO/HEHS-96-72 (Washington, D.C.: GAO, 1996); Robert J. Levine,
“Institutional Review Boards: A Crisis in Confidence,” Annals of Internal
Medicine 134, no. 2 (2001):161-63; National Bioethics Advisory Commission
(NBAC), Ethical and Policy Issues in Research Involving Human Participants
(Bethesda, Md.: NBAC, 2001); Office of Inspector General, U.S. Department
of Health and Human Services (OIG), Institutional Review Boards: A Time
for Reform, Report No. OEI-01-97-00193 (Washington, D.C.: DHHS OIG,
1998); Office of Inspector General, U.S. Department of Health and Human
Services (OIG), Protecting Human Research Subjects: Status of
Recommendations, Report No. OEI-01-97-00197 (Washing, D.C.: DHHS
OIG, 2000)).
440
Ibid.
218
aspects of research protocols but also for reviewing the scientific merit of the
protocol, ensuring institutional compliance with all research rules and
regulations, and assessing potential conflicts of interest related to the
proposed research.441 Although some of these functions are necessary for an
adequate ethical analysis, such as issues of compliance and minimal
knowledge of the scientific merit of the proposal, measures could be taken to
reduce the burden on IRBs. Because research is becoming more complex,
the ethical issues associated with research are more nuanced, resources for
IRBs are more limited, and accountability for institutional compliance more
severe.442 What is needed is a change in the institutional culture so that IRBs
are given more support and encouragement, from the highest levels of
institutional administration, not only to ensure compliance but to engage in
moral reflexivity and to develop more hands-on approaches (such as
monitoring the enrollment process, interviewing subjects, and educating the
research team) to ensure that investigators are adequately fulfilling their moral
obligation to respect research subjects.
The Institute of Medicine recently recommended that IRBs be relieved
of some of their scientific and institutional burden so that they can better
attend to the ethical review of research. Instead of one committee being
responsible for reviewing the scientific merit of research, assessing the
potential conflicts of interest, ensuring institutional compliance with rules and
441
IOM, Responsible Research.
442
Ibid.
219
regulations, managing institutional risk, and engaging in ethical deliberations,
the IOM recommends that these tasks be delegated among several different
committees:
The Institutional Review Board (IRB), as the principal representative of the
interests of potential research participants, should focus its full committee
deliberations and oversight primarily on the ethical aspects of protection
issues. To reflect this role, IRBs should be appropriately renamed within
research organizations’ internal documents that define institutional
structure and policies. The committee suggests the name “Research
Ethics Review Board” (Research ERB).443
The Research ERB, according to the IOM’s recommendation would be
provided with summaries of the scientific review of the project as well as
potential financial conflicts of interest before it began its ethics review. It is my
understanding that this is already occurring at many institutions to some
degree (e.g., at some institutions and for some protocols scientific review
occurs at the departmental level and is then summarized for the IRB). It
should be made more uniform, however, since it presumably saves the IRB (or
Research ERB) significant time, creating the opportunity for it to engage in
more serious reflection about the various ethical aspects of each research
protocol.
Many IRBs, however, fail to engage in serious ethical analysis, not just
because of the practical impediments such as lack of time, but also because
they have not been given sufficient ethical guidance. What is needed,
therefore, is for the duty of respect for research subjects to be explicitly
incorporated into the regulations. For example, in section 46.103, “Assuring
443
Ibid., Recommendation 3.1, 9.
220
compliance with this policy,” the regulations could require that institutional
assurances include not just “a statement of principles governing the institution
in the discharge of its responsibilities for protecting the rights and welfare of
human subjects of research,”444 but an explicit assurance that the institution is
committed to ensuring that research subjects are, in ever way possible,
treated with the respect and appreciation that they deserve. It would be
necessary to include a definition of what it means to respect research
subjects. This definition should include both the behavioral aspects of respect
as well as the attitudinal component that is discussed above. It is my hope
that this would encourage change at the institutional level so that ethical
reflection about what is required in order to ensure that research subjects are
being adequately respected will occur. With less distraction, more time,
increased support from the highest levels of institutional administration, and
enhanced ethical guidelines, IRB members will be better able to investigate
the actual treatment of research subjects and to put more resources and
energy into analyzing what constitutes proper respect for subjects of
research.445
444
Protection of Human Subjects, Code of Federal Regulations, Title
45, sec. 46.103(b)(1).
445
The IOM makes several recommendations that seem to support a
more robust notion of respect for research subjects. For example, they
recommend that the protection system be more transparent, with
communications among all relevant stakeholders open to the public and an
opportunity for “those who stand to benefit or be harmed by the research …
to comment on the research design and operation, to participate in the
research, and to have access to study findings.” IOM, Responsible
Research, 14. Additionally, they recommend that injured subjects be
compensated:
221
The Challenge of Changing Attitudes
Adopting a robust definition of respect for research subjects would
require a change in both attitude and behavior, not only among individual
investigators, but also at an institutional level. Essentially, the institutional
culture of medical research would have to adjust. Even if it were possible to
develop a list of behaviors that were respectful and a list of those that were
disrespectful to research subjects, it would not be enough to simply prohibit
disrespectful acts or to require specific acts of respect. One can be treated
respectfully without being respected, but if the feeling of respect is missing,
then the respectful conduct will amount to little more than token politeness.
While etiquette is important, the moral duty of respect for research subjects
requires much more. This leads to a second objection to the duty of respect;
that it is simply too difficult to change attitudes. Yet, if one reflects on the
history of research ethics, it becomes apparent that attitudes have changed
significantly. This change in attitude is reflected in how research subjects are
viewed, spoken about, and treated. For example, they are no longer called
“guinea pigs;” instead, the term “research participant” is preferred. Also,
informed consent, though not perfect, is universally recognized as an ethical
Organizations conducting research should compensate any research
participant who is injured as a direct result of participating in research,
without regard to fault. Compensation should include at least the costs
of medical care and rehabilitation, and accrediting bodies should
include such compensation as a requirement of accreditation.
Ibid., Recommendation 6.8, 15.
222
imperative.446 It is no longer assumed that certain vulnerable members of
society owe a debt that is paid through their involuntary involvement in
research.
These changes have resulted from at least two developments. First,
the regulation of biomedical and behavioral research and the accreditation of
research institutions have forced researchers and research institutions to
acknowledge and respect the rights of subjects. When ethical standards are
translated into legal regulations, morality gets transformed from an ought to a
must. The law regulates behavior, but when individuals are educated about
the ethical norms that inform the law, an attitudinal change occurs. Similarly,
institutional accreditation has helped to change perspectives about institutional
responsibility and ethics. Second, the public scrutiny of unethical research
practices, which led to the regulation of research, together with the birth of
bioethics has resulted in increased moral reflection and public discourse about
the ethics of medical research. The law can only take us so far. Its purpose is
to set minimum standards of acceptable behavior, but interpretation, dialogue
and education are essential if we are to expect more. Jessica Berg and her
colleagues argue that in order to change attitudes about respect and informed
consent in medicine, we must move beyond regulation and develop systematic
educational programs:
446 Moreno points to Alan Donagan’s essay on informed consent,
which was published in 1977, as symbolizing the change in attitude that had
occurred regarding informed consent. He points out that “in Donagan’s
essay the invigorated informed consent requirement is taken as nearly a
self-evident moral obligation in clinical medicine.” Moreno, “Goodbye to All
That,” 15.
223
Although some changes have occurred in doctor-patient interactions,
we believe that in the long run attempts to force people to respect
others are doomed to failure. One can create a framework in which
respect can develop. One can even compel behavior similar to what
would occur were respect to exist. But respect is so personal a
characteristic that it either flows from a genuine source, or not at all …
The legal requirements have gone as far as they can. The framework
for respect has been created, and codes of behavior have been
prescribed. And that has not been enough …
Even granting the unlikely assumption that elements of physicians’
overt behavior could be controlled by law, it is clear that attitudinal
change must be accomplished by different means.447
The means to attitudinal change are through deliberation, education, and
conversation. Only through public discourse and education can we correct the
misconception that respect for research subjects means nothing more than
respect for their autonomy. Only through contemplation can we develop a
more robust understanding of respect for research subjects. And only through
dialogue can we work through the implications of recognizing a moral duty of
respect for research subjects. This dissertation is an effort to begin the
conversation. My modest hope is that it will lead to more thoughtful
consideration about respect for research subjects and that it will inspire a
dialogue, which will eventually lead to attitudinal, behavioral, and policy
changes.
Lack of Respect: Fact or Fiction?
While this dissertation is primarily a historical and analytical
examination of the ethics of respect in research, I advocate for a robust notion
447
Jessica W. Berg, Paul S. Appelbaum, Charles W. Lidz, and Lisa S.
Parker, Informed Consent: Legal Theory and Clinical Practice, 2nd ed. (New
York: Oxford University Press, 2001), 320.
224
of respect for research subjects, which rests on an assumption that research
subjects are not currently receiving adequate respect. This is an empirical
claim that has never been tested. Some may argue that research subjects are
highly regarded and usually treated with tremendous respect. Although I have
my suspicions, I do not in fact know whether or not this is true.
To my knowledge, there has been no direct empirical study of respect
in medical research. There has, however, recently been an interesting study
on the relative importance of respect in clinical medicine. In 2001 The
Commonwealth Fund conducted a national health care quality survey. 448 This
was a telephone survey of 6,722 adults living in the United States. Part of the
survey focused on the patient-physician interaction and asked respondents
how they felt during their last visit to the doctor. Interestingly, the
questionnaire differentiated between respect and respect for autonomy.
Respondents were asked whether they felt that they were treated with dignity
and respect by their doctors. They were also asked whether they were
involved in decisions as much as they wanted (i.e.: whether they felt that their
autonomy was respected). Seventy-six percent (76%) of the population that
was surveyed reported being treated with a great deal of dignity and respect.
Seventy-five percent (75%) of the population surveyed reported being involved
in decisions to the extent desired.449 Of those who felt treated with disrespect,
448
Karen Scott Collins et al., Diverse Communities, Common
Concerns: Assessing Health Care Quality for Minority Americans
(Commonwealth Fund, March 2002), www.cmwf.org.
449
Ibid.
225
thirty percent (30%) gave a reason that was related to the way in which they
were spoken to or the manner in which they were treated: they felt talked
down to, they were treated rudely, they were not listened to, or they were
ignored. Seventeen percent (17%) felt disrespected because of insurance
reasons, and eight percent (8%) felt discriminated against. Eleven percent
(11%) of the population surveyed either somewhat or strongly agreed with the
statement “I often feel as if my doctor looks down on me and the way I live my
life.”450
Mary Catherine Beach and her colleagues analyzed the results of this
survey and evaluated the independent associations between respect and
respect for autonomy and four outcome measures (trust in physicians,
satisfaction, adherence to therapy, and receipt of optimal preventive care).451
They found that both being involved in decisions and being treated with
respect were independently and significantly (P<.001) associated with higher
levels of trust and satisfaction. Being treated with respect was marginally
associated (P=.054) with the probability of receiving optimal preventive care,
but being involved in decisions was not. Finally, “being involved in decisions
tended to be more strongly associated with adherence to treatment for whites,
while being treated with dignity tended to be more strongly associated with
450
Ibid.
451
M. C. Beach, J. J. Arbelaez, R. Johnson, and L. A. Cooper,
“Patients’ Perspectives on the Relative Importance of Respect for Persons
Compared to Respect for Autonomy,” abstract, Journal of General Internal
Medicine 19, supp. 1 (2004): 188.
226
adherence to treatment for racial/ethnic minorities.452 This suggests that not
only is respect for autonomy important, but also that respect for patients is
crucial. As Beach and her colleagues concluded: “Physicians ought to involve
patients in decisions, but this does not replace treating patients with dignity.” 453
These studies reveal interesting information about the role of respect in
clinical medicine. Additional data would be helpful. For example, it is not clear
from this survey what the respondents meant by the sentence “I was treated
with a great deal of dignity and respect.” How were they defining respect and
dignity and what is the relationship between these two terms? Also, although
we have some information about why respondents felt disrespected, there is
no indication of what made respondents feel respected. Finally, what was the
correlation between respondents’ feelings of respect and their feelings of
being involved in decisions to the extent they desired? Information such as
this would be helpful in interpreting the results of this important survey.
Similar empirical work needs to be done in the field of biomedical and
behavioral research. Medical care and medical research often overlap and
many research subjects are also patients. However, there are important
distinctions between research and practice.454 It would be interesting to know
whether research subjects are viewed and treated differently from patients and
whether there is a difference between how different categories of research
452
Ibid.
453
Ibid.
454
National Commission, Belmont Report.
227
subjects are viewed and treated (e.g., healthy volunteers versus subjectpatients). This, however, is another empirical question and must be tested.
The interpretation and function of respect in both the clinical and research
environment thus deserves greater attention and further study.
There are many empirical questions that would be interesting and
important to ask. Given the lack of work in this area, it would probably be wise
to start with qualitative research investigating subjects’, investigators’, and IRB
members’ definitions of respect and their feelings about the role that respect
plays in biomedical and behavioral research. Subjects could be asked, either
qualitatively or quantitatively, whether or not or to what degree they feel
respected by investigators (and how or why). Conversely, investigators could
be asked if they feel respect for research subjects (and how or why), if they
think they treat research subjects with respect (and how or why), and if they
feel respected by research subjects (and how or why). It would be interesting
to study the relationship between research subjects’ feelings of being
respected and investigators’ reported attitudes of respect for subjects. It
would also be interesting to look at the association between respect for
research subjects and outcome measures (e.g., trust, satisfaction, adherence,
understanding, enrollment, study outcomes, and individual health outcomes
for subject-patients). Finally, it would be important to study IRB members’
views about the duty of respect for research subjects, to study individual IRB
members’ interpretations of what it means to respect research subjects, and
perhaps to do a content analysis of institutional policies to see if there is any
consistency in institutional interpretations of the duty of respect for research
228
subjects. These are just a few of the research questions about respect for
research subjects that could be tested empirically.
Although empirical research is an important tool for understanding a
given area of study, good empirical work cannot be done without prior
conceptual analysis. This theoretical work helps to identify the issues and
generate the hypotheses. Through this dissertation I have explored the
concept of respect for research subjects. I have argued that the concept of
respect has not been given serious enough attention in the field of research
ethics. The moral imperative to respect research subjects is grounded in a
long history of disrespect and the horrific consequences that ensued. I
propose a theory of respect that is much richer than respect for individual
autonomy. I believe that the integrity of the research enterprise is contingent
on a more robust conception of respect for research subjects. I invite
thoughtful consideration and meaningful dialogue about respect for research
subjects, and I look forward to continuing the conversation and to moving from
this conceptual work into a theoretically-informed empirical exploration of
respect for research subjects.
229
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VITA
Amy L. McGuire, J.D.
Amy L. McGuire was born on May 28, 1974 in Brooklyn, New York. She is the
daughter of Marlene Rosenblum, M.S.W. and Paul D. Rosenblum, M.D. Her
husband is Sean E. McGuire, M.D., Ph.D. She has two sons, Thomas Morgan
McGuire, born September 22, 2000 and Matthew Philip McGuire, born
December 17, 2002. McGuire is an Assistant Professor of Medicine in the
Center for Medical Ethics and Health Policy at Baylor College of Medicine.
Immediately before joining the faculty at Baylor, McGuire held a three-year
fellowship in Medical Jurisprudence at the University of Texas Medical Branch.
Education
B.A., December 1995, University of Pennsylvania, Philadelphia, Pennsylvania
J.D., May 2000, University of Houston Law Center, Houston, Texas
Publications
McGuire, Amy L., McCullough, Laurence B., Weller, Susan, Whitney, Simon
N. “Missed Expectations?: Physicians’ Views of Patients’ Participation in
Medical Decision Making.” Medical Care (forthcoming).
Whitney, Simon N., McGuire, Amy L., McCullough, Laurence B. “A typology of
shared decision making, informed consent, and simple consent.” Annals of
Internal Medicine 140 (2004): 54-59.
Winslade, William J., McGuire, Amy L., Bustillos, Daniel, McKinney, E.
Bernadette. The Texas Medical Jurisprudence Examination: A Self-Study
Guide. 10th ed. Galveston, Texas: Institute for the Medical Humanities, 2004.
McGuire, Amy L. “Clearing the Mist: Perspectives on a JD/PhD Program in the
Medical Humanities.” American Journal of Bioethics 2, no. 4 (2003),
http://bioethics.net.
Winslade, William J., McGuire, Amy L., Bard, Jennifer S., Erwin, Cheryl. The
Texas Medical Jurisprudence Examination: A Self-Study Guide, 9th ed.
Galveston, Texas: Institute for the Medical Humanities, 2002.
McGuire, Amy L. “AIDS as a Weapon: Criminal Prosecution of HIV Exposure.”
Houston Law Review 36, no. 5 (1999):1787-1817.
256