Human Subject Protections - The University of Illinois Archives

Human Subject Protections
Some Thoughts on Costs and Benefits in the Humanistic Disciplines
C. K. Gunsalus
University of Illinois at Urbana-Champaign
The federal protection of human subjects of research in the United States has from the
start been scandal-driven. Rooted in the revelations of the 1966 Beecher Report,1 the Tuskegee
syphilis study2 and advances in medical research that were challenging religious and societal
concepts of life and death3, our protection system has been shaped by media revelations and
political reactions. Regulations in this area have, in consequence, grown by fits and starts, with
bouts of intense study and scrutiny interspersed with quiescent periods. This cycle has been
had a self-perpetuating quality, as the complacency and frequent under-funding of the fallow
periods have heightened the rhetorical level of the alternating periods, given the regular lack of
follow-through on implementing the recommendations of successive studies and reports.4
We have been left with regulations that both under-reach and over-reach, that are both
too broadly and too narrowly applied. Now, we as we may be nearing the close of another
period of scrutiny, we face the on-going need to protect human subjects from exploitation
without unneeded and costly regulatory burdens. The current cycle of scrutiny was catalyzed
by scientific advances—cloning, insertion of modified human genes and stem cell research—
that raise religious and societal concerns about the meaning of being human. Consistent with
the history in this area, current attention was sustained by reports of deaths in medical research
and the consequent media coverage.5
Once again, the “crisis management” dynamic6 is in play. Before this cycle closes,
however, we have an opportunity to bring some thoughtful consideration to bear on the
application of the current regulations to scholarly activities in the humanistic disciplines—
activities that were not generally considered when the regulations were designed, and to which
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thoughtless application can cause harm, not only to the scholarly activities, but to important
principles including First Amendment protections and academic freedom.
At its January 2002 meeting, the National Human Research Protections Advisory
Committee (NHRPAC) took testimony about the costly effects upon the scholarly endeavor of
presumably well-intentioned actions by local Institutional Review Boards (IRBs). These
included reports by faculty members in history, anthropology and journalism about worthy
projects delayed or never undertaken because of the onerous regulatory process.7 One historian
(CK) told of IRB concerns that “subjects” should not be asked about illegal activities when
some of those providing oral histories might have broken laws routinely in the course of civil
disobedience. The same historian testified that a university administrator had informed IRB
members they had a duty “to protect individuals and communities from research that could
prove embarrassing to them.” The response: “If I am studying racism, am I to protect people
from their own racism?” [other pernicious effects succinctly described here or is this enough?]
A Brief Summary of Human Subject Protection History and Scope
It’s fair to say that a consistent theme throughout the evolution of US regulations in this
area is mistrust of experts. David Rothman in his Strangers at the Bedside: A History of How
Law and Bioethics Have Changed Medical Decision-Making traces the trends that came
together to wrest control from physicians and move the locus of decision-making to patients,
families, lawyers and courts. Through a cycle of scandals, public controversies and regulatory
accretion, we came to the current state of human subject regulation.
In the United States, most (but not all) federally-funded research on humans is governed
by a regulation now known as the Common Rule. Of the XX federal agencies that fund
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research, XX subscribe to the Common Rule, and the others are under executive order to come
into compliance.8 By virtue of the bureaucratic mechanism by which universities pledge their
compliance with federal requirements, virtually all universities apply the federal rules to all
research conducted at their institutions, by their students and employees and under their
auspices.9 Interestingly, the scope of federal regulation of research with human subjects in the
United States is more narrow than that with animal subjects: all research, where performed and
with whatever funding, involving covered animal is subject to federal oversight. That involving
humans is restricted to research funded by subscribing federal agencies and conducted at
institutions filing assurances with the Office of Human Research Protection.10
Briefly, although the first federal regulations were issued by the National Institutes of
Health in 1966, current regulations are rooted in the work of a congressionally-mandated body,
the National Commission for the Protection of Human Subjects of Biomedical and Behavioral
Research. Working from 1974 to 1978, it produced a seminal report known as the “Belmont
Report,”11 which identified the ethical principles that have persisted as the foundation of all US
human subject regulation since that time: “respect for persons” “beneficence”, and “justice.”12
In practice, “the principle of respect for persons underlies the need to obtain informed
consent; the principle of beneficence underlies the need to engage in a risk/benefit analysis and
to minimize risks; and the principle of justice requires that subjects be fairly selected.”13 These
practices are enforced by bodies at research institutions known as IRBs. Broadly speaking, IRB
review and approval is required for all research involving human subjects before the research
can proceed.14
Although virtually all consideration of policy in this area has been focused upon
biomedical and behavioral research, it has been clear since the Common Rule was issued that its
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scope was intended to extend beyond those areas.15 Despite the stated intended scope, the
National Commission, the follow-on Presidential Commission (dates), the Advisory Committee
on Human Radiation Experimentation (date), and the National Bioethics advisory commission,
were all chartered to examined “biomedical and behavioral research and focused their work in
those areas.”16 Until the work of the NHRPAC in that area in 2001, I cannot find any federal
commission or agency that examined the application of federal regulations to humanistic
Nonetheless, by the time of the presidentially-appointed National Bioethics Advisory
Commission (NBAC) in 1997, its working belief statement was that “No person in the United
States should be enrolled in research without the twin protections of informed consent by an
authorized person and independent review of the risks and benefits of the research.”18
The distance from the Belmont report’s focus on “subjects of biomedical and behavioral
research” to the current focus on “research” seems considerable. The transformation from two
broad areas of research to “all” research is part of the current problem identified by the AAUP
and raises the central issue of what our public policy goals are and should be.
What are the Issues?
In a 1998 paper commissioned by the National Bioethics Advisory Commission, I
addressed some of the dilemmas we face in balancing regulatory costs and benefits by
assembling examples of un-regulated research carrying serious risks to its participants and by
discussing activities that might fall within the scope of current or proposed regulatory language
that that do not expose participants to risks warranting federal or institutional oversight.19
Presently unregulated activities include genetic tests and in vitro fertilization research
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developed without IRB oversight because the work is performed at unregulated for- or not-forprofit entities, research funded by a pharmaceutical company involving children of short
stature identified by private physicians for payment, and “fright response” research in which
participants were subjected to disturbing stimuli.20
On the other end of the spectrum, activities that fall within the language—but perhaps
not the intent—of federal regulation have become the subject of increasing controversy.
Additional analysis at least as as rigorous as that devoted over recent decades to biomedical
and behavioral research seems warranted. In particular, we need better guidelines for how the
federal regulations and local IRBs relate to scholarship in the humanities, journalism and some
branches of social science. The analytical approach used in assessing the risks and benefits of
biomedical research do not fit well the modes of scholarship in these disciplines, and examples
are emerging of projects delayed, abandoned or never undertaken because of the effects of wellmeaning but probably misplaced IRB oversight.
A 2001 report by the American Association of University Professors (AAUP) on the
oversight of social science research by IRBs highlighted a number of these issues.21 Responses
to that report, including comments made by panelists during January 2002 meeting convened to
explore the topic and published in Academe, continue the discussion.22 These contributions
focus on social science research, and explore the emerging view that “the government’s
regulations, known as the Common Rule, as applied by campus institutional review boards to
humanities and social science research, sweep too broadly.”23
The AAUP initiative explores the problems that have arisen from the application of the
biomedical research paradigm to ethnographic research, to oral history interviewing, and to the
teaching of journalism and mass communication. The participants propose a variety of
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solutions, from specialized IRBs with appropriate expertise for reviewing work in these
disciplines, to discipline-based guidelines for best practices and expedited reviewing
procedures24 to excluding all research from oversight unless it poses “a danger of physical
Some of these proposed solutions are more realistic than others. Discipline-based
guidelines are sorely needed and should provide the thousands of local IRBs26 with guidance on
ethical and practical matters in areas that may frequently be beyond the expertise of their
members. At larger institutions, specialized IRBs may be both practical and possible. But
excluding all research that does not pose a risk of physical harm seems to be an unlikely
outcome of the current debates, and naïve in light of the history in this area. Over the last 40
years, there has been an extensive consideration of the public policy issues presented by
behavioral research, and regulatory abandonment of that area seems unlikely.
The AAUP conversations, moreover, may be conflating issues that should be examined
separately. There are at least two different kinds of questions raised by the examples that have
emerged, and different principles apply to the resolution of each. First, we must be able to
articulate the point at which work performed by university-based teachers and scholars
becomes “research” such that it should be reviewed and overseen by an IRB. Only after the
determination than an activity constitutes “research,” should the particular guidelines that
apply be at issue. In examining these questions, a useful model may be to adopt the approach
of the first U.S. blue ribbon committee to study this topic, which worked to identify, and then to
apply, foundation ethical principles to shape and guide the resulting recommended regulatory
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II. What is Research?
The federal definition, in use for more than 30 years, is “[r]esearch means a systematic
investigation, including research development, testing and evaluation, designed to develop or
contribute to generalizable knowledge.” The regulation proceeds to define human subject as “a
living individual about whom an investigator (whether professional or student) conducting
research obtains (1) data through intervention or interaction with the individual, or (2)
identifiable private information.”27 This definition grew out of the Belmont Report and has
changed little (AT ALL? CK) since that time. But because the charge and focus of the National
Commission was on biomedical and behavioral research, some of the issues we now confront
were not considered with the same intensity (or, in some cases, at all) as, for example, the
question of where is the line between research and theraputic intervention, or the ethical
parameters for oversight of behavioral research. (Both topics were the subject of multiple
studies commissioned as background for the Belmont Report.)
My work for NBAC identified activities that have not traditionally been considered as
within the scope of the federal regulations, but that nonetheless arguably fall within the scope
of the federal regulatory definitions. These areas are increasingly problematic as heightened
sensitivity to ethical issues involving human subjects—and institutional liability when problems
develop—leads to ever-more rigorous scrutiny and restrictions by IRBs and institutional
officials. Nnot coincidentally, we are now seeing new interpretations of existing regulations
that are bringing within the purview of IRBs activities not previously addressed by them. This,
then, is the general background that leads to the current controversy surrounding scholarly
activities in the humanistic disciplines.
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One rule of thumb regularly used by IRB members to determine whether an activity is
“research” is whether the efforts were undertaken with an eventual eye to publication. This
threshold question actually works fairly well in biomedical research: if a practitioner or
scientist began a project and assembled data in a way that would support publication in the
peer-reviewed literature, the chances are pretty high that some kind of “research” was
underway, and that consequently, those upon whom hypotheses were being tested had an
ethical right to knowledgeable participation.
Examples of the analyses applied by IRBs focus upon elements of the federal definitions
that should apply only after the threshold question “is this research” are answered affirmatively.
Thus, when a publication—either envisioned or actual—involves “communication or
interpersonal contact,” an element of the federal definition, but the publication is a first-person,
autobiographical narrative by the author of that interaction, it is not at all clear that the activity
constitutes “research” as contemplated by the framers of the regulations.
For example, is it research when physicians write newspaper columns about their
experiences with and reactions to various patients or diseases? Is it research when a journalist
interviews a series of public officials (clearly these are “interactions” with “individuals”) and
publishes a story about corruption at city hall? If not, why would the same work pursued by a
graduate student in a journalism program become research? And why would we consider it
“research” when a faculty member writes in a professional journal about his classroom teaching
experiences? In universities, the latter two examples have both been defined as “research” by
institutional officials intent upon imposing conditions upon the process or resulting
publications. Is this the correct outcome? Is it one we support? Does this approach contribute
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to the public policy goals of a unified system of human subject protections? Who should be
involved in the discussions that will lead to local or national “answers” to these questions?
In my NBAC paper, I suggested that a published comparison of two different techniques
for facial surgery undertaken by a cosmetic surgeon was research on human subjects, and that
the “patients” deserved protection, regardless of the source of funding for the work being
compared.28 It seems sensible that the obverse should also apply: activities that are not
research if performed in the private sector should not become research for the sole reason that
they are performed in a university setting. (There may be other aspects of their performance in
universities that might transform them into research, but not the setting alone, surely.)
I came to the conclusion, perhaps too quickly, that a fundamental change in the federal
definition of “research” was not warranted. The practical difficulties alone in changing the
definition upon which our entire regulatory system rests are immense: achieving consensus for
a change across the spectrum of researchers represented in this country is a daunting task.
But it is not necessary to change the definition to achieve greater clarity and consensus
as to what is not research, and thus should not ever be subject to oversight and regulation in the
first place. What is important is to issue guidance, ideally developed nationally with the
assistance and support of national disciplinary societies, and perhaps convened by the AAUP,
to clarify what kinds of activities are and are not research. Meanwhile, it seems worthwhile to
convene locally-based discussions of the aspects of these questions that affect teaching and scholarship.
[hook for CAS/LAS local initiative?]
Outline for remainder:
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Other categories to consider and considerations that apply to them: academic freedom
(to teach and to publish without prior restraint), first amendment, chilling of exploration (2002
Academe examples). Compare and contrast with considerations in behavioral research? Where
are the lines? How to figure that out?
humanistic endeavors in general (need to talk with Jesse/Leon Dash/Dennis Baron
about the categories here);
A Special Problem: Writing About Teaching
If a faculty member writes an essay about an experience teaching a class, when is this an
autobiographical essay and when does it become research? Consider the essays printed
frequently in the Chronicle for Higher Education on first-person experiences in academia. If a
faculty member writes about a particularly illuminating classroom exchange, or discourses
anecdotally about the difference between freshmen now and 25 years ago, it’s hard to see how
this could be considered “research.”
But at one research institution recently, an IRB administrator initially took the position
that a faculty member’s essay (accepted for publication in a professional, peer-reviewed journal)
describing a class and interactions with one student in particular, constituted “research” and
thus required IRB review and approval before publication because it involved “interaction”
with a human (subject) and was intended to produce generalizable knowledge. Before
strenuous intervention by the faculty member’s department head, dean and the president of the
local chapter of the American Association of University Professors (AAUP), the position of the
IRB administrator was that the manuscript had to be withdrawn from publication while the IRB
reviewed it.29
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There are unquestionably serious ethical issues that arise in writing about teaching. The
Conference on College Composition and Communication has promulgated a set of “Guidelines
for the Ethical Treatment of Students and Student Writing in Composition Studies.”30 Issues
range from how to treat disclosures by students (for example, about deeply personal issues
from suicide to sexual abuse to participation in criminal activities) to intellectual property
questions (where the line on fair use in quoting a student paper? Who “owns” answers written
on exams?) to legal considerations about privacy. And overlaid over all of this is the question of
when is a piece of writing by a faculty member about classroom experiences a personal
reflection and when does it become research? Where do issues of academic freedom and prior
restraint enter our considerations?
Considerations in writing about teaching: Academic freedom, first amendment,
copyright/intellectual property, FERPA/student privacy. Examples. Composition studies.
Morgan piece. Wright piece.
The ends of the spectrum are relatively easy to identify: a faculty member who begins a
semester with the intent of comparing student grades and outcomes in a course, for example,
with overall grade point averages, is conducting research. The faculty member is approaching
the work with the intent to collect data in a systematic way and to publish the results, with the
hope of being able to make generalizable conclusions. But between that, and the other end of
the spectrum where a faculty member is musing about a lifetime of teaching in an
autobiographical fashion, the lines are a bit fuzzy. What moves an activity from one end of the
spectrum to the other?
When is this exempt under the pedagogy exemption?
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Research on teaching (published comparison of grade outcomes: exempt or not?) vs.
writing about teaching; how to differentiate.
Special issues in clinical education:
student and client privacy; IRB oversight or not? Conflict between IRB and professional
ethical issues. (compare and contrast with the issues in journalism raised in the Academe 2002
The traditional mechanism for determining whether an activity is exempt is to submit it
to the IRB for its determination. As the 2001 AAUP report points out, there is no appeal
mechanism for IRB determinations, and this mechanism for IRBs without adequate grounding
in the disciplines at issue seems problematic at best. This is an important issue to address and
to resolve.
IV. If It’s Research, What Activities Should Qualify for Expedited Review?
Ethnographic studies
Oral history
Where does journalism belong?
Survey research (consent by participating)
Other topics raised in the literature and CKG 1998 NBAC paper.
V. Conclusion
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Beecher, H. K. (1966). “Ethics and Clinical Research.” New England Journal of Medicine (74).
Bad Blood ? some other source?
Rothman, D. J. Strangers at the Bedside: A History of How Law and Bioethics Transformed Medical
Decision Making. Basic Books, 1991. NEED PAGE REFERENCE
studies with multiple un-implemented studies:
Report and Recommendations of the National Commission for the Protectino 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, 1978,
Report of the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and
Behavioral Research, Protecting Human Subjects, U. S. Government Printing Office, Washington, D.C.,
Report of the General Accounting Office to the Ranking Minority Member, Committee on Governmental
Affairs, United States Senate, Scientific Research: Continued Vigilance Critical to Protecting Human
Subjects, U. S. Government Printing Office, Washington, D.C., March 1996.
United States Government, Human Radiation Interagency Working Group. Building Public Trust:
Actions to Respond to the Report of the Advisory Committee on Human Radiation Experiments. March
1997; Final Report:
Advisory Committee on Human Radiation Experiments. United States Government Printing Office,
Washington, D.C., October 1995. Office of Inspector General, Department of Health and Human Services,
Institutional Review Boards: Their Role in Reviewing Approved Research (OEI-01-97-00190);
Institutional Review Boards: Promising Approaches (OEI-01-98-0091); Institutional Review Boards: The
Emergence of Independent Boards (OEI-01-97-00192); Institutional Review Boards: A Time for Reform
(OEI-01-97-00193). United States Government Printing Office, Washington, D.C., June 1998.
cloning, stem cell stuff, gelsinger, etc? cite a series
Nishimi testimony—cited in CKG NBAC paper; find refs
1/29/02 NRHPAC testimony
find sources in CKG paper
need a good cite for this
need a good cite for this
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That report also cites the foundation provided by both the Nuremberg Code and the Helsinki
Cite and quote Belmont report here. Respect for persons involves a recognition of the personal
dignity and autonomy of individuals, and special protection of those persons with diminished autonomy.
Beneficence entails an obligation to protect persons from harm by maximizing anticipated benefits and
minimizing possible risks of harm. Justice requires that the benefits and burdens of research be
distributed fairly.
Institutional Review Board Guidebook, Introduction, PUT FULL CITE HERE
Some federal agencies have come to require evidence of IRB approval before a proposal will be
considered for funding, a development leading to many complaints, as it increases the workload of IRBs
in that they must review research that may never be performed because it does not get funded. SOURCE
Cite CFR from first common rule issuance.
Check and cite. Also, there’s one more commission missing in the list, I think.
18National Bioethics Advisory Commission. Full Commission Meeting. Arlington, Virginia. May 17,
CKG NBAC paper
CKG NBAC paper
American Association of University Professors. “Protecting Human Beings: Institutional Review
Boards and Social Science Research.” Academe. May-June20001. pp.???
“Should All Disciplines Be Subject to the Common Rule: Human Subjects of Social Science Research.”
Academe. May/June 2002, pp. 62-69
Ibid. Introduction. p. 62.
Ibid. Jonathan T. Church, Chair, Department of Sociology and Anthropology, Arcadia University. p.
Ibid. Margaret A .Blanchard, William Rand Kenan Jr. Professor, School of Journalism and Mass
Communication, University of North Carolina at Chapel Hill.p. 69.
Cite Puglisi estimate of 3,000-5,000 from CKG private communication. Referenced in CKG NBAC
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Code of Federal Regulations, Title 45, Public WelfareDepartment Of Health And Human
Services,National Institutes Of Health,Office For Protection From Research Risks, Part 46,
Protection Of Human Subjects. Revised November 13, 2001. Effective December 13, 2001.
CKG NBAC paper; cite page.
Intervention includes both physical procedures by which data are gathered (for example, venipuncture)
and manipulations of the subject or the subject's environment that are performed for research purposes.
Interaction includes communication or interpersonal contact between investigator and subject. Private
information includes information about behavior that occurs in a context in which an individual can
reasonably expect that no observation or recording is taking place, and information which has been
provided for specific purposes by an individual and which the individual can reasonably expect will not
be made public (for example, a medical record). Private information must be individually identifiable
(i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the
information) in order for obtaining the information to constitute research involving human subjects.
Personal communications. [how to obsure identity while still making assertions in a public paper??]
what’s proper here?
CCC Ethical Guildelines… NCTE publication date