Chapter 3
Research Ethics and
Philosophies
Introduction
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Every social scientist needs to consider how to
practice their discipline ethically.
Whenever we interact with other people as social
scientists we must give paramount importance to
the rational concerns and emotional needs that will
shape their responses to our actions.
It is here that ethical research practice begins, with
the recognition that our research procedures
involve people who deserve as much respect for
their well-being as we do for ours.
Historical Background
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Formal procedures for the protection of participants
in research grew out of some widely publicized
abuses.
The Nuremberg War Crime Trials and Hitler’s
experiments
The Tuskegee syphilis experiments in the 1930’s
Milgram’s obedience experiments – Yale 1960
Out of these and other experiments that violated
human rights, the U.S. created a National
Commission for the Protection of Human Subjects
of Biomedical and Behavioral Research.
Ethics
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Three basic ethical principles for the protection
of human subjects were established:
Respect for persons: Treating persons as
autonomous agents and protecting those with
diminished autonomy.
Beneficence: Minimizing possible harms and
maximizing benefits.
Justice: Distributing benefits and risks of
research fairly.
Ethics, cont.
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Federal regulations require that every institution
that seeks federal funding for biomedical or
behavioral research on human subjects have
an institutional review board (IRB) that
reviews research proposals.
IRBs at universities and other agencies apply
ethics standards that are set by federal
regulations but can be expanded or specified by
the IRB itself (Sieber 1992:5, 10).
Ethics, cont.
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The American Sociological Association (ASA),
and The American Psychological Association
(APA) like other professional social science
organizations, have adopted, for practicing
researchers, ethics guidelines that are more
specific than the federal regulations.
Professional organizations may also review
complaints of unethical practices when asked.
Problem: most codes apply to standards of
practice, not research
Ethical Principles
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2.
Achieving Valid Results. Commitment to
achieving valid results is the necessary starting
point for ethical research practice.
Honesty and Openness. The scientific
concern with validity requires that scientists be
open in disclosing their methods and honest in
presenting their findings.
Ethical Principles, cont.
3.
Protecting Research Participants. The Code’s
standards concerning the treatment of human subjects
include federal regulations and ethics guidelines
emphasized by most professional social science
organizations:
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Research should cause no harm to subjects.
Participation in research should be voluntary, and therefore
subjects must give their informed consent to participate in
the research.
Researchers should fully disclose their identity.
Anonymity and/or confidentiality must be maintained for
individual research participants unless it is voluntarily and
explicitly waived.
Benefits from a research project should outweigh any
foreseeable risks.
Ethical Principles, cont.
4.
Avoid harming research participants. Although
this standard may seem straightforward, it can be
difficult to interpret in specific cases and harder yet
to define in a way agreeable to all social scientists.
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Does it mean that subjects should not be at all harmed
psychologically as well as physically?
That they should feel no anxiety or distress whatever
during the study or only after their involvement ends?
Ethical Principles, cont.
5.
6.
Obtain informed consent. To be informed,
consent must be given by persons who are
competent to consent, have consented voluntarily,
are fully informed about the research, and have
comprehended what they have been told (Reynolds
1979).
Avoid deception in research, except in limited
circumstances. Deception occurs when subjects
are misled about research procedures to determine
how they would react to the treatment if they were
not research subjects.
Ethical Principles, cont.
7.
8.
Maintain privacy and confidentiality.
Procedures to protect each subject’s privacy
such as locking records and creating special
identifying codes must be created to minimize
the risk of access by unauthorized persons.
The Benefits outweigh the risks – don’t
always know the risks
The Uses of Research
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Scientists must also consider the uses to which
their research is put.
Although many scientists believe that personal
values should be left outside the laboratory,
some feel that it is proper—even necessary—
for scientists to concern themselves with the
way their research is used.
Conclusions
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The extent to which ethical issues are a
problem for researchers and their subjects
varies dramatically with the type of research
design.
Survey research, in particular, creates few
ethical problems.
Some experimental studies have put people in
harms way and for some have resulted in
death.
Conclusions, cont.
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Ultimately, these decisions about ethical
procedures are not just up to you, as a researcher,
to make.
Your university’s IRB sets the human subjects
protection standards for your institution and may
even require that you submit your research
proposal to them for review.
So you need to review the human subjects
guidelines of professional association in your field,
consult your university’s procedures for the conduct
of research with human subjects and then proceed
accordingly.
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historical uses of unethical research
contributed toward present values and
ethics in research
unethical Nazi experiment, the Stanley
Milgram's experiment, the Tuskegee
Syphilis study, the Willowbrook study,
and the Laud Humphrey's "Tearoom
Sex" study
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led to the creation of the Belmont
Report and the Institutional Review
Board (IRB) which were formed to
protect human subjects involved in
research. (more later)
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The National Research Act was
enacted by the 93rd United States
Congress. It created the National
Commission for the Protection of
Human Subjects of Biomedical and
Behavioral Research to oversee and
regulate the use of human
experimentation in medicine.
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It was partly a response to the
infamous Tuskegee syphilis study.
The act was signed into law on July
12, 1974.[1]
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The Belmont Report attempts to
summarize the basic ethical principles
identified by the Commission* in the
course of its deliberations. (1976-78)
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The Belmont Report is one of the
leading works concerning ethics and
health care research. It allows for the
protection of participants in clinical
trials and research studies[3] .
Unethical Historical studies
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research abuse by Nazi doctors during
World War II
sixteen German physicians practiced
unethical medical experiments on
Jews, gypsies, and political prisoners.
In 1947, out of this horror, came the
Nuremberg Code
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Under this code, the physicians were
convicted for crimes against humanity.
Stanley Milgram's experiment
Milgram was a psychologist from Yale
University. He conducted a study on
the conflict between obedience toward
authority and ones personal
conscience.
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those accused at the World War II,
Nuremberg War Criminal trials
Their defense was based on
"obedience" and that they were just
following their supervisor's orders.
how people reacted toward an
authority figure while giving an
apparent electrical shock
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so called "teachers" (who were
unknown subjects of the experiment)
were recruited by Milgram.
Asked to administer an electrical shock
of increased intensity to a "learner" for
each mistake he made during the
experiment.
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fictitious story given to these
"teachers" was that the experiment
was exploring effects of punishment
(for incorrect responses) on learning
behavior.
"teacher" was not aware that the
"learner" in the study was an actor
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When the "learner" gave an incorrect
response, the volt would increase by
15 volts intervals.
Some teachers went to the maximum
of 450 volts
At times the "teacher" questioned the
experiment but continued
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study raised many questions about
how the subjects could bring
themselves to administer such high
shocks
More important to our interests are the
ethical issues it raised about research
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1. What right does a researcher have
to expose subjects to such stress?
2. What activities should be or not be
allowed in marketing research?
3. Does the search for knowledge
always justify such "costs" to subjects?
4. Who should decide such issues?
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1932, the Tuskegee Syphilis Study
40-year project administered by the
US Public Health Service in Macon
County, Alabama.
American Government promised 400
men free treatment for ‘bad blood’
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The treatment was never given to the
men and was in fact withheld.
The sample was made up of poor
African American men who were told
that they had "bad blood” that had
syphilis
did not receive standard treatment for
syphilis
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The men in the study were not
informed of the research design and
it's risks to them.
symbolized the medical misconduct
and blatant disregard for human rights
that takes place in the name of science
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They were not mad scientists; rather
they were government physicians,
respected men of science
The study's unethical features did not
come to light until 1972
over one hundred of the infected men
died and others suffered from serious
syphilis related conditions
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a class action civil suit of $1.8 billion
was filed against those who were
involved in the study. The case never
came to trial. Each participant only
received $37,500 in damages, and
the* heirs of the deceased received
$15,000.
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1963 to 1966, the Willowbrook Study
involved a group of children diagnosed
with mental retardation, who lived at
the Willowbrook State Hospital in
Staten Island, New York
children were deliberately infected with
the hepatitis virus
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Investigators defended the injections
by pointing out that the vast majority of
them acquired the infection anyway
while at Willowbrook, and it would be
better for them to be infected under
carefully controlled research
conditions.
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study's purpose was to study the
history of the disease when left
untreated
and later to assess the effects of
gamma globulin as a therapeutic
intervention
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study generated a variety of concerns,
such as the deliberate infection of the
children and the attempts to convince
the* parents to enroll them in the study
in exchange for admission to the
hospital (which was deliberately short
of space).
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the mid-1960s, Laud Humphreys –
Tea Room Trade
a sociologist, he recognized that the
public and the law enforcement held
stereotypical beliefs about men who
committed impersonal sexual acts with
one another in public restrooms
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"Tearoom sex", as fellatio in public
restrooms is called, accounted for the
majority of homosexual arrests in the
US
For his PhD dissertation at
Washington University, Humphreys
decided that is was important for
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society to gain a better understanding
of who these men were and what
motivated them to seek quick,
impersonal sexual gratification.
answer this question by means of
participant observation and structured
interviews
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Humphreys stationed himself in
"tearooms" and offered to serve as a
"watchqueen“
He observed hundreds of acts and
gained the confidence of some of the
men he observed
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Humphreys secretly followed some
men and recorded the license
numbers on their vehicles
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Humphreys showed up at their private
homes and claimed to be a health
service interviewer. He asked them
questions about their marital status,
race, job, and other personal
questions.
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Humphreys' findings destroyed many
stereotypes. He found that 54% of the
men were married, and 38% were
neither bisexual nor homosexual. Most
of the men were successful, well
educated, economically stable, and
highly praised in the community.
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Only 14% of the men he observed
were homosexual and part of the gay
community (http://web.missouri.edu).
Humphreys' research was
administered in the mid- 1 960's before
the IRB was in existence
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So what became of all this in regards
to ethical research?
In 1979, the federal government
developed regulations of ethical
principals underlying the current
regulations and standards that are
contained in the Belmont Report.
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It was the capstone of the National
Commission for the Protection of
Human Subjects of Biomedical and
Behavioral Research. It outlines the
ethical principals upon which the ethics
of a research study are evaluated in
the United States.
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The Belmont Report embodies the
moral consensus upon which stand
our present US Federal regulations
governing the ethics of human
subjects research conduct with
Federal funds from the majority of
Federal agencies.
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Belmont Report's requirements
matured into the Institutional Review
Board (IRB) system that we have
today.
This goals is accomplished by having
the IRB assure that the following
requirements are satisfied:
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1. risk to subjects are minimized
2. risk to subjects are reasonable in
relation to anticipated benefits,
3. selection of subjects is equitable,
i.e. fair. informed consent is sought
form each subject or his/her legally
authorized representative,
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4. informed consent is sought form
each subject or his/her legally
authorized representative,
5. informed consent is appropriately
documented,
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6. when appropriate, the research plan
makes provisions for monitoring data
collection,
7. privacy and confidentiality of
research subjects is appropriately
protected, and
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8. when some or all of the subjects are
likely to be vulnerable to coercion or
undue influence, additional safeguards
have been included.
The IRB has to approve that these
requirements are followed before they
approve a research study and must
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review these documents on, at the
least, an annual basis.
However, IRB’s are made up of human
beings who are not perfect and
research has been conducted
unethically due to irresponsible IRB’s
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The Nuremburg Code was established
in Germany in 1949: “The voluntary
consent of the human subject is
absolutely essential.” Children were
excluded from all research.
From 1946-1961, the Nuremburg Code
was not considered pertinent to
Harvard University researchers.
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Harvard researchers felt that they had
a moral sense that differentiated them
from previous generations and
prevented the need for codes, rules,
and regulations. Many research
studies were conducted in the United
States, including Human Radiation
Experiments
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The Fernald School was the site of the
1946–53 joint experiments by Harvard
University and MIT that exposed
young male children to tracer doses of
radioactive isotopes
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at the Fernald School in Waltham, MA.
There, seventy-four “mentally
retarded” children were fed radioactive
calcium and iron in oatmeal to
determine the absorption of those
nutrients.
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A 1995 class-action suit resulted in a
1998 District court decision awarding
the victims a $1.85 million settlement
from MIT and Quaker.[9]
Diminished autonomy debate
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Of the many conflicting views
regarding children as research
subjects, the core issues are whether
children need to be protected as
vulnerable persons or whether they
should be viewed as humans who are
social beings and ought to contribute
to the good of others.
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Research in children prior to 1966 has
a history of using convenient
populations, including children of
researchers and poor or orphaned
children. There were no research
policies passed before 1966 that
directly addressed children.
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We now recognize that research
inherently carries risk and is not
always beneficial. The question today
is: How is it possible to ensure
equitable access to benefits while
protecting the interests of patientsubjects?
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New “scandals” are emerging. The
Office of Human Research Protections
(OHRP) has shut down programs at
some major research institutions and
there have been a number of
Congressional inquiries and reports.
There is also increased legal attention
focused on research.
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Ethical considerations:
Informed consent in pediatrics is a
misnomer. Informed consent in
pediatrics equals parental permission
and assent of the child.
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Assent means that the child is aware
of the condition or disorder,
understands what to expect,
understands the procedure or
treatment, and expresses support for
participation in the study.
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There is likely a lower age at which
dissent (or assent) is not possible.
Should the age of assent be set at
when a child understands when
something is being done against his or
her wishes? Or when a child can
appreciate being used for another’s
purpose?
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Data shows that children over the age
of eleven have the ability to
comprehend important aspects of
research. Younger children can only
reason in terms of tangible objects
(e.g., blood draw).
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These findings only demonstrate that
younger children struggle with the
customary approach to consent.
Assent and consent are not the same
thing.
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Differences Between Research and
Innovative Therapy
The traditional view is that we need a
reason for distinguishing
“experimentation” from “treatment.”
The critical ethical distinction is that
the physician serves as a double
agent.
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In innovative therapy, the physician’s
primary concern is the interest of the
patient. In research, the physician’s
primary concern is to benefit society.
History (abuses and unethical
research) justified the creation of
regulations and rules and, eventually,
a common rule was created.
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Regulations, protocols, and policies
have changed over time and should
continue to do so but the debate about
use of children (elderly and mentally
diminished subjects) in research and
innovative therapy continues
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How old does a child need to be to
distinguish the difference between
clinical care and research? 14?
Today, information must be provided
to parents with general information
about the purpose of the clinical
research.
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The researchers must use specific
measures to distinguish research from
clinical care.
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Pediatric ethics must consider what is
in the best interests of the children,
whenever and wherever research is
considered or conducted. Whether
commercial or privately funded, the
IRB should be weighing risk and
benefit. But best interest is abstract.
New Issue
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Today IRBs should be looking at
payment to physicians as well as to
subjects as issue of ethical concern
How is this influencing research, why
it’s done and who participates?