Essay Grade

Psychological and Social Risks of Behavioral
Research
BY SUSAN M . LABOTT AND TIMOTHY P. JOHNSON
isks to human subjects assok x ciated with participation in
JL S.research are an important
consideration in the design of studies and in the informed consent
process. Yet, there are significant
gaps in our knowledge about the
psychological and social risks of
behavioral research. Our review of
federal regulations governing
research with humans and empirical
work pertaining to behavioral
research risks shows that we have
little data on the frequency of specific psychological and social risks and
on the implications of these risks for
research subjects who experience
them. We make suggestions for further research in this area to address
the current ambiguities.
Risk Assessment
n p h e Belmont Report,^ issued by
JL the National Commission for
the Protection of Human Subjects of
Biomedical and Behavioral
Research, described the need for
Institutional Review Boards (IRBs)
to evaluate the risk-benefit ratio of
research studies. IRBs were urged to
consider the probability and severity
of potential risks, the justifiability of
risks, the likelihood of anticipated
benefits, and alternative ways to
obtain the benefits of the proposed
research. The federal regulations for
research with humans expand upon
this idea by providing guidelines for
the evaluation of risks and benefits.
The regulations require that all risks
Susan M. Labott and Timothy P. Johnson,
“Psychological and Social Risks of Behavioral
Research,” IRB: Ethics & Human Research z6 No.
3 (1004): 11-15.
IRB: ETHICS &. HUMAN RESEARCH
to subjects should be minimized to
the extent possible. The importance
of the potential knowledge gained
through the research can be considered in this determination, but the
potential long-range risks and benefits of applying the knowledge
should not. Further, the regulations
require that “reasonably foreseeable” risks be disclosed to subjects
during the process of consent, along
with any anticipated benefits.^
The controversial regulatory definition of minimal risk involves a situation in which “the probability
and magnitude of harm or discomfort anticipated in the research are
not greater in and of themselves
than those ordinarily encountered in
daily life or during the performance
of routine physical or psychological
examinations or tests.”‘ One problem in assessing minimal risk
involves issues of the definition of
“daily life.” Whose daily life? That
of an investigator or of a potential
subject who is currently homeless?
Further, is a study with a potentially
significant harm that has a low likelihood of occurrence the same as a
study with relatively lesser harm but
a greater likelihood that many subjects will experience it?” Lastly, is
risk level determined a priori, or
after the investigator’s safeguards to
protect subjects are in place?
Regardless, research that does not
meet the criteria of minimal risk is
defined as greater than minimal risk
and warrants additional safeguards.
The National Bioethics Advisory
Commission provides suggestions
for risk assessment that include data
on the nature, likelihood, and
acceptability of risks, but notes that
these assessments are difficult to
make because of unknown information about many of the risks associated with human subjects research.5
In spite of the inherent problems,
researchers and IRBs regularly make
risk estimates.
Regardless of the category of
risk, researchers and ethicists agree
that risks need to be minimized to
the extent possible. That is, a study
should be designed in the safest
manner and procedures should be in
place to manage any problems that
do occur. Further, the process of
informed consent requires that the
risks (and benefits) be clearly
described so that individuals can
consider and weigh these along with
other aspects of the research as they
make their decisions about participation.
Behavioral versus Biomedical
Research Risk
A t this point the perspectives on
.ibehavioral versus biomedical
research risk diverge, partly because
behavioral research is generally minimal risk while biomedical research
is more likely to be greater than
minimal risk; the clarity with which
risks can be specified also differs. In
the area of biomedical research, the
nature and acceptability of potential
risks can be determined to a great
extent, at least qualitatively, and can
be evaluated in the context of potential benefits. For example, consider
research on two new medical procedures designed to slow the progression of cancer. The most significant
risk of one procedure is infection.
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for the second procedure it is death.
Clearly these risks are qualitatively
different in that an infection can be
treated with antibiotics, is likely to
be reversible, and will probably have
no long-term consequences. For
many potential subjects, this risk
may be acceptable, especially if there
is a corresponding potential for medical benefit. The risk of death is likely to be unacceptable to most people, unless there is a high likelihood
that the procedure could result in
significant benefit, i.e., a cure for the
cancer. In this context, the risks are
clearly different; their impact is evaluated accordingly, and is weighed
against the potential benefit (which
may be dramatic). For many biomedical protocols, risk frequency
can also be quantified. For example,
negative reaction rates and other side
effects for many medications are well
established (i.e., one person in a
thousand or a million may have a
life-threatening reaction to a given
drug), and this information is commonly used to assist potential
research subjects in evaluating the
risks of participation.
In the area of behavioral research,
how to assess risks is less clear. First,
psychological and social risks are
less tangible than physical risks, and
we do not know their nature in an
exact way. For example, what exactly is emotional discomfort and how
reversible is it? Second, there is often
no anticipated benefit to consider in
relation to the risks of behavioral
research. Much behavioral research
offers no individual benefit for participants at all, providing no compelling reason to become involved in
research that offers any (even minimal) risk. Third, although it is not
difficult to identify potential social
and psychological risks, estimating
the frequency or degree of Ukelihood
associated with each currently
amounts to little more than guesswork. Finally, some would argue
that because psychological and social
risks do not result in physical harm.
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they are not actual “risks” at all.
Psychological and Social Risks
W
hat exactly are thi; psychological and social risks of
research? The National Research
Council (NRC), in its thorough
review of issues related to human
subject protection, has designated six
categories of potential subject harms:
physical, psychological, social, economic, legal, and dignitary.* Prentice
has also indicated that social and
psychological risks may occur, not
only to the research participant, but
also to family members who may
experience negative consequences as
a function of their family member’s
participation.” The psychological
risks that have been discussed in the
literature include depression, altered
self-concept, increased anxiety,
decreased confidence in others, guilt,
shame, fear, embarrassment, boredom, frustration, receiving information about oneself that is unpleasant,
and inconvenience.^ Social risks generally involve stigma, decreased
opportunities, or negative changes in
relationships.’
• Confidentiality. The area of
risk that has been studied most deals
with the issue of confidentiality, likely the most significant social risk of
research. Singer and colleagues have
studied this issue extensively, providing information on the effects of
confidentiality assurances on survey
research. In one set of studies, assurances of confidentiality decreased
willingness to participate in a survey
because they elicited subjects’ expectations that the information requested would be sensitive.”‘ In a metaanalysis of studies on this issue, confidentiality assurances affected
response, but only when data
requested were sensitive; when data
were not sensitive, negligible effects
of confidentiality assurances were
obtained.^^ When several researchers
reviewed responses to the 1990 mail
census, they discovered that privacy
and confidentiality concerns had a
significant effect on the census mail
return. ^^ Further, the effect of privacy and confidentiahty concerns differed for black and white respondents. It is also important to note
that these studies raise the issue of
psychological discomfort (e.g., anxiety, apprehension, embarrassment),
which msiy result from the confidentiality assurance itself.^’
• Emotional Distress. The risk
of emotional distress has been considered in the area of trauma
research. Here, the concern is that
recall and discussion of a traumatic
event may result in re-traumatization
of the individual. Newman and colleagues examined the risks involved
and the potential vulnerability of this
populatic’n.^’t They found little
empirical evidence to specifically
address the risks, and conclude that
there is a need to generate data on
the prevalence of adverse occurrences and to determine if individuals with c:ertain trauma-related
symptoms are more vulnerable than
others. They also suggest that studies
on violence and trauma may provide
some benefit to participants. Such
studies might be a way for individuals to beg;in to seek help from professionals, or as a way to begin to use a
negative experience to potentially
help others.
In an empirical study addressing
this issue, women were asked to
respond 1:0 a survey that included
items about childhood abuse and
maltreatment; a subset of participants was also interviewed.^’ Only
10% of the survey respondents
reported unexpected upset, and these
were individuals with higher levels of
post-traumatic stress disorder symptoms. Many participants (23% questionnaire, 86% interview) reported
benefit and only 5% reported regret
for having participated. Finally, the
appraisals of benefit and regret
about the; interview were generally
stable over the 48 hours post-interview. The authors suggest that the
follow-u]5 contact contributed to the
satisfaction that participants report-
IRB:
ETHICS & HUMAN RESEARCH
ed, and proper informed consent
procedures helped to minimize upset
and regret. However, they also noted
that more extensive informed consent procedures, especially for those
with a history of maltreatment,
might further decrease the unexpected upset reported by some participants.
• Social Risks. In one of the few
studies of social risks associated with
biomedical research, an attempt was
made to delineate the social harms
associated with participation in a
Phase II trial of an HFV vaccine. ^^
Because participation in a study of
this type can result in positive HIV
tests for uninfected individuals, the
potential for negative social consequences occurs. These authors questioned 247 participants in a vaccine
trial about adverse social consequences (job- health- or life insurance-related problems, travel problems, disclosure of participation, and
the presumption by others that the
volunteer has AIDS). Forty-five
respondents (18.2%) reported they
had experienced at least one of these
adverse social consequences in relation to trial participation. Individuals
also rated how upset they were by
the event; the overall mean was 4.0
on a 10-point scale (i=not at all to
io=extremely upset). Despite this,
94% of the participants said they
would join the study again.
Therefore, while social harms
occurred fairly frequently, these
problems were less upsetting to participants than might have been
expected. However, other subject
samples that differ culturally may
have different perceptions of these
risks.
• Other Risks. With respect to
the other psychological and social
risks, we have little information to
guide our evaluations of their
impacts. For example, consider
research on emotion and mood.
Many subjects (including vulnerable
populations) have been subjected to
inductions specifically designed to
alter mood, either in a positive or
IRB:
ETHICS & HUMAN RESEARCH
Table 1 . Process of Risk Evaluation
Investigators
1. Provide information on potential risks and benefits
2. Provide information on probability, magnitude, and harm associated with each risk
IRBs
1. Evaluate validity of investigator’s assessment of the above, considering alternate
procedures with less risk
2. Ensure risks are clear to potential subjects
3. Evaluate risks against benefits
4. Do not consider potential long-term effects of the information gained from the
research
5. Be aware of the difficulties and biases in estimating potential risks
negative way. The studies are generally construed as acceptable research,
because the changes in mood are
seen as “minimal risk” and transitory, and because appropriate safeguards are in place for individuals
who could be harmed, e.g., counselors are available. Yet, we do not
actually know the consequences of
these manipulations on human subjects, the subjects’ perceptions of
acceptability, or under what conditions individuals may be at greater
risk.
Embarrassment is another potential risk. Everyone has suffered
embarrassment when others in the
social world are witness to events or
obtain personal information. We
assume that, in most cases, this experience results in minimal impact on
the individual. However, some individuals, those most sensitive to social
evaluation, may not be resilient with
respect to experiences of this sort.
Group data collection in which individuals share personal information
may produce significant risk for
embarrassment of individuals, but
we have no data on the potential
long-term consequences for individual participants.
Oakes presented anecdotal
reports described by IRB members in
which survey questions seemed to
cause harm to survey respondents.^”
In one case a man completing a
questionnaire about cancer commit-
ted suicide following his participation. In another, several individuals
completing surveys on rape became
upset and asked for help during the
survey. In a third, an adolescent
responding to questions about sexual
preference misinterpreted the questions as suggesting that he was
homosexual; he attacked the
researcher and had to be restrained.
It is, of course, important to
acknowledge that the evaluation of
risk is subjective, and that individuals may vary dramatically in their
views on the unpleasantness of a
particular risk. Further, as noted by
Sieber in a discussion of risk associated with sexuality surveys, some
subject perceptions of risk are associated with imagined outcomes (rather
than actual ones).*^ As researchers,
then, we may need to address the
perceptions of both actual and perceived risks. This is a topic that
remains largely unexplored.
Guidance for IRBs on Risk
Assessment
“Tpable 1 provides a summary of
JL the principles described above
for the evaluation of research risk.
While this appears to be a fairly
straightforward process, the NRC
noted that it is difficult to estimate
the severity, likelihood, and duration
of specific risks, although it is fairly
easy to imagine specific harms occur-
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ring to study participants. The NRC
also pointed out that we have no
data on how much IRBs over- or
underestimate risks. Singer and
Levine note that IRB members generally make assessments of risk based
on their own experience, with almost
no information on subjects’ perceptions of the probability, magnitude,
duration, and consequences of these
risks/’
Several studies have examined differences in risk perception across
various groups. In a study of risk in
industrial psychology research, Ilgen
and Bell asked IRB members, university faculty, human resource managers, and job applicants to evaluate
the risks associated with study protocols.^” Of note was the finding that
IRB members perceived significantly
greater risk than human resource
managers when standard consent
procedures were not used. The IRB
members, university faculty, and
human resource managers all perceived greater risk than the job
applicants when the survey items
were sensitive. Another study by
Schreier and Stadler compared the
evaluations of student research participants, psychologist investigators,
and IRB members when evaluating a
research protocol.^^ The IRB members and psychologists were similar
in that they reported less comfort
endorsing the study and saw less
benefit of it than did the student participants. Finally, Kimmel has provided evidence of bias in the estimates of risk made by psychologists,
reporting that gender, specialty area,
and work setting all influenced risk
estimates.^^
The NRC, as well as Singer and
Levine, noted that IRBs might be
applying greater scrutiny to behavioral protocols, using provisions (on
minimal risk research) that were
developed for higher risk biomedical
protocols. The effect of this is more
cumbersome procedures for behavioral researchers, without any additional protection for research partici-
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pants. The NRC noted i.hat IRBs are
quite variable in the extent to which
they use exempt and expedited procedures; greater use of these categories adds flexibility to the review
process.
Future Directions
e are not arguing that research
involving psychological or
social risks is inappropriate or unethical. Rather, there is a need for
empirically-based understanding of
these risks so that they can be evaluated more clearly and communicated
to human subjects where relevant.
We agree vk^ith Oakes that there is a
need to understand “the risks posed
and literally experienced in social scientific investigations. “^3 Methods
are needed to evaluate the frequency
and impact of social and psychological risks, as well as differences in risk
perception in various populations.
As the situation stands now, human
subjects are frequently presented
with “minimal risk” studies involving the possibility of psychological
and social harms, and are left to
determine the risks for themselves.
Although it seems ironic to call
for more research on the nature of
research risks, there are some lowcost actions that could be immediately taken to help addiess our current lack of knowledge. For example, as the NRC recommended,
researchers could be encouraged to
build debriefing questions into their
research studies in order to begin
collecting information regarding perceptions of risk and harm in behavioral research.^”* Simple probes
designed to learn about subject perceptions and reactions to specific
behavioral research procedures
would be particularly valuable.
Fendrich and colleagues employed
debriefing probes to evaluate subject
reactions to a request to provide hair
samples as part of a survey interview
concerned with substance use behavior.^5
W
The development and widespread
adoption of common sets of procedures for evaluating subject perceptions of research risks could provide
importani: empirical information
regarding the nature, severity, and
frequency of research risks as perceived by participants. Of course,
development of feedback mechanisms to ensure this information is
routinely shared with IRBs would
also be important. Such information
would pnjve useful to protocol
reviewers., enabling them to consider
more directly subject reactions to
potential risks when evaluating new
behavioral protocols. This information would also prove invaluable to
future research subjects, potentially
providing them with risk assessments
similar to those now available in biomedical research.
• Susan M. Labott, PhD is Director, Health
Phychology Service, Department of Psychiatry
at the University of Illinois at Chicago;
Timothy P. Johnson, PhD is Director, Survey
Research Lj.boratory, College of Urban
Planning and Public Affairs at the University
of Illinois at Chicago; Both are Vice-Chairs of
the behavioral IRB at UIC.
Referenctis
1. National Commission for the Protection
of Human Subjects of Biomedical and
Behavioral lilesearch. The Belmont Report:
Ethical Principles and Guidelines for the
Protection of Human Subjects of Research.
Washington, D.C.: Government Printing
Office, 1979.
2. 45 Cl-R 46. Protection of Human
Subjects.
3. 45 CFR 46.102.
4. Barnbaum D. Making more sense of
“minimal risk.” IRB: Ethics & Human
Research ioo2;24:io-i3.
5. National Bioethics Advisory
Commission. Research Involving Persons with
Mental Disorders That May Affect
Decisionmaking Capacity. Rockville, MD,
1998.
6. National Research Council. Protecting
Participant! and Facilitating Social and
Behavioral Sciences Research. National
Academies Press: Washington, D.C., 2003.
7. Prentice ED, Gordon BG. Institutional
review board assessment of risks and benefits
associated with research. In: National
Bioethics Advisory Commission. Ethical and
Policy Issues in Research Involving Human
Participants, Vol. II, Bethesda, MD, 2001.
8. Hermeren G. Human and social consequences of research. Research Ethics
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6o-369; Sieber JE. Planning research:
Basic ethical decision-making. In: Sales BD,
Folkman S, eds. Ethics in Research with
Human Participants. American Psychological
Association: Washington, D.C., 2000:13-26.
9. See ref. 8, Sieber 2000.
10. Singer E, Hippler H, Schwarz N.
Confidentiality assurances in surveys:
Reassurance or threat? International Journal
ofPuhlic Opinion Research
i^^z;4:z$6-i68.
11. Singer E, Von Thurn DR, Miller ER.
Confidentiality assurances and response.
Public Opinion Quarterly 199$-,59:66-77.
12. Singer E, Mathiowetz NA, Couper
MP. The impact of privacy and confidentiality
concerns on survey participation. Public
Opinion Quarterly i993;57:465-482.
13. See ref. 10, Singer 1992.
14. Newman E, Kaloupek DG, Keane
TM, Folstein SE Ethical issues in trauma
research. In: Kantor GK, Jasinski JL, eds. Out
of the Darkness. London: Sage, 1997, p. 271-
trauma-focused research. General Hospital
Psychiatry I999;2i:i87-i96.
16. Sheon AR, Wagner L, McElrath MJ,
Keefer MC, Zimmerman E, Israel H, Berger
D, Fast P. Preventing discrimination against
volunteers in prophylactic HIV vaccine trials.
Journal of Acquired Immune Deficiency
Syndromes and Human Retrovirology
281.
20. Ilgen DR, Bell BS. Conducting industrial and organizational psychological
research: Institutional review of research in
15. Newman E, Walker EA, Gefland A.
Assessing the ethical costs and benefits of
17. Oakes JM. Survey research. In: Amdur
RJ, Bankert EA, eds. Institutional Review
Board: Management and function. Jones and
Bartlett: Sudbury, MA, 2002, p. 428-433.
18. Sieber JE. The ethics and politics of
sensitive research. In: Renzetti CM, Lee RM,
eds. Researching Sensitive Topics. London:
Sage, 1993, p.14-26.
19. Singer E, Levine EJ. Protection of
human subjects of research: Recent developments and future prospects for the social sciences. Public Opinion Quarterly
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35
21. Schreier BA, Stadler HA. Perspectives
of research participants, psychologist investigators, and institutional review boards.
Perceptual and Motor Skills i99x;74:10671072.
22. Kimmel AJ. Predictable biases in the
ethical decision making of American psychologists. American Psychologist 99i;t6:7S6788.
23. Oakes JM. Risks and wrongs in social
science research: An evaluator’s guide to the
IRB. Evaluation Review 2oo2;26:443-479, p.
467.
24. See ref. 6, National Research Council
2003.
25. Eendrich M, Johnson T, Wislar JS,
Sudman S. The feasibility of hair testing in a
household survey on drug abuse. In:
Mieczkowski T, ed. Drug Testing Technology:
Assessment of Field Applications. Boca Raton,
FL: CRC Press, 1999, p. 235-253.
NEWS & NOTES
Food and Drug Administration.
“Innovation Stagnation: Challenge and
Opportunity on the Critical Path to
New Medical Products.”
IRB roles and responsibilities.
http://www.iom.edu/report.asp?id=i94
March Z004. FDA white paper that
analyzes the factors contributing to the
slowdown of new drug and biological
medical products reaching patients.
http://www.fda.gov/oc/initiatives/
criticalpath/whitepaper.pdf
Department of Health and Human
Services. “Clinical Research and the
HIPAA Privacy Rule.”
Institute of Medicine. “The Ethical
Conduct of Clinical Research Involving
Children.”
March 2004. Under the Best
Pharmaceuticals For Children Act of
200Z (RL. 107-109), Congress charged
the IOM to review the current regulatory context involving research with
children and to make recommendations regarding the regulations’ appropriateness in relation to child participants’ ages; IRB interpretation of regulatory criteria in approving research;
the parental permission and child
assent processes; child and parental
expectations and comprehension about
research participation; payment for
research participation; regulatory compliance and enforcement issues; and
IRB: ETHICS & HUMAN RESEARCH
2Z
Detailed information that includes a
Frequently Asked Questions and
Answers section explaining how the
Privacy rule affects researchers and
IRBs.
http://privacyruleandresearch.nih.gov/
clin_research.asp
National Institutes of Health. Office of
Biotechnology Activities. Recombinant
DNA Advisory Committee (RAC)
Informed Consent Working Croup.
“Cuidance on Informed Consent For
Cene Transfer Research.”
February 2004. Provides researchers,
IRBs, and others with guidance in
applying Appendix M of the NIH
Guidelines for Research Involving
Recombinant DNA Molecules (gene
transfer research).
http://www4.0d.nih.gov/0ba/rac/ic/
National Institutes of Health. Office of
Biotechnology Activities. NIH Genetic
Modification Clinical Research
Information System (CeMCRIS).
A comprehensive resource that provides information about NIH-registered human gene transfer trials, e.g.,
investigators and institutions conducting these trials, types of gene products
in use, and study protocol summaries.
http://www.gemcris.od.nih.gov/
United Kingdom Department of
Health. “Proposals for New Legislation
on Human Organs and Tissue.”
A summary of the proposed Human
Tissue Bill and justification for its passage. The bill provides a consistent
legal framework for the storage and
use of human organs and tissue
obtained from adults and children.
http://www.dh.g0v.uk/assetR00t/04/07/
United Kingdom Parliament. Human
Tissue Bill (text).
http://wvvrw.parliament.the-stationery0ffice.c0.uk/pa/cm200304/cmbills/009/
2004009.htm
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