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2
Basic Concepts
IN THIS CHAPTER we introduce two overarching themes that are
critical for our findings and recommendations. First is the need
for continued vigilance by all those involved in the U.S. human re-
search participant protection system researchers, institutional review
boards (IRBs), research institutions, funding agencies, and the Office
for Human Research Protections (OEIRP) to maintain the principles
for participant protection that were articulated in the Belmont Report
produced by the National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research (19791. Second is the
need to maintain that vigilance in a way that is commensurate with the
risk of each research protocol. Following a summary of the Belmont
Report principles and practices that follow from them, the chapter con-
siders more fully issues of hat Act, benefit, risk, and minimal risk. It then
considers the current mismatch between the risks of research projects
and the type of review afforded them by many IRBs. Finally, as context,
the chapter discusses examples of social, behavioral, and economic sci-
ences (SBES) research and issues for participant protection.
PRINCIPLES AND PRACTICES FOR ETHICAL RESEARCH
General Principles
Although U.S. policies and regulations for protection of human re-
search participants date back to the 1 960s (see Chapter 3), basic ethical
principles underlying and informing such regulations were not articu-
lated until 1979, when the national commission issued the Belmont
Report. That report identified three major ethical principles for the
conduct of research on humans respect for persons, beneficence, and
justice:
Respect for Persons—the obligation to treat individuals as
autonomous agents whose decisions on whether or not to
participate in research are to be respected and not overrid-
den by a researcher. Prom this principle follows the require-
ment for researchers to obtain voluntary informed consent
23
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24 PROTECTING PARTICIPANTS ED FACILITATING SOCIAL AND BEHAVIOR SCIENCES SEARCH
from participants. Special recognition must be given to is-
sues of respect when dealing with people who are immature,
incapacitated, or whose autonomy is constrained. Those
with limited capacities need to be protected from harm by
providing for consent by authorized proxies and by taking
extra care to minimize research risks or, in some cases, pre-
cluding their participation in research.
Beneficence the obligation to secure participants' well-
being by protecting them from harm to the extent possible
and by maximizing the benefits to them especially, but also
to society that are expected to result from the research.
From this principle follows the requirement for researchers
and IRBs to assess risks of harm and probability of benefits
in a systematic manner.
Justice the obligation to show fairness in the selection of
research participants with regard to the distributions of the
burdens and benefits of the research. Prom this principle
follows the requirement for researchers to select partici-
pants in an equitable manner for particular studies and for
funding agencies to consider the distribution of burdens and
benefits across society (e.g., to ensure that certain groups
are not systematically excluded from or included in research).
Applying Principles to the Conduct of Research
Everyone concerned with research on humans should be fully cog-
nizant of the Belmont principles in designing and reviewing protocols
and monitoring ongoing research. Resolving conflicts among princi-
ples, however, can prove challenging in practice and underscores the
necessity of the ethical review processes that are in place for research
with humans. In practice, the three principles translate into consider-
ation of three requirements: informed consent, assessment and appro-
priate balancing of risks and benefits, and fair procedures for selection
of research participants. In addition, although not explicitly articu-
lated in the Belmont Report, the principles support the protection of
confidentiality. (See also Box 1-1 in Chapter 1, which lists the criteria
that IRBs must consider in reviewing research protocols.)
Informed Consent providing an individual with compre-
hensible information regarding known risks of harm, possi-
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BASIC CONCEPTS
ble benefits, and other details of the proposed study prior to
the point at which the person freely chooses to participate.
By providing full information to prospective participants,
researchers assure that each of them can decide whether he
or she is willing to participate given his or her situation and
personal tolerance for risk. Consider, for example, a test of
an experimental drug for the treatment of a mental illness
when the drug is known to have a number of potentially
serious side effects. A less invasive example would be a psy-
chological experiment in which a lengthy series of mental
tests are administered to elderly persons over the course of
a few hours. In the second case some temporary fatigue or
distress is likely, which may be regarded as harmful to some
people. Regardless of an experimenter's belief in the poten-
tial benefits to the participant or the long-term benefits from
the research, it would be unethical for the experimenter to
subject the person to these kinds of risks without consent.
The right to decide about participation on the basis of
full information is not limited to studies that pose significant
risks of harm. It exists for studies that are as inconsequen-
tial as stating color preferences for automobiles in market
research, as well as for studies probing the effect of grieving
on the emotional health of a surviving spouse. Under care-
fully considered circumstances, however, it can be appro-
priate to use less than fully informed consent for example,
keeping information about a particular feature of a study
from a prospective participant until the study is completed
when such information would likely alter the participant's
behavior, the knowledge to be gained is important, and the
risk to the participant from omitting the particular informa-
tion is minimal.
Assessment of Harms, Risks, and Benefits—weighing and
appropriately balancing the risks of harm and the potential
for benefits from participation in the proposed study. A1-
though there is little disagreement about the desirability of
minimizing harm and maximizing benefits from participa-
tion in research, determining for a specific research proto-
col the type and extent of harm, the probability or likelihood
of harm, and the benefits likely to be obtained from partic-
ipation is, at best, inexact. Such assessments are almost
always subjective and often involve issues on which reason-
25
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26 PROTECTING PARTICIPANTS AND FACILITATING SOCIAL AND BEHAVIORAL SCIENCES RESEARCH
able people disagree. Yet such judgments cannot be avoided
(see "Harms, Risks, and Benefits" below).
Fair Selection of Research Participants assuring fair pro-
cedures and outcomes in the selection of research partic-
ipants. Achieving fairness requires consideration of those
who are included in research and those who are excluded.
If participation is believed to be beneficial to either the par-
ticipants or the populations represented by them, then ex-
cluding some people raises an issue of fairness. For exam-
ple, early studies of cardiovascular disease rarely included
women, leading to knowledge with potential limitations for
understanding cardiovascular diseases in women. If partic-
ipation is believed to carry significant risks of harm, then
restricting research to particular population groups is also
an issue of fairness, particularly if those groups are subject
to coercion (e.g., prisoners who are denied privileges or of-
fered added privileges to participate).
Confidentiality Protection keeping the participant's iden-
tity confidential. Confidentiality is another means of show-
ing respect for a person. A person has the right to expect
that, if he or she participates in research under conditions of
confidentiality, the researcher will respect and assure
that confidentiality. Confidentiality may also address benef-
icence. In some cases, making research information public
could put a participant at risk. For example, if sensitive per-
sonal information became known to the person's employer,
it could put his or her job or benefits in jeopardy.
HARMS, RISKS, AND BENEFITS
In this section we briefly discuss some of the critical factors sur-
rounding the judgments about harms, risks, and benefits that are nec-
essar~y to address the ethical principle of beneficence.
Types of Harm
Drawing on the final report of the National Bioethics Advisory Com-
mission (NBAC) (2001:71-72) and adding examples from SBES re-
search, below we discuss six types of harms that can occur to research
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BASIC CONCEPTS
27
participants: physical, psychological, social, economic, legal, and dig-
nitary. 1
.
.
Physical harm from research can include death, injury, pain, suf-
fering, or discomfort. Examples in biomedical research range
from death due to an experimental drug administered in a can-
cer study to discomfort from having to keep still for a long time
during an MRI (magnetic resonance imaging) study. Examples in
SBES research range from death or injury due to the failure of
an alternative automated method of helping blind people cross at
traffic signals to discomfort from being subjected to loud noises
or bright lights during a stimulus-response study. Physical harm,
including injury and death, can also result from a breach of con-
fidentiality that discloses sensitive information (e.g., that one is
participating in a study of gang violence, which could lead to re-
taliation by gang members).
· Psycl~olog~cal harm from research can include negative self-
perception, emotional suffering (e.g., anxiety or shame), or aber-
rations in thought or behavior (e.g., agreeing to a hateful state-
ment under pressure from the research environment). In both
biomedical and SBES research, psychological harm from the re-
search procedure can range from momentary anxiety or embar-
rassment to long-lasting, intense psychological distress and fear,
which could in extreme cases result in suicide. A biomedical ex-
ample is when a participant in a genetics study learns that he or
she is likely to develop a disease for which there is no treatment
or cure. An SBES example is when a participant in a study on
traumatic events recalls memories that are intensely distressing.
Psychological harm, such as distress, anger, or guilt, can also re-
sult from disclosure of sensitive or embarrassing information col-
lected in the research.
Social harm can involve negative effects on relationships or in-
teractions with other people. Such effects are most likely to re-
sult from a breach of confidentiality, in which a participant's an-
swers become known to others. Examples of social harm include
discriminator behavior resulting in loss of insurance or employ-
ment from knowledge of study results (e.g., that one has or is
likely to contract a specific disease). Stigmatization is another
Recent guidance from the National Science Foundation (2002:17-18) is similar but
omits dignitary harm and includes "moral harm when participation in research strength-
ens the subjects' inclinations to behave unethically."
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28 PROTECTING PARTICIPANTS AND FACILITATING SOCIAL AND BEHAVIORAL SCIENCES RESEARCH
social harm that can result from knowledge about a person's par-
ticipation in a study or particular findings.
· Economic harm usually involves financial loss, which can result
from study participation (e.g., the need to pay for transportation
or child care in order to participate), from disclosure of study
findings or participation (e.g., loss of health insurance or employ-
ment), or as a side effect of other harms (e.g., having to pay court
costs in a lawsuit that results from a breach of confidentiality).
· Legal hann can include arrest, conviction, incarceration, and
civil lawsuits. Such harm can result, for example, from a breach
of confidentiality in studies of possession or use of illegal drugs,
sexual abuse, or shoplifting behavior, or in situations in which
state law requires that certain types of researchers report partic-
ular activities, such as child abuse.
· Dignitary harm can result when individuals are treated as means
to an end and not as people deserving respect for their own values
and preferences. Such harm can happen in studies that do not
appropriately obtain informed consent.
Research projects can pose risks of more than one type of harm
(e.g., stigmatization, psychological stress, and financial loss from dis-
closure of confidential information). Research projects can also result
in harm to people not directly involved in the research (see National
Bioethics Advisory Commission, 2001:721. For example, family mem-
bers could be stigmatized or otherwise harmed by a breach of confi-
dentiality that disclosed information about a family from an individ-
ual's participation in genetic research. Figure 2-1 shows a distribution
of the kindest of harm that a sample of investigators of biomedical and
SBES research projects anticipated could potentially result to partici-
pants in their projects, with a slightly different categorization than we
use.
Differences in methods used in SBES research relate to the appro-
priate focus of IRBs in determining the kinds of potential harm to hu-
man participants. For research involving interventions, such as a labo-
ratory experiment in which the participant is subjected to a stimulus, a
primary focus must be on the potential harm to the participant from the
intervention itself. The potential harm from a breach of confidentiality
is also of concern. For research in which the participant is answer-
ing questions from a researcher, the primary focus is on the harm that
could result from a breach of confidentiality. The psychological harm
from asking sensitive questions is also of concern and is affected by
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BASIC CONCEPTS
In
-
o
o
o
Pi
~4
o ~
~ o
be
Pi
o _
to
o _
UP
o _
ret
.. 1
o
Lit I
1 1 1
| O BehavioraVSocial l
| · ClinicaVBiomedical |
~ ~°? v? ~ `~°; ~°/ 0~
Figure 2-1 Types of Possible Harm Anticipated by Investigators for
Protocols, by Type of Research
29
NOTE: Classification by investigators (n = 632): behav~oral/social research includes social science,
behavioral science, educational research, and health services research; clinical/biomedical research
includes clinical research, biomedical science, and epidemiology.
SOURCE: 1995 survey of IRBs in Bell, Whiton, and Connelly (1998:Figure 1 la).
whether the researcher assures the participant that any such question
can be skipped. For research that involves no contact between the re-
searcher (or research team) and the participant, the primary concern
is the potential harm from a breach of confidentiality.
Procedures to encourage participation also raise the potential for
harm. For experiments, one problem may arise when volunteers be-
come so motivated by direct incentives to participate, such as the pos-
sibility that they or a close relative or friend will benefit from an experi-
mental treatment, that they fail to take adequate account of the risks of
participation. Another problem can occur if volunteers are so coerced
(overtly or in subtle ways) that their right to voluntarily participate is
not respected (e.g., students who perceive that participating in an ex-
periment is necessary to remain on good terms with the instructor).
Yet another problem can arise for surveys for which achieving high re-
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30 PROTECTING PARTICIP~TS ED FACILITATING SOCIAL ED BEHAVIOR SCIENCES SEARCH
spouse rates among randomly selected (presumably disinterested) peo-
ple is a key issue for the quality of the research results: What are the
appropriate procedures to ensure participation without harming par-
ticipants by the recruitment procedure (e.g., by making their identity
known to others)?
Estimating Risks of Harm
It is generally not difficult to imagine types of harm that particular
research projects may pose. What is often difficult to estimate accu-
rately is the severity of the harm and the likelihood that it will occur
that is, to estimate risk. It is particularly difficult to estimate risk for
many types of nonphysical harms given the absence of a good base of
evidence. As the National Bioethics Advisor Commission (2001:72)
notes:
Determinations concerning the probability of physical harms
are often easier to make than those involving the proba-
bility of nonphysical harms. For example, the magnitude
and probability of harms associated with a blood draw are
well known and can be objectively quantified. This is gen-
erally not the case for psychological, social, economic, and
legal harms.... IRBs, therefore, can err in either direction
fitalics added], by assuming a higher probability and rec-
ommending unnecessary protections or preventing research
from being conducted or by assuming a lower probability
and allowing research to occur without all the appropriate
protections.... fAlso,] although a good deal of information
has been gathered about some nonphysical harms for ex-
ample, the risks from disclosures associated with transmit-
ting or storing certain types of information the possibility
of such harms is not widely appreciated.
Assessments of the extent to which IRBs overestimate (or underes-
timate) risks of different types of harms are limited (see "Role of IRBs"
below). Moreover, even if IRBs and researchers agree on the risks
of a particular research study, it may still be a matter of judgment as
to whether the study meets the Common Rule definition of posing no
more than "minimal risk" to participants (see "Minimal Risk" below).
Benefits
Benefits can be as difficult to identify and quantify as the risks of
harm. Balancing risks of harm against likely benefits, particularly
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BASIC CONCEPTS
31
when the benefits are indirect, is also far from easy. For experimental
biomedical research, benefits are often thought of as improved medi-
cal treatments for illnesses or disabilities. Yet a major issue for clinical
trials of experimental drugs or devices is that participants may con-
fuse research with medical care and expect an immediate benefit to
themselves when such benefit may not be likely even if the participant
receives the experimental treatment and not a placebo.
For most, if not all, SBES research, there is usually little direct ben-
efit to participants in the sense that the results of the research will be
of immediate help to them, but SBES and biomedical research can
provide two other kinds of benefits. The first type of benefit is when
knowledge about humans and human societies helps decision making
in the public and private sectors by individuals, households, businesses,
organizations, and governments. For example, from psychological re-
search much has been learned about the human brain and the kinds of
stimuli that are essential to the development of cognitive, social, and
emotional skills. This knowledge has been used by parents, educators,
and others to help children grow. From economic decision-making
research, knowledge has been gained about how people respond to
financial incentives. This knowledge has been used to craft policies
to encourage saving. From survey research have come indicators of
consumer spending and confidence in the economy that are important
forecasters of economic growth or recession.
A second type of benefit in much SBES and biomedical research
comes from the study procedure. This type includes such benefits as
the opportunity for education and gaining access to information (e.g.,
information about nutrient contents of foods in a study of food-buying
patterns of low-income families or resources for child-rearing advice
in a study of mother-child interactions) and the opportunity to earn
the esteem of other participants and the research team. These kinds
of benefits can be meaningful to participants and help build positive
long-term relationships with a research program (see Sieber, 1992:Ch.
91.
MINIMAL RISK
Driven primarily by the nature of the IRB process, a normative
"minimal-risk" construct has evolved. It plays a central role in the
sequential decisions by IRBs regarding the type of review for each pro-
tocol. If the protocol involves research with human participants (see
Chapter 6), the first decision is whether the IRB will exempt the pro-
tocol from review. If the first decision is to review the protocol, the
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32 PROTECTING PARTICIPANTS AND FACILITATING SOCIAL ACID BEHAVIORAL SCIENCES RESEARCH
next decision is whether the IRB will conduct an expedited review or a
full committee review. The latter is required when the protocol is not
eligible for exemption and the IRB determines that it involves more
than minimal risk. Having determined the type of review, the IRB
then must conduct that review to evaluate the research practices and
procedures of the protocol as they relate to the ethical treatment of
human participants, including judgments about the key practices dis-
cussed earlier informed consent, balancing of risks and benefits, se-
lection, and confidentiality considering both the vulnerability of the
population of interest and who is being invited to participate in the
study. IRBs must impose stringent requirements for informed consent
when the IRB judges a protocol to be more than minimal risk.
The Common Rule (45 CFR 36.102i) defines "minimal risk" to mean
that "the probability and magnitude of harm or discomfort anticipated
in the research are not greater in and of themselves than those ordinar-
ily encountered in daily life or during the performance of routine phys-
ical or psychological examinations or tests." Beyond that definition,
little concrete guidance is available to IRBs for determining minimal
risk.
Moreover, the definition itself is ambiguous in several respects. For
example, a "routine" psychological test may be of more than minimal
risk when it is performed on severely depressed people. Furthermore,
different populations experience different risks in daily life for exam-
ple, the risks that combat soldiers willingly accept as part of training
are much greater than the risks that white-collar workers would ac-
cept as part of their jobs. Also, some populations (e.g., poor children
in bad neighborhoods) experience high levels of risk in their daily lives
through no choice of their own.
Not surprisingly, views differ on what constitutes minimal risk. The
National Human Research Protections Advisory Committee Social and
Behavioral Science Working Group recently attempted to define mini-
mal risk as meaning "that the worst harm that could occur in a study
should not be very serious even if many subjects experience it, and,
if the harm is serious, then the probability of any given subject expe-
riencing it should be quite low."2 This formulation suggests not only
that projects posing no or minor harm to participants and having a
low probability that harm will occur are minimal risk, but also that
projects posing no or minor harm to participants and having a high-
probability that harm will occur are minimal risk. Recent guidance
from the National Science Foundation (2002:9) agrees, noting, in par-
2This is a draft statement; see http://www.asanet.org/public/humanresearch/
riskharmO2.html [4/10/03].
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BASIC CONCEPTS
33
ticular, that a high probability harm can be minimal risk provided that
the magnitude of the harm is very low. An example is an innocuous sur-
vey that annoys the respondent by taking longer than he or she would
like. Even if most or all respondents are annoyed, an innocuous survey
is still minimal risk because the harm to any one respondent is mi-
nor and fleeting, and people experience similar transitory annoyances
every day.
In addition, the working group formulation suggests that projects
posing serious harms to participants can be minimal risk if the prob-
ability of such harm occurring to any given participant is extremely
low. Barnbaum (2002), however, argues that such projects should not
be treated as minimal risk because serious harm could occur for one
or more participants. For example, a police officer who participated
in a study of police officers' views on police corruption and violence
could lose his or her job if confidentiality were breached and his or her
participation disclosed.
We agree that the example cited by Barnbaum should not be treated
as minimal risk. However, just because a serious harm can be imagined
does not mean that a project must be treated as more than minimal
risk. In a survey of the general population, it is almost always possible
to imagine that some respondent somewhere could have a negative re-
action to being questioned that could, theoretically, result in a serious
harm, such as a relapse for a person suffering from depression. How-
ever, such relapses may occur for many reasons in the course of daily
life. If adequate measures are taken to inform prospective respondents
of the nature of the survey and their right not to answer some or all
questions, then the mere possibility that a random respondent might
have an adverse reaction should not be sufficient reason to take the
project out of the minimal-risk category. For that to occur, there should
be evidence that particular questions have had significant adverse ef-
fects, or there should be a direct link of the possible harm to the type
of respondent, as in the case of the police officer example.3
We further believe that, when determining the level of risk, it is im-
portant to consider not only the possible intensity of the harm, but also
its likely duration. For example, the occurrence of psychological harm
in a research project could result in one of three situations: (1) a min-
imal and fleeting annoyance or other emotion; (2) a sharp but short-
lived feeling of anxiety, embarrassment, anger, or other emotion; or
(3) an intense and long-lasting feeling of anxiety, anger, guilt, or other
strong emotion. Of these three situations, we argue that the second as
sin Chapter 6 we discuss the need for SEES researchers to document harm to par-
ticipants as a means to build an evidence base; see also Chapter 7 for a discussion of the
desirability of systematic research on risks and harm of different kinds of research.
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48 PROTECTING PARTICIPANTS AlID FACILITATING SOCIAL AND BEHAVIORAL SCIENCES RESEARCH
BOX2-1
Laboratory Experiment Examples
Economic Decision-Making Experiment The research question is how differing
rewards (usually monetary) and rules of behavior affect decision making (e.g., the
decision to join a coalition and increase the likelihood of a smaller reward or to stand
apart and hope to receive a larger reward that is less certain). A small number of
participants (less than, say, 50) are brought together in a laboratory, classroom, or on
the Internet. They are given precise, detailed instructions on how they are to interact
and how they will be rewarded on the basis of their decisions and the decisions of other
participants. They are informed that they may leave at any time. Their decisions are
recorded, and they are rewarded accordingly (in private, anonymously, and after the
experiment). Reward amounts are small, usually $50 or less. No personal identifiers
are kept from the experiment, and no other data (or very limited data, e.g., gender) are
collected from participants.
Commentary This type of experiment is minimal risk—it attempts
to replicate commonly encountered decisions (e.g., bargaining over
merchandise or votes); the rewards offered are not large enough to be
an undue incentive to participate or to cause participants more than
momentary dismay (or glee) at the outcome; identifying information is
not retained and so the risk that participants' identities could be linked
with their decisions is minimal. Such experiments could be exempted from
IRB review or reviewed by an expedited procedure. Written consent to
participate may not be needed. When students are involved (as is typically
the case), care is needed to make sure they understand that deciding not
to participate will not affect their grades in the course.
Social Psychology Experiment with Deception The research question is the extent
to which people engage in ethnic stereotyping. A small number of participants (less
than, say, 50) are brought together in a laboratory or classroom. They are told that the
purpose of the experiment is to determine how fast people can associate characteristics
(e.g., good, bad) with lists of names (which differ in cues about ethnic origin). Their
results are recorded, and they are told at the conclusion of the experiment about its
true purpose. No personal identifiers are kept from the experiment, nor are other data
obtained about participants except their ethnic origin and perhaps their age and gender.
Commentary This type of experiment is minimal risk it attempts to
replicate common behavior; there are no incentives to participate; the
procedure itself is not stressful; identifying information is not retained;
and the inadvertent release of participants' identities and results would
cause them only momentary embarrassment at most. The deception
invoked covers only the purpose of the experiment, and participants are
fully debriefed. Such experiments could be reviewed by an expedited
procedure; they could not be exempted given the need to consider the
deception involved. Another issue to consider would be fair selection of
participants—ideally, a set of experiments would include a range of ethnic
groups.
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BASIC CONCEPTS
49
BOX 2-2
Field Experiment Examples
Welfare Policy Experiment The research question of interest is whether welfare
recipients are more likely to find a job lasting at least 6 months if they receive training
in specific work skills or coaching in job-related behavior skills (e.g., putting together
a resume, interviewing for a job, punctuality). In, say, three cities in which coaching is
standard practice, the design randomly assigns 2,000 current welfare recipients each
to treatment A (skill training) and treatment B (job behavior coaching). Participants are
fully informed about the nature of the experiment and that it will not affect their welfare
benefits and are promised confidentiality. They are given detailed interviews about their
work and welfare history before assignment and reinterviewed at 3-month interviews
over a 15-month period (to allow for training and job search time and to observe
whether the job lasts at least 6 months). Data from administrative records (time on
welfare, benefit amounts, other income) are also obtained. Microdata files containing
data for each participant are prepared, stripped of identifiers, and the data processed
to minimize the risk that individual participants could be re-identified. The files are
deposited with a university archive for secondary analysis.
Commentary This type of experiment is of more than minimal risk,
principally because of the extensive amount of data collected, some of
which could be sensitive (e.g., if a respondent reports illicit income). The
treatment poses little added risk because skill training is (or has been)
an expected part of welfare assistance in many jurisdictions. Protecting
confidentiality, particularly of the public-use microdata files, is the key
concern. Fair selection of participants is also a concern that is, how the
jurisdictions are chosen and whether any are included that offer neither
job behavior coaching nor work skill training as standard practice.
If the experiment is evaluating a federal benefits program for a federal
program agency, then it is eligible for exemption under the Common Rule
(see Box 1-1 in Chapter 1). However, every involved IRB that does not
grant an exemption must approve the experiment, or they may delegate
review to one institution that has an approved federal-wide assurance
(with OHRP's approval of the delegation).
Employment Discrimination Experiment The research question is whether people
with felony records experience discrimination in job hiring and whether the effect varies
by race. The investigators sample want ads in the Sunday newspapers for factory jobs in
a city. They send a pair of candidates to respond to each ad by filling out applications in
person at the employer's site. Pairs are assigned to employers randomly. Pairs vary by
race (some pairs are two black men, some are two white men); the members of each
pair have similar characteristics (age, education, etc.), except that one member of each
pair purports to have a felony conviction. Candidates report if they are called back with
a job offer. Employers are not debriefed because it is illegal in the state to discriminate
against job applicants who are convicted felons. Data are reported in aggregate form
only, and employer identifiers (name, address) are destroyed.
Commentary This experiment is minimal risk because there is no way to
link call-back responses to employers and, therefore, no way to embarrass
them or subject them to the risk of prosecution. Deception is essential
to obtain unbiased responses, and the absence of debriefing about the
deception is essential to making the study minimal risk.
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50 PROTECTING PARTICIPANTS AND FACILITATING SOCIAL AND BEHAVIORAL SCIENCES RESEARCH
visual observation and documentation of conversations within a small
group; the audiotaping of conversations of family members; and the vi-
sual observation and documentation of neighborhood characteristics.
In some observational studies, the researcher's presence and study
methods are known to the participants; in others, the researcher at-
tempts to record activities unaffected by knowledge on the part of par-
ticipants that they are being observed. The purpose of the research is
to describe the nature of the activities of those observed; secondarily,
the research may argue that the findings would be replicated in other
settings. See Box 2-3 for two examples a minimal-risk study of street-
crossing behavior, with no interaction of the researcher and partici-
pants, and a more-than-minimal-risk study of the behavior of patrons
of a bar, with interaction between the researcher and participants.
Unstructured or Semistructured Interviews with Participants
Unstructured or partially structured interviews are used in a wide
range of social and behavioral investigations to elicit an individual's
interpretation of events, beliefs, and behavior. Oral histories of public
figures or individuals involved in a public event might include unstruc-
tured or semistructured interviews. Ethnographers may use informal
unstructured interviews during the initial phase of their worked Infor-
mal unstructured interviews also may be used throughout a study to
build rapport or explore newly emerging topics of interest.
Unstructured interviews have a topical focus but are marked by
minimal control over the informants' responses. An investigator work-
ing in the area of [IIV prevention, for example, may use unstructured
interviews with injection drug users to explore beliefs and practices as-
sociated with accessing treatment programs. While the general topic
has been defined, there is no attempt to follow a predetermined line of
inquiry using an interview guide of questions to be asked. In an un-
structured interview, the conversation follows the direction taken by
the interviewer based on the responses of the interviewee.
In contrast, semistructured interviews involve the use of an inter-
view guide to assist the investigator in systematically studying a partic-
i7lIammersley and Atkinson (1995:248) define ethnographic research to include the
following features: "a strong emphasis on exploring the nature of particular social phe-
nomena, rather than setting out to test hypotheses about them; a tendency to work pri-
marily with 'unstructured' data, that is data that have not been coded at the point of
data collection in terms of a closed set of analytic categories; investigation of a small
number of cases, perhaps just one case, in detail; analysis of data that involves explicit
interpretation of the meanings and functions of human actions, the product of which
mainly takes the form of verbal descriptions and explanations, with quantification and
statistical analysis playing a subordinate role at most."
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BOX 2-3
Natural Behavior Observation Examples
Street-Crossing Observation, No Interaction The purpose of the study is to
observe street-crossing behavior of pedestrians (e.g., whether they obey walk signs) in
relation to such factors as time of day, number of people crossing, and number of cars
in the street. The investigator(s) stands at the crossing, makes notes of what occurs (time,
number and gender of pedestrians, etc.), and takes still photographs. The investigator
makes no effort to interact with pedestrians or to obtain identifiers. Faces are blanked
out on the photographs, and they are not published.
Commentary The project is minimal risk and eligible for exemption.
The setting is a public place in which there is no expectation of privacy.
The only concern is keeping the photographic material confidential and
unpublished (since consent was not obtained).
Observation of Behavior at a Bar by a Regular Customer (Participant Ob-
servation) The purpose of the research is to document the social interactions at a
neighborhood bar and compare the results with similar studies that have been con-
ducted in other places or other times. The investigator becomes a regular customer,
informing the bartender and customers that he or she is doing a book about the bar and
will not publish anything in the book about the individual without his or her permission
and will not use real names. The investigator conducts research over a 6-month period
(typing notes in a palm pilot during restroom breaks and after leaving the bar each
evening), writes a book, and carefully reviews applicable sections and statements with
each person prior to publication, obtaining signed releases.
Commentary This project is of more than minimal risk given that sensitive
material may be discussed by participants with the investigator and that
others may recognize participants despite the use of pseudonyms. A key
concern is informed consent and when it must be obtained.
ular set of issues. Questions are listed in a specific order and are often
followed by leads for exploring the topic in greater detail. Semistruc-
tured interviews might be implemented in situations in which the re-
searcher needs to be sure that the same data are collected from all par-
ticipants. Semistructured interview guides also may be used in focus
groups with small numbers of individuals selected on the basis of spe-
cific criteria to discuss a particular topic (e.g., a sample of women with
known risk factors for breast cancer discussing genetic testing; fam-
ily members caring for an elderly parent with Alzheimer's disease). A
moderator facilitates discussion using a flexible interview guide, and
the discussion may continue for 1-2 hours; the conversation is audio-
taped and transcribed.
Data collected from participants using unstructured or semistruct-
ured interviews may not be summarized in a statistical fashion. The
inference from the data collection is often targeted to a relatively small
group (a village, a network of friends, a work group). In these in-
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52 PROTECTING PARTICIPANTS AND FACILITATING SOCIAL AND BEHAVIORAL SCIENCES RESEARCH
stances, information is valuable because it provides richly elaborated
data about the question under investigation. In other cases, researchers
may use unstructured and semistructured interviews in addition to
quantitative methods to develop an in-depth and robust understanding
of a problem. For example, a study of advance care planning in a hos-
pice program might include a survey of a random sample of patients
and their families and health providers, along with semistructured in-
terviews with some study participants.
See Box 2-4 for three examples of research using unstructured or
semistructured interviews; two of the examples are minimal risk, one
of which involves changes in the interview protocol as the study pro-
ceeds.
Structured Interviews in Sample Surveys
Much quantitative SEES research involves collection of data in sam-
ple surveys, which identify a target population and draw a subset with
probability methods to assure that each member of the population has
a known, nonzero chance of selection. Once the sample is identified,
the researcher cannot substitute other cases without threatening the
ability of the research to describe the target population. Participa-
tion is sought by having interviewers visit or telephone sample persons
or by contacting them by the mail or the Internet. Surveys are de-
signed to describe the attributes of large populations with measurable
levels of uncertainty from sampling. See Box 2-5 for two examples-
one a minimal-risk telephone survey and the other a complex, more-
than-minimal-risk longitudinal survey with linkages to administrative
records.
Secondary Analyses of Existing Survey and Records Data
Secondary analyses perform no new data collection. Instead, sur-
vey data collected by another researcher are reanalyzed on a topic
not previously researched with the data, or records collected for some
other purpose are statistically analyzed to study the attributes of a pop-
ulation covered by the record system. Such records may include pro-
gram agency records, medical records, academic records, and crimi-
nal and civil justice records.
Examples of secondary analyses with survey data include studies of
labor force behavior with the public-use microdata files from the Cen-
sus Bureau's Current Population Survey or the University of Michigan's
Panel Study of Income Dynamics. These files are preprocessed by the
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BASIC CONCEPTS
53
issuing agency to ensure the confidentiality of individuals in the sam-
ple.
Examples of secondary analyses with records include studies of
income dynamics using Social Security Administration earnings data
and studies of occupational mobility using personnel records of a firm.
Records data are most often anonymized prior to the analysis. The sub-
jects of the research sometimes cannot be reached by the holder of the
record system and do not know of the analysis; other times, they can
be reached.
See Box 2-6 for two examples an analysis of public-use files from a
large government survey and a study of school transcript records, both
minimal risk.
CONCLUSION
We have discussed a broad array of issues related to the determina-
tion of harm, risk, benefit, and minimal risk in SBES research, along
with evidence that many IRBs despite punishing workloads—do not
appear to be using the flexibility in the Common Rule regulations to
exempt eligible research or to use an expedited procedure to review
minimal-risk SBES and biomedical research. Our discussion of types
of SBES research illustrates the diversity of the field and the challenge
of developing examples to include in guidance. We argue in subsequent
chapters for detailed guidance for researchers and IRBs that will im-
prove understanding and encourage the use of the flexibility that is cur-
rently possible according to the Common Rule to protect participants
in ways that are commensurate with risk. Such guidance will also help
researchers design studies that appropriately balance risks and benefits
and that incorporate good practices for human participant protection.
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54 PROTECTING PARTICIPANTS AND FACILITATING SOCIAL AND BEHAVIORS SCIENCES RESEARCH
BOX 2-4
Unstructured or Semistructured Interview Examples
Epidemiological and Ethnographic Study of Injection Drug Users The goal of
this study is to examine the diffusion of benefits associated with injection drug users'
participation in needle exchange programs. This multisite project involves more than
500 injection drug users in three cities. Participants are interviewed several times over
a 4-year period and agree to have researchers observe them while they are engaged
in drug-related activities in order to determine risky behaviors for HIV transmission.
Participants also agree to show researchers their drug paraphernalia, including needles
used to administer drugs. Both unstructured and semistructured ethnographic interviews
are conducted, and a detailed survey is completed. Information on sensitive topics
such as drug use history and sexual behavior is obtained. The survey does not include
personally identifiable information. Transcripts of interviews do not include names of
participants. All data are kept in locked files. Given the vulnerability of the population
because of their involvement in illicit activities, two of the sites allow verbal informed
consent; however, the third study site requires written informed consent from all study
participants.
Commentary The primary risk to participants in this study is the potential
breach of confidentiality that could result in stigmatization, physical or
emotional harm, or possibly incarceration. This study requires full board
approval from an IRB because of the vulnerability of the population and
the potential risks involved. However, this example calls attention to
the inconsistent application of federal requirements for written informed
consent in behavioral studies. The IRBs at the study sites requiring
only verbal consent have considerable experience reviewing research
proposals addressing social and health behavior of drug users; the IRB
requiring written consent has little experience with research on drug
users. Given the sensitive nature of the study and the importance of
protecting the names of participants, written informed consent should
not be necessary to conduct this study. However, investigators should be
required to document carefully the procedures used to obtain informed
consent and methods for recording the consent discussion.
Case Study of Informed Consent Practices in International Genetic Re-
search A semistructured interview is administered to 20 health professionals in a
Nigerian town to explore challenges associated with obtaining informed consent in
community-based genetic research being conducted in their area. The study participants
are invited to participate in this case study because of their involvement in international
scientific investigations. Interviews last approximately 1 1/2 hours. Verbal consent is
obtained. Identifying information is removed from the interview transcripts. Transcripts
are kept in a locked file.
Commentary This study is minimal risk. Verbal consent is appropriate.
The IRB could implement expedited review. The primary risk is the
potential for breach of confidentiality regarding sensitive information
that may be communicated during the interview. The IRB should require
investigators to indicate procedures for obtaining consent, strategies for
protecting confidentiality, and, if audiotapes are used during the interview,
when they will be destroyed or erased or how they will be protected if they
are stored permanently in a research archive.
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BOX 2-4 (continued)
Ethnographic Study of Communication about Death and Dying Among
Hospice Staff The goal of this study is to explore patterns of communication about
death and the dying process among health professionals working in a hospice. The
investigator has discussed the study goals and procedures with the hospice administra-
tion. After the study has been approved, the staff is informed about the study objectives.
Patients and family members are advised of the study. The ethnographer conducts
field observations over a 6-month period and conducts unstructured and semistructured
interviews with hospice staff. Verbal consent is obtained from all individuals interviewed.
If interviews are recorded, consent is recorded at the beginning of the interview. The
semistructured interview guide used initially is changed on the basis of responses of
the staff to specific questions; some questions are deleted, and new questions added.
Field notes are recorded using code names for individuals observed. Interview data and
audiotapes are locked.
Commentary This type of study involves minimal risk. The primary risk
to participants is the potential for breach of confidentiality, particularly
concerning sensitive information regarding communication about death
and dying. An IRB would be justified in requiring full board approval
because of the sensitive nature of the topic and because patients and
families are implicated in the research, even though they will not be
interviewed directly. Verbal consent is appropriate when semistructured
interviews are conducted. The IRB should ask investigators to outline
procedures for obtaining informed consent and strategies for protecting
confidentiality, including the disposition of audiotapes if they are used
for interviews. The change in the semistructured interview guide should
not require full board approval by the IRB. The modified semistructured
interview guide should be submitted to the IRB when the study is scheduled
for annual review. However, the IRB should be notified if there are any
substantive changes in the research design involving major alterations
of the methods or the study population (e.g., if the investigator decides
to include interviews with patients and family members who are hospice
clients after the study has begun).
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56 PROTECTING PARTICIPANTS ED FACILITATING SOCIAL ED BEHAVIOR SCIENCES SEARCH
BOX 2-5
Structured Interview (Sample Survey) Examples
Consumer Telephone Survey To estimate consumer confidence in the economy, a
7-minute telephone interview is conducted of a sample of 1,000 adults in households
whose phone numbers are randomly generated by computer software. One adult is
selected to report on household plans for purchase of major appliances, savings plans,
and opinions about economic prospects for the household and the nation as a whole
over the next 6 months. Sample households are repeatedly called until contact is made;
interviewers inform respondents that the survey is completely voluntary and address
concerns that reluctant respondents may have about participating; no incentive is offered;
respondents who initially refuse are called again to seek reconsideration of participating.
No names or addresses are collected, and only basic background characteristics are
obtained (number of household members, type of household, household income in
broad categories). Data are deposited with an archive for secondary use.
Commentary This type of survey is minimal risk. It could be exempted
from review or reviewed by an expedited procedure. Consent is tacit as
is usual in telephone surveys with content that is not stressful and when
respondents are informed that they may terminate the interview at any
time.
Longitudinal In-Person Health and Retirement Survey To study retirement
behavior and health of older adults, a sample of 12,000 adults aged 51-62 in the
base year is drawn and interviewed at 2-year intervals (spouses are also interviewed); a
new sample is drawn periodically. The interviews are in person; advance letters inform
respondents about the survey; the interviews are 1 hour in length each; topics include
detailed work history, income, benefits, health status and history, retirement plans and
expectations, and other characteristics; incentives are used to promote participation.
Data are linked with administrative records, including social security earnings records
and descriptions of employer pension and health benefit plans. Some of the data are
provided for public use; access to the full microdata requires special arrangements.
Commentary This survey is large, complex, and clearly of more than
minimal risk because of the sensitivity of the questionnaire content
and the risk of breach of confidentiality. Key issues are protecting the
confidentiality of the data for secondary use, developing an effective
consent process that does not unnecessarily discourage response, and
determining an appropriate incentive level to encourage participation.
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BASIC CONCEPTS
~7
BOX 2-6
Secondary Analysis Examples
Analysis of Changes in Poverty Levels with the Survey of Income and Pro-
gram Participation (SIPP) The survey is collected by the Census Bureau, which
processes the data on public-use files to minimize the risk of re-identification of
respondents.
Commentary Even though SIPP obtains highly detailed information on
sensitive topics (e.g., detailed sources of income), this is a minimal-risk
study that can be exempted from review. The Census Bureau is known
to be a leader in confidentiality protection; also, the survey is voluntary,
and the Bureau collects the data in an ethical manner. There is no more
protection that an IRB can provide for the respondents than the Bureau
has already provided in preparing the public-use file.
Analysis of School Transcript Records The purpose of the study is to correlate
SAT scores with college grades for recent graduates. The researcher obtains the data,
stripped of identifiers, from university registrars; conducts the analysis; and returns the
data to the universities.
Commentary This type of analysis is minimal risk given that the
researcher has no way of linking student records to individual students.
The principal concern is whether the students gave consent for their
records to be used for research; another concern is whether students
might be identifiable by inference.
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58 PROTECTING PARTICIPANTS AND FACILITATING SOCIAL AND BEHAVIORAL SCIENCES RESEARCH
BOX 2-1
Laboratory Experiment Examples
Economic Decision-Making Experiment The research question is how differ-
ing rewards {usually monetary) and rules of behavior affect decision making (e.~.,
.. . . . . . . .... .. .. ... ... . . .. .
the decision to join a coalition and increase the likelihood ot a smaller reward or
to stand apart and hope to receive a larger reward that is less certain). A small
number of participants (less than, say, 50) are brought together in a laboratory,
classroom, or on the Internet. They are given precise, detailed instructions on how
they are to interact and how they will be rewarded on the basis of their decisions
and the decisions of other participants. They are informed that they may leave
at any time. Their decisions are recorded, and they are rewarded accordingly
(in private, anonymously, and after the experiment). Reward amounts are small,
usually $50 or less. No personal identifiers are kept from the experiment, and no
other data (or very limited data, e.g., gender) are collected from participants.
Commentary This type of experiment is minimal risk- it attempts
to replicate commonly encountered decisions (e.g., bargaining over
merchandise or votes); the rewards offered are not large enough
to be an undue incentive to participate or to cause participants
more than momentary dismay (or glee) at the outcome; identifying
information is not retained and so the risk that participants' identities
could be linked with their decisions is minimal. Such experiments
could be exempted from IRB review or reviewed by an expedited
procedure. Written consent to participate may not be needed. When
students are involved (as is typically the case), care is needed to
make sure they understand that deciding not to participate will not
affect their grades in the course.
Social Psychology Experiment with Deception The research question is
the extent to which people engage in ethnic stereotyping. A small number of
participants (less than, say, 50) are brought together in a laboratory or classroom.
They are told that the purpose of the experiment is to determine how fast people
can associate characteristics (e.g., good, bad) with lists of names (which differ
in cues about ethnic origin). Their results are recorded, and they are told at the
conclusion of the experiment about its true purpose. No personal identifiers are
kept from the experiment, nor are other data obtained about participants except
their ethnic origin and perhaps their age and gender.
Commentary This type of experiment is minimal risk it attempts to
replicate common behavior; there are no incentives to participate;
the procedure itself is not stressful; identifying information is not
retained; and the inadvertent release of participants' identities and
results would cause them only momentary embarrassment at most.
The deception invoked covers only the purpose of the experiment,
and participants are fully debriefed. Such experiments could be
reviewed by an expedited procedure; they could not be exempted
given the need to consider the deception involved. Another issue
to consider would be fair selection of participants—ideally, a set of
experiments would include a range of ethnic groups.
Representative terms from entire chapter:
sbes research
