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Executive Summary
THE U.S. SYSTEM for protecting people who volunteer to partic-
ipate in research is widely perceived to need improvement. A
major concern is that the linchpins of the protection system-
institutional review boards (IRBs) are overloaded and underfunded
and so may not be able to adequately protect participants from harm
in high-risk research, such as clinical trials of experimental drugs.
Three other concerns often voiced about research in the social
behavioral, and economic sciences (SBES), but generally applicable to
human participant protection are important. The first is that the re-
view process too often focuses on documenting consent to participate
in research so as to satisfy the letter of federal requirements, when
IRBs and researchers instead need to focus on developing the most
effective processes for helping individuals reach an informed, volun-
tary decision about participation. The second concern is that IRBs, re-
searchers, and the entire human participant protection system may pay
too little attention to the challenge of countering increasing threats to
the confidentiality of research data because of technological and other
changes, such as the ability to readily access and link large databases
through the Internet. The third concern is that the review process may
delay research or impair the integrity of research designs, without nec-
essarily improving participant protection, because the type of review
is not commensurate with risk—for example, full board review for
minimal-risk research that uses such methods as surveys, structured
interviews, participant observation, laboratory experiments, and anal-
yses of existing data.
PANEL CHARGE AND SCOPE
The Panel on Institutional Review Boards, Surveys, and Social Sci-
ence Research was established by the Committee on National Statistics
and the Board on Behavioral, Cognitive, and Sensory Sciences, both
standing committees of the National Academies' National Research
Council. The panel was charged to examine the structure, function,
and performance of the IRE system as it relates to SEES research and
to recommend research and practice to improve the system.
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2 PROTECTING PARTICIPANTS AND FACILITATING SOCIAL AND BEHAVIORAL SCIENCES RESEARCH
.
Our panel's work complements that of the Institute of Medicine's
Committee on Assessing the System for Protecting Human Research
Participants, which issued its final report, Responsible Research, in
2002. That report addresses primarily the problems of high-risk re-
search. We commend that report, which stresses that participant pro-
tection in the United States is a dynamic system of many actors. The
report makes useful recommendations to virtually all actors, includ-
ing the Congress, the Office for Human Research Protections (OHRP)
in the U.S. Department of Health and Human Services, agencies that
support research and collect data for research use, high officials of
research institutions, IRBs, researchers, individual participants, and
many interested associations and other organizations.
Although addressed primarily to SEES research, our findings and
recommendations have broader application given that the boundaries
between research domains are not and cannot be sharply drawn. We
address three topics in depth: issues for obtaining informed, voluntary
consent; issues for protecting data confidentiality; and review proce-
dures for minimal-risk research. We consider more briefly system-level
issues regarding the relationships and interactions among actors in-
volved in participant protection. Throughout, we stress commitment
to upholding the principles for ethical research articulated in the land-
mark 1979 Belmont Report: respect for persons (informed consent),
beneficence (minimizing risks and maximizing benefits of research),
and justice (selection of participants in ways that fairly distribute the
burdens and benefits of research). Given scarce IRB resources, we be-
lieve that commitment to protection requires that review procedures
be commensurate with risk. The Common Rule regulations ("Federal
Policy for the Protection of Human Subjects") contain sufficient flexi-
bility for this purpose: the challenge is how best to encourage IRBs to
use the flexibility in the regulations appropriately for different types of
research methods, topics, and study populations.
ENHANCING INFOR1\1ED CONSENT
Informed consent is a bedrock principle of ethical research with
human participants. For more-than-minimal-risk research, a process
that allows consent to be truly informed is critical; for minimal-risk re-
search, such a process respects individual autonomy. Despite decades
of research on consent issues, mostly in biomedical research and mostly
involving written forms, there appears to have been little progress in
devising more effective forms and procedures for achieving informed
consent or in adapting consent procedures to the needs of special pop-
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EXECUTIVE SUMMARY
ulations (e.g., language minorities).
Recommendation 4.1: Social, behavioral, and economic
science researchers should conduct research on procedures
for obtaining and documenting informed consent that will
facilitate comprehension of benefits, harms, and risks of
harm, confidentiality protection, and other key features of
research protocols for different types of SEES research and
populations studied.
Recommendation 4.2: The Office for Human Research
Protections should develop detailed guidance for IRBs and
researchers on appropriate consent procedures for differ-
ent types of populations including language minorities and
such vulnerable groups as undocumented immigrants-
studied in social, behavioral, and economic sciences research.
3
The issue of third-party consent has gained salience in recent years
due to reports of studies in which third parties complained that their
privacy was invaded by collection of sensitive data about them from
others. Examples of research that should not require third-party con-
sent, even though information about third parties is sought, are studies
in which respondents are asked about their perceptions or attitudes re-
garding others, studies in which the third person asked about is com-
pletely anonymous (e.g., a respondent's first teacher), and studies that
present no more than minimal risk for third parties.
Recommendation 4.3: The Office for Human Research Pro-
tections should develop detailed guidance for IRBs and re-
searchers, including specific examples, on when it is and
is not necessary to obtain consent from third parties about
whom participants are asked to provide information.
The current preoccupation of the review process with the documen-
tation of consent may shift attention from protecting participants to
protecting the research institution. Requiring a signed consent form
for all types of research may inhibit participation in minimal-risk re-
search (e.g., mail surveys of the general adult population) by otherwise
willing candidates. In some situations, requiring signed written con-
sent may endanger participants when there is risk of serious harm from
breaching confidentiality and the only link of participants to the project
is the signed consent form. The Common Rule allows for waiver of
written signed consent when appropriate for minimal-risk research; it
also allows elements of informed consent (e.g., the purpose of a partic-
ular aspect of the research) to be omitted under certain circumstances.
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4 PROTECTING PARTICIPANTS AND FACILITATING SOCIAL AND BEHAVIORAL SCIENCES RESEARCH
Recommendation 4.4: The Office for [Iuman Research
Protections should develop detailed guidance for IRBs and
researchers- with clear examples for a variety of social, be-
havioral, and economic sciences research methods and
study environments on when it is appropriate to waive
signed written consent.
Recommendation 4.5: The Office for Human Research Pro-
tections should develop detailed guidance for IRBs and re-
searchers, including specific examples, on when it is accept-
able to omit elements of informed consent in social, behav-
ioral, and economic sciences research.
ENHANCING CONFIDENIIALI1Y PROTECTION
Breach of confidentiality, that is, the release of data that permit
identifying an individual participant, is often the major source of po-
tential harm to participants in SEES research. For example, a survey
that poses no risk of physical injury and no more than minor psycho-
logical annoyance may yet obtain data that could adversely affect a
respondent's employability, insurability, or other aspects of life if it be-
came known. Even if no sensitive information is obtained, maintaining
confidentiality is required to respect participants when they have been
assured that their information will be protected.
The risk of inadvertent or advertent disclosure is increasing due
to several factors: the growing number and variety of administrative
records from public and private agencies that are readily available
on the Internet and potentially linkable to research data; the growing
number of rich, longitudinal data sets that require retention of contact
information for respondents over long periods of time and that may
be more readily linked to other data sources with sophisticated match-
ing techniques; the increased emphasis by funding agencies on data
sharing among researchers to permit replication and facilitate further
research at low cost; and the increased use of Internet-based data col-
lection technology that may be vulnerable to security breaches.
Recommendation 5.1: Because of increased risks of iden-
tification of individual research participants with new meth-
ods of data collection and dissemination, the human research
participant protection system should continually seek to de-
velop and implement state-of-the-art disclosure protection
practices and methods. Toward this goal:
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EXECUTIVE SUMMARY
.
s
· researchers should explicitly describe procedures to pro-
tect the confidentiality of the data to be collected in pro-
tocols they submit to IRBs;
· IRBs should pay close attention to the adequacy of pro-
posed procedures for protecting confidentiality;
· federal funding agencies should support research on
techniques to protect the confidentiality of SBES data
that are made available for research use; and
the Office for Human Research Protections should reg-
ularly promulgate good practices in analyzing disclo-
sure risks and limiting those risks.
Increased attention to confidentiality protection does not mean that
IRB review is needed for every type of analysis. Anecdotal evidence
suggests that many IRBs are reviewing research with publicly avail-
able microdata files, even though such research qualifies for exemp-
tion. Such review uses up scarce IRB and investigator resources yet
is unlikely to afford greater protection to respondents than is already
incorporated in the design and content of the file.
Recommendation 5.2: To facilitate secondary analysis of
public-use microdata files, the Office for Human Research
Protections, working with appropriate federal agencies and
interagency groups, should establish a new confidentiality
protection system for these data. The new system should
build upon existing and new data archives and statistical
agencies.
Recommendation 5.3: Participating archives in the new
public-use microdata protection system should certify to re-
searchers whether data sets obtained from such an archive
are sufficiently protected against disclosure to be acceptable
for secondary analysis. IRBs should exempt such secondary
analysis from review on the basis of the certification pro-
vided.
EFFECTIVE REVIEW OF MINIMAL-RISK RESEARCH
The work of IRBs begins with four sequential decisions about re-
search projects:
(1) whether the project constitutes "research" under the Common Rule;
(2) whether it involves "human participants;"
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6 PROTECTING PARTICIPANTS AND FACILITATING SOCIAL AND BEHAVIORAL SCIENCES RESEARCH
(3) whether it falls into one of the specified categories that are exempt
from IRB review; and
(4) if it is not exempt, whether it is minimal risk and eligible for review
by the chair or subcommittee (expedited review) rather than the
full board.
In the current environment of heightened scrutiny of IRB operations
because of serious harms (even death) to research volunteers, IRBs of-
ten opt for full board review of minimal-risk research, even when such
review is not appropriate or necessary for protection of participants
and detracts from the attention needed for more-than-minimal-risk re-
search.
More detailed guidance on review of minimal-risk research can en-
courage IRBs to use the flexibility in the regulations in an appropriate
way. It can also reduce the substantial variability among IRBs in the
use of such procedures as expedited review and so facilitate multisite
research and make it easier for researchers to carry projects from one
institution to another without encountering very different IRB stan-
dards. Such guidance should include clear examples for a variety of
methods and populations studied. For example, research with pub-
licly available aggregate data (e.g., tallies of census data for cities) does
not involve human subjects under the regulations, and research with
publicly available microdata of individual records qualifies for exemp-
tion when the data are certified by the supplier agency to be protected
against breach of confidentiality.
Recommendation 6.1: To promote review appropriately
tailored to risk, the Office for Human Research Protections
should develop detailed guidance for IRBs and researchers
(with clear examples for a variety of methods) on what kinds
of social, behavioral, and economic sciences (SBES) re-
search protocols qualify as "research" with "human sub-
jects." OHRP should also develop detailed guidance, in-
cluding examples, regarding SEES research that IRBs are
strongly encouraged to exempt from review and research
that IRBs are strongly encouraged to review with an expe-
dited procedure.
Recommendation 6.2: Institutional review boards should
use efficient procedures to review minor changes to minimal-
risk research protocols that arise during the period of autho-
rization. When appropriate, IRBs should approve protocols
that allow researchers flexibility in making specific design
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EXECUTIVE SUMMARY
decisions during the course of their research without the
need to seek further review. (An example would be one of
two forms of a question both minimal risk to be decided
on the basis of a pretest.)
NEEDED INFORMATION
7
We found, as did the Institute of Medicine study, that there is little
regularly available systematic information about the functioning of the
U.S. human research participant protection system. Data on harms
encountered by research participants and their economic and other
costs are scant. Only a handful of major surveys, smaller surveys, and
case studies have examined IRB operations and the consequences for
participant protection and timely research.
Recommendation 6.3: In order to build knowledge of re-
search risks, OHRP and funding agencies should encourage
researchers to build into their studies such steps as debrief-
ing participants to learn about types, incidence, and mag-
nitude of harm encountered in social, behavioral, and eco-
nomic sciences research. Researchers should seek publica-
tion of their results.
Recommendation 6.4: The Office for Human Research Pro-
tections should establish an ongoing system for collecting
and publishing data that can help assess how effectively
IRBs protect human research participants, how efficiently
they review research, and how commensurate review is with
risk.
Recommendation 6.5: Federal research funding agencies,
including the National Science Foundation and the National
Institutes of Health, should fund in-depth studies to better
understand the operations and effects of the IRB system and
to develop useful indicators of IRB performance.
SYSTEM-LEVEL ISSUES
The U.S. system for human research participant protection involves
many components and is dynamic, evolving as social and economic
changes affect various system components and they in turn respond.
We consider five system-level issues that need continued attention: (1)
guidance and support for IRBs; (2) qualifications and performance
standards for IRBs and researchers; (3) communication among IRBs
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8 PROTECTING PARTICIPANTS AND FACILITATING SOCIAL AND BEHAVIORAL SCIENCES RESEARCH
and researchers; (4) organization of and among IRBs; and (5) the de-
velopment of national policy for human research participant protec-
tion. In most instances, we endorse recommendations of other groups,
such as the Institute of Medicine and the National Bioethics Advisory
Commission. In two areas that are particularly important for SBES
research we offer recommendations.
Recommendation 7.1: To improve IRB-researcher commu-
nication and facilitate the review process, IRBs should:
· clearly distinguish and justify changes to research de-
signs that are required for human participant protec-
tion from suggested changes that are advisory; and
develop ways to work cooperatively with investigators,
such as providing opportunities for face-to-face meet-
ings to discuss significant changes in research proto-
cols that the IRB requires.
Recommendation 7.2: Any committee or commission that
is established to provide advice to the federal government on
human research participant protection policy should repre-
sent the full spectrum of disciplines that conduct research
involving human participants. In particular, such a body
should include members who represent the range of the so-
cial, behavioral, and economic sciences.
The benefits of involving the SBES community should include not
only increased support for and understanding of human participant
protection policies among SBES researchers, but also useful cross-
fertilization of knowledge and practice between SBES and biomedical
researchers and IRB members. Such cross-fertilization will help the
protection system better shoulder the difficult tasks of facilitating in-
formed consent, protecting confidentiality, estimating risk, and taking
other steps to fully protect and respect the many millions of Americans
who have volunteered to participate in research to advance knowl-
edge.
Representative terms from entire chapter:
participant protection
