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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: