Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences (2014) / Chapter Skim
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1 Introduction and Background
1 Introduction and Background
Pages 13-32
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From page 13... ...
Box 1-1 below provides a brief description of the Common Rule; a more lengthy explanation is provided in Appendix A.2 This committee applauds and supports the issuance of the ANPRM, and the committee's review -- concerning how updated human subjects protections regulations can effectively respond to current research contexts and methods -- counts the ANPRM as a major stimulus. The committee takes this opportunity seriously and has engaged a wide variety of researchers and human-subjects regulatory experts in its process.
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From page 14... ...
consensus report align with the central aims of the ANPRM. With a specific focus on social and behavioral sciences, this report addresses the dramatic alterations in the research landscapes that institutional review boards (IRBs)
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Further, many critics see little evidence that most IRB review of social and behavioral research effectively does much to protect research subjects from psychological or informational risks. Over regulating social and behavioral research in general may serve to distract attention from attempts to identify those social and behavioral research studies that do pose threats to the welfare of subjects and thus do merit significant oversight.
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From page 16... ...
With regard to the scope of the committee's task and the recommendations forthcoming in this report, it is the committee's assumption that the regulatory changes that will result -- from the ANPRM issued by the HHS Office for Human Research Protections (OHRP) , the many organizations that responded to the ANPRM, and the efforts of the present committee -- will take the form of one set of revised Common Rule regulations governing both biomedical and social and behavioral sciences.
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From page 17... ...
• Identify topics for research emerging from the proposed rulemaking that will assist in developing best practices for implementing the new human research protections and assessing the effectiveness of the rules and their implementation by IRBs and researchers. biomedical sciences as the reference discipline for examples, with the social and behavioral sciences in the background, this consensus study provides an opportunity for the social and behavioral sciences to take the foreground in offering strategies and examples of how the revisions to the Common Rule could best fit social and behavioral science research methods.
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From page 18... ...
Overall, the report's twin goals for all these audiences are to protect human subjects and to facilitate research that benefits society. Key Challenges that Drive the Report This report's focus on 21st century social and behavioral sciences aims to balance human subjects protection -- which encompasses respect, justice, and beneficence -- with advancing the societal utility of research.
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From page 19... ...
To HHS and IRBs, this report recommends several best practices that would streamline human subjects protection, including best practices relating to full IRB review, the prototypic IRB activity. Chapter 5 examines crosscutting issues related to protecting humansubjects research data in the information age and addresses questions posed by the ANPRM related to methods that would work best for social and behavioral sciences.
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From page 20... ...
Social and behavioral science research has long respected the rights and welfare of human research participants. Early on, a broad shift occurred in the climate of ethical awareness within the varied social and behavioral research communities.
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From page 21... ...
. Similarly, the American Political Science Association formed a committee in 1967 that published a report the next year, which resulted in the association's first written code.10 The Oral History Association has likewise had an active commitment to professional ethics since its founding: like the American Political Science Association, it adopted a first statement of "goals and guidelines" in 1968.11 The American Sociological Association published its first ethics code in 1970.12 Since the 1970s, they have also developed and expanded ethics education resources,13 just as universities -- where most researchers are trained and many are employed -- have likewise strengthened their internal mechanisms for reviewing academic ethics cases and for cultivating ethical awareness in their students.
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From page 22... ...
While the committee agrees that this is partially true, another contributing factor, particularly over the past decade, has been the tendency for IRBs to interpret their charge increasingly broadly; "human subjects research" has been interpreted to encompass oral history interviewing, linguistic elicitation, and even occasionally the activities of creative writing instructors and students (e.g., Wright, 2004)
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From page 23... ...
Participants in some types of research may indeed benefit from their participation, but this is not a defining attribute of research. Specific Benefits, Burdens, and Costs of the Social and Behavioral Sciences Matter to Revising the Common Rule Generalizable knowledge resulting from social and behavioral science research benefits society.
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. • Social and behavioral science research develops and evaluates the effectiveness of interventions.
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This exchange optimizes the process in the organ transplant "market." • Social and behavioral science research reduces air pollution and pro tects the environment. Designs for emissions permits markets have proved successful in reducing nitrogen oxide (NOx)
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From page 26... ...
Measuring the benefits of IRB review in terms of unethical studies that were prevented has obvious drawbacks: proving the influence of one factor in preventing an event requires ruling out a myriad of other factors potentially at play. A systematic review of the empirical literature evaluating IRBs concluded that much research needs to be undertaken to "understand how IRBs accomplish their objectives, what issues they find important, what quality IRB review is, and how effective IRBs are at protecting human research participants" (Abbot and Grady, 2011, p.
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From page 27... ...
Situating the Report in the Changing Nature of Social and Behavioral Science Research Large changes have occurred in social and behavioral science research since the Common Rule was applied to these disciplines. These changes occurred because knowledge in these fields has evolved (thereby blurring the lines between biomedical and social science research)
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From page 28... ...
The informational risks of shared research data are themselves a research focus in social sciences, computer science, and statistics. To be current, a revision of the Common Rule needs to take into account these changes in society and research tools.
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human research protection organizations: Workload and membership. Journal of Empirical Research on Human Research Ethics, 3(4)
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Committee on Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences.
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. Human subjects research protections: Enhancing protections for research subjects and reducing burden, delay, and ambiguity for investigators.
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32 PROPOSED REVISIONS TO THE COMMON RULE Wickens, C.D., and Hollands, J.G.
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