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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This 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. COMMITTEE CHARGE AND SCOPE To respond to the need for additional clarification regarding human subjects protection and the promotion of research in the social and behavioral sciences, the Division of Behavioral and Social Sciences and Education of the National Research Council (NRC)
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Consistent with prior NRC reports, the committee includes as disciplines in social and behavioral sciences the following: anthropology, cognitive science, communication and information sciences, economics, education research, demography, geography, health services research, history, political science, psychology, social work, sociology, statistics, and related fields. Through review of prior NRC reports on the topic of human subjects protections, reports of federal advisory bodies on human subjects protections, papers of professional associations that responded to the ANPRM, and the evidence from the empirical literature, and using the committee's deliberations and expertise in these areas, the report provides, and supports, the rationale for committee recommendations in the following areas.
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Some of these changes reflect concomitant changes in the risks of everyday life that humans face. The following committee recommendations were made to • redefine "human-subjects research," to provide criteria for what types of research should be considered as not human-subjects re search, and to provide examples of social and behavioral science that could be considered as not human-subjects research; • endorse the adoption of a new category of "excused" research, to provide criteria for what types of research should be considered "excused," and to provide examples of social and behavioral sci ences that could be considered in this excused category; and • operationalize procedures for implementing the new category of excused research.
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. Recommendation 2.6: HHS should specify in the revised Federal Regu lations that excused research covers studies where the research proce dures involve informational risk that is no more than minimal (when appropriate data security and information protection plans are in place)
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Investigators should be informed when their research is part of an examination or audit sample and, if issues are identified, they should be granted an appropriate period of time to make adjustments or submit a protocol for IRB review. DETERMINING MINIMAL RISK IN SOCIAL AND BEHAVIORAL RESEARCH The committee examines two core issues bearing on IRB decision making: minimal risk determinations and their role in expedited review.
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to assist in operationalizing the definition of minimal risk and to assist in distinguishing between vulnerabilities in participants' lives and their vulnerability to research risks. The committee also offers elements of OHRP guidance statements that would help investigators and IRBs distinguish among research that would be excused from IRB review, research requiring expedited review, and research requiring full review.
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The committee also pointed to corresponding research that is needed to • build a stronger evidence base for identifying the probability and magnitude of risks in daily life and the nature of age-indexed rou tine medical, psychological, or educational examinations, tests, or procedures of the general population; • develop and assess appropriate algorithms for calculating risk from both the probability and magnitude of harm and determining when this calculated risk meets minimal risk criteria; • encourage and provide empirical evidence for effective procedures for minimizing potential physical and psychological research harms to no more than minimal risk levels; and • study the effects of social and behavioral research on research participants so that evidence-based assessments of "known and foreseeable" risk are more feasible. In particular, research is needed to properly address nonphysical risks of research and the methods that create them.
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Recommendation 4.2: HHS should eliminate language in the regula tions suggesting that written informed consent disclosures and writ ten documentation that consent has been obtained are the preferred norm and include language permitting informed consent by nonwritten means when appropriate, without requiring action by the IRB to grant a waiver of documentation. Recommendation 4.3: HHS should revise regulations to require that statements relating only to institutional or sponsor liability be clearly separated from the informed consent information directly related to the research participation.
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In recommending that HIPAA not be mandated as the data protection and security standard, the committee is not suggesting that another particular set of standards be mandated for social and behavioral sciences, but rather that there be an array of data protection approaches that best fit the data protection needs. These can include • planning data protection with the concept of a portfolio approach considering safe people, safe projects, safe data, safe settings, and safe outputs; • utilizing a wide range of statistical methods to reduce risk of disclosure; • consulting resources and data protection models to help research ers and IRBs such as university research data management service groups, individual IT/protection experts, and specialized institu tions such as the Inter-university Consortium for Political and Social Research at the University of Michigan, Ann Arbor, and NORC at the University of Chicago; • existing standards for data protection promulgated by the National Institute of Standards and Technology; and • developing a future national center to define and certify the levels of informational risk of different types of studies and correspond ing data protection plans to ensure risks are minimized.
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The revised regulations and OHRP guidance on data use should make clear that secondary users must honor confidentiality agreements but that no further consent from human subjects is needed to use such data. The revised regulations should also make clear that data providers may share data without consent of human subjects as long as users adhere to the original confidentiality agreements and other conditions of use.
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federal science and statistical agencies sponsor the development of disclosure risk assessment and risk mitigation strategies that are consistent with the needs of "big data" used in the social and behavioral sciences. IMPROVEMENT IN IRB PROCESSES All of the report incorporates committee suggestions on how IRB procedures might be improved.
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Recommendation 6.3: In each institution in which research involving human participants is carried out, a system should be developed for the appeal of IRB decisions. Finally in order to assist in developing best practices for implementing the new human research protections and assessing the effectiveness of the rules and their implementation, the committee recommends that research be conducted on the costs and benefits for institutions, IRBs, investigators, and sponsors of regulating social and behavioral research on human subjects.
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