Proposed Revisions to the Common Rule Perspectives of Social and Behavioral Scientists: Workshop Summary (2013) / Chapter Skim
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Appendix A: Workshop Agenda
Appendix A: Workshop Agenda
Pages 83-90
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From page 83... ...
appointed a panel to address the proposed revisions to the Common Rule that have particular relevance to the behavioral and social sciences. The purpose of this two-day workshop is to explore the implications of the proposed revisions and of alternative approaches for protecting human participants while advancing the behavioral, social, and educational sciences.
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From page 84... ...
DAY 1: THURSDAY, MARCH 21, 2013 8:15 am Check in and Continental breakfast 8:45 Introduction of Members of the Welcome and Committee on Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences National Research Council, Executive Robert M Hauser, Director, Division of Behavioral and Social Sciences and Education 9:00 Opening Remarks Introduction: This session will briefly provide the context for the workshop by explaining why the focus is on social, behavioral, and educational sciences; how research methods overlap with those used in biomedical sciences, and an introduction to the six major topics that will be addressed in the workshop.
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From page 85... ...
Campbell, University of Illinois Speaker 1: at Chicago, Institute for Health Research and Policy (Discussion of the issues in the context of research on aging, health, racial, ethnic, and socioeconomic disparities; and suggestions for calibrating levels of review to levels of risk.) 10:40 Brian Mustanski, Northwestern University Speaker 2: Feinberg School of Medicine (Discussion of issues in the context of sexuality and health research with LGBT youth; participants' appraisals of risk and benefits in behavioral and social science research.)
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From page 86... ...
[The ANPRM asked for input on proposed revisions to the Common Rule that would require the use of a standardized consent form and for a new rule that would require consent to be obtained for all future uses of biospecimens, whether identifiable or not, and for re-consenting people for further use of existing research data.] Margaret Foster Riley, University of Virginia 1:10 Speaker 1: Sally Powers, University of Massachusetts, Amherst (Discussion of the issues in the context of research on biopsychosocial factors hypothesized to contribute to depression in family systems, particular focus on "complex consents.")
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From page 87... ...
Issues relate to privacy and data security, third parties, future use, analysis, de identification, re-consent, breaches through computer losses or accidents. [The ANPRM asked for input on proposed revisions to the Common Rule that would require adopting HIPAA standards for the protection of privacy and data security and also for a new rule that would require consent to be obtained for all future uses of biospecimens, whether identifiable or not, and for re-consenting people for further use of existing research data.]
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From page 88... ...
[The ANPRM asked for input on proposed revisions to the Common Rule that would allow for a single IRB for multisite studies.] Robert Levine, Yale University, Interdisciplinary Center for Bioethics 9:10 Speaker 1: Pearl O'Rourke, Human Research Affairs, Partners Health Care System, Inc.
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From page 89... ...
[The ANPRM asked for input on a proposed revision to the Common Rule that would create a new category of "excused" research to replace the "exempt" category and possibly imposing additional regulation relating to data protection and consent on this new category.] Issues relate to IRB oversight of excused research, continuing review; plus issues such as education/guidance to IRBs, mission creep, appeals processes, asymmetrical incentives.
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From page 90... ...
Moreover, once the draft report is written, it must go through a rigorous review by experts who are anonymous to the committee, and the committee then must respond to this review with appropriate revisions that adequately satisfy the National Research Council's Report Review Committee and the chair of the National Research Council before it is considered a National Research Council report. Therefore, observers who draw conclusions about the committee's work based on today's discussions will be doing so prematurely.
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