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Project Title:
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Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences
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| PIN:
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DBASSE-BBCSS-12-04
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Major Unit:
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Division of Behavioral and Social Sciences and Education
Institute of Medicine
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Sub Unit:
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Committee on National Statistics
DBASSE Committee on Population
Board on Health Sciences Policy
DBASSE Board on Behavioral, Cognitive, and Sensory Sciences
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RSO:
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Rivard, Jeanne
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Subject/Focus Area:
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Behavioral and Social Sciences; Education
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Planning Meeting: Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences
January 15, 2013 - January 15, 2013
Keck Center
500 5th Street, NW
Washington D.C. 20001
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If you would like to attend the sessions of this meeting that are open
to the public or need more information please contact:
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| Contact Name:
Jennifer Diamond
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| Email:
jdiamond@nas.edu
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| Phone:
202-334-3345
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Fax:
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Agenda:
DRAFT AGENDA SUBJECT TO CHANGE
The sessions listed below will be open to the public.
Tuesday, January 15, 2013, 8am-5pm
The National Academies
Keck Center, Room 101
500 Fifth Street, NW
Washington DC 20001
Division of Behavioral and Social Sciences and Education
Board on Behavioral, Cognitive, and Sensory Sciences
Workshop on Revisions to the Common Rule for the Protection of Human Subjects in
Research in the Behavioral and Social Sciences
9:30 Welcome
Robert M. Hauser, Director of Division of Behavioral and Social Sciences and Education (DBASSE)
Committee Member and Staff Introductions
9:45 Sponsor Perspective: Charge and Expectations of the Study
Kelli Craig-Henderson, Deputy Division Director; Social, Behavioral and Economic Sciences directorate; National Science Foundation
10:15 Most Critical Issues - Identification and discussion of most critical and feasible issues addressed by the proposed revisions to Common Rule that should be the main topics of the workshop
Examples of issues that have surfaced as key:
• Adopting HIPAA standards for the protection of privacy and data security
• Obtaining consent for all future uses of biospecimens, whether identifiable or not, and for re-consenting people for further use of existing research data.
• Using 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.
• Calibrating the levels of IRB review to the levels of risk (e.g., breaking out psychological risk from information risks; considering categories of risk and harm)
• Using standardized consent form
• Regulations covering all research, regardless of funding sources, at institutions receiving some federal funding from a Common Rule agency
11:15 Implications of Proposed Rules - Identify possible workshop speakers to explain/clarify how the proposed rules (in identified critical issue areas) could affect different types of research studies and methods
12:00 Working Lunch
Continued Panel Discussion from prior session
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Closed Session Summary Posted After the Meeting
The following committee members were present at the closed sessions of the meeting:
Melissa E. Abraham
Thomas J. Coates
Celia B. Fisher
Susan Fiske
Robert M. Groves
Felice J. Levine
Robert J. Levine
Richard E. Nisbett
Charles R. Plott
Margaret Riley
Yonette F. Thomas
David R. Weir
The following topics were discussed in the closed sessions:
Committee composition and balance
Sources of bias and conflict of interest
Statement of Task
Proposed workshop topics
Workshop dates
The following materials (written documents) were made available to the committee in the closed sessions:
Meeting Agenda
Statement of Task
Committee and study information
Selected NRC reports
Peer review papers
Date of posting of Closed Session Summary:
February 7, 2013
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