Social and Behavioral Science Research: Where Weve Been and Where Were Going

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Social and Behavioral Science ResearchWhere
Weve Been and Where Were Going

• Bernard A. Schwetz, DVM, PhD
• Director, Office for Human Research Protections
• Bernard.Schwetz_at_hhs.gov
• CUNY IRB Symposium
• The City University of New York
• New York, NY
• September 7, 2006

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Connecting with the Social and Behavioral Science
Community

• OHRP Conferences
• SACHRP, July 2004
• Oral History Interviews
• Detailee at OHRP
• Qs As on our website
• Human Subjects Research Subcommittee
• IRB Conference, November 20-21, 2006
• Outreach to COSSA

3
OHRP National Conferences and Research Community
Forums

• Interdenominational Theological Center, Atlanta
  Mar 05
• LA Tech University, Ruston, LA
  Feb 05
• CA State University, Long Beach, CA Feb
  05
• IN University, Bloomington, IN Oct 04
• University of GA, Athens, GA Jul 03
• University of Southern CA, Los Angeles, CA
  Jul 01
• (six of thirty six conferences)

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Secretarys Advisory Committee on Human Research
Protections

• Meeting since July 2003
• Subcommittees
• Accreditation
• Subpart C
• Subpart D
• Subpart A
• Many panel discussions, including social and
  behavioral science

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Social and Behavioral Research PanelJuly 27, 2004

• Michael Fendrich, Ph.D., University of IL
• Survey research, suggested guidance on
• 1) IRB determination of risk level
• 2) waiver of elements of informed consent
• Joan Sieber, Ph.D., CA State University
• Use the flexibility inherent in the regulations
• Protect subjects with minimal regulatory burden
• Philip Rubin, Ph.D., Yale University
• Working together to craft flexible solutions that
  impose minimal regulatory burden
• Karen Hegtvedt, Ph.D., University of Washington
• Regulatory reasonableness, guidance on waivers
  and informed consent

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Oral History Interview

• do they fit under the Common Rule? YES
• do they require IRB review? SOMETIMES
• Issues what is research?
• what is a human subject?
• what is generalizable knowledge?
• what is harm or risk?

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Actions by OHRP

• communications with the Oral History Association
• Qs As OHRP website
• new guidance what is research?

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Social and Behavioral Scientist on Detail to OHRP

• Dr. Ivor Pritchard
  Department of Education
• During the two-year detail
• Education activities
• Policy and guidance development

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Qs As on the OHRP Website

• Check the OHRP website
• Information on many different topics

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Social and Behavioral Research Working Group

• Human Subject Research Subcommittee
• Committee on Science
• National Science and Technology Council
• Co-chairs, SB Research Working Group
• Stuart Plattner, National Science Foundation
  (retired)
• Jeffrey Rodamer, Department of Education
• Sally Flanzer, Agency for Healthcare Research and
  Quality
• Co-chairs, HSRS
• B. A. Schwetz, OHRP
• Peg (M) Barrett, NSF, now with NIH

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Charge to the Working Group

• Review reports on protection of human subjects in
  social and behavioral research
• Institute of Medicine and National Research
  Council of the NAS
• National Human Research Protections Advisory
  Committee
• National Bioethics Advisory Committee
• Develop a coordinated and prioritized set of
  recommendations for action.

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Final Report Accepted on February 9, 2005

• Further work in progress
• Expedited review of social and behavioral
  research
• Informed consent and waivers in social and
  behavioral research
• Develop a research agenda that will lead to
  evidence-based protections

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IRB Conference November 20-21, 2006Washington,
DC

• Alternatives to local IRBs
• Sequel to workshop held on November 17-18, 2005
• Biomedical and social and behavioral science
• Mark you calendar!

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Consortium of Social Science Associations

• OHRP reaching out to the social and behavioral
  community
• Dialog with Dr. Myron Gutman, Univ. of MI
• President of COSSA
• Speaker at the June meeting of HSRS
• COSSA is on the planning committee for the IRB
  conference

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Closing Thoughts

• OHRP efforts to be increasingly aware of the
  concerns and needs of the social and behavioral
  research community
• Trying to help bridge the regulatory gap
• Flexibility is needed one size doesnt fit
  all for biomedical or social and behavioral
  research

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How to Contact OHRP?

• Address
• Office for Human Research Protections
• 1101 Wootton Parkway, Suite 200
• Rockville, Maryland 20852
• PhoneToll-Free Telephone within the U.S. (866)
  447-4777(240) 453-6900
• Fax [phone]
• Email
• ohrp_at_osophs.dhhs.gov
• Website
• http//www.hhs.gov/ohrp/