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Office for Human Research Protections (OHRP)

Meeting of the Secretary’s Advisory Committee on Human Research Protections (SACHRP)
Tuesday, October 19, 2010 – Wednesday, October 20, 2010
Hubert H. Humphrey Building, Room 800

DRAFT AGENDA

Tuesday, October 19, 2010

8:30 am – 8:45 am

Welcome: Opening Remarks

 

Barbara Bierer, M.D.
SACHRP Chair

 

 

8:45 am – 9:00 am

Report of Issues/Remarks

 

Jerry Menikoff, M.D., J.D., 
Director, OHRP

 

 

9:00 am – 10:00 am

Summary of Public Comment:
Office for Civil Rights Notice of Proposed Rulemaking
Christina Heide, J.D., Senior Health Information Privacy Policy Specialist, OCR

 

 

10:00 am – 10:15 am                     

BREAK

 

 

10:15 am – 12:30 pm

Report of Subcommittee on Harmonization (SOH)
David Forster, J.D., SOH Co-chair
Mark Barnes, J.D., SOH Co-chair
Susan Stayn, J.D., SOH member

 

 

12:30 pm – 1:30 pm

LUNCH

 

 

1:30 pm – 3:00 pm

Report of Subpart A Subcommittee (SAS)
Dan Nelson, M.S., CIP, SAS Co-chair
Elizabeth A. Bankert, M.A., SAS Co-chair
David Borasky, M.P.H., CIP, SAS member

 

 

3:00 pm – 3:15 pm

BREAK

 

 

3:15 pm – 3:45 pm

Update on Federated IRB Model
Speakers TBA

 

 

3:45 pm – 4:45 pm

CTSA Consortium Report
Speakers TBA

 

 

4:45 pm – 5:00 pm

Public Comment

 

 

5:00 pm – 5:15 pm

Wrap-up Discussion and Adjourn

Meeting of the Secretary’s Advisory Committee on Human Research Protections (SACHRP)
Tuesday, October 19, 2010 – Wednesday, October 20, 2010
Hubert H. Humphrey Building, Room 800

DRAFT AGENDA

Wednesday, October 20, 2010

8:30 am – 8:45 am

Remarks

 

Barbara Bierer, M.D.
SACHRP Chair

 

 

8:45 am – 9:15 am

OHRP update:
Withdrawal of Subjects from Research
Request for Comment on FWA Revision
Mike Carome, M.D., OHRP

 

 

9:15 am – 11:15 am

The Use of Deception in Human Subjects Research
Frank Miller, Ph.D.
Faculty, NIH Clinical Center Department of Bioethics

Joan E. Sieber, Ph.D., Founder and Editor-in-Chief of Journal of Empirical Research on Human Research Ethics

 

 

11:15 am – 11:30 am

BREAK

 

 

11:30 am – 1:00 pm

Focus on Data “Identifiability”
Sara C. Hull, Ph.D.
Director, NHGRI Bioethics Core
Faculty, NIH Clinical Center Department of Bioethics
Bradley Malin, Ph.D.
David W. Craig, Ph.D., 
Associate Director & Investigator 
Neurogenomics Division 
The Translational Genomics Research Institute

Bradley Malin, Ph.D. Assistant Professor
Dept of Biomedical Informatics
School of Medicine
Vanderbilt University
Health Information Privacy Lab

Jane Kaye, D. Phil.
Director, HeLEX, Centre for Health, Law and Emerging Technologies
Department of Public Health, University of Oxford

1:00 pm- 2:00 pm

LUNCH

 

 

2:00 pm – 3:30 pm

Identifiability panel, continued

 

 

3:30 pm –3:45 pm

Public Comment

 

 

3:45 pm – 4:00 pm

Wrap-up Discussion and Adjourn