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March 3-4, 2009 Meeting Agenda

The Department of Health and Human Services
Meeting of the Secretary’s Advisory Committee on Human Research Protections (SACHRP)
Tuesday, March 3, 2008 — Wednesday, March 4, 2008
The Sheraton National Hotel
900 South Orme Street, Arlington, Virginia

AGENDA

Tuesday, March 3, 2009

 

8:30 am — 8:35 am

Welcome: Opening remarks
Barbara Bierer, M.D.
SACHRP Chair

8:35 am — 8:45 am

Report of Issues/Remarks
Jerry Menikoff, M.D., J.D.,
Director, OHRP

8:45 am — 9:00 am

Remarks of Assistant Secretary for Health
Steven K. Galson, M.D., M.P.H.
RADM, USPHS

9:00 am — 10:15 am

NAS Report: "Health Research and the Privacy of Health Information - The HIPAA Privacy Rule"
Wendy Visscher, Ph.D, RTI International
Sheryl Nass, Ph.D., IOM Study Director

AAHC Report: “HIPAA Creating Barriers to Research and Discovery”
Gary T. Chiodo, DMD, FACD
Chief Integrity Officer
Oregon Health & Science University

Office of Civil Rights
Christina Heide, J.D.

10:15 am — 10:30 am

BREAK

10:30 am — 11:30 am

HIPAA Panel Discussion

11:30 am — 11:45 am

Public Comment

11:45 pm — 1:00 pm

LUNCH

1:00 pm — 2:00 pm

SACHRP HIPAA Recommendations: Review and Discussion
Mark Barnes, J.D., Huron Consulting Group

2:00 pm — 3:00 pm

Report of Subpart A Subcommittee (SAS)
Dan Nelson, M.S., CIP
Elizabeth A. Bankert, M.A.
SAS Co-chairs

3:00 pm — 3:15 pm

BREAK

3:15 pm — 4:30 pm

Report/Discussion of SAS:
Consent for Future Unspecified Tissue Use

4:30 pm — 4:45 pm

Public Comment Period

4:45 pm — 5:00 pm

Wrap-up discussion and Adjourn


Wednesday, March 4, 2009

 

8:30 am — 8:45 am

Remarks
Barbara Bierer, M.D.
SACHRP Chair

8:45 am — 9:45 am

SACHRP Task Force Report:
Prioritization of SACHRP recommendations to date

9:45 am — 11:00 am

Report of Subcommittee for the Inclusion of Individuals with Impaired Decision-making in Research (SIIIDR)
David Strauss, M.D.
Laurie Flynn
SIIIDR Co-chairs

11:00 am — 11:15 am

BREAK

11:15 am — 1:00 pm

Report/Discussion of SIIIDR

1:00 pm — 2:00 pm

LUNCH

2:00 pm — 2:15 pm

Public Comment

2:15 pm — 3:15 pm

The Intersection of FDA and Common Rule: Review of Minor Changes and Selected Issues
David Forster, J.D., WIRB (SACHRP)
Jeff Cooper, M.D., Huron Consulting Group
Gary Chadwick, PharmD, MPH, CIP, University of Rochester (SAS)

3:15 pm — 3:30 pm

Public Comment: Panel Presentation

3:30 pm — 4:45 pm

FDA and Common Rule Discussion

4:45 pm — 5:00 pm

Wrap-up Discussion and Adjourn