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Office for Human Research Protections (OHRP)

The Department of Health and Human Services
Meeting of the
Secretary's Advisory Committee on Human Research Protections (SACHRP)
Tuesday, March 9, 2010 — Wednesday, March 10, 2010
Hubert H. Humphrey Building, Room 800

AGENDA

Tuesday, March 9, 2010

 

8:30 am — 8:50 am

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

8:50 am — 9:00 am

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

9:00 am — 9:45 am

Summary of Public Comment:
OHRP Draft Guidance on IRB Continuing Review of Research, and IRB Approval of Research with Conditions

Michael Carome, M.D., OHRP

9:45 am — 10:00 am

BREAK

10:00 am — 12:15 pm

Focus on Harmonization: ICH and CTTI
Robert Temple, M.D.
Deputy Center Director for Clinical Science
CDER, FDA

Rob Califf, M.D.
Director, Duke Translational Medicine Institute

Francis Crawley, Ph.D.
Executive Director
Good Clinical Practice Alliance — Europe (GCPA)

12:15 — 1:30 pm

LUNCH

1:30 pm — 3:15 pm

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

3:15 pm — 3:30 pm

BREAK

3:30 pm — 4:45 pm

Subpart A Subcommittee Report, cont’d

4:45 pm — 5:00 pm

Public Comment

5:00 pm — 5:15 pm

Wrap-up Discussion and Adjourn


Wednesday, March 10, 2010

 

8:30 am — 8:45 am

Remarks
Barbara Bierer, M.D.
SACHRP Chair

8:45 am — 10:30 am

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

10:30 am — 10:45 am

BREAK

10:45 am — 12:15 pm

Report of Subpart A Subcommittee (SAS), cont'd Informed Consent Working Group discussion

12:15 pm — 1:15 pm

LUNCH

1:15 pm — 2:00 pm

Future SAS Directions,/p>

2:15 pm — 4:00 pm

Introduction of Subcommittee on Harmonization
David Forster, J.D.
Mark Barnes, J.D.

4:00 pm — 4:15 pm

Public Comment

4:15 pm — 4:30 pm

Wrap-up Discussion and Adjourn