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October 27-28, 2008 Meeting Agenda

Meeting of the Secretary’s Advisory Committee on Human Research Protections (SACHRP)
Monday, October 27, 2008 — Tuesday, October 28, 2008
The Sheraton National Hotel
900 South Orme Street, Arlington, Virginia

Monday October 27, 2008

 

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
Ivor Pritchard, Ph.D.,
Acting Director, OHRP

8:45 am - 9:00 am

Remarks of Principal Deputy Assistant Secretary for Health and Swearing in of New Members

9:00 am - 10:30 am

SACHRP Recommendations and Federal Process

  • Status of SACHRP recommendations to date
    Mike Carome, OHRP
  • Federal rulemaking process
    Chris Mahler, OGC

10:30 am - 10:45 am

BREAK

10:45 am - 12:15 pm

SACHRP Recommendations and OHRP Process

  • Guidance and policy-making process
    Irene Stith-Coleman, OHRP
  • OHRP staffing, budget, and activities
    Ivor Pritchard, OHRP

12:15 pm - 1:45 pm

LUNCH (includes ethics training for SACHRP members)

1:45 pm - 3:30 pm

Report of Subpart A Subcommittee (SAS)

3:30 pm - 3:45 pm

BREAK

3:45 pm - 4:30 pm

Report of Subpart A Subcommittee (SAS)

4:30 pm - 4:45 pm

Public Comment Period

4:45 pm - 5:00 pm

Wrap-up discussion and Adjourn


Tuesday, October 28, 2008

 

8:30 am - 8:45 am

Remarks
Barbara Bierer, M.D.
SACHRP Chair

8:45 am - 10:00 am

Report of Subcommittee for the Inclusion of Individuals with Impaired Decision-making in Research (SIIIDR)

10:00 am - 10:15 am

BREAK

10:15 am - 12:00 am

Report of SIIIDR

12:00 pm - 1:00 pm

LUNCH

1:00 pm - 2:30 pm

Community Perspectives on SIIIDR Recommendations:

  • Bill Thies
    Alzheimer’s Association
  • Ron Honberg
    National Alliance on Mental Illness
  • Sue Swenson
    Developmental disabilities representative, Parent of disabled child
  • Eileen Zacharias
    Acute Respiratory Distress Syndrome Foundation
  • Jere Boyer
    Human subjects research professional, Parent of disabled child

2:30 pm - 2:45 pm

BREAK

2:45 pm - 4:00 pm

Further discussion

4:00 pm - 4:15 pm

Public Comment Period

4:15 pm - 4:30 pm

Wrap-up discussion and adjourn