October 27-28, 2008 Meeting Agenda

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