01-7443. Meeting of the National Human Research Protections Advisory Committee

AGENCY:

Office of Public Health and Science, Office for Human Research Protections, DHHS.

ACTION:

Notice of second meeting.

SUMMARY:

Pursuant to section 10(d) of the Federal Advisory committee Act, as amended (5 U.S.C. appendix 2), notice is hereby given of a meeting of the National Human Research Protections Advisory Committee.

The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the contact person listed below. Individuals planning on attending the meeting and who want to ask questions must submit their requests in writing in advance of the meeting to the contact person listed below.

DATES:

The Committee will hold its next meeting on April 9-10, 2001. The meeting will convene from 8:30 a.m. to its recess at 5:30 p.m. on April 9 and resume at 8:30 a.m. to 5 p.m. EST on April 10.

ADDRESSES:

Bethesda Marriott—Pooks Hill Road, Bethesda, Maryland 20814, [phone].

FOR FURTHER INFORMATION CONTACT:

Ms. Kate-Louise Gottfried, Executive Director, National Human Research Protections Advisory Committee, Office for Human Research Protections, 6100 Executive Boulevard, Room 310B (MSC 7507), Rockville, Maryland 20892-7507, [phone]. The electronic mail address is: [e-mail].

SUPPLEMENTARY INFORMATION:

The National Human Research Protections Advisory Committee was established on June 6, 2000 to provide expert advice and recommendations to the Secretary of HHS, Assistant Secretary for Health, the Director, Office for Human Research Protections, and other departmental officials on a broad range of issues and topic pertaining to or associated with the protection of human research subjects.

The draft meeting agenda for the second meeting of this committee is below. Updates to this agenda will be posted on the NHRPAC website at: http://ohrp.osophs.dhhs.gov/​nhrpac/​nhrpac.htm.

Draft Agenda

Monday April 9, 2001

8:30 a.m.-9:15 a.m. Welcome: (45 minutes)

Introduction of New Members (brief comments about yourself; areas of particular concern) (5 minutes each)

Mary Faith Marshall, Ph.D., Chairperson NHRPAC

Office for Human Research Protection Updates (10 minutes)

Greg Koski, Ph.D., M.D., Director of OHRP, Executive Secretary, NHRPAC, Chairman, HSRS

Clarification of NHRPAC Roles (10 minutes)

Mary Faith Marshall, Ph.D.

9:15 a.m.-9:30 a.m. The Department's Commitment to Protection of Human Subjects (15 minutes)

The Honorable David Satcher, M.D., Ph.D., Surgeon General (Invited)

9:30 a.m.-11 a.m. Update: Financial Relationships (1 hour, 30 minutes)

Mark Barnes, J.D., Chair, Working Group

Stuart L. Nightingale, M.D., Senior Medical Advisor to the Assistant Secretary for Planning & Evaluation

10:30 a.m.-10:45 a.m. Break (15 minutes)

11 a.m.-11:45 a.m. Update: Declaration of Helsinki (45 minutes)

Greg Koski, Ph.D., M.D.

Stuart L. Nightingale, M.D.

11:45 a.m.-12:15 p.m. Public Comment (30 minutes)

12:15 p.m.-1:30 p.m. Lunch—On your own

1:30 p.m.-4:30 p.m. Genetics

1:30 p.m.-2:15 p.m. Genetic Research: An overview (45 minutes)

Francis Collins, M.D., Ph.D., director, National Human Genome Research Institute

2:15 p.m.-4:30 p.m. Panel Discussion

Moderator, Francis Collins, M.D., Ph.D.

Family Members:

Should Family Members of Survey Subjects, Themselves become Subjects of a Protocol—if so, Must Informed Consent be Obtained for Investigator to Retain Private Information on these Individuals?

2:15 p.m.-3:15 p.m. Guest Panel: (1 hour)

Jeff Botkin, M.D., M.P.H., Department of Pediatrics, The University of Utah Medical Center (15 minutes)

Terry Arledge, Ph.D., GalaxoSmithKline (15 minutes)

Sharon Terry, Genetic Alliance (15 minutes)

Terry Seargent (15 minutes)

3:15 p.m.-3:30 p.m. Break (15 minutes)

3:30 p.m.-4:30 p.m. Discussion (45 minutes)

4:30 p.m.-5:15 p.m. Public Comment (1 hour)

5:15 p.m.-5:30 p.m. Closing Comments/Adjourn (15 minutes)

Tuesday, April 10, 2001

8:30 a.m.-8:45 a.m. Brief Recap of Day One (15 minutes)

Questions/Clarifications

Mary Faith Marshall, Ph.D.

8:45 a.m.-9:00 a.m. The National Institutes of Health and Human Subject Protections (15 minutes)

Ruth Kirschstein, M.D., Acting Director, National Institutes of Health

9:00 a.m.-12:00 p.m. Children (3 hours)

9:00 a.m.-9:45 a.m. Discussion of Current Definitions and their Interpretation (45 minutes)

NHRPAC Committee

9:45 a.m.-10:15 a.m. Children's Workgroup (30 minutes)

Alan Fleischman, M.D., Senior Vice President, NY Academy of Medicine, Clinical Professor of Pediatrics and Clinical Professor of Epidemiology & Social Medicine, Albert Einstein College, New York

10:15 a.m.-10:30 a.m. Break (15 minutes)

10:30 a.m.-11:45 a.m. Committee Discussion (1 hour, 15 minutes)

11:45 a.m.-12:00 p.m. The National Science Foundation and Human Subject Protections (15 minutes)

Rita Colwell, Ph.D., Director, National Science Foundation

12:00 p.m.-1:30 p.m. Lunch—on your own (1 hour, 30 minutes)

1:30 p.m.-3:00 p.m. Update: Social Science (1 hour, 30 minutes)

Felice Levine, Ph.D., Executive Officer, American Sociological Association (30 minutes)

Jeff Cohen, Ph.D., Director, Education, OHRP

Discussion (1 hour)

3:00 p.m.-3:15 p.m. Break (15 minutes)

3:15 p.m.-4:15 p.m. Public Comment (1 hour)

4:15 p.m.-5:00 p.m. Meeting Recap (45 minutes)

Review Recommendations:

Financial Relationships

Declaration of Helsinki

Genetics

Secondary Subjects

Children

Social Science

Mary Faith Marshall, Ph.D.

5:00 p.m. Thank You—Adjourn

Dated: March 20, 2001.

Greg Koski,

Director, Office for Human Research Protections.