[Federal Register Volume 66, Number 58 (Monday, March 26, 2001)]
[Pages 16475-16476]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-7443]



Office of the Secretary

Meeting of the National Human Research Protections Advisory 

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, (301) 897-9400.

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, (301) 496-7005. The 
electronic mail address is: [email protected].

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 
    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)
    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 

[[Page 16476]]

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
    Secondary Subjects
    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.
[FR Doc. 01-7443 Filed 3-23-01; 8:45 am]