[Federal Register Volume 66, Number 58 (Monday, March 26, 2001)]
[Notices]
[Pages 16475-16476]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-7443]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
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.
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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
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
[[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
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.
[FR Doc. 01-7443 Filed 3-23-01; 8:45 am]
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