[Federal Register Volume 66, Number 131 (Monday, July 9, 2001)]
[Page 35796]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-17070]

[[Page 35796]]



Office of the Secretary

Meeting of the National Human Research Protections Advisory 

AGENCY: Office of Public Health and Science, Office for Human Research 

ACTION: Notice of July 30-31, 2001 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 July 30-31, 2001. 
The meeting will convene from 8:30 a.m. to its recess at approximately 
5:30 p.m. on July 30 and resume at 8:30 a.m. to 5:00 p.m. EST on July 

ADDRESSES: DoubleTree Hotel, 1750 Rockville Pike, Rockville, MD, 

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 topics 
pertaining to or associated with the protection of human research 
    The draft agenda for the Committee's July meeting 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 July 30, 2001

8:30-8:45am  HHS&Human Subject Protection, Arthur Lawrence, Ph.D., 
Acting Principal Deputy Assistant, Secretary for Health  [15 minutes]
8:45am-9:15am  The Perilous Intersection of Protection, Human Research 
Subjects and Conflicts, of Interest, Michael Wood, M.D., President and 
CEO The Mayo Foundation  [30 minutes]
9:15am-9:30  Welcome: Overview of Meeting Mary Faith marshall, Ph.D. 
Chairperson NHRPAC  [15 minutes]
9:30am-10:00am  Final Review & Approval of NHRPAC Response to Financial 
Relationships Interim Guidance Mark Barnes, J.D. Chair, Working Group  
[30 minutes]
10:00am-12:30pm  Update: Children's Workgroup Alan Fleischman, M.D. 
Chair, Working Group  [2 hours, 30 minutes]
[10:30am-10:45am]  BREAK  [15 minutes]
12:30-1:30pm  LUNCH--On your own
1:30pm-3:30pm  The Office for Human Research Protectiosn (OHRP)  [2 
    Introduction Greg Koski, Ph.D., M.D. Director, OHRP  [10 minutes]
    Education Jeffrey Cohen, Ph.D. Director, Division of Education  [15 
    Assuance George Gasparis, Acting Director, Division of Assurances 
and Quality Improvement  [15 minutes]
    Compliance Kristina Borror, Ph.D. Division of Compliance  [15 
    International Melody Lin, Ph.D., Deputy Director and Director, 
Office for International Activities  [10 minutes]
    Policy, Irene Stith-Coleman, Ph.D., Director, Office of Policy, 
Planning, and Special Projects  [10 minutes]
3:30pm-3:45  BREAK  [15 minutes]
3:45-5:30  Update and Discussion: Third Parties: Research Subjects? 
Mary Kay Pelias, J.D., Ph.D. Chair, Working Group  [1 hour, 45 minutes]
5:30pm-5:pm  Closing Comments/ADJOURN  [15 minutes]

Tuesday, July 31, 2001

8:30 am-8:45 am  The Honorable Diane DeGette, Congresswoman, Colorado  
[15 minutes]
8:45 am-9:15 am  Human Subject Protections, General Accounting Office 
(GAO), Marcia G. Crosse, Ph.D., Assistant Director, Health Care--Public 
Health Issues  [30 minutes]
9:15 am-9:45 am  National Bioethics Advisory Committee (NBAC), Marjorie 
Speers, Ph.D., Acting Executive Director, NBAC  [30 minutes]
9:45 am-10:45 am  HIPAA and the Privacy Regulation: The Implications 
for Research, Julie Kaneshiro, M.P.P., Policy Analyst, OSP, National 
Institutes of Health  [1 hour]
10:45 am-11:00 am  BREAK  [15 minutes]
11:00 am-12:30 pm  Informed Consent & Decisional Capacity Overview, 
Mary Faith Marshall, Jeremy Sugarman, MD, MPH, MA, Director, Center for 
the Study of Medical Ethics and Humanities, Professor of Medicine and 
Philosophy, Duke University Medical Center, Don Rosenstein, M.D., Chief 
Psychiatry Consultation-Liaison Service, National Institute of Mental 
Health, Adil Shamoo, Ph.D., Department of Biochemistry and Molecular 
Biology, University of Maryland School of Medicine, Jim McNulty, 
President, Depressive/Manic Depressive Association of Rhode Island  [1 
hour, 30 minutes]
12:30 pm-1:30 pm  LUNCH--on your own  [1 hour]
1:30 pm-2:30 pm  Informed Consent (Continued)  [1 hour]
2:30 pm-4:30 pm  Update: Social Science, Felice Levine, Ph.D., 
Executive Officer, American Sociological Association; Jeffrey Cohen, 
Ph.D., Director, Education, OHRP  [2 hours]
[3:00 pm-3:15 pm]  BREAK
4:30 pm-5:00 pm  Recap of Meeting & Action Items, Mary Faith Marshall, 
Ph.D., Chairperson, NHRPAC
5:00 pm  ADJOURN

Kate-Louise Gottfried,
Executive Director, National Human Research Protections Advisory 
[FR Doc. 01-17070 Filed 7-6-01; 8:45 am]