[Federal Register Volume 73, Number 121 (Monday, June 23, 2008)]
[Notices]
[Page 35391]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-14035]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Meeting of the Secretary's Advisory Committee on Human Research 
Protections

AGENCY: Department of Health and Human Services, Office of the 
Secretary, Office of Public Health and Science.

ACTION: Notice.

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SUMMARY: Pursuant to Section 10(a) of the Federal Advisory Committee 
Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's 
Advisory Committee on Human Research Protections (SACHRP) will hold its 
sixteenth meeting. The meeting will be open to the public.

DATES: The meeting will be held on Tuesday, July 15, 2008, from 8:30 
a.m. until 4:30 p.m. and Wednesday, July 16, 2008, from 8:30 a.m. until 
4:30 p.m.

ADDRESSES: The Sheraton National Hotel, 900 South Orme Street, 
Arlington, Virginia 22204. Phone: 703-521-1900.

FOR FURTHER INFORMATION CONTACT: Ivor Pritchard, PhD, Acting Director, 
Office for Human Research Protections, or Julia Gorey, J.D., Acting 
Executive Director, SACHRP; U.S. Department of Health and Human 
Services, 1101 Wootton Parkway, Suite 200, Rockville, Maryland 20852; 
240-453-6900; fax: 240-453-6909; E-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION: Under the authority of 42 U.S.C. 217a, 
Section 222 of the Public Health Service Act, as amended, SACHRP was 
established to provide expert advice and recommendations to the 
Secretary of Health and Human Services and the Assistant Secretary for 
Health on issues and topics pertaining to or associated with the 
protection of human research subjects.
    On July 15, 2008, SACHRP will receive and discuss a report from the 
Subcommittee on Inclusion of Individuals with Impaired Decision-Making 
in Research. The Subcommittee on Inclusion of Individuals with Impaired 
Decision-Making in Research is charged with developing recommendations 
for consideration by SACHRP about whether guidance and/or additional 
regulations are needed for research involving individuals with impaired 
decision-making capacity. This subcommittee was formed as a result of 
discussions during the July 31-August 1, 2006 SACHRP meeting. In 
addition, an invited panel will discuss ethical issues associated with 
tissue repositories and biological specimens, including questions 
surrounding community consent, appropriateness and validity of consent 
for unspecified uses, and appropriate waiver of consent.
    On July 16, 2008, the Committee will receive and discuss a report 
from the Subpart A Subcommittee. The Subpart A Subcommittee is charged 
with developing recommendations for consideration by SACHRP about the 
application of Subpart A of 45 CFR part 46 in the current research 
environment. This subcommittee was established by SACHRP at its October 
4-5, 2006 meeting. In addition, SACHRP members will make brief 
presentations on the problems and issues they see with the present 
Human Subjects Protection System, followed by a period of discussion.
    Public attendance at the meeting is limited to space available. 
Individuals who plan to attend the meeting and need special assistance, 
such as sign language interpretation or other reasonable 
accommodations, should notify the designated contact persons. Members 
of the public will have the opportunity to provide comments on both 
days of the meeting. Public comment will be limited to five minutes per 
speaker. Any members of the public who wish to have printed materials 
distributed to SACHRP members for this scheduled meeting should submit 
materials to the Acting Executive Director, SACHRP, prior to the close 
of business Monday, June 30, 2008. Information about SACHRP and the 
draft meeting agenda will be posted on the SACHRP Web site at: http://www.hhs.gov/ohrp/sachrp/index.html.

    Dated: June 16, 2008.
Ivor A. Pritchard,
Acting Director, Office for Human Research ProtectionsActing Executive 
Secretary, Secretary's Advisory Committee on Human Research 
Protections.
 [FR Doc. E8-14035 Filed 6-20-08; 8:45 am]
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