[Federal Register Volume 73, Number 48 (Tuesday, March 11, 2008)]
[Notices]
[Pages 13004-13005]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-4793]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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
fifteenth meeting. The meeting will be open to the public.
DATES: The meeting will be held on Thursday, March 27, 2008 from 8:30
a.m. until 4:30 p.m. and Friday, March 28, 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 FUTHER INFORMATION CONTACT: Ivor Pritchard, Ph.D., Acting Director,
Office for Human Research Protections (OHRP), or Kevin Prohaska, D.O.,
M.P.H., Acting Executive Director, SACHRP; U.S. Department of Health
and Human Services, 1101 Wootton Parkway, Suite 200, Rockville,
Maryland 20852; 240-453-8231; 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 March 27, 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 common designs associated with
quality improvement, quality assurance, and
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health services activities, as well as ethical considerations that may
be relevant to such activities.
On March 28, 2008 the Committee will receive and discuss reports
from an ad hoc subcommittee and from the Subpart A Subcommittee. The ad
hoc subcommittee was established after the October 29-30, 2007 meeting
of SACHRP to consider recommendations relative to encouraging diversity
in clinical trials and conducting research in the disaster setting. 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.
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, March 17, 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: March 5, 2008.
Ivor A. Pritchard,
Acting Director, Office for Human Research Protections, Acting
Executive Secretary, Secretary's Advisory Committee on Human Research
Protections.
[FR Doc. E8-4793 Filed 3-10-08; 8:45 am]
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