[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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]
BILLING CODE 4150-36-P