[Federal Register Volume 74, Number 196 (Tuesday, October 13, 2009)]
[Notices]
[Pages 52491-52492]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-24482]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Secretary's Advisory Committee on Human Research Protections
AGENCY: Office of Public Health and Science, Office of the Secretary,
Department of Health and Human Services.
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
twenty-first meeting. The meeting will be open to the public.
DATES: The meeting will be held on Tuesday, October 27, 2009 from 8:30
a.m. until 5 p.m. and Wednesday, October 28, 2009 from 8:30 a.m. until
5 p.m.
ADDRESSES: The Sheraton National Hotel, 900 South Orme Street,
Arlington, Virginia 22204. Phone: 703-521-1900.
FOR FUTHER INFORMATION CONTACT: Jerry Menikoff, M.D., J.D., Director,
Office for Human Research Protections (OHRP), or Julia Gorey, J.D.,
Executive Director, SACHRP; U.S. Department of Health and Human
Services, 1101 Wootton Parkway, Suite 200, Rockville, Maryland 20852;
240-453-8141; 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 October 27, 2009, the Committee will be briefed on harmonization
efforts undertaken by the National Institutes of Health and discuss
possible implications for future SACHRP committee work. Following this,
Dr. Marjorie Speers will present and discuss the Association for the
Accreditation of Human Research Protection Programs' recently revised
standards for accreditation. The day will conclude with a report from
the Subpart A Subcommittee focusing on issues surrounding consent for
future use of specimens or data; this 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.
On October 28, 2009, SACHRP will hear remarks from the Assistant
Secretary for Health, Dr. Howard Koh. This will be followed by a panel
presentation focusing on types of informed consent tools and mechanisms
[[Page 52492]]
that strive to augment the informed consent document and increase a
subject's understanding of research participation. The meeting will
conclude with a panel of speakers focusing on the regulatory barriers
that may be associated with Community Based and Participatory Research.
Public comment will be heard on both days.
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 Executive Director, SACHRP, prior to the close of
business Thursday, October 22, 2009. 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: October 6, 2009.
Jerry Menikoff,
Director, Office for Human Research Protections, Executive Secretary,
Secretary's Advisory Committee on Human Research Protections.
[FR Doc. E9-24482 Filed 10-9-09; 8:45 am]
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