[Federal Register Volume 75, Number 125 (Wednesday, June 30, 2010)]
[Notices]
[Pages 37813-37814]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-15807]
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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
twenty-third meeting. The meeting will be open to the public.
Information about SACHRP and the meeting agenda will be posted on the
SACHRP Web site at: http://www.hhs.gov/ohrp/sachrp/index.html.
DATES: The meeting will be held on Tuesday, July 20, 2010 from 8:30
a.m. until 5:15 p.m. and Wednesday, July 21, 2010 from 8:30 a.m. until
5:15 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 July 20, 2010, the SACHRP Subpart A Subcommittee (SAS) will
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make a report focusing on informed consent and future use of specimens
or data. SAS 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 2006 meeting. Following the SAS
report and lunch, there will be a panel of speakers discussing the
emergence of ethics consultations services, and whether such ethical
discussions should occur more appropriately within the domain of the
IRB. July 20 will conclude with time devoted to a discussion of future
directions for SAS.
On July 21, 2010, the morning will begin with a panel discussing
regulatory challenges that are posed by the increasing use of the
internet and electronic media in human subjects research. After lunch,
a panel will focus on the genetic research involving members of the
Havasupai Indian tribe, which was the focus of a recently settled
lawsuit brought by the Havasupai Indian tribe against the Arizona State
University, and the implications this research and the related legal
settlement present for informed consent and biospecimen research. The
day will conclude with a report from the Subcommittee on Harmonization
(SOH). The SOH was established by SACHRP at its July 2009 meeting, and
is charged with identifying and prioritizing areas in which regulations
and/or guidelines for human subjects research adopted by various
agencies or offices within HHS would benefit from harmonization,
consistency, clarity, simplification and/or coordination. 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 Friday, July 16, 2010.
Dated: June 23, 2010.
Jerry Menikoff,
Director, Office for Human Research Protections, Executive Secretary,
Secretary's Advisory Committee on Human Research Protections.
[FR Doc. 2010-15807 Filed 6-29-10; 8:45 am]
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