[Federal Register Volume 75, Number 125 (Wednesday, June 30, 2010)]
[Notices]
[Pages 37813-37814]
From the Federal Register Online via the Government Printing 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: Julia.Gorey@hhs.gov.

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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