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Meeting of the Secretary's Advisory Committee on Human Research Protections

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Department of Health and Human Services, Office of the Secretary, Office of Public Health and Science.




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 thirteenth meeting. The meeting will be open to the public.


The meeting will be held on Monday July 30, 2007, from 8:30 a.m. until 5 p.m. and Tuesday, July 31, 2007, from 8:30 a.m. until 4:45 p.m.


The Sheraton National Hotel, 900 South Orme Street, Arlington, VA 22204. Phone: 703-521-1900.

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Bernard Schwetz, D.V.M., PhD, Director, Office for Human Research Protections (OHRP), or Catherine Slatinshek, Executive Director, Secretary's Advisory Committee on Human Research Protections; Department of Health and Human Services, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852; 240-453-8139; fax: 240-453-6909; e-mail address:

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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 30, 2007, SACHRP will receive and discuss updated information and a report from the Subpart A Subcommittee on issues involving 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. The Committee also will receive a report and action list from the Subcommittee on Inclusion of Individuals with Impaired Decision-Making in Research. This subcommittee was formed as a result of discussions during the July 31-August 1, 2006, SACHRP meeting. In addition, the Committee will receive a briefing on the Final Report of the National Conference on Institutional Review Boards, held in Washington, DC in November 2006.

On July 31, 2007, the Committee will receive presentations and hear discussions from representatives on a panel that will examine issues involving informed consent, including length and complexity of informed consent documents, views from subjects on these issues, and insights from the human subjects research community. The Committee will also hear presentations from panelists on diversity of ethnic and racial representation in clinical trials.

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 20, 2007. Information about SACHRP and the draft meeting agenda will be posted on the SACHRP Web site at:​ohrp/​sachrp/​index.html.

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Dated: June 20, 2007.

Bernard A. Schwetz,

Director, Office for Human Research Protections, Executive Secretary, Secretary's Advisory Committee on Human Research Protections.

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[FR Doc. E7-12229 Filed 6-22-07; 8:45 am]