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Secretary's Advisory Committee on Human Research Protections

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




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.


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.


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

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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:

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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 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 Start Printed Page 52492that 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:​ohrp/​sachrp/​index.html.

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Dated: October 6, 2009.

Jerry Menikoff,

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

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[FR Doc. E9-24482 Filed 10-9-09; 8:45 am]