Secretary's Advisory Committee on Human Research Protections

AGENCY:

Office of Public Health and Science, Office of the Secretary, DHHS.

ACTION:

Notice.

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

DATES:

The meeting will be held on Monday, July 31, 2006 from 8 a.m. until 5 p.m. and Tuesday, August 1, 2006 from 8 a.m. until 1:15 p.m.

ADDRESSES:

The North Bethesda Marriott Hotel and Conference Center, 5701 Marinelli Road, North Bethesda, Maryland 20852.

FOR FURTHER INFORMATION CONTACT:

Bernard Schwetz, D.V.M., Ph.D., 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) 453-6900; fax: (240) 453-6909; e-mail address: sachrp@osophs.dhhs.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 31, 2006, SACHRP will receive and discuss preliminary reports from the Subpart A Subcommittee and issues involving the application of subpart A of 45 CFR part 46 in the current research environment. In addition, the Subcommittee on Research Involving Children will present findings and final recommendations to the members of the Committee. These subcommittees were established by SACHRP at its October 4-5, 2004 meeting and at its inaugural meeting on July 22, 2003, respectively.

On Tuesday, August 1, 2006, the Committee will receive an update on the activities of the Federal Adverse Events Task Force. The Institute of Medicine will present a summary of their report on the Ethical Considerations for Research Involving Prisoners, and the Committee will hear presentations and invite discussion from representatives of a panel on issues related to research involving adult subjects with impaired decision making capacity.

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 Wednesday, July 26, 2006. 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.