05-6021. Meeting of the Secretary's Advisory Committee on Human Research Protections

AGENCY:

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

ACTION:

Notice.

SUMMARY:

Pursuant to Section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold its seventh meeting. The meeting will be open to the public.

DATES:

The meeting will be held on Monday, April 18, 2005, from 8:30 a.m. to 5 p.m. and on Tuesday, April 19, 2005 from 8:30 a.m. until 4:30 p.m.

ADDRESSES:

The Radisson Hotel Old Town Alexandria, 901 North Fairfax Street, Alexandria, Virginia 22314.

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; [phone]; fax: [phone]; e-mail address: [e-mail].

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 (HHS) and the Assistant Secretary for Health on issues and topics pertaining to or associated with the protection of human research subjects.

On April 18, 2005, SACHRP will receive and discuss preliminary reports from its two subcommittees, the Subpart A Subcommittee, which is evaluating the application of HHS regulations for the protection of human subjects at subpart A of 45 CFR part 46 in the current research environment, and the Subcommittee on Research involving Children, which is assessing the HHS regulations and policies for research involving children. The subcommittees were established by SACHRP at its October 4-5, 2004, meeting and at its inaugural meeting on July 22, 2003, respectively. In addition, the Committee will receive the final report from the Subpart C Subcommittee which addressed issues related to HHS regulations and policies for research involving prisoners.

On April 19, 2005, the Committee will receive presentations and participate in discussions on the following topics: investigator education; human research protection program accreditation standards for investigator education; the role of the institutional official in a human research protection program; and incentives and disincentives for IRB monitoring and audit programs.

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 material distributed to SACHRP members for this scheduled meeting should submit materials to the Executive Director, SACHRP, prior to the close of business on Wednesday, April 13, 2005. Information about SACHRP and the draft meeting agenda will be posted on the SACHRP Web site at http://www.hhs.gov/​ohrp/​sachrp.

Dated: March 22, 2005.

Bernard A. Schwetz,

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