E7-3882. Secretary's Advisory Committee on Human Research Protections

AGENCY:

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

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

DATES:

The meeting will be held on Thursday, March 29, 2007 from 8:30 a.m. until 5:15 p.m. and Friday, March 30, 2007 from 8:30 a.m. until 4 p.m.

ADDRESSES:

The Sheraton National Hotel, 900 South Orme Street, Arlington, VA 22204. Phone: [phone].

FOR FURTHER INFORMATION CONTACT:

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

On March 29, 2007, SACHRP will receive and discuss updated information and a report from the Subpart A Subcommittee and 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, 2004 meeting. The Committee will receive a report and task list from the newly formed Subcommittee on Issues Impacting those with Impaired Decision-Making Capacity. This subcommittee was formed as a result of discussions during the July 31-August 1, 2006 SACHRP meeting. In addition, the Committee will hear presentations from panelists who will examine issues related to the inclusion of subjects who are unable or have limited ability to provide informed consent to participate in research.

On March 30, 2007, the Committee will receive presentations and hear discussions from representatives of a panel that will examine conflict of interest issues and institutional policies that address conflict of interest as it pertains to IRB review. The Committee will also hear presentations from panelists on topics pertaining to investigator responsibilities and certification, and whether new or expanded guidance should be considered to address new issues that have emerged in this area.

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, March 23, 2007. 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.

Dated: February 28, 2007.

Bernard A. Schwetz,

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