E8-4793. Secretary's Advisory Committee on Human Research Protections

AGENCY:

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

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

DATES:

The meeting will be held on Thursday, March 27, 2008 from 8:30 a.m. until 4:30 p.m. and Friday, March 28, 2008 from 8:30 a.m. until 4:30 p.m.

ADDRESSES:

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

FOR FUTHER INFORMATION CONTACT:

Ivor Pritchard, Ph.D., Acting Director, Office for Human Research Protections (OHRP), or Kevin Prohaska, D.O., M.P.H., Acting Executive Director, SACHRP; U.S. Department of Health and Human Services, 1101 Wootton Parkway, Suite 200, Rockville, Maryland 20852; 240-453-8231; 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 27, 2008 SACHRP will receive and discuss a report from the Subcommittee on Inclusion of Individuals with Impaired Decision-Making in Research. The Subcommittee on Inclusion of Individuals with Impaired Decision-Making in Research is charged with developing recommendations for consideration by SACHRP about whether guidance and/or additional regulations are needed for research involving individuals 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, an invited panel will discuss common designs associated with quality improvement, quality assurance, and health services activities, as well as ethical considerations that may be relevant to such activities.

On March 28, 2008 the Committee will receive and discuss reports from an ad hoc subcommittee and from the Subpart A Subcommittee. The ad hoc subcommittee was established after the October 29-30, 2007 meeting of SACHRP to consider recommendations relative to encouraging diversity in clinical trials and conducting research in the disaster setting. The Subpart A 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.

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 Acting Executive Director, SACHRP, prior to the close of business Monday, March 17, 2008. 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: March 5, 2008.

Ivor A. Pritchard,

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