E9-3015. Meeting of the Secretary's Advisory Committee on Human Research Protections

AGENCY:

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

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

DATES:

The meeting will be held on Tuesday, March 3, 2009 from 8:30 a.m. until 5 p.m. and Wednesday, March 4, 2009 from 8:30 a.m. until 5 p.m.

ADDRESSES:

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

FOR FURTHER INFORMATION CONTACT:

Jerry Menikoff, J.D., M.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: [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 3, 2009, SACHRP will receive and discuss a report from an internal task force charged with prioritizing SACHRP's existing recommendations to OHRP. The Committee will then hear a presentation of the recent National Academy of Sciences report entitled “Health Research and the Privacy of Health Information—The HIPAA Privacy Rule,” followed by a presentation of the Association of Academic Health Centers' recent survey on the impact of the HIPAA Privacy Rule on research. Lastly, SACHRP will hear a report from the Subpart A Subcommittee, which 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, 2004 meeting.

On March 4, 2009, the Committee will receive and discuss a report from the Subcommittee on Inclusion of Individuals with Impaired Decision-Making in Research. That subcommittee is charged with developing recommendations for consideration by SACHRP about whether guidance or additional regulations are needed for research involving individuals with impaired decision-making capacity. It was formed as a result of discussions during the July 31-August 1, 2006 SACHRP meeting. The day will conclude with a panel discussion addressing harmonization issues associated with the Common Rule and the FDA regulations.

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, February 27, 2009. 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 6, 2009.

Jerry Menikoff,

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