Meeting of the Secretary's Advisory Committee on Human Research Protections

AGENCY:

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

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 twenty-fifth meeting. The meeting will be open to the public. Information about SACHRP and the meeting agenda will be posted on the SACHRP Web site at: http://www.dhhs.gov/ohrp/sachrp/mtgings/index.html.

DATES:

The meeting will be held on Tuesday, July 19, 2011 from 8:30 a.m. until 5 p.m. and Wednesday, July 20, 2011 from 8:30 a.m. until 5 p.m.

ADDRESSES:

U.S. Department of Health and Human Services, 200 Independence Avenue, SW., Hubert H. Humphrey Building, Room 800, Washington, DC 20201.

FOR FURTHER INFORMATION CONTACT:

Jerry Menikoff, M.D., J.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: 240-453-6909; e-mail address: Julia.Gorey@hhs.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 19, 2011, SACHRP will hear a presentation by the Executive Director of the Presidential Commission for the Study of Bioethical Issues focusing on the work of the Commission; this will be followed by SACHRP discussion. After lunch, SACHRP will hear the report of the Subpart A Subcommittee (SAS). SAS is charged with developing recommendations for consideration by SACHRP regarding the application of subpart A of 45 CFR part 46 in the current research environment; this Subcommittee was established by SACHRP in October 2006. Recommendations to be discussed focus on the return of research results to subject, internet-based research, and improvements to the informed consent process.

On July 20, 2011, the morning will open with a report from the Subcommittee on Harmonization (SOH). The SOH was established by SACHRP at its July 2009 meeting, and is charged with identifying and prioritizing areas in which regulations and/or guidelines for human subjects research adopted by various agencies or offices within HHS would benefit from harmonization, consistency, clarity, simplification and/or coordination. In the afternoon, SACHRP will hear a panel of speakers discussing consequences and processes surrounding scientific misconduct and fraud.

Public Comment will be heard on both days.

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 July 15, 2011.