2010-15807. 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 twenty-third 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.hhs.gov/​ohrp/​sachrp/​index.html.

DATES:

The meeting will be held on Tuesday, July 20, 2010 from 8:30 a.m. until 5:15 p.m. and Wednesday, July 21, 2010 from 8:30 a.m. until 5:15 p.m.

ADDRESSES:

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

FOR FUTHER 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: [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 July 20, 2010, the SACHRP Subpart A Subcommittee (SAS) will make a report focusing on informed consent and future use of specimens or data. SAS 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 2006 meeting. Following the SAS report and lunch, there will be a panel of speakers discussing the emergence of ethics consultations services, and whether such ethical discussions should occur more appropriately within the domain of the IRB. July 20 will conclude with time devoted to a discussion of future directions for SAS.

On July 21, 2010, the morning will begin with a panel discussing regulatory challenges that are posed by the increasing use of the internet and electronic media in human subjects research. After lunch, a panel will focus on the genetic research involving members of the Havasupai Indian tribe, which was the focus of a recently settled lawsuit brought by the Havasupai Indian tribe against the Arizona State University, and the implications this research and the related legal settlement present for informed consent and biospecimen research. The day will conclude 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. 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 Friday, July 16, 2010.

Dated: June 23, 2010.

Jerry Menikoff,

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