2010-3271. Meeting of the 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-second meeting. The meeting will be open to the public.

DATE:

The meeting will be held on Tuesday, March 9, 2010 from 8:30 a.m. until 5 p.m. and Wednesday, March 10, 2010 from 8:30 a.m. until 5 p.m.

ADDRESSES:

U.S. Department of Health & 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: [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On March 9, 2010, OHRP staff will provide a summary of public comments received on two recent draft guidance documents: Institutional Review Board (IRB) Continuing Review of Research and IRB Approval of Research with Conditions. Following this presentation, there will be a panel that will examine the context for resolution of regulatory harmonization issues through the Clinical Trials Transformation Initiative and the International Council on Harmonization and Good Clinical Practice. After lunch, the day will conclude with a report from the Subpart A Subcommittee (SAS) focusing on issues surrounding consent for 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.

On March 10, 2010, co-chairs of the Subcommittee on Harmonization (SOH) will discuss the charge, initial steps, and membership of this new group. 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. The remainder of March 10 will be devoted to continuing the previous day's focus on the work of the Subpart A Subcommittee. 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 Thursday, March 4, 2010. 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 16, 2010.

Jerry Menikoff,

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