[Federal Register Volume 77, Number 183 (Thursday, September 20, 2012)]
[Page 58383]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-23143]



Secretary's Advisory Committee on Human Research Protections

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

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

DATES: The meeting will be held on Tuesday, October 9, 2012 from 8:30 
a.m. until 5:00 p.m. and Wednesday, October 10, 2012 from 8:30 a.m. 
until 4:30 p.m.

ADDRESSES: U.S. Department of Health and Human Services, 200 
Independence Avenue SW., Room 705A, 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; email address: [email protected].

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.
    The meeting will open Tuesday, October 9, with remarks from SACHRP 
Chair Dr. Barbara Bierer and OHRP Director Dr. Jerry Menikoff, followed 
by a report from the Subpart A Subcommittee (SAS). SAS will discuss 
their recent work, including considerations for revisions to the 
expedited review list, principal investigator responsibilities, and 
informed consent waiver criteria. 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. Tuesday 
afternoon will be a discussion of informed consent issues in cluster 
randomized trials, featuring Dr. Andrew McRae, Research Director of the 
Division of Emergency Medicine, University of Calgary.
    On the morning of October 10, the Subcommittee on Harmonization 
(SOH) will give a report and discuss their recent work, including local 
context guidance recommendations. 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. Wednesday afternoon SACHRP will discuss a revised 
document on the issue of the use of the Internet in human subjects 
research, drafted by Drs. Elizabeth Buchanan and Dean Gallant. 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 October 1, 2012.

    Dated: September 13, 2012.
Jerry Menikoff,
Director, Office for Human Research Protections, Executive Secretary, 
Secretary's Advisory Committee on Human Research Protections.
[FR Doc. 2012-23143 Filed 9-19-12; 8:45 am]