[Federal Register Volume 76, Number 123 (Monday, June 27, 2011)]
[Pages 37354-37355]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-16051]



Meeting of the Secretary's Advisory Committee on Human Research 

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 

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: [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.
    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

[[Page 37355]]

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.

    Dated: June 21, 2011.
Jerry Menikoff,
Director, Office for Human Research Protections, Executive Secretary, 
Secretary's Advisory Committee on Human Research Protections.
[FR Doc. 2011-16051 Filed 6-24-11; 8:45 am]