[Federal Register Volume 77, Number 120 (Thursday, June 21, 2012)]
[Page 37408]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-15080]



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-eighth 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 10, 2012 from 8:30 
a.m. until 5:00 p.m. and Wednesday, July 11, 2012 from 8:30 a.m. until 
4:30 p.m.

ADDRESSES: U.S. Department of Health & Human Services, 200 Independence 
Avenue SW., Hubert H. Humphrey Building, Room 705A, Washington, DC 

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, July 10, 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 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. The topic for discussion Tuesday afternoon will be the Internet 
in human subjects research, with a series of FAQs drafted by Dr. 
Elizabeth Buchanan and Dean Gallant presented for consideration.
    On the morning of July 11, SACHRP and representatives from OHRP 
will discuss the requirements surrounding local context in human 
subjects research, and considerations for new HHS guidance. This 
discussion will help inform the report and recommendations to follow 
from the Subcommittee on Harmonization (SOH). 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 member Drs. Lainie 
Friedman-Ross and Daniel Hausman will discuss IRB issues concerning 
community engagement in research.
    Public comment will be heard on both days. 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.
    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. 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 3, 

    Dated: June 15, 2012.
Jerry Menikoff,
Director, Office for Human Research Protections, Executive Secretary, 
Secretary's Advisory Committee on Human Research Protections.
[FR Doc. 2012-15080 Filed 6-20-12; 8:45 am]