[Federal Register Volume 77, Number 120 (Thursday, June 21, 2012)]
[Notices]
[Page 37408]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-15080]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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
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: Julia.Gorey@hhs.gov.
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,
2012.
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]
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