[Federal Register Volume 78, Number 35 (Thursday, February 21, 2013)]
[Pages 12061-12062]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-03976]



Meeting of the Secretary's Advisory Committee on Human Research 

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 a 
meeting that will be open to the public. Information about SACHRP and 
the full meeting agenda will be posted on the SACHRP Web site at: 

DATES: The meeting will be held on Tuesday, March 12, 2013 from 10:30 
a.m. until 5:00 p.m. and Wednesday, March 13, 2013 from 8:30 a.m. until 
4:30 p.m. Tuesday morning will begin with a two-hour closed 
administrative session, with the meeting opening to the public at 10:30 

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; 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.
    On Tuesday, March 12, following opening remarks from Dr. Jerry 
Menikoff, OHRP Director, and Dr. Jeffrey Botkin, SACHRP Chair, there 
will be a presentation from HHS staff describing the history of SACHRP 
and the process for creating regulatory guidance and regulatory change; 
a discussion of SACHRP members' priorities for future discussion topics 
will follow. Subpart A Subcommittee will next discuss their recent 
work, including considerations for revisions to the expedited review 
list. Subpart A Subcommittee 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. Following opening remarks on 
the morning of March 13, a special panel of experts will discuss 
Improving the Informed Consent Process; this discussion will initiate a 
new SACHRP spotlight on this topic. The Subcommittee on Harmonization 
(SOH) will next give a report and discuss their recent work, including 
an examination of human subject research issues affecting cluster 
randomized trials, and issues associated with the use of differing 
agencies' certificates of confidentiality. 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

[[Page 12062]]

offices within HHS would benefit from harmonization, consistency, 
clarity, simplification and/or coordination. SACHRP will conclude 
Wednesday afternoon with discussion of a revised document on the issue 
of the use of the internet in human subjects research. 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 March 8, 2013.

    Dated: February 15, 2013.
Jerry Menikoff,
Director, Office for Human Research Protections, Executive Secretary, 
Secretary's Advisory Committee on Human Research Protections.
[FR Doc. 2013-03976 Filed 2-20-13; 8:45 am]