[Federal Register Volume 79, Number 128 (Thursday, July 3, 2014)]
[Pages 38031-38032]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-15593]



Meeting of the Secretary's Advisory Committee on Human Research 

AGENCY: Office of the Secretary, Office of the Assistant Secretary for 
Health, 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 Monday, July 21, 2014, from 8:30 
a.m. until 5:00 p.m. and Tuesday, July 22, 2014, from 8:30 a.m. until 
4:00 p.m.

ADDRESSES: Note new location! Fisher's Lane Conference Center, Terrace 
Level, 5635 Fisher Lane, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jerry Menikoff, M.D., J.D., Executive 
Secretary, SACHRP and 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, through

[[Page 38032]]

the Assistant Secretary for Health, on issues and topics pertaining to 
or associated with the protection of human research subjects.
    The meeting will open to the public at 8:30 a.m., on Monday, July 
21. Following opening remarks from Dr. Jerry Menikoff, Executive 
Secretary, SACHRP and OHRP Director, and Dr. Jeffrey Botkin, SACHRP 
Chair, the Subpart A Subcommittee (SAS) will give their initial report 
on the new SAS initiative examining informed consent. A panel of 
speakers will discuss comprehension and tools for validating 
comprehension in informed consent. 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.
    On the afternoon of July 21, the Subcommittee on Harmonization 
(SOH) will present their initial work on the topic of the intersection 
of the HHS and FDA regulations and ``big data''; this presentation will 
be highlighted by a special expert panel discussion. The morning of 
July 22, the SOH will present their work to date on the topic of return 
of general results, also assisted by a special expert panel discussion. 
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.
    A public comment session will be offered on both days.
    Public attendance at the meeting is limited to space available. 
Individuals who plan to attend and need special assistance, such as 
sign language interpretation or other reasonable accommodations, should 
notify the SACHRP at the address/phone listed above at least one week 
prior to the meeting. Pre-registration is required for participation in 
the on-site public comment session; individuals may pre-register the 
day of the meeting or by contacting the Executive Director, SACHRP, by 
COB July 17. Individuals who would like to submit written statements 
should email or fax their comments to SACHRP at least five business 
days prior to the meeting.

    Dated: June 27, 2014.
Julia Gorey,
Executive Director, Secretary's Advisory Committee on Human Research 
[FR Doc. 2014-15593 Filed 7-2-14; 8:45 am]