80 FR 35655 - Meeting of the Secretary's Advisory Committee on Human Research Protections

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 80, Issue 119 (June 22, 2015)

Pursuant to Section 10(a) of the Federal Advisory Committee Act, 5 U.S.C., 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: http:// www.dhhs.gov/ohrp/sachrp/mtgings/index.html.

[Federal Register Volume 80, Number 119 (Monday, June 22, 2015)]
[Notices]
[Pages 35655-35656]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-15286]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Meeting of the 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, 5 U.S.C., 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: http://www.dhhs.gov/ohrp/sachrp/mtgings/index.html.

[[Page 35656]]


DATES: The meeting will be held on Tuesday, July 21, 2015, from 8:30 
a.m. until 5:00 p.m. and Wednesday, July 22, 2015, from 8:30 a.m. until 
4:30 p.m.

ADDRESSES: Fishers Lane Conference Center, Terrace Level, 5635 Fishers 
Lane, Rockville, Maryland 20852.

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 through 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 Tuesday, July 
21, 2015. Following opening remarks from Dr. Jerry Menikoff, Executive 
Secretary of SACHRP and OHRP Director, and Dr. Jeffrey Botkin, SACHRP 
Chair, the Subpart A Subcommittee (SAS) will present their report on 
informed consent for minimal risk research. SAS was established by 
SACHRP in October 2006 and 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.
    In the afternoon of July 21, the Subcommittee on Harmonization 
(SOH) will present their report, including recommendations pertaining 
to waiver of consent in cluster randomized trials, the application of 
the HHS regulations to data registries, and the topic of 
``benchmarking'' in human subjects research. 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. On July 22, the SOH will discuss the return of 
individual research results with special considerations regarding HIPAA 
and CLIA.
    In the afternoon special guest speaker Dr. Robert Klitzman will 
present on his recent work, The Ethics Police. The meeting will adjourn 
at 4:30 p.m. on July 22, 2015. Time for public comment sessions will be 
allotted 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 one of the designated SACHRP points of contact at the address/
phone number 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. 
Individuals who would like to submit written statements should email or 
fax their comments to SACHRP at [email protected] at least five business 
days prior to the meeting.

    Dated: June 17, 2015.
Jerry Menikoff,
Executive Secretary, Secretary's Advisory Committee on Human Research 
Protections, Director, Office for Human Research Protections.
[FR Doc. 2015-15286 Filed 6-19-15; 8:45 am]
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