[Federal Register Volume 84, Number 190 (Tuesday, October 1, 2019)]
[Pages 52116-52117]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21255]



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 the Federal Advisory Committee Act, 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 website at: http://www.dhhs.gov/ohrp/sachrp-committee/meetings/index.html.

DATES: The meeting will be held on Wednesday, October 16, 2019, from 
8:30 a.m. until 4:30 p.m., and Thursday, October 17, 2019, from 8:30 
a.m. until 3:00 p.m.

ADDRESSES: 6700B Rockledge Drive, Bethesda, MD 20817.

Director, SACHRP; U.S. Department of Health and Human Services, 1101 
Wootton Parkway, Suite 200, Rockville, Maryland 20852; telephone: 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 Subpart A Subcommittee (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.
    The Subcommittee on Harmonization (SOH) was established by SACHRP 
at its July 2009 meeting and 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 
    The SACHRP meeting will open to the public at 8:30 a.m., on 
Wednesday, October 16, 2019, followed by opening remarks from Dr. Jerry 
Menikoff, Director of OHRP and Dr. Stephen Rosenfeld, SACHRP Chair.
    The SAS subcommittee will discuss their revised recommendation 
questions posed to SACHRP regarding Deceased Organ Intervention 
Research (DDIR), with an emphasis on recipient informed consent. This 
will be followed by a discussion of Ethical Issues and Regulatory 
Considerations Regarding Re-consent, and Charging Subjects to 
Participate in Clinical Trials. The meeting is scheduled to end at 
approximately 4:30 p.m.
    The meeting will begin at 8:30 a.m., Thursday, October 17, 2019. 
The SOH subcommittee will discuss draft recommendations regarding End 
User Licensing Agreements & Terms of Service; Considerations for IRB 
Review, and finally, Site Monitoring under the New sIRB Mandate. 
Additional time is reserved for emerging topics and continuing the 
previous day's discussions. The meeting will adjourn at approximately 
3:00 p.m.
    Time will be allotted for public comment on both days. On-site 
registration is required for participation in the live public comment 
session. Note that public comment must be relevant to topics currently 
being addressed by the SACHRP. Individuals submitting written 
statements as public comment should email or fax their comments to 
SACHRP at [email protected] at least five business days prior to the 
    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.

[[Page 52117]]

    Dated: September 25, 2019.
Julia G. Gorey,
Executive Director, Secretary's Advisory Committee on Human Research 
[FR Doc. 2019-21255 Filed 9-30-19; 8:45 am]