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.

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.

FOR FURTHER INFORMATION CONTACT:

Julia Gorey, J.D., Executive 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: SACHRP@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, 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 coordination.

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 SACHRP@hhs.gov at least five business days prior to the meeting.

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.