Tarius SAC Tracker®

 

Background Analysis: US HHS Advisory Committee to Discuss Topics Related to Human Research Protections – OCT 16-17, 2018 (SACHRP)

Announcement

The US Department of Health and Human Services (HHS) has scheduled a meeting of the Secretary's Advisory Committee on Human Research Protections (SACHRP) on Tuesday to Wednesday, October 16-17, 2018 to discuss topics related to Human Research Protections and the revised Common Rule.

Background – SACHRP

The SACHRP was established to provide expert advice and recommendations to the HHS Secretary on general issues and topics associated with the protection of human research subjects. The Committee typically meets 2-3 times annually. Recent SACHRP meetings have focused on interpreting aspects of the revised Common Rule and on drafting related recommendations to the HHS Secretary. The SACHRP recommendations are made available to the public at the following website:

https://www.hhs.gov/ohrp/sachrp-committee/recommendations/sachrp-recommendations/index.html

Background – Common Rule

The Federal Policy for the Protection of Human Subjects was first published in 1991 and later codified in separate regulations by other federal departments and agencies. The HHS regulations are codified in section 45 of the Code of Federal Regulations (CFR), in part 46, and they are broken into four subparts: subpart A, also known as the “Common Rule”; subpart B, providing additional protections for pregnant women, human fetuses, and neonates; subpart C, providing additional protections for prisoners; and subpart D, providing additional protections for children.

On January 19, 2017, a Final Rule was issued in the Federal Register to revise the existing Common Rule. The intent of the revised Common Rule is to strengthen patient protections while reducing the administrative burden for low-risk research. On January 22, 2018, an Interim Final Rule was posted in the Federal Register that extended the effective and general compliance dates of the initial Final Rule from January 19, 2017 to July 19, 2018. On April 20, 2018, a Notice of Proposed Rulemaking was posted in the Federal Register, proposing an additional six-month delay of the general compliance date, to January 21, 2019. This NPRM was intended to provide regulated entities additional time for the preparations necessary to implement the 2018 Requirements.

On June 18, 2018, HHS and 16 other federal departments and agencies issued a Final Rule to delay for an additional 6 months the general compliance date for changes in the revised Common Rule, while allowing the use of three burden-reducing provisions during the delay period.

Background – Agenda

On Tuesday, October 16, the meeting will open with remarks from Dr. Jerry Menikoff, Director of OHRP, and Dr. Stephen Rosenfeld, SACHRP Chair. Following these remarks, the two SACHRP Subcommittees, the Subpart A Subcommittee (SAS) and the Subcommittee on Harmonization (SOH), will present their recommendations regarding the description of “key information,” as required by the revised Common Rule at §46.116(a)(5)(i). This will be followed by a discussion of recommendations of the interpretation of the revised Common Rule’s exemptions §46.104(d)(1) and (2) for HHS funded research. Lastly, the committee will continue its July discussions on the Office of Inspector General Report, July 7, 2017: “OHRP Generally Conducted Its Compliance Activities Independently, But Changes Would Strengthen Its Independence.”

On Wednesday, October 17, the SAS subcommittee will present and discuss recommendations on the interpretation of “reasonably available” at §46.408(b) of the Common Rule, as well as discuss issues surrounding payment of subjects for participation in research. Modifications to the previous day’s work will be discussed and finalized.

What’s Next?

Tarius will send a Results Wire soon after the meeting. This report will include the voting outcomes, if applicable, and key outcomes of the discussion.

METADATA: Sponsor: none Drug Name: none Drug Class: none Indication: none


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DISCLAIMER: The information in this document is for informational purposes only. The SAC Tracker Background Analysis contains information from publicly available sources, including FDA, sponsor, scientific, and clinical websites. Tarius A/S assumes no liability for any inaccurate or incomplete information, or for any actions taken in reliance thereon. © Tarius A/S. All rights reserved.