Background Analysis: US HHS Advisory Committee to Discuss Human Research Protections Topics – MAR 13-14, 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, March 13-14, 2018. The Committee will review recommendations pertaining to the Common Rule and other topics related to human research protections.

Background

The SACHRP was established to provide expert advice and recommendations to the HHS Secretary on issues and topics associated with the protection of human research subjects. The Subpart A Subcommittee (SAS) is charged with developing recommendations to SACHRP regarding subpart A of 45 Code of Federal Regulations (CFR) part 46 in the current research environment. The Subcommittee on Harmonization (SOH) is charged with identifying area of regulations or guidelines for human subjects research that would benefit from harmonization or coordination among US Agencies.

On January 19, 2017, the HHS issued a Final Rule to revise the existing Common Rule, the Federal Policy for the Protection of Human Subjects under 45 CFR, Part 46. The Common Rule applies to clinical trials that receive funding from a Common Rule federal agency. The Final Rule that was issued in January 2017 is the first substantial revision to the policy in 26 years, since its initial implementation in 1991. The updated rule is intended to strengthen patients’ protections while also reducing the administrative burden for low-risk research.

The effective and general compliance dates are July 19, 2018, and were extended, by the issuance of an Interim Final Rule, from the initially published dates of January 19, 2018. Currently, the affected US departments and agencies are in the process of developing a new Proposed Rule, with the aim of further delaying implementation of the 2018 requirements. Provisions pertaining to cooperative research have a different compliance date of January 20, 2020.

Agenda

The Agenda for the meeting includes the following:

·         SAS and SOH subcommittees will present their recommendations regarding the description of “key information,” as required by the revised Common Rule’s §46.116(a)(5)(i);

·         The Committee will discuss SOH recommendations on the research use of repositories and registries under various consent models, under both the current and the revised Common Rule; and

·         The SOH will present and discuss recommendations on the European Union’s General Data Protection Regulation and its impact on US human subjects research.

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.