Advisory Committees - Other US Advisory Committees - Secretary's Advisory Committee on Human Research Protections (SACHRP)
On Tuesday and Wednesday, July 25-26, 2017, the Secretary’s Advisory Committee on Human Research Protections (SACHRP) met to discuss topics related to human research protections. The Committee reviewed recommendations pertaining to the new Common Rule, the Federal Policy for the Protection of Human Subjects under 45 CFR, Part 46.
The Committee met to discuss topics related to human research protections. The Committee reviewed recommendations pertaining to the new “Common Rule” (the Federal Policy for the Protection of Human Subjects) and recent FDA Draft Guidance regarding the use of real-world evidence to support regulatory decision-making for medical devices.
The Committee will review recommendations pertaining to the Common Rule and the use of real-world evidence for devices.
The Committee met to discuss topics related to human research protections.
The Committee heard reports and discussed recommendations from its Subcommittees.
The US Department of Health and Human Services (HHS) held a meeting of the Secretary's Advisory Committee on Human Research Protections (SACHRP) on Wednesday and Thursday, October 21-22, 2015. The Committee heard Subpart A Subcommittee (SAS) and Subcommittee on Harmonization (SOH) reports on the recent Notice of Proposed Rulemaking (NPRM) titled Federal Policy for the Protection of Human Subjects (80 FR 53933, Sep. 8, 2015), also known as The Common Rule. The Subcommittees also presented their recommendations for the Committee’s submission of comments to the NPRM. The Committee then discussed those recommendations and, at the December 3-4, 2015 SACHRP meeting, will either accept or modify them for submission to the Docket.
The Committee reviewed Subcommittee reports about the application of the Common Rule (45 CFR part 46, subpart A, entitled “Basic HHS Policy for Protection of Human Research Subjects”) in the areas of minimal risk research, big data, clinical data registries, cluster randomized trials, and the return of results to subjects.
This meeting focused on issues in the use of newborn dried bloodspots in research; harmonization of regulations and/or guidelines for human subjects research; Health Insurance Portability and Accountability Act (HIPAA) and Clinical Laboratory Improvement Amendments (CLIA) issues with individual research results; and pediatric studies for drugs and biologics.
Secretary's Advisory Committee on Human Research Protections (SACHRP)
SACHRP is governed by the Federal Advisory Committee Act and provides expert advice and recommendations to the Secretary on issues and topics pertaining to the protection of human research subjects. The Committee was created by Secretary Thompson in 2001 after dissolution of the prior National Human Research Protections Advisory Committee (NHRPAC). To date SACHRP has focused its attention on areas such as research involving children, prisoners, and individuals with impaired decision-making capacity; informed consent and the use of biospecimens; harmonization of human subjects regulations and guidance; the reduction of regulatory burden; the HIPAA Privacy Rule; community-engaged research, and accreditation.