Regulatory Focus™ > News Articles > Human Protections Oversight Body Seeks New Members

Human Protections Oversight Body Seeks New Members

Posted 06 September 2012 | By

Officials at the US Department of Health and Human Services (DHHS) are looking for two new members to serve on the Secretary's Advisory Committee on Human Research Protections (SACHRP), the agency announced in a Federal Register posting.

SACHRP is a part of DHHS's Office of Human Research Protections, which, along with the US Food and Drug Administration (FDA), is responsible for overseeing the rights and welfare of participants enrolled in clinical trials conducted by or supported by DHHS.

Its duties include applying the regulations of Title 21 of the Code of Federal Regulations (CFR), and in particular Parts 50 and 56, which govern the use of institutional review boards (IRBs) and protections afforded to human subjects. OHRP also maintains an electronic system through which all IRBs are required to register and in which all protocols for FDA-regulated products reviewed during the last year are maintained.

SACHRP, meanwhile, "Provides advice and recommendations to the Secretary, DHHS and the Assistant Secretary on matters pertaining to the continuance and improvement of functions within the authority of DHHS directed toward protections for human subjects in research," DHHS explains in the notice.

The advisory committee places a special emphasis on protections for so-called "special populations": neonates, children, prisoners, mentally impaired individuals, pregnant women, embryos, fetuses, international studies and orphan disease populations.

The group is also involved in evaluating some policies with regulatory applications, including assurance systems, how minimal research risk standards are applied, how waivers are granted, the need for educational programs, and how IRBs are monitored and overseen.

Two spots are open on SACHRP, with terms to last four years beginning on 1 March 2013.

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