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SACHRP: Secretarial Waiver Needed to Transplant Organs Subjected to Research

Federal officials should begin the process of creating a national board to review studies involving organs subject to research interventions that will be transplanted into living recipients, and of establishing a waiver of some informed consent requirements, according to HHS’s highest ranking panel on human subjects research.

Earlier this summer, the Secretary’s Advisory Committee on Human Research Protections approved recommendations regarding deceased donor intervention research (DDIR), one of two actions by SACHRP members at the meeting.[1] SACHRP also finalized comments to NIH regarding its proposed data-sharing policy. Additionally, members discussed issues of social justice in research and public health surveillance activities but did not yet have formal recommendations on these topics.

SACHRP has been examining DDIR since January 2019 as requested by the Office for Human Research Protections (OHRP), but the issue dates back to criticisms consumer advocacy group Public Citizen leveled against the Department of Veterans Affairs (VA) in 2016.[2]

At that time, Public Citizen accused the VA and the Health Resources and Services Administration, as well as investigators from the University of California, San Francisco, and Oregon Health & Science University, of sponsoring and conducting unethical research it said also violated the federal Common Rule.

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