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To Obey or Not Obey with Holocaust Survivor Vera Sharav

ByVera Sharav

Vera Sharav is a Holocaust survivor and founder of the Alliance for Human Research Protection. She’s spent decades advocating for ethical medical standards and individual rights. Known for her outspoken views on public health, Vera has been deemed controversial for comparing the Holocaust with the global response to the COVID-19 pandemic. Nonetheless, she continues to bravely highlight dangerous parallels, emphasizing the importance of personal conscience in the face of tyranny.

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Comments submitted by Vera Hassner Sharav, John H. Noble, Jr., Ph.D and Howard Fishman, MEd, MSW for AHRP

To: Dr. Bernard Schwetz Acting Commissioner Food and Drug Administration, Dockets Management Branch (HFA-305) Food and Drug Administration

Re: COMMENT ON: Docket #00N-0074 April 24, 2001 Interim Rule: "Additional Safeguards for Children in Clinical Investigations of FDA-Regulated Products

Excerpt: The FDA rightly chose not to permit the section 46.408 (c) waiver by IRBs of parental or guardian permission, as it leaves the specific circumstances for such a violation of parental rights to the discretion of local Institutional Review Boards (IRB). Given the stream of revelations of gross ethical and procedural violations at one after another of the nation’s premier research institutions, assumptions that “procedural safeguards are in place,” or that IRBs can be relied upon to make decisions that protect the best interests of human subjects – adults and children – has been debunked.

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