Monthly Archives: August 2001

A group of patient and social justice advocates plan to form an Alliance for Human Research Protection to provide oversight on clinical research from laypersons' point of view, says John H. Noble Jr., a founder and professor of social justice at the Catholic University of America. He lambastes Internal Review Boards (IRBs) designed to protect human subjects as agents of institutions "who are hustling the bucks" from industry and other sources. Noble says IRBs need to be "severed from research institutions" and provided adequate resources as part of the accepted overhead costs of conducting clinical trials.

The Scientist News reports on AHRP as New Advocacy Group ...

  AHRP Alliance for Human Research Protection AHRP Speaks Out  Return to Home PageAHRP Speaks Out Press ReleasesAugust 17, 2001 Following the August 16, 2001 landmark decision* of the Maryland Court of Appeals, the Alliance for Human Research Protection (AHRP) became interested in the case involving exposure of children to […]

August 17, 2001

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.

FDA: Regulatory Protections for Children