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.

A landmark decision by Maryland's highest court, the Court of Appeals of Maryland, is a victory for the human rights of children. The decision affirms the responsibility of parents, the government, researchers and institutional review boards (IRB) to protect children from non-therapeutic experiments that may put their health at risk.

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.

To: Mary Faith Marshall, Ph.D, Chairperson, National Human Research Protections Advisory Committee, Department of Health and Human Services

Re: Specific Comment on FDA's Decision to Adopt HHS 45 CFR 46 Subpart D, EXCLUDING §46.408 (c)

Dissenting opinion of Vera Hassner Sharav, Founder and President, AHRP: Alliance for Human Research Protection, member, Children's Workgroup of the National Human Research Protections Advisory Committee, Department of Health and Human Services (HHS)

This dissenting opinion reflects the position of AHRP and was prepared in collaboration with Howard Fishman, M.S. W., M.Ed, and John H. Noble, Jr., PhD, AHRP board members.

Submitted to the Office of Human Research Protection
by Vera Hassner Sharav and Marie M. Cassidy, Ph.D, D.Sc.

AHRP recognizes that to include children in clinical trials for any medication presents a dilemma of truly Solomonic proportions. It is a choice between continuing the practice of prescribing untested drugs for children, as is currently the operational system, or conducting meaningful trials to determine both safety and effectiveness.

Congressional Testimony submitted by Vera Sharav

Statement For the Record Submitted to
The U.S. Senate Sub-Committee: Public Health & Safety of the Senate Health, Education, Labor & Pensions Committee Hearing

Our efforts helped bring to public attention major medical ethics violations in Federally-funded research in which uninformed, vulnerable American citizens are put at high risks without justification. As a result, such individuals have often suffered severe consequences - some have lost their lives unnecessarily. Based on the evidence - including testimonies by families and patients - we believe five factors contribute to unethical human experiments:

A partial, Annotated Bibliography by Vera Hassner Sharav

For distribution: January, 2000

Although patients, families and the public were not informed - some would argue they were deceived - clinical psychiatrists and researchers have long known about severe adverse drug reactions (ADR) and disabling changes in the central nervous system in a high percentage of patients taking standard neuroleptic drugs.