Conflicts of Interest Undermine Safety for Human Subjects

Widely disparate perspectives are presented in an article in the Maryland Daily Record re: The Court of Appeals of Maryland decision (Gimes v Kennedy Krieger Institute, Aug 16, 2001). That 6-to-1 landmark decision severely criticized the practice of exposing healthy children to risks of harm in health related research. Children, we must bear in mind, are powerless to exercise that inviolable human right, the right to refuse to assume risks for research.

Will this decision undermine the legitimacy of research that puts healthy children at risk in clinical trials? AHRP believes it will, and that the decision will be sustained by other courts in other states.

FDA: Regulatory Protections for Children

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.

Testimony Re: Research Involving Children

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.

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