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.

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Comments on AHRP Amicus Brief (Kennedy Krieger)

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 lead paint. We were particularly drawn to the Court’s clear and unambiguous recognition of the rights of children and their families to appropriate safeguards in medical research settings.

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AHRP Amicus Brief – Kennedy Krieger Institute

Text of AHRP Amicus Brief filed with the Maryland Court of Appeals in support of the Court’s ruling against Kennedy Krieger Institute for exposing children to lead poison in an experiment. The Court of Appeals Decision Validates AHRP’s Stand Against Using Children in Harmful Research Experiments.

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AHRP Comments on Landmark Decision by the Court of Appeals of Maryland

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.

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The Scientist News reports on AHRP as New Advocacy Group to Police Human Research

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.

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August 17, 2001

  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 . . . Continue reading →

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.

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