1999: Experiments on the most vulnerable The research community has consistently demonstrated its disregard for individual patient-subjects’ safety.   1999: One hundred babies are test subjects of the drug, Propulsid One hundred infants were enrolled by Dr. Susan Orenstein at Children’s Hospital (Pittsburgh) in a clinical trial testing Propulsid for infant acid reflux—i.e., colic which…

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October 1, 2001 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. ___________________________________________________ IN THE COURT OF APPEALS…

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Dissenting Opinion: Against Waiving Parental Permission for Research July 25, 2001 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,…

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Protecting Human Subjects in Research: Are Current Safeguards Adequate? AHRP Testimony submitted to Congressional Committee April 23, 2002 Vera Hassner Sharav, President, and John H. Noble, Jr., Ph.D., steering committee member, The Alliance for Human Research Protection (AHRP), before the Subcommittee on Public Health, Committee on Health, Education, Labor, & Pensions, United States Senate at…

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Testimony Submitted to the  Office of Human Research Protection (OHRP) by Vera Hassner Sharav and  Marie M. Cassidy, Ph.D, D.Sc. April, 2001 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,…

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