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.
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.
OHRP suspends Johns Hopkins Research license for Fed funded research July 19, 2001 The death of Ellen Roche, a healthy young woman before she was killed in a fatal hexamethonium inhalation experiment at Johns Hopkins University, has opened Pandora’s box, demonstrating that the safety of human research subjects has had…
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.
Seattle Times Series on Fred Hutchinson Cancer Center 2001 Seattle Times Series, UNINFORMED CONSENT An in-depth, documented, 5-part investigative series, in The Seattle Times, beginning Sunday, March 11, 2001, turned the spotlight on cancer research at the world renowned Fred Hutchinson Cancer Center in Seattle — with supporting documents available…
Washington Post_Harvesting China’s Blood_installment 4 December 20, 2000. Washington Post. In what is, so far, the most devastating installment in the Washington Post series about the unholly alliances that comprise the booming human research industry, America’s premier academic research center is shown–not only to have violated ethical research standards in…
Harvard-affiliated gene studies in China face federal inquiry – Boston Globe. August 1, 2000. Harvard-affiliated gene studies in China face federal inquiry, by Deborah Nelson. Genetic research in China is booming. The biotech industry, in collaboration with scientists from America’s elite research centers & the U.S. government, is looking at…
Is it ethical to expose healthy children to risks of drug- induced pathology on a speculative, unproven theory?
Chemically Induced Psychosis Experiments: An Inhumane Paradigm in Psychiatric Research Congressional Testimony submitted by Vera Sharav * February 2, 2000 Statement For the Record Submitted To U.S. Senate Sub-Committee: Public Health & Safety of the Senate Health, Education, Labor & Pensions Committee Hearing Our efforts helped bring to public attention…
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:
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.
