Testimony by Vera Hassner Sharav before the Committee on the Use of Third Party Toxicity Research with Human Research Participants; Science, Technology, and Law Program; The National Academies of Science Committee on the Use of Third Party Toxicity Research with Human Research Participants

My name is Vera Sharav and I am the president and founder of The Alliance for Human Research Protection (AHRP) a citizens' watchdog organization monitoring human research to ensure that the moral principles enshrined in the Nuremberg Code and the Declaration of Helsinki are preserved and followed in experiments involving human beings.

Presented by Vera Hassner Sharav
14th Tri-Service Clinical Investigation Symposium
Sponsored by The U.S. Army Medical Department and The Henry M. Jackson Foundation for the Advancment of Military Medicine

The cornerstone of public trust in medical research is the integrity of academic institutions and the expectation that universities, which rely on public funding, have a responsibility to serve the public good. Financial conflicts of interest affect millions of American people - those who are subjects of clinical trials testing new drugs and those who are prescribed drugs after their approval.

Current federal regulations set no limits on the level of risk that a competent adult may voluntarily choose to undertake for the sake of science. The regulations require prior approval by a review board (IRB) to ensure the research meets scientific and ethical justification, to ensure that the risks and benefits (if any) are fully disclosed to the subject, and that the subject can exercise the right to give or withhold informed consent.

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.

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.