Protecting Human Subjects in Research: Are Current Safeguards Adequate?

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.

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.

Chemically Induced Psychosis Experiments: An Inhumane Paradigm in Psychiatric Research


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: