An Open Letter to Officials of the National Institute of Mental Health Fri, 30 Apr 2004 ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Promoting openness and full disclosure https://ahrp.org From: Vera Hassner Sharav, President David Cohen, Ph.D. Secretary The ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) To: Thomas Insell, MD,…
July 18, 2002 Anthrax Vaccine Not Safe and Effective – Emergency Medicine News FYI In her letter in the July issue of Emergency Medicine News (below) Dr. Meryl Nass cites a body of evidence linking the anthrax vaccine with systemic adverse medical reactions, and 100,000 to possibly 200,000 veterans who…
AHRP Position Statement on Mental Health Screening – FDA Hearing Re: Drug Advertising Wed, 02 Nov 2005 FDA is holding public hearings (Nov 1, 2) Re: Direct-to-Consumer Promotion of Medical Products at: National Transportation Safety Board Boardroom and Conference Center 429 L’Enfant Plaza, SW., Washington, DC 2 Time: 9:00 –5:00….
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…
OHRP Found NHLBI Lung Experiments Violated Informed Consent Mon, 7 Jul 2003 On July 3 the federal Office of Human Research Protections (OHRP) issued a stinging indictment of the research review and approval process at some of the nation’s most prestigious research institutions–including the National Heart Lung and Blood Institute…
AHRP Letter to Editor re: ARDS published NEJM Fri, 11 Jul 2003 A truncated version of a Letter to the editor submitted by John H. Noble, Jr., PhD and Vera Sharav appears in the current July 10, 2003, issue of The New England Journal of Medicine. Note: On April 3,…
US Gov Pesticide Exposure Experiments: Target Children–$970 per child – Wash Post Wed, 3 Nov 2004 The Washington Post reports (below) that the Environmental Protection Agency (EPA) announced plans to enroll 60 young children in Duval County, Florida – infants to age 3 – exposing them to pesticides to study…
THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) https://ahrp.org 142 West End Ave. Suite 28P New York, NY 10023 Testimony by The Alliance for Human Research Protection Committee on Ways and Means Hearing on Protections for Foster Children Enrolled in Clinical Trials May 18, 2005 On March 10, 2004, The ALLIANCE…
INTRODUCTION: This bill seriously endangers, if not completely undermines, the democratic process and the rule of law. It will absolutely destroy the unalienable rights of trial by jury and informed consent. It is a radical transfer of the US Treasury into the hands of unaccountable private companies whose record shows far more concern about profits than in protecting and improving the health of the American people. It also concentrates the power of life and death in the hands of one very fallible human being and creates an unaccountable federal bureaucracy not subject to disclosure, independent oversight or the safeguards of accountability necessary in a free republic.
The Alliance for Human Research Protection (AHRP) welcomes the opportunity to respond to the question “What is the Best Way to Protect Children?”
Our recommendation – which is backed up by evidence that children have suffered harm in medical research – is to significantly limit the discretion of IRBs to approve greater than minimal risk research without direct benefit for the child-subjects under 46.406.
We recommend staying the course in requiring that any such proposed experiment undergo a transparent open evaluation with ample opportunity for public oversight and comment – as required under the provisions of 46.407.
My name is Vera Hassner Sharav, and I am president of The Alliance for Human Research Protection: a national human rights organization that exposes unethical research practices which undermine the dignity, rights, and safety of human subjects.
In 1947, an American military tribunal sat in judgment of the Nazi doctors at Nuremberg, and laid down ten essential principles that define “permissible medical experiments” in a civilized society. Those principles are enshrined in the Nuremberg Code which is the cornerstone of all medical research ethics. The nations of the world adopted the Code as a safeguard to prevent future medical atrocities.
When a federal judge ruled the vaccine to be an "investigational drug and a drug being used for an unapproved purpose" on December 22, 2003, FDA hurriedly issued a Final Rule for anthrax vaccine. The agency submitted its Final Rule just eight days after a federal court injunction, having failed to do so for 19 years. In a January 7, 2004 court hearing the same judge called FDA’s actions "highly suspicious." On October 27, 2004 FDA’s arbitrary and capricious promulgation of this Final Rule resulted in a permanent injunction, remanding the license to your agency to complete according to the law. The injunction also halted what the judge called DoD’s "illegal" mandatory anthrax vaccination program.
