Statement of the AHRP Opposing the SACHRP Children’s Committee Recommendations

THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) www.ahrp.org Proposed Changes to Subpart D Regulations Increase Risks to Children in Non-Therapeutic Research Statement of the AHRP Opposing the SACHRP Children’s Committee Recommendations April 18, 2005 The Alliance for Human Research Protection (AHRP) welcomes the opportunity to respond to the question “What…

Statement of the AHRP Opposing the SACHRP Children’s Committee Recommendations

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.

Statement by Vera Hassner Sharav, Anthrax Band Reunion Press Conference

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.

HIV Foster Babies, Children Used to test safety of Experimental Drugs – NY Post

HIV Foster Babies, Children Used to test safety of Experimental Drugs – NY Post Sun, 29 Feb 2004 As a society, we need to be concerned that too many within the medical research community seem to have abandoned the foremost principle of medical ethics: First, do no harm. The latest…

Best Pharmaceuticals for Children Act of 2002


Comments submitted by The Alliance for Human Research Protection
to The National Academy of Sciences
Committee of the Institute of Medicine on Clinical Research Involving Children

AHRP has been closely monitoring pediatric research trends since passage of the FDA Modernization Act of 1997. We believe that medications used in children should be thoroughly tested for safety, effectiveness and appropriate dose. But unlike adults who can exercise their autonomous right to informed consent, children who are enrolled in clinical trials are non-consensual human subjects. They should not, therefore, be made to assume the burden of testing possibly toxic drugs whose safety is unknown.

Class Action Lawsuit Filed Following Deaths at VA_Albany

Class Action Lawsuit Filed Following Deaths at VA_Albany Thu, 20 Mar 2003 A class action lawsuit has been filed on March 18, 2003 in U.S. District Court(NY), by attorney Alan Milstein, on behalf of “all persons who participated in human subject experiments” conducted by defendants, oncologist Dr. James Holland and…