This controversial, commercial experiment is being conducted without informed consent in trauma patients who require blood to survive. PolyHeme is being tested in patients in ambulances and at hospital emergency facilities where these trauma patients are denied life-saving real blood.
Federal investigation confirms AHRP complaint re: use of foster children in AIDS drug / vaccine experiments. Columbia University "says it will institute mandatory training for faculty members whose research involves children so it complies with federal rules protecting vulnerable youths."
Testimony by Vera Hassner Sharav, President ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) www.ahrp.org Hearing of the NYS Assembly Committee on Health and Committee on Children and Families September 8, 2005 New York City I speak on behalf of the ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP), the organization that filed the…
On behalf of the Alliance for Human Research Protection, or AHRP, I want to thank the members of the Committee, for this opportunity to share with you our understanding of the complex problems presented by medical research involving vulnerable populations, such as prisoners and children. We appreciate your difficult job, and recognize that you will need to exercise courage in your assigned mission, which is to protect prisoners from research abuse and exploitation.
“Courage,” in this context, means the courage to acknowledge uncomfortable facts about current practice and to speak truth to power,
AHRP Testimonies and Presentations Sep 8, 2005: AHRP Testimony: NYS Hearing –AIDS Drug /Vaccine Experiments on Foster Children July 18, 2005: Cheaper than Chimpanzees Statement by Vera Hassner Sharav before the Committee on Ethical Consideration for Revisions to DHHS Regulations on Protection of Prisoners Involved in Research July 2-Â 8, 2005:…
AHRP Speaks Out Dec 12, 2005: Mental Health Screening: A PhRMA Friendly Remedy for Societal Problems. Presentation by Vera Sharav, American Public Health Association Nov 2005: Analysis of S. 1873 – The Biodefense and Pandemic Vaccine and Drug Development Act of 2005 – Karen R. Effrem, MD June 1-3, 2005:…
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…
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.
ALLIANCE FOR HUMAN RESEARCH PROTECTION Homepage 142 West End Ave. Suite 28P New York, NY 10023 March 10, 2004 Dr. Michael Carome Chief of Compliance Office of Human Research Protections David Horowitz Director, Office of Compliance Food & Drug Administration Dept. of Health and Human Services cc: Dr. Bernard Schwetz,…
RE: Phase I Drug trials used foster children in violation of 45 CFR 46.409 and 21 CFR 50.56
The Alliance for Human Research Protection (AHRP) has reason to believe that federal regulations for the protection of children as research subjects have been seriously violated in federally funded HIV research.
We have learned that a series of Phase I and Phase II drug experiments were conducted on infants and children who were under the guardianship of the New York City Agency for Children’s Services (ACS), and living at Incarnation Children’s Center, a foster care facility under contract with ACS.
Comments submitted by The Alliance for Human Research Protection Re: Best Pharmaceuticals for Children’s Act of 2002 The National Academy of Sciences Committee of the Institute of Medicine on Clinical Research Involving Children August 18, 2003 Vera Hassner Sharav, President John H. Noble, Jr., Ph.D, Treasurer David Cohen, Ph.D, Secretary…
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.
