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.
Thank you for the opportunity to submit this testimony for the record.
My name is Meryl Nass, M.D., and I have worked for the past twenty years as an emergency physician and internist in community hospitals in the northeastern US. I have also studied many aspects of bioterrorism since 1989. I am the person who first demonstrated, in 1992, that one could investigate an epidemic retrospectively, and prove that it was due to biological warfare, using Rhodesia’s 1978-80 anthrax epidemic as a model.[1]
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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.
Infomail Archive 2003 News Stories on Human Research Protection and Commentary by Vera Hassner Sharav Dec 19, 2003: Eli Lilly Prozac UK Fact Sheet: “Not Recommended” for Children – PMDD Withdrawn in UK Dec 19, 2003: Not-So-Public-Relations: Drug Industry & Bioethics – is it casuistry or sophistry? Dec 18, 2003:…
Ripping Off the Rights of Children Thu, 17 Apr 2003 “Parents are frustrated that corrupt politics are playing such a large role in their children’s fate. Many believe Sen. Frist has large financial ties to pharmaceutical companies and doesn’t care at all about the future of thousands of sick children.”…
