THE IMPACT OF THE FDA MODERNIZATION ACT ON THE RECRUITMENT OF CHILDREN FOR RESEARCH Vera Hassner Sharav Published in ETHICAL HUMAN SCIENCES & SERVICES Summer 2003, vol. 5 pp. 83-108 Abstract This paper argues that contrary to the claims made by the research stakeholders in industry, academia and government, the…
Johns Hopkins University Experiment on Lead Paint Puts Children in Danger August 24, 2001 FYI Additional details are emerging about the lead-paint study conducted on infants and children by researchers at the Kenney Krieger institute which is affiliated with Johns Hopkins University. Today’s New York Times reports (below) that the…
Walter Reed Seeking Volunteers to Test Anthrax Vaccine_WP Tue, 25 Mar 2003 A clinical trial to test the anthrax vaccine is being conducted at Walter Reed Army Institute of Research. The investigators are seeking civilian volunteers who are being solicited in the Washington area through newspaper advertisements. The Alliance for…
Repeal of Thimerosal Rider under Omnibus Approriations Bill Thu, 20 Feb 2003 Congress has acted! On Valentine’s Day, Congress passed the Omnibus Appropriation Act, repealing the thimerosal protection rider that had been slipped into Homeland Security Act. Vaccine manufacturers are no longer protected from liability. Parents may exercise their right…
SAMHSA Backs Away From TeenScreen & TMAP Mon, 24 Oct 2005 On October 17, a meeting took place with Charles Currie in Washington DC – with some in attendance by conference call. Currie is the Administrator of the Substance Abuse and Mental Health Services Administration (SAMHSA), the federal agency charged…
August 20, 2001 A landmark decision by Maryland’s highest court, the Court of Appeals of Maryland, is a victory for the human rights of children. The decision affirms the responsibility of parents, the government, researchers and institutional review boards (IRB) to protect children from non-therapeutic experiments that may put their health…
Marcia Angell: The Body Hunters & The Constant Gardner Mon, 19 Sep 2005 Marcia Angell’s insightful and informative review of the film and John le Carre’s book, The Constant Gardner, needs no additional commentary: "On the basis of the research I did for my book I believe that most of…
Protecting People with Mental Disabilities and Impairments against Biomedical Research Abuse[*] By John H. Noble, Jr., Ph.D, The Catholic University of America, Washington, DC, USA Vera Hassner Sharav, MLS, Alliance for Human Research Protection, New York, USA People with mental disabilities and impairments historically have been targeted by biomedical researchers…
Highest Court in Maryland Validates AHRP’s Position in Decision to Affirm Federal Prohibition on Non-Therapeutic Experimentation on Children To read the full text (98 pages) of the Maryland Court of Appeals decision, go to the following URL for a pdf version: http://www.law.uh.edu/healthlaw/law/StateMaterials/Marylandcases/grimesvkennedykreiger.pdf (Depending on the speed of your connection, it…
Efforts to Expand Emergency Exception from Informed Consent Thu, 6 Oct 2005 The following announcement posted to the IRB Forum by Dr. Robert Nelson, a KOL (key opinion leader) within the close-knit IRB community– who serve as gatekeepers of human research –demosntrates that the culture of secrecy is entrenched in…
Anthrax Vaccine Consent Form / Should You Roll Up Your Sleeves_WSJ Sat, 29 Mar 2003 The Administration’s determination to push its two controversial vaccine programs forward–smallpox and anthrax–even as medical experts urge caution in light of the serious health risks posed by these vaccines – raises serious questions about whose…
Hopkins Study: Medical Consent Forms Confusing Wed, 19 Feb 2003 A Johns Hopkins study reviewed the template of informed consent forms of 114 campuses– nearly all the country’s accredited medical schools. It applied two widely used readability tests and found the consent forms approved by local institutional review boards (IRB)…
