Who is a Human Subject? Who has the Right to Informed Consent? March 11, 2002 "The voluntary consent of the human subject is absolutely essential." [Nuremberg Code, 1947] "Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or…
OHRP Investigation of experimental treatment for Acute Respiratory Distress Syndrome. ARDSNet studies: ARMA, FACCT, and ALVEOLI Table of Contents to Fax from OHRP page 1 Oct. 7, 2002 OHRP letter to: Ronald S. Newvbower, Ph.D(Mass. General Hospital), Lee E. Limbird, Ph.D. (Vanderbilt University), and Robert Kay, MD) (Cleveland Clinic Foundation)…
AP Exclusive: Top US Officials at NIH Knew of AIDS Drug Risks and Failed to Inform White House Mon, 13 Dec 2004 The Associated Press reports: "Less than a month after Bush announced a $500 million plan to push nevirapine across Africa to slow the AIDS epidemic, the Health and…
Wed, 04 May 2005 Researchers Tested AIDS Drugs on Children, Associated Press On March 10, 2004, The Alliance for Human Research Protection filed a complaint with the FDA and the federal Office of Human Research Protection about a series of AIDS drug experiments conducted on New York City children in…
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) August 21, 2002 Comments Re: DHHS Notice of Proposed Recommendation Regarding Support of Research Protocol: "Precursors to Diabetes in Japanese American Youth" Grant Number I R01 DK59234-01 The proposed experiment would involve 450 children healthy children, aged 8-10 years old, 300 of Japanese ancestry…
THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) 142 West End Ave, Suite 28P New York, NY 10023 212-595-8974 ahrp@researchprotection.org September 4, 2002 Michael Carome, MD Associate Director for Regulatory Affairs Office for Human Research Protections The Tower Building 1101 Wootton Parkway, Suite 200 Rockville, Maryland 20852 Re: Acute Respiratory Distress…
August 7, 2002 University of California Seeks to Ease Curbs on Patient Protection in Research – LA Times FYI Thanks to a series of articles, in the San Francisco Chronicle and Los Angeles Times, the public has been made aware about the back-door efforts to pass a bill in California…
University of Washington Violated Federal Protections for Human Research Subjects Thu, 21 Apr 2005 A major research scandal reveals that the University of Washington in Seattle is in gross systemic violations of federal research regulations. Experiments that were conducted on vulnerable populations – including, pregnant women, neonates, children, prisoners–should never…
THE ALIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) 142 West End Avenue, Suite 28P New York, NY 10023 www.ahrp.org FDA Docket Number 02N-0466 Comments re: Proposed smallpox vaccine trial to test the safety of Dryvax administration to children 2 to 5 years of age Recent public and professional debate about smallpox…
OHRP Response to AHRP re: Surrogate Consent to Research Office of the Secretary Department of Health & Human Services Office of Public Health and Science Office for Human Research Protections Rockville, Maryland E-mail: mcarome@osophs.dhhs.gov August 28, 2002 Vera Hassner Sharav President, The Alliance for Human Research Protection John H. Noble,…
Aug 20, 2002 Medical Science Violating Children – 450 healthy children targeted – Redflagsweekly FYI Redflagsweekly is the first online health news service to pick up on a news item provided in yesterday’s AHRP Infomail about a proposed experiment (whose researcher seeks government funding) to be conducted on 450 children…
<p> Big Pharma’s Shameful Secret – Bloomberg News <br> Most Clinical Trials Stopped Early for “perceived” benefit later turned out false – JAMA </p> <p> Thu, 3 Nov 2005 </p> <p> A six part Special Report by Bloomberg News reveals that “Every year, drug companies spend $14 billion to test…
