Government Investigations 1990 to August 2001 National Bioethics Advisory Committee Report: ETHICAL AND POLICY ISSUES IN RESEARCH INVOLVING HUMAN PARTICIPANTS, 1998 Exhibit 3.1: Office of Protection from Research Risks (OPRR) Compliance Oversight Investigations Resulting in Restrictions/Actions to Institutions that have Multiple Project Asssurances (MPA) between January 1990 – June 2000…
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…
July 08, 2002 Critique: U.S. to Vaccinate 500,000 Workers Against Smallpox 7 Jul 2002 FYI Dr. Meryl Nass, a member of the board of The Alliance for Human Research Protection and a recognized expert on Gulf War Syndrome and the use and consequences of experimental vaccines, raises serious concerns about…
Infomail 2005 News Stories on Human Research Protection and Commentary by Vera Hassner Sharav Subscribe to the AHRP infomail list Dec 16: Drugs, Devices & Doctors – NYT Paul Krugman Dec 11: Scientific Fraud & Corruption on Both sides of Atlantic: Merck / Proctor & Gamble Dec 11: Gov Accountability…
Comments re: Smallpox Vaccine Trial on 2-5 year old children Mon, 2 Dec 2002 Recent public and professional debate about a smallpox vaccine trial and its risks provides the framework for evaluating the ethical justification for conducting clinical trials on children. The Alliance for Human Research Protection has submitted documented…
Abuses Endangered Veterans in Cancer Drug Experiments – NYT Sun, 6 Feb 2005 Paul H. Kornak pleaded guilty to fraud, making false statements and criminally negligent homicide in the death of an Air Force veteran, James DiGeorgio – one of the patients he used as subjects in medical experiments that…
MEMORANDUM Date: June 10, 2002 From: THE ALLIANCE FOR HUMAN RESEARCH PROTECTION Re: Opposition to AB 2328 To: Members of the California Health and Human Services Committee and Staff: Senator Deborah Ortiz (Chair), Mr. John Miller Senator Ray Haynes (Vice Chair), Ms. Debbie Rogers Senator Jim Battin, Ms. Katie Tinney…
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…
Federal Investigation of ARDS Study (Accute Respiratory Distress) OHRP conducted a compliance oversight evaluation of the 12 major sites participating in this clinical trial. OHRP’s determination letters documenting the outcomes of these evaluations can be viewed at the OHRP website at the following URLs: Note: OHRP found that federal informed…
July 26, 2002 Cancer Trials: 60% to 70% of subjects are children – Wall Street Journal The Wall Street Journal reports that there is a shortage of people volunteering to test experimental cancer drugs. “Overall, only 3% to 4% of cancer patients participate in trials. Most of those participants are…
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Tel. 212-595-8974 Fax: 212-595-9086 142 West End Ave. Suite 28P New York, NY 10023 Co-founders: Vera Hassner Sharav, President John H. Noble, Jr., PhD, Treasurer David Cohen, Ph.D., Secretary March 27, 2003 March 27, 2003 Senate Committee on Health, Education, Labor, and Pensions Dear…
