Informed Consent


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 […]

AHRP Comments on Smallpox Vaccine Testing on Children


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 […]

Federal Investigation of ARDS Study (Accute Respiratory Distress)




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 […]

Abuses Endangered Veterans in Cancer Drug Experiments – NYT


Int’l Registration of Clinical Research WHO Tue, 6 Apr 2004 On April 3, the World Health Organization (WHO) and Current Controlled Trials, Ltd (based in London, Philadelphia and Tokyo) announced that all randomized controlled clinical trials approved by the WHO ethics committee will be registered in a unique international registry […]

Int'l Registration of Clinical Research WHO




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 […]

Children are Humans: Don't Sacrifice their Rights, Dignity & Welfare


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) […]

OHRP Letter to ARDSNetwork re: Investigation of Acute Respiratory DistressSyndrome


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, […]

OHRP Response to AHRP re: Surrogate Consent to Research