World Medical Association DECLARATION OF HELSINKI Â Ethical Principles for Medical Research Involving Human Subjects Adopted by the 18th WMA General Assembly Helsinki, Finland, June 1964 and amended by the 29th WMA General Assembly, Tokyo, Japan, October 1975; 35th WMA General Assembly, Venice, Italy, October 1983; 41st WMA General Assembly, Hong…
Ethical Violations / Investigations Today Congressional Investigations Office of Human Research Protections (OHRP) Letters of Determination: http://ohrp.osophs.dhhs.gov/detrm_letrs/lindex.htm Office of Protection from Research Risks* (OPRR) List of Compliance Oversight Investigations Resulting in Restrictions or Actions to federally licensed Institutions between 1990 – 2000. *Reorganized in 2000 as OHRP Mar 30: AHRP…
Ethical Standards and Codes Institute of Medicine of the National Academy of Sciences. Committee Report & Public Briefing, Oct. 3, 2002 The Hippocratic Oath The Nuremberg Code Declaration of Helsinki The Belmont Report Additional Codes and Declarations Relevant to the Health Professions: Amnesty International Federal Policy for Protection of Human…
Congressional Investigations Senate Finance Committee Investigates FDA Aug 4: Sen. Grassley letter (416 K pdf) to 8 drug companies requests list of all antidepressant tests on children (1/1/1990–7/23/2004) Aug 3: Drug safety Hearings-Sept-Congress/ FDA – Lilly Plans to Disclose Data Jul 15: Senate Letter to FDA re: disclosure of risks…
China Daily A farming family’s recollection 2003-09-25 http://www1.chinadaily.com.cn/en/doc/2003-09/25/content_267233.htm Near-death experience after 55-year-old father of four inhales ‘fog-like’ spray China Features reporters XIONG LEI and WEN CHIHUA recently visited Zongyang County, in East China’s Anhui Province, to further dig into the allegations surrounding Harvard’s genetic studies in China. Their investigation was…
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,…
Amnesty International’s Compilation of Additional Codes and Declarations Relevant to the Health Professions To read about the various codes of professional ethics for the various health professions, please click on the blue URL below (pdf file). http://www.web.amnesty.org/aidoc/aidoc_pdf.nsf/index/ACT750052000ENGLISH/$File/ACT7500500.pdf
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…
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…
Randomized Controlled Trials: Evidence Biased Psychiatry By David Healy, MD MRCPsych Introduction A new drug gets introduced to the market. It has been approved after stringent scrutiny by the FDA, which requires ever more convincing evidence that it works and that its safe. The new treatment will always cost more…
Reply to the American College of Neuropharmacology’s Report on SSRI and Suicidal Behavior in Children Jonathan Leo, Ph.D. Introduction The American College of Neuropsychopharmacology (ACNP) recently released an Executive Summary from its Task Force on SSRIs and Suicidal Behavior. The task force concluded that "taking Selective Serotonin Reuptake Inhibitors (SSRIs)…
FDA response to AHRP procedural questions From: Cerny, Igor Sent: Wednesday, January 07, 2004 11:52 AM To: Cc: Patel, Anuja; Laughren, Thomas P Subject: RE: FDA Advisory Committee Meeting: Procedural Concerns Follow Up Flag: Follow up Flag Status: Flagged Dear Ms. Sharav: Thank you for your email of December 1,…
