July 29, 2002 University of Calif, SF: Patients Rights Violated – San Francisco Chronicle FYI The San Francisco Chronicle reports in a front page article that the federal Office of Human Research Protection determined that University of California, San Francisco, violated patients’ rights by conducting medical research without legal informed…
China Daily update: Harvard genetic research in rural China Wed, 1 Oct 2003 “It’s the responsibility of the dean of the School of Public Health and, ultimately, it’s my responsibility as president of [Harvard] university to see to it that where wrong can be put right it is and, more…
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…
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…
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…
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…
Protecting Human Subjects in Research: Are Current Safeguards Adequate? AHRP Testimony submitted to Congressional Committee April 23, 2002 Vera Hassner Sharav, President, and John H. Noble, Jr., Ph.D., steering committee member, The Alliance for Human Research Protection (AHRP), before the Subcommittee on Public Health, Committee on Health, Education, Labor, &…
<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…
Research dispute prompts patient-trials debate_Seattle Times Mon, 19 May 2003 Newhouse News Service reports that the continuing dispute about the ethics and design of a multi-site lung ventilation experiment sponsored by the National Heart, Lung, and Blood Institute (NHLBI) and conducted by the ARDSNetwork on 861 critically ill patients with…
AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav April 10a, 2002 U.S. Bio-Tech Start-ups Conducting CheapPreliminary Studies in China FYI Harvard University is not the only one exploiting China’spoor population for medical experiments. Violations of…
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…
Testimony Submitted to the Office of Human Research Protection (OHRP) by Vera Hassner Sharav and Marie M. Cassidy, Ph.D, D.Sc. April, 2001 AHRP recognizes that to include children in clinical trials for any medication presents a dilemma of truly Solomonic proportions. It is a choice between continuing the practice of…
