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…
Fed Investigation Report: AIDS Drug Tests on Foster Kids Violated Rules Thu, 16 Jun 2005 related link: OHRP Letter of Determination, Columbia University Medical Center, May 23, 2005 (32 K pdf) The Associated Press reports that an investigation by the U.S. Department of Health and Human Services’ Office of Human…
Johns Hopkins University Experiment on Lead Paint Puts Children in Danger August 24, 2001 FYI Additional details are emerging about the lead-paint study conducted on infants and children by researchers at the Kenney Krieger institute which is affiliated with Johns Hopkins University. Today’s New York Times reports (below) that the…
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…
Research Protection: SCIENCE / Fed Paper Mon, 28 Oct 2002 SCIENCE magazine (below) reported about “the bumpy road” of Dr. Greg Koski’s tenure as director of the federal Office of Human Research Protections (OHRP), and how his resignation is being perceived by some. An article in The FEDERAL PAPER focused…
AHRP Initiatives Campaign for the Protection of Vulnerable Individuals September 13, 2002: National Disability Rights Activists Oppose Cal. AB2328 September 5, 2002: Do the Ends Justify the Means in Human Research? September 4, 2002: AHRP Replies to OHRP Response re Surrogate Consent (ARDS Study). August 28, 2002: OHRP Response…
Was Traci Johnson driven to suicide by anti-depressants? That’s a trade secret, say US officials Sun, 19 Jun 2005 The dirty secret is finally tumbling out: Government agencies that are supposed to protect the public interest are shielding drug manufacturers by helping to conceal deaths and suicides in drug experiments….
Dissenting Opinion: Against Waiving Parental Permission for Research July 25, 2001 To: Mary Faith Marshall, Ph.D, Chairperson, National Human Research Protections Advisory Committee Department of Health and Human Services Re: Specific Comment on FDA’s Decision to Adopt HHS 45 CFR 46 Subpart D, EXCLUDING §46.408 (c) Dissenting opinion of Vera…
September 5, 2002. OHRP Backtracks on Public Disclosure – Bureau of National Affairs FYI In Aug. 2000, when the Office of Human Research Protections replaced the former Office of Protection from Research Risks there was much talk about openness, accessibility, transparency and public accountability. One new feature was the posting…
Death of Baby Prompts Scrutiny of Research Risks_St. Louis Post Dispatch 16 Feb 2003 Eighteen month old, Daniella Rogers, died on May 3, 2002, two months after undergoing a clinical trial of chemotherapy treatments at St. Louis Children’s Hospital. When her parents, John and Oksana Rogers, learned that their baby…
ALLIANCE FOR HUMAN RESEARCH PROTECTION* (AHRP) April 10, 2000 Gary Ellis, Ph.D, Director Michael A. Carome, M.D. Chief Compliance Oversight Branch Division of Human Subject Protections Office of Protection from Research Risks Rockville, MD 20892-7507 Re: High Risk Experiment With Children Who Have No Medical Diagnosis Dear Dr. Ellis &…
Ethics / Science of ARDS Controversy Continues – J Medical Ethics-BMJ Thu, 6 Oct 2005 The ethics and science of a controversial clinical trial sponsored by the US government and conducted at multiple sites by the ARDS Network comprising of prestigious academic medical centers is the subject of a continuing…
