University of Calif, SF: Patients Rights Violated_SF Chronicle

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…

Government Investigations, 1990 – 2001

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

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 Lead Paint Experiment Endangers Children

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…

AHRP Initiatives

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

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….

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Dissenting Opinion: Against waiving parental permission for research

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…