FDA: regulatory protections for children. Comments submitted by Vera Hassner Sharav, John H. Noble, Jr., Ph.D and Howard Fishman, MEd, MSW for AHRP August 6, 2001 To: Dr. Bernard Schwetz Acting Commissioner Food and Drug Administration Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville,…
FOIA: OHRP Investigation – Brigham and Women’s Hospital Letter page one: Letter page 2: Letter page 3:
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 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…
