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…
AHRP Campaign to Protect Children from Harm Oct 15: FDA Orders Black Box Warnings on Antidepressants labels and Patient Information Guides to Warn about Suicide risk Oct 3: BBC PANORAMA TONIGHT – Taken on Trust – 13 years-Medical Deception Sep 30: GSK Sales Reps told NOT to Divulge Paxill Data…
August 26, 2002 OHRP Retreats from Providing Public Info re: Compliance Activities FYI A newly posted announcement by the Office of Human Research Protection (OHRP), dated July 15, rescinds the agency’s announced policy of making public the content of its letters of determination following the agency’s investigation of compliance /…
AHRP Letter to Editor re: ARDS published NEJM Fri, 11 Jul 2003 A truncated version of a Letter to the editor submitted by John H. Noble, Jr., PhD and Vera Sharav appears in the current July 10, 2003, issue of The New England Journal of Medicine. Note: On April 3,…
Protecting People with Mental Disabilities and Impairments against Biomedical Research Abuse[*] By John H. Noble, Jr., Ph.D, The Catholic University of America, Washington, DC, USA Vera Hassner Sharav, MLS, Alliance for Human Research Protection, New York, USA People with mental disabilities and impairments historically have been targeted by biomedical researchers…
