Update: Ramifications of Swine Flu Vaccine Immunity
In 2006, PREPA was passed due to fear of an avian flu pandemic, in the event the avian
flu virus mutated to enable person-to-person spread. Avian flu then had a 70% death rate.
Does the FDA have the authority to trump the Declaration of Helsinki?
The FDA is sliding rapidly down the slippery slope, abandoning widely accepted, international ethical research standards articulated in the internationally accepted, Declaration of Helsinki–to facilitate commercial medical experiments.
Congressional Investigation of NIH: Cash Gifts From Grantees
Congressional Investigation of NIH: Cash Gifts From Grantees Tue, 8 Jul 2003 The Scientist reports that a Congressional committee is investigating the for “possible violations of federal criminal and ethics laws” involving Richard Klausner (former director of the National Cancer Institute) and other officials who accepted “lecture awards” and other…
Infomail Archive 2004
Infomail 2004 News Stories on Human Research Protection and Commentary by Vera Hassner Sharav Dec 31: FDA to review “missing” drug company documents Dec 30: Family of Woman Killed by AIDS Drug Test Sues Doctors, Manufacturer Dec 30: Doctors, Too, Ask: Is This Drug Right? Dec 29: Bill would shield…
Featured News
AHRP Speaks Out AHRP Press Briefing 9/14/04: Antidepressants & suicide-related risks for children Open Letter to NIMH re Prozac & Concealed Suicide Attempts Open Letter to Officials at NIMH AHRP Briefing 2/2/04: Scientists present suicide evidence Conflicts of Interest policy – New York Times Phase I Drug Trials Used Foster…
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…
OHRP Backtracks on Public Disclosure – BNA
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…
AHRP in the News
Alliance for Human Research Protection in the Press Feb 17, 2005: FDA Critics Slam Plan for Safety Reform – Nature “This is smoke and mirrors and musical chairs,” says Vera Sharav, president of the New York-based Alliance for Human Research Protection. “They will be using the very same officials that…
Yale Complaint
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 &…
Almost 1/2 of faculty on IRBs have ties to industry – Harvard Partners
Almost 1/2 of faculty on IRBs have ties to industry – Harvard Partners Fri, 15 Aug 2003 A survey by faculty at the Institute for Health Policy, Massachusetts General Hospital (MGH) and Harvard Medical School found that “Consulting relationships with industry are common among faculty IRB members….Our previous research with…
Students call for ouster of researcher
Subject: Students call for ouster of researcher_AAMC COI guidelines Date: Tue, 24 Sep 2002 17:03:54 -0400 Students of the University of Pennsylvania reacted to the NBC’s Dateline airing of Jesse Gelsinger’s tragic death–a casualty of a lethal culture. In an editorial in the Daily Pennsylvanian (an independent student newspaper), the…
Who is a Human Subject?
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…