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.
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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.
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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…
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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…
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NIH Rule change Re: Whistle blowers – Comments before June 15
NIH Rule change Re: Whistle blowers – Comments due before June 15 Mon, 19 Apr 2004 Dear friends and colleagues, A request for comment about NIH proposed new research misconduct rule See Fed Register: http://ori.dhhs.gov/multimedia/acrobat/42CFRParts50and93.pdf The new rule, I believe is meant to protect research institutions from the effective sting…
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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…
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OHRP Compliance Letters
ETHICAL AND POLICY ISSUES IN RESEARCH INVOLVING HUMAN PARTICIPANTS National Bioethics Advisory Commitee (NBAC) Final Report, 2001 Exhibit 3.1: Office of Protection from Research Risks (OPRR) Compliance Oversight Investigations Resulting in Restrictions/Actions to Institutions that have Multiple Project Assurances (MPA) between January 1990 – June 2000 Year, Institution and Action…
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Calls Mounting for FDA Revamp / Americans Are the most medicated population in the world – DHHS
Calls Mounting for FDA Revamp / Americans Are the most medicated population in the world – DHHS Sun, 26 Dec 2004 A government survey by the U.S. Department of Health and Human Services, confirms that Americans are the most medicated population in the world – 44 percent of Americans had…
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AHRP Comments – Precursors to Diabetes in Japanese American Youth
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) August 21, 2002 Comments Re: DHHS Notice of Proposed Recommendation Regarding Support of Research Protocol: "Precursors to Diabetes in Japanese American Youth" Grant Number I R01 DK59234-01 The proposed experiment would involve 450 children healthy children, aged 8-10 years old, 300 of Japanese ancestry…
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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…
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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…
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FDA Requests Fed Investigation Of Itself After It Lost Medical Records
FDA Requests Fed Investigation Of Itself After It Lost Medical Records Wed, 16 Apr 2003 FDA Commissioner, Dr. Mark McClelan has requested an independent investigation of a bone density study conducted jointly by an FDA investigator and another affiliated with the Henry Jackson Foundation for the Advancement of Military Medicine….