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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Ethical Violations and Investigations Today
Ethical Violations / Investigations Today Congressional Investigations Office of Human Research Protections (OHRP) Letters of Determination: http://ohrp.osophs.dhhs.gov/detrm_letrs/lindex.htm Office of Protection from Research Risks* (OPRR) List of Compliance Oversight Investigations Resulting in Restrictions or Actions to federally licensed Institutions between 1990 – 2000. *Reorganized in 2000 as OHRP Mar 30: AHRP…
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Infomail Archive, 2005
Infomail 2005 News Stories on Human Research Protection and Commentary by Vera Hassner Sharav Subscribe to the AHRP infomail list Dec 16: Drugs, Devices & Doctors – NYT Paul Krugman Dec 11: Scientific Fraud & Corruption on Both sides of Atlantic: Merck / Proctor & Gamble Dec 11: Gov Accountability…
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DHHS Report: Contradicting itself on drug imports – OpEd Peter Rost
DHHS Report: Contradicting itself on drug imports – OpEd Peter Rost Wed, 5 Jan 2005 Dr. Peter Rost, a Pfizer Vice-President of Marketing knows about the financial underpinnings of drug pricing. He has taken a consciencious public position (unsusual in that industry) because he believes the American public has a…
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OHRP Found NHLBI Lung Experiments Violated Informed Consent
OHRP Found NHLBI Lung Experiments Violated Informed Consent Mon, 7 Jul 2003 On July 3 the federal Office of Human Research Protections (OHRP) issued a stinging indictment of the research review and approval process at some of the nation’s most prestigious research institutions–including the National Heart Lung and Blood Institute…
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Research Compliance Note. Thomas Dalglish, JD, PhD
Analysis of 94 OHRP Letters of Determination, July 1, 2000 to January 31, 2001 Research Compliance Note. Thomas Dalglish, JD, PhD * The views expressed in the ‘Research Compliance Note’ below are the personal opinions of the author, do not reflect any official position of the University of Washington, and…
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More than 100 top regulatory officials represented industry as lobbyists, lawyers… – Denver Post
More than 100 top regulatory officials represented industry as lobbyists, lawyers… – Denver Post Mon, 24 May 2004 To understand why government policies affecting healthcare, drug safety, food safety and the environment appear to promote industry interests at the expense of public safety and health, the Denver Post has investigated…
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Lawsuit filed re: ALLHAT Hypertension research death of human subject
Lawsuit filed re: ALLHAT Hypertension research death of human subject Thu, 17 Jul 2003 The Bureau of National Affairs reports: “Just months after a groundbreaking blood pressure study made headlines across the nation, a principal investigator in the trial and his team have been sued in connection with the death…
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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…