April 2003. American Journal of Bioethics. Children in Clinical Research: A Conflict of Moral Values. Vera Hassner Sharav http://mitpress.mit.edu/journals/AJOB/3/1/sharav.pdf ABSTRACT (attached & below) This paper examines the culture, the dynamics and the financial underpinnings that determine how medical research is being conducted on children in the United States. Children have…
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…
Efforts to Expand Emergency Exception from Informed Consent Thu, 6 Oct 2005 The following announcement posted to the IRB Forum by Dr. Robert Nelson, a KOL (key opinion leader) within the close-knit IRB community– who serve as gatekeepers of human research –demosntrates that the culture of secrecy is entrenched in…
Hearing on Antidepressants Canceled – Washington Post Wed, 21 Jul 2004 The Washington Post confirms AHRP’s assessment about the real reason for the derailment of a much awaited congressional hearing at which the giants of the pharmaceutical industry were to testify: “A Democratic staff member who spoke on the condition…
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…
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…
Experimentation on Newborns: Is it Ethical? News Stories on Human Research Protection and Commentary by Vera Hassner Sharav May 13, 2002 FYI The Wall Street Journal reported: "One outrage now before a court has stunned even bioethicists who thought they’d seen it all. In 1985, University of Wisconsin (UW) researchers…
Fast growing business: Unethical clinical trials in India – Asia Times Tue, 27 Jul 2004 Asia Times reports: “India increasingly emerges as a preferred destination for outsourcing clinical trials – testing of new drugs on humans – the country may also be heading toward providing the greatest source of human…
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…
Dr. Wolpe’s Accusations and Dr. Healy’s Response —–Original Message—– From: Paul Root Wolpe Sent: Tuesday, October 28, 2003 4:30 PM To: VERACARE Subject: Re: Ethics of U Penn surgical “drug implant” experiment Vera, We will have to agree to disagree, so this will be my last email on this. A…
September 9, 2002 Human Pesticide Experiment: The Slippery Slope – Sunday Herald Note: more info. available on AHRP’s human pesticide experiment page. FYI Pesticide experiments are unethical because human beings are exposed to poisonous substances. Because there is absolutely no potential therapeutic purpose, such experiments violate the Nuremberg Code. The…
Broken Brains or Flawed Studies? Thu, 24 Jul 2003 Broken Brains or Flawed Studies? A critical review of ADHD imaging studies by Jonathan Leo, Ph.D and David Cohen, Ph.D methodically demonstrates how scientifically flawed methodology undermines the integrity and claimed findings of over 30 imaging studies that are the basis…
