Recent developments in gene transfer research: risk and ethics Mon, 10 Jan 2005 An analysis by Dr. Jonathan Kimmelman, in the British Medical Journal provides an illuminating, clearly articulated discussion about the ethical dilemmas that challenge gene transfer experiments – essentially a kind of human genetic engineering involving somatic cells, in which a genetically engineered…

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Advisory Committee tells FDA: strengthen warnings on SSRI drug labels now Wed, 4 Feb 2004 On February 2, more than 60 families and children from all across America testified at a public FDA advisory committee hearing describing (in 2 minutes) how their children suffered drug-induced harm after being prescribed an SSRI antidepressant drug. Some parents…

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July 23, 2002 Unhealthy Hospitals – 103,000 preventable deaths in 2000 – Chicago Tribune FYI The next time someone suggests that you to enter a clinical trial at a hospital, beware: “The number of people needlessly killed by hospital infections is unbelievable, but the public doesn’t know anything about it. For years, we’ve just been…

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Testimony by Vera Hassner Sharav, President ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) www.ahrp.org Hearing of the NYS Assembly Committee on Health and Committee on Children and Families September 8, 2005 New York City I speak on behalf of the ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP), the organization that filed the federal complaint about the enrollment…

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THE ALLIANCE FOR HUMAN RESEARCH PROTECTION Testimony by Vera Hassner Sharav Committee on the Use of Third Party Toxicity Research with Human Research Participants Science, Technology, and Law Program The National Academies of Science January 8, 2003 My name is Vera Sharav and I am the president and founder of The Alliance for Human Research…

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Testimony by Vera Hassner Sharav before the Committee on the Use of Third Party Toxicity Research with Human Research Participants; Science, Technology, and Law Program; The National Academies of Science Committee on the Use of Third Party Toxicity Research with Human Research Participants

My name is Vera Sharav and I am the president and founder of The Alliance for Human Research Protection (AHRP) a citizens’ watchdog organization monitoring human research to ensure that the moral principles enshrined in the Nuremberg Code and the Declaration of Helsinki are preserved and followed in experiments involving human beings.

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Dying for a Cure: Pediatric Cancer Trial Undisclosed facts – NBC, Chicago Thu, 14 Nov 2002 How can parents protect their children from harmful medical experiments if the facts are withheld from them? So far, Congress has enacted no law to protect children from experiments that disregard their life-safety in clinical trials. An investigative news…

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Dissenting Opinion (NHRPAC Children Workgroup) re: Proposed Reinterpretation of Fed. Regs Protecting Children (45 CFR 46, sections 404 and 406) May 14, 2002 To: Alan Fleischman, MD, Chair, Children’s Workgroup of NARPAC        Mary Faith Marshall, Ph.D., Chair, NARPAC From: Vera Hassner Sharav Re: Dissenting Opinion re: Report to NHRPAC, proposing changed reinterpretation of federal regulations:…

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Current federal regulations set no limits on the level of risk that a competent adult may voluntarily choose to undertake for the sake of science. The regulations require prior approval by a review board (IRB) to ensure the research meets scientific and ethical justification, to ensure that the risks and benefits (if any) are fully disclosed to the subject, and that the subject can exercise the right to give or withhold informed consent.

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