Dissenting Opinion: Against Waiving Parental Permission for Research July 25, 2001 To: Mary Faith Marshall, Ph.D, Chairperson, National Human Research Protections Advisory Committee Department of Health and Human Services Re: Specific Comment on FDA’s Decision to Adopt HHS 45 CFR 46 Subpart D, EXCLUDING §46.408 (c) Dissenting opinion of Vera…
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…
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…
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AIDS vaccine Worse Than Useless?_ISS Wed, 25 Jun 2003 An article published by the Institute of Science and Society (ISS locatedin the UK) cautions that experience thus far with 51 NIH-sponsored AIDSvaccinetrials (Phase I and II) belie the claimed positive findings made in anarticle in the currentissue of Vaccine, which…
Senate HELP Committee Votes to Send Children to Front Line of Drug Tests Sat, 22 Mar 2003 Washington Post columnist, Al Kamen, writes about the difficulty the Center for Disease Control (CDC) is having convincing its own staff members to be inoculated with the smallpox vaccine, despite (or perhaps because…
VA Orders Nationwide Review of Research_BNA Wed, 12 Mar 2003 Following several research-related deaths at the Albany VA, it was revealed that the researcher under whose care several patients died in clinical trials, was not even a licensed physician. The Bureau of National Affairs (BNA) Health Care Report states that…
China Daily update: Harvard genetic research in rural China Wed, 1 Oct 2003 “It’s the responsibility of the dean of the School of Public Health and, ultimately, it’s my responsibility as president of [Harvard] university to see to it that where wrong can be put right it is and, more…
FDA Advisor: “Ignore breast implant vote” Wed, 5 Nov 2003 Dr. Thomas Whalen, Chairman of FDA’s advisory committee that had voted on Nov 3 to approve with restrictions the resumption of silicone breast implants, wrote a letter to FDA Commissioner, Marc McLellan, urging him to ignore the committee’s vote and…
Integrity of Scientific Findings Marred Tue, 2 Dec 2003 Two cases shed light on a cultural malaise and the price we pay when scientists fail to adhere to scrupulous scientific methods: Dr. Thomas Butler, chief of infectious diseases division of Texas Tech University, ran afoul of the law; Dr. George…
Brain Development &Teen Mood Swings – ABC Sun, 24 Aug 2003 ABC reports about a brain imaging study using MRI that tracks the brains of normal children. This study provides physical evidence about the biological development of the normal brain and the individual pace of normal development. What’s new, according…
FDA Approves Lilly’s Growth Hormone for Healthy Children Mon, 28 Jul 2003 The FDA has approved Eli Lilly’s injectable human growth hormone (hGH) therapy, Humatrope, for healthy children who are short but have no hormonal deficiency. Lilly claims that its trials in 300 healthy short children resulted in an increase…
