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 some drug firms from punitive…

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August 26, 2002 OHRP Retreats from Providing Public Info re: Compliance Activities FYI A newly posted announcement by the Office of Human Research Protection (OHRP), dated July 15, rescinds the agency’s announced policy of making public the content of its letters of determination following the agency’s investigation of compliance / noncompliance with federal human protection…

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AHRP Letter to Editor re: ARDS published NEJM Fri, 11 Jul 2003 A truncated version of a Letter to the editor submitted by John H. Noble, Jr., PhD and Vera Sharav appears in the current July 10, 2003, issue of The New England Journal of Medicine. Note: On April 3, 2003 the NEJM published several…

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Greatest Experiment Ever Performed: exploding the Estrogen Myth Wed, 9 Jul 2003 A newly published book by Barbara Seaman, “The Greatest Experiment Ever Performed on Women: Exploding the Estrogen Myth,” Hyperion Press, should provide women with the ammunition they need to confront the medical / pharmaceutical / establishment, including the FDA and the National Institutes…

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Suffer the Little Children in the Research for Cures_USA Today Thu, 29 May 2003 USA Today focuses on safety issues affecting children who are being sought as human guinea pigs by the thousands. They are being recruited clinical trials to test new drugs– whose safety is unproven. “Was the death of Ryan Lucio — and…

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Don’t Medicate Away Student Angst – Chronicle Higher Ed Sun, 15 Jun 2003 The Chronicle of Higher Education has published a superb essay by Joli Jensen, a professor of communications from the University of Tulsa. Jensen recognizes the harmful effects of medicating students to suppress their experience of normal, turbulent, and necessary emotions. Hers is…

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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 and 150 Caucasians. The experiment…

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THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) www.ahrp.org Proposed Changes to Subpart D Regulations Increase Risks to Children in Non-Therapeutic Research Statement of the AHRP Opposing the SACHRP Children’s Committee Recommendations April 18, 2005 The Alliance for Human Research Protection (AHRP) welcomes the opportunity to respond to the question “What is the Best Way to…

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The Alliance for Human Research Protection (AHRP) welcomes the opportunity to respond to the question “What is the Best Way to Protect Children?”

Our recommendation – which is backed up by evidence that children have suffered harm in medical research – is to significantly limit the discretion of IRBs to approve greater than minimal risk research without direct benefit for the child-subjects under 46.406.

We recommend staying the course in requiring that any such proposed experiment undergo a transparent open evaluation with ample opportunity for public oversight and comment – as required under the provisions of 46.407.

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