Do the Ends Justify the Means in Human Research? Thu, 5 Sep 2002 A moral struggle is taking place in which research stakeholders–including medical institutions that profit from biomedical research, and their emissaries in government oversight agencies–argue that ethics should be breached to further the interest of research. Patients’ rights…
Thank you for your considered response to our July 29 letter to the director of the Office of Human Research Protection.
We are astonished to learn that OHRP found that all 12 major research institutions involved in this multi-site trial had violated Federal protections (45 CFR 46.117):
(a) "in all cases OHRP found that the informed consent documents approved by the institutional review boards (IRBs) for the research failed to describe adequately the reasonably foreseeable risks and discomforts of the research."
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 is not approvable under federal regulations, 45 CFR 46 Subpart D because it involves greater than minimal risk and no potential direct benefit to the children.
THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) New York, NY 10023 212-595-8974 July 29, 2002 Greg Koski, MD, Ph.D. Office of the Secretary Office of Public Health and Science Office of Human Research Protection The Tower Building 1101 Wooten Parkway, Suite 200 Rockville, MD 20852 RELATED PAGES OHRP Investigation of…
High Mortality Rates in Clinical Trials Mon, 4 Nov 2002 Serious concerns are being raised about the high death rate in clinical trials. According to several articles in the American Journal of Respiratory and Critical Care Medicine, the lives of critically ill patients have been put at increased risk due…
Acute Respiratory Distress Syndrome – ARDSNet experiment criticized – OHRP Fri, 28 Feb 2003 An Acute Respiratory Distress Syndrome (ARDS) study conducted between 1996 and 1999, on critically ill patients at 20 medical facilities (14 major research centers belonging to the ARDS Network), was published in The New England Journal…
Why did OHRP SHRED informed consent documents? Sat, 25 Oct 2003 China Daily’s premier medical correspondent, XIONG LEI, raises embarrassing questions that should trouble Americans, not just the bioethics and research community. She makes a plea for justice for some 200,000 Chinese farmers who were used in 12 genetic experiments…
Harvard research in China: Open Letter to Pres. Summers Sat, 12 Apr 2003 On May 15, 2002, The Boston Globe reported that Lawrence Summers, the President of Harvard University, “expressed deep regret that a dozen Harvard-run genetic studies in China failed to give test subjects adequate information about potential pitfalls.”…
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…
Presented by Vera Hassner Sharav
14th Tri-Service Clinical Investigation Symposium
Sponsored by The U.S. Army Medical Department and The Henry M. Jackson Foundation for the Advancment of Military Medicine
The cornerstone of public trust in medical research is the integrity of academic institutions and the expectation that universities, which rely on public funding, have a responsibility to serve the public good. Financial conflicts of interest affect millions of American people – those who are subjects of clinical trials testing new drugs and those who are prescribed drugs after their approval.
CONFLICTS OF INTEREST Presented by Vera Hassner Sharav 14th TRI-SERVICE CLINICAL INVESTIGATION SYMPOSIUM Sponsored By THE U.S. ARMY MEDICAL DEPARTMENT And THE HENRY M. JACKSON FOUNDATION FOR THE ADVANCMENT OF MILITARY MEDICINE May 5-7, 2002 The cornerstone of public trust in medical research is the integrity of academic institutions and…
AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav April 29, 2002 China Daily: Harvard Project ViolatesFarmers’ Rights FYI American experiments on impoverished populations inunderdeveloped countries needs much more oversight than seems to have beenprovided. XIONG…
