Rehnquist Warns Drug Makers _Marketing Actimune for Unapproved Use_NYT Mon, 28 Apr 2003 1. The New York Times reports that Janet Rehnquist, the Inspector General of the Department of Health and Human Services, has issued “a compliance guide for drug manufacturers” in which they are waned that many of their…
FDA Warning Letter Re: Fatal Experiment: Hexamethonium Inhalation_Johns Hopkins Tue, 22 Apr 2003 An FDA Warning Letter was sent to Dr. Alkis Togias of the Johns Hopkins University Asthma & Allergy Center (March 31, 2003). The letter lists specific federal safety requirements and their violation in the hexamethonium inhalation experiment…
References for THE IMPACT OF THE FDA MODERNIZATION ACT ON THE RECRUITMENT OF CHILDREN FOR RESEARCH Vera Hassner Sharav Published in ETHICAL HUMAN SCIENCES & SERVICES Summer 2003, vol. 5 pp. 83-108 Agency for Health Care Research & Quality. (1999). Treatment of attention-deficit/hyperactivity disorder: Summary, evidence Report / Technology assessment…
Infomail Archive – Pre 2003 News Stories on Human Research Protection and Commentary by Vera Hassner Sharav December 28, 2002: Will 2 to 5 year old Amer. kids be exposed to Smallpox Vaccine? Israeli Intelligence says “No immediate threat” December 24, 2002: Moral turpitude: Herpes experiment surpasses Tuskegee December 20,…
Ethics Questioned in Lung Disease Trial–Feds Demand Patient Data – Newhouse News December 13, 2002 A news breaking story by Bruce Seeman of Newhouse News (excerpts below) reveals a major systemic breakdown in medical ethics–“there’s something rotten in the state of [biomedical research].” Complaints about a lung disease air ventilation…
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…
AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav May 13, 2002 Experimentationon Newborns: Is it Ethical? FYI The Wall Street Journal reported: "Oneoutrage now before a court has stunned even bioethicists who thought they’d seenit…
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…
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.
AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav April 14, 2002Clinical Trials Given "At Your Own Risk" FYI TIME Magazine’s cover story, "At Your Own Risk,"(excerpts below) focuses on several high profile research scandals that…
April 4, 2002. Boston Globe. Institute of Medicine worries that public trust is threatened by deaths. By Michael Kranish and Alice Dembner. The IOM report did not satisfy some longtime observers. ”The IOM committee, headed by a Harvard University dean, disingenuously recommended entrusting `the responsibility for ensuring that protective rules…
