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…
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…
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.
Moral turpitude: Herpes experiment surpasses Tuskegee. December 24, 2002. The National Institute of Allergy and Infectious Diseases has awarded St. Louis University, close to $37 million to conduct an investigational herpes vaccine trial (Herpevac) on young women. The experiment demonstrates that the moral culture in which American medical researchers practice…
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.
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.
"The voluntary consent of the human subject is absolutely essential," reads the Nuremberg Code of 1947, which was drafted in direct response to the sheer barbarity of Nazi-era medical experiments on Jews and other captive groups.
Public Comments Re: Smallpox Vaccine Trial on 2 to 5 Year Old Children Please do not place young children in jeopardy by testing this vaccine on them. Children’s bodies and minds are still fragile and growing, and a vaccine that has so far caused many adverse reactions in adults can…
