AHRP Recommendations for the protection of children in clinical research

THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Contact: Vera Hassner Sharav Tel. No: 212-595-8974 E-mail: John H. Noble, Jr., Ph.D Tel. No: 703-425-2120 PRESS RELEASE – October 21, 2002 AHRP Recommendations for the protection of children in clinical research (1) Federal regulations are predicated on our moral responsibility to protect…

AHRP Press Release Children Policy Recommendations

AHRP Recommendations for the protection of children in clinical research

(1) Federal regulations are predicated on our moral responsibility to protect children – who are not volunteers – from being subjected to medical or behavioral experiments that are not in their best interest. Thus, federal regulations – 45 CFR 46 Sub-part D – restrict the use of children in medical experiments involving greater than minimal risk, if there is no potential medical benefit for them or their condition.

Dissenting Opinion – Proposed Children’s Workgroup Reinterpretation of Fed Regs 45 CFR 46 sects. 404 & 406

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…

Conflicts of Interest in Clinical Trials

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.

Sharav Presentation before US Army Medical Dept., May 6, 2002

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…

Protecting Human Subjects in Research: Are Current Safeguards Adequate?

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.

InfoMail for March 31, 2002

  AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav March 31, 2002 Harvard research jeopardizedthe welfare of disadvantaged Chinese people while violating federal regulations. FYI Sadly, Harvard joins the list of prestigious academicresearch institutions that have…

InfoMail for March 8, 2002

  AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav March 8, 2002  FDA and Pharmaceutical Industry inPrivate Deal to Speed Drug Approval Process FYI According to the Washington Post, the FDA hasreached an agreement with the…

InfoMail for February 19, 2002

  AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav February 19, 2002 How a New FDA Policy Led toSeven Deadly Drugs FYI The Seattle Times reports, "Therelationship between the FDA and pharmaceutical industry changed fundamentallyunder former President…