Linguistic Tinkering with Regulatory Terminology Increases Risk of Harm for Children: "minimal risk" "minor increment of minimal risk" and "disorder or condition" January 28, 2001 A cornerstone of the Declaration of Helsinki (adopted by the World Medical Association in 1964, and reaffirmed on Oct. 2000) is the distinction between research…
Public Comments Re: Smallpox Vaccine Trial on 2 to 5 Year Old Children The Code of Federal Regulations (45 CFR 46.407) requires that any experiment involving children which puts them at greater than minimal risk without a potential benefit to justify the risk, requires the Secretary of Health and Human…
Protecting Human Subjects in Research: Are Current Safeguards Adequate? AHRP Testimony submitted to Congressional Committee April 23, 2002 Vera Hassner Sharav, President, and John H. Noble, Jr., Ph.D., steering committee member, The Alliance for Human Research Protection (AHRP), before the Subcommittee on Public Health, Committee on Health, Education, Labor, &…
Ethical and Scientific Objections to FDA’s Proposed Licensure of Anthrax Vaccine Fri, 01 Apr 2005 Government agencies are maneuvering to weaken legal protections prohibiting the exposure of human beings to experimental drugs, vaccines and procedures without their voluntary informed consent. Even after a federal court has ordered the Pentagon to…
Ethics / Science of ARDS Controversy Continues – J Medical Ethics-BMJ Thu, 6 Oct 2005 The ethics and science of a controversial clinical trial sponsored by the US government and conducted at multiple sites by the ARDS Network comprising of prestigious academic medical centers is the subject of a continuing…
Comments re: Smallpox Vaccine Trial on 2-5 year old children Mon, 2 Dec 2002 Recent public and professional debate about a smallpox vaccine trial and its risks provides the framework for evaluating the ethical justification for conducting clinical trials on children. The Alliance for Human Research Protection has submitted documented…
Subject: Drug Test Loopholes Date: Mon, 7 Oct 2002 09:08:50 -0400 The medical, legal and ethical repercussions of the use of untested medical products–including the smallpox vaccine– have not been publicly debated. Below is a column by Meryl Nass, MD, that appeared online at Redflagsweekly.com in August, addressing the inadequate…
Soldier vaccinated with anthrax / smallpox died shortly from pneumonia: Army coverup- UPI Sat, 9 Aug 2003 It would appear that suppressing negative results – in this case, probably death from pneumonia that followed inoculation with two experimental vaccines – anthrax and smallpox – is the norm and practice both…
AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav March 15a, 2002 Harm to Alzheimer ExperimentalPatients FYI ABC reports that Bob Helms, the self-described humanguinea pig, has written a book about his experience and observations about…
More detailed comments Children should not be tested for the Dryvax vaccine for the following reasons: 1) The original trials for the Dryvax vaccine already show that children respond similarly to adults when administered this substance. Since the effective dosage for adults has already been tested, it would be…
ETHICAL AND POLICY ISSUES IN RESEARCH INVOLVING HUMAN PARTICIPANTS National Bioethics Advisory Commitee (NBAC) Final Report, 2001 Exhibit 3.1: Office of Protection from Research Risks (OPRR) Compliance Oversight Investigations Resulting in Restrictions/Actions to Institutions that have Multiple Project Assurances (MPA) between January 1990 – June 2000 Year, Institution and Action…
Testimony Submitted to the Office of Human Research Protection (OHRP) by Vera Hassner Sharav and Marie M. Cassidy, Ph.D, D.Sc. April, 2001 AHRP recognizes that to include children in clinical trials for any medication presents a dilemma of truly Solomonic proportions. It is a choice between continuing the practice of…
