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…
Cover Letter – AHRP Ethical and Scientific Objections to FDA’s Proposed Licensure of Anthrax Vaccine related links: Comments Submitted to FDA re Anthrax Vaccine (312K pdf) Who Is Protecting The Public Health? By Meryl Nass, Z Magazine March 29, 2005 Lester Crawford, Ph.D., D.V.M. Acting FDA Commissioner U. S. Food…
April 2003. American Journal of Bioethics. Children in Clinical Research: A Conflict of Moral Values. Vera Hassner Sharav http://mitpress.mit.edu/journals/AJOB/3/1/sharav.pdf ABSTRACT (attached & below) This paper examines the culture, the dynamics and the financial underpinnings that determine how medical research is being conducted on children in the United States. Children have…
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…
July 29, 2002 University of Calif, SF: Patients Rights Violated – San Francisco Chronicle FYI The San Francisco Chronicle reports in a front page article that the federal Office of Human Research Protection determined that University of California, San Francisco, violated patients’ rights by conducting medical research without legal informed…
China Daily update: Harvard genetic research in rural China Wed, 1 Oct 2003 “It’s the responsibility of the dean of the School of Public Health and, ultimately, it’s my responsibility as president of [Harvard] university to see to it that where wrong can be put right it is and, more…
Former President of Amer Heart Assoc Caught in Fraud Mon, 16 Dec 2002 The British Medical Journal reports about the FDA took action against American cardiologist Dr. David Faxon, immediate past president of the American Heart Association for medical ethics violations, such as: falsification of data, false claims about his…
DHHS Reverses its Legal Position Petitioning FOR Federal Whistleblower Protection for Dr. Fishbein Thu, 3 Feb 2005 The Washington Post reports: “Department of Health and Human Services filed a legal petition this week in support of an employee the department is trying to fire. HHS told the Merit Systems Protection…
Government Investigations 1990 to August 2001 National Bioethics Advisory Committee Report: ETHICAL AND POLICY ISSUES IN RESEARCH INVOLVING HUMAN PARTICIPANTS, 1998 Exhibit 3.1: Office of Protection from Research Risks (OPRR) Compliance Oversight Investigations Resulting in Restrictions/Actions to Institutions that have Multiple Project Asssurances (MPA) between January 1990 – June 2000…
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) August 21, 2002 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…
THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) 142 West End Ave, Suite 28P New York, NY 10023 212-595-8974 ahrp@researchprotection.org September 4, 2002 Michael Carome, MD Associate Director for Regulatory Affairs Office for Human Research Protections The Tower Building 1101 Wootton Parkway, Suite 200 Rockville, Maryland 20852 Re: Acute Respiratory Distress…
July 08, 2002 Critique: U.S. to Vaccinate 500,000 Workers Against Smallpox 7 Jul 2002 FYI Dr. Meryl Nass, a member of the board of The Alliance for Human Research Protection and a recognized expert on Gulf War Syndrome and the use and consequences of experimental vaccines, raises serious concerns about…
