Update: Ramifications of Swine Flu Vaccine Immunity
In 2006, PREPA was passed due to fear of an avian flu pandemic, in the event the avian
flu virus mutated to enable person-to-person spread. Avian flu then had a 70% death rate.
-
-
Does the FDA have the authority to trump the Declaration of Helsinki?
The FDA is sliding rapidly down the slippery slope, abandoning widely accepted, international ethical research standards articulated in the internationally accepted, Declaration of Helsinki–to facilitate commercial medical experiments.
-
Calls Mounting for FDA Revamp / Americans Are the most medicated population in the world – DHHS
Calls Mounting for FDA Revamp / Americans Are the most medicated population in the world – DHHS Sun, 26 Dec 2004 A government survey by the U.S. Department of Health and Human Services, confirms that Americans are the most medicated population in the world – 44 percent of Americans had…
-
OHRP Compliance Letters
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…
-
FDA Requests Fed Investigation Of Itself After It Lost Medical Records
FDA Requests Fed Investigation Of Itself After It Lost Medical Records Wed, 16 Apr 2003 FDA Commissioner, Dr. Mark McClelan has requested an independent investigation of a bone density study conducted jointly by an FDA investigator and another affiliated with the Henry Jackson Foundation for the Advancement of Military Medicine….
-
AHRP Comments – Precursors to Diabetes in Japanese American Youth
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…
-
Government Investigations, 1990 – 2001
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…
-
OHRP Backtracks on Public Disclosure – BNA
September 5, 2002. OHRP Backtracks on Public Disclosure – Bureau of National Affairs FYI In Aug. 2000, when the Office of Human Research Protections replaced the former Office of Protection from Research Risks there was much talk about openness, accessibility, transparency and public accountability. One new feature was the posting…
-
Almost 1/2 of faculty on IRBs have ties to industry – Harvard Partners
Almost 1/2 of faculty on IRBs have ties to industry – Harvard Partners Fri, 15 Aug 2003 A survey by faculty at the Institute for Health Policy, Massachusetts General Hospital (MGH) and Harvard Medical School found that “Consulting relationships with industry are common among faculty IRB members….Our previous research with…
-
AHRP Comments on Smallpox Vaccine Testing on Children
THE ALIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) 142 West End Avenue, Suite 28P New York, NY 10023 www.ahrp.org FDA Docket Number 02N-0466 Comments re: Proposed smallpox vaccine trial to test the safety of Dryvax administration to children 2 to 5 years of age Recent public and professional debate about smallpox…
-
AHRP Initiatives
AHRP Initiatives Campaign for the Protection of Vulnerable Individuals September 13, 2002: National Disability Rights Activists Oppose Cal. AB2328 September 5, 2002: Do the Ends Justify the Means in Human Research? September 4, 2002: AHRP Replies to OHRP Response re Surrogate Consent (ARDS Study). August 28, 2002: OHRP Response…
-
2 to 5 year old children targeted for Smallpox Vaccine trial_DHHS
2 to 5 year old children targeted for Smallpox Vaccine trial_DHHS Sat, 2 Nov 2002 An announcement in the Federal Register, Oct 31, 2002, by the Office of Public Health and Science and Food and Drug Administration calls for public review and comment about proposals to the Secretary of Health…