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OHRP Found NHLBI Lung Experiments Violated Informed Consent

OHRP Found NHLBI Lung Experiments Violated Informed Consent Mon, 7 Jul 2003 On July 3 the federal Office of Human Research Protections (OHRP) issued a stinging indictment of the research review and approval process at some of the nation’s most prestigious research institutions–including the National Heart Lung and Blood Institute…

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…

Lawsuit filed re: ALLHAT Hypertension research death of human subject

Lawsuit filed re: ALLHAT Hypertension research death of human subject Thu, 17 Jul 2003 The Bureau of National Affairs reports: “Just months after a groundbreaking blood pressure study made headlines across the nation, a principal investigator in the trial and his team have been sued in connection with the death…

Infomail Archive, 2005

Infomail 2005 News Stories on Human Research Protection and Commentary by Vera Hassner Sharav Subscribe to the AHRP infomail list Dec 16: Drugs, Devices & Doctors – NYT Paul Krugman Dec 11: Scientific Fraud & Corruption on Both sides of Atlantic: Merck / Proctor & Gamble Dec 11: Gov Accountability…

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….

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…

AHRP Files Federal Complaint Re: Non-Consensual “Blood Substitute” Experiment on Trauma Patients

This controversial, commercial experiment is being conducted without informed consent in trauma patients who require blood to survive.  PolyHeme is being tested in patients in ambulances and at hospital emergency facilities where these trauma patients are denied life-saving real blood.