NIH Rule change Re: Whistle blowers – Comments before June 15

NIH Rule change Re: Whistle blowers – Comments due before June 15 Mon, 19 Apr 2004 Dear friends and colleagues, A request for comment about NIH proposed new research misconduct rule See Fed Register: http://ori.dhhs.gov/multimedia/acrobat/42CFRParts50and93.pdf The new rule, I believe is meant to protect research institutions from the effective sting…

Ethical Violations and Investigations Today

Ethical Violations / Investigations Today Congressional Investigations Office of Human Research Protections (OHRP) Letters of Determination: http://ohrp.osophs.dhhs.gov/detrm_letrs/lindex.htm Office of Protection from Research Risks* (OPRR) List of Compliance Oversight Investigations Resulting in Restrictions or Actions to federally licensed Institutions between 1990 – 2000. *Reorganized in 2000 as OHRP Mar 30: AHRP…

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AHRP Letter to Editor re: ARDS published NEJM

AHRP Letter to Editor re: ARDS published NEJM Fri, 11 Jul 2003 A truncated version of a Letter to the editor submitted by John H. Noble, Jr., PhD and Vera Sharav appears in the current July 10, 2003, issue of The New England Journal of Medicine. Note: On April 3,…

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Protecting Human Subjects in Research: Are Current Safeguards Adequate?

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, &…

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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….