Federal Investigation of ARDS Study (Accute Respiratory Distress)

Federal Investigation of ARDS Study (Accute Respiratory Distress) OHRP conducted a compliance oversight evaluation of the 12 major sites participating in this clinical trial. OHRP’s determination letters documenting the outcomes of these evaluations can be viewed at the OHRP website at the following URLs: Note: OHRP found that federal informed…

The Impact of the FDA Modernization Act on the Recruitment of Children for Research

THE IMPACT OF THE FDA MODERNIZATION ACT ON THE RECRUITMENT OF CHILDREN FOR RESEARCH Vera Hassner Sharav Published in ETHICAL HUMAN SCIENCES & SERVICES Summer 2003, vol. 5 pp. 83-108 Abstract This paper argues that contrary to the claims made by the research stakeholders in industry, academia and government, the…

More than 100 top regulatory officials represented industry as lobbyists, lawyers… – Denver Post

More than 100 top regulatory officials represented industry as lobbyists, lawyers… – Denver Post Mon, 24 May 2004 To understand why government policies affecting healthcare, drug safety, food safety and the environment appear to promote industry interests at the expense of public safety and health, the Denver Post has investigated…

OHRP Response to AHRP re: Surrogate Consent to Research

OHRP Response to AHRP re: Surrogate Consent to Research Office of the Secretary Department of Health & Human Services Office of Public Health and Science Office for Human Research Protections Rockville, Maryland E-mail: mcarome@osophs.dhhs.gov August 28, 2002 Vera Hassner Sharav President, The Alliance for Human Research Protection John H. Noble,…

Death of Baby Prompts Scrutiny of Research Risks_St. Louis Post Dispatch

Death of Baby Prompts Scrutiny of Research Risks_St. Louis Post Dispatch 16 Feb 2003 Eighteen month old, Daniella Rogers, died on May 3, 2002, two months after undergoing a clinical trial of chemotherapy treatments at St. Louis Children’s Hospital. When her parents, John and Oksana Rogers, learned that their baby…

Protecting People w Mental Disabilities & Impairments against Biomedical Research Abuse

Protecting People with Mental Disabilities and Impairments against Biomedical Research Abuse[*] By John H. Noble, Jr., Ph.D, The Catholic University of America, Washington, DC, USA Vera Hassner Sharav, MLS, Alliance for Human Research Protection, New York, USA People with mental disabilities and impairments historically have been targeted by biomedical researchers…

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, &…