Who decides if it’s treatment or a medical experiment?

Current worrisome trends U.S. government and academic bioethicists and institutional ethics review boards (IRB) have expunged the explicit honest terminology of the Nuremberg Code: “experiment” has been replaced by the innocuous term “study”; “human subject” is being replaced by “participant”; and the . . . Continue reading →

Medical Research Stakeholders Seek to Overturn Informed Consent Protections

Part 2 of 4. The Medical Research Enterprise: a confluence of self-interest groups: government officials, academic researchers. . . . Continue reading →

Another View Academics for Informed Consent

Ruth Macklin

“The OHRP and SUPPORT — Another View” by a group of 45 physicians, ethicists, and scholars in allied fields who have stepped up to the plate to express their support for OHRP’s determination. . . . Continue reading →

OHRP Letter to ARDSNetwork re: Investigation of Acute Respiratory DistressSyndrome

OHRP Investigation of experimental treatment for Acute Respiratory Distress Syndrome. ARDSNet studies: ARMA, FACCT, and ALVEOLI Table of Contents to Fax from OHRP page 1 Oct. 7, 2002 OHRP letter to: Ronald S. Newvbower, Ph.D(Mass. General Hospital), Lee E. Limbird, Ph.D. (Vanderbilt . . . Continue reading →

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 . . . Continue reading →

Hearing: Americans Denied Human Right to Say NO to Experimental Research Under FDA Rule

Tomorrow Hearing  FDA’s Emergency Research Rule–CNN News at 8:00 P.M will inform the public about how the FDA Rule impacts on American citizens who can be put at increased risk to test an experimental treatment without their knowledge or consent.

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AHRP Testimonies re: Fatal ARDS Lung Experiment

On June 10, 2003, a panel of experts convened by the federal Office of Human Research Protections (OHRP) heard presentations by critics who had filed complaints about $37 million government sponsored, multi-site experiment conducted by major academic institutions participating in the ARDSNetwork, and by the ARDSNet investigators who defend the trial.

The experiment tested two extreme, rarely used methods of mechanical lung ventilation in 861 critically ill, vulnerable patients suffering from acute lung disease (ALD) or acute respiratory distress syndrome (ARDS).

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