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ethics review boards (IRB) have expunged the explicit honest terminology of the Nuremberg Code: “experiment” has been replaced by the innocuous term “study”; “human subject” is being replaced by “participant”; and the .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 →
Part 3 of 4. Though bioethicists self-consciously avoid using the term — because of its inextricable link to Nazi ideology. . . . Continue reading →
Part 2 of 4. The Medical Research Enterprise: a confluence of self-interest groups: government officials, academic researchers. . . . Continue reading →
“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 →
“In real ethics, there are some things that must never be done. Bioethics is . . . enticed onward by the question, Why not?. . . Continue reading →
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 →
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 →
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.
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).