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Government Experiments Increase Risk of Death

Several major government-sponsored experiments conducted at major academic institutions highlight increasingly inappropriate clinical trial designs that disregard the individual survival needs of critically ill patients who cannot give or refuse consent to research. Their incapacity is exploited in experiments that increase the risk of death. 1996 – 1999: The National…

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2003: VA 90-day national “stand down” for all human subject research

In 2003, the Veterans Affairs ordered a 90-day national “stand down” for all human subject research activities “in response to the death of subjects”; as well as use of “unqualified researchers.” In January 2004, the Director of Defense Research and Engineering (DDR&E) initiated a review of all Defense Department human subjects…

Schism Between Ethical Principles and the US Regulatory System

A system that was established to safeguard human subjects by implementing those ethical principles is, instead, geared toward lending the appearance of legitimacy to ethical expediency and corner-cutting at the expense of safety for the subjects of clinical trials and for consumers who are at increased risk of harm from defective drugs and devices.

Chief Respiratory Care Mass General Hospital-Harvard-Rejects ARDS Recommendation

A critical editorial by Dr. Robert M Kacmarek, Head of Respiratory Care Services at Massachusetts General Hospital and professor at Harvard University—the coordinating center for the ARDS Network, calls into question the validity of the ARDS Network recommendation of treating all patients with ALI-ARDS with a fixed, low air ventilation setting (6 mL/ kg).