Category Archives: Randomized Clinical Trials

A Fight Against Providing Informed Consent in SUPPORT- Part II Standard

There have been a number of articles written by well-known physicians and bioethicists expressing great concern over the recent Office for Human Research Protection, OHRP, letter of criticism with respect to the SUPPORT clinical trial. This blog discussed this controversy in the post of May 23, 2013. This controversy has turned dark with efforts to intimidate the OHRP.. Not attractive in the arena of customarily well reasoned debates in the bioethics community. The latest in this saga is a plea signed off on by, as they describe themselves, a group of scholars and leaders in bioethics that was published in…

A Fight Against Providing Informed Consent and The Risk of Randomization in the SUPPORT Clinical Trial Standard

A Fight Against Providing Informed Consent and The Risk of Randomization: Informed Consent in the Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT)  by Bernard W. Freedman,JD, MPH     In their article Risk, Consent, and SUPPORT  David Magnus and Arthur Caplan chastise the Office for Human Research Protections (OHRP) for their findings of a failure to provide adequate informed consent as required by federal regulations, in a clinical trial.  The OHRP is right in their position. The underlying clinical trial, Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT), published in 2010, sought to evaluate the effects of different levels of…