BTG buys Oncoverse–Amanda Goltz explains all
3 hours ago
“The voluntary consent of the human subject is absolutely essential.
This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved, as to enable him to make an understanding and enlightened decision. This latter element requires that, before the acceptance of an affirmative decision by the experimental subject, there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person, which may possibly come from his participation in the experiment.Some 67 years later, a generation of medical researchers with no first hand memories of either Nuremberg or what preceded it, are finding the absolute nature of this ethics code to be a hindrance in their morally superior efforts to save the world from health care system inefficiencies. In this day and age of readily and abundantly available electronic data, the antiquated processes of obtaining proper consent from experimental subjects one by one, for simple things like comparative effectiveness research (CER) or quality improvements (QI), are slowing down the computerized trains of progress. After all, we are not talking about hacking people with machetes or purposely infecting them with horrible diseases or any of the nightmarish scenarios that brought about the terror embedded in the Nuremberg Code. We are talking about a clearly beneficent learning system, made possible by health information technology, where every patient is a research subject and every doctor is a research assistant, and we all cheerfully share and cooperate to advance our collective medical knowledge and to make health care better and cheaper. The inconsequential details can be safely left to our betters, who are now, always will be, and in America always have been, on the side of angels.
The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.”