Under the right conditions, full informed consent is not ethically required for some types of health research, according to leading bioethics experts.
Under the right conditions, full informed consent is not ethically required for some types of health research, according to leading bioethics experts. In the February 20 issue of the New England Journal of Medicine Ruth R. Faden and Tom L. Beauchamp, and Nancy E. Kass, argue that in some cases a time-consuming consent process is not only unnecessary from the standpoint of protecting patients, but also potentially harmful to patients when it functions as an obstacle to gaining new knowledge that can improve the quality of the care patients receive.
The position is a considerable break from ethics principles that have guided research ethics and regulation for decades.
The commentary addresses two concepts generating debate in the healthcare and bioethics fields: the idea of learning healthcare systems, as articulated by the Institute of Medicine (IOM), in which “continuous learning” from clinical practice feeds directly into improving future patient care; and randomized comparative effectiveness research (CER), in which patients are randomly assigned to different, widely used treatments for their condition – all of which are thought to be effective and safe – to determine which treatments work best for which patients.
“In a mature learning healthcare system with ethically robust oversight policies and practices, some randomized CER studies may justifiably proceed with a streamlined consent process and others may not require patient consent at all,” the commentary states.
However, the authors note that no such system exists today with fully developed ethical safeguards, including patient engagement, to allow a study impacting patient care to be ethically acceptable.
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