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Informed Consent, Comparative Effectiveness, and Learning Health Care
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Journal Article
Informed Consent, Comparative Effectiveness, and Learning Health Care
2014
Overview
The authors argue that in a learning health care system with ethically robust oversight policies, a streamlined consent process could replace formal written informed-consent procedures for many studies, and patient consent would not be required at all for some trials.
Interest in learning health care systems and in comparative-effectiveness research (CER) is exploding. One major question is whether informed consent should always be required for randomized comparative-effectiveness studies, particularly studies conducted in a learning health care system. Our answer to this question is no. It will often be unethical to go forward with CER in which patients are randomly assigned to different interventions without their written, prospective, informed consent. However, in a mature learning health care system with ethically robust oversight policies and practices, some randomized CER studies may justifiably proceed with a streamlined consent process and others may not . . .
Publisher
Massachusetts Medical Society
