By Faden, Ruth R., Tom L. Beauchamp, and Nancy E. Kass.
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 notequire patient consent at all.
Faden, Ruth R., Tom L. Beauchamp, and Nancy E. Kass. “Informed consent, comparative effectiveness, and learning health care.” N Engl J Med 370.8 (2014): 766-768.