Informed Consent, Comparative Effectiveness, and Learning Health Care :: Informed Consent for Pragmatic Trials — The Integrated Consent Model

New England Journal of Medicine
February 20, 2014  Vol. 370 No. 8
http://www.nejm.org/toc/nejm/medical-journal

Health Law, Ethics, and Human Rights
Informed Consent, Comparative Effectiveness, and Learning Health Care
Ruth R. Faden, Ph.D., M.P.H., Tom L. Beauchamp, Ph.D., and Nancy E. Kass, Sc.D.
N Engl J Med 2014; 370:766-768February 20, 2014DOI: 10.1056/NEJMhle1313674
http://www.nejm.org/doi/full/10.1056/NEJMhle1313674
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.

Health Law, Ethics, and Human Rights
Informed Consent for Pragmatic Trials — The Integrated Consent Model
Scott Y.H. Kim, M.D., Ph.D., and Franklin G. Miller, Ph.D.
N Engl J Med 2014; 370:769-772February 20, 2014DOI: 10.1056/NEJMhle1312508
http://www.nejm.org/doi/full/10.1056/NEJMhle1312508
The authors argue that informed consent is ethically necessary in pragmatic trials that randomly assign individual patients to treatments, even when treatment options are within the standard of care. They propose integration of a streamlined consent process into routine practice.