AMA Journal of Ethics^®

AMA Code of Medical Ethics’ Opinion 1.1.6, “Quality,” states quite clearly that “physicians individually and collectively share the obligation to ensure that the care patients receive is safe, effective, patient centered, timely, efficient, and equitable” [1]. The very first piece of guidance that this opinion gives to physicians in this area is that they should engage in efforts to improve the quality of health care by keeping current with best care practices and maintaining professional competence. Principle V reads in whole that “A physician shall continue to study, apply, and advance scientific knowledge, maintain a commitment to medical education, make relevant information available to patients, colleagues, and the public, obtain consultation, and use the talents of other health professionals when indicated” [2]. Professional judgment is based on experience as well as learned knowledge and skills. Relying on one’s own professional judgment, sharing that judgment with others, and seeking consultation when necessary are foundational elements of practicing medicine [3].

Occasionally, however, physicians will find it necessary or beneficial to deviate from standards of care by improving on an existing intervention or using an existing intervention in a novel way. This type of innovative practice is discussed in Opinion 1.2.11, “Ethically Sound Innovation in Medical Practice” [4]. When deviating from the standard of care in a particular situation, physicians are still responsible for innovating on the basis of sound scientific evidence and clinical expertise. The opinion sets guidance for patient safety in these situations, such as specific elements to address when obtaining informed consent, including disclosure of the physician’s experience with this innovative therapy, any known or anticipated risks and benefits, burdens of the recommended therapy, and why this particular route is being recommended. Physicians should also be transparent and share findings (positive, negative, or neutral) from their use of innovative therapies in some manner, so that the greater profession can benefit from this knowledge.

Medicine is largely a self-regulating profession, and Opinion 1.2.11 acknowledges this by providing guidance to all physicians. To promote responsible innovation, the medical profession should

require that physicians who adopt innovative treatment or diagnostic techniques into their practice have appropriate knowledge and skills…. Provide meaningful professional oversight of innovation in patient care; and … encourage physician-innovators to collect and share information about the resources needed to implement their innovative therapies effectively [4].

By cultivating these conditions, the medical profession can help create an environment in which physicians are able to successfully draw upon their expertise, experience, skills, and knowledge in order to practice innovative medicine when appropriate.