How should one think about innovation in medicine and surgery? Increasingly, the answer to this question has involved reference to what might be called the regulatory ethics paradigm (REP). The regulatory ethics paradigm holds that deviations from standard care involve a degree or kind of experimentation that requires the application of a set of procedures designed to assure the protection of the rights and welfare of the subjects of research.

In REP, innovative treatments are regarded as questionable until they are framed in a research protocol with formal mechanisms of informed consent. The protocol must be reviewed and approved by an Institutional Review Board (IRB) or equivalent. The regulatory ethics paradigm in effect imposes the condition that clinical innovations be conducted according to scientific research methodologies. It creates the presumption that without review by an IRB, innovation cannot be conducted in an ethically defensible fashion. The regulatory ethics paradigm also requires the preparation of investigational protocols according to sound evidentiary and methodological standards. In so doing, it creates a presumption that innovations that are not rigorously validated are ethically dubious. These assumptions have deep roots.

The Belmont Report, for example, articulated the orienting intuition that “radically new procedures . . . should . . . be made the object of formal research at an early stage [emphasis added] in order to determine whether they are safe and effective”.¹ The Belmont Report takes the view that formal research to establish safety and efficacy of new interventions is usually feasible at an early stage in the development of a novel intervention. It thus establishes a bias that innovative treatments be conducted and evaluated under a research protocol that has passed muster at an IRB review.

Given the …