Innovative Practice, Clinical Research, and the Ethical Advancement of Medicine

Abstract

Innovative practice occurs when a clinician provides something new, untested, or nonstandard to a patient in the course of clinical care, rather than as part of a research study. Commentators have noted that patients engaged in innovative practice are at significant risk of suffering harm, exploitation, or autonomy violations. By creating a pathway for harmful or nonbeneficial interventions to spread within medical practice without being subjected to rigorous scientific evaluation, innovative practice poses similar risks to the wider community of patients and society as a whole. Given these concerns, how should we control and oversee innovative practice, and in particular, how should we coordinate innovative practice and clinical research? In this article, I argue that an ethical approach overseeing innovative practice must encourage the early transition to rigorous clinical research without delaying or deferring the development of beneficial innovations or violating the autonomy rights of clinicians and their patients.

Keywords:

• medical innovation
• clinical ethics
• research ethics
• health regulation
• standard of care
• patient rights

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A Model Ethics Board for Innovative Practice and Centers of Excellence

ACKNOWLEDGMENTS

The author thanks Dave Wendler, Christine Grady, two anonymous reviewers, and audiences at the University of Texas at Dallas and the National Institutes of Health for their invaluable assistance with this article. The views expressed here are the author’s own and do not reflect the policies or positions of the National Institutes of Health, the U.S. Public Health Service, or the U.S. Department of Health and Human Services. This research was supported by the Intramural Research Program of the National Institutes of Health Clinical Center. ▪

Notes

1. Intractable disagreement among the hypothetical expert clinicians about which among multiple interventions is best for a given condition yields a disjunctive standard (i.e., clinicians should use either X, or Y, or…).

2. Questions about the ethics of learning activities in innovative practice are part and parcel to larger debates about the ethics of learning health care systems and quality assurance/quality improvement initiatives. See Faden and colleagues (2013).

3. This reason suggests that if an institution’s dual-deviation review is not carried out by an IRB, then reviewers would need support and assistance from the local IRB in evaluating plans for innovative practice.