Clinical innovation ethics frameworks: A systematic narrative review

Miriam Wiersma; Ian Kerridge; Wendy Lipworth

doi:10.1016/j.healthpol.2023.104706

Clinical innovation ethics frameworks: A systematic narrative review

Health Policy. 2023 Mar:129:104706. doi: 10.1016/j.healthpol.2023.104706. Epub 2023 Jan 5.

Authors

Miriam Wiersma¹, Ian Kerridge², Wendy Lipworth³

Affiliations

¹ Faculty of Medicine and Health, Sydney School of Public Health, Sydney Health Ethics, Rm 134, Edward Ford Building A27, The University of Sydney, NSW 2006, Australia. Electronic address: mwie6377@uni.sydney.edu.au.
² Faculty of Medicine and Health, Sydney School of Public Health, Sydney Health Ethics, Rm 134, Edward Ford Building A27, The University of Sydney, NSW 2006, Australia; Haematology Department, Royal North Shore Hospital, Reserve Road, St Leonards, NSW 2065, Australia; Department of Philosophy, Macquarie University, Macquarie Park, NSW 2109, Australia.
³ Faculty of Medicine and Health, Sydney School of Public Health, Sydney Health Ethics, Rm 134, Edward Ford Building A27, The University of Sydney, NSW 2006, Australia; Department of Philosophy, Macquarie University, Macquarie Park, NSW 2109, Australia.

PMID: 36639310
DOI: 10.1016/j.healthpol.2023.104706

Abstract

Background: It is common for doctors to engage in clinical innovation-i.e. to use novel interventions that differ from standard practice, and that have not yet been shown to be safe or effective according to the usual standards of evidence-based medicine-in the belief that this will benefit their patients. Clinical innovation is currently poorly defined and lacks cohesive oversight mechanisms.

Methods: A systematic narrative review, with the aim of identifying areas of similarity and divergence in innovation ethics frameworks developed across different medical specialties.

Results: 47 articles were included in the review. Few ethical issues raised by the ethics frameworks appear to be unique to distinct areas of practice. While variations exist in the oversight mechanisms suggested, these are again not specific to areas of practice, but rather reflect either cautious or more permissive attitudes towards clinical innovation.

Conclusions: There is considerable overlap amongst ethics frameworks developed for use in diverse areas of practice. This reflects a tendency to treat innovative interventions in each area of practice as "exceptional" and a failure to develop "higher order" frameworks such as those that have been developed for research. Those involved in the oversight of clinical innovation need to aim for a balance between exceptionalism and harmonisation.

Keywords: Governance; Innovation; Review.

Publication types

Systematic Review
Review

MeSH terms

Creativity
Evidence-Based Medicine*
Humans
Inventions* / ethics
Physicians*