Research Ethics and Policy Series (REPS): Rinad Beidas, PhD and Katelin Hoskins, PhD, MBE, CRNP

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Salient ethical issues in implementation science: Pragmatic tradeoffs, unintended consequences, and sustainability

Rinad Beidas, PhD

Katelin Hoskins, PhD, MBE, CRNP
NIMH T32 Postdoctoral Fellow, Center for Mental Health, Department of Psychiatry, Perelman School of Medicine; Associate Fellow, Leonard Davis Institute of Health Economics, University of Pennsylvania

Implementation science is the study of methods to increase the use of evidence-based practices in routine clinical care and to reduce the research-to-practice gap. Implementation science has a set of distinct foci including stakeholder engagement, characterization of contextual factors at the patient- (e.g., preferences), clinician- (e.g., knowledge), and organizational- (e.g., leadership) level, and measurement of implementation outcomes. Because of the primary emphasis on intervention delivery and scale-up, this research generates distinct ethical considerations. We use ASPIRE, a type III hybrid effectiveness trial of strategies to implement firearm safety promotion as a universal suicide prevention strategy in pediatric primary care, as a case exemplar to investigate salient ethical issues that may arise during implementation research. Using examples from ASPIRE, we examine (1) pragmatic tradeoffs (e.g., acceptability and effectiveness) in study design and execution; (2) sustainability and health system integration as up-front considerations; and (3) unintended consequences with implications for health equity. We also identify other ripe ethical topics for further exploration within implementation research, including evidence for the research-to-practice gap, power dynamics and stakeholder engagement, and contextual equipoise (i.e., genuine uncertainty about the contextual conditions in which implementation will be effective). In conclusion, we will highlight future directions for empirical work at the intersection of bioethics and implementation science.
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