Ethical Issues in Implementation Science: A Qualitative Interview Study of Participating Clinicians.

Background: Implementation science presents ethical issues not well addressed by traditional research ethics frameworks. There is little empirical work examining how clinicians whose work is affected by implementation studies view these issues. Accordingly, we interviewed clinicians working at sites participating in an implementation study seeking to improve patient handoffs to the intensive care unit (ICU).

Methods: We performed semi-structured interviews with 32 clinicians working at sites participating in an implementation study aiming to improve patient handoffs from the operating room to the ICU. We analyzed the interviews using an iterative coding process following a conventional content analysis approach.

Results: Clinicians' greatest concern about involvement was possible damage to interpersonal relations with more senior clinicians. They were divided about whether informed consent from clinicians was necessary but were satisfied with the study's approach of sending out mass communications about the study. They did not think opting out of the implementation portion of the study was feasible but saw this inability to opt out as unproblematic because they equated the study with routine quality improvement. Those clinicians who helped launch the study at their sites recounted several different ways of doing so beyond simply facilitating access.

Conclusions: The risks that clinicians identified stemmed more from their general status as employees than their specific work as clinicians. Implementation researchers should be attuned to the ethical ramifications of involving employees of varying ranks. Implementation researchers using hybrid designs should also be sensitive to the possibility that practitioners affected by a study will equate it with quality improvement and overlook its research component. Finally, the interactions that go into facilitating an implementation study are more various than the "gatekeeping" typically discussed by research ethicists. More research is needed on the ethics of the myriad interactions that are involved in making implementation studies happen.