Clapp Justin T, Zucker Naomi, Hernandez Olivia K, Bass Ellen J, Lane-Fall Meghan B
University of Pennsylvania, Philadelphia, Pennsylvania, USA.
The Ohio State University, Columbus, Ohio, USA.
AJOB Empir Bioeth. 2025 Jan-Mar;16(1):22-31. doi: 10.1080/23294515.2024.2388537. Epub 2024 Aug 13.
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).
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.
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.
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.
实施科学提出了传统研究伦理框架未能很好解决的伦理问题。很少有实证研究考察其工作受实施研究影响的临床医生如何看待这些问题。因此，我们采访了在参与一项旨在改善向重症监护病房（ICU）患者交接工作的实施研究的机构工作的临床医生。
我们对在参与一项旨在改善从手术室到ICU患者交接工作的实施研究的机构工作的32名临床医生进行了半结构化访谈。我们采用传统内容分析方法，通过迭代编码过程对访谈进行分析。
临床医生对参与研究的最大担忧是可能损害与资深临床医生的人际关系。他们对临床医生的知情同意是否必要存在分歧，但对研究采用的大规模发送研究信息的方式感到满意。他们认为不参与研究的实施部分不可行，但认为无法退出没有问题，因为他们将该研究等同于常规质量改进。那些在其所在机构协助开展研究的临床医生讲述了除了简单提供便利之外的几种不同的开展方式。
临床医生所识别出的风险更多源于他们作为员工的一般身份，而非作为临床医生的具体工作。实施研究人员应关注涉及不同职级员工所带来的伦理影响。采用混合设计的实施研究人员还应意识到，受研究影响的从业者可能会将其等同于质量改进并忽视其研究成分。最后，促进实施研究的互动比研究伦理学家通常讨论的“把关”更为多样。需要对实施研究过程中涉及的无数互动的伦理进行更多研究。
