Pragmatic clinical trials (PCTs) offer important benefits, such as generating evidence that is suited to inform real-world health care decisions and increasing research efficiency. However, PCTs also present ethical challenges. One such challenge involves the management of information that emerges in a PCT that is unrelated to the primary research question(s), yet may have implications for the individual patients, clinicians, or health care systems from whom or within which research data were collected. We term these findings as ?pragmatic clinical trial collateral findings,? or ?PCT-CFs?. In this article, we explore the ethical considerations associated with the identification, assessment, and management of PCT-CFs, and how these considerations may vary based upon the attributes of a specific PCT. Our purpose is to map the terrain of PCT-CFs to serve as a foundation for future scholarship as well as policy-making and to facilitate careful deliberation about actual cases as they occur in practice.

中文翻译：

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实用临床试验中的伦理和附带调查结果。

务实的临床试验（PCT）提供了重要的好处，例如生成适合于指导现实世界的医疗保健决策的证据并提高研究效率。但是，PCT也存在道德挑战。这样的挑战之一涉及对PCT中出现的与主要研究问题无关的信息的管理，但这些信息可能对从中或从中收集研究数据的单个患者，临床医生或医疗系统产生影响。我们将这些发现称为“实用的临床试验附带发现”。或“ PCT-CF”。在本文中，我们探讨了与PCT-CF的标识，评估和管理相关的道德考虑，以及这些考虑如何根据特定PCT的属性而变化。