Diagnostic errors cause substantial harm to patients but remain largely unappreciated within the patient safety movement in health care.¹ The National Academy of Medicine defines a diagnostic error as “failure to (a) establish an accurate and timely explanation of the patient’s health problem(s) or (b) communicate that explanation to the patient,” but this universal definition can be difficult to apply in a fast-paced critical care environment, such as the intensive care unit.¹ An operational definition adopted by some researchers is that a diagnostic error is present if there is unequivocal evidence of a missed opportunity during the diagnostic process to establish a timely and accurate diagnosis.² This is especially applicable in settings such as the neonatal intensive care unit, where the length of stay is often prolonged and most diagnoses will be discovered before discharge. The key to determining if a diagnostic error occurred is to establish whether there was an opportunity to make the diagnosis sooner. However, when performing retrospective evaluations for the presence of diagnostic errors, researchers operate without a direct association with either the treating clinician or patient. This leads to the following quandary: do researchers have an ethical obligation to inform patients or clinicians when they discover previously unrecognized diagnostic errors? In this Viewpoint, we review the current literature on the ethics of disclosing adverse events, such as diagnostic errors, and then formulate a framework to guide the researcher in this scenario.

诊断错误会对患者造成重大伤害，但是在医疗保健领域的患者安全运动中，诊断错误仍未引起重视。¹美国国家医学科学院（National Academy of Medicine）将诊断错误定义为“未能（a）建立对患者健康问题的准确及时的解释或（b）向患者传达该解释”，但是这种通用定义可能很难应用于重症监护室等快节奏的重症监护环境。¹一些研究人员采用的操作定义是，如果有明确的证据表明在诊断过程中错过了建立及时准确诊断的机会的机会，则存在诊断错误。²这尤其适用于诸如新生儿重症监护室这样的环境，在这些环境中，住院时间通常会延长，大多数诊断将在出院前发现。确定是否发生诊断错误的关键是确定是否有机会更快地进行诊断。但是，在对诊断错误的存在进行回顾性评估时，研究人员的工作与治疗的临床医生或患者没有直接联系。这导致了以下困惑：研究人员是否有道德义务在发现先前无法识别的诊断错误时通知患者或临床医生？在这种观点下，我们回顾了有关披露不良事件（例如诊断错误，