Sahan Katherine, Cowan Ethan, Sheehan Mark
The Ethox Centre, Oxford Population Health, University of Oxford, Big Data Institute, Old Road Campus, Roosevelt Drive, Oxford, UK.
Icahn School of Medicine at Mount Sinai, New York, USA.
Theor Med Bioeth. 2025 Jun;46(3):231-246. doi: 10.1007/s11017-025-09710-9. Epub 2025 Apr 1.
The Exception from Informed Consent (EFIC) permits patient enrolment into therapeutic emergency research where obtaining informed consent is challenging. Yet this fails to resolve a core ethical conflict in the research and has generated controversy. This is because existing justification and practice has relied on applying EFIC per study-a wholesale permission to enroll irrespective of circumstance-instead of per patient. Our novel justification for enrolment centers on applying EFIC per patient, which empowers the enrolling clinician to judge whether to enroll patients with an Exception. This contrasts with the idea that clinician judgment is surplus to the judgements already made by institutions in deciding the research may proceed. Instead, we show that enrolling clinician's judgment is ethically significant and should not be overlooked: attending to this strengthens the research ethically and reduces controversy. There should be a bigger role for the clinician in the research enrolment space.
知情同意豁免（EFIC）允许在获取知情同意具有挑战性的情况下，将患者纳入治疗性紧急研究。然而，这未能解决研究中的一个核心伦理冲突，并引发了争议。这是因为现有的理由和做法依赖于针对每项研究应用EFIC——即无论情况如何一概允许纳入——而不是针对每个患者。我们提出的纳入患者的新理由以针对每个患者应用EFIC为核心，这使负责纳入患者的临床医生能够判断是否对患者进行豁免纳入。这与以下观点形成对比，即临床医生的判断对于机构在决定研究可以进行时已经做出的判断而言是多余的。相反，我们表明负责纳入患者的临床医生的判断在伦理上具有重要意义，不应被忽视：关注这一点在伦理上加强了研究并减少了争议。临床医生在研究纳入环节中应发挥更大的作用。
