Smischney Nathan J, Onigkeit James A, Hinds Richard F, Nicholson Wayne T
Department of Anesthesiology, Mayo Clinic, 200 First Street Southwest, Rochester, Minnesota 55905 USA.
J Clin Ethics. 2015 Spring;26(1):61-7.
U.S. federal regulations require that certain ethical elements be followed to protect human research subjects. The location and clinical circumstances of a proposed research study can differ substantially and can have significant implications for these ethical considerations. Both the location and clinical circumstances are particularly relevant for research in intensive care units (ICUs), where patients are often unable to provide informed consent to participate in a proposed research intervention.
Our goal is to elaborate on the updated 2013 U.S. Food and Drug Administration (FDA) guidance document regarding an exemption from the requirement of obtaining informed consent from patients or their surrogates and to address certain elements within that document, thereby assisting clinicians in developing a framework for emergency research in accordance with the regulatory bodies at their own institutions and in the United States.
Review of the 2011 and updated FDA guidance document on exemption from informed consent.
The current process of obtaining informed consent within ICUs needs to be revisited, especially for research in which timely informed consent is not likely. In particular, the process of obtaining informed consent may not be appropriate or even ethical for critically ill patients in extremis who require an intervention for which there is no current acceptable standard of care and clinical equipoise exists. We provide clinicians with a viewpoint that further elaborates on the FDA guidance document.
The viewpoints provided herein are those of the authors and are therefore inherently limited by the personal views of a selected few. Other clinicians or researchers may not interpret the FDA guidelines in a similar manner. Moreover, the discussion of a guideline document is a limitation in and of itself. The guidelines set forth by the FDA are precisely that-guidelines. Therefore, they may not be followed as outlined in the guidance document within one's own institution. Our goal is that, by elaborating on the guidelines for planned research involving human subjects in the ICU, institutional regulatory bodies may gain a better understanding in drafting their own document when faced with a clinician or a researcher who wishes to conduct planned research in an ICU.
We believe that the interpretations provided will allow clinicians to safely undertake planned research in ICUs without endangering the main tenets of ethical research involving human participants. This research is needed for the advancement of care in the critically ill.
美国联邦法规要求遵循某些伦理要素以保护人体研究受试者。拟开展的研究的地点和临床情况可能有很大差异，并且对这些伦理考量具有重大影响。地点和临床情况对于重症监护病房（ICU）的研究尤为相关，在ICU中患者往往无法对参与拟议的研究干预给予知情同意。
我们的目标是详细阐述2013年美国食品药品监督管理局（FDA）关于免除从患者或其代理人处获得知情同意要求的更新指导文件，并探讨该文件中的某些要素，从而协助临床医生根据其所在机构及美国监管机构制定紧急研究框架。
查阅2011年及更新后的FDA关于免除知情同意的指导文件。
需要重新审视当前在ICU中获取知情同意的过程，特别是对于不太可能及时获得知情同意的研究。尤其是，对于处于危急状态、需要进行尚无当前可接受的护理标准且存在临床 equipoise的干预措施的重症患者，获取知情同意的过程可能不合适甚至不符合伦理。我们为临床医生提供一种观点，进一步详细阐述FDA指导文件。
本文提供的观点是作者的观点，因此必然受到少数人个人观点的限制。其他临床医生或研究人员可能不会以类似方式解读FDA指南。此外，对一份指导文件的讨论本身就是一种局限性。FDA制定的指南确切地说是指南。因此，在个人所在机构内可能不会按照指导文件中概述的那样遵循这些指南。我们的目标是，通过详细阐述ICU中涉及人体受试者的计划研究指南，机构监管机构在面对希望在ICU进行计划研究的临床医生或研究人员时，在起草自身文件时可能会有更好的理解。
我们认为所提供的解释将使临床医生能够在不危及涉及人类受试者的伦理研究主要原则的情况下，安全地在ICU中开展计划研究。这对于危重症护理的进步是必要的。
