Tisherman Samuel A
A professor in the Department of Surgery and the Program in Trauma at the University of Maryland School of Medicine in Baltimore. He also serves as director of the Surgical Intensive Care Unit and the Center for Critical Care and Trauma Education at the R Adams Cowley Shock Trauma Center, part of the University of Maryland Medical Center.
AMA J Ethics. 2018 May 1;20(5):467-474. doi: 10.1001/journalofethics.2018.20.5.stas1-1805.
Trauma care requires rapid interventions to optimize the chances for survival. Many patients are either in shock or unconscious and are, therefore, unable to provide informed consent even for standard procedures. Research-related interventions must similarly be initiated rapidly with no opportunity to obtain consent from the patient or the patient's legally authorized representative. Federal regulations allow for an exception from informed consent in these circumstances once the investigators complete a process of community consultation and public disclosure. The challenges for investigators include how to define the at-risk community for enrollment in the trial and then how to adequately reach out to that community. Many approaches have been used, with varying success. What constitutes true engagement with the community needs to be further explored.
创伤护理需要迅速采取干预措施，以优化生存几率。许多患者处于休克状态或失去意识，因此即使是对于标准程序，也无法提供知情同意。与研究相关的干预措施同样必须迅速启动，没有机会获得患者或患者法定授权代表的同意。一旦研究人员完成社区咨询和公开披露程序，联邦法规允许在这些情况下免除知情同意。研究人员面临的挑战包括如何界定参与试验的高危社区，以及如何充分与该社区进行沟通。已经采用了许多方法，效果各异。什么才是与社区的真正互动还有待进一步探索。
