Impediments to obtaining informed consent for clinical research in trauma patients
Impediments to obtaining informed consent for clinical research in trauma patients
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DOI：
10.1097/ta.0b013e318165c15c
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发表时间：
2008-04-01
影响因子：
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通讯作者：
Scalea, Thomas M.
中科院分区：
文献类型：
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作者：
Dutton, Richard P.;Stansbury, Lynn G.;Scalea, Thomas M.
背景知情同意是创伤护理临床研究的必要条件，但也是一个实质性障碍。已经建立了一些模型，但仍然存在争议，并且几乎没有客观的数据可以说明这一争论。我们前瞻性地评估了2，011例连续患者入住马里兰州医学系统大学的R亚当斯考利休克创伤中心，以便在入院后1小时内同意进行假设的研究试验或是否可以从合法授权代表处获得同意（3小时内。然后将这些数据与人口统计学、运输、生理学和损伤数据联系起来。结果：1,734例患者获得了完整的数据：982例（57%）似乎能够同意，752例（43%）似乎无法同意。在后者中，LAR同意可能适用于404例，剩下348例（46%，占所有入院的20%）不同意。那些显然能够同意的人比那些不能同意的人受到的伤害要少得多，但随后发现三分之一的人在给予同意时有客观障碍，还有三分之一的人的发现强烈暗示了损害。对于那些无法同意的人，随后的LAR同意与未成年人或女性密切相关。缺乏LAR同意与故意伤害的受害者，是一个非洲裔美国人的男性和欧洲裔美国人的男性只有被运送更远的距离。结论：严重受伤的创伤患者很少能提供同意的研究研究，和LARs往往是不可用的。有理由进一步努力制定可行的机制，处理知情同意例外情况。
Background. informed consent is required for, but a substantial barrier to, clinic research in trauma care. Exceptions have been established but remain controversial, and little objective data are available to illuminate this debate.Methods: We prospectively assessed 2,011 consecutive patients admitted to the R Adams Cowley Shock Trauma Center of the University of Maryland Medical System for the potential to give consent for a hypothetical research trial within 1 hour of admission or whether consent could be obtained from a legally authorized representative (LAR) within 3 hours. These data were then linked with demographic, transport, physiologic, and injury data.Results: Complete data were available for 1,734 patients: 982 (57%) appeared able to consent and 752 (43%) appeared unable to consent. Of the latter, LAR consent was potentially available for 404, leaving 348 (46%, 20% of all admissions) unconsentable. Those apparently able to consent were significantly less injured than those unable, but a third were subsequently found to have objective barriers to giving consent, and a further third had findings strongly suggestive of impairment. For those unable to consent, subsequent LAR consent was strongly associated with being a minor or being a woman. Lack of LAR consent was strongly associated with being the victim of intentional injury, with being an African-American male and-for European-American men only-with being transported greater distances.Conclusions: Severely injured trauma patients can seldom provide consent for research studies, and LARs are often unavailable. Further efforts to develop workable mechanisms for exception from informed consent are justified.