Morrison C Anne, Horwitz Irwin B, Carrick Matthew M
Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas 77030, USA.
J Surg Res. 2009 Nov;157(1):115-22. doi: 10.1016/j.jss.2009.03.051. Epub 2009 May 3.
As in any area of medicine, clinical trials are crucial to the advancement of trauma care and the establishment of evidence-based guidelines. This work identifies consent regulations that impede advances in trauma resuscitation research and examines several ethical issues underlying current policies in the United States which regulate how clinical trials are conducted in an emergency setting. Trauma is a leading cause of mortality in the U.S. Minorities and those in low socioeconomic groups are subject to a disproportional amount of traumatic injuries and have worse treatment outcomes than non-minority individuals. Current regulations guiding consent requirements in emergency research were enacted to protect such vulnerable populations from exploitation. Ironically, these same regulations also serve as barriers to clinical trials in trauma research, thus depriving these same vulnerable groups from the benefits of advances in trauma care.
A literature review was conducted on areas affecting emergency medical research including: informed consent, socioeconomic and racial disparities, federal regulations in trauma research and biomedical ethics.
In the ten year period following the passage of the FDA's Common Rule (21 CFR 50.24) in 1995, 21 published emergency research studies were conducted under the waiver of informed consent. Misconceptions regarding federal regulations and cumbersome internal review board approval processes are frequently cited as significant barriers to conducting prospective randomized trials in the emergency setting.
Given the history of past abuses in medical research, the principle of maintaining autonomy of choice is of paramount importance. However, trauma resuscitation is unique in that patients are either unconscious or of limited mental capacity at the time treatment is required, and thus the standard of informed consent is unable to be achieved as in other areas of medicine. While this paradox was recognized by the FDA in 1995 with the creation of an exception to the requirement for informed consent in emergency research (the "Common Rule"), the wording of this exception is ambiguous, and has consequently deterred trauma investigators from pursuing valuable research endeavors. In particular, the language requiring "community consultation" and demonstration that existing treatments are "unproven or unsatisfactory" have been identified as the most problematic terms to satisfactorily address by those aiming to conduct trauma research. It is imperative that the current exemptions to the Common Rule be more thoroughly operationalized, so that greater advancement in emergency medicine research can be promulgated, while concurrently maintaining a high standard of protection for the rights of trauma patients.
与医学的任何领域一样，临床试验对于创伤护理的进步和循证指南的建立至关重要。这项工作确定了阻碍创伤复苏研究进展的同意规定，并审视了美国当前政策背后的几个伦理问题，这些政策规定了在紧急情况下如何进行临床试验。创伤是美国主要的死亡原因。少数族裔和社会经济地位较低的人群遭受的创伤性损伤比例过高，且治疗结果比非少数族裔个体更差。指导紧急研究中同意要求的现行规定旨在保护此类弱势群体不被剥削。具有讽刺意味的是，这些规定也成为创伤研究临床试验的障碍，从而使这些弱势群体无法受益于创伤护理的进展。
对影响紧急医疗研究的领域进行了文献综述，包括：知情同意、社会经济和种族差异、创伤研究的联邦法规以及生物医学伦理。
在1995年美国食品药品监督管理局（FDA）的《联邦法规汇编》第21编第50.24条通用规则通过后的十年里，有21项已发表的紧急研究在免除知情同意的情况下进行。对联邦法规的误解和繁琐的内部审查委员会批准程序经常被认为是在紧急情况下进行前瞻性随机试验的重大障碍。
鉴于医学研究过去存在滥用情况的历史，维护选择自主权的原则至关重要。然而，创伤复苏的独特之处在于，在需要治疗时患者要么昏迷要么心智能力有限，因此无法像在医学的其他领域那样达到知情同意的标准。虽然FDA在1995年通过为紧急研究中的知情同意要求设立例外情况（“通用规则”）认识到了这一矛盾，但该例外情况的措辞含糊不清，因此阻碍了创伤研究人员开展有价值的研究工作。特别是，要求“社区咨询”以及证明现有治疗方法“未经证实或不令人满意”的措辞已被确定为旨在进行创伤研究的人员最难令人满意地满足的条款。必须更全面地实施当前对通用规则的豁免，以便在促进急诊医学研究取得更大进展的同时，为创伤患者的权利维持高标准的保护。
