Pretz Jennifer L, Magnus David, Spain David A
Stanford Center for Biomedical Ethics, Department of Surgery, Stanford University School of Medicine, Stanford, California, USA.
J Trauma. 2009 Dec;67(6):1443-7. doi: 10.1097/TA.0b013e3181bba255.
Experimentation involving human subjects requires careful attention to the protection of their rights. Beginning with the Belmont Report in 1979, the United States has developed various sets of rules and regulations that identify the requirements for performing human subject research. In addition, these standards attempt to define the fundamental difference between what constitutes research versus clinical treatment versus innovation. We explore the intersection between two areas of independent bioethics, surgical innovation and emergency research; the point we refer to as emergency innovation.
A systematic literature review in each of the fields of emergency research and surgical innovation was completed. The ethical principles involved in each field were identified. In addition, a recent case of surgical innovation within the context of emergency treatment is evaluated for the ethics invoked.
One of the great challenges in emergency innovation is that the main protection offered in innovation (heightened informed consent) is not possible in the emergency context where in fact informed consent is waived. Interestingly, the rest of the protections outlined for each field are not mutually exclusive. They can and should be utilized in any project that takes place at this intersection. However, as there are no strict regulations in place for the collision of these two fields, the possibility of having the majority of the involved ethical principles misinterpreted or ignored is very real.
For emergency innovation, where it is unclear what ethical principles and regulatory powers apply, it is imperative to be unambiguous about the purpose of the investigation, to adhere to all applicable ethical principles, and to have utmost consideration for protection of the research subject. To determine intent, the goals of the study must be outlined precisely - and if those include the prospect of publication, institutional review board (IRB) approval should be involved early. If, however, the innovation is subtle and the goal geared toward improved patient care, a small feasibility trial would be an appropriate first step before transitioning to a formal larger study approved by an IRB. In either case, the degree of the change in practice must be carefully evaluated and the vulnerability of the research subjects respected. With careful attention paid to all applicable ethical principles at the emergency innovation intersection, medical progress can continue at minimized risk to the human subject participants.
涉及人类受试者的实验需要密切关注对其权利的保护。自1979年《贝尔蒙报告》发布以来，美国制定了多套规则和法规，明确了进行人类受试者研究的要求。此外，这些标准试图界定研究、临床治疗与创新之间的根本区别。我们探讨了两个独立的生物伦理学领域——外科创新与急诊研究的交叉点；我们将这一点称为急诊创新。
完成了对急诊研究和外科创新各领域的系统文献综述。确定了每个领域涉及的伦理原则。此外，对近期在急诊治疗背景下的一例外科创新案例进行了伦理考量评估。
急诊创新面临的一大挑战是，创新中提供的主要保护措施（强化知情同意）在急诊情况下无法实现，因为事实上急诊情况下知情同意被豁免。有趣的是，为每个领域概述的其他保护措施并非相互排斥。它们可以而且应该在这个交叉点开展的任何项目中得到应用。然而，由于这两个领域的碰撞没有严格的规定，大多数相关伦理原则被误解或忽视的可能性是切实存在的。
对于急诊创新，在不清楚适用哪些伦理原则和监管权力的情况下，必须明确调查目的，遵守所有适用的伦理原则，并最大限度地考虑保护研究对象。为确定意图，必须精确概述研究目标——如果这些目标包括发表前景，应尽早获得机构审查委员会（IRB）的批准。然而，如果创新较为细微且目标是改善患者护理，在过渡到由IRB批准的正式大型研究之前，进行小型可行性试验将是合适的第一步。在任何一种情况下，都必须仔细评估实践中的变化程度，并尊重研究对象的脆弱性。在急诊创新交叉点认真关注所有适用的伦理原则，医学进步就能在将对人类受试者参与者的风险降至最低的情况下继续推进。
