Ethics in Resuscitation Research: Understanding and Incorporating Community Views

描述(由申请人提供)：迫切需要临床研究来改进急性危及生命的疾病的治疗，如心脏性猝死和创伤性脑损伤。由于患有这些疾病的患者病情严重，无法在知情的情况下表示同意，因此在紧急情况下进行研究在伦理上具有挑战性。联邦法规允许紧急情况下的知情同意(EFIC)例外，但很少有EFIC研究获得批准，留下了关键的临床问题没有得到回答。EFIC研究中的一个重大挑战是，有争议的要求咨询将进行研究的地区的社区。由于社区协商的目标和实现这些目标的方法仍然不清楚，IRBs、研究人员和赞助商都在努力满足这一要求。该项目是与神经紧急治疗试验(NETT)小组的独特合作，嵌入了NETT关于癫痫持续状态(Rampart)和创伤性脑损伤(PROTECT III)的试验。它的目的是提高对社区咨询过程和社区对EFIC研究的看法的理解。它的具体目的是：1.评估参加Rampart试验的患者对EFIC的看法和经验。2.对Rampart试验中的社区咨询进行了系统的探索性研究。3.使用目标2中的指标对Protect III试验中不同的社区咨询方法进行综合前瞻性评估。4.为EFIC研究和社区咨询制定政策建议。该项目将分两个阶段进行，并采用多种方法。第一阶段将包括对调查人员和IRB成员的访谈和调查，观察社区咨询工作，以及对Rampart的登记参与者进行深入访谈，Rampart是一项关于癫痫持续状态的院前治疗研究。第二阶段将使用从第一阶段制定的指标来评估在PROTECT III中建议和进行的社区咨询努力，PROTECT III是关于闭合性头部创伤的黄体酮的第三阶段研究。这种独特的合作是一个极好的培训机会，将为寻求改善心血管和神经紧急情况治疗的研究人员提供宝贵的数据。

DESCRIPTION (provided by applicant): Clinical research is sorely needed to improve treatment of acute, life-threatening conditions such as sudden cardiac death and traumatic brain injury. Because patients with these conditions are severely ill and unable to give informed consent, research in emergency settings is ethically challenging. Federal regulations permit an exception from informed consent (EFIC) in emergency settings, but few EFIC studies have been approved, leaving crucial clinical questions unanswered. A significant challenge in EFIC research is the controversial requirement to consult communities in the area where research will be conducted. IRBs, investigators, and sponsors struggle with this requirement, as the goals of community consultation and the methods for achieving those goals remain unclear. This project is a unique collaboration with the Neurological Emergency Treatment Trials (NETT) group, is embedded within NETT trials on status epilepticus (RAMPART) and traumatic brain injury (PROTECT III). It is designed to improve understanding of the process of community consultation and community views on EFIC research. Its specific aims are to: 1. Assess the views and experiences of patients enrolled in the RAMPART trial regarding EFIC. 2. Conduct a systematic exploratory study of community consultation in the RAMPART trial. 3. Use metrics from Aim 2 to conduct a comprehensive prospective evaluation of different community consultation methods in the PROTECT III Trial. 4. Develop policy recommendations for EFIC research and community consultation. The project will take place in two phases and employ multiple methods. The first phase will involve interviews and surveys with investigators and IRB members, observation of community consultation efforts, and in-depth interviews with enrolled participants in RAMPART, a study of pre-hospital treatment of status epilepticus. The second phase will use metrics developed from the first phase to assess community consultation efforts proposed and conducted in PROTECT III, a Phase III study of progesterone in closed head trauma. This unique collaboration is an excellent training opportunity and will produce valuable data for investigators seeking to improve treatment for cardiovascular and neurologic emergencies.