Patients' Experiences of Emergency Research (PEER)- Views of Patients included in

描述(由申请人提供)：迫切需要对急性神经疾病的治疗进行临床研究，如创伤性脑损伤、癫痫持续状态和中风。NINDS和NIH致力于通过支持神经紧急情况治疗试验(NETT)小组和其他解决这些重要公共卫生威胁的研究来开展这项研究。尽管进行这些研究在伦理上势在必行，但其他伦理挑战，特别是在许多紧急情况下无法获得患者同意，对研究构成了重大障碍。联邦法规允许紧急情况下的知情同意(EFIC)例外，但许多机构和调查人员对EFIC研究缺乏经验，法规本身存在争议和模棱两可，对于何时适合此类研究仍存在分歧(1-4)。此外，媒体的争议和公众对EFIC研究看法的不确定性引发了人们对患者及其家人在未经同意的情况下纳入研究的潜在反应的担忧(5；6)。该项目名为“患者在急诊研究中的经历(PEER)”，直接回应了NIH关于知情同意的挑战研究的请求，以及NINDS关于专门解决EFIC研究挑战的研究请求。Peer将首次评估参加EFIC研究的患者的经历和观点。在普通公众和受可能成为EFIC研究对象的疾病影响的人群中，关于支持EFIC研究的现有数据冲突(7-11)，而且从来没有研究评估过实际登记参加EFIC研究的患者的意见。了解登记患者的经历和意见将为EFIC研究的预期支持水平提供基准，揭示这一最重要人群的关切，确定改善EFIC研究登记经验的策略，并评估法规要求的社区咨询和公开披露工作的影响和有效性。这项同行研究将是对参加EFIC研究的受试者的经验和观点进行的第一次系统评估。它将涉及对Rampart中包括的患者进行半结构化访谈，这是NINDS资助的一项在NETT内进行的研究，并评估EMS人员对癫痫持续状态的药物治疗。PEER将包括5个不同地点的患者，并将利用NETT调查人员在EFIC研究方面的专业知识，以及NETT内同时存在的伦理项目。具体目标包括：评估入选患者对Rampart的看法及其在其中的登记情况；评估入选患者对EFIC研究的总体看法以及他们在EFIC研究中的入选情况；确定意见的原因和预测因素；以及评估主要法规保护的影响和有效性。该项目代表了促进对EFIC研究伦理的理解的努力的一个组成部分，以便在尊重入选患者的同时促进重要研究。公共卫生相关性：严重的急性神经系统疾病，如中风、创伤性脑损伤和癫痫持续状态，是美国发病率和死亡率的主要原因，临床研究对于改进针对这些重要公共卫生威胁的往往无效或研究较少的治疗方法至关重要。然而，这项重要的研究往往因伦理挑战和围绕无法同意参与研究的急症患者的临床试验而受到伦理挑战和争议的阻碍。“患者在急诊研究中的体验(PEER)”项目将通过首次征集未经同意参加癫痫持续状态院前治疗的随机对照试验的患者的意见和经验，来推进NIH促进急需的临床研究的合乎道德的进行的目标。

DESCRIPTION (provided by applicant): There is a critical need for clinical research on treatment of acute neurological conditions such as traumatic brain injury, status epilepticus, and stroke. NINDS and NIH have committed to this research through support of the Neurological Emergencies Treatment Trial (NETT) group and other studies addressing these important public health threats. Despite the ethical imperative to conduct these studies, other ethical challenges, particularly the inability to obtain patient consent in many emergencies, have posed significant barriers to research. Federal regulations permit an exception from informed consent (EFIC) in emergency settings, but many institutions and investigators have little experience with EFIC research, the regulations themselves are controversial and ambiguous, and there remains disagreement about when such studies are appropriate (1-4). Furthermore, media controversy and uncertainty about public views of EFIC research have prompted concern about the potential reactions of patients and their families to inclusion in studies without consent (5; 6). This project, entitled "Patients' Experiences in Emergency Research (PEER)," responds directly to the NIH request for research on challenges to informed consent and to the NINDS request for research specifically addressing challenges in EFIC research. PEER will, for the first time, assess the experiences and views of patients enrolled in an EFIC study. Existing data conflict regarding support for EFIC research among the general public and among persons affected by conditions likely to be the subject of EFIC research (7-11), and no study has ever assessed the views of patients actually enrolled in an EFIC study. Understanding enrolled patients' experiences and views will provide benchmarks for expected levels of support in EFIC studies, bring to light concerns of this most important population, identify strategies for improving the experience of enrollment in EFIC studies, and provide an assessment of the impact and effectiveness of the community consultation and public disclosure efforts required by regulations. The PEER study will represent the first systematic assessment of the experiences and views of subjects enrolled in an EFIC study. It will involve conducting semi-structured interviews with patients included in RAMPART, an NINDS-funded study conducted within the NETT and evaluating pharmacologic treatment of status epilepticus by EMS personnel. PEER will include patients at each of 5 diverse sites and will capitalize on expertise regarding EFIC research among NETT investigators and the presence of concurrent ethics projects within NETT. Specific aims include: assessing enrolled patients' views of RAMPART and their enrollment in it; assessing enrolled patients' views of EFIC research generally and their enrollment in an EFIC study; identifying reasons for and predictors of views; and assessing the impact and effectiveness of major regulatory protections. This project represents an integral component of the effort to advance understanding of the ethics of EFIC research in order to facilitate important studies while respecting enrolled patients. PUBLIC HEALTH RELEVANCE: Severe, acute neurological conditions such as stroke, traumatic brain injury, and status epilepticus, represent major causes of morbidity and mortality in the Unites States, and clinical research is essential to improving often ineffective or poorly studied treatments for these important public health threats. However, this important research is often complicated and impeded by ethical challenges and controversy surrounding the enrollment in clinical trials of emergently ill patients who are unable to provide consent for research participation. The "Patients' Experiences in Emergency Research (PEER)" project will advance the NIH goal of facilitating the ethical conduct of much-needed clinical research by soliciting, for the first time, the views and experiences of patients enrolled without consent in a randomized controlled trial of pre-hospital treatment of status epilepticus.