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系统疾病（如创伤性脑损伤、癫痫持续状态和中风）的治疗进行临床研究。NINDS和NIH通过支持神经急救治疗试验小组和其他针对这些重要公共卫生威胁的研究，致力于这项研究。尽管进行这些研究在伦理上是必要的，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知情同意（EFIC）的例外情况，但许多机构和调查人员缺乏EFIC研究的经验，法规本身存在争议和模棱两可，对于何时进行此类研究仍然存在分歧（1-4）。此外，媒体的争议和公众对EFIC研究观点的不确定性引发了对患者及其家属在未经同意的情况下被纳入研究的潜在反应的担忧（5;6）。该项目名为“患者在紧急研究中的经验（PEER）”，直接响应了美国国立卫生研究院关于对知情同意的挑战进行研究的请求，以及NIH关于专门针对EFIC研究挑战进行研究的请求。PEER将首次评估参加EFIC研究的患者的经历和观点。关于EFIC研究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的支持的现有数据存在冲突（7-11），并且没有研究评估过实际参加EFIC研究的患者的观点。了解入组患者的经历和观点将为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注，确定改善EFIC研究入组体验的策略，并对法规要求的社区咨询和公开披露工作的影响和有效性进行评估。PEER研究将首次对EFIC研究中受试者的经验和观点进行系统评估。它将包括对RAMPART患者进行半结构化访谈，RAMPART是一项由ninds资助的研究，在NETT内进行，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研究人员在EFIC研究方面的专业知识以及NETT内部同时存在的伦理项目。具体目的包括：评估入组患者对RAMPART的看法及其入组情况；评估入组患者对EFIC研究的总体看法以及他们入组EFIC研究的情况；确定观点的原因和预测因素；评估主要监管保护措施的影响和有效性。该项目是促进对EFIC研究伦理理解的一个重要组成部分，目的是在尊重入组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，临床研究对于改善这些重要公共卫生威胁的治疗方法至关重要，这些治疗方法往往无效或研究不足。然而，这项重要的研究往往是复杂的，并受到伦理挑战和争议周围的临床试验招收急诊病人谁不能提供同意参与研究。“紧急研究中的患者经验（PEER）”项目将推动NIH的目标，促进急需的临床研究的伦理行为，首次征求未经同意的患者的意见和经验，参与一项关于癫痫持续状态院前治疗的随机对照试验。

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.