End-of-Life Research Ethics: Concerns, Approaches, and Impact

描述（由申请人提供）：美国人口老龄化的增长导致人们呼吁增加对临终者及其家人的临终关怀（EOL）的研究。2004年美国国立卫生研究院（NIH）关于改善EOL护理的科学状况会议指出，目前的知识状况处于起步阶段，并确定需要对概念模型、基础设施、方法问题、治疗、结果和政策进行更多的研究。会议的建议包括呼吁对伦理问题进行研究，认识到在EOL进行的研究提出了与同意、能力、代理决策以及风险和收益评估相关的复杂伦理问题，这些问题可能会抑制这一重要研究的开展，并成为这一领域科学进步的障碍。关于如何最好地平衡研究的迫切需要与临终者及其家属的权利的问题反映了困扰调查人员、机构审查委员会（IRBs）和科学审稿人的伦理问题。然而，缺乏关于管理这些问题的最佳实践的经验数据，以协助研究的发展，平衡伦理考虑与科学进步。为了确定进行EOL研究的最佳实践，本提案的目的是：1)比较研究者、机构审查委员会和科学审稿人在生命末期研究中确定的伦理问题；2)确定研究者、机构审查委员会和科学审稿人用于解决生命末期研究中的伦理问题的方法；3)描述研究者、机构审查委员会和科学审稿人确定的伦理问题对临终研究行为的影响。临终研究将从网络和当前文献中确定。40-50项研究的主要研究者将被要求分享研究文件，包括拨款提案、科学评论和IRB通讯。将与个案主要调查人员进行定性电话访谈，以澄清文件中提出的问题以及伦理问题对其研究的影响。这项研究是创新的，因为它使用了一个探索性的案例研究设计，利用主要数据来源来获取有关负责研究伦理行为的关键利益相关者的观点的信息。研究结果将有助于加强和促进EOL人类受试者研究的道德行为，以改善对临终者及其家属的护理。公共卫生相关性：迫切需要增加对临终关怀的研究，但伦理问题已被确定为这一领域发展的可能障碍。拟议的研究旨在评估负责审查、批准和研究伦理行为的关键利益相关者的观点，以更好地了解伦理问题如何影响临终研究的发展。在这项研究完成后，数据将用于：(a)描述在进行临终研究时出现的伦理问题的特征；(b)确定解决伦理问题的方法，用于设计和审查生命终结研究；(c)了解伦理问题对进行临终研究的影响。

DESCRIPTION (provided by applicant): The growth of the aging population in the United States has led to calls for increased research focused on enhancing end-of-life (EOL) care for dying persons and their family members. A 2004 National Institutes of Health (NIH) State of the Science Conference on Improving EOL Care noted that the current state of knowledge is in its infancy and identified the need for more research on conceptual models, infrastructure, methodological issues, treatment, outcomes, and policy. The Conference recommendations included a call for research on ethical issues, recognizing that research conducted at the EOL raises complex ethical questions related to consent, capacity, proxy decision-making, and the evaluation of risks and benefits that may inhibit the conduct of this vital research and serve as a barrier to the advancement of the science in this area. Questions about how to best balance the pressing need for research with the rights of the dying and their families reflect ethical concerns that trouble investigators, institutional review boards (IRBs), and scientific reviewers alike. Yet, empirical data are lacking regarding best practices for managing these issues to assist in the development of research that balances ethical considerations with the advancement of science. In order to identify best practices for the conduct of EOL research, the aims of this proposal are to: 1) Compare what investigators, institutional review boards, and scientific reviewers identify as ethical concerns in end-of-life research; 2) Identify approaches used by investigators, institutional review boards, and scientific reviewers to resolve ethical concerns in end-of-life research; and 3) Describe the impact of ethical concerns identified by investigators, institutional review boards, and scientific reviewers on the conduct of end-of-life research. End-of-life research will be identified from the web and current literature. Principal investigators of 40-50 studies will be asked to share study documents including grant proposals, scientific reviews, and IRB communications. Qualitative telephone interviews will be conducted with case principal investigators to clarify questions raised by the documents and the impact of ethical concerns on their research. This study is innovative because it uses an exploratory case study design capitalizing on primary data sources to obtain information about the perspectives of key stakeholders responsible for the ethical conduct of research. Study findings will serve to enhance and promote the ethical conduct of human subjects research at the EOL to improve care of the dying and their family members. PUBLIC HEALTH RELEVANCE: There is a pressing need for increased research on end-of-life care, but ethical concerns have been identified as a possible impediment to the development of this field. The proposed study is designed to assess the perspectives of key stakeholders responsible for the review, approval, and ethical conduct of research to better understand how ethical concerns shape the development of end-of-life studies. At the completion of this study, data will be available to: (a) describe the characteristics of ethical concerns that arise in the conduct of end-of-life research; (b) identify approaches to resolve ethical concerns for use in the design and review of end-of-life research; and (c) understand the impact of ethical concerns on the conduct of end-of-life research.