Indiana University School of Nursing, 1111 Middle Drive, Indianapolis, IN 46202, USA.
J Palliat Med. 2012 Aug;15(8):880-9. doi: 10.1089/jpm.2011.0515. Epub 2012 Jun 25.
Ethical concerns were identified as a potential barrier to advancing palliative and end-of-life science at the 2004 National Institutes of Health State of the Science Meeting. However, data are lacking about the nature of ethical concerns and strategies for balancing the need to advance science with human subjects protections.
A qualitative case-study design was used to follow 43 end-of-life studies from proposal development through the review process and implementation. Investigators participated in semi-structured telephone interviews and provided document data regarding their experiences with grant and IRB reviews. Using constant comparative analysis within and across cases, the investigators identified commonly encountered and unique concerns and strategies for managing these concerns.
Investigator strategies fell into two broad categories: 1) Recruitment and consent strategies related to subject identification and enrollment; and 2) Protocol-related strategies related to the process of data collection. These strategies shared the overarching meta-themes of compassion, as evidenced by a heightened sensitivity to the needs of the population, coupled with vigilance, as evidenced by close attention to the possible effects of study participation on the participants' well-being, clinical care, and the needs of research staff.
Ethical concerns have led to the development of compassionate and vigilant strategies designed to balance the potential for risk of harm with the need to advance the science of palliative and end-of-life care. These strategies can be used by investigators to address ethical concerns and minimize barriers to the development of palliative and end-of-life care science.
2004 年，美国国立卫生研究院（NIH）科学状况会议确定，伦理问题是推进姑息治疗和临终关怀科学的潜在障碍。然而，关于伦理问题的性质以及平衡推进科学与保护人类受试者需求的策略的数据却很缺乏。
采用定性案例研究设计，对 43 项临终研究进行了跟踪，这些研究从提案制定到审查过程和实施都有涉及。调查人员参加了半结构化电话访谈，并提供了关于他们在资助和 IRB 审查方面的经验的文件数据。研究人员通过对案例内和案例间的不断比较分析，确定了常见的和独特的关注点，以及管理这些关注点的策略。
调查人员的策略分为两类：1）与研究对象确定和纳入有关的招募和同意策略；2）与数据收集过程有关的方案相关策略。这些策略都有一个总体的主题，即同情，这表现为对人群需求的高度敏感，同时还保持警惕，即密切关注研究参与对参与者的福祉、临床护理和研究人员需求的潜在影响。
伦理问题导致了制定富有同情心和警惕性的策略，旨在平衡潜在的伤害风险与推进姑息治疗和临终关怀科学的需求。这些策略可以被研究人员用来解决伦理问题，并尽量减少姑息治疗和临终关怀科学发展的障碍。
