LeBlanc Thomas W, Wheeler Jane L, Abernethy Amy P
Division of Medical Oncology, Department of Medicine, Duke University Medical Center, Durham, North Carolina 27710, USA.
J Pain Palliat Care Pharmacother. 2010 Sep;24(3):244-50. doi: 10.3109/15360288.2010.493579.
A fundamental tension surrounds the ethics of conducting research in vulnerable populations, and specifically, research involving patients at or near the end-of-life. In Palliative Medicine, these patients' care has historically been based on compassion, clinical judgment and experience, and anecdote rather than on data generated through high-quality clinical trials. A robust evidence base to support clinical practice in the end-of-life setting is lacking. Multiple ethical objections to the conduct of research at the end of life have impeded efforts to build such an evidence base. Arguments can be categorized into claims that the goals of research conflict with the goals of care; research unduly burdens vulnerable patients and families/caregivers; genuine equipoise does not exist; and research in the palliative care setting is too difficult. The authors explore and respond to these objections, noting the vital importance of research at this stage of the illness trajectory. The authors conclude that barriers to palliative care research are surmountable, and, indeed, that the "research imperative" and principles laid out in the Belmont Report of 1979 require us to rigorously study clinical interventions used for palliative care patients-so as to provide optimal safety and outcomes for present and future patients.
围绕在弱势群体中开展研究的伦理问题，尤其是涉及临终或接近临终患者的研究，存在着一种根本性的矛盾。在姑息医学中，这些患者的护理历来基于同情、临床判断、经验和轶事，而非高质量临床试验所产生的数据。缺乏支持临终环境下临床实践的有力证据基础。对临终研究的开展存在多种伦理反对意见，阻碍了建立这样一个证据基础的努力。这些反对意见可分为以下几类：研究目标与护理目标相冲突；研究给脆弱的患者及其家庭/护理人员带来过度负担；不存在真正的 equipoise（此处可能是专业术语，未明确含义，保留原文）；以及在姑息治疗环境中开展研究过于困难。作者探讨并回应了这些反对意见，指出在疾病轨迹的这一阶段进行研究至关重要。作者得出结论，姑息治疗研究的障碍是可以克服的，事实上，1979年《贝尔蒙报告》中提出的“研究必要性”和原则要求我们严格研究用于姑息治疗患者的临床干预措施，以便为当前和未来的患者提供最佳的安全性和治疗效果。
