Abernethy Amy P, Capell Warren H, Aziz Noreen M, Ritchie Christine, Prince-Paul Maryjo, Bennett Rachael E, Kutner Jean S
Duke Clinical Research Institute, Durham, North Carolina, USA; Duke Cancer Institute, Duke University School of Medicine, Durham, North Carolina, USA.
University of Colorado School of Medicine, Aurora, Colorado, USA.
J Pain Symptom Manage. 2014 Dec;48(6):1211-21. doi: 10.1016/j.jpainsymman.2014.05.005. Epub 2014 May 28.
Palliative care has faced moral and ethical challenges when conducting research involving human subjects. There are currently no resources to guide institutional review boards (IRBs) in applying standard ethical principles and terms-in a specific way-to palliative care research. Using as a case study a recently completed multisite palliative care clinical trial, this article provides guidance and recommendations for both IRBs and palliative care investigators to facilitate communication and attain the goal of conducting ethical palliative care research and protecting study participants while advancing the science. Beyond identifying current challenges faced by palliative care researchers and IRBs reviewing palliative care research, this article suggests steps that the palliative care research community can take to establish a scientifically sound, stable, productive, and well-functioning relationship between palliative care investigators and the ethical bodies that oversee their work.
在开展涉及人类受试者的研究时,姑息治疗面临着道德和伦理挑战。目前,尚无资源指导机构审查委员会(IRB)以特定方式将标准伦理原则和术语应用于姑息治疗研究。本文以最近完成的一项多中心姑息治疗临床试验为例,为IRB和姑息治疗研究人员提供指导和建议,以促进沟通,实现开展符合伦理的姑息治疗研究、保护研究参与者并推动科学发展的目标。除了识别姑息治疗研究人员和审查姑息治疗研究的IRB目前面临的挑战外,本文还提出了姑息治疗研究界可以采取的步骤,以在姑息治疗研究人员与监督其工作的伦理机构之间建立科学合理、稳定、高效且运作良好的关系。