Kimmelman Jonathan, Resnik David B, Peppercorn Jeffrey, Ratain Mark J
Studies of Translation, Ethics and Medicine (STREAM), Biomedical Ethics Unit, Social Studies of Medicine, McGill University, Montréal, Canada.
National Institute of Environmental Health Sciences, Research Triangle Park, NC, USA.
J Natl Cancer Inst. 2017 Apr 1;109(4). doi: 10.1093/jnci/djw315.
A large volume of trials involve invasive, nontherapeutic research procedures, like organ biopsy or sham surgeries, that can pose risks comparable with the experimental treatment itself but that have no direct benefit for volunteers. Though such procedures can enhance the value of clinical investigations, recent studies suggest that many studies involving invasive, nontherapeutic research procedures are not well planned and reported; some studies suggest that their results are often not utilized in the planning of new investigations. This commentary offers recommendations for how investigators, sponsors, and ethics committees might improve evaluation and implementation of studies involving invasive nontherapeutic procedures. We conclude by urging more demanding scientific standards for the rationale, design, and reporting of burdensome, nontherapeutic research procedures-particularly where they involve risk of serious complications.
大量试验涉及侵入性、非治疗性研究程序，如器官活检或假手术，这些程序可能带来与实验性治疗本身相当的风险，但对志愿者没有直接益处。尽管此类程序可提高临床研究的价值，但最近的研究表明，许多涉及侵入性、非治疗性研究程序的研究规划和报告并不完善；一些研究表明，其结果往往未被用于新研究的规划中。本评论针对研究者、资助者和伦理委员会如何改进对涉及侵入性非治疗性程序研究的评估和实施提出了建议。我们最后敦促对繁重的非治疗性研究程序的基本原理、设计和报告采用更严格的科学标准，尤其是在这些程序涉及严重并发症风险的情况下。
