Perspect Biol Med. 2020;63(2):346-358. doi: 10.1353/pbm.2020.0023.
Forty years ago, the Belmont Report counseled that a "systematic, nonarbitrary analysis of risks and benefits" is vital to ensuring the ethical appropriateness of research with human subjects. Since then, research ethics has devoted considerable attention to the first half of this advice, emphasizing the ethical importance of assessing and minimizing the risks of research with human subjects. Significantly less attention has been devoted to a systematic assessment of the potential benefits of research participation. To the extent that benefits for individual participants are considered at all, commentators tend to focus on their potential to undermine the goal of minimizing risks. A chance for clinical benefit may obscure the fact that research poses risks not present in clinical care, while an offer of financial compensation or ancillary care may induce individuals to accept risks that conflict with their long-term interests. This article argues that, while undoubtedly important, minimizing risks fails to offer sufficient protection for research participants, especially those who cannot consent, because it neither ensures that the risks of research are justified nor protects participants from exploitation. Belmont's advice to develop systematic and nonarbitrary ways to ensure that research participants receive appropriate benefits needs to be heeded as well.
四十年前，《贝尔蒙报告》建议，“系统地、非任意地分析风险和收益”对于确保以人为研究对象的研究的伦理适当性至关重要。自那时以来，研究伦理已经对这一建议的前半部分给予了相当多的关注，强调了评估和最小化以人为研究对象的研究风险的伦理重要性。而对研究参与的潜在收益进行系统评估则没有得到太多关注。在考虑到个别参与者的利益的情况下，评论员往往倾向于关注它们可能破坏最小化风险目标的潜力。临床获益的机会可能掩盖了这样一个事实，即研究带来了临床护理中不存在的风险，而提供经济补偿或辅助护理可能会诱使个人接受与其长期利益相冲突的风险。本文认为，虽然风险最小化无疑很重要，但它不能为研究参与者提供充分的保护，特别是那些不能同意的参与者，因为它既不能确保研究的风险是合理的，也不能防止参与者受到剥削。贝尔蒙的建议是制定系统和非任意的方法，以确保研究参与者获得适当的收益，这一建议也需要得到重视。
