Resnik David
Perspect Biol Med. 2017;60(1):117-129. doi: 10.1353/pbm.2017.0023.
On March 28, 2017, the National Academy of Sciences, Engineering, and Medicine (NASEM) released a much-anticipated report on the Environmental Protection Agency's controlled human inhalation exposure studies. This essay reviews the ethical controversies that led to the genesis of the report, summarizes its key findings, and comments on its approach to informing human subjects about the risks of inhalation exposure studies. NASEM's report makes a valuable contribution to our understanding of the scientific and ethical issues involved in conducting human inhalation exposure studies. Its definition of "reasonably foreseeable risks" provides useful guidance to investigators, research participants, and institutional review board members.
2017年3月28日，美国国家科学院、工程院和医学院（NASEM）发布了一份备受期待的关于美国环境保护局控制人体吸入暴露研究的报告。本文回顾了导致该报告产生的伦理争议，总结了其主要发现，并对其向人体研究对象告知吸入暴露研究风险的方式进行了评论。NASEM的报告为我们理解进行人体吸入暴露研究所涉及的科学和伦理问题做出了宝贵贡献。其对“合理可预见风险”的定义为研究者、研究参与者和机构审查委员会成员提供了有用的指导。
