Doerr Megan, Meeder Sara
Director at Sage Bionetworks.
Director of Human Research Protections at Maimonides Medical Center.
Ethics Hum Res. 2022 Jul;44(4):34-38. doi: 10.1002/eahr.500130.
Much of precision medicine is driven by big health data research-the analysis of massive datasets representing the complex web of genetic, behavioral, environmental, and other factors that impact human well-being. There are some who point to the Common Rule, the regulation governing federally funded human subjects research, as a regulatory panacea for all types of big health data research. But how well does the Common Rule fit the regulatory needs of this type of research? This article suggests that harms that may arise from artificial intelligence and machine-learning technologies used in big health data research-and the increased likelihood that this research will affect public policy-mean it is time to consider whether the current human research regulations prohibit comprehensive, ethical review of big health data research that may result in group harm.
精准医学的很大一部分是由大健康数据研究推动的，即对海量数据集进行分析，这些数据集代表了影响人类福祉的遗传、行为、环境和其他因素的复杂网络。有些人将《共同规则》（管理联邦资助的人体研究的法规）视为各类大健康数据研究的监管万灵药。但《共同规则》在多大程度上符合这类研究的监管需求呢？本文认为，大健康数据研究中使用的人工智能和机器学习技术可能带来的危害，以及这类研究对公共政策产生影响的可能性增加，意味着是时候考虑当前的人体研究法规是否禁止对可能导致群体伤害的大健康数据研究进行全面、符合伦理的审查了。
