Associate Director at the Presidential Commission for the Study of Bioethical Issues (Washington, DC). Senior Advisor at the Presidential Commission for the Study of Bioethical Issues (Washington, DC) and the Bobby Lee Cook Professor of Law at Georgia State University (Atlanta, GA).
J Law Med Ethics. 2013 Fall;41(3):697-710. doi: 10.1111/jlme.12080.
The STD experiments in Guatemala from 1946-1948 have earned a place of infamy in the history of medical ethics. But if the Guatemala STD experiments were so "ethically impossible," how did the U.S. government approve their funding? Although much of the literature has targeted the failings of Dr. John Cutler, we focus on the institutional context and research ethos that shaped the outcome of the research. After the end of WWII, Dr. Cassius Van Slyke reconstructed the federal research contracts process into a grant program. The inaugural NIH study section recommended approval of the Guatemala STD experiments at its first meeting. The funding and oversight process of the Guatemala research was marked with serious conflicts of interest and a lack of oversight, and it was this structure, as opposed to merely a maleficent individual, that allowed the Guatemala STD experiments to proceed. We conclude that while current research regulations are designed to prevent the abuses perpetrated on the subjects of the Guatemala STD experiments, it takes a comprehensive understanding of research ethics through professional education to achieve the longstanding ideal of the responsible investigator, and ensure ethical research under any regulatory scheme.
1946 年至 1948 年在危地马拉进行的 STD 实验在医学伦理史上声名狼藉。但是,如果危地马拉 STD 实验如此“在伦理上不可能”,美国政府怎么会批准资助呢?尽管许多文献都针对约翰·卡特勒博士的失误,但我们关注的是影响研究结果的制度背景和研究风气。第二次世界大战结束后,卡西乌斯·范斯莱克博士将联邦研究合同程序重建为赠款计划。NIH 研究分会在第一次会议上建议批准危地马拉 STD 实验。危地马拉研究的资金和监督过程存在严重的利益冲突和监督缺失,正是这种结构,而不是仅仅是一个邪恶的个体,使得危地马拉 STD 实验得以进行。我们的结论是,虽然当前的研究法规旨在防止对危地马拉 STD 实验对象的滥用,但需要通过专业教育全面了解研究伦理,才能实现负责任的研究人员的长期理想,并确保在任何监管方案下进行符合伦理的研究。