Resnik David B
National Institute of Environmental Health Sciences, Research Triangle Park, North Carolina 27709, USA.
Account Res. 2007 Jan-Mar;14(1):35-55. doi: 10.1080/08989620601122842.
In this article, I assess the benefits and risks of studies that intentionally expose research subjects to environmental agents. I describe these types of studies, identify their benefits and risks, compare them to other research methods that can be used to investigate the relationship between environmental exposures and disease, and discuss some issues related to research design and risk minimization. I argue that the benefits of intentional environmental exposure studies outweigh the risks when 1) the knowledge gained is likely to improve our understanding of the relationship between environmental exposure and disease, 2) this knowledge cannot be obtained by other methods, 3) the experiments are well designed, 4) the subjects will receive some benefits, such as medical evaluations, 5) risks are minimized, and 6) the risks to human subjects are less than those encountered in a typical Phase I drug study. Only in rare circumstances (i.e., when an intentional environmental exposure study is needed to implement an important environmental or public health intervention or regulation) may such studies expose research subjects to risks as high as those encountered in a typical Phase I drug trail.
在本文中，我评估了故意让研究对象接触环境因素的研究的益处和风险。我描述了这类研究，确定了它们的益处和风险，将它们与可用于调查环境暴露与疾病之间关系的其他研究方法进行了比较，并讨论了一些与研究设计和风险最小化相关的问题。我认为，当以下情况发生时，故意环境暴露研究的益处超过风险：1）所获得的知识可能会增进我们对环境暴露与疾病之间关系的理解；2）这些知识无法通过其他方法获得；3）实验设计良好；4）研究对象将获得一些益处，如医学评估；5）风险降至最低；6）对人类研究对象的风险低于典型的I期药物研究中所遇到的风险。只有在极少数情况下（即当需要进行故意环境暴露研究以实施重要的环境或公共卫生干预或监管时），此类研究才可能使研究对象面临与典型I期药物试验中所遇到的风险一样高的风险。
