Bass Pat F, Maloy John W
Office of Research, Louisiana State University Health Sciences Center Shreveport, Shreveport, LA.
Assistant Vice Chancellor for Research Management, Louisiana State University Health Sciences Center Shreveport, Shreveport, LA.
Ochsner J. 2020 Spring;20(1):56-61. doi: 10.31486/toj.19.0087.
Before undertaking a research project, investigators must determine if the planned activity is human subjects research or a quality improvement project because specific regulations govern the conduct of human subjects research. Making this determination, however, can be confusing because human subjects research and quality improvement projects share similar characteristics. The definitions, questions, and examples provided in this article will help investigators decide between quality improvement projects and human subjects research or determine when to seek regulatory guidance. While quality improvement and human subjects research are both rigorous processes and at times involve similar methods, the two types of studies have distinctly different overall aims. Quality improvement projects use data-driven methods to improve health delivery and quality. Such projects examine changes in human behavior and are largely experiential learning processes. Research is a systematic investigation designed to develop or contribute to generalizable knowledge. In most instances, the goals of human subjects research and quality improvement projects do not intersect, and quality improvement projects are generally not subject to US Department of Health and Human Services (HHS) regulatory protections. However, some projects are both quality improvement and human subjects research, and sometimes, a quality improvement project develops into a human subjects research project. Investigators must be aware of the criteria defining human subjects research to ensure that HHS regulations for the protection of human subjects are applied when necessary.
在开展研究项目之前，研究人员必须确定计划开展的活动是人体受试者研究还是质量改进项目，因为针对人体受试者研究的开展有特定的规定。然而，做出这种区分可能会令人困惑，因为人体受试者研究和质量改进项目有一些相似的特征。本文提供的定义、问题及示例将帮助研究人员在质量改进项目和人体受试者研究之间做出抉择，或确定何时寻求监管指导。虽然质量改进和人体受试者研究都是严谨的过程，有时还会采用相似的方法，但这两类研究的总体目标截然不同。质量改进项目运用数据驱动的方法来改善医疗服务和质量。此类项目研究人类行为的变化，在很大程度上是经验性学习过程。研究是一种旨在发展或促进可推广知识的系统调查。在大多数情况下，人体受试者研究和质量改进项目的目标并不交叉，质量改进项目一般不受美国卫生与公众服务部（HHS）监管保护。然而，有些项目既是质量改进项目又是人体受试者研究项目，有时，一个质量改进项目会演变成人体受试者研究项目。研究人员必须了解界定人体受试者研究的标准，以确保在必要时适用HHS关于保护人体受试者的规定。
