Corneli Amy, McKenna Kevin, Hanlen-Rosado Emily, Calvert Sara B, Mah Eric, Rosenfeld Stephen J
Associate professor in the Department of Population Health Sciences, a faculty member at the Duke Clinical Research Institute, and a lead social scientist of the Clinical Trials Transformation Initiative at Duke University School of Medicine.
Research program leader in the Department of Population Health Sciences and a senior research associate of the Clinical Trials Transformation Initiative at Duke University School of Medicine.
Ethics Hum Res. 2023 Sep-Oct;45(5):15-26. doi: 10.1002/eahr.500179.
The National Institutes of Health (NIH) requires use of a single institutional review board (sIRB) for multisite, nonexempt, NIH-funded research with human participants. The Clinical Trials Transformation Initiative (CTTI) conducted in-depth interviews with 34 stakeholders at two universities and in research administration leadership positions at multiple institutions about their experiences implementing the sIRB model, focusing on the NIH policy's goals soon after the policy was enacted. While some stakeholders suggested that using an sIRB has streamlined and reduced inefficiencies associated with the local IRB model, more stakeholders indicated that the sIRB model has not simplified the ethics review process and instead created new inefficiencies due to unclear roles and responsibilities for staff and institutions; a lack of systems and processes for implementing the sIRB model, including communication systems; and increased workloads. CTTI used these findings to propose a new framework for evaluating the NIH sIRB policy.
美国国立卫生研究院（NIH）要求，对于涉及人类受试者的多中心、非豁免、由NIH资助的研究，需使用单一机构审查委员会（sIRB）。临床试验转化倡议（CTTI）对两所大学的34名利益相关者以及多个机构的研究管理领导职位人员进行了深度访谈，了解他们实施sIRB模式的经验，重点关注该政策颁布后不久NIH政策的目标。虽然一些利益相关者表示，使用sIRB简化了流程并减少了与当地机构审查委员会（IRB）模式相关的低效率，但更多利益相关者指出，sIRB模式并未简化伦理审查流程，反而由于工作人员和机构的角色与职责不明确、缺乏实施sIRB模式的系统和流程（包括沟通系统）以及工作量增加而产生了新的低效率。CTTI利用这些发现提出了一个评估NIH的sIRB政策的新框架。
