Narrat Inq Bioeth. 2021;11(1):101-105. doi: 10.1353/nib.2021.0040.
In early 2020, clinicians and researchers rushed to understand the SARS-CoV-2 virus and how to go about treating and preventing it. Caring for patients while simultaneously learning about a disease not seen before created challenges on several levels. Much of the spotlight was on the researchers doing this critical work; however, these narratives remind us of the enormous effort and commitment shown by IRB members and research administrators responsible for research infrastructure. Despite the sense of urgency and obligation to plan and conduct clinical research during the pandemic, IRBs guaranteed that researchers still adhered to the core ethical principles that protect the rights and welfare of human subjects so that critical research could continue. Many themes emerge in these stories, including the need for flexibility in processes for both staff and research participants and the perception that IRB members serve as "research gatekeepers." With approaches to clinical research evolving, the SARS-CoV-2 pandemic may be the catalyst needed to make sustainable improvements to our research processes, roles, and goals.
2020 年初，临床医生和研究人员急于了解 SARS-CoV-2 病毒以及如何治疗和预防它。在照顾患者的同时，同时了解一种以前从未见过的疾病，这在几个层面上都带来了挑战。许多焦点都集中在从事这项关键工作的研究人员身上；然而，这些叙述提醒我们，负责研究基础设施的 IRB 成员和研究管理人员付出了巨大的努力和承诺。尽管在大流行期间计划和进行临床研究的紧迫感和义务感很强，但 IRB 保证研究人员仍然遵守保护人类受试者权利和福利的核心伦理原则，以便继续进行关键研究。这些故事中出现了许多主题，包括工作人员和研究参与者的流程需要灵活性，以及 IRB 成员充当“研究把关人”的观念。随着临床研究方法的不断发展，SARS-CoV-2 大流行可能是推动我们研究流程、角色和目标可持续改进的必要因素。
