沙特阿拉伯的机构审查委员会：基于调查的首次关于其职能和运作的报告。

Institutional review boards in Saudi Arabia: the first survey-based report on their functions and operations.

机构信息

Biostatistics, Epidemiology and Scientific computing Department, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia.

Neuroscience center, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia.

出版信息

BMC Med Ethics. 2023 Jul 10;24(1):50. doi: 10.1186/s12910-023-00928-7.

DOI:10.1186/s12910-023-00928-7

PMID:37430255

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10334562/

Abstract

BACKGROUND

Institutional review boards (IRBs) are formally designated to review, approve, and monitor biomedical research. They are responsible for ensuring that researchers comply with the ethical guidelines concerning human research participants. Given that IRBs might face different obstacles that cause delays in their processes or conflicts with investigators, this study aims to report the functions, roles, resources, and review process of IRBs in Saudi Arabia.

METHOD

This was a cross-sectional self-reported survey conducted from March 2021 to March 2022. The survey was sent to 53 IRB chairpersons and the administration directors (or secretary) across the country through email after receiving verbal consent. The validated survey consisted of eight aspects: (a) organizational aspects, (b) membership and educational training, (c) submission arrangements and materials, (d) minutes, (e) review procedures, (f) communicating a decision, (g) continuing review, and (h) research ethics committee (REC) resources. A total of 200 points indicated optimal IRB functions.

RESULTS

Twenty-six IRBs across Saudi Arabia responded to the survey. Overall, the IRBs in this study scored a total of 150/200 of the points on the self-assessment tool. Relatively newer IRBs (established less than ten years ago) conducted meetings at least once in a month, had annual funding, had more balanced gender representation, tended to score higher than older IRBs. The organizational aspect score was the lowest among all items in the survey (14.3 score difference, p-value < 0.01). The average turnaround time for expedited research from proposal submission to final decision was 7 days, while it was 20.5 days for the full committee review.

CONCLUSION

Saudi IRBs performed generally well. However, there is room for focused improvement with respect to extra resources and organizational issues that require closer evaluation and guidance from the regulatory bodies.

摘要

背景

机构审查委员会（IRB）是正式指定负责审查、批准和监测生物医学研究的机构。它们负责确保研究人员遵守涉及人类研究参与者的伦理准则。鉴于 IRB 可能面临导致其程序延迟或与研究人员产生冲突的不同障碍，本研究旨在报告沙特阿拉伯的 IRB 的职能、角色、资源和审查程序。

方法

这是一项横断面自我报告调查，于 2021 年 3 月至 2022 年 3 月期间进行。在获得口头同意后，通过电子邮件向全国的 53 名 IRB 主席和行政主任（或秘书）发送了经过验证的调查问卷。调查问卷由八个方面组成：（a）组织方面，（b）成员和教育培训，（c）提交安排和材料，（d）会议记录，（e）审查程序，（f）传达决定，（g）持续审查，和（h）研究伦理委员会（REC）资源。总分为 200 分，表明 IRB 功能最佳。

结果

沙特阿拉伯的 26 个 IRB 对调查做出了回应。总体而言，本研究中的 IRB 在自我评估工具上共得分为 150/200 分。相对较新的 IRB（成立不到十年）至少每月召开一次会议，有年度资金，性别代表性更加均衡，得分往往高于较旧的 IRB。组织方面的得分是调查中所有项目中最低的（得分差异 14.3，p 值<0.01）。从提案提交到最终决定的快速研究的平均周转时间为 7 天，而全委员会审查的时间为 20.5 天。