Rajab Mohammad Hasan, Alkawi Muhammad Z, Gazal Abdalla M, Alshehri Faizah A, Shaibah Hassan S, Holmes Lisa Doraine
Biostatistics, Epidemiology, and Public Health, College of Medicine, Alfaisal Univerity, Riyadh, SAU.
Neurology, King Faisal Specialist Hospital and Research Center, King Abdul Aziz City for Science and Technology, Riyadh, SAU.
Cureus. 2019 Oct 3;11(10):e5829. doi: 10.7759/cureus.5829.
Introduction Maintaining research ethics within a university and monitoring the campus Institutional Review Board (IRB) are essential responsibilities not to be taken lightly. IRBs occasionally need to be reviewed to see that they, as well as researchers, are adhering to rules and regulations on ethics through their submission and review procedures. Since there are no established measures for assessing IRB quality, it is unclear how to determine whether IRBs are achieving their intended aims. This study used the feedback and input of campus members at a newly-established, private, non-profit university within the Kingdom of Saudi Arabia (KSA) to evaluate their campus IRB. Methods Following the university's IRB approval, and in close collaboration with the Saudi National Committee of Bioethics (NCBE), this cross-sectional study was conducted from February through May of 2019. Self-administered surveys were sent out via university emails to faculty and students at Alfaisal University in Riyadh of Saudi Arabia. The questions in the surveys included inquiries on participants' demographics, their familiarity with campus IRB research ethics, their satisfaction with IRB procedures, the challenges encountered during the IRB submission and review process, the effectiveness of a recent IRB-coordinated research ethics campaign, and any suggestions for IRB improvement. Surveys were sent to faculty members and students at five colleges on campus. Results Of the campus members who were sent surveys, 8% responded (175). Of those who responded, 29.7% had submitted at least one research proposal for IRB review during the past three years (2016-2019), and more than half of this group were satisfied with the IRB submission and review procedures. For those who had submitted at least one research proposal, respondents reported the more usual challenges that researchers tend to encounter, such as time-consuming and tedious IRB review processes and ambiguous IRB guidelines and regulations. The less typical IRB challenges that were reported, and that are unique to academia, include the IRB tendency to deny undergraduate student requests to serve as principal investigators of their research projects. Concerning IRB efforts to educate and train campus members on research ethics, only 26.3% of the participants were aware of the recently performed research ethics campaign, and 7.6% of the participants attended the end-of-campaign workshop. Of those who attended the workshop, 76.9% reported that the campaign and workshop effectively met their expectations. Conclusions This study revealed several issues encountered by university faculty and students seeking campus IRB approval for their research projects. The main academia-specific challenge was over whether undergraduate students could serve as PIs for research projects, and a universal one was that they find the IRB process to be very time-consuming and tedious, which is a situation that has already been relayed in several other articles on IRB issues. About two-thirds of respondents reported a lack of familiarity with the topic of research ethics. This challenge makes it clear that information on research ethics is not effectively reaching enough campus members in the busy environment of academia.
引言
在大学内部维护研究伦理并监督校园机构审查委员会(IRB)是至关重要的职责,不可掉以轻心。IRB偶尔需要接受审查,以确保其以及研究人员在提交和审查程序中遵守伦理规则和规定。由于没有既定的评估IRB质量的措施,目前尚不清楚如何确定IRB是否实现了其预期目标。本研究利用沙特阿拉伯王国(KSA)一所新成立的私立非营利大学的校园成员的反馈和意见来评估其校园IRB。
方法
在获得该大学IRB批准后,本横断面研究于2019年2月至5月与沙特国家生物伦理委员会(NCBE)密切合作开展。通过大学电子邮件向沙特阿拉伯利雅得阿法赛勒大学的教职员工和学生发送了自填式调查问卷。调查问卷中的问题包括询问参与者的人口统计学信息、他们对校园IRB研究伦理的熟悉程度、他们对IRB程序的满意度、在IRB提交和审查过程中遇到的挑战、最近一次IRB协调的研究伦理活动的有效性以及对IRB改进的任何建议。调查问卷发送给了校园内五个学院的教职员工和学生。
结果
在收到调查问卷的校园成员中,8%(175人)回复了。在回复者中,29.7%在过去三年(2016 - 2019年)至少提交了一份研究提案以供IRB审查,其中超过一半的人对IRB的提交和审查程序感到满意。对于那些至少提交了一份研究提案的人,受访者报告了研究人员通常会遇到的挑战,比如IRB审查过程耗时且繁琐,以及IRB的指导方针和规定不明确。所报告的不太常见的、且是学术界特有的IRB挑战包括IRB倾向于拒绝本科生担任其研究项目主要研究者的请求。关于IRB在研究伦理方面对校园成员进行教育和培训的工作,只有26.3%的参与者知晓最近开展的研究伦理活动,7.6%的参与者参加了活动结束时的研讨会。在参加研讨会的人中(76.9%)报告称该活动和研讨会有效地达到了他们的期望。
结论
本研究揭示了大学教职员工和学生在为其研究项目寻求校园IRB批准时遇到的几个问题。主要的学术界特有的挑战是本科生是否可以担任研究项目的主要研究者,普遍存在的一个问题是他们发现IRB流程非常耗时且繁琐,这一情况在其他几篇关于IRB问题的文章中也有提及。约三分之二的受访者表示对研究伦理主题不熟悉。这一挑战表明,在学术界繁忙的环境中,关于研究伦理的信息没有有效地传达给足够多的校园成员。