医疗保健专业人员对研究伦理委员会的角色和职能的知识、观点及认知:一项基于网络的横断面调查

Healthcare Professionals' Knowledge, Views, and Perceptions of the Roles and Functions of Research Ethics Committees: A Web-Based Cross-Sectional Survey.

作者信息

Seiil Birzhan, Zimba Olena, Korkosz Mariusz, Bekaryssova Dana, Zhakipbekov Kairat, Qumar Ainur B, Yessirkepov Marlen, Kocyigit Burhan Fatih

机构信息

Department of Biology and Biochemistry, South Kazakhstan Medical Academy, Shymkent, Kazakhstan.

Department of Rheumatology, Immunology and Internal Medicine, University Hospital in Kraków, Kraków, Poland.

出版信息

J Korean Med Sci. 2025 Feb 3;40(4):e9. doi: 10.3346/jkms.2025.40.e9.

Abstract

BACKGROUND

This survey examined healthcare professionals' knowledge, views, and perceptions of the responsibilities and functions of Research Ethics Committees (RECs). The study aimed to analyze ethical principles and operational issues faced by RECs and guide researchers, journal editors, and publishers on publication ethics notes.

METHODS

A cross-sectional survey was conducted using the SurveyMonkey.com platform to assess healthcare professionals' knowledge, views, and practices concerning RECs' responsibilities, functions, and roles. The survey focused on REC definitions, functions, research types that require REC approval, and research protocols' evaluation time frames. It also reflected on ethics considerations and REC adaptations during the coronavirus disease 2019 (COVID-19) pandemic, REC member qualifications, evaluation periods, and additional challenges confronting RECs. Convenience sampling was adopted, and the survey was distributed via social media platforms.

RESULTS

The survey was based on an analysis of questionnaires filled by 182 responders (104 females [57.1%] and 76 males [41.8%]), with a median age of 36. The survey respondents were from 28 different countries. The top three countries with most responders were Kazakhstan (n = 83), Türkiye (n = 33) and Poland (n = 10). Most participants (n = 128, 70.3%) were familiar with the definition of RECs and recognized the importance of REC approval for clinical trials and interventional research. Research study protocols should be submitted for REC evaluation and approval during the planning phase, according to 145 responders (79.7%). Participants emphasized the significance of formal ethics training for REC members. The involvement in research approved by RECs was also viewed as an important precondition for membering RECs. Participants suggested online submissions (n = 127, 69.8%), virtual meetings (n = 99, 54.4%), and fast evaluation schedules for low-risk research protocols (n = 77, 42.3%) during the COVID-19 pandemic.

CONCLUSION

Healthcare professionals comprehend the basics of REC duties and responsibilities. However, improvements in the consistency and efficiency of ethics evaluations are still warranted. The COVID-19 pandemic stressed the importance of adaptive REC procedures; researchers, editors, and publishers learned a vitally important lesson. More efforts are warranted to increase REC member training, simplify administrative procedures, and define standard operating procedures in times of crisis. Continuous progress in these areas will allow RECs to maintain high ethical standards while supporting productive research. Editors and publishers will greatly benefit from related advances in research ethics considerations.

摘要

背景

本调查研究了医疗保健专业人员对研究伦理委员会(RECs)的职责和功能的知识、观点及看法。该研究旨在分析研究伦理委员会所面临的伦理原则和操作问题,并就出版伦理规范向研究人员、期刊编辑和出版商提供指导。

方法

使用SurveyMonkey.com平台进行了一项横断面调查,以评估医疗保健专业人员对研究伦理委员会的职责、功能和作用的知识、观点及实践情况。该调查聚焦于研究伦理委员会的定义、功能、需要研究伦理委员会批准的研究类型以及研究方案的评估时间框架。它还反映了2019年冠状病毒病(COVID-19)大流行期间的伦理考量和研究伦理委员会的调整、研究伦理委员会成员资格、评估周期以及研究伦理委员会面临的其他挑战。采用便利抽样法,并通过社交媒体平台分发调查问卷。

结果

该调查基于对182名受访者(104名女性[57.1%]和76名男性[41.8%])填写的问卷进行分析,受访者的中位年龄为36岁。受访者来自28个不同国家。受访者最多的前三个国家是哈萨克斯坦(n = 83)、土耳其(n = 33)和波兰(n = 10)。大多数参与者(n = 128,70.3%)熟悉研究伦理委员会的定义,并认识到研究伦理委员会批准对临床试验和干预性研究的重要性。根据145名受访者(79.7%)的说法,研究方案应在规划阶段提交给研究伦理委员会进行评估和批准。参与者强调了对研究伦理委员会成员进行正规伦理培训的重要性。参与经研究伦理委员会批准的研究也被视为成为研究伦理委员会成员的一项重要前提条件。参与者建议在COVID-19大流行期间采用在线提交(n = 127,69.8%)、虚拟会议(n = 99,54.4%)以及对低风险研究方案采用快速评估时间表(n = 77,42.3%)。

结论

医疗保健专业人员理解研究伦理委员会职责的基本内容。然而,伦理评估的一致性和效率仍有必要提高。COVID-19大流行凸显了适应性研究伦理委员会程序的重要性;研究人员、编辑和出版商吸取了至关重要的教训。有必要做出更多努力,以增加研究伦理委员会成员培训、简化行政程序并在危机时期确定标准操作程序。这些领域的持续进展将使研究伦理委员会在支持富有成效的研究的同时保持高伦理标准。编辑和出版商将从研究伦理考量方面的相关进展中受益匪浅。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/39ee/11790396/bbfd6725db8b/jkms-40-e9-g001.jpg

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