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沙特阿拉伯利雅得一家三级医疗医院的医学专业人员对研究伦理的认知:一项评估培训需求的调查

Awareness of Medical Professionals Regarding Research Ethics in a Tertiary Care Hospital in Riyadh, Saudi Arabia: A Survey to Assess Training Needs.

作者信息

Alahmad Ghiath, Alshahrani Khalid Malawi, Alduhaim Renad Abdulaziz, Alhelal Rawan, Faden Rawa M, Shaheen Naila A

机构信息

King Abdullah International Medical Research Center (KAIMRC), King Saud Bin Abdulaziz University for Health Sciences, Riyadh 11481, Saudi Arabia.

College of Medicine, Imam Mohammad Ibn Saud Islamic University, Riyadh 11432, Saudi Arabia.

出版信息

Healthcare (Basel). 2023 Oct 12;11(20):2718. doi: 10.3390/healthcare11202718.

Abstract

BACKGROUND

Ethics is an essential component of human research, and knowledge and awareness of ethical guidelines are required to conduct research involving human subjects and ensure the participants' safety.

OBJECTIVES

To investigate medical professionals' and researchers' knowledge of national and international research ethics guidelines, key principles in human research projects, ethical issues in different types of research, the importance of informed consent, and institutional review boards.

MATERIALS AND METHODS

A cross-sectional study with 251 participants, including physicians, nurses, and researchers from three different research centers and hospitals in Riyadh city, was carried out using an electronic self-structured questionnaire. The sample size was estimated using OpenEpi, Version 3. The questionnaire contained six different sets of questions to analyze knowledge about research ethics and guidelines. The results were analyzed using SAS version 9.4 (SAS Institute Inc., Cary, NC, USA).

RESULTS

About 53.78% of the participants had received research ethics education, out of which 78.51% of the participants expressed the need for more training in research ethics education. The Belmont Report showed a high level of unawareness among nurses (88.3%), physicians (73.8%), and researchers (55.32%). Nurses had a high level of positive attitude about all the key principles of human research. The highest level of awareness of ethical issues in clinical trials and interventional studies was found among researchers (54%), and the lowest level of awareness was exhibited by nurses (19.32%). Nurses (74.34%) and physicians (62.79%) had the lowest positive attitudes about obtaining children's assent in pediatric research. Physicians and researchers had a higher awareness of the IRB than nurses.

CONCLUSION

Researchers were well-versed in research ethics, regulatory guidelines, and ethical issues in various types of research, whereas nurses were enthusiastic about key principles in human research and the importance of informed consent. This study shows that a very low percentage of nurses have received research ethics education and emphasizes the critical importance of including research ethics education in nursing curricula, as the involvement of nurses in research is inevitable. This study also shows the lack of knowledge among nurses, researchers, and doctors about various international guidelines. It emphasizes the importance of adding regulatory guidelines to the curriculum and teaching them effectively to students. Also, periodic workshops should be conducted to enhance the practical knowledge of the professionals regarding the guidelines and guide them in overcoming the practical difficulties they encounter during their practice.

摘要

背景

伦理学是人体研究的重要组成部分,开展涉及人类受试者的研究并确保参与者的安全需要具备伦理准则的知识和意识。

目的

调查医学专业人员和研究人员对国家和国际研究伦理准则、人体研究项目的关键原则、不同类型研究中的伦理问题、知情同意的重要性以及机构审查委员会的了解情况。

材料与方法

采用电子自填式问卷对利雅得市三个不同研究中心和医院的251名参与者进行横断面研究,参与者包括医生、护士和研究人员。使用OpenEpi 3版估计样本量。问卷包含六组不同的问题,用于分析对研究伦理和准则的了解情况。结果使用SAS 9.4版(美国北卡罗来纳州卡里市SAS研究所)进行分析。

结果

约53.78%的参与者接受过研究伦理教育,其中78.51%的参与者表示需要更多的研究伦理教育培训。《贝尔蒙报告》显示护士(88.3%)、医生(73.8%)和研究人员(55.32%)的知晓率较低。护士对人体研究的所有关键原则持高度积极态度。研究人员对临床试验和干预性研究中的伦理问题知晓率最高(54%),护士的知晓率最低(19.32%)。在儿科研究中获取儿童同意方面,护士(74.34%)和医生(62.79%)的积极态度最低。医生和研究人员对机构审查委员会的了解高于护士。

结论

研究人员精通各种类型研究中的研究伦理、监管准则和伦理问题,而护士热衷于人体研究的关键原则和知情同意的重要性。本研究表明,接受过研究伦理教育的护士比例非常低,并强调在护理课程中纳入研究伦理教育的至关重要性,因为护士参与研究是不可避免的。本研究还表明护士、研究人员和医生对各种国际准则缺乏了解。它强调在课程中增加监管准则并有效地向学生传授这些准则的重要性。此外,应定期举办研讨会,以增强专业人员对准则的实践知识,并指导他们克服实践中遇到的实际困难。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d4ca/10606152/eabe6da8c048/healthcare-11-02718-g001.jpg

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