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Clinical research ethics review process in Lebanon: efficiency and functions of research ethics committees – results from a descriptive questionnaire-based study

机译：黎巴嫩临床研究伦理审查过程：研究伦理委员会的效率和职能–基于描述性问卷的研究结果

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Clinical trials conducted in Lebanon are increasing. However, little is known about the performance of research ethics committees (RECs) in charge of reviewing the research protocols. This study aimed to assess the level of adherence to the ethics surrounding the conduct of clinical trials and perceptions of team members regarding roles of the RECs during the conduct of clinical trials in Lebanon. The research question was: Are RECs adherent to the ethics surrounding the conduct of clinical trials (chapters II and IV in ‘Standards and Operational Guidance for Ethics Review of Health-related Research with Human Participants’ in Lebanon?’ This was a quantitative and descriptive questionnaire-based study conducted among RECs of university hospitals in Lebanon. The questionnaire had to be completed online and included general questions in addition to items reflecting the different aspects of a REC performance and effectiveness. All the questionnaire was assigned a total score of 175 points. General information and questions assigned point values/scores were analysed using descriptive statistics: frequency and percentage, mean score?±?standard deviation. Ten RECs participated in the study (52 persons: four chairs, one vice-president, 47 ordinary members). Forty-seven (90.4%) had previous experience with clinical research and 30 (57.7%) had a diploma or had done a training in research ethics. Forty-one percent confirmed that they were required to have a training in research ethics. All RECs had a policy for disclosing and managing potential conflicts of interest for its members, but 71.8% of participants reported the existence of such a policy for researchers. Thirty-three point three percent reported that the RECs had an anti-bribery policy. The questionnaire mean score was 129.6?±?22.3/175 points reflecting thus an excellent adherence to international standards. Inadequate training of REC members and the lack of anti-bribery policies should be resolved to improve their performance.
机译：在黎巴嫩进行的临床试验正在增加。但是，对于负责审查研究方案的研究伦理委员会（REC）的绩效知之甚少。这项研究旨在评估围绕临床试验进行的道德规范的遵守程度，以及团队成员对在黎巴嫩进行临床试验期间REC的作用的看法。研究的问题是：REC是否遵守围绕临床试验进行的道德规范（黎巴嫩“与人类健康相关的伦理学审查的标准和操作指南”在黎巴嫩的第二章和第四章？）这是定量和描述性的在黎巴嫩的大学医院的REC中进行了基于问卷的研究，该问卷必须在线完成，除了反映REC性能和有效性的不同方面的项目外，还应包括一般性问题，所有问卷的总分均为175分。使用描述性统计数据分析一般信息和分配分数/分数的问题：频率和百分比，平均得分±标准偏差。十名REC参加了研究（52人：四位主席，一位副主席，47位普通成员） 。四十七（90.4％）位曾有临床研究经验，而30位（57.7％）具有文凭或曾接受研究训练伦理。 41％的人确认他们必须接受研究伦理培训。所有REC都有其成员披露和管理潜在利益冲突的政策，但是71.8％的参与者报告说存在针对研究人员的这种政策。 33％的受访者表示，REC有反贿赂政策，占33％。问卷平均得分为129.6？±？22.3 / 175分，因此非常符合国际标准。应解决对REC成员的培训不足和缺乏反贿赂政策的问题，以提高其绩效。

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