伦理委员会委员和调查人员对伦理委员会实施电子伦理委员会软件的看法

Yashashri Shetty, Padmaja Marathe, Manasi Lad, Prajakta D. Auti, J. Katkar, Vishal Singh
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引用次数: 0

摘要

背景:过去 4 年中,印度一些机构的伦理委员会(EC)引进了电子伦理委员会软件(Create 4)。该软件为研究者和伦理委员会之间的提交、在线审查和交流提供了便利。本研究旨在评估不同利益相关者(研究者、主席、委员秘书(MS)、委员会成员、行政人员)对软件使用经验、面临的挑战和改进建议的看法:方法:经教委批准,在获得参与者的书面知情同意后,对其进行登记。针对各类调查人员、教委成员和行政人员专门设计并验证了调查问卷。问卷严格保密。数据采用描述性统计方法进行分析:共有 64 名利益相关者参与,其中包括 34 名调查员、18 名委员会成员、2 名主席、4 名成员秘书和 6 名行政人员。电子软件得到了大多数利益相关者的认可。 总体而言,该软件方便用户使用。面临的一些挑战包括:缺乏对研究人员和新任专家委员会成员的充分培训,在逐一下载研究文件时遇到不便,以及需要确保工作场所的互联网接入不中断。用户执委会应确保研究人员和执委会成员精通技术,并事先接受培训。有人建议,在上传文件时需要内置自动填写选项:利益相关者认为电子软件很有用,并提出了优化使用的建议。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Perception of ethics committee members and investigators on implementation of e-EC software for ethics committees
Background: An e-EC software (Create 4) was introduced since past 4 years at few institutional ethics committees (EC) in India. The software provided facilities for submission, online review and communication between investigator and EC. The study was to assess the perception of different stakeholders: investigators, chairperson, member secretary (MS), EC members, administrative staff regarding their experiences of using software, challenges faced and recommendations for improvisation. Methods: Following approval of the institutional EC, the participants were enrolled after obtaining their written informed consent. The questionnaires specifically designed and validated for each category of investigators, EC members and administrative staff were administered. Strict confidentiality was maintained. The data was analysed using descriptive statistics. Results: A total of 64 stakeholders who participated, there were 34 investigators, 18 EC members, 2 Chairpersons, 4 member secretaries, 6 administrative staff. The e-software was accepted well by majority of the stakeholders.  Overall, the software was found to be user-friendly. A few challenges faced were:  lack of adequate training for investigators and new EC members, inconvenience faced while downloading study documents one by one and the need to ensure uninterrupted internet access at workplace. The user ECs should ensure that the investigators and EC members are tech-savvy and they receive prior training. It was suggested that there needs to be an autofill option built-in while uploading document/s. Conclusions: E-software was found to be useful by the stakeholders and provided suggestions to optimize its us.
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