Assessing Research Ethics Committees in Myanmar: Results of a Self-Assessment Tool.

Assessing Research Ethics Committees in Myanmar: Results of a Self-Assessment Tool.
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评估缅甸的研究伦理委员会:自我评估工具的结果。

DOI:
10.1007/s41649-020-00113-7
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发表时间:
2020-03
影响因子:
2.9
通讯作者:
Silverman HJ
Silverman HJ
中科院分区:
其他
文献类型:
--
作者:
Oo ZZ;Wun M;Oo YTN;Mya KS;Silverman HJ

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自2010年以来,缅甸的人体研究有所增加,因此增加了研究伦理委员会(REC)的设立,以审查这些研究研究。然而,尚未对反映缅甸区域经济共同体业务的特征进行评估。评估缅甸医疗机构的区域经济合作组织的结构和流程。我们对在低收入和中等收入国家运营的区域经济实体使用了自我评估工具。这一工具包括以下十个领域:组织方面、成员和道德培训、提交安排和材料、会议纪要、涉及审查程序的政策、对具体议定书和知情同意项目的审查、传达决定、持续审查、区域经济共同体资源和机构承诺。我们向缅甸15家医疗机构的REC分发了这份自填式问卷,每个REC的一名代表填写了这份问卷,并匿名返回。我们使用描述性、双变量和多变量统计来分析数据。在满分200分中,缅甸医疗机构的总平均分为112.6±12.77,低于其他国家医疗机构的总平均分137.4±35.8.平均得分低于60%的领域包括组织承诺、成员资格和道德培训、持续审查和REC资源。许多区域经济共同体拥有多样化的成员和适当的性别平衡,但缺乏必要的政策。结果表明,缅甸区域经济共同体在其“结构和程序”以及机构承诺程度方面有很大的改进空间。自我评估工具被证明是评估RECs质量的有价值的方法。
Human subject research has increased in Myanmar since 2010 and accordingly, the establishment of research ethics committees (RECs) have increased to review these research studies. However, characteristics that reflect the operations of RECs in Myanmar have not been assessed. To assess the structures and processes of RECs at Medical Institutions in Myanmar. We used a self-assessment tool for RECs operating in low and middle-income countries. This tool consists of the following ten domains: organizational aspects, membership and ethics training, submission arrangements and materials, meeting minutes, policies referring to review procedures, review of specific protocol and informed consent items, communication a decision, continuing review, REC resources, and institutional commitment. We distributed this self-administered questionnaire to RECs from 15 Medical Institutions in Myanmar and one representative from each REC completed this questionnaire and returned it anonymously. We used descriptive, bivariate, and multivariate statistics to analyse the data. Out of maximum 200 points, the total mean score for Myanmar Medical Institutions was 112.6 ± 12.77, which is lower compared to the aggregate mean score of 137.4 ± 35.8 obtained from RECs in other countries. Domains in which the average percentage score was less than 60% included organizational commitment, membership and ethics training, continuing review and REC resources. Many RECs have a diverse membership and appropriate gender balance but, lacked essential policies. The results show that for Myanmar RECs there is significant room for improvement in their “structures and processes” as well as the extent of institutionl commitment. The self-assessment tool proved to be valuable method to assess the quality of RECs.
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