马来西亚临床和生物医学研究伦理审查的挑战:一项混合方法研究。

IF 1.7 4区哲学 Q2 ETHICS

Journal of Empirical Research on Human Research Ethics Pub Date : 2021-12-01 Epub Date: 2021-07-22 DOI:10.1177/15562646211033191

Hooi Y See, Mohd S Mohamed, Siti N M Nor, Wah Y Low

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引用次数: 1

摘要

马来西亚临床和生物医学研究伦理审查的经验证据有限。我们进行了一项融合混合方法研究，其中包括在线调查和半结构化访谈，以检查临床和生物医学研究伦理审查中的挑战。收集的数据显示，伦理审查过程不一致、重复和不充分。研究结果表明，马来西亚迫切需要建立一个集中的伦理审查机制和一个全国性的伦理审查互认制度，以提高伦理审查制度的有效性和效率。马来西亚和多国研究资助国之间的联合研究伦理委员会审查也应该得到鼓励，因为它可以解决缺乏专业知识和培训的问题。

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Challenges in the Ethical Review of Clinical and Biomedical Research in Malaysia: A Mixed Methods Study.

Empirical evidence of the ethical review of clinical and biomedical research in Malaysia is limited. We have conducted a convergent mixed methods research, which comprises an online survey and semistructured interviews to examine the challenges in the ethical review of clinical and biomedical research. Data collected reveal that the ethics review process is inconsistent, duplicate, and inadequate. The results indicate a strong need for a centralized ethical review mechanism and a national system for mutual recognition of ethics reviews to improve the effectiveness and efficiency of the ethics review system in Malaysia. A joint research ethics committee review between Malaysia and sponsoring countries for multinational research should also be encouraged as it could address the concerns of the lack of expertise and training.

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来源期刊

Journal of Empirical Research on Human Research Ethics 医学-医学：伦理

CiteScore

3.50

自引率

7.70%

发文量

审稿时长

>12 weeks

期刊介绍： The Journal of Empirical Research on Human Research Ethics (JERHRE) is the only journal in the field of human research ethics dedicated exclusively to empirical research. Empirical knowledge translates ethical principles into procedures appropriate to specific cultures, contexts, and research topics. The journal''s distinguished editorial and advisory board brings a range of expertise and international perspective to provide high-quality double-blind peer-reviewed original articles.