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

被引：3
|
作者：
See, Hooi Y. [1 ]
Mohamed, Mohd S. [1 ]
Nor, Siti N. M. [1 ]
Low, Wah Y. [2 ,3 ]
机构：
[1] Univ Malaya, Dept Sci & Technol Studies, Fac Sci, Kuala Lumpur 50603, Malaysia
[2] Univ Malaya, Fac Med, Kuala Lumpur, Malaysia
[3] Univ Malaya, Asia Europe Inst, Kuala Lumpur, Malaysia
来源：
JOURNAL OF EMPIRICAL RESEARCH ON HUMAN RESEARCH ETHICS | 2021年 / 16卷 / 05期
关键词：
ethical review; clinical trials; biomedical research; challenges; research ethics committee; Malaysia; SELF-ASSESSMENT TOOL; SUB-SAHARAN AFRICA; TRAINING NEEDS; COMMITTEE MEMBERS; CAPACITY; INCOME; COLLABORATION; RESOURCES; ISSUES; ASIA;
D O I：
10.1177/15562646211033191
中图分类号：
B82 [伦理学（道德学）];
学科分类号：
摘要：
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.
引用
收藏
页码：487 / 500
页数：14
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