Addressing procedural challenges of ethical review system: Towards a better ethical quality of clinical trials review in Malaysia

The review of clinical trials with human participants in Malaysia is governed by a decentralized control system. The clinical trial protocols are reviewed by 13 registered research ethics committees (RECs) in Malaysia. A governmental body, the National Pharmaceutical Control Bureau, is responsible f...

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Main Authors: See, Hooi Yan, Mohamed, Mohd Salim, Mohd Noor, Siti Nurani, Low, Wah Yun
Format: Article
Published: Taylor & Francis 2019
Subjects:
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author See, Hooi Yan
Mohamed, Mohd Salim
Mohd Noor, Siti Nurani
Low, Wah Yun
author_facet See, Hooi Yan
Mohamed, Mohd Salim
Mohd Noor, Siti Nurani
Low, Wah Yun
author_sort See, Hooi Yan
collection UM
description The review of clinical trials with human participants in Malaysia is governed by a decentralized control system. The clinical trial protocols are reviewed by 13 registered research ethics committees (RECs) in Malaysia. A governmental body, the National Pharmaceutical Control Bureau, is responsible for the inspection and oversight of these registered RECs to ensure that they comply with the regulatory requirements. However, this study highlights that each REC in Malaysia has a different standard operating procedure and ethical review process. Other procedural challenges identified include inadequate membership, poor mechanism for research monitoring after ethical approval, and insufficient resources. Establishments of a national standard of REC and a central ethics committee are suggested to ensure procedural compliance in the oversight of clinical trials in Malaysia. While there is a growing concern that procedural compliance may not have a direct impact on the protection of human subjects, our key point is that an ethical review system compliant with the national standards could serve as a strong framework to support and enhance the ethical quality of decision-making and judgement. We believe that being aware of how influential procedural compliance can be would help committees improve the ethical quality of their research review.
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spelling um.eprints-199972019-01-15T01:33:29Z http://eprints.um.edu.my/19997/ Addressing procedural challenges of ethical review system: Towards a better ethical quality of clinical trials review in Malaysia See, Hooi Yan Mohamed, Mohd Salim Mohd Noor, Siti Nurani Low, Wah Yun Q Science (General) R Medicine The review of clinical trials with human participants in Malaysia is governed by a decentralized control system. The clinical trial protocols are reviewed by 13 registered research ethics committees (RECs) in Malaysia. A governmental body, the National Pharmaceutical Control Bureau, is responsible for the inspection and oversight of these registered RECs to ensure that they comply with the regulatory requirements. However, this study highlights that each REC in Malaysia has a different standard operating procedure and ethical review process. Other procedural challenges identified include inadequate membership, poor mechanism for research monitoring after ethical approval, and insufficient resources. Establishments of a national standard of REC and a central ethics committee are suggested to ensure procedural compliance in the oversight of clinical trials in Malaysia. While there is a growing concern that procedural compliance may not have a direct impact on the protection of human subjects, our key point is that an ethical review system compliant with the national standards could serve as a strong framework to support and enhance the ethical quality of decision-making and judgement. We believe that being aware of how influential procedural compliance can be would help committees improve the ethical quality of their research review. Taylor & Francis 2019 Article PeerReviewed See, Hooi Yan and Mohamed, Mohd Salim and Mohd Noor, Siti Nurani and Low, Wah Yun (2019) Addressing procedural challenges of ethical review system: Towards a better ethical quality of clinical trials review in Malaysia. Accountability in Research, 26 (1). pp. 49-64. ISSN 0898-9621, DOI https://doi.org/10.1080/08989621.2018.1556646 <https://doi.org/10.1080/08989621.2018.1556646>. https://doi.org/10.1080/08989621.2018.1556646 doi:10.1080/08989621.2018.1556646
spellingShingle Q Science (General)
R Medicine
See, Hooi Yan
Mohamed, Mohd Salim
Mohd Noor, Siti Nurani
Low, Wah Yun
Addressing procedural challenges of ethical review system: Towards a better ethical quality of clinical trials review in Malaysia
title Addressing procedural challenges of ethical review system: Towards a better ethical quality of clinical trials review in Malaysia
title_full Addressing procedural challenges of ethical review system: Towards a better ethical quality of clinical trials review in Malaysia
title_fullStr Addressing procedural challenges of ethical review system: Towards a better ethical quality of clinical trials review in Malaysia
title_full_unstemmed Addressing procedural challenges of ethical review system: Towards a better ethical quality of clinical trials review in Malaysia
title_short Addressing procedural challenges of ethical review system: Towards a better ethical quality of clinical trials review in Malaysia
title_sort addressing procedural challenges of ethical review system towards a better ethical quality of clinical trials review in malaysia
topic Q Science (General)
R Medicine
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