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Legal aspects of articular cartilage tissue engineering experimentation: a review on Malaysian acts, regulations and guidelines

Radzi, Muhammad Aa'zamuddin Ahmad and Zawawi, Majdah and Munirah, Sha'ban and Azharuddin, Nur Syamimi Mohd and Noor Azmi, Azran Azhim and Hashi, Abdurezak Abdulahi (2020) Legal aspects of articular cartilage tissue engineering experimentation: a review on Malaysian acts, regulations and guidelines. Malaysian Journal of Medicine and Health Sciences, 16 (3). pp. 272-284. E-ISSN 2636-9346

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Presently, there is no specific federal legislation governing articular cartilage tissue engineering (ACTE) experimentation practices in Malaysia. However, there are related regulations and guidelines provided by government agencies to oversee and guide such practices. The rules and regulations provided in the documents have the essential aim of safeguarding public health through ensuring that non-clinical studies reach a certain quality, efficient and safe for human use. There are themes identified when scrutinising relevant documents which includes, the need for authorised personnel and the establishment of facilities in conducting such experiments, the aspect of cell-scaffold construct development, the use of human materials, the aspect of biosafety, animal care and use during the experiments, and considerations on the impact on the environment. The individual laboratory or facility shall adopt and adapt these standards as deemed appropriate by the ACTE researchers to ensure that non-clinical studies are conducted in a proper and ethical manner.

Item Type: Article (Review)
Additional Information: 5735/83063
Uncontrolled Keywords: Articular cartilage, Tissue engineering, Legislation, Experimentation
Subjects: K Law > KBP Islamic Law > KBP1 Islamic law.Shariah.Fiqh > KBP100 Sources.Quran, Hadith, Ijma', Qiyas.
R Medicine > R Medicine (General)
R Medicine > RA Public aspects of medicine
Kulliyyahs/Centres/Divisions/Institutes (Can select more than one option. Press CONTROL button): Ahmad Ibrahim Kulliyyah of Laws
Kulliyyah of Allied Health Sciences
Kulliyyah of Science > Department of Biotechnology
Date Deposited: 21 Sep 2020 14:39
Last Modified: 02 Jul 2021 22:59
URI: http://irep.iium.edu.my/id/eprint/83063

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