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Human Research Ethics Research Integrity

Can dynamic consent facilitate the protection of biomedical big data in biobanking in Malaysia? (Papers: Mohammad Firdaus Abdul Aziz & Aimi Nadia Mohd Yusof | May 2019)

Posted by saviorteam in Human Research Ethics on October 20, 2019
Keywords: Big data, Biomedical, Biospecimens, Consent, Data management, Genetics, Good practice, Human research ethics, Institutional responsibilities, International, Privacy, Respect for persons

The Linked Original Item was Posted On May, 25 2019

File locked with padlock as concept for file security and privacy/limited access

Abstract
As with many other countries, Malaysia is also developing and promoting biomedical research to increase the understanding of human diseases and possible interventions. To facilitate this development, there is a significant growth of biobanks in the country to ensure continuous collection of biological samples for future research, which contain extremely important personal information and health data of the participants involved. Given the vast amount of samples and data accumulated by biobanks, they can be considered as reservoirs of precious biomedical big data. It is therefore imperative for biobanks to have in place regulatory measures to ensure ethical use of the biomedical big data. Malaysia has yet to introduce specific legislation for the field of biobanking. However, it can be argued that its existing Personal Data Protection Act 2010 (PDPA) has laid down legal principles that can be enforced to protect biomedical big data generated by the biobanks. Consent is a mechanism to enable data subjects to exercise their autonomy by determining how their data can be used and ensure compliance with legal principles. However, there are two main concerns surrounding the current practice of consent in biomedical big data in Malaysia. First, it is uncertain that the current practice would be able to respect the underlying notion of autonomy, and second, it is not in accordance with the legal principles of the PDPA. Scholars have deliberated on different strategies of informed consent, and a more interactive approach has recently been introduced: dynamic consent. It is argued that a dynamic consent approach would be able to address these concerns.

Keywords
Biobanking, Autonomy, Data protection, Informed consent, Dynamic consent

Abdul Aziz, Mohammad Firdaus, and Aimi Nadia Mohd Yusof. 2019. Can dynamic consent facilitate the protection of biomedical big data in biobanking in Malaysia? Asian Bioethics Review 11 (2) 1-14.  https://doi.org/10.1007/s41649-019-00086-2.
Publisher: https://link.springer.com/article/10.1007%2Fs41649-019-00086-2

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Ethics Review Boards for Research With Human Participants: Past, Present, and Future (Maya Peled-Raz, et al | November 2020)

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