Can dynamic consent facilitate the protection of biomedical big data in biobanking in Malaysia?


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.

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  1. 1.

    “Medical purposes” refers to “the purposes of preventive medicine, medical diagnosis, medical research, rehabilitation and the provision of care and treatment and the management of healthcare services.” See section 40 (4) of the Malaysia Personal Data Protection Act 2010.

  2. 2.

    ‘Data user’ refers to “a person who either alone or jointly or in common with other persons processes any personal data or has control over or authorises the processing of any personal data, but does not include a data processor.” See section 4 of the Malaysia Personal Data Protection Act 2010.

  3. 3.

    “Data subject” refers to “an individual who is the subject of the personal data.” See section 4 of the Malaysia Personal Data Protection Act 2010.

  4. 4.

    (i) “for the purpose for which the personal data was to be disclosed at the time of collection of the personal data”; (ii) “a purpose directly related to the purpose referred to in subparagraph (i)”; or (iii) to any party other than a third party that was already informed to the research subjects at the beginning of the collection


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Correspondence to Mohammad Firdaus Abdul Aziz.

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Abdul Aziz, M., Mohd Yusof, A. Can dynamic consent facilitate the protection of biomedical big data in biobanking in Malaysia?. ABR 11, 209–222 (2019).

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  • Biobanking
  • Autonomy
  • Data protection
  • Informed consent
  • Dynamic consent