Can dynamic consent facilitate the protection of biomedical big data in biobanking in Malaysia?
Original Paper
Mohammad Firdaus Abdul Aziz, Aimi Nadia Mohd Yusof
Asian Bioethics Review, 25 May 2019; pp 1–14
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.

Biobanking and the consent problem [BOOK CHAPTER]
Timothy Caulfield, Blake Murdoch
Law 2019 – Chapter 10, 26 April 2019; pp 173–184
Abstract
From a research perspective, interest in biobanking continues to intensify. Governments and industry have invested heavily in biobanks, as exemplified by initiatives such as the UK Biobank and the United States’ Precision Medicine Initiative. But despite this enthusiasm, many profound legal and ethical challenges remain unresolved. Indeed, there continue to be disagreements about how best to obtain consent and the degree and nature of control that research participants retain over donated samples and health information. Emerging social trends – including concerns about commercialization and perceived rights of continuing control (“biorights”) – seem likely to intensify these issues.

Dynamic Consent and biobanking: a means of fostering sustainability? [BOOK CHAPTER]
Jane Kaye, Megan Prictor
Law 2019 – Chapter 7, 26 April 2019; pp 117-129
Abstract
Biobanks are rich repositories of biological materials (such as DNA) and other health and demographic data, often collected over a long period, that can be used for a variety of research purposes to improve the health of individuals and populations. It is important that the value of biobanks is maximized, but at this point in time, there are a number of challenges to achieving this. There are continued debates over the most appropriate mode of gaining consent from people who contribute tissue samples and data to biobanks, that will uphold high ethical standards and enable autonomous decisionmaking. As in other fields, there are changing legal and regulatory frameworks that can have significant implications for biobank management. There are also increasing concerns as to whether biobanks are achieving maximum usage and what the longer-term sustainability plans of maintaining these repositories should be. In this chapter, we outline some of the risks facing biobanks, using examples drawn from a range of international settings. We suggest that the concept of “Dynamic Consent,” a digital platform for engaging research participants, has the capacity to ensure a more engaged and informed cohort of participants, that might in turn address many of the legal and sustainability challenges currently facing biobanks. In this chapter, current uses of Dynamic Consent platforms in biobanking research in the UK, continental Europe, and the USA, and outline considerations for future application and evaluation of this tool to help enhance the relevance, ethical operation, sustainability, and interoperability of biobanks, are examined.