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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“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.
‘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.
“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.
(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
Asia Cohort Consortium. n.d. Participating Cohorts. available at https://www.asiacohort.org/ParticipatingCohorts/index.html. Accessed 30 Sept 2018.
Beauchamp, Tom L., and James F. Childress. 2001. Principles of biomedical ethics. New York, NY: Oxford University Press.
Biller-Andorno, Nikola, and Alexander M. Capron. 2016. Ethical issues in governing biobanks: Global perspectives. New York: Routledge.
Budin-Ljøsne, Isabelle, Anne Marie Tassé, Bartha M. Knoppers, and Jennifer R. Harris. 2011. Bridging consent: from toll bridges to lift bridges? BMC Medical Genomics 4 (1): 69. https://doi.org/10.1186/1755-8794-4-69
Caulfield, Timothy. 2007. Biobanks and blanket consent: The proper place of the public good and public perception rationales. King’s Law Journal 18 (2): 209–226. https://doi.org/10.1080/09615768.2007.11427674
Caulfield, Timothy, and Blake Murdoch. 2017. Genes, cells, and biobanks: Yes, there’s still a consent problem. PLoS Biology 15 (7): e2002654. https://doi.org/10.1371/journal.pbio.2002654
De Souza, Yvonne G., and John S. Greenspan. 2013. Biobanking past, present and future: Responsibilities and benefits. AIDS27 (3): 303-312. https://doi.org/10.1097/QAD.0b013e32835c1244
Deschênes, Mylène, G. Cardinal, Bartha M. Knoppers, and K.C. Glass. 2001. Human genetic research, DNA banking and consent: A question of ‘form’? Clinical Genetics 59 (4): 221–239. https://doi.org/10.1034/j.1399-0004.2001.590403.x
Gibbons, Susan M.C., and Jane Kaye. 2007. Governing genetic databases: Collection, storage and use. King’s Law Journal 18 (2): 201–208. https://doi.org/10.1080/09615768.2007.11427673
Hansson, Mats G. 2009. Ethics and biobanks. British journal of cancer 100 (1): 8-12. https://doi.org/10.1038/sj.bjc.6604795
Hansson, Mats G., Joakim. Dillner, Claus R. Bartram, Joyce A. Carlson, and Gert Helgesson. 2006. Should donors be allowed to give broad consent to future biobank research? Lancet Oncology 7 (3): 266–269. https://doi.org/10.1016/S1470-2045(06)70618-0
Hoeyer, Klaus, Bert-Ove Olofsson, Tom Mjörndal, and Niels Lynöe. 2005. The ethics of research using biobanks: Reason to question the importance attributed to informed consent. Archives of internal medicine 165 (1): 97–100. https://doi.org/10.1001/archinte.165.1.97
Hofmann, Bjørn. 2009. Broadening consent—And diluting ethics? Journal of Medical Ethics 35 (2): 125–129. https://doi.org/10.1136/jme.2008.024851
Jamal, Rahman, Syed Zulkifli Syed Zakaria, Mohd Arman Kamaruddin, Nazihah Abd Jalal, Norliza Ismail, Norkhamiwati Mohd Kamil, Noraidatulakma Abdullah, Norhafizah Baharudin, Noor Hamidah Hussin, Hanita Othman Nor Muhammad Mahadi, and the Malaysian Cohort Study Group. 2014. Cohort profile: The Malaysian Cohort (TMC) project: a prospective study of non-communicable diseases in a multi-ethnic population. International Journal of Epidemiology 44 (2): 423-431. https://doi.org/10.1093/ije/dyu089
Kaye, Jane, Edgar A. Whitley, Nadja Kanellopoulou, Sadie Creese, Kay J. Hughes, and David Lund. 2011. Dynamic consent: a solution to a perennial problem? In BMC 343: d6900. https://doi.org/10.1136/bmj.d6900
Kaye, Jane, Liam Curren, Nick Anderson, Kelly Edwards, Stephanie M. Fullerton, Nadja Kanellopoulou, et al. 2012. From patients to partners: Participant-centric initiatives in biomedical research. Nature Reviews Genetics 13 (5): 371-376. https://doi.org/10.1038/nrg3218
Kaye, Jane, Edgar A. Whitley, David Lund, Michael Morrison, Harriet Teare, and Karen Melham. 2015. Dynamic consent: A patient interface for twenty-first century research networks. European Journal of Human Genetics 23 (2): 141-146. https://doi.org/10.1038/ejhg.2014.71
Knoppers, Bartha M., Jennifer R. Harris, Anne Marie Tassé, Isabelle Budin-Ljøsne, Jane Kaye, Mylène Deschênes, and Ma'n H. Zawati. 2011. Towards a data sharing code of conduct for international genomic research. Genome Medicine 3 (7): 46. https://doi.org/10.1186/gm262
Liao, S.M. 2009. Is there a duty to share genetic information? Journal of Medical Ethics 35 (5): 306–309. https://doi.org/10.1136/jme.2008.027029
Malaysia, Privacy and Data Protection Act 2010
Malaysian Cohort. n.d. Introduction. available at http://www.ukm.my/mycohort/ms/pengenalan/. Accessed 29 Sept 2018.
Marshall, Eliot. 2001. Company plans to bank human DNA profiles. Science 291 (5504): 575. https://doi.org/10.1126/science.291.5504.575A
Martin, Paul, and Jane Kaye. 1999. The use of biological sample collections and personal medical information in human genetics research. London: The Wellcome Trust. Available at https://wellcome.ac.uk/sites/default/files/wtd003283.pdf. Accessed 22 May 2019.
Master, Zubin, Lisa Campo-Engelstein, and Timothy Caulfield. 2015. Scientists’ perspectives on consent in the context of biobanking research. European Journal of Human Genetics 23 (5): 569-574. https://doi.org/10.1038/ejhg.2014.143
Medical Research Council. 1999. Human tissue and biological samples for use in research. Report of the Medical Research Council Working Group to develop operational and ethical guidelines. London: Medical Research Council.
Nuffield Council on Bioethics. 2015. The collection, linking and use of data in biomedical research and health care: Ethical issues. Available at http://nuffieldbioethics.org/wp-content/uploads/Biodata-a-guide-to-the-report-PDF.pdf. Accessed 31 March 2019.
Nuremberg Code. 1947.
Orchard-Webb, David. 2018. 10 largest biobanks in the world. Biobanking.com, 28 May 2018. Available at https://www.biobanking.com/10-largest-biobanks-in-the-world/. Accessed 29 Sept 2018.
Parodi, Barbara. 2015. Biobanks: A definition. In Ethics, Law and Governance of Biobanking: National, European and International Approaches, edited by Deborah Mascalzoni, 15-19. Dordrecht: Springer.
Prictor, Megan, Harriet J.A. Teare, and Jane Kaye. 2018. Equitable participation in biobanks: The risks and benefits of a “dynamic consent” approach. Frontiers in Public Health 6: 253. https://doi.org/10.3389/fpubh.2018.00253
Rothstein, Mark A. 2005. Expanding the ethical analysis of biobanks. The Journal of Law, Medicine & Ethics 33 (1): 89–101. https://doi.org/10.1111/j.1748-720X.2005.tb00213.x
Sheehan, Mark. 2011. Can broad consent be informed consent? Public Health Ethics 4 (3): 226–235. https://doi.org/10.1093/phe/phr020
Steinsbekk, Kristin Solum, Bjørn Kåre Myskja, and Berge Solberg. 2013. Broad consent versus dynamic consent in biobank research: Is passive participation an ethical problem? European Journal of Human Genetics 21 (9): 897-902. https://doi.org/10.1038/ejhg.2012.282
Tutton, Richard, and Oonagh Corrigan, eds. 2004. Genetic databases: Socio-ethical issues in the collection and use of DNA. Abingdon: Routledge.
UNESCO. 2005. Universal declaration on bioethics and human rights.
Williams, Hawys, Karen Spencer, Caroline Sanders, David Lund, Edgar A. Whitley, Jane Kaye, and William G. Dixon. 2015. Dynamic consent: A possible solution to improve patient confidence and trust in how electronic patient records are used in medical research. JMIR Medical Informatics 3 (1): e3. https://doi.org/10.2196/medinform.3525
World Medical Association. 2013. World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects. JAMA 310 (20): 2191-2194. https://doi.org/10.1001/jama.2013.281053
Zain, R.B., R.J. Raja Latifah, I.A. Razak, S.M. Ismail, A.R. Samsuddin, S.A. Atiya, B.Y. Hashim, A. Jallaludin, W.M. Nasir, S.C. Cheong, A.Z. Bustam, W.M.W. Mahadzir, M.T. Abraham, Z.A.A. Rahman, G. Krishnan, N.P. Kipli, J. Norma, K.K. Tay, and K.M.Yuen. 2005. Oral cancer and precancer research in Malaysia - The database and tissue resource bank. Oral Oncology 1(1), 123–123. https://doi.org/10.1016/s1744-7895(05)80305-0
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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). https://doi.org/10.1007/s41649-019-00086-2
- Data protection
- Informed consent
- Dynamic consent