consent, vulnerability, return of findings, independent review, stigma, biobanking, policy analysis, policymakers
Although a few public and private biobanks have been established in Malaysia over the past decades,2,3,4,6 there is currently no specific legislation that governs the operation of biobanks and the research use of tissues and samples stored therein.1
Despite not being specific to the governance of biobanking in Malaysia, the Human Tissue Act 1974 and the Personal Data Protection Act 2010 may be relevant when human biological samples are used for research purposes. For example, Section 2 of the Human Tissue Act 1974 states that it is lawful to use any part of a deceased body for research if the deceased had expressed a request during their life. However, it only mentions that samples can be used for research purposes without explaining the types of research permitted, the process involved in retrieving the samples, and the consent process. Meanwhile, the Personal Data Protection Act 2010 is relevant to governing sensitive information obtained during research. Section 40 subsection (1)(b)(iv) mentions that a person shall not process any sensitive data unless they have obtained explicit consent from the subject to process the sensitive data for medical purposes. Further, subsection (4) of the Act mentions that medical purposes include medical research. Even though it does mention the need for explicit consent in research, it does not provide detailed explanation of the required consent process.
The National Committee for Clinical Research (NCCR) published the Malaysian Guideline on the Use of Human Biological Samples for Research in 2015.5 The guideline aimed to address important ethical issues that should be considered when conducting research with human biological tissues and samples. However, it remains inadequate to govern the conduct of research in biobanking.
Questions
Consider the below questions as if you are a policymaker who is tasked with addressing several gaps in the available policy framework for research involving biobanks in Malaysia.
What policy recommendations would you make to address informed consent for biobanking and the research use of tissues and samples stored in biobanks? For example, who would you recommend obtaining consent for biobanking? What consent process would you recommend for biobanking that addresses future, potentially unknown, uses of biospecimens? What policy position should be advanced to address use of specimens that were collected from someone under the age of majority? When, if ever, might the requirement to obtain informed consent be acceptably waived?
What policy provisions, if any, would you recommend to address patient access to primary and incidental findings, the right to withdraw of samples or data, and the right of ownership or benefit sharing, taking into account individual rights, the interests of society, and practical constraints?
What sort of independent review, if any, should be required prior to access and use of samples stored in a biobank? What should such a review process address?
What, if any, special provisions should be included in policy to address samples derived from vulnerable or stigmatized groups or that involve stigmatizing conditions?
What other critical ethical or regulatory requirements would be important to address in your policy recommendations?
References
Statutes
Human Tissue Act 1974
Personal Data Protection Act 2010
