Biobanking: A Challenging Ethical Landscape

By Cristina Piñel Neparidze 

Nowadays, when science experts envision and discuss the means by which new horizons in medicine (e.g. personalised and regenerative medicine) may be materialised and sustained, the word “biobank” very often comes into play. Biobanks are infrastructures that allow storage of biological samples for research purposes. They therefore give researchers access to data representing a large number of people, and hence the information drawn from those can be used by science to conduct ever-improving, complex and wide research studies. 

As an example, many diseases, like sickle-cell anaemia, β-thalassemia and cystic fibrosis, are associated with single-nucleotide polymorphisms (SNPs) (Razali et. al., 2012), and, therefore, genome-wide association studies, using data from thousands of individuals accessed by biobanking, can identify these genetic associations as potential disease biomarkers. Additionally, emerging regenerative therapies in the field of stem cells, such as skin grafts and bone marrow transplants, rely on long-term or short-term storage of tissues. Biobanking is therefore used as a convenient method to store biological samples for a desired period of time, reducing costs and patient inconvenience (Harris et. al., 2018). 

Nonetheless, ethical issues are commonly present in many aspects of biobanking: firstly, these infrastructures deal with human samples, and therefore can challenge individual autonomy when it comes to information storage and processing. To put this into context, the 2014 Ebola outbreak in Sierra Leone precipitated large-scale biobanking of diagnostic samples, with materials being collected from the affected populations and being widely shared. This biobank contributed substantially to the knowledge and control of Ebola disease, but the ethical adequacy of these agreements is questionable, as is the absence of a complete inventory of the samples collected, and their location, ownership, and consent for future use (Ashcroft et. al. 2013). Who is actually competent to give informed consent and donate a sample? When individuals donate part of their body to a biobank, how is that human sample processed? Who is the owner of the sample? Who should decide how it should be used? Who has the right to know individual results of research (Budimir et. al., 2011)? If this concern is contextualized now, amidst the COVID-19 pandemic, shouldn’t one ask oneself who gets to access, process and potentially store current samples for testing?

Secondly, biobanks also raise the issue that participants or donors may not “own” their own samples. This is based on “res nullius”, which is the traditional understanding that body parts do not have an owner once they are detached. Though many ethicists have argued that there are valid reasons for the implementation of the “no property” rule, as allowing property would restrain research to the point where it would become unfeasible, one cannot help but wonder whether absence of biological sample ownership could lead to an increase in unethical practices with it (Widdows et. al., 2011). 

Additionally, another ethical dilemma that biobanking brings to the table is feedback to participants: it is still nebulous whether, within the biobanking practice, incidental findings (which are, for example, unexpected findings of clinical significance from a given donated sample) will be communicated to donors, given these are unrelated to the purpose of the research. If a supposedly healthy donor donates blood for an allogenic bone marrow transfusion, but is not notified that their creatinine levels are abnormally high, how are they going to be aware that they have a potential kidney problem (Widdows et. al. 2011)?  

Moreover, bearing in mind that one of the main purposes of biobanking is to allow research to be more complex and accurate by providing a large number of samples, it is still questionable whether such samples are accurate representations of the current population. As an example, if biobanking provides samples for genome wide association studies screening for a single-nucleotide polymorphism (SNP) related to a certain disease, a “representation problem” could arise if the majority of samples provided are from one specific ethnicity. This would potentially lead to misleading information, resulting in patients from underrepresented ethnicities being misdiagnosed (Popejoy et. al., 2016). 

Lastly, the increased value of tissue samples stored in biobanks, particularly the ones with substantial clinical characterization, has led to the commercialisation of biological tissues, genotype and sequence data, and phenotypic/environmental data. While the use of a commercial third party or designated trustee may be advantageous in helping to protect the privacy and interests of participants, the involvement of a commercial entity in a biobank initiative can result in significantly negative public perceptions and fears of commercial exploitation as well as limited and/or costly access to samples, limitations on data dissemination, and trust (Haga et. al., 2008). 

To summarise, as the creation and use of biobanks increases around the world, the need for careful consideration and analysis of ethical, legal, and social implications remains. Implications of the ethics discussion of biobanks are interesting not just for the sake of biobanks themselves, but also for the very foundation of the future medicine. The future will inevitably bring personalized medicine, which will share a number of similarities with the contemporary biobanks, and thus highlight the need to protect sensitive information, levels of accessibility, the need to prevent data misuse, and the possibility to predict individual health-related outcomes based on the genomic information. 

References: 

David, A., Razali, R., Wass, M. N. & Sternberg, M. J. E. (2012) Protein–protein interaction sites are hot spots for disease‐associated nonsynonymous SNPs. Human Mutation. 33 (2), 359-363. Available from: doi: 10.1002/humu.21656.

Harris, D. (2018) Biobanking and Regenerative Medicine: An Overview. Journal of Clinical Medicine. 7 (6), 131. Available from: doi: 10.3390/jcm7060131.

Ashcroft, J. W. & Macpherson, C. C. (2019) The complex ethical landscape of biobanking. The Lancet.Public Health. 4 (6), e274-e275. Available from: doi: 10.1016/S2468-2667(19)30081-7.

Budimir, D., Polasek, O., Marusić, A., Kolcić, I., Zemunik, T., Boraska, V., Jeroncić, A., Boban, M., Campbell, H. & Rudan, I. (2011) Ethical aspects of human biobanks: a systematic review. Croatian Medical Journal. 52 (3), 262-279. Available from: doi: 10.3325/cmj.2011.52.262.

Widdows, H. & Cordell, S. (2011) The Ethics of Biobanking: Key Issues and Controversies. Health Care Analysis. 19 (3), 207-219. Available from: doi: 10.1007/s10728-011-0184-x.

Popejoy, A. B. & Fullerton, S. M. (2016) Genomics is failing on diversity. Nature (London). 538 (7624), 161-164. Available from: doi: 10.1038/538161a.

Haga, S. B. & Beskow, L. M. (2008) Ethical, Legal, and Social Implications of Biobanks for Genetics Research. Advances in Genetics. 60 505-544. Available from: doi: 10.1016/s0065-2660(07)00418-x.

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