Abstract
Biobanks act as the custodians for the access to and responsible use of human biological samples and related data that have been generously donated by individuals to serve the public interest and scientific advances in the health research realm. Risk assessment has become a daily practice for biobanks and has been discussed from different perspectives. This paper aims to provide a literature review on risk assessment in order to put together a comprehensive typology of diverse risks biobanks could potentially face. Methodologically set as a typology, the conceptual approach used in this paper is based on the interdisciplinary analysis of scientific literature, the relevant ethical and legal instruments and practices in biobanking to identify how risks are assessed, considered and mitigated. Through an interdisciplinary mapping exercise, we have produced a typology of potential risks in biobanking, taking into consideration the perspectives of different stakeholders, such as institutional actors and publics, including participants and representative organizations. With this approach, we have identified the following risk types: economic, infrastructural, institutional, research community risks and participant’s risks. The paper concludes by highlighting the necessity of an adaptive risk governance as an integral part of good governance in biobanking. In this regard, it contributes to sustainability in biobanking by assisting in the design of relevant risk management practices, where they are not already in place or require an update. The typology is intended to be useful from the early stages of establishing such a complex and multileveled biomedical infrastructure as well as to provide a catalogue of risks for improving the risk management practices already in place.
Highlights
Recent years have seen an expansion of existing biobanking structures and emergence of new biobanks focusing on populations, diseases, biological samples and data, leading to an above-average increase in research that make use of these infrastructures (Astrin and Betsou 2016) as well as expansion of biobanks into greater networks (Ortega-Paíno andAkyüz et al Life Sciences, Society and Policy (2021) 17:10Tupasela 2019)
We provide a comprehensive catalogue of potential risks in biobanking, for the participant or various stakeholders, and for the biobank, biobank employees, biobanking community or even broader arena of biomedical research
With this typology of risks, we are providing a collection of risks that may conceptually apply differently to individual biobanks; in developing this typology, we have shown that there is an entanglement of risks and we argue that an adaptive risk governance is mandatory for success of a biobank
Summary
Recent years have seen an expansion of existing biobanking structures and emergence of new biobanks focusing on populations, diseases, biological samples and data, leading to an above-average increase in research that make use of these infrastructures (Astrin and Betsou 2016) as well as expansion of biobanks into greater networks (Ortega-Paíno andAkyüz et al Life Sciences, Society and Policy (2021) 17:10Tupasela 2019). We provide a comprehensive catalogue of potential risks in biobanking, for the participant or various stakeholders, and for the biobank, biobank employees, biobanking community or even broader arena of biomedical research. This typology of risks is not to be regarded as complete or rigid in structure, but rather a framework to approach risk management as an active process that constantly needs to be reviewed and updated. Considering the experience of scientific institutions on risk mitigation and communication, biobanking is building on lessons learned from the past and benefiting from a longterm experience of academic research that has contributed to human health
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