Biobanking and risk assessment: a comprehensive typology of risks for an adaptive risk governance

Life Sciences, Society and Policy

Łukasz Kozera¹  Michaela Th. Mayrhofer¹  Olga Tzortzatou²  Gauthier Chassang³  Melanie Goisauf⁴  Kaya Akyüz⁴  Signe Mezinska⁵ 

[1]BBMRI-ERIC, Graz, Austria

[2]BBMRI-ERIC, Graz, Austria

[3]Biomedical Research Foundation of the Academy of Athens, Athens, Greece

[4]BBMRI-ERIC, Graz, Austria

[5]CERPOP, Université de Toulouse, Inserm, Université Paul Sabatier, Toulouse, France

[6]BBMRI-ERIC, Graz, Austria

[7]Department of Science and Technology Studies, University of Vienna, Vienna, Austria

[8]BBMRI-ERIC, Graz, Austria

[9]Institute of Clinical and Preventive Medicine, University of Latvia, Riga, Latvia

关键词: Biobanking;    Biobank management;    Risk governance;    Risk assessment;    ELSI;    Data privacy;    Typology;    Sustainability;    Stakeholders;   

DOI  :  10.1186/s40504-021-00117-7

来源: Springer

【 摘 要 】

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.

【 授权许可】

CC BY