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Biobanking and risk assessment: a comprehensive typology of risks for an adaptive risk governance
Life Sciences, Society and Policy Pub Date : 2021-12-13 , DOI: 10.1186/s40504-021-00117-7
Kaya Akyüz 1, 2 , Gauthier Chassang 1, 3 , Melanie Goisauf 1, 2 , Łukasz Kozera 1 , Signe Mezinska 1, 4 , Olga Tzortzatou 1, 5 , Michaela Th Mayrhofer 1
Affiliation  

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.



中文翻译:

生物样本库和风险评估:适应性风险治理的综合风险类型

生物库是获取和负责任地使用由个人慷慨捐赠的人类生物样本和相关数据的保管人,这些数据是为公共利益和健康研究领域的科学进步服务的。风险评估已成为生物样本库的日常实践,并已从不同角度进行了讨论。本文旨在提供有关风险评估的文献综述,以便对生物样本库可能面临的各种风险进行综合分类。在方法论上设置为类型学,本文中使用的概念方法基于对科学文献、相关伦理和法律文书以及生物样本库实践的跨学科分析,以确定如何评估、考虑和减轻风险。通过跨学科的绘图练习,考虑到不同利益相关者的观点,例如机构参与者和公众(包括参与者和代表组织)的观点,我们制定了生物样本库潜在风险的类型。通过这种方法,我们确定了以下风险类型:经济、基础设施、制度、研究社区风险和参与者风险。本文最后强调了适应性风险治理作为生物样本库良好治理不可或缺的一部分的必要性。在这方面,它通过协助设计相关风险管理实践,在这些实践尚未到位或需要更新的情况下,为生物样本库的可持续性做出贡献。

更新日期:2021-12-14
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