BBMRI-ERIC, Graz, Austria.
Department of Science and Technology Studies, University of Vienna, Vienna, Austria.
Life Sci Soc Policy. 2021 Dec 13;17(1):10. doi: 10.1186/s40504-021-00117-7.
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.
生物库是人类生物样本和相关数据的保管者，这些样本和数据是由个人慷慨捐赠的，旨在为公共利益和健康研究领域的科学进步服务。风险评估已成为生物库的日常实践，并从不同角度进行了讨论。本文旨在对风险评估进行文献回顾，以便将生物库可能面临的各种风险进行综合分类。本文采用的方法是类型学，其概念方法基于对生物库中科学文献、相关伦理和法律工具以及实践的跨学科分析，以确定如何评估、考虑和减轻风险。通过跨学科的映射练习，我们根据不同利益相关者的观点，如机构参与者和公众，包括参与者和代表性组织，制定了生物库中潜在风险的类型学。通过这种方法，我们确定了以下风险类型：经济风险、基础设施风险、制度风险、研究共同体风险和参与者风险。本文最后强调了适应性风险治理作为生物库良好治理的一个组成部分的必要性。在这方面，它通过协助设计相关的风险管理实践，为生物库的可持续性做出了贡献，而这些实践在生物库中尚不存在或需要更新。该类型学旨在从建立这种复杂的多层次生物医学基础设施的早期阶段就发挥作用，并为改进现有的风险管理实践提供风险目录。
