CIRSFID ALMA-AI, University of Bologna, Bologna, Italy.
Department of Rare Skeletal Disorders, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.
Biopreserv Biobank. 2021 Dec;19(6):483-492. doi: 10.1089/bio.2021.0057. Epub 2021 Dec 3.
The discussion concerning the measure of the quality of a biobank should focus not only on the number of stored samples and their quality but also on the assessment of their access arrangements and governance. This article aims at contributing to the ongoing debate on samples and data access governance in biobanking by presenting the case of the Telethon Network of Genetic Biobanks (TNGB). We attempt to contribute to the need for clear and available access criteria and harmonization in access arrangements to maximize the influence of biobanks in the progress of biomedical research. We reviewed all the sample requests submitted to the TNGB from 2008 to 2020, focusing on those rejected by the Access Committee and the reasons behind the rejections. The analysis of the reasons behind the rejected requests allowed us to analyze how those relate to the issues of scientific misconduct, prioritization, and noncompliance with the biobank's mission. We discuss those issues in light of the actions and motivations used by TNGB in the access decision-making process. Based on this analysis, we suggest that a cross-implementation of a checklist for access assessment would improve the whole access process, ensuring a more transparent and smoother governance. Finally, we conclude that the TNGB's Charter and approach toward access governance could contribute as an important reference point to deal with the issues that have emerged in the international discussion on the topic.
关于生物库质量的衡量标准，不仅应关注存储样本的数量及其质量，还应评估其获取安排和治理情况。本文旨在通过介绍 Telethon 遗传生物库网络 (TNGB) 的案例，为生物库中样本和数据获取治理的持续辩论做出贡献。我们试图为明确和可用的获取标准以及获取安排的协调做出贡献，以最大限度地发挥生物库在推进生物医学研究方面的作用。我们审查了 2008 年至 2020 年提交给 TNGB 的所有样本请求，重点关注被获取委员会拒绝的请求以及被拒绝的原因。对被拒绝请求背后的原因进行分析，使我们能够分析这些原因与科学不端行为、优先级和不符合生物库使命等问题之间的关系。我们根据 TNGB 在获取决策过程中使用的行动和动机来讨论这些问题。基于此分析，我们建议采用访问评估检查表的交叉实施方法，将改进整个访问流程，确保治理更加透明和顺畅。最后，我们得出结论，TNGB 的章程和获取治理方法可以作为处理该主题国际讨论中出现的问题的重要参考点。
