Ethical, legal, and social implications in research biobanking: A checklist for navigating complexity

Pub Date : 2023-07-10 DOI:10.1111/dewb.12411

Olga Tzortzatou-Nanopoulou, Kaya Akyüz, Melanie Goisauf, Łukasz Kozera, Signe Mežinska, Michaela Th. Mayrhofer, Santa Slokenberga, Jane Reichel, Talishiea Croxton, Alexandra Ziaka, Marina Makri

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Abstract

Biobanks’ activity is based not only on securing the technology of collecting and storing human biospecimen, but also on preparing formal documentation that will enable its safe use for scientific research. In that context, the issue of informed consent, the reporting of incidental findings and the use of Transfer Agreements remain a vast challenge. This paper aims to offer first–hand tangible solutions on those issues in the context of collaborative and transnational biobanking research. It presents a four-step checklist aiming to facilitate researchers on their compliance with applicable legal and ethical guidelines, when designing their studies, when recruiting participants, when handling samples and data, and when communicating research results and incidental findings. Although the paper reflects the outcomes of the H2020 B3Africa project and examines the transfers from and to the EU as a case study, it presents a global checklist that can be used beyond the EU.

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生物库研究中的伦理、法律和社会影响：应对复杂性的清单。

生物库活动的基础不仅是确保收集和储存人类生物样本的技术，还包括编制正式文件，使其能够安全地用于科学研究。在这种情况下，知情同意、偶然发现的报告和转让协议的使用仍然是一个巨大的挑战。本文旨在为合作和跨国生物库研究中的这些问题提供第一手切实可行的解决方案。本文提出了一份四步核对表，旨在帮助研究人员在设计研究、招募参与者、处理样本和数据以及交流研究成果和意外发现时遵守适用的法律和伦理准则。虽然本文反映了 H2020 B3Africa 项目的成果，并以欧盟为案例研究了从欧盟转移和向欧盟转移的情况，但它提出了一份可在欧盟以外使用的全球核对表。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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