New checklist helps researchers navigate biobank legal minefields
Biobanks handling human tissue samples now have a standardized four-step compliance tool to manage informed consent, data transfers, and incidental findings across borders. The checklist—developed through an EU research project but applicable globally—addresses a critical gap that has stalled collaborative research and created liability risks for institutions managing biological specimen collections.
Originaltitel: Ethical, legal, and social implications in research biobanking: A checklist for navigating complexity
<p>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.</p>