Weil Carol J
Consultant, Human research protections and Bioethics, Bethesda, Maryland, USA.
Biopreserv Biobank. 2023 Feb;21(1):14-22. doi: 10.1089/bio.2021.0094. Epub 2022 Feb 9.
Rapid and dramatic advances in molecular sequencing technology, as well as medical discoveries from genome-wide association and other precision medicine studies, have highlighted the longstanding ethical and legal challenges research biobanks consistently face. Whose authority is needed to conduct research with excised tissue, and how that authority may be exercised with respect and transparency, are central questions. This review article explores how scholars have addressed ethical and legal controversies such as the proper breadth and scope of consent for collection and future research use of biological specimens and data, the importance of disclosing individual research results and secondary findings, and collecting cadaver tissue from deceased persons. This article focuses on the legal and regulatory environment for conducting and/or supporting biospecimen research in the United States of America. It takes the position that proper biobank governance strategies, which ensure accountability and model respect toward biospecimen contributors, as well as transparency in communications between participants and researchers, reduce the likelihood of downstream legal disputes.
分子测序技术的迅速和显著进展，以及全基因组关联研究和其他精准医学研究中的医学发现，凸显了研究生物样本库长期以来一直面临的伦理和法律挑战。开展切除组织研究需要谁的授权，以及如何以尊重和透明的方式行使该授权，是核心问题。这篇综述文章探讨了学者们如何处理伦理和法律争议，例如生物样本和数据收集及未来研究使用的同意的适当范围和广度、披露个体研究结果和次要发现的重要性，以及从死者身上收集尸体组织等问题。本文重点关注在美国开展和/或支持生物样本研究的法律和监管环境。它认为，适当的生物样本库管理策略，即确保问责制、向生物样本提供者示范尊重，以及参与者与研究人员之间沟通的透明度，可降低下游法律纠纷的可能性。
