Interdisciplinary Stem Cell Institute and Dr. John T. Macdonald Foundation Department of Human Genetics, Miami, FL, USA.
Centre for Medical Ethics, Faculty of Medicine, University of Oslo, Oslo, Norway and Cancer Registry of Norway, Norwegian Institute of Public Health, Oslo, Norway.
Stem Cell Reports. 2024 Sep 10;19(9):1233-1241. doi: 10.1016/j.stemcr.2024.07.006. Epub 2024 Aug 15.
Governance infrastructures streamline scientific and ethical provenance verification of human pluripotent stem cell (SC) lines. Yet, scientific developments (e.g., SC-derived embryo models, organoids) challenge research governance approaches to stored biospecimens, questioning the validity of informed consent (IC) models. Likewise, e-health platforms are driving major transformations in data processing, prompting a reappraisal of IC. Given these developments, participatory research platforms are identified as effective tools to promote longitudinal engagement, interactive decision-making, and dynamic governance. Learning from European initiatives piloting dynamic IC for biobanking and SC research, this Perspective explores the benefits and challenges of implementing dynamic IC and governance for SC.
治理基础设施简化了人类多能干细胞 (SC) 系的科学和伦理来源验证。然而，科学的发展（例如，SC 衍生的胚胎模型、类器官）对存储生物样本的研究治理方法提出了挑战，质疑了知情同意 (IC) 模型的有效性。同样，电子健康平台正在推动数据处理的重大变革，促使重新评估 IC。鉴于这些发展，参与式研究平台被确定为促进纵向参与、互动决策和动态治理的有效工具。本观点借鉴了在生物库和 SC 研究中试点动态 IC 的欧洲举措，探讨了为 SC 实施动态 IC 和治理的好处和挑战。
