Dynamic governance: A new era for consent for stem cell research
Rosario Isasi, Heidi Beate Bentzen, Morris Fabbri, Antonie Fuhr, Joel C. Glover, Nancy Mah, Deborah Mascalzoni, Sabine Mueller, Stefanie Seltmann, Armin Kurtz
Abstract
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.