Concurrent Breakout Sessions
DESCRIPTION OF SESSION
The rise of synthetic data and digital twin technologies is transforming biomedical research and clinical trial design, allowing investigators to model interventions on simulated “participants.”. Marketed as efficient, ethical, and low-risk, these technologies obscure profound ethical concerns, particularly for First Nations, Métis, and Inuit communities whose data, identities, and bodies have long been extracted, simulated, or represented without consent.
This session responds to the CAREB 2025 theme, “The Power of Presence in Research Ethics: Live, Virtual, United,” by demonstrating how these emerging tools create the opposite: research without presence, without relationship, and without accountability. Synthetic datasets and digital twins risk generating “datafied Indigenous bodies” from legacy datasets, administrative health systems, or algorithmic predictions, none of which fall cleanly under existing REB definitions of human participant research. As a result, these technologies can bypass and undermine community governance, Indigenous Data Sovereignty (IDSov) principles and relational ethics, raising urgent questions for research oversight bodies across Canada.
Drawing on our work in Indigenous clinical trials, distinctions-based data governance, and rights-based research infrastructures, we map the ethical fault lines created by simulated research environments and identify how current ethics systems are not equipped to protect communities when the “participants” are synthetic, but the harms are real.
Through case analyses and relational dialogue, we offer pathways for REBs, institutions, and communities to approach the increasing use of synthetic data with a critical lens and to ensure that Indigenous sovereignty, consent, and governance remain central in digital research landscapes.