Isak Mazanti Cold, S. Tonning, M. Meyer, Jacob Steinmetz, J. Møller, B. Rasmussen, Anders Perner, M. H. Møller, J. Stensballe, Mads Houghton Michaelsen, Laura Wrisberg Kæstel, J. Jakobsen, C. Hassager, A. Granholm, Kasper Iversen, J. Kjærgaard, J. Grand
2026.1.23ACTA ANAESTHESIOLOGICA SCANDINAVICA
tlooto Summary
This work has shown that in certain emergency medical situations, participants are unable to provide prospective informed consent before inclusion, or the urgency of the situation deems it non‐futile to await consent before the intervention, legal guardians can provide proxy consent initially.
Abstract
Informed consent is a fundamental part of clinical research involving human participants. However, in certain emergency medical situations, participants are unable to provide prospective informed consent before inclusion, or the urgency of the situation deems it non‐futile to await consent before the intervention. This has led to the introduction of legal guardians who can provide proxy consent initially, where the legal guardian, next‐of‐kin, and the participant themselves later can give or withdraw consent regarding continued follow‐up. Prior to the initiation of an emergency trial in Denmark, it has been accepted and approved by national or regional research ethics committees, as well as The Danish Medicines Agency if it is a drug study.
Citation format
COLD, Isak Mazanti, et al. Informed consent in randomized emergency clinical trials in denmark: A systematic review and national survey protocol. ACTA ANAESTHESIOLOGICA SCANDINAVICA, 2026, 70(3): e70193.