Informed Consent in Randomized Emergency Clinical Trials in Denmark: A Systematic Review and National Survey Protocol

BACKGROUND: 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.

OBJECTIVE: The objective of this systematic review is to first identify all conducted emergency trials in Denmark and then contact the researchers of those trials through a national survey. This will serve as the basis for providing a systematic evaluation of the consent procedures and how they are utilized in emergency setting trials in Denmark through both quantitative and qualitative data.

METHODS: This protocol describes a two-phase study, consisting of a systematic review identifying all emergency trials in Denmark throughout the different iterations of legislation, and a national survey regarding the use of proxy consent in the trials identified in the systematic review. An information specialist will generate the search string to identify all relevant trials by searching relevant databases. These trials will have data extracted, and the corresponding authors of the trials will be contacted and invited to conduct a survey. This survey will contain quantitative questions about the amount of included participants and to what extent consent was either denied or not obtained. Furthermore, an anonymized section of the questionnaire will investigate qualitatively the opinions, suggestions, and beliefs of the emergency researchers regarding the consent procedures.