Regulatory Framework Compliance of Emergency Medical Research

Background: Presentation to the Ethics Committee (EC) is a part of the medical research regulatory framework. Therefore, French Society of Emergency Medicine (SFMU) searched for this information during the submission of abstract for the annual SFMU's congress. The aim was to assess the responses of authors submitting an abstract to the SFMU requesting EC approval. Procedure: An investigator, ignoring the purpose of the study, reviews all abstracts presented to the congress in 2014. However, two other investigators had reviewed the abstract again. We collected: if the study was prospective or retrospective, if randomization or none, with intervention or none and EC approval, none or not applicable. We analyzed the EC evaluation essential for the randomized studies, recommended for all prospective studies and/or with intervention on a patient or staff member and possible for other cases. Results: Six hundred and ninety-five submissions were reviewed. 159 (23%) were multicentric studies. EC approval was issued for 105 (15%) abstracts and 528 (76%) were considered as not applicable. Authors considered the EC advice of 13 (59%) randomized studies, 120 (68%) interventional studies, and 277 (72%) prospective studies as not applicable. Conclusion: The EC advice was insufficiently requested, even for randomized studies. This underreporting is a high-risk judicial factor for research structures. A reminder about the regulatory framework and an increased supervision from the SFMU would be necessary.