Davide Zoccatelli,1 Martin R. Tramèr,1,2 Nadia Elia1,3
In July 2010, the European Journal of Anaesthesiology (EJA) began to progressively implement requests to authors to specify 5 items related to ethical approval (EA) in their manuscripts: name and address of the responsible ethics committee (EC), name of the chairperson, protocol number, and date of approval. We sought to assess if provision of these details facilitated identification of, contact with, and confirmation of approval by ECs.
We identified all articles published in EJA in 2011 that required EA according to the Swiss Federal Act on Research involving Human Beings, focusing on the year 2011 because the reporting of EA was still heterogeneous. From each of the included studies we extracted which and how many of the required items were reported, and attempted to identify the EC based on the reported information in the EA declaration. We contacted each identified EC to seek confirmation of their role in the EA of the respective studies. We compared proportions of ECs identified and number of ECs confirming their role for studies reporting 5 items vs those reporting 4 or fewer using a χ2 test (α, 0.05; bilateral).
Of 193 articles published in 2011, 76 required and 74 (97%) declared EA. The name and address of an EC were mentioned in 63 (85%) EA declarations, protocol number in 51 (69%), date of approval in 48 (65%), and name of a chairperson in 45 (59%). All 5 items were reported in 34 (47%) articles, and 4 or fewer items were reported in 40 (53%) articles. We were able to identify and contact 44 (59%) ECs; 36 (48%) eventually responded, of which 24 (32%) confirmed approval, 10 (14%) were unable to confirm approval for a variety of reasons, and 2 (3%) refused to confirm approval for legal reasons. Reporting all 5 items, compared with 4 or fewer, increased the chance that an EC would be identified (P = .02), and would confirm its approval (P = .05).
The reporting of 5 items related to EA facilitates the identification of the competent EC, and increases the likelihood that the EC would confirm having given EA. However, identification of, and successful contact with EC remains difficult. Future research should identify which information could allow easier and successful identification and contact with ECs.
1Division of Anesthesiology, Department Anesthesiology, Pharmacology and Intensive Care Medicine, Geneva University Hospitals, Geneva, Switzerland, firstname.lastname@example.org; 2Faculty of Medicine, University of Geneva, Geneva, Switzerland; 3Institute of Global Health, University of Geneva, Geneva, Switzerland
Conflict of Interest Disclosures:
Dr Tramèr is a member of the Peer Review Congress Advisory Board but was not involved in the review or decision for this abstract. No other conflicts are reported.