[Consulting Ethics Committees about a Multicenter Observational Study in Germany - A Report on Effort and Costs]

Ethics committees (ECs) have an indispensable monitoring and regulatory function in research on human beings. In multicenter observational studies, approvals of several local ECs are often required. The aim of this analysis was to provide an overview of the resources used and the process for consulting ECs about a multicenter observational study in Germany.

For this purpose, a cross-sectional analysis was carried out. Resources and activities within the consultation process were documented by the central study management for the period April 2018-April 2019. The study for which the consultation was obtained involved 106 certified colorectal cancer centers in 15 federal states in Germany.

We submitted applications to ECs in 14 medical associations and 7 university hospitals. In total, 6,305 euros consultation fees were charged by the ECs, with the fees varying between 50 and 1,400 euros. For the application documents, at least 2,986 sheets of DIN A4 paper were printed and sent by post to the EC. Partly, several copies of the application documents were required. The central study management spent about 210 working hours. The median of the processing time was 32 days (range: 5-177 days).

In order to significantly reduce the financial, material and personnel costs for scientists and ECs, a standardized and nationwide procedure for consulting ECs about multicenter studies should be pursued in the future. In the interests of economic and ecological sustainability, online procedures should be considered.