Time and costs of the ethics approval process for retrospective studies in Hanover, Germany.

Abstract

Purpose: Financial pressure on the German healthcare system is rising, and physicians face high pressure in balancing patient care and research. Into this environment comes an ethics approval process for retrospective studies that is becoming more complex and requires a greater volume of documentation. The objective of this study was to first describe and calculate the costs incurred by the ethics approval process.

Methods: Using ChatGPT and Gemini, the required times for preparation, creation, and submission, as well as the time required for the ethics committee to process and vote on ethics approval, were estimated. Costs were calculated based on the newest version of the collective agreement for physicians at German university hospitals (Tarifvertrag für Ärzte an Universitätskliniken).

Results: Time required for submitting adds up to approximately 4-10 hours, and 4.5-8.5 hours for submission control and voting, respectively. Summing up, this amounts to 161.7-388.1 € for submission and 241.6-456.3 € for the ethics committee, respectively. In total, 8.5-18.5 hours are required for ethics approval for a retrospective study, resulting in a total of 403.3-844.4 €.

Conclusion: Ethics approval is of major relevance to ensure good ethical practice and shall therefore not be omitted. Nevertheless, processes can be tightened to facilitate clinical research, free up resources, and save costs.