[Duration and variation of the ethics approval process in Germany - an example from a non-interventional study with 44 participating centers].

BACKGROUND

The bureaucratic and administrative burden for obtaining the obligatory Institutional Review Board (IRB) approval, which confirms the ethical integrity of a scientific project, is high. In order to participate in multicenter studies, most participating centers in Germany require a local second approval. We investigated the variation in the time it took the participating centers of a non-interventional multicenter study to obtain this approval.

METHODS

Descriptive investigation of the amount of time it takes to gain an IRB approval for a multicenter observational study on the quality of life of sarcoma patients conducted throughout Germany. Stratified analyses were carried out on the basis of potential predictors of this duration and reasons for requests for revisions by the IRB were identified.

RESULTS

44 applications for ethics approval were submitted to 26 IRBs. To obtain the 25 second approvals took 53.6 days on average (standard deviation 49.8 days, median 34 days). While State Medical Chambers needed an average of 20.3 days for a local second approval, university hospitals needed 72.4 days. 81.3 % of the university IRBs and 33.3% of the IRB of the State Medical Chambers made specific requests. Ten IRBs followed the recommendations of the primary approval without undertaking their own assessment (average 41.3 days), five IRBs examined the application in an abbreviated procedure (51.4 days), and ten examined it thoroughly (67.1 days).

CONCLUSION

Submitting ethics approval applications for observational studies in a clinical setting involved considerable effort and long waiting times in 2017 and 2018. Simplified review procedures or a waiver of examination by local IRBs do not necessarily mean shorter processing times. In general, there is a continued need for further progress.