Research governance delays for a multicentre non-interventional study

Abstract

Summary Objectives To evaluate the delay in research governance approval for a non-interventional, multicentre study in the United Kingdom. Design The times taken from application to the granting of research governance approval for an observational study of childhood stroke with ethical approval were prospectively recorded. Setting Ninety-two acute NHS Trusts in the United Kingdom. Main outcome measures Median delay (in working days) between application and research governance approval. Results The median delay between application and research governance approval was 43 working days (interquartile range 27–62, range 0–147). The reason for delay beyond 43 working days was inexplicable in 30 (70%) of 44 trusts. Conclusions There is considerable variation in the processes undertaken by research and development departments that can lead to significant delays in commencing an ethically approved study. Any improvements to the systems for gaining approval are welcome.