Research governance delays for a multi-centre, non-interventional study

AA Mallick, FJK O'Callaghan

Research output: Contribution to journalArticle (Academic Journal)peer-review

19 Citations (Scopus)

Abstract

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.
Translated title of the contributionResearch governance delays for a multi-centre, non-interventional study
Original languageEnglish
Pages (from-to)195 - 198
Number of pages4
JournalJournal of the Royal Society of Medicine
Volume102(5)
DOIs
Publication statusPublished - May 2009

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