Research governance delays for a multicentre non-interventional study.
OBJECTIVE
To evaluate the delay in research governance approval for a non-interventional, multicentre study in the United Kingdom.


METHODS
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.


METHODS
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.
Mallick
Andrew A
AA
Bristol Institute of Child Life and Health, Academic Unit of Child Health, Level 6, UBHT Education Centre Upper Maudlin Street, Bristol BS2 8AE, UK.
O'Callaghan
Finbar J K
FJ
D035843:Biomedical Research / Q000941:ethics / Q000331:legislation & jurisprudence*; D032984:Ethics, Research; D006077:Government Agencies; D015337:Multicenter Studies as Topic / Q000331:legislation & jurisprudence*; D013222:State Medicine; D013997:Time Factors; D006113:United Kingdom