The negative effect of red tape on research.
OBJECTIVE
To describe the kind of the difficulties encountered when seeking research governance approval for a nationwide public health and genetic study-the Drug-Induced Arrhythmia Risk Evaluation study-in England.


METHODS
Description of the processes followed when seeking research governance approval for the Drug-Induced Arrhythmia Risk Evaluation study-a case control study with annual follow-up of cases and controls over 5 years, set in the English National Health Service (NHS).


RESULTS
The authors describe wide variations in NHS research governance approval procedures in England.


CONCLUSIONS
NHS research governance procedures in England are impeding the process of epidemiological studies; there is the need for a centralised NHS R&D approval of studies, which is analogous to MREC for ethical approval.
Boshier
A
A
Drug Safety Research Unit, Bursledon Hall, Blundell Lane, Southampton, UK. andrew.boshier@dsru.org
Shakir
S A W
SA
Telfer
P
P
Behr
E
E
Pakrashi
T
T
Camm
A J
AJ
D004739:England; D032984:Ethics, Research; D033161:Government Regulation; D006805:Human Experimentation / Q000941:ethics / Q000331:legislation & jurisprudence / Q000592:standards*; D006801:Humans; D012109:Research Support as Topic / Q000941:ethics / Q000331:legislation & jurisprudence / Q000592:standards*