The negative effect of red tape on research.
Boshier A1,2, Shakir SAW1,2, Telfer P1, Behr E3, Pakrashi T3 and Camm AJ3
1Drug Safety Research Unit, Bursledon Hall, Blundell Lane, Southampton, UK
2University of Portsmouth, UK
3Department of Cardiac and Vascular Sciences, St George’s Hospital Medical School, London, UK.
Summary
Purposes: To describe the kind of 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.
Conclusion: 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.
KEY WORDS - Drug-induced arrhythmia, research governance, NHS R&D, epidemiology.
