How to get your application through ethical review (or how not to rile your ethics committee)

Without ethical approval, your clinical trial will be stymied even if it does win funding, says Hugh Davies, research ethics adviser at the Heath Research Authority and consultant paediatrician at John Radcliffe Hospital, Oxford.

Research has brought undoubted benefit. Two centuries ago we didn’t live that long (unless we were lucky), and we lived fearful of illness. Improvements in our understanding, built on research, have changed this. David Wootton in his book Bad Medicine (OUP, 2007) contends that doctors only stopped killing their patients when they analysed their treatments, in other words they researched their care to find out if they were helping their patients.

That this is still evident is clear. Nevertheless, the historical records of research reveal misdemeanours and unethical practice, which have harmed and in some cases killed. While research is still needed, so is its proper design and review by independent bodes such as Research Ethics Committees (RECs). Their authority derives from international guidance issued by bodies such as the World Health Organization and the World Medical Association’s Declaration of Helsinki, national law and professional regulations.  In the UK, the Governance Arrangements for Research Ethics Committees (GAfREC) defines the role and procedures of RECs: research applications are reviewed at a scheduled meeting and at the end RECs are required to make one of three decisions: favourable, favourable with conditions or unfavourable.