Applications to a research ethics committee

Summary 

Research involving children must always be submitted for ethical approval. Ethics committees must balance the importance of the research against the risks to the individual taking part, and the rights of the individual not to be exploited. New arrangements for Research Ethics Committees (RECs) introduced in 2004 make the process more straightforward, and an ethical opinion should be available within 60 days of application. For multicentre studies and drugs trials, applications should be made through the central office for research ethics committees (www.corec.co.uk). For multicentre trials a single opinion is valid throughout the UK, but each local research ethics committee must consider whether their region can participate. Before submitting a study protocol for ethical review it is necessary to consider if it fulfils the criteria for the research governance framework. It is also essential to have clear study protocols, information sheets and consent forms that can be easily understood.

Keywords: Research ethics, Research governance, Paediatrics