Research governance regulations and paediatric research

Summary 

The publication of ‘The Research Governance Framework for Health and Social Care’ and the new rules for ethical committees will have a profound impact on the conduct of research within the National Health Service (NHS). Organizations will be required to work together to assure the quality of research. This will involve independent peer review. Monitoring arrangements, particularly around documentation and consent will be developed. Prioritization, according to local and national research strategy, will also be required. New approval mechanisms will take account of strategic fit, scientific validity and the ability of the host organization to provide support for the project. Ethical committees will require assurance on these points before considering a project. Clinical trials involving medicinal products will fall into a new system of registration to ensure quality control. Chief investigators will be required to demonstrate good practice in relation to all aspects of research. This paper aims to provide practical guidance to assist researchers in understanding and dealing with the new rules and in demonstrating good research practice. The implications for the future of research are discussed.

Keywords: Research governance, Ethical committee, LREC, MREC, Informed consent