The impact of the Research Governance Framework upon neonatal and other research

The UK Research Governance Framework introduced in 2001,1 initiated sweeping changes to the regulation of UK research. The framework implements the Medicines for Human Use (Clinical Trials) Regulations 2004, the European Union Clinical Trials Directive (EUCTD) and additional regulatory requirements. Other substantial changes were the establishment of the Comprehensive Clinical Research Network and Medicines for Children Research Network (MCRN) in 2005, and in 2006, a strategy to stimulate patient-focused research and place the National Health Service (NHS) centre, stage was presented in ‘Best Research for Best Health’.2 The Research Governance Framework arose largely in response to the Griffiths Report3 4 into a neonatal trial, the Continuous Extrathoracic Negative Pressure (CNEP) trial. Among the many consequences was that the intended benefits to patients of placing the NHS at the heart of initiatives to improve clinical research have been seriously compromised by over-regulation.

The first decade of the 21st century saw newborn research in the UK come close to a standstill. In 2002, the British Association of Perinatal Medicine cancelled its annual Trials Group Meeting because of lack of attendance. By 2006, there were only three large multicentre trials in the UK involving medicines in neonates, all led by academic investigators (INIS: International Neonatal Immunotherapy Study; PROGRAMS: A multicentre, randomised controlled trial of PROphylactic GRAnulocyte-Macrophage colony stimulating factor (GM-CSF) to reduce Sepsis in preterm neonates; NIRTURE: Neonatal Insulin Replacement Therapy in Europe). Approximately 8000 applications are reviewed by the UK National Research Ethics Service (NRES) each year. In 2009, research in children of any age represented only around 1 in 10 of all applications, of which less than 10% were trials of an investigational medicinal product (NRES, personal communication) and such trials in newborns were very few indeed. Babies, thus, continue to be at the highest risk of receiving …