@article {Hutchingse2, author = {H Hutchings and G Lloyd and H Snooks and I Russell}, title = {A1 Financial and time costs of R\&D governance and regulation in England and Wales: evidence from the SAFER 2 trial}, volume = {28}, number = {11}, pages = {e2--e2}, year = {2011}, doi = {10.1136/emermed-2011-200645.1}, publisher = {British Association for Accident and Emergency Medicine}, abstract = {In response to a recent review targeted at reducing bureaucracy in medical research related to R\&D governance and regulation, we collated our experiences from a multi centre trial in prehospital emergency care underway in England and Wales. We present recommendations about how to improve the system to avoid delays and spiralling costs. The SAFER 2 trial is an National Institute for Health Research (NIHR) Health Technology Assessment-funded cluster randomised controlled trial evaluating clinical and cost effectiveness of protocols for paramedics to refer older people for whom a 999 call has been made for a reported fall to community based care. We have encountered various issues relating to R\&D processes, including: unclear guidelines about how R\&D permissions work both within and across UK countries; inconsistencies in processes between sites; complex processes at global and local level; differing interpretations of the Attributing Revenue Costs of non-commercial research in the NHS (ARCO); multiple routes for reclaiming costs incurred by NHS Trusts through participating in research; difficulty of completing R\&D permissions processes while uncertainty exists around the financial consequences of participation; and uncertainties related to ethical practice in research in emergency care. As a direct consequence of these issues we have encountered significant delays resulting in an application for an extension to the HTA for {\textsterling}420 000. We make a number of practical recommendations based on these experiences that could improve the R\&D process. First, that the Department of Health (DoH) allocates sole responsibility for awarding research costs, excess treatment costs \& service support costs to NIHR, thus removing at a stroke scope for interminable boundary disputes. Second, that the DoH issues more comprehensive standard operating procedures for Research Ethics Committees (REC), Comprehensive Local Research Networks and Trust R\&D Departments, thus minimising inconsistent decision-making and duplication. Thirdly, that the National Research Ethics Service issues clear guidance to RECs on acceptable procedures for consenting in difficult circumstances, including emergency care and about when {\textquotedblleft}opting out{\textquotedblright} is permissible.}, issn = {1472-0205}, URL = {https://emj.bmj.com/content/28/11/e2.1}, eprint = {https://emj.bmj.com/content/28/11/e2.1.full.pdf}, journal = {Emergency Medicine Journal} }