1. From Proposal to Execution: How Primary Care Research & Development Departments and Researchers Work Together Dorothy Newbury-Birch 1 Shona Haining 2 Catherine Adams 2 1 Institute of Health and Society, Newcastle University. 2 NHS North of Tyne, working on behalf of Newcastle PCT, North Tyneside PCT and Northumberland Care Trust Advise on feasibility of protocol through links with service R&D departments can be the conduit between researchers and the service, advising on the feasibility of undertaking the study in terms of service configuration and whether the research ’fits’ with the local service and population as well as any local issues that may impact on the study. Prior to starting the projects the SIPS and Aesops protocols were disseminated by NHS North of Tyne R&D Dept to GPs in the area to ascertain views on the feasibility of the study. Advise and signpost on a range of research governance processes. Ethics approval In both the SIPS and AESOPS studies help was received on gaining site specific approvals Completing the ethics form Ethics forms are complex to complete and help was obtained from R&D to do this. Honorary contracts Advice and support to complete forms for honorary contracts for non- NHS staff in 3 trust areas and 3 PCTs was given for the SIPS project. Financial arrangements Reimbursement of service support costs was facilitated via the R&D office. Dealing with research that bridges different agencies and organisations The SIPS project is multi-disciplinary and involved a number of agencies – A&E Depts, Criminal Justice System and Independent Contractors. Prison research in particular has specific requirements in terms of ethics approval and issuing of honorary contracts. A close working relationship between R&D and the research team facilitated the process of seeking the getting regulatory approvals in place. Monitoring process and formal project audit 10% of all projects are formally audited to ensure research governance requirements are met. This is done in order to support the research team and identify any problem areas. The North East strand of SIPS was formally audited in March 2009. All files, protocols, honorary contracts, project timetable, ethical approvals, documentation and storage of data were reviewed The audit concluded that: The study team was well organised and showed many examples of good practice. The team had maintained excellent communication links with R&D throughout the project. Documentation and project management was described as excellent. The R&D Department provides expert advice and support to researchers on all aspects of research governance, helping researchers through the study approvals, application processes and providing on-going support through the life of the project from design to dissemination A series of multi-centre randomised controlled trial examining the effectiveness and cost-effectiveness of opportunistic alcohol screening and brief interventions in PHC, AED and CJS A multi-centre randomised controlled trial examining the effectiveness and cost-effectiveness of opportunistic screening and stepped care interventions for older hazardous alcohol users in primary care Ongoing support through the duration of the research project NHS North of Tyne R&D Dept. are available for help and advice at any stage of the research process and can be contacted at: NHS North of Tyne, Bevan House 1 Esh Plaza, Sir Bobby Robson Way, Great Park, Newcastle upon Tyne NE13 9BA or visit www.northoftyne.nhs.uk/publications/research/