Challenges in applying for ethical approval across jurisdictions as part of an INTERREG Project and how they might be addressed

Background/Introduction The Centre for Personalised Medicine was established in April 2017 following an award of €8.6 million from INTERREG VA. This cross-border project includes 14 partner organisations, 10 PhDs and five research clusters in disease areas including unscheduled care in diabetes. A major strength of the project is the multidisciplinary team of clinicians, academic and commercial expertise. Material & Methods In the UK, ethics approval is granted by the Research Ethics Service (RES) while research governance approval is given by the Trust/Health Board. Letterkenny University Hospital’s (LUH) research ethics committee gives approval for studies linked to that hospital. Exploring the use of Freestyle Libre in inpatient diabetes care to improve clinical decision making is one study in this project. Unfavourable opinion was issued for this study by North of Scotland RES in March and Chairman’s approval was granted by LUH in June. Results Challenges have been experienced across the sites and much time and effort dedicated in the initial 8 months to locating ethics and governance procedures. Various issues have led to delays in approvals including different arrangements and timescales in each site; time spent locating procedures; lack of programming of meetings; delays and lack of responses to emails and calls. There is a need for a clear set of procedures to be developed for large projects such as this that are faced with these types of challenges and the impact this has on researchers’ workload and progress. Conclusion There is growing evidence that research-active hospitals have better outcomes with research providing important information on the outcomes of treatments, interventions and importantly, equity of access to research for patients. It is important that research procedures are joined up across sites to ensure common standards and requirements, reciprocal arrangements, timely meetings and responses are in place.