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Guide to Research Governance

The NIHR Exeter Clinical Research Facility may only support research that is conducted in accordance with the Department of Health guidance "Research Governance Framework for Health & Social Care" and if relevant, in accordance with the Department of Health guidance "Governance Arrangements for NHS Research Ethics Committees".

The Clinical Research Facility thus provides a service to help researchers ensure that their studies undergo appropriate approvals in a timely and efficient manner. The CRF can adopt pre-approved studies but are keen to adopt studies in essence before they go through the approval process so that they may benefit from our expertise in experimental design and protocol development.  Please arrange a meeting with us (crf@exeter.ac.uk) or fill in a application form to use the CRF.

All staff involved in clinical research are required to attend GCP (Good Clinical Practice) courses.  To find out when the next course is running contact l.garcia@nhs.net

The three main areas of research governance are: ethics, sponsorship and R&D approval.

Ethics

All research involving human subjects needs to be reviewed by an ethics committee. 
Which ethics committee should I get my project approved by?

Sponsorship

Sponsorship refers to the organisation who takes responsibility for a study.  As Peninsula NIHR Clinical Research Facility is a partnership between PCMD and RDEFT many projects require joint sponsorship.  For studies at University of Exeter sites that do not involve NHS patients or NHS staff as volunteers or principal investigators there is no need to get NHS sponsorship.  Protocols for these studies should be sent to Nick Church (n.j.church@exeter.ac.uk) so that he may ensure necessary insurance and indemnity for these projects.  It is important to ensure that Nick Church is aware of the start and end dates of projects, especially if projects overrun beyond their anticipated duration.  All projects involving NHS staff employed through RD&E or in facilities on NHS sites must be sponsored or co-sponsored by the R&D dept of RD&E.  To arrange sponsorship/co-sponsorship please contact Chris Gardner (christopher.gardner@nhs.net).  If your project is already approved by the  NIHR Exeter Clinical Research Facility please transfer your IRAS forms to crf@exeter.ac.uk at least 2 weeks prior to your ethics submission date.  The CRF will organise sponsorship on your behalf and will check your application to ensure everything is correct prior to submission.

R&D approval

All studies involving NHS staff, patients or NHS localities need to be approved by the R&D department. The CRF R&D contact for local studies is Lynda Garcia Ext 6933 (l.garcia@nhs.net) and for network studies is Sue Crampton.   Studies that involve recruiting from a primary care setting (e.g. GP surgeries) need to be also approved by the PCT. Sue & Gyan can also help with this too.

A set of flowcharts are available HERE guiding you through the R&D process.  Please read these documents well in advance of applying to ethics to ensure that your application is dealth with a smoothly and efficiently as possible.  Lynda Garcia, Sue Crampton, Gill Baker & Bea Knight can provide help and advice and it is recommended that researchers have face-to-face meetings with this team early on.

CRF and departmental requirements

Copies of all applications, protocols, patient info sheets, approval letters and amendments should be filed in the CRF office (crf@exeter.ac.uk) and departmental ethics files.