Surviving an NHS REC and R&D application

I’m quite fast and organised so I tend to assume that things can be finished in shorter times than people say. Please believe me when I tell you that it can easily take up to year for all the lights in a REC and R&D application to shine green.

A lot of things will be out of your control, and the number of centres involved in your study correlates very well with the paperwork and time delays you will incur. So plan ahead and prepare yourself mentally too.

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Prepare the following documents:

– A full protocol including background, method, procedure, materials, participants, statistical analysis, ethical issues, and data protection
– Invitation letter
– Information Sheet and Consent form. Guidance and templates from NRES (the National Research Ethics Service) is available here
– Written ethical approval from you local institute.

– CV’s for all the people involved in the study (an IRAS template is available)
– Completed local risk assessments (Once you’ve submitted the RA’s for approval move on to the next steps)

The documents should all be dated, and have a version number and REC reference number (which is created when the application form is completed). 

Prepared them all? Good stuff!  Now:

– Inform yourself on information governance
– Talk to your local Research Governance Office (RGO)
– Go through the IRAS tutorial
– Decide who’s going to be Chief
– Fill IRAS forms during which all the required forms (for REC, R&D etc.) will be filled automatically. Note the difference between an IRAS form and the forms that actually need to be submitted
– Transfer your project to your supervisor for final review
– Transfer different forms to responsible people for authorization
– Send IRAS form along with other necessary documents to RGO for sponsorship and insurance
– Prepare required documents for each organization that has been listed in your project account
– Apply for enhanced CRB if required (very likely) by the hosting institutions

And good luck with your study 🙂

 

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