Internal Ethics review and NREC/ HRA approval

[Alexis Holden]

Hello
I would like to ask a question around University ethics process for NREC/HRA approved projects. In view of the recent changes to the approval process for projects with the NHS (e.g. IRAS/NREC and HRA), what is your internal university process for dealing with these projects? Do these get (re)reviewed by an internal ethics committee – for example by Chairs Action – after the final NREC/HRA approval has been granted? Or are they just ‘noted’ by the internal University ethics committee?
Many thanks for any replies.
Regards
Alexis

Dr. Alexis J. Holden
Head of Research Services
University of Central Lancashire, Preston
E: ajholden@uclan.ac.uk

[Alison Lloyd]

Hi Alexis,

At my institution NHS (or via IRAS) applications are all reviewed by my colleague and I as part of the sponsorship approval process prior to submission. There is no other internal review. Following approval, we remind the applicant(s) about annual reports, and review amendments etc, but there are all managed by me and my colleague alone. We as contacts on behalf of the institution sponsor keep complete records of all the documentation submitted and any correspondence with the REC/HRA etc. throughout the life course of the study. We decided that no other review was required as the NHS/HRA process is very rigorous. Does this help?

Would you find it useful for me to give you a call to have a chat about it in more detail?

With warm regards,

Alison

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