RECs will rely on the checks undertaken by R&D offices;
- the favourable opinion of the REC for a site will be conditional upon the permission of the relevant NHS organisation
- the checks that form the SSA are already part of standard R&D review
- the health departments will formally confirm that these checks are included in the procedures for R&D review
At the moment the R&D offices are waiting for further information on how this will be carried out.
This will mean that from the 1st April 2009 there will be changes to the way researchers apply for Research Ethics Approval which are as follows
From 1 April 2009, researchers will no longer need to send Site Specific Information (SSI) Forms to RECs for any NHS site for any type of study. SSI Forms for NHS sites will be used solely for applications for NHS management permission. This will require changes to the existing online application systems.
The NRES online form system (http://www.nres.npsa.nhs.uk) will not be updated to implement this change as it would constitute an inappropriate use of resources. The NRES online form system will therefore no longer be available for new applications from the end of March 2009. Researchers will need to use the Integrated Research Application System (IRAS)
IRAS will provide guidance to applicants on the new arrangements. From 1 April 2009 IRAS will include the facility to enter brief details about existing studies with applications previously completed in the NRES online system (or earlier paper systems). This will allow applicants to set up new sites and submit amendments for existing studies using IRAS.
To avoid unnecessary work in future for amendments or new sites, we strongly recommended that researchers use IRAS now for all new applications for REC or R&D review.