What happens after the REC meeting?
For what to expect after the REC meeting, see Attending a REC meeting.
Once I have ethical approval from a main REC, do I also need approval from the local RECs?
For multi-site studies taking place in an NHS organisation, the main REC is the REC undertaking the ethical review of the application and it is not necessary to seek approval from any local REC. For non-NHS sites, it is still the responsibility of the REC system to undertake the site-specific assessment. For more information, see How do I obtain SSA approval, below.
One ethical decision per research project is valid for the whole of the UK. Once you have ethical approval from a main REC, you do not need further ethical review of the protocol from any NHS REC in the UK. The only exception to this is if you are undertaking a project which involves adults who are unable to consent for themselves in Scotland and any other UK country. In this case two applications will need to be made: see Guidance and page 228 of the Standard Operating Procedures for more information on this issue.
ow do I obtain SSA approval?
SSA at NHS sites
From 1 April 2009, Site-Specific Assessment (SSA) has been transferred to R&D offices for NHS sites and is integrated into the normal research governance review. Therefore, SSI Forms must be submitted as part of the R&D application for all NHS sites for all study types.
For further information see:
The favourable opinion of the main REC is given on condition that permission is given by the NHS organisation.
SSA at non-NHS sites
This is still the responsibility of the REC system.
The REC undertaking the SSA is known as the “SSA REC” and may be either the main REC or an appropriate local REC.
(Designated SSA RECs may be appointed for specialist research units outside the NHS.)
I am amending the Participant Information Sheet and Consent Form for my study; do I need to convert to the latest format?
You can convert these documents to the latest format recommended in the NRES guidance if you wish to and think that it would benefit participants. However, this is not a requirement for documents that have already received ethical approval.
You will need to update the date and version number of the document once amended so that an audit trail can be followed.
Do I need to re-consent participants if I have amended the Participant Information Sheet or Consent Form?
Yes, if it is a substantial amendment where the changes will affect those participants already consented into the study. All participants should be fully informed when taking part in research.