You may be issued with different letters when you apply for approvals. Here’s our guide explaining what these letters are for.
HRA initial assessment letter
This letter indicates that your application has been received and it is intended that you start to liaise with sites and NHS R&D once this is received. You can also liaise with sites and NHS R&D prior to this.
This letter doesn’t mean that assessment is complete. The letter gives a list of documents received and may also include some questions which the assessor needs further clarification on.
The letter will also confirm:
Whether formal confirmation of capacity and capability will be required by each site
Whether you need to appoint a Principal investigator at each site
Whether GCP training will be required
Whether letters of access will be required
Whether the study will be applying to be included in the CRN portfolio.
You should read through the letter carefully, answer any questions and follow the instructions given in the letter. You should also check that the document list includes all documents.
REC valid application letter
This letter indicates that a study has been accepted for REC review and confirms details of the meeting where the study will be discussed. It will also confirm the REC reference number. It confirms the list of documents to be reviewed – again these should be checked to ensure all documents are included.
The letter discusses site arrangements, as RECs now assess non-NHS sites. You should read the detail to find out what you need to do, and what will be done, to assess sites.
REC approval letter
REC letters will all confirm that a study summary will be published on the HRA website. The letter will confirm the opinion given by the REC but should also indicate that you need to wait until final HRA approval is issued before you can proceed any further. The letter will describe the discussion around the study which took place at the meeting.
All REC letters will give a list of approved documents and the versions approved – these should be the documents you go on to use and if any changes are made to these then an amendment will be required.
When a study has REC approval, any amendments submitted also need to be submitted to the REC, and the REC will also issue an opinion to confirm or reject an amendment.
Sometimes the REC gives favourable opinion (which is approval), however sometimes the REC gives one the following opinions:
Unfavourable - The letter confirms that REC favourable opinion has not been given and you are not able to proceed with your study. The study requires some fundamental changes which mean that you will need to make a new application. The letter will explain the reasoning behind the decision and what the future options are.
Favourable with conditions - This indicates that the favourable opinion is subject to some conditions, which will be outlined in the letter. This opinion does not allow you to proceed until the conditions have been met and a further letter issued to confirm acceptance. You may need to go back to the REC to submit the conditions.
Provisional opinion - This indicates that the REC gives a favourable opinion on the condition that some minor changes are made. This would not normally require you to go back to the REC but could require changes to be submitted in correspondence. Again this opinion does not allow you to proceed until the changes are made and a further letter issued to confirm acceptance.
HRA approval letter
This letter confirms final HRA approval. You may have liaised with the HRA during the assessment process and detail of this should be included and confirmed in this letter. You should read the letter carefully as it will detail what you need to do next. There will be another document attached “After HRA approval – guidance for sponsors and investigators” which you should also read.
The lead R&D contact listed on your IRAS form should be sent a copy of this letter (details of who is sent copies is below the signature) – but all other R&D offices and sites will need to be informed of the HRA’s decision and sent this letter.
HRA assessment criteria - This describes how the different parts of the HRA assessment have been carried out and is worth reading through in case any further information is provided
Participating NHS organisations in England - This gives more detail about working with NHS sites in England and what you should do
Confirmation of capacity and capability - This details whether sites will be expected to give a formal confirmation of capacity and capability, how you will be expected to liaise with sites, and links to other documents which may be useful to advise you
Principal investigator suitability - This confirms whether you need to appoint a principal investigator at each site and whether you need to undertake GCP training
HR good practice resource pack expectations - This describes whether you need to obtain letters of access, research passports, or honorary research contracts to undertake your research. The HR good practice resource pack which tells you more about the requirements can be found here: https://www.nihr.ac.uk/about-us/CCF/policy-and-standards/research-passports.htm
Other information to aid study set-up - This describes anything else you may need to consider and also confirms whether you intend to apply for the study to be included in the CRN portfolio.
Final outcome letter
Where approval has been sought from CAG, a letter will be received to confirm whether this has been agreed, specifying any conditions which you must adhere to when processing data which falls under the CAG requirements.
For research studies,CAG approval is only a part of the approval process and you will also need to receive a letter of HRA approval.