Update to the Organisation Information Documents for NHS organisations participating in research

The two Organisation Information Document templates for non-commercial sponsors, NHS/HSC R&D offices, NHS/HSC contract managers, which relate to regulatory approval processes and study set up, have been updated:

The main template is for use with all non-commercial research in the NHS/HSC.
The similar Data Processing only Organisation Information Document for use between partner university sponsor and NHS/HSC organisations with a joint research office (JRO)

If you are a participating organisation, you might see the previous Organisation Information Documents for some time. We are not asking sponsors to transfer information already completed on an older Organisation Information Document onto the new template.

You should continue to use localised Organisation Information Documents that have been shared with you, which are based on the previous Organisation Information Document template.

What are the Organisation Information Documents used for?

The Organisation Information Documents have three functions:

The outline Organisation Information Documents authorised by the sponsor are part of the IRAS approvals submission for studies in the NHS/HSC. The outline Organisation Information Documents help the study-wide reviewers to understand the study better, including how it will be delivered, whether all participating organisations will do the same activities and what investigator oversight is needed.
To help the sponsor or applicant and the participating NHS/HSC organisation to discuss local set-up and delivery of the study. The localised Organisation Information Document(s) is shared by the applicant with participating NHS/HSC organisations as part of the local information pack. You should use the main body of the document to guide and record the outcome of discussions, whether or not it is also used as the contract for the study.
As the contract between the sponsor and the participating organisation for non-commercial, non-interventional studies. When also used in this way, you should agree any contract arrangements when discussing set-up and delivery in the main body of the document. This includes agreeing the financial arrangements. You should only complete the contractual appendices and participating organisation authorisation when the Organisation Information Document is being used as the contract for the study.

What is the update to the main Organisation Information Document?

This update focuses on the Organisation Information Document’s appendices. It aligns them with the equivalent clauses in model non-commercial agreement (mNCA) for interventional studies. Minor updates have also been made to the main body of the Organisation Information Documents. These are the main updates to the appendices:

appendix 1 – add in clauses for definitions, order of precedence and termination;
appendix 1 – minor modifications to cater for the Clinical Negligence Scheme for General Practices (CNSGP) in England (which is not a membership scheme);
appendices 1, 4 and 5 – clarify the status of personal data and the handling of confidential information;
appendix 2 – provide further detail to facilitate payments;
appendix 4 – account for the status of the UK outside of the European Economic Area;
appendices 1 and 5 – clarify when clauses are relevant to both actual and any potential participants.

What is the update to the Organisation Information Document for data processing only?

The data processing only Organisation Information Document is used when participating NHS/HSC organisations agree with their JRO university sponsor that they do not need to use the full Organisation Information Document, or a Local Information Pack. This Organisation Information Document provides a data processing agreement to comply with GDPR Article 28(3). It has been updated to:

add definitions;
account for the status of the UK outside of the European Economic Area.

When should I use the new Organisation Information Documents?

Applicants should start using the new Organisation Information Documents from now.

You don’t need to use a new version of the Organisation Information Documents if you have already done any of the following with a previous version:

submitted the outline Organisation Information Documents with your IRAS application
shared or received the localised Organisation Information Documents in the local information pack
sent or received the localised Organisation Information Documents to use as the contract

The previous Organisation Information Documents will continue to be accepted in IRAS submissions until the end of September 2024.

If you are a participating organisation, you might see the previous Organisation Information Documents for some time. The Health Research Authority (HRA) is not asking sponsors to transfer information already completed on an older Organisation Information Document onto the new template. You should continue to use any localised Organisation Information Documents shared with you which are based on the previous Organisation Information Document template.

Will other areas of the Organisation Information Documents be updated to help with study set-up?

Not yet. The HRA knows that this is an area where further improvements can be made. They are listening to the feedback you share already. They will be in touch with you in future about how you can continue to contribute your thoughts when they are ready to do further work in this area.

For more detailed information visit the IRAS Help website.