Modifications for projects conducted in the NHS/HSC
IMPORTANT: The guidance on this page details the process you need to follow when sharing modifications with, and implementing modifications at, participating NHS/HSC organisations. It is therefore only applicable if you are an applicant, researcher or sponsor making modifications to a project involving the NHS/HSC. You can find general guidance on preparing and submitting modifications for all study types in the IRAS Help section here.
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Introduction
A modification is a change to a research project after you have received the initial approvals.
If you plan to make a modification to your research project, check whether you need to notify any review bodies. There is more information in the IRAS guidance on notification of modifications , including the Modification Tool. When you complete the Modification Tool it tells you which review bodies you need to notify.
After you have submitted your modification to the review bodies, you need to tell your participating NHS/HSC organisations about it. The guidance on this page will help you to do this. There is also a high-level flowchart to show how modifications are implemented in different nations.
The UK Policy Framework for Health and Social Care says you should implement modifications uniformly across all relevant research sites, as well as any Participant Identification Centres (PICs). However, the modification might not affect participating organisations in the same way. Participating organisations do not need to implement the modification at the same time unless you want them to.
In this guidance the term:
- ‘participating organisation’ means any NHS/HSC organisation involved in the research as a research site or PIC
- ‘research site ’ or ‘PIC’ only means NHS/HSC research site or NHS/HSC PICs
All three terms include the R&D office, local research team and anyone else at the organisation who is involved in the research, unless we mention them on their own.
The guidance on this page does not apply to:
The guidance on this page covers the following:
- Understanding modification categories
- Modifications to add new NHS/HSC sites or PICs
- Sharing modifications with participating NHS/HSC organisations
- Working with participating NHS/HSC organisations to implement modifications
- Feedback
1. Understanding modification categories
When preparing a modification for submission to review bodies, complete the Modification Tool. The Modification Tool will tell you the modification's category based on how you complete it. A modification category is separate from whether it is substantial, a modification of an important detail or minor modification. The category confirms whether the modification has delivery implications for all, some, or none of the participating organisations. It tells participating organisations to check whether they need to do anything to implement the modification.
You are responsible for completing the Modification Tool correctly. The Modification Tool has a ‘glossary of options’ tab which will help you to do this. The declaration section should be completed by the sponsor or another person with explicit delegated authority from the sponsor (authorised delegate). Modifications must not be submitted without prior authorisation from or on behalf of the sponsor. Check with the sponsor and refer to local SOPs for the processes within your organisation.
There are 3 categories: A, B, and C. The table below describes each category in more detail. Adding new participating organisations on their own is different to the categorisation. Section 2 provides more information about adding new NHS/HSC organisations.
| Category: | This category includes any modification to a research project that has: |
| A | Implications for, or affects, all participating organisations. This may involve changes to activity or cost implications. |
| B | Implications for, or affects, specific participating organisations. This may involve changes to activity or cost implications for these organisations. |
| C | No implications that require management or oversight by the participating organisations. The modification is still provided for information. There are no changes to site activity or cost implications. Participating organisations might need to take some action, such as updating contact details. |
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2. Modifications to add new NHS/HSC sites or PICs
The change of investigator at a site, in a multi-centre CTIMP or device trial, or the addition of a new site which requires investigator oversight will be a modification of an important detail under the 2025 regulations. The expectation is that sponsors will have arrangements in place to ensure selection of suitable site and selection and training of investigators. These arrangements will need to be submitted to the REC for review with the initial application. Significant changes to these arrangements will be treated as a substantial modification. There will no longer be different expectations depending on whether the trial is taking place in the NHS or at a non-NHS site.
A change of sponsor is a modification of an important detail under the 2025 regulations. This is because it is no longer a legal requirement for the REC to consider the suitability of the sponsor. If the change in sponsor would require changes to insurance arrangements and/or study documents (beyond only changing the name of the sponsor within study documents) then this would be a substantial modification.
We recommend that you add new NHS/HSC research sites or PICs as a separate modification to any other changes you’re making to the study. This lets the set-up of those sites/PICs happen while other modifications are being reviewed separately. These new participating organisations can then be set up sooner.
When adding a new participating organisation, list details of the new organisations in the Modification Tool. Select the appropriate option from the “Participating Organisation” Area of Change in the Modification Tool when making this type of modification.
When setting up new NHS/HSC sites, follow the guidance about the local study set-up process for the nation the site is in. This guidance includes information about using the UK Local Information Pack and adding new NHS/HSC sites to ongoing studies. If you’re adding new PICs, follow the guidance on how to set up new PICs.
The study cannot start in the new organisation until:
- the required reviews and approvals listed in the Modification Tool are in place
- the participating organisation has formally confirmed it is ready to start the study
The rest of the guidance on this page does not apply to new NHS/HSC sites or PICs. See the relevant pages for further guidance in the links above.
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3. Sharing modifications with participating NHS/HSC organisations
How you share the modification depends on where the participating organisations are in the UK.
The guidance below is in three sections:
a) informing participating organisations in England, Wales or Northern Ireland
b) informing participating organisations in Scotland
c) category A and B amendments: 35 day implementation date
Participating organisations need full, clear, quantified details of all changes in local activity which are needed to implement the modification. This includes any new or modified agreements and/or budgets. Providing this information early helps to fix issues sooner so you can implement the modification without delay.
a) Informing participating organisations in England, Wales and/or Northern Ireland
After you submit your modification, share it with relevant participating organisations in England, Wales and/or Northern Ireland. Use the relevant email template below. The template email helps you to clearly tell participating NHS/HSC organisations about the impact of the modification on them, supporting their review and local processes.
Make sure you send this email to the R&D Office and local research team, and where applicable the Regional Research Delivery Network (RRDN). Attach the completed and locked Modification Tool and any amended documents. There are template emails for sharing:
b) Informing participating organisations in Scotland
Email modifications for single centre studies directly to the R&D office and local research team. You can use the relevant email template as per 3a above. If you don’t use the template, ensure that you provide the same information in your email.
For multicentre studies, email the modifications to the local research teams at relevant participating organisations. You can use the relevant email template as per 3a above. If you don’t use the template, ensure that you provide the same information in your email. You do not need to send the modification to R&D offices of participating organisations. The national coordinating function (NHS Research Scotland Permissions Coordinating Centre in Scotland) will confirm the 35-day implementation date to R&D offices. They will also share the amendment and documents with the R&D offices of the participating organisations on your behalf.
c) Category A and B amendments: 35-day implementation date
After you have submitted a category A or B amendment, participating organisations have up to 35 days to decide whether they can implement it. The 35-day implementation period starts at different times depending on the nation your participating organisation is in. There is a diagram of 35-day implementation dates in different nations to help you understand when this timeline starts for your participating organisations. The 35-day implementation period does not apply to category C modifications.
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4. Working with participating NHS/HSC organisations to implement modifications
Check the flowchart of decisions and actions that can be taken after participating organisations have received the modification but before it is implemented. This is described in full in this section.
Category A modifications (all participating organisations) and Category B modifications (affected participating organisations only)
Category A modifications have an impact on all participating organisations. Category B modifications have an impact on some but not all participating organisations.
Relevant participating organisations should assess category A and B modifications by the 35-day implementation date. They use this time to check:
- whether they can support the modification
- whether they need to arrange anything to implement the modification
- if they need to discuss any arrangements with you, including if they cannot implement the modification within the 35 days.
They are strongly encouraged to tell you about problems or confirm they have no objection to the modification as soon as possible within the 35 days. They should do this even if you do not have the relevant approvals in place.
You should:
- discuss changes to participating organisations’ activity or costs with them as early as possible if you know they are affected
- discuss arrangements to implement the modification with the participating organisation
- share any relevant approvals with participating organisations as soon as you receive them
- agree the date on which you want to implement the modification with organisations
- for multi-centre studies taking place in Scotland, share any relevant approvals with the national coordinating function as soon as you receive them
Prompt, clear communication between you both helps participating organisations to find and, where possible, resolve any problems. It also helps them to implement the modification quickly.
Although it is unlikely, a participating organisation could find it is unable to take on some or all the modified activity. If this happens, discuss with the participating organisation how you could deal with this. You can then agree on the most appropriate option to adopt together. Options include:
- not taking part in sub-studies
- changing the site type, for example from a site to a PIC
- closing the site or PIC altogether.
This list is not exhaustive.
An organisation should work to the most recent approved documents as appropriate to their type of participation. If you need to change the study so the organisation can continue to take part, they may need to reject the current modification. You should then submit a new modification.
Category B modifications (unaffected organisations)
You do not need to share Category B modifications with organisations that are not affected by it.
Category C modifications
Share category C modifications with participating organisations so they can take appropriate action. Appropriate action might include:
- archiving old versions of documents and replacing them with updated versions for use
- updating their local database with changes to contact details
Category C modifications do not need a capacity or capability review by participating organisations.
Implementing modifications
You can only implement Category A and B modifications before the 35-day timeline when both of the following conditions are met:
- the necessary approvals and reviews are complete
- the participating organisation has confirmed you can implement the modifications before this date
You can implement category A and B modifications at relevant participating organisations at the end of the 35-day period so long as:
- they never objected to the modification
- you are both happy that any objections the participating organisation did raise have been fixed
- required approvals listed in the Modification Tool are in place
Participating organisations are strongly encouraged to confirm they can accept the modification before the 35-day deadline when they have no objection to raise about it. We also encourage them to do the following as soon as possible:
- identify any issues that affect the implementation of the modifications and discuss how to fix them with you
- confirm they can accept the modifications once the issues have been fixed
When changes to contracts and payments are not finalised, the participating organisation can still implement the modifications. This includes new contracts and payments. You should agree to implement the modifications with the participating organisation and continue to discuss contracts and payments in good faith. You should also implement the modification if you are waiting to execute the contract.
You can implement category C modifications as soon as the necessary approvals as listed in the Modifications tool are in place and reviews are complete.
Confirming implementation of all modifications - for participating organisations in England, Wales and/or Northern Ireland only:
Use the template email to notify participating organisations that a modification can be implemented . The template email helps you to be clear and consistent when you tell participating organisations about this. Send the email to the R&D office, local research team, and (for participating organisations in England) the RRDN for studies included on the NIHR RDN Portfolio.
Confirming implementation of all modifications - for participating organisations in Scotland only:
Tell the local research team when you want to implement the modification at their organisation. You can use the email template for England, Wales and Northern Ireland to help you do this.
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5. Feedback
If you have any feedback or questions about the content on this page, please email iras.queries@hra.nhs.uk
Page last updated:28 April 2026