Amendments for projects conducted in the NHS/HSC
IMPORTANT: The guidance on this page details the process you need to follow when sharing amendments with, and implementing amendments at, participating NHS/HSC organisations. It is therefore only applicable if you are an applicant, researcher or sponsor making amendments to a project involving the NHS/HSC. You can find general guidance on preparing and submitting amendments for all study types in the IRAS Help section here. |
An amendment is a change to a research project after you have received the initial approvals.
If you plan to make an amendment to your research project, check whether you need to notify any review bodies.
There is more information in the IRAS guidance on notification of amendments, including the Amendment Tool. When you complete the Amendment Tool it tells you which review bodies you need to notify.
After you have submitted your amendment 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 amendments are implemented in different nations.
The UK Policy Framework for Health and Social Care says you should implement amendments uniformly across all relevant research sites, as well as any Participant Identification Centres (PICs).
However, the amendment might not affect participating organisations in the same way. Participating organisations do not need to implement the amendment 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 site or PIC
- ‘site’ or ‘PIC’ only means NHS/HSC sites 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:
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Understanding amendment categories
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Amendments to add new NHS/HSC sites or PICs
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Sharing amendments with participating NHS/HSC organisations
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Working with participating NHS/HSC organisations to implement amendments
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Feedback
When preparing an amendment for submission to review bodies, complete the Amendment Tool. The Amendment Tool will tell you the amendment category based on how you complete it. An amendment’s category is separate from whether it is substantial or non-substantial. The category confirms whether the amendment 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 amendment.
You are responsible for completing the Amendment Tool correctly. The Amendment Tool has a ‘glossary of amendment 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). Amendments 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 amendment to a research project that has:
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| A |
Implications for, or affects, all participating organisations. This may involve changes to activity or cost implications.
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| B |
Implications for, or affects, specific participating organisations. This may involve changes to activity or cost implications for these organisations.
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| C |
No implications that require management or oversight by the participating organisations. The amendment 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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We recommend that you add new NHS/HSC research sites or PICs as a separate amendment to any other changes you’re making to the study. This lets the set-up of those sites/PICs happen while other amendments 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 Amendment Tool. Select the appropriate option from the “Participating Organisation” Area of Change in the amendment tool when making this type of amendment.
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 amendment 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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How you share the amendment depends on where the participating organisations are in the UK.
The guidance below is in three sections:
a) informing participating organisations in England and/or Wales
b) informing participating organisations in Scotland and/or Northern Ireland
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 amendment. This includes any new or amended agreements and/or budgets. Providing this information early helps to fix issues sooner so you can implement the amendment without delay.
a) Informing participating organisations in England and/or Wales
After you submit your amendment, share it with relevant participating organisations in England and Wales. Use the relevant email template below. The template email helps you to clearly tell participating NHS organisations about the impact of the amendment on them, supporting their review and local processes.
Make sure you send this email to the NHS R&D Office and local research team, and where applicable the LCRN. Attach the completed and locked Amendment Tool and any amended documents.
There are template emails for sharing:
b) Informing participating organisations in Scotland and/or Northern Ireland
Email amendments 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 amendment 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 amendment to R&D offices of participating organisations. The national coordinating function (NHS Research Scotland Permissions Coordinating Centre in Scotland and the Research Gateway in Northern Ireland) 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 amendments.
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Check the flowchart of decisions and actions that can be taken after participating organisations have received the amendment but before it is implemented. This is described in full in this section.
Category A amendments (all participating organisations) and Category B amendments (affected participating organisations only)
Category A amendments have an impact on all participating organisations. Category B amendments have an impact on some but not all participating organisations.
Relevant participating organisations should assess category A and B amendments by the 35-day implementation date. They use this time to check:
- whether they can support the amendment
- whether they need to arrange anything to implement the amendment
- if they need to discuss any arrangements with you, including if they cannot implement the amendment within the 35 days.
They are strongly encouraged to tell you about problems or confirm they have no objection to the amendment 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 amendment 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 amendment with organisations
- for multi-centre studies taking place in Northern Ireland and/or 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 amendment quickly.
Although it is unlikely, a participating organisation could find it is unable to take on some or all the amended 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 amendment. You should then submit a new amendment.
Category B amendments (unaffected organisations)
You do not need to share Category B amendments with organisations that are not affected by it.
Category C amendments
Share category C amendments 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 amendments do not need a capacity or capability review by participating organisations.
Implementing amendments
You can only implement Category A and B amendments 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 amendment before this date
You can implement category A and B amendments at relevant participating organisations at the end of the 35-day period so long as:
- they never objected to the amendment
- you are both happy that any objections the participating organisation did raise have been fixed
- required approvals listed in the amendment tool are in place
Participating organisations are strongly encouraged to confirm they can accept the amendment 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 amendment and discuss how to fix them with you
- confirm they can accept the amendment once the issues have been fixed
When changes to contracts and payments are not finalised, the participating organisation can still implement the amendment. This includes new contracts and payments. You should agree to implement the amendment with the participating organisation and continue to discuss contracts and payments in good faith. You should also implement the amendment if you are waiting to execute the contract.
You can implement category C amendments as soon as the necessary approvals as listed in the amendment tool are in place and reviews are complete.
Confirming implementation of all amendments - for participating organisations in England and/or Wales only:
Use the template email to notify participating organisations in England and Wales that an amendment 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 LCRN for studies included on the NIHR CRN portfolio.
Confirming implementation of all amendments - for participating organisations in Scotland and/or Northern Ireland only: Tell the local research team when you want to implement the amendment at their organisation. You can use the email template for England and Wales to help you do this.
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If you have any feedback or questions about the content on this page, please email iras.queries@hra.nhs.uk
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Page last updated: 18 January 2023