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Amendments for projects conducted in NHS/HSC



Amendments for projects conducted in the NHS/HSC



Coronavirus / COVID-19 - key guidance




IMPORTANT:

On 2 June 2020 changes were introduced to the way amendments are notified to Research Ethics Committees and NHS/HSC



IMPORTANT NOTE: If you are considering an amendment to comply with the General Data Protection Regulations (GDPR) then before you go any further please refer to the information provided on behalf of the UK which can be found on the Health Research Authority (HRA) website. In the majority of cases it will not be necessary to submit an amendment.

Introduction


An amendment is a change to a research project after an applicant has received the initial approvals. If you plan to make an amendment to your research project, you will need to determine whether you need to notify the review body(ies) from whom you have received approvals. Different review bodies have different requirements. These are set out in the IRAS guidance on notification of amendments.

IMPORTANT: The guidance provided on this page applies only to research projects with NHS/HSC R&D Permission or HRA and HCRW Approval. If your study does not yet have these, please refer to IRAS Help pages for seeking NHS/HSC R&D Permission or HRA and HCRW Approval.

The guidance on this page does not apply to:
  • Research Tissue Banks (RTB) and Research Databases (RDB) as these do not need NHS/HSC R&D Permission or HRA and HCRW Approval;
  • Urgent Safety Measures. These should be sent to all participating organisations on receipt to ensure the participants' safety. Subsequent notifications, including resulting amendments should be submitted, as appropriate and according to relevant guidance; or
  • Notifications of the end of a study. These are not amendments and should be notified using the appropriate Notice of End of Study form.


The guidance is divided into the following sections:

Amendment categorisation


The completed Amendment Tool will output the recommended amendment category automatically based on your responses to the questions.
The sponsor or authorised delegate is responsible for ensuring that the amendment tool is completed correctly, and for comparing the outcomes against their own expectations of how the amendment should be processed.

Category: This category includes any amendment to a research project that has:

A
Implications for, or affects, all participating NHS/HSC organisations hosting the research project.

B
Implications for, or affects, specific participating NHS/HSC organisations hosting the research project.

C
No implications that require management or oversight by the participating NHS/HSC organisations hosting the research project. However the amendment should still be provided for information.

Note - Updated Investigator Brochure (IB; Clinical Trials of Investigational Medicinal Products (CTIMPs) only):
Where the IB update, annual or otherwise, constitutes a non-substantial amendment for REC and MHRA and this is the only amendment (e.g. the update to IB does not give rise to updated pharmacy manual or protocol) the updated IB should not be submitted for categorisation. These amendments will always be category C and they will not be assessed by NHS/HSC if submitted. The IB should be provided to each participating NHS/HSC organisation.

New NHS/HSC site
Guidance on adding additional NHS/HSC sites is provided in the section below.
Where the amendment is to add a new NHS/HSC site to the project, the set-up of this new site should proceed according to the process for local study set-up for the nation where the new site is located.




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Amendments to add additional NHS/HSC sites


If you are adding a site that is in a nation not previously involved in the project, you should indicate this at the relevant question of the Amendment Tool and make this clear in the covering letter when submitting your amendment to the lead nation. This will help to ensure that the relevant information is passed on as efficiently as possible.

You do not need to provide an updated IRAS Form Part C alongside an amendment to add a new NHS/HSC site. You should list the names of the new sites in the description of amendment box in the Amendment Tool.

Please note that on 5 June 2019, the UK Local Information Pack brought in some key changes to the process and documentation for setting up NHS/HSC participating organisations. For further information refer to the UK Local Information Pack guidance and in particular the section related to adding new NHS/HSC sites to ongoing studies.



 

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What happens after you have submitted your amendment?



If you have not yet submitted your amendment, instructions on how to do so can be found here.


The following points apply to NHS/HSC organisations in all nations:

  • Sponsors should not expect to receive a letter or email of confirmation from NHS/HSC organisations before implementing the amendment. If all relevant regulatory approvals are in place and there has been no objection from site, the amendment can be implemented after 35 days.
  • Sponsors should not expect to receive a letter or email of confirmation from NHS/HSC organisations before implementing the amendment.
  • Category A and B amendments may be implemented sooner than 35 days in cases where all regulatory approvals have been issued and where the NHS/HSC organisation has confirmed that the amendment may be implemented prior to this date.
  • Upon receipt of the amendment, the coordinating function of the lead nation will share the amendment with the coordinating function of any other participating nation(s). There is no need to separately submit to each nation.



Implementing category A and B amendments in participating NHS/HSC organisations


Participating NHS organisations in England and/or Wales:

After you have submitted your amendment, you should share your completed Amendment Tool with confirmation of amendment category and, if applicable, amended documents together with relevant participating NHS organisations in England and/or Wales.

In doing so, you should include the NHS R&D Office, LCRN (where applicable) as well as the local research team.

A template email to notify participating NHS organisations in England and/or Wales is provided on the HRA website.

Once you have notified participating NHS organisations in England and/or Wales of the amendment, they should prepare to implement the amendment. You may then implement your amendment at all participating NHS organisations in England and/or Wales 35 calendar days from the day on which you provide the organisation(s) with the amendment and any amended documents; so long as:

    a. HRA and HCRW Approval has been issued for the amendment where this is required.
    • Where approval is pending, you should not implement the amendment until you receive an email from the HRA or HCRW confirming HRA and HCRW Approval
    • Where it is approved, you may implement the amendment after 35 days, providing points (b) and (c) are satisfied.
    • If HRA and HCRW Approval is issued after the 35 day deadline, you may implement the amendment upon receipt of HRA and HCRW Approval, providing points (b) and (c) are satisfied.
    b. A participating NHS organisation does not request additional time to assess.
    • If you are notified that a participating organisation needs more time to assess the amendment you should not implement until they are ready to do so. You should work with the organisation to resolve any outstanding issues.
    c. A participating NHS organisation does not decline to implement the amendment
    • If a participating NHS organisation declines the amendment, you should discuss with that organisation and take appropriate actions in agreement with the NHS organisation.



In Northern Ireland and/or Scotland

For multicentre studies there is no need for you to send the amendment to R&D offices of participating organisations in these nations as the National Coordinating Function will pass this on to them along with any amended documents on your behalf.

However, you should share these documents with the research teams at relevant participating NHS/HSC organisations in Northern Ireland and/or Scotland who should prepare to implement the amendment. When approval is received you may implement your amendment at all participating NHS/HSC organisations in Northern Ireland and/or Scotland 35 days after organisations have received the amendment and all supporting documentation as long as:

    a. You have received all relevant regulatory approvals necessary for the amendment
    • If the last regulatory approval is received after the 35 day deadline, you may implement the amendment upon receipt of this approval, providing points (b) and (c) are satisfied.
    b. A participating NHS/HSC organisation does not request additional time to assess.
    • If you are notified that a participating organisation needs more time to assess the amendment you should not implement until they are ready to do so. You should work with the organisation to resolve any outstanding issues.
    c. A participating NHS/HSC organisation does not decline to implement the amendment
    • If a participating NHS/HSC organisation declines the amendment, you should discuss with that organisation and take appropriate actions in agreement with the NHS/HSC organisation.

 

Single centre study amendments should be sent directly to the R&D office and research team at the participating organisation.



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Page last updated: 25 June 2020



 
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