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Amendments for projects conducted in NHS/HSC



Amendments for projects conducted in the NHS/HSC



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 IRAS guidance on notification of amendments.

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


All amendments to projects with HRA Approval or NHS/HSC permissions should be submitted according to the process that is applicable for your project except where the activity should not be notified as an amendment.

Once you have submitted the amendment, it is categorised by the lead country to ensure that the amendment is handled in a manner that is appropriate to the scale of the amendment and the potential risks to, and the liability of, the NHS/HSC organisation(s) implementing the amendment - see table below. Please note that:
  1. This categorisation is completed once for each amendment submission; and
  2. When you receive the correspondence confirming the category it will contain instructions about how to proceed and so please ensure that you read this correspondence in full.


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 submitted 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
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.

Applicants may be familiar with amendments being classified as 'substantial' or 'non-substantial' (also known as 'minor'). These distinctions are used by both Research Ethics Committees (RECs) within the UK Health Departments' Research Ethics Service (for all research) and the Medicines and Healthcare products Regulatory Agency (MHRA) for Clinical Trials of Investigational Medicinal Products (CTIMPs). It is the Sponsors responsibility to decide whether an amendment is substantial and therefore whether it needs to be notified to REC and/or MHRA. While this system of classifying amendments is not used by NHS/HSC (see table above), if an amendment is substantial the the same form may be used to notify REC/MHRA and NHS/HSC. For more information see sections below on 'Amendment notification forms' and 'How to submit amendments'.

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Activities that should not be notified to NHS/HSC as amendments


There are some activities that are undertaken during a project, which should not be submitted as amendments for NHS/HSC review and categorisation. These include:
  1. Addition of translated versions of participant facing documentation.
  2. Where there has been a routine review or renewal process during the study with an outcome that does not change the research project. For example:
    • Where a Data Monitoring Committee meeting concludes a study should proceed without any changes.
    • Where insurance is renewed but there is no change to the level or breadth of cover.
    • Annual updates and reviews of study documentation that do not make any changes, such as an annually updated edition of the Investigator's Brochure where no changes are made except the last review date.
  3. Changes to the research team at participating NHS/HSC organisations, except where it is the appointment of a new Principal Investigator (PI). Appointment of a new PI at a participating NHS/HSC organisation is notifiable as an amendment.

Note: while the activities listed above should not be submitted as amendments for review and categorisation, they may need to be sent to participating sites (Principal Investigator (PI), site teams, local NHS/HSC R&D offices) so that the local site files can be updated. In these circumstances, the local NHS/HSC R&D office are not expected to review and categorise the amendment.

There may also be amendments of a confidential nature that the Sponsor is required to submit to the MHRA that have no implications for, or affect, the participating NHS/HSC organisations hosting the research project. In these circumstances the amendments should not be notified to NHS/HSC. This would also apply to updates to an Investigator's Brochure (IB) that do not have any impact on participating NHS/HSC organisations, the departments within participating NHS/HSC organisations supporting the research and/or the researchers at the site(s).

If, after reading the guidance above, you are not sure whether the change to your project should be submitted for NHS/HSC review and categorisation, please send an email to IRAS.queries@nhs.net providing information about your proposed amendment and your IRAS ID. Advice will be sought from a group that has been established for reaching UK-wide consensus on amendments that do not need NHS/HSC review and categorisation. We aim to provide this advice within 5 working days of your request.

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Grouping of amendments


If you have several amendments to make to your project in a short space of time, you should consider submitting them all in one 'group'. In many instances this will facilitate review of your amendments and facilitate implementation of changes to your project. However, if your amendment is time critical you should submit this amendment as soon as you are able.

Some examples of when grouping may be appropriate are:
  • When you need to make a series of amendments all relating to a specific change.
    For example, an amendment to update the protocol, which will lead to revision of the participant information sheet (PIS) and consent form. These changed documents should be submitted as one package of related amendments.
  • A series of sequential amendments with unrelated changes all within a short space of time of each other (often at the start of a study). In this situation you are encouraged to consider submitting all amendments together.
  • Where you expect the likely categorisation of several amendments that you wish to submit within a short timeframe to be the same, then you should consider whether them to submit them as a single package. Note that where a package of amendments is submitted the whole package is given the highest category of any of the component amendments (e.g. if your package includes amendments that are individually category A and C, the whole group would be categorised as A).
  • Where you wish to correct simple typographical errors, which do not change the meaning of the protocol, or which alter the format, but not the wording, of the project documentation. These changes may be included when you submit a future amendment.

The following amendments should not be grouped with other amendments:
  • Addition of new NHS/HSC participating organisations; and/or
  • Change of local Principal Investigator (PI).

The addition of new NHS/HSC participating organisations and/or changes to PIs should be submitted separately to other amendments to expedite the review process. While it is best practice to have had an initial discussion with a site, it is not necessary to have agreed with the hosting organisation that they will be a site before submitting the amendment to add the new NHS/HSC site. Note that if you are adding multiple new NHS/HSC sites then these may be grouped into a single amendment submission.

IMPORTANT NOTE: If you are intending to group your amendments and the package includes both substantial and non-substantial then you should use a substantial amendment form to describe the substantial amendment(s) and a non-substantial amendment form to describe the non-substantial amendment(s). You should submit the forms and supporting documentation according to the process that is relevant for your project; in some instances this may mean you should not group the substantial and non-substantial amendments.

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Amendment notification forms


Substantial amendments

Should be notified using a Notice of Substantial Amendment Form. These forms are generated in IRAS by navigating to the Amendments tab of your project form, and clicking 'Create Notice of Substantial Amendment' button. The response you have given to IRAS Filter Question 2 will ensure that IRAS generates the appropriate type of substantial amendment form for your study. The same Notice of Substantial Amendment form should be used to notify the amendment to all the appropriate bodies i.e. REC, MHRA (CTIMPs) and NHS/HSC. The form should be appropriately authorised prior to submission and any supporting documentation supplied as part of your notification package. Note: if the project is a CTIMP then you may use the 'Annex 2 Form' available from EudraCT as an alternative to using the form generated in IRAS although the forms are identical.

Non-substantial amendments and projects that do not have NHS/HSC REC review

Amendments should be notified using the template form for notifying non-substantial amendments.

The Non-Substantial Amendment Form should be authorised prior to submission.

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Numbering your amendments


To keep track of your amendments, you should allocate each amendment a reference number. We recommend that the amendments are numbered sequentially. You should also maintain a clear record of the amendments in the form of an amendment log. An example of an amendment log is provided here. If you are notifying several review bodies of an amendment, consistency of approach in the numbering system is recommended to avoid confusion.

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Submitting your amendment for NHS/HSC review and categorisation


It is not currently possible to submit amendments electronically in IRAS. You should therefore email your amendment (form(s) and any supporting documentation). The route for submission of your amendment to NHS/HSC will depend on a number of factors. Please refer to the table below:

Lead country: Location of REC: Is the amendment a Notification of Substantial Amendment that is submitted to REC? Submit your amendment as follows:
England England Yes Email to the REC only (they will share with the HRA Amendments team)
Scotland, Wales or Northern Ireland Yes Email to: hra.amendments@nhs.net by copying in on email submission to the REC
Anywhere in the UK No Email to: hra.amendments@nhs.net

Northern Ireland except single centre studies Anywhere in the UK Yes or No Email to: research.amendments@hscni.net
Northern Ireland - single centre studies Yes or No Submit directly to HSC Trust / research site

Scotland except single centre studies Anywhere in the UK Yes or No Email to: nhsg.NRSPCC@nhs.net
Scotland -single centre studies Yes or No Email directly to the NHS site

Wales Anywhere in the UK Yes or No Email to: Research-permissions@wales.nhs.uk

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What happens after you have submitted your amendment?


After you have submitted your amendment you should wait to receive communication, which will usually be in the form of an email or letter. IMPORTANT: You should read all correspondence very carefully as it may require further action from you before the amendment can be implemented.

The communication will confirm:
  • Whether the submission is complete.
  • The amendment category A, B or C or new NHS/HSC site
  • The implementation date (if applicable).
  • Any actions you are expected to undertake (e.g. providing information to sites; planning implementation of amendment with sites).

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Guidance version 1.1; published 20 September 2017



 
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