News and updates from HRA

Date: 26 March 2021

New eligibility criteria for student research from 1 September 2021

The HRA and the devolved administrations, supported by the Wessex Institute at the University of Southampton, have reviewed their approach to study approval for student research.

The review aimed to ensure students have the best learning experience of health and social care research, and to reduce the time that the HRA, DAs and NHS Research Ethics Committees (RECs) spend advising on and reviewing student applications.

The HRA and the devolved administrations, supported by the Wessex Institute at the University of Southampton, have reviewed their approach to study approval for student research.

The review aimed to ensure students have the best learning experience of health and social care research, and to reduce the time that the HRA, DAs and NHS Research Ethics Committees (RECs) spend advising on and reviewing student applications.

In March 2020 the HRA paused student research approvals to create capacity for urgent COVID-19 research. Now, from 1 September 2021, they are introducing new eligibility criteria for standalone student research.

The new criteria mean that some Master’s level students will be able to apply for ethics review and HRA/HCRW Approval or devolved administration equivalent. Standalone research at undergraduate level that requires ethics review and/or HRA/HCRW Approval (or devolved administration equivalent) cannot take place. Arrangements for doctoral research remain unchanged. Full details are in table one – permitted student research table. They’ve also made it clear when students are able to take the role of Chief Investigator, see table two – which type of students may act as Chief Investigator.

It is possible for students to learn about health and social care research without completing standalone projects. Looking at other ways to build skills and experience better reflects modern research and emphasises team science. View the video of an event ‘Exploring good practice in Student Research’ to hear from course leaders about how successful these alternative approaches have been (registration is required to view) or read our website for further information and ideas https://www.hra.nhs.uk/student-research/.

Read more at the HRA website here

Key changes to UK amendment process 

The devolved administrations, the HRA and the MHRA have agreed to make two key changes to the UK amendment process with effect from 25 March 2021.

Firstly, the addition of a new NHS/HSC site or a change of PI at an NHS/HSC site for a CTIMP study will now be classified as a Non-Substantial Amendment*. This was previously considered a Substantial Amendment. The change is designed to speed up new site set up. This is possible because new sites were categorised as substantial due to EU guidance and therefore, from January 2021, we can take a different interpretation for NHS/HSC sites due to the UK system in place.

The devolved administrations, the HRA and the MHRA have agreed to make two key changes to the UK amendment process with effect from 25 March 2021.

Firstly, the addition of a new NHS/HSC site or a change of PI at an NHS/HSC site for a CTIMP study will now be classified as a Non-Substantial Amendment*. This was previously considered a Substantial Amendment. The change is designed to speed up new site set up. This is possible because new sites were categorised as substantial due to EU guidance and therefore, from January 2021, we can take a different interpretation for NHS/HSC sites due to the UK system in place.The amendment tool will provide the appropriate categorisation and guidance on the next steps to take. The Standard Operating Procedures for Research Ethics Committees have also been updated to reflect this change (read more on this below). There is no change to the classification of amendments relating to new sites/change of PI at non-NHS sites in CTIMP studies.

Secondly, the amendment tool can now be used to notify MHRA of substantial amendments in place of the Annex 2. This should save applicant’s time by reducing the number of forms to be completed. The Annex 2 may still be used to notify the MHRA of ‘bulk’ amendments (identical changes to multiple studies at one time) and will be available on the MHRA website.

The amendment tool is being updated and the new version (V1.5) will be available from tomorrow. We’ve produced a short video on how to complete the tool. (You will need to first register on the HRA’s Learning Management System and then follow the link to the video). If you have any further questions, contact amendments@hra.nhs.uk for support.

It is important to use the latest version of the tool otherwise your amendment may be incorrectly categorised. Please check for the latest version before submitting each amendment.

All four UK nations are working together to improve the amendments process. The introduction of the excel-based amendment tool provides the opportunity to test an approach that tailors guidance to the individual amendment. In the longer term, this will be incorporated into new functionality in IRAS – making submission and approval of amendments quicker and easier for everyone involved.  You can provide feedback on the amendment tool using our online survey.

*Submitting Non-Substantial Amendments

Upon submission of either a Non-Substantial or Non-Substantial, No Study-wide Review amendment, you will receive a system generated confirmation email. You should then follow the guidance in the amendment tool on how to communicate the amendment to the participating site(s) as this will vary depending on where the sites are located and the categorisation of the amendment (A, B or C).

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