The following guidance applies to clinical research that has Health Research Authority (HRA) and/or NHS Research Ethics Committee (UEC) approval. It is important to note that this is not an exhaustive list of guidance and if researchers have additional queries they should raise this with their Head of Department, Associate Dean Research & Innovation or RIGO.
Please be aware that as a Sponsor we are following national and local site guidance and will need to establish where your study falls within prioritisation efforts. Therefore, we cannot guarantee that we will be able to provide Sponsor green light to re-start all studies, and each request will be considered on a case-by-case basis.
The local site (i.e. hospital, GP surgeries, prisons) will first have to allow researcher access to the site before any re-opening of a project can be considered by the University. Once you have confirmation from the site that they are re-opening for research and access, you must complete any external site approval required for restarting and you must contact RIGO for advice.
The Local site must first have notified the researcher that they are re-starting research before the re-opening of a project can be considered by the University. Once you have confirmation from the site that they are re-opening for research, you must complete any site approval required for restarting along and confirmation that the conducting the research incurs no additional risk over that of your professional role. In all instances you must contact RIGO for advice.
The local site, whether they are identifying participants, collecting samples on a researcher’s behalf or the researcher requires access and is collecting samples directly, must first have notified the researcher that they are re-starting research, before any re-opening of a project can be considered by the University. You must contact health and safety for advice on the measures that need to be in place for bringing samples on site.
(See the recommendations of the ‘restart framework’ from the NIHR for additional guidance.)
Please check with the Sponsor for specific advice.
Updated 16 April 2021
The HRA have decided to stop reviewing applications for individual undergraduate and master’s student projects until at least 1 September 2021.
Please see this new guidance which relates to health and social care research projects conducted by undergraduate and master’s students.
Principal investigators (PIs) for NHS studies, whether sponsored by the University or otherwise, should keep abreast of the advice from the HRA which is being updated regularly.
PIs should check this on a daily basis.
PIs should consider whether any site changes are required to reduce the clinical or administrative burden on NHS sites and staff. These changes will be regarded as a non-substantial amendment. The Sponsor must be notified of site changes. Where the University of Surrey is Sponsor, this would be via email@example.com. These changes should be implemented at the sites on the date specified by the Sponsor. It is important that the Sponsor and the PI have agreed who will communicate these changes to the sites.
Any changes to the monitoring arrangements must not result in breaches of patient confidentiality.
Some studies may require halting temporarily in order to reduce burden on NHS sites and staff or to reduce exposure to participants. Some studies may also require extending the duration of the project. Most funders are in the process of providing guidance should this be the case. View the NIHR guidance.
The most important action for researchers is to ensure participants and researchers are safe and whatever measures are necessary to ensure safety should be taken.
PIs should consider how risk of exposure to Covid-19 can be reduced for participants.
PIs should also consider whether any changes need to be made with regards to participant visits, in order to reduce the clinical and administrative burden on NHS sites including hospitals and GP surgeries.
For example, this could mean changing site visits to phone or postal questionnaires or considering whether vulnerable participants should be discontinued or no longer recruited if they are placed at risk, this may include those over the age of 70, those with underlying health risks or pregnant women.
Most of these changes would be regarded as a non-substantial amendment. The Sponsor must be notified. Where the University of Surrey is Sponsor, this would be via firstname.lastname@example.org. These changes should be implemented at the sites on the date specified by the Sponsor. It is important that the Sponsor and the PI have agreed who will communicate these changes to the sites.
If a change is deemed to increase the risk to participants, for example due to fewer participant checks, the Sponsor may consider the change as a substantial amendment requiring submission to the HRA and NHS REC.
Where necessary the normal process of taking urgent safety measures would apply with HRA/NHS REC being notified afterwards. RIGO should be notified as soon as possible if an urgent safety measure is taken email@example.com.
The HRA guidance (link above) explains what may be considered a non-substantial and substantial amendment. Non-substantial amendments do not require the PI to inform the HRA/NHS REC but the Sponsor must still be informed.
Further advice can be sought from firstname.lastname@example.org.
Yes, all changes whether non-substantial, substantial or an urgent safety measure must be informed to the Sponsor. In the case of University of Surrey sponsored studies this would be via RIGO email@example.com.
All new research projects linked to COVID-19 must be coordinated through the NIHR, researchers are being asked to not contact local clinical research networks, trust R&D officers or healthcare departments. This is to enable NIHR to coordinate the national effort.
COVID-19 Urgent Public Health Research is being prioritised to gather the necessary clinical and epidemiological evidence that will inform national policy and enable new diagnostic tests, treatments and vaccines to be developed and tested for COVID-19.
The NIHR can give you access to government support to coordinate and deliver these studies, this support includes the expedition of site identification and the appropriate distribution of public health research to maximise distribution and minimise over commitment of resources.