Research involving the NHS
Research involving the NHS and COVID-19
29 July 2020
NHS-related research activity involving recruitment of participants, face-to-face contact with patients/participants, and any in-person site visits related to research projects, that was postponed or paused may now be possible with careful consideration and planning, Sponsor approval and NHS approvals. You must contact email@example.com before starting or restarting research involving the NHS.
See the guidance on research involving the NHS and COVID-19 for more information.
Please bear in mind that processing NHS approvals can take time, and that in the current situation, all staff, including administrative, are facing unprecedented demands. In normal circumstances we would advise leaving at least 2 months for the processing of NHS approvals.
There are some expedited processes in place for review of research directly relating to COVID-19 but be aware that there are no reductions in the expected standards when it comes to such applications - they must include all the usual documents and be completed as carefully and fully as under normal circumstances.
The University encourages researchers to consider undertaking clinical research, research or other projects involving the NHS, MOD or health and social care services.
These types of activities often require additional approvals or documentation and those intending on undertaking such work should contact firstname.lastname@example.org for advice.
This includes any project involving:
- sites under the remit of these organisations
- direct interaction with patients, staff, or sevice users, or their family members or carers
- indirect interaction with patients, staff or service users such as through collection, analysis or access to their samples or data
Even work which is not research, such as service evaluations or audits, but which involve these organisations will often require some form of approval.
Clinical research and the University's ethical review application form
The University collects data, for insurance purposes, on clinical research being undertaken by researchers at the University. To aid this, the ethical review application form includes a check box -'is this clinical research?'.
You should check this box if your research fits the following definition.
Clinical research in this context (capturing details for insurance purposes) is taken to mean research involving human participants that includes an investigation or series of investigations conducted with the aim of:
- treating disease, physiological or psychological conditions
- preventing disease, physiological or psychological conditions
- diagnosing or ascertaining the existence, degree of or extent of a disease, physiological or psychological condition
- assisting with or altering in any way the process of conception or investigating or participating in methods of conception or contraception
- preventing, modifying or interfering with the normal operation of a physiological or psychological function.
This definition may change depending on the current insurer's criteria and, while updates on any changes will be communicated to your School ethics committee, you may wish to check this webpage regularly.
General guidance on obtaining NHS, MOD or health and social care governance approvals
External approvals for this type of work, which often includes ethical approval, must be obtained first and then ratified by a School ethics committee.
Get in contact with email@example.com to check whether you will need any external approvals and, if so, which approvals you will need and how to obtain them. Get in contact as early as possible as acquiring external approvals may take months.
When applying for NHS ethical approval, researchers are still required to use the University's template documents.
Research involving the NHS and Covid-19
Research involving in-person face-to-face contact within the NHS, or which used key NHS resources, was initially restricted to only research required for patient safety or directly related to Covid-19. This restriction has now been lifted. However, while research involving the NHS is beginning to resume, NHS resources continue to be under pressure and there are issues to consider around risk, safety and ethics.
At the University level, restrictions on research involving in-person face-to-face contact with human participants have also been eased. This type of research may now begin or restart, but only if it is carefully planned and considered. This is covered in more detail on the interim guidance for research involving humans webpage but to summarise, research involving in-person face-to-face contact must satisfy three conditions:
- It must be permissible (so complies with applicable University, local and national restrictions and in the case of the NHS, any NHS board requirements, capacity limitations or restrictions).
- It must be safe (determined through the risk assessment processes for travel and fieldwork or use of research sites including NHS sites).
- It must be ethical (determined through the ethical review process, to ensure the enhanced ethical issues that are a result of the circumstances and increased safety risks are addressed).
We are still in the midst of a pandemic and this means there are substantial considerations in regard to participant and researcher safety, and the ethics of conducting research at such a time. Due to this, research using online and remote methods is still strongly encouraged where at all possible.
What this means in practice for new and restarting research involving the NHS that is Sponsored by the University
Your first step should always be to get in contact with the Sponsor by emailing firstname.lastname@example.org but the information here will give you an idea of what to expect and what we will ask you to do.
The NIHR Restart Framework is being used within the NHS to guide the restarting of research and is supported by the CSO. Take some time to review this - you may notice that there are parallels between the framework and the University’s interim guidance on in-person face-to-face research involving humans.
By mapping the University’s guidance onto the NIHR Framework, (and through communications as Sponsor with local NHS Research and Development (R&D) offices), we have translated what these mean in practice for Chief Investigators (CIs) who wish to start or restart NHS research.
This guidance is most relevant to CIs conducting research that involves in-person face-to-face contact with participants or in-person visits to access NHS sites, resources or equipment. If your study does not involve these but it was paused due to COVID-19, or if you are moving to or restarting research using online or remote methods, contact email@example.com to discuss.