Research involving the NHS
Research involving the NHS and COVID-19
15 January 2021
You must contact email@example.com before starting or restarting research involving the NHS, MOD or health and social care services.
NHS-related research activity involving recruitment of participants, in-person contact with patients/participants, and in-person site visits related to research projects may be possible but requires:
- Careful consideration and planning, including health and safety risk assessments
- Sponsor approval
- NHS approvals.
Due to the current circumstances research involving in-person contact with participants can only continue if it directly relates to Covid-19 or is required to prevent harm to participants.
Processing NHS approvals can take time - in current circumstances, all staff, including administrative, are facing unprecedented demands. Under normal circumstances we would advise allowing at least 2 months for the processing of NHS approvals.
The final decision whether research activity can take place is given by the participating NHS sites' Research and Development function.
Expedited processes in place for review of urgent Covid-19 research. However, there are no reductions in standards expected of applications - they must be be completed as carefully and fully as always.
See the guidance on research involving the NHS and Covid-19 on this pafe for more information.
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 service 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 on the form if your research fits the following definition. You should also check with email@example.com that there are no specific insurance requirements for your research.
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 firstname.lastname@example.org 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
Some research involving the NHS is continuing. However, NHS resources continue to be under pressure and there are issues to consider around risk, safety and ethics.
At the University level, the guidance for in-person contact with human participants requires that this type of research 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).
Due to the current circumstances research involving in-person contact with participants can only continue if it directly relates to covid-19 or is required to prevent harm to participants.
While we are in pandemic 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 strongly encouraged where at all possible.
Masters and undergraduate students considering research involving the NHS or social care services should see the guidance from the Health Research Authority (HRA) on research for educational purposes.
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 email@example.com 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 firstname.lastname@example.org to discuss.