NHS staff, service users or their families?
The Department of Health’s Research Governance Framework (RGF) for Health and Social Care applies to research involving the following groups:
- NHS staff;
- NHS patients (including deceased patients) and their relatives; or
- research on NHS premises.
There are several key points to note here:
- The scale of the work does not matter. Your study may not be about NHS services, and you may only plan to include a very small number of people. If the research includes any of the above categories, it will need approval within the terms of the Department of Health’s Research Governance Framework (RGF) for Health and Social Care.
- The RGF only applies to NHS patients who are sampled through NHS systems. For example, all members of the population who are registered with a GP are NHS patients, but you don’t necessarily need approval within the NHS system for general population research – you only need NHS approvals if you are sampling through health services.
- You need to check if the work you are planning to do counts as ‘research’, rather than ‘audit’ or ‘evaluation’ under the terms of the RGF. See ‘what counts as research for the RGF’ for more detail.
- Student projects are assessed by the same criteria as other forms of work and treated as research, where they count as research (as above).
If you think it is possible that your proposed work comes within the remit of the NRES system, you need to take some time to read the bits of the NRES guidance that are relevant to your research. This section of our website will give you an overview of the key considerations, along with some pointers about how to find your way through the process. It is not intended to be a substitute for the more detailed and specific guidance that NRES provide, and we strongly recommend that you take time to read that guidance if it is relevant for your project – you will save yourself time in the long run.
If your project counts as ‘research’
Research within the remit of the RGF is subject to a number of governance requirements, which can be time-consuming and can seem daunting. It’s important to recognise that this takes time to work through – you can speed things up a bit by being thorough and well-prepared, but you can’t avoid it completely. Here we list the things that you will need to do if you are working in an NHS context.
There are two main permissions that you will need to do to work in an NHS context:
- Permission from the Research and Development committee of the local NHS Primary Care Trust or Trusts where you are working
- Ethics approval from an National Research Ethics Service (NRES) ethics committee
You can apply for both of these things on the Integrated Research Application System (IRAS) form. The aim of the IRAS system is to streamline the application process, and – in so far as possible – to avoid duplication of information.
It might not always feel like that. This is, in essence, a complex system, and it is important that you allow yourself a few days to work through the form and read the guidance. It’s also worth noting that National Research Ethics Service (NRES) provide a range of training courses for researchers – as well as their online information – and it’s worth making time for this if you possibly can.
In the course of developing this website, we interviewed several people from the National Research Ethics Service. Their advice was to accept that the form takes a bit of time. In the words of one, ‘make yourself a mug of coffee’ and spend some time reading the guidance before you even start on the form.
In terms of the information to include on the form, the principles are the same as in applying for other forms of ethics approval:
- Use the ESRC Research Ethics Principles to frame your thinking about the issues involved.
See our ethics principles page for guidance on how the principles apply to different elements of your research. - Be as detailed as possible.
This can often be a source of delay in ethics applications, because the committee requests more information, or a more detailed explanation of an issue that they are concerned about. Spending more time on the application before it goes in can often cut out some of the back and forth communication with the committee, and save you time in the long run. - Be careful to justify your decisions.
This is always important, but particularly true for social science applications to NHS ethics committees. A common complaint from social scientists applying to NHS committees is that they lack understanding of social science methodology, and expect social science research to fit a clinical model – e.g. in terms of procedures for securing consent or in information sheets. There is some debate about whether those criticisms are valid – and the National Research Ethics Service has commissioned research which indicated that qualitative studies did not have more problems with NHS approval than clinical experimental studies. However, it is safest to make sure that you carefully justify your methodological approach, particularly in relation to key ethics considerations like the principles of freely given and fully informed consent. - Attend a meeting of the ethics committee, if invited.
NHS Ethics Committees often give applicants the opportunity to attend a committee meeting to discuss their application. It is a very good idea to make time for this, and take time to prepare carefully. See our guidance on attending ethics committee meetings .
Fast track or proportionate review
At the time of writing the Ethics Guidebook, NRES was piloting a ‘proportionate ethical review’ system in a four London-based Research Ethics Committees. Applications within the pilot have to meet eligibility criteria in terms of location, and in relation to the nature of the research. The principle is that applications meeting eligibility criteria, which raise ‘no material ethical issues’ (as defined by an assessment tool), are reviewed by a sub-committee of the main Research Ethics Committee – and hence applications can be reviewed more quickly (and with a lighter touch) than if they were presented to the main meeting of the Research Ethics Committee.
Depending on the success of the pilot, this scheme may be extended more widely in future, and so it is worth checking if it applies in your area if you think your application may be eligible. We have not produced the guidance in detail here (follow the link above), but the most relevant eligibility criteria for social science research as are follows (taken from the ‘No Material Ethical Issues’ tool):
- Research using data or tissue that is anonymous TO THE RESEARCHER
- Questionnaire research that does NOT include highly sensitive areas or where accidental disclosure would NOT have serious consequences
- Research interview / focus group that does NOT include highly sensitive areas or where accidental disclosure would NOT have serious consequences
The guidance notes that these categories can include research with children, as well as with adults.
Other approval needed for NHS research
In addition to ethics approval, you may also need to get approval from NHS R&D (Research and Development) for the organisations where you hope to carry out your research. There is detailed guidance on the NRES site on what is needed and how to apply.
Be aware that R&D requirements can include checks on indemnity insurance, honorary contracts with the Trust in which the research is being done, and checks on research quality (such as evidence of peer review). All these things can be time consuming, and there are not really any shortcuts - so the earlier you start these arrangements, the better.
R&D approval can be particularly challenging if you are working in more than one NHS Trust, and need multiple R&D approvals. In these cases you can try to agree a lead R&D office, so that approval from them will apply across all the NHS organisations in which you are working. Efforts are being made to make the R&D system more coordinated, but this is still work in progress. The system available to you will depend on where your lead R&D office is based:
In England, the National Institute for Health Research has developed a coordinated system for health research. Not all research is eligible to go through this system. If you are doing research in multiple NHS Trusts in England, it is worth spending a bit of time going through their guidance - it is clear, although there is a lot of it - to see if your research is eligible to go through their system. You can also submit an enquiry to their helpdesk. Spending a little time to see if you are eligible could save you some time in the long run.
In Scotland, NHS Research Scotland coordinates the process of securing permission from Health Boards. Again, refer to their website for detailed information about how to apply.
In Wales, a central Primary Care R&D office has been established to coordinate applications. You can find detailed information and guidance on how to apply on the All Wales Primary Care Research Governance and Management website.
Elsewhere, including Northern Ireland, you should check directly with the relevant R&D office. You can find more information on the NHS R&D Forum website.
