The governance process ensures that all research that takes place within the NHS is ethical, well thought out, properly financed, safe for patients and in keeping with the aims of the NHS. It also ensures that the people conducting research are properly trained and vetted, again to ensure robust research and patient safety.
The governance process applies to research studies as defined by the UK Policy Framework for Health and Social Care Research 2017. Service evaluation, audit and surveillance projects do not require the process, but we are also able to advise on whether a project fits the criteria for research or one of the other project types (see “is it research”). Contact us for advice on this - however please note we are not able to provide confirmation of whether a project is research or service evaluation without a version-controlled protocol.
Please note that, as of 1st April 2016, all studies taking place in the NHS in England and Wales need to go through the Health Research Authority (HRA)/Health and Care Research Wales (HCRW) for approval. This replaces the previous submissions to REC and NHS R&D and is a slightly different process. Submissions are still completed through the IRAS form. Any studies taking place in Scotland and/or Northern Ireland will also require separate permission for these countries, but this should not require multiple applications and will be coordinated through the lead country.
Application for all of the UK nations is via the IRAS system. To complete your IRAS application, visit www.myresearchproject.org.uk. You will need to attach all the study documentation to your application, including participant documents (invitations, information sheets and consent forms), evidence of insurance, study protocol, and Organisation information document which detail what activities you are planning to carry out at each site (NB the Organisation information document replaced the statement of activities and schedule of events in England and Wales, as well as the SSI form in other UK nations, from 5th June 2019). Most studies require approval from an NHS Research Ethics Committee (REC) which needs to be booked via the central booking service. The application to REC is also via the IRAS form. See this guide to find out whether you need review by a REC. Studies which do not require approval from an NHS REC need to contact central booking (see above) to get a 'dummy' REC number to include in the IRAS form.
For a guide to using IRAS click here.
Before you start the IRAS process, consult with your university to find out whether they need their own ethics committee to review the study first. Sometimes universities have a separate application form for this process, where others use the IRAS form.
To conduct a research study in the NHS, which means either recruiting patients or staff through their role in the NHS, or using patient or staff data, or taking place on NHS premises, you will need to consult with the NHS organisation where you intend to conduct the research, which will need to confirm capability and capacity of the organisation to take part in the study. For research in primary care each GP practice you want to use as a research site or Participant Identification Centre (PIC) has to sign off to say they have capability and capacity (some PIC sites with very small involvement, e.g. advertising the study via a poster, do not need to go through a sign-off process, as long as they are HRA-approved). If your study is taking place in primary care in West Yorkshire you also need to liaise with us and we will issue an advisory email to GP practices regarding capability and capacity and confirming that a study has liaised with R&D. A webinar explaining how sponsors should work together with sites can be found here. You can also find information in your HRA approval letter about how you will be expected to get confirmation of capacity and capability.
HRA approval is only issued after all required regulatory approvals are completed - these can also include specialist approvals if your study involves certain elements. You will be issued an HRA approval letter which confirms that final approval has been received.
We can help you to identify sites. Please contact us for information. For other areas or for secondary or community care organisations please also see the RD Forum to identify which NHS organisation will be able to offer you support.
You may need to undertake GCP (Good Clinical Practice) training (see here for guidance) or obtain a research passport or letter of access (see here for guidance) before undertaking your research. Letters of access are required for accessing NHS sites. Research passports and letters of access for West Yorkshire CCGs and all GP practices in these CCG areas are managed by the West Yorkshire R&D team. Please contact us: email@example.com.