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Research governance procedures, particularly those related to work in the NHS, were introduced with the best of intentions, but they have unfortunately led to an enormous increase in bureaucracy.
For all research projects there are three main areas to cover: (1) ethics; (2) data protection; and (3) risk assessment. Those doing research requiring NHS ethics will, in addition, need to grapple with gaining approval from: the UCL/UCLH Joint Research Office, the Health Research Authority and whichever NHS Trusts are hosting your research.
This document is intended to be a checklist of what you need to do after your research plan is finalised, to successfully complete all necessary research governance procedures, before your study gets underway. In addition, all researchers need to be familiar with the Department of Health's UK Policy Framework for Health and Social Care Research, which outlines the considerations that all parties in a research project need to take into account, and the BPS Code of Human Research Ethics.
If you experience problems with the process, most of the time these can be solved by you and your supervisor discussing things with the appropriate body - the JRO, the REC, the HRA or the Trust. Research governance can be very bureaucratic and prone to delays, but usually if you are assertive and proactive you can get things moving. If you find you are unable to make progress, you can contact the research directors.
Ethics
The general background to research ethics was given in the Research Methods lectures. All trainees must have ethical approval for their major research project unless they are of a type that are specifically listed as exempt. The decision on which ethics committee to approach depends partly on where your research will take place and partly on whether your participants will be NHS patients or "healthy volunteers".
a) NHS participants
NHS ethics approval is needed if your research involves any of the following:
1. Patients and users of the NHS. This includes all potential research participants recruited by virtue of the patient's or user's past or present treatment by, or use of, the NHS. It includes NHS patients treated under contracts with private sector institutions.
2. Individuals identified as potential research participants because of their status as relatives or carers of patients and users of the NHS, as defined above.
3. The use of, or potential access to, NHS premises or facilities.
4. Research which falls under the Mental Capacity Act
NHS ethics review is not normally required for research involving NHS staff recruited as research participants by virtue of their professional role.
If you are not sure, the HRA has some online tools that help decide whether you need NHS ethics. The first helps you decide whether your study falls under the formal definition of research . The second helps you decide whether you need NHS Research Ethics Committee review .
The procedure for gaining approval is outlined on the website of the Health Research Authority, HRA. It is helpful to think of research governance for projects requiring an NHS ethics application as following six key steps:
Step 1. Initiate contact with Trust R&D department
Right at the start of the project it is important to make contact with the R&D department of the sites where you plan to recruit and get an indication that they are happy for you to conduct the research there. It would be very useful at this point to establish a shared understanding of what steps you will need to take to get their permission to conduct the research. For example, you should find out whether they will require you to have additional DBS checks / a research passport in order to conduct research in their trust.
Once you have worked out what hurdles you need to clear in terms of Trust R&D regulations, you can reach a full understanding of what needs to be in place before you start data collection.
Step 2. Contact the UCL/UCLH Joint Research Office (JRO)
The JRO act as the sponsor to UCL trainees' research that requires NHS ethics. Under the Department of Health's Research Governance Framework, all NHS research must have a sponsor who takes responsibility for its overall good conduct.
You should email the JRO on uclh.randd@nhs.net to be assigned a Portfolio Coordinator, who will guide you through the process. You will work with them when preparing the ethics application and HRA documents. Sometimes your contact may leave and be replaced - if this happens you may need to work hard to get the new person up to speed.
The JRO checks documents that will be submitted for ethical and HRA review, and will request some additional information - you will need to complete a protocol document in the JRO format - ask your JRO contact for a proforma. JRO are a gatekeeper for RECs and the HRA - you cannot apply for these without having first met JRO requirements.
Be prepared for this stage to be subjects to delays - numerous documents have to be written (see steps 3 and 4 below) and you will get a lot of feedback from your JRO contact. They are busy - you may need to be insistent and proactive in chasing up responses.
(Later, once your project is approved by REC / HRA, you must send a copy of your ethics approval to the JRO. It is your responsibility to do this.)
Step 3. Prepare Documents for Ethical Review
This requires the completion of a standard application, called the IRAS form (Integrated Research Application System form), which is submitted to an NHS research ethics committee (REC). The IRAS form needs to be completed online via a site with the memorable URL of https://www.myresearchproject.org.uk/.
HRA has recently instituted a fast-track system, called Proportionate Review, for studies which pose minimal risks. You can check the HRA website to estimate whether your study qualifies for proportionate review.
When you have a good draft of the IRAS form, you will send it to your JRO contact for review.
Step 4. Prepare Documents for Health Research Authority (HRA) approval
Any project making an NHS ethics application must gain HRA approval. This is sought in parallel to ethical review, and draws upon the IRAS form and related documents. The HRA will require you to complete a Statement of Activities and a Schedule of Events, templates for which are available on the HRA Website.
These documents will also need to be seen by your JRO contact.
Step 5. Submit the application
Submission to the REC and the HRA is done through the same website where you got the IRAS form: www.myresearchproject.org.uk. However, the two approvals now follow separate paths.
The REC will meet to discuss your ethics approval, and you may be expected to attend the panel. They will feed back, possibly requesting amendments prior to final approval.
HRA will handle their part of the application separately, but make sure the REC approval is notified to the HRA, the panel should do this but have been known to overlook it.
Step 6. Formalize Trust approval
Once you have REC and HRA approval, you need to finalise arrangements with the NHS Trust(s) where you will be collecting data. The HRA will specify what you need to do before research can start. The Trust will have to confirm "Capacity and Capability" to host the research. There may be other specific requirements. Some Trusts have in the past demanded research passports or honorary contracts. In most cases this should not be necessary -- you should be covered by your contract with Camden & Islington, as is the norm with clinical placements. However if a Trust insist, one possible solution is a "Letter of Access" that can be issued by the NHS trust with which you have a substantive contract.
If a trust continues to insist that you require an honorary contract, research passport or letter of access, it is a good idea to consult with your supervisor and/or John/Vaughan about this before proceeding with the paperwork.
Support from the course
If you find that you are having problems with it please do not suffer in silence! You should contact your supervisor, and if necessary John & Vaughan.
b) Non-NHS Participants
Non-NHS participants can include people with or without particular disorders, as long as they are not recruited via the NHS (e.g. participants recruited via schools, non-NHS organisations or websites) or the research is not conducted under the Mental Capacity Act. In this case, you apply to one of two UCL ethics committees.
- If the project just involves non-invasive research with healthy adult participants, and it is part of your UCL supervisor's programme of research, it can be approved by the PaLS ethics committee. The application must be made by your UCL supervisor, and it has to be part of their research programme, not for a one-off study. Your supervisor can access the relevant documentation on the PaLS ethics section of the staff intranet. Check with your supervisor whether they already have permission for their programme of research - your project may need to be entered as an amendment to this. Advice on PaLS ethics can be obtained from PaLS ethics chair Jean-Baptiste Pingault (j.pingault@ucl.ac.uk).
- In all other cases (e.g. research with children or "vulnerable adults", or interviews about sensitive topics) the study must be approved by the main UCL Research Ethics Committee. Those forms will need to be checked and signed by Jean-Baptiste Pingault . Please make sure you allow plenty of time for that part of the process as he will not always be able to respond immediately.
If the research involves both healthy volunteers and NHS participants, you need only apply to the NHS ethics committee.
Data protection
The information you need on fulfilling UCL data protection requirements can be accessed via the data protection section of the PALS intranet. Please follow the instructions on that web page, concerning completing a Research Registration Form, emailing it to the UCL Data Protection Team, and notifying the appropriate people within PALS.
For ethics applications, your data protection approval must be obtained beforehand.
Risk assessment
The Psychology and Language Science (PaLS) Division requires that a Risk Assessment Form be completed for each research project, and signed off by each researcher. (The PaLS version of the form is needed, rather than the generic UCL one, because it is specifically designed for psychology projects) unless you are applying to central UCL ethics.
The form should be completed in conjunction with your UCL supervisor. You must ensure that your supervisor has an electronic copy of the final version of the form. Also you need to email a copy to the Research Administrator.
At the end of your project (NHS projects only)
Once your NHS project is complete you and your supervisor will need to complete a brief progress report / study completion report for the NHS ethics committee that approved your research. You may also be asked to send a copy to the UCL / UCLH JRO.
Request for updates
If you find any inaccuracies, in this document, or if any of the links do not work, please inform John King (john.king@ucl.ac.uk) or Vaughan Bell (vaughan.bell@ucl.ac.uk). Unfortunately, many of these procedures change with bewildering rapidity.