Getting your NHS research project approved: A guide for students
All student research involving the NHS requires approval before you can start to conduct your study. This summary gives a guide about which approvals are needed, what documents you need to prepare, and tips for ensuring a smooth approval process.
Basic Approval Information
Depending on the kind of research you wish to conduct, you will need one or more of the following approvals:
· University Ethics Approval
· NHS Ethics Approval
· NSFT/ NHS Trust Research Approval
Additional approvals may also be needed, depending on the study and how you wish to undertake it, but in this document, we will only cover the 3 main approvals listed above.
University/Institutional Ethics Approvals
As a student, you are likely affiliated with a university for educational purposes. Your University will require a Faculty Ethical approval before you can start, whether you plan to work in the NHS or not. Speak to your institutional advisor to find out the submission and review process for your institution.
NHS Ethics Approvals
Most research in the NHS requires an NHS Ethical Approval, provided through the national Health Research Authority. Only one NHS Ethics approval is required per study, regardless of how many NHS organisations you plan to involve.
The following types of studies require NHS Ethical review:
· Any studies involving contact with NHS service users or carers of service users
· Studies involving identifiable clinical data of service users.
· Any studies involving collecting tissue from participants
· Any studies involving prisoners.
The following studies no longer require NHS Ethical review:
· Studies involving NHS Staff interviews only (unless asking sensitive/intrusive questions).
· Studies only using NHS Facilities without involving service users.
· Studies only using anonymised clinical data which has already been collected as part of normal care.
There are 2 levels of NHS Ethics review – proportionate, for studies which are considered to be of low ethical risk, or Full review, for studies generally involving more intrusive research or research involving vulnerable people, which could be considered higher risk.
NSFT & NHS Trust Research Approvals
All research undertaken with NSFT service users, carers, staff, data or on NSFT premises requires NSFT Research Approval (otherwise known as R&D approval or Research Governance Approval). This is entirely separate to Ethics approval, as it concentrates on assessing the feasibility and risks of delivering the study practically within the Trust.
If you plan to conduct your research in more than one NHS organisation, then you will need to gain approval from each participating NHS site, as local feasibility and considerations are different in each organisation, however the submission process for each is the same.
How to apply for Ethical and R&D Approval
All applications for approval in the NHS are required to be completed in the Integrated Research Application System, otherwise known as IRAS. This is a web-based application system from which applications for Ethics and NSFT approval are completed within a single integrated dataset. IRAS can be accessed here (free registration required): www.myresearchproject.org.uk
In addition to completing the application forms, you will need the following documents:
· A well-written protocol
· Patient Information Sheets/Consent Form
· Any other documentation given to prospective participants and/or clinicians i.e. Posters, flyers etc.
· A copy of any questionnaires or interview schedules to be undertaken in the research.
· Researcher CVs.
· Evidence that the clinical area/service that you are involving has been consulted and is happy to take part i.e. email confirmation or signature on the application forms.
· A copy of the Indemnity/Insurance document provided by your University.
The Research Office is more than happy to meet with you to go through the IRAS form and check that everything has been completed correctly. Training to use IRAS is also available. Please email to arrange an appointment.
Timelines
Be aware that gaining approvals to conduct research in the NHS is unlikely to happen within a few days. Depending on the complexity of your project, ethical issues raised, and the number of sites that you wish to visit, then approvals can take weeks to months. Here are some tips to get your research through the process smoothly:
a) Ask for your project to be peer-reviewed before you submit. The NSFT Research Committee offers a peer-review for studies in the pre-submission stage. This will give you early feedback about the ethics and feasibility of your study and standard of your documentation, and will raise queries that will give you a guide about what to clarify or change before you submit for Ethics and NSFT approvals.
b) Answer queries promptly: One of the biggest hold-ups of approvals is that the applicants do not respond to Committee queries promptly, meaning that approvals can be delayed. When you receive the outcome from the committees, prepare to answer queries or make revisions to paperwork within 7 days. It is also advisable that you attend the Committee meetings if possible, as this gives an opportunity to answer queries right there and then.
c) Communicate early: Speak to NSFT Research, NHS Ethics and Faculty Ethics to find out about timelines and submission deadlines for your review. That way, you can plan ahead for the submission process and have a realistic expectation of when your study should be approved.
NHS approvals Submission Process:
NHS Ethics Committees:
Contact the Central Booking Service (CBS) on 0161 625 7836 to book a place onto a Research Ethics Committee. During the conversation you will be asked to:
· Provide your IRAS Project ID
· Answer a series of questions about your study.
· Confirm that you are ready to submit on the same day.
You can then submit your REC application form to Ethics electronically through IRAS – IRAS will allow you to attach all your supporting documentation to the application form check-list directly.
NSFT Research:
Once the NSFT has performed a peer-review of your study and you have obtained all necessary ethical approvals, please email with all approved documentation attached, with copies of your Ethical approval letters and PDFs of your IRAS R&D and SSI forms.
Gaining Ethical and R&D Approvals
Your submitted application will be sent to the monthly reviewing committees for approval. If the committees have queries or alterations need to be made, this can mean that your application will take longer to be approved. By the end of the process, every committee should have approved the same documentation, with the same version numbers and dates, so organisation is key!
Gaining Access to the NSFT to conduct Research
If you are not an employee of the Trust, but wish to come onto NSFT premises to conduct your research, then you will need either an honorary research contract or a research letter of access, depending on your employer and the nature of the work that you plan to do. Contact NSFT Research to find out which level of access you need, and obtain the application forms.
Starting Your Research
You will only be able to start your research (i.e. approach or identify participants) once you have the R&D approval and Ethical Approval (if required) letters in your hand. If an NHS Ethical review is required i.e. patient-related study, NSFT approval will not be given until the Ethics full approval has been received.
Research Training
If your research involves actively recruiting participants from the NSFT, then you should have a valid Good Clinical Practice (GCP) certificate. To obtain the certificate, you will need to attend a GCP Training course or complete an online course. Course and booking details are available through the Research Office. GCP training should be refreshed every 24 months to remain valid. Other courses are available through NSFT Research to help manage your study after approvals.
NSFT Student Research Approvals Flow-chart
Useful Links and Information:
UEA Ethics Committee – application forms and process http://www.uea.ac.uk/medicine-health-sciences/graduate-school/essential-information-for-current-students-and-supervisors/research-ethics
NHS Health Research Authority – http://www.hra.nhs.uk/research-community/applying-for-approvals/
National Guidance and templates for Consent Forms and Information sheets: http://www.hra.nhs.uk/research-community/before-you-apply/participant-information-sheets-and-informed-consent/
NSFT Research Procedure: 2 – Student Approvals. V1 Jul14