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:
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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:
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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:
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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 Research Procedure: 2 – Student Approvals. V1 Jul14
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:
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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.
Q: What makes a good application?
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 RDofficemailbox@nsft.nhs.uk 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:
You can avoid some of the usual pitfalls of review
outcomes by thinking about these factors in your
protocol and application:
a) Detail – you can never have too much
information in your application. The more
practical detail, the fewer queries that
committees will likely have!
b) Some key areas to think about: Participant
recruitment strategy and numbers required,
Confidentiality and protection of participant
data, quality of participant information
sheets.
c) Justifying the importance and potential
impact of your study on patient care– the
‘so what?’ factor.
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.
NSFT Research Procedure: 2 – Student Approvals. V1 Jul14
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:
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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 RDofficemailbox@nsft.nhs.uk 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 Research Procedure: 2 – Student Approvals. V1 Jul14
NSFT Student Research Approvals Flow-chart
Write Protocol and prepare supporting
documentation.
Complete draft IRAS application
forms.
Submit to NSFT Research Committee
for early peer-review and feedback.
Revise documentation and application
forms based on feedback
Complete submission and submit to
University Ethics Committee.
Complete submission and submit to
NHS Ethics Committee
Undertake
GCP training
Speak to NSFT Research
about obtaining access to
NSFT premises
Be aware:
More revisions
may be needed
during these
stages!
Resubmit ethically approved
documentation to NSFT
Research for final NSFT approval.
Start your Study!
Useful Links and Information:
UEA Ethics Committee – application forms and process http://www.uea.ac.uk/medicine-healthsciences/graduate-school/essential-information-for-current-students-and-supervisors/researchethics
NHS Health
approvals/
Research
Authority
–
http://www.hra.nhs.uk/research-community/applying-for-
National Guidance and templates for Consent Forms and Information sheets:
http://www.hra.nhs.uk/research-community/before-you-apply/participant-information-sheets-andinformed-consent/
NSFT Research Procedure: 2 – Student Approvals. V1 Jul14