The application process using IRAS and HRA approval
The application process using IRAS and HRA approval
For lead site/single site studies at UH
Applications for approvals to conduct research in the NHS are
made using the Integrated Research Application
System (IRAS). This is a single system which streamlines
the process for gaining ethics and other governance permissions and
approvals (MHRA/HRA/REC). The system allows researchers to enter
information about their study into one data set only and is
designed to save time and effort by preventing duplication of
information in separate applications for each type of approval.
Oncreating a new study within IRASyou will first be asked to
complete a number of filter questions. Depending on your responses
a suite of project specific application forms will be created. For
example, if you tick that your study is a Clinical Trial of an
Investigational Medicinal Product (CTIMP), the form required for
applying to the Medicines and Healthcare Products Regulatory Agency
(MHRA) will be created.
Please note if you would like your study to beconsidered for the
NIHR Portfolioplease ensure that filter question 5b is ticked
"yes". This will create the relevant Portfolio Adoption Form.
Once you have completed the filter questions and these have been
saved, if you click on the "navigate" box this will take you to a
screen whereby you will be able to see the list of forms that have
been created for your project on the left-hand side.
When any of the individual forms are selected a number of tabs
appear on the screen. One of these will be entitled "checklist".
This will tell you which project specific documents are required to
be submitted with that form to create a valid application pack to
each relevant agency. There will also be another tab entitled
"submission" which will detail the submission process to each of
the relevant agencies.
Please note that for single site studies a Statement of
Activities and Schedule of Events for the UH Bristol site will need
to be submitted if the study is co-ordinated and managed by a
dedicated trials unit/team who is separate from delivery staff. The
latest versions of these forms can be downloaded from the HRA
Please contact us as early as possible if you are unsure what
documentation to complete on 0117 342 0233. Where UH Bristol is the
lead site for a multicentre trial a Statement of Activities and
Schedule of Events per 'site type' will need to be created for all
the other sites.
If UH Bristol is only a participating site:
You will not need to create the project on IRAS as this will be
completed by the lead site.
Help and FAQs
Please note there is a lot of help available within the IRAS system with a section on FAQs. There
is also further guidance from the HRA:
Does my project need ethical
The National Research Ethics Service (NRES)
works with colleagues in Scotland, Wales and Northern Ireland to
maintain the established UK-wide framework for ethical review of
research carried out in the NHS.
NRES produced an algorithm to help researchers determine
whether their project requires ethical review by a Research Ethics
Committee. It should be noted that from 1 September 2011 changes
were made to the Governance Arrangements for Research Ethics
Committees (GAFREC) meaning that it is no longer necessary to
submit to the National Research Ethics Service for review studies
where the requirement is based solely on the use of NHS staff as
participants or the use of NHS premises. Other changes will mean
some studies involving only tissue or data may be exempt however a
large number of exceptions necessitate review of each
study against the guidance. This change relates only to the
National Research Ethics Service, studies not requiring NRES
approval may still require HRA Approval and/or University Ethics
Approval and should still be processed through IRAS.
What is HRA Approval?
HRA Approval is the process for the NHS in England that brings
together the assessment of governance and legal compliance,
undertaken by dedicated HRA staff, with the independent REC opinion
provided through the UK research ethics service. It replaces the
need for local checks of legal compliance and related matters by
each participating NHS R and D office in England (previously called
R and D approval).
Since the 31 March 2016, HRA Approval is the process for
applying for approvals for all project-based research in the NHS
led from England.
All NHS based studies in England, regardless of whether NHS
ethical review is required, will need to apply for HRA Approval. In
those instances where ethical review is applicable, this will be
included in the HRA review. You will also need to seek
confirmation of capacity and capability from participating
NHS organisations in England as outlined in the HRA Approval
HRA Approval applies only to the NHS in England. If your study
has sites in Northern Ireland, Scotland or Wales the
existing process of submission of SSI Forms, local review
and NHS permission continues to apply to the NHS sites in the
You can read more about the development and implementation of
HRA Approval on the
HRA website. In addition the HRA have released a
Q&A document to address many of the queries researchers are
likely to have. The document can be found on the
If after reading the guidance on the HRA website you still have
queries please contact one of the Research Management team on 0117
Capacity and Capability review
Capacity and capability review is required for
participating sites in accordance with the HRA approval letter.
Please liaise as early as possible with the R&I department in
order to initiate assessment of capacity and capability. Please
note it is sponsor responsibility to arrange capacity and
capability review with participating sites although they may
delegate this to a member of their team.
Further details of how to arrange capacity and capability
review at sites including the submission process can be found on
What happens during capacity and capability review
at UH Bristol
One of the R&I department's Research Management
Facilitators will be allocated to your study and will use the
applicable capacity and capability workflow on EDGE to carry out
their review. They will be in touch with you and the sponsor/lead
site regarding any queries. If you have an EDGE logon you will be
able to view the workflow in the site level record.
When the review is complete the Research Management
Facilitator will communicate via email to all applicable personnel
whether UH Bristol has capacity and capability to deliver the
research. After this email is received the sponsor may have a
process for issuing green light to recruit at this site. Please
note you cannot recruit until you have capacity and capability
confirmation and where applicable sponsor green light.
If you have also applied for NIHR Portfolio adoption you
should not recruit until confirmation of adoption is