What approvals do I need?
We strongly encourage you to get in touch as early in the research approval process as you can for advice and support about the easiest way to get going. If you need support with multiple organisations, the NIHR Regional Research Delivery Networks can help.
If you are planning to run a research project in our organisation, this needs to be formally registered and approved. The two main approvals are:
- Health Research Authority (HRA) Approval
- Trust Approval (Confirmation of Capacity and Capability)
Some studies may require additional approvals depending on the nature of the research. More information is available on the HRA website (https://www.hra.nhs.uk/approvals-amendments/what-approvals-do-i-need ).
HRA Approval
The HRA website has all the information that you need to apply for approval, and different routes depending on the type of study.
You will need HRA approval if your study involves any of the following:
Recruitment of NHS patients or staff
Use of NHS premises or resources (e.g. pharmacy, radiology, laboratories)
Access to NHS data or tissue
HRA approval ensures patient safety and research quality. It includes:
Review by an NHS Research Ethics Committee (REC), if required
Assessment of regulatory compliance on behalf of NHS organisations
Whatever the combination of approvals you need, they can all be applied for using an online portal called the Integrated Research Application System (IRAS). You can register for an account at www.myresearchproject.org.uk. This system will guide you through the process and advise if you will need to attend an Research Ethics Committee review panel.
Setting up an IRAS account
Getting started with an IRAS account
To open an IRAS account you'll need to go to: www.myresearchproject.org.uk and follow the process on-screen, after which you will receive an email confirming your details.
Once you are ready to start, click on ‘New Project,’ - the first page that appears is a ‘filter’ page. The answers you provide on this page will generate the approvals forms which are specifically needed for your study. It is really important that you answer these questions as accurately as you can.
The application process
Use the following guide to help you go through the IRAS approvals process: https://www.myresearchproject.org.uk/ELearning/getting-started.html
For each of the questions on the form there is a small green ‘i’ to help clarify the content needed.
Uploading study documents
Once you have completed the full dataset form you will need to upload a number of documents to the system to complete your application i.e. your consent form, CV, participant information sheet, etc.
There is a checklist available to help you decide what is needed. To access this you will need to select the IRAS form from the project forms menu on the left (See the previous screen shot). You can then click on the checklist tab which provides you with lots of information about what documents to attach and how to do it.
This will ensure that all the appropriate documents are sent to the correct approval body with the IRAS form. We would suggest using appropriate file names to identify the content of the document, clear version control and dates for each document.
You will also need to upload the Organisation Information Document and the Schedule of Events/Schedule of Events Cost Attribution Template (oOECAT). These are required to clarify with the NHS trust you are working with needs to do in order to carry out the research i.e. the resource implications.
You will need an Organisation Information Document for each NHS site type i.e. if different ones for Recruiting Sites vs Participant Identification Centre (PIC). The Organisation Information Document sets out exactly what each site will be doing as part of the project as a whole. The Organisation Information Document also can be used as an agreement and covers lots of useful areas.
When completing these forms it is important not to add trust specific details and only generic study information. For more information about study documents including Organisation Information Document and SoECATs and for templates of these forms you can follow this link to the HRA website.
It is a really good idea to contact us so we can assist in completing these forms which will speed up the approvals process.
Trust Approval (Confirmation of Capacity and Capability)
In addition to HRA approval, you must obtain formal confirmation from the HIOWH Central Research Office team before starting any research activity. This is called Confirmation of Capacity and Capability which essentially checks if it is feasible to support the research (we have the right patients, clinical services are happy to support, there is adequate resource etc).
To do this, get in touch with hiowh.research@nhs.net for advice on what you need.
When ready, you will need to provide a collection of documents called a ‘Local Information Pack’ via email. Documents include:
A copy of the IRAS form as submitted for HRA Approval
Your study protocol (final version)
Participant information and consent documents
Relevant agreements/ contracts
Organisation Information Document (OID)
Schedule of Events Cost Attribution the, plates (SoECAT)
HRA Approval letter when issued
Final confirmation that you can start will be sent via email.
HR Arrangements for non employees of HIOWH
If you are not an employee of HIOWH, we will need to put HR arrangements in place in accordance with the HR Good Practice Resource Pack (Research Passport guidance)
We will support with the documentation you need to obtain one of the following:
Honorary Contract
Research Passport
Letter of Access