You will usually need to apply for ethical approval from the University – please contact your University Research department for assistance.
Before you apply, you will need...
-
To define your research question (you can find some advice plus further links here)
-
To consider PICO
-
To write a protocol detailing what you intend to do
-
To identify local Principal Investigators (for student research the Chief Investigator will usually be your academic supervisor. It is not normally allowed for a student to be Chief Investigator, except for PhD studies)
-
To identify a sponsor and get their agreement to sign off your application. For student research the sponsor is usually the University research office
-
To check whether any other regulatory approvals are necessary
-
To consider whether you want to apply to be included in the CRN portfolio (NB if you do wish to be adopted onto the portfolio, this will automatically require you to complete an HRA application)
-
To identify whether your project has any Excess Treatment Costs. You will need to apply for ETCs to be funded by the NHS. See below for further guidance.
You do have the option to apply for HRA approval, even though your study does not require it. If you want to do this, you will need:
-
To complete an IRAS form, get the appropriate electronic signatures and submit it
-
If there are any financial considerations or staff time, you will need to complete a statement and schedule of activities for each site type and send it to all sites to confirm their capability and capacity to undertake the research, along with the Local Information Pack. Please also copy in the NHS R&D contact which performs an advisory and oversight role. If you need help identifying sites, the NHS R&D contact can also help with this.
To complete your IRAS application, visit www.myresearchproject.org.uk
For a guide to using the IRAS system see https://www.myresearchproject.org.uk/ELearning/IRAS_E_learning.htm
If you do not wish to apply to the HRA, please send all your study documents (as sent to the University ethics committee), for example patient information sheets, protocol etc. to research@bradford.nhs.uk and include your University ethical approval and sponsor letter. You will then need to wait for confirmation from the West Yorkshire R&D Team that the study may go ahead. It is advisable to contact the team as early as possible in the process to allow time for processing and any queries.
To conduct a research study in the NHS, which means either recruiting patients or staff through their role in the NHS, or using patient or staff data, or taking place on NHS premises; you will need to consult with the NHS organisation, which will need to confirm capability and capacity of the organisation to take part in the study.
For research in primary care, each GP practice you want to use as a research site or Participant Identification Centre (PIC) has to sign off to say they have capability and capacity. If your study is taking place in primary care in West Yorkshire you also need to copy in the West Yorkshire R&D Team. The West Yorkshire R&D Team can also advise the practices on this process. A webinar explaining how sponsors should work together with sites can be found here.
The team can also help you to identify sites. For other areas or for secondary or community care organisations please also see https://rdforum.nhs.uk/rd-contacts-directory/ to identify which NHS organisation will be able to offer you support.
If you need advice, please contact research@bradford.nhs.uk or for technical queries with the IRAS form helpdesk@myresearchproject.org.uk
You may need to undertake GCP (Good Clinical Practice) training (see here for guidance) or obtain a research passport or letter of access (see here for guidance) before undertaking your research.