You should write and publish a protocol for your NIHR-funded research project.
For clinical trials, you must publish trial protocols within 12 months from completing the primary study.
The Health Research Authority (HRA) has produced guidance and templates to help researchers develop high-quality protocols for submission for ethical and other approvals. The templates contain all the elements that review bodies consider to help applicants provide all the information required in their protocol.
See protocol information on the HRA website
For qualitative research and for clinical trials of investigational medicinal products, you’ll need to look at specific protocol guidance and templates.
The SPIRIT Statement provides evidence-based recommendations for the minimum content of a clinical trial protocol and the template is in line with these guidelines and all regulatory requirements.
See further guidance on Clinical Trials Toolkit.
The Health Research Authority (HRA) needs to approve most NIHR-funded research projects. The HRA oversees ethical, governance and legal aspects of research in England.
Researchers can apply for HRA approval for their research through the Integrated Research Application System (IRAS).
IRAS is a single system for applying for the permissions and approvals for health and social care research in the UK. The system:
- enables you to enter the information about your project once, instead of duplicating information in separate application forms
- uses filters to ensure that the data collected and collated is appropriate to the type of study, and consequently the permissions and approvals required
- helps you to meet regulatory and governance requirements.
Planning a multicentre study?
The Health Research Authority has a Research Passport system that allows you to move easily between NHS Trusts without requiring HRA approval at each organisation.