Governance, approvals and registration
The Research Governance Framework outlines the principles of good research governance and is vital for ensuring that health research is conducted to high scientific and ethical standards. All research must be completed in accordance with this framework.
You may also wish to review the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines.
Specific monitoring for each programme is in place. Where specified, primary research projects are expected to establish an overarching review group.
Guidance documents are available below:
Researchers can apply for the necessary permissions for their research (including ethical approval, clinical trial authorisation and NHS R&D approval) through the Integrated Research Application System (IRAS). The Health Research Authority is a useful resource. It has published guidance for Research Ethics Committees, which will be of interest to most NIHR-funded researchers.
To support researchers carrying out CTIMPs to develop high-quality protocols for submission for ethical and other approvals, the Health Research Authority has produced protocol guidance and a template. The template is in line with regulatory requirements and the SPIRIT guidelines and although the template is not mandatory, it contains all the elements that review bodies wish to consider.
Protocols following the guidance and template are less likely to raise queries that can cause delays. While the guidance and template is targeted at CTIMPs, some useful elements could be applied to all research types e.g. inclusion of a section to track amendment history.
All NIHR-funded primary research projects are required to register onto the International Standard Randomised Controlled Trial Number Register (ISRCTN). Registration advice is provided in the documentation supplied by your programme as part of the application, contracting and start-up processes.
All NIHR-funded projects that include a systematic review as part of their protocol (even if embedded within a trial) are required to register their protocols on the PROSPERO database (an international database of prospectively registered systematic reviews in health and social care). Registration advice is provided in the documentation supplied by your programme as part of the application, contracting and start-up processes.
All projects are encouraged to appoint a dedicated Trial Manager. We have produced a generic job description which you may find useful. Please let us know about any appointments you make.
For further guidance on setting up and managing your research in line with regulatory requirements, please visit the Clinical Trials Toolkit page.