Before a proposal is submitted
Researchers should consider the research approval process at the study design stage. The Research Governance Framework for Health and Social Care for the NHS makes clear that no research with human participants, their organs, tissue or data, may begin or continue in the NHS until a sponsor accepts responsibility.
- The designation ‘sponsor’ describes a set of functions for which one of the lead organisation to take on overall responsibility. It will normally be one of the following:
- the lead health or social care organisation,
- the lead employer of the researchers, or
- the main funder.
- The sponsor needs to be involved in finalising your protocol to ensure any of their standard systems and templates are built into the study.
- The sponsor must be satisfied that clear agreements are reached, documented and carried out, providing for proper initiation, management, monitoring and financing.
- A list of recognised sponsors is on the DH website. With the expected implementation of Directive 2001/20/EC, organisations on the list are being given the opportunity to reconsider their position in the light of the Directive’s requirements. The list of sponsors will now be reconstituted, and a link will be provided to the updated document when available.
If it is intended that a project is to be sponsored by an NHS organisation, the permission to do so should be discussed before the proposal is submitted.
After funding is awarded
If the NIHR makes an award from one of its programmes, researchers should go to the Integrated Research Application System (IRAS) website and complete the required documentation.
The Integrated Research Application System:
- Is a single system for applying for the permissions and approvals for health and social care / community care research in the UK
- 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
- Retains familiar aspects of the NRES form system
IRAS captures the information needed for the relevant approvals from the following review bodies:
- Administration of Radioactive Substances Advisory Committee (ARSAC)
- Gene Therapy Advisory Committee (GTAC)
- Medicines and Healthcare products Regulatory Agency (MHRA)
- Ministry of Justice
- NHS / HSC R&D offices
- NRES/ NHS / HSC Research Ethics Committees
- National Information Governance Board(NIGB)
- Social Care Research Ethics Committee
There is no need to apply for any other permissions separately. If you would like help in completing the forms for an NIHR funded proposal and the project is going to take place in the South East Coast region, contact the NIHR Clinical Research Network Kent, Surrey and Sussex.