***Note: HRA Approval replaces the need for NHS permission by each participating organisation in England. ***
When your application is received it will be checked to ensure it is complete. You are expected to supply any missing information or documents promptly.
The NHS permission process will:
- Review the feasibility of undertaking the research locally, assess the logistics for the local supporting departments, undertake contract and budget negotiations, ensure compliance with legislation, assess local research team suitability, and issue Letters of Access or Honorary Research Contracts
- Arrange access to research nurse or other resources or financial support, as appropriate
- Support the process where research involves NHS patients taking part through private or charity providers
You should note the following points to avoid unnecessary delays in the review process:
- Contracts – It is strongly recommended that you use the NHS model agreements. Failure to do so is likely to delay your project while a legal review is undertaken, and may incur a charge.
- Finance – For commercially funded research you are recommended to use the Industry Costing Template.
- Research Passports and Honorary Contracts or Letters of Access – The local R&D office will determine the necessary contractual arrangements for the research team.
- Radiation – For research involving ionising radiation (eg X-rays and CT scans), whether additional or standard practice, the NHS organisation is legally required to assess each individual study.
When will I get approval?
NHS permission will be provided once the following are in place, in accordance with the Research Governance Framework for Health & Social Care (RGF):
- Allocation of adequate arrangements & resources to meet the standards set out in the RGF
- Ethics approval in place (where required)
- Appropriate contractual arrangements are in place
- Study Sponsor has taken responsibility for the study
- Allocation of responsibilities agreed and documented
- MHRA approval in place (where required)
- IRMER or ARSAC approval (where required)
- Appropriate internal authorisation to conduct the study locally may be required.
- Appropriate insurance or indemnity arrangements are in place.
Information about current review timelines are available from the coordinated permission systems. You can also ask each NHS organisation that you apply to about their current review times.
If you encounter difficulties with a study processed through a coordinated permission system, which cannot be resolved with the local R&D team, please contact the relevant coordinating centre.
Any formal complaints should be addressed to the relevant coordinating centre.
For studies processed outside coordinated permission systems, you should contact the senior management of the NHS organisation if you have concerns about the review or oversight of your project.