What research approvals do I need?

Once you have established that your project is research, you should begin to consider what approvals you may need. Your Research Study Officer can help to guide you through this process.

HRA Approval is required for all research projects to open in the NHS in England. It includes a review by a Research Ethics Committee (REC). Applications for HRA approval are made using IRAS (Integrated Research Applications System) and are e-submitted directly to the HRA through the IRAS system. Guidance on completing the IRAS form is found here IRAS Help – Using IRAS – New Users (myresearchproject.org.uk)

Research Ethics Committees (RECs) review research applications and provide an opinion about whether the research itself is ethical. They look at areas such as the proposed participant involvement and are entirely independent of research sponsors, funders, and investigators. For most applications to the HRA, the REC review forms part of the overall HRA Approval process.  To confirm if your study needs REC review please complete this toolkit.

Studies involving new medicines or medicines used in a different way and non CE marked devices, will require authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA is a government agency responsible for ensuring that medicines and medical devices are safe for use in clinical trials. The MHRA looks at (amongst other things) the safety and quality standards of medicines, medical equipment and blood products. You will need to apply for the MHRA and REC combined review.

You may need to consult the Confidentiality Advisory Group (CAG)  if you intend to access confidential patient information without consent, outside of the direct care team in England and Wales.  CAG is an independent body which provides advice on the use of confidential patient information. Public involvement should be central to your research project and should be planned at the earliest opportunity. For CAG applications you should involve the public prior to submitting your application. CAG expects to see evidence of public involvement that specifically tests the public acceptability of using confidential patient information without consent for the purpose of your application. What this means in practice is providing a public group with a plain language summary of your project that includes the purpose of the project, how confidential patient information is used without consent and the safeguards that will be in place. You should seek views on these specific topics. Read more about CAG-specific public involvement requirements

The R&D office will need to complete a local, formal feasibility procedure that will assess capacity and capability at our site.

Your research project cannot start until confirmation of capacity and capability (C&C) has been received.

C&C includes (but is not limited to) the assessment of the local information pack (LIP), coordinating with potential support departments, costing the project (these costings will need to be approved by the finance team). The R&D team will also arrange for the contract to be reviewed and signed.

Once your approvals are in place and C&C is confirmed, all that is needed is the green light from the sponsor to begin research activities.