Research governance

Under the UK Policy Framework for Health and Social Care Research all health and social care research projects require a Sponsor. The Sponsor is the organisation or partnership that takes on overall responsibility for proportionate, effective arrangements being in place to setup, run and report a research project. All health and social care research should have a Sponsor. This includes all research that involves NHS patients, their tissue or information.

Confirmation of Sponsorship requires evidence of:

• Contractual relationship of Chief Investigator (protocol author) to the Trust
• Funding
• Insurance
• Public and Patient Involvement and Engagement (PPIE) consultation
• Independent Scientific Review
• Protocol

All research studies need a protocol describing how the research will be conducted. The protocol describes the research question: hypothesis, objectives, primary outcome and - if applicable - secondary outcomes, justifies the importance, and the methodology of how it will be answered. Protocols should have appropriate peer review before submission to research ethics committees and other relevant regulatory bodies.

For further guidance about writing your protocol please contact the R&D office at: RandD@cpft.nhs.uk

All research that involves NHS organisations where the Trust has a duty of care to patients and service users or NHS staff and volunteers will also require approval from the Heath Research Authority (HRA). HRA Approval is provided after ethical approval is received and brings together the assessment of governance and legal compliance, so that you only need to submit one application. Depending on your study type, you may also need approvals from the Medicines and Healthcare Products Regulatory Agency (MHRA) if conducting a drug or device trial; or the Confidentiality Advisory Group (CAG) if you intend to access confidential patient information without consent.

This application process is managed through a single online system known as the Integrated Research Application System (IRAS). This captures all the necessary information needed by different agencies and allows electronic submission of supporting documents. If you are a new user to this system we recommend you take the IRAS e-learning module.

The application will need to be authorised by the sponsor, so for CPFT research projects this needs to be reviewed by the Research Governance Team before submission: RandD@cpft.nhs.uk

For more information visit the HRA Approval webpage.

Before a study can commence, when the appropriate regulatory approvals are in place, CPFT R&D undertakes a governance assessment or Capability and Capacity (C&C) review of the study to confirm that the Trust is able to support its delivery and that the research will be carried out safely, in line with appropriate Trust policies and procedures.

All departments involved in the research need to be aware of the study and confirm they have the capacity and appropriate resources in place to meet study requirements. Where support departments are involved in the research, the study will also be reviewed by staff involved, in pharmacy or radiology for example.

For studies where CPFT is the host organisation, R&D will review contracts and funding as appropriate, particularly where the sponsor is a commercial entity, and negotiations of budgets and contracts follow a national commercial study set up process.

When all study approvals are in place and the governance checks are completed, CPFT R&D will issue a Capacity and Capability (C&C) letter. A study can commence only once this letter has been issued.

Click to find further information and guidance on setting up your research within an NHS from the Health Research Authority.

To access National Institute for Health and Care (NIHR) Research Delivery Network (RDN) support in England, and be included on the RDN Portfolio, research studies must meet the eligibility criteria for RDN support outlined by the Department of Health and Social Care (DHSC).

Once accepted onto the RDN Portfolio, all studies must follow good portfolio practice throughout the delivery of the study. This is outlined in the terms and conditions. 

Click for more information on NIHR Research Portfolio Adoption.

Researchers who are employed by a university or charitable organisation need to apply for a Research Passport to access our site and recruit patients. This allows us to ensure that all research staff are appropriately qualified, trained and vetted before starting work.

The Research and Development office will issue an honorary research contract (HRC) or a letter of access (LoA) to researchers following submission of a successful application. The decision on whether an HRC or LoA is appropriate depends on the nature of the research activity and supporting documentation required by the Trust.

All up to date guidance and research passport application forms can be found on the My Research Project website.

If you have any queries, please contact RandD@cpft.nhs.uk for further advice and guidance.