Research approval process
The sponsor of a research study is the organisation taking on overall responsibility for the research.
A sponsor is an individual, organisation or group taking legal responsibility for the arrangements to initiate, manage, monitor and report on a study. A sponsor may also finance a study but does not normally do so and sponsors should not be confused with funding agencies. An NHS Trust, University, a charity, or a commercial organisation normally takes on the role of sponsor.
CPFT sponsors studies and can also be a co-sponsor with the University of Cambridge.
If the sponsor is CPFT or another NHS entity, the study is covered by NHS indemnity rules. If the sponsor is the University, a charity or commercial organisation, indemnity needs to be provided by their insurance policies.
Note: NHS Indemnity does NOT currently cover non-NHS employees who have designed the protocol for a study. The protocol indemnity usually stays with the employer of the author/chief investigator. If you are a University employee you need to contact University Research Services. Find more information about University of Cambridge insurance.
Before a study can commence, when the appropriate regulatory approvals are in place, CPFT R&D undertakes a governance assessment of the study to confirm that the Trust is able to support delivery of the study 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.
Service user and carer involvement is an important part of the CPFT R&D approval process. Involving services users and carers from the very early stages of research makes research more relevant, respectful and beneficial to the people we support. Research studies sponsored by CPFT need to demonstrate appropriate levels of service user and carer involvement and all locally developed research projects are reviewed by service users and/or carers. For further information and advice please contact the User and Carer R&D Manager,
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.
All clinical research projects using patients, identifiable data or tissue require a favourable opinion from a committee of the national Research Ethics Service (RES) before they can proceed. Studies involving anonymised data or tissue, or research involving NHS staff and NHS facilities may not always need NHS ethical review. Studies that involve non-NHS participants, such as healthy volunteers, school children or care home residents may instead apply for ethics review from a non NHS committee, usually within the university.
The Research Ethics Committee will review the study ensuring that it is properly designed, necessary, of value and ethical. They are particularly interested in protecting the rights and safety of any potential research participants. In order to go through the ethics approval system, several items need to be in place prior to submission. All research studies require a sponsor, funding and the scientific value of the research assessed by means of independent external peer review.
All research that involves NHS organisations where the Trust has a duty of care to patients/service users or NHS staff/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 this needs to be reviewed by R&D before submission. If your study requires ethics review you will be able to book your study in for an appropriate committee meeting at this stage.