Information for professionals

You must register all non-commercial, or industry-funded (but not led), research studies with the MKUH Research and Development office. The Department of Health published the Research Governance Framework that needs to be followed. The Research Governance Framework applies to any research involving NHS patients, their data or tissue and NHS staff, resources or facilities. It includes independent contractors, student projects and commercial research.

This means a study must:

1. Have a sponsor – the individual or organisation that takes responsibility for confirming there are proper arrangements to initiate, manage and monitor and finance the study. To download a sponsorship request checklist, click To download a sponsorship request checklist, click here.
2. Be approved by an independent Research Ethics Committee (REC) – to protect the dignity, rights and safety of participants.
3. Have R&D approval from the NHS organisation hosting the research – ie the site where the research is being conducted.

Flowchart for R&D Registration

Project Authorisation Procedure

Registering projects is important for a number of reasons:

• It is good practice.
• We are required by NHS funding arrangements to register research. The Trust needs to maintain a record in order to demonstrate to the Department of Health, NIHR, and the Care Quality Commission (CQC), the level of research activity in the Trust. In addition, Quality Accounts require the demonstration of increased participation in research activity and an account of the number of research participants recruited each year in the Trust.
• The Trust Board requires assurance of the level and quality of research conducted by their staff and/or on their premises.
• One of the conditions by which the Trust receives NHS R&D funding is the provision of active project information to the Local Clinical Research Networks (LCRN).
• It helps the R&D department to establish links with researchers and offer appropriate advice and support.
• The registration process enables researchers to gain mandatory peer review for their projects.

Before applying for HRA Permission and Trust Authorisation, regardless of whether researchers have been contacted to take part in a national study or have a research idea of their own, they should first ensure that the project is defined as research and not audit or service evaluation. The Chief investigator can determine whether their study requires ethical review or the R&D Department can give project specific advice.

For student projects, their university ethical review application process should be followed. For studies involving staff only In general no ethical review is required. Contact Veronica Edgell in the R&D Department on 01908 995137 for further advice.

For studies that do not require review by Research Ethics Committee, follow the guidance on the IRAS or on the HRA website, submit application along with research proposal, consent forms, sponsor arrangements and CV of Chief investigator.

Researchers are advised to discuss their application at an early stage with the proposed sponsor, the lead NHS R&D department and the NIHR Design Service (if appropriate). Protocols and/or research proposals should be forwarded to [email protected], indicating the level of support required. One to one appointments can also be arranged where required. A feasibility check list should be utilised. SAE and SOE should only be sent after the feasibility check is done.

Researchers understand their roles and responsibilities when carrying out clinical research in the NHS and have undertaken the appropriate training. This usually takes the form of Good Clinical Practice (GCP) training. GCP is the standard and guidelines to which all research is conducted.

Local Trust researchers must ensure their projects have been subjected to peer review prior to ethics application. Generally, two reviews are required by the research ethics committee. If these are not included in the application for authorisation it will be considered as an invalid application and the researcher will be advised to resubmit. The R&D Department can give further advice on gaining peer review.

Researchers external to the Trust who wish to conduct research at MKUH need to ensure that they have identified a Local Principal Investigator or Collaborator. Further advice is available from the R&D Department.

MKUH can act as sponsor for projects. Further advice is available from the R&D Department.

Research projects should be adequately costed, including sufficient funds to reimburse participant travel costs and extra research costs. All projects will be subjected to financial R&D Authorisation.

Project financial and contract administration

R&D takes responsibility for the administration of internally and externally funded projects. This service includes:

• Income collection (invoicing and grant claims)
• Administration of accounts
• Provision of budgetary statements (in conjunction with finance)
• Contractual and administrative problem solving
• Approval of and appointment of research staff
• Research costs, NHS support costs and treatment costs