Research Governance and R&D Governance Approval
Research Governance is the process applied to all research and service evaluation to ensure that it is of high quality and, where appropriate, ethically sound. It is a process borne out of the Research Governance for Health and Social Care (2005, second edition) which was set up to assure the quality of research. The framework can be found here.
At a local level it generally comprises of 3 main stages:
- Scientific Review
- Ethical Review
- R&D Governance Approval
All R&D SOPs can be accessed via the Standard Operating Procedures page of our Webpage.
Scientific Review is the first stage in the Governance process that is designed to review new proposed studies to ensure that they are of high quality and employ an appropriate methodology in relation to the question that is being asked. This applies to Research, Service Evaluation and Staff Surveys.
For more information contact the Research Management & Governancei team in the Research Support Service Office on 03002 44 5462 or 03002 44 5463.
Scientific Review is normally the responsibility of the study sponsor and, for projects sponsored by one of the Consortium Trusts it is a requirement before a study can be submitted for ethical review or final R&D Governance Approval.
Research studies that involve NHS Patients/Carers will require review by an NHS Research Ethics Committee.
Research involving only NHS Staff will not, in the majority of cases, require an NHS Ethical Review.
Service Evaluations will not require an NHS Ethical Review.
NHS Ethical Review is organised through the Integrated Research Application System (IRAS) which allows electronic application for ethical review as well as other relevant approvals, such as a Clinical Trials Authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA).
Further guidance on the NHS Ethical Review process can be found on the National Research Ethics Service (NRES) website.
Further information on what studies require ethical review can be found at the following links:
R&D GOVERNANCE APPROVAL
R&D Governance Approval is the final stage in the Governance Process that requires researchers to apply for approval from the Trust hosting the research. No research or service evaluation can commence in any of the Consortium Trusts without this in place.
R&D Governance Approval can also be known as Trust Approval, R&D Approval or Trust Governance Approval - they all mean the same thing.
Further guidance on the process please ring on 03004 22 5462 or 03004 225463.
National Institute for Health Research Portfolio studies can now be approved through the Coordinated System for Gaining NHS Permissions for Clinical Research (CSP).
This is a national, online system designed to streamline the approval process. The online CSP process can be triggered at the point of application to an Ethics Committee.