Research Governance
Research Governance may loosely be defined as a range of regulations, principles and standards which exist to achieve and improve research quality across all aspects of health and social care.
Research governance applies to everyone connected to clinical research, whether as a chief investigator, care professional, researcher, their employer(s) or support staff. Clinical research is any health-related research that involves humans, their tissue and/or data.
The UK policy framework for health and social care research replaces the Research Governance Frameworks (RGF) previously issued in each of the four UK countries. The policy framework sets out principles of good practice in the management and conduct of health and social care research that take account of legal requirements and other standards.
Research sponsorship is required under UK policy framework for health and social care research for all studies that involve the NHS or Social Care Organisations (eg patients or carers). It is also required for Clinical Trials of Investigational Medicinal Products (CTIMP), and studies of devices, human tissue and invasive research involving prisoners or adults lacking capacity. All these studies will need an NHS Research Ethics Committee or Social Care Research Ethics Committee review.
NHS REC Approval
As a general rule of thumb, all research taking place within the NHS requires NHS REC approval. The HRA have a useful decision tool available via their website if you are unsure as to whether your research project requires NHS REC approval. For researchers undertaking research outside of the NHS (e.g. international only studies or studies recruiting students) Ethical Approval must be obtained from the University Research Ethics Committee. In the case of International studies Ethical Approval will also be required from each participating country.
Is my project research?
The term ‘research’ has a specific meaning in the UK Policy Framework for Health and Social Care Research as defined by the HRA and if a proposal does not fall within this definition it will not require review by a NHS REC. If a proposal is not classified as ‘research’ by the HRA, ethical approval may still required from the University REC. Activities which do not fall within the definition of ‘research’ but may still require ethical approval from the University REC include audit, service evaluation, case studies or case reports, consensus methods and patient & staff surveys.
The HRA website has useful guidance on categorising research proposals and on defining research. We recommend that this tool is consulted at the earliest stages of study design and set up to help determine the required approvals. If having considered the guidance you are still unsure whether your project is classified as research, please send a 1 page summary protocol to the HRA queries line (HRA.Queries@nhs.net).
HRA Approval
HRA Approval is the process for the NHS in England that brings together the assessment of governance and legal compliance, undertaken by dedicated HRA staff, with the independent NHS REC opinion provided through the UK Health Departments’ Research Ethics Service. It replaces the need for local checks of legal compliance and related matters by each participating organisation in England. This allows participating organisations to focus their resources on assessing, arranging and confirming their capacity and capability to deliver the study. HRA assessment is carried out in parallel with NHS REC review. Further details can be found on the HRA website.