What is governance?
Research governance can be defined as the broad range of regulations, principles and standards of good practice that exist to achieve, and continuously improve, research quality across all aspects of healthcare in the UK and worldwide.
Who does research governance apply to?
The framework is of direct relevance to all those who host, conduct, participate in, fund and manage health and social care research. It is not just for investigators, managers or any one professional group. All service and academic staff have a role to play in the conduct of research. Participants in research and the public in general can also help to ensure that standards are understood and met.
Examples of such research would include:
- Analysis of data from a patient’s medical notes
- Conducting surveys
- Using non-invasive imaging
- Using blood or other tissue samples
- Inclusion in trials of drugs, devices, surgical procedures or other treatments
Why do we need it?
Proper governance of research is essential to ensure that the public can have confidence in, and benefit from, high-quality research in health and social care. The public has a right to expect scientific, ethical and financial standards are applied and that transparent decision-making processes with clear allocation of responsibilities and robust monitoring arrangements are in place.
Research governance is needed to:
- Safeguard participants in research
- Protect researchers/investigators (by providing a clear framework to work within)
- Enhance ethical and scientific quality
- Minimise risk
- Monitor practice and performance
- Promote good practice and ensure lessons are learned
The framework aims to forestall poor performance, adverse incidents, research misconduct and fraud, and to ensure that lessons are learned and shared when poor practice is identified. Learning from adverse events will promote good practice, enhance the ethical and scientific quality of research, and safeguard the public.
What is the Research Governance Framework (RGF)?
The Department of Health (DoH) launched the Research Governance Framework (RGF) to complement existing governance arrangements in clinical practice and financial management in the National Health Service.
Research governance was intended to prevent poor performance, adverse incidents, misconduct or fraud and promote public confidence in research. There has been considerable progress in implementing this Framework to provide clear national standards, a system through which these are applied and managed via local screening committees, training and education in the management and conduct of research and national monitoring.
Moving forward: replacing the Research Governance Framework
Upon becoming a Non-Departmental Public Body (NDPB) on 1 January 2015, the HRA took responsibility for issuing guidance for research in England, which will replace the Research Governance Framework (RGF).
The HRA and Devolved Administrations undertook a review and produced a draft revision to the framework which was issued for comment in spring 2015. They are now reviewing responses received from across the UK and will issue a final version of the policy framework for publication later in 2016.
Implementing the RGF
A core standard for health care organisations is that they have systems to ensure the principles and requirements of this research governance framework are consistently applied. Health care organisations have to take this standard into account in discharging their duty of care under the Health and Social Care Act 2003.
The Health Research Authority: National Research Ethics Service (NRES) ensures that research ethics committees (RECs) operate in the same way within a set timescale.
NHS Research and Development (NHS R&D)
Each NHS Trust is served by an R&D department which ensures that all necessary approvals are set in place before a project begins and that researchers are appropriately qualified and trained.
If you are researching in the NHS, you should seek guidance from the Oxford Health NHS Foundation Trust R&D office, or the appropriate alternate office where the research will take place. The R&D office will provide advice about what you need to do as far as the Trust is concerned.
Five elements of the RGF
The Research Governance Framework has five elements:
- ethics and patient information
- health & safety & employment
- finance & intellectual property rights
Last updated: 14 August, 2017