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.
Implementing the RGF
The HRA Research Ethics Service
- This system ensures that HRA research ethics committees (RECs) operate in the same way within a set timescale. Further information can be found on the HRA website.
- RECs are accountable to the Health Research Authority in England.
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 OUH NHS 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.
Developments in universities
There is no national system for ethical review in universities. Each has developed/ is developing Research Ethics Committees, each with their own terms of reference and standard operating procedures. The University of Oxford committee is the Central University Research Ethics Committee (CUREC).
Elements of the RGF
Research Governance has five elements: science, information, finance, health and safety, ethics.
Science is concerned with:
- The purpose of the research. Researchers should, within their proposals, justify the reasons for their investigations, explain the possible benefits that may arise from their research and to whom these might apply. Duplicating previous research, without a sound reason, may be unethical.
- Research design, which should be appropriate to the aims of the investigation. The RGF requires peer review for all research proposals, to offer independent advice on its quality, at a level commensurate with the scale of the projected work.
- Approval by the relevant regulatory bodies, such as the MHRA (CTIMPs and Device trials); the Human Fertilisation and Embryology Authority (HFEA – embryos/gametes); and the Human Tissue Authority (HTA – cellular material).
- Retention of data collected for an appropriate period to allow further analysis by the original or other research teams, subject to consent, and to support monitoring by regulatory and other bodies.
Information refers to free access to information:
- Research is conducted for the benefit of patients, users, care professionals and the Public. There should be free access to information on research being conducted and on the findings of research - positive or negative – once subjected to appropriate scientific review. Information should be understandable to the public.
- For commercial development of medicines, medical devices etc. consideration must be given to the protection of intellectual property or commercial confidentiality. The timing of the publication of research findings should take account of this.
Finance refers to two issues:
- the potential costs of an individual project
- financial management of the project
- There must be transparency and accountability in the use of public funds to support health and social care research.
- University researchers applying for bursaries or grants are advised to contact the Medical Sciences Team to discuss their projects as part of their applications and make a detailed plan for expenditure.
- If you are paying your own project costs it is still advisable to estimate the amount you will spend and provide a detailed plan showing how the money will be spent.
- NHS Research and Development (R&D) Departments are responsible for ensuring that the costs are clearly stated and that the Trust concerned does not incur unacceptable expense. Each Trust has financial procedures in place to assist members of staff who are awarded bursaries and grants to conduct their research. These procedures are designed to ensure sound financial management and that proper accounts are submitted to the awarding body. Students applying for bursaries or grants are advised to make an appointment to discuss their project with the finance manager in their Trust as part of their application. This will include a detailed plan showing how the money is to be spent.
|Health and Safety|
Health and Safety regulations require that researchers:
- Identify the actual and potential physical, psychological and social risks that may arise for participants, the researcher or other individuals associated with the conduct of a project
- Show how these risks will be addressed, including containment, shielding and monitoring, as required
Ethics concerns the dignity, rights, safety and well-being of all those who take part in a study.
- When it involves NHS patients, service users, care professionals or volunteers, or their organs, tissue or data, be reviewed independently to ensure ethical standards are met (i.e. it respects the dignity, rights, safety and well-being of participants). The ethical review process is a legal requirement.
- Have an identified Sponsor, who will take on responsibility for initiation, management and financing of a study. It is a legal requirement for clinical trials. The Sponsor must, amongst other things, be satisfied that ethical standards are followed.
- Have arrangements for obtaining informed consent if appropriate. This will be assessed during the Sponsorship review process.
- Use human tissue or organs carefully. Consent from patients or relatives of the deceased is important. Such research must comply with the Human Tissue Act 2004, which came into effect in 2006.
- Use and protect patient data appropriately. All those involved in research must be aware of their legal and ethical duties. Particular attention must be given to systems for ensuring confidentiality of personal information and to the security of those systems.
- Involve service users and carers of their representative groups, wherever possible, in design, conduct and reporting.
- Respect the multi-cultural nature and diversity of human society and conditions.
- Take account of risks to participants. Risks must be in proportion to the potential benefit, and risks, pain and discomfort must be kept to a minimum. Risks must be explained clearly to the relevant REC and to participants.
- Arrangements for compensation must always be explained to participants in the event of non-negligent harm.