Research Governance Framework for Health and Social Care
The Research Governance Framework for Health and Social Care (RGF) applies to research undertaken in or by the Department of Health, its non-Departmental Public Bodies and the NHS as well as research undertaken by or within social care agencies.
It covers clinical and non-clinical research; research undertaken by NHS or social care staff using the resources of health and social care organisations; and any research undertaken by industry, charities, research councils and universities within the health and social care systems that might have an impact on the quality of those services.
The RGF applies to all research in health and social care conducted by Cardiff University staff in NHS facilities or involving NHS patients, their data or any human organs or tissue. Clinical Trials which fall under the EU Clinical Trials Directive (2001/20/EC) and the Medicines for Human Use (Clinical Trials) regulations 2004 must also adhere to this Framework.
The aim of the RGF is to bring together general principles of good practice.
The Framework is of direct relevance to all those who host, conduct, participate in, fund and manage health and social care research.
NHS resources include:
- patients and users of the NHS. This includes all potential research participants recruited by virtue of the patient or user's past or present treatment by, or use of, the NHS. It includes NHS patients treated under contracts with private sector institutions
- individuals identified as potential research participants because of their status as relatives or carers of patients and users of the NHS, as defined above
- access to data, organs or other bodily material of past or present NHS patients
- foetal material and IVF involving NHS patients
- the recently deceased in NHS premises
- the use of, or potential access to, NHS premises or facilities
- NHS staff recruited as research participants by virtue of their professional role
The Framework has five main themes:
- Ethical Conduct of Research
- Scientific Quality
- Health, Safety and Employment
Why is the Research Governance Framework needed?
The Research Governance Framework is needed to:
- safeguards participants in research
- protects researchers/investigators
- enhances ethical and scientific quality
- minimises risk
- monitors practice and performance
- promotes good practice
Any research involving NHS or social care services must have a Research Governance Sponsor. The Sponsor is the organisation that takes responsibility for confirming there are appropriate arrangements to initiate, manage, monitor, and finance a study. To ensure that studies taking place within Cardiff University meet the necessary standards, studies are required to be registered with Research, Innovation & Enterprise Services at Cardiff University. Research, Innovation & Enterprise Services will determine whether Sponsorship approval will be given. In addition Research, Innovation & Enterprise Services will only formally accept sponsorship once confirmation of the following requirements have been obtained:
- R&D approval with participating NHS Health Boards/Trusts
- Ethical approval
- Confirmation of the appropriate indemnity cover
Researchers will be required to complete and return Cardiff University's Advanced Project Information Proforma (APIP) before sponsorship can be accepted. To access the APIP form and for further guidance on the procedures for obtaining sponsorship, please visit the Applying for Sponsorship page.