Research Governance Framework
Research Governance can be defined as the broad range of regulations, principles and standards of good practice that exist to ensure the highest standards of quality in research. This covers scientific quality, ethical standards and all aspects of research management.
Cardiff University Research Governance Framework
Cardiff University has its own Research Governance Framework outlining the principles of good research practice. All members of staff and students involved in research at the University should adhere to this Framework.
Research Governance Framework for Health and Social Care
The Research Governance Framework for Health and Social Care has been drawn up by the Department of Health. It aims to ensure that all research undertaken within health and social care organisations conforms to a common set of standards. All research involving NHS resources must adhere to this Framework.
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 dead 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 is separated into five main themes:
- Ethical Conduct of Research
- Scientific Quality
- Health, safety and Employment
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 the Research Governance Framework for Health and Social Care.
Why do we need the Research Governance Framework?
The Research Governance Framework is needed to:
- safeguard participants in research
- protect researchers/investigators
- enhance ethical and scientific quality
- minimise risk
- monitor practice and performance
- promote good practice