Research governance provides a framework for research and to assist in the transfer of learning and best practice to improve patient care. Research attempts to find new knowledge by asking clearly defined questions using systematic and rigorous methods.
A research governance framework describes:
- the arrangements needed to define and communicate clear quality standards
- the delivery mechanisms to ensure that these standards are met
- the arrangements to monitor quality and assess adherence to standards nationally.
It is important that existing sources of evidence, especially systematic reviews, are considered carefully before undertaking new research. Research that duplicates other work unnecessarily, or is not of sufficient quality to contribute something useful to existing knowledge, is considered unethical. All proposals for healthcare research must be subjected to review by experts in the relevant fields able to offer independent advice on its quality.
Research involving medicines is regulated under the Medicines Act and all trials of new medicinal products on people must be notified to the Medicines Control Agency which can offer advice and undertake advisory inspections. Likewise, research that involves new medical devices is regulated by the Medical Devices Agency. Special regulations govern the use of human embryos, the release of genetically modified organisms and food or food processes. Data collected in the course of research must be retained for an appropriate period to allow further analysis by the original or other research teams, subject to consent, and to support monitoring of good research practice by regulatory and other authorities.
Research may involve the use of potentially dangerous or harmful equipment, substances or microbes. The safety of participants, and of research and other staff must be given priority at all times, and health and safety regulations must be strictly observed.