Biomedical Sciences Research Institute

Research Regulation

Research Governance is the regulation, monitoring and quality assurance of research on human beings, and includes appropriate legislation and procedures that impact upon universities, the NHS and other bodies.

The growing focus on research governance (or the regulation of research being conducted on human subjects) lies partly in the response to events such as the Alder Hey and other organ retention inquiries. Concerns about the conduct of research on human beings, its value and the treatment by investigators of subjects (including their tissues and data) led to calls for increased scrutiny of who is carrying out research and why. This resulted in the emergence of two major areas of legislation and regulation which now have a direct impact on how research is conducted and regulated within the UK:

The Department of Health’s Research Governance Framework for Health & Social Care currently governs all research being conducted in collaboration with the NHS/HPSS (and research of this nature is also required to comply with various NHS and HPSS Trust research management procedures).

The Human Tissue Act 2004 currently regulates all research involving the use and storage of human tissue for research purposes. This legislation has imposed a responsibility on the University to ensure the quality and integrity of all studies that impact upon human subjects whether recruited from the patients of health and social services, the students or staff of the University, or the wider population. The University has, therefore, implemented a policy to ensure that all research on human subjects being conducted by staff or students of the University is subjected to appropriate scrutiny prior to proceeding. Such research must be reviewed (by the appropriate Ethics Filter Committee within the University) to ensure inter alia that it is viable and valid, that the investigators are appropriately qualified and that there are no unacceptable risks to subjects or researchers. Appropriate records of all such research must be maintained by the researchers and by the University.

The UU policy on research governance and ethics should be implemented in conjunction with the UU Policy on Research Involving Human Tissue and the UU Code of Practice for Professional Integrity in the Conduct of Research.