Quality assurance

The University promotes a responsible research culture and recognises the need to manage the risk arising from studies involving human participants, their data and/or tissue. A close collaboration with researchers, administrators, collaborators and regulatory bodies ensures standards that enhance research quality and safeguard the public.


Monitoring

The University currently monitors approximately 10% of active studies via a Service Level Agreement with University Hospitals Bristol NHS Foundation Trust. Reports are reviewed by the Head of Research Governance who will deal with any issues that might arise and agree the corrective and preventative action plan with the research team and appropriate internal / external third parties. Any recurring issues are included in the University's Research Governance training programme.

(Back to top)

Internal audit

The Research Governance Team facilitates the internal audit programme for the University's Human Tissue Working Group to ensure University compliance with the Human Tissue Act 2004.

The University has an internal audit programme and the research governance team is audited in line with the internal audit rota. A detailed audit in respect of Research Governance in the University was undertaken in April 2012.

(Back to top)

Inspection

The University is frequently inspected by regulatory bodies such as the Medicines and Healthcare products Regulatory Agency (most recently in 2012) and the Human Tissue Authority (most recently in 2011).

Action plans from these audits inform the development of standard operating procedures, policies and training.

A compliance report is submitted to the MHRA every 2 years.

(Back to top)

Annual reporting of quality assurance criteria

The Research Governance team will submit an annual research integrity report to the University Ethics of Research Committee that includes a summary about the level of risk and risk management and quality assurance measures. The number of active studies and the related level of risk is included.The report also includes information about misconduct procedures.

(Back to top)

Risk review

The University has a risk management process in place and the Research Governance Team manages the following risks in line with University policy:

(Back to top)