Useful Documents

Non-Clinical Monitoring

Research is governed and structured by a number of policies, regulations and standards, and as a result should be conducted ethically and safely.  Study participants donate their time and contributions for the benefit of our researchers and research ambitions, and so should be respected at all points of the research journey.

As a University, BU has an obligation to ensure that its staff and students are likewise safeguarded, whilst maintaining oversight of the research activity taking place, which often extends to partners overseas.

Item 6.4 of the Research Ethics Code of Practice states that:

‘BU may undertake monitoring of approved research projects to ensure compliance. An Ethics Panel may monitor the progress of the research project to ensure compliance with the terms of approval.’

To align with the Code of Practice and in order to ensure that our research is being conducted safely, and in line with the original ethics application, the RDS Governance team will actively monitor/audit ethically approved studies at BU.  The feedback from these monitoring visits will be collated and reported to the Research Ethics Committee (REC).

As with the process of gaining ethics approval, the intention of monitoring our research is to assist researchers and supervisors. This is a time to iron out any issues and to discuss best practice, whilst also safeguarding the researcher and supervisor so that they are confident of the ethical propriety of their project.

Studies will be selected at random and the researchers and colleagues will be notified by the Governance team of their intention to monitor. Researchers and teams are responsible for complying with monitoring requests and making available all the requested documents for review during the monitoring visit. They must also be available for queries or clarifications that will aid the monitoring visit and the final report of findings and recommendations.