Adverse Events

The University Research Ethics Committee requires that any adverse event (serious or non-serious) be formally reported and recorded. The University’s procedure for reporting an adverse event relating to studies involving human tissue is detailed separately. This applies only to studies in the University’s Faculty of Science which store human tissue principally for research in connection with disorders or functioning of the human body and anthropological research.

Serious Adverse Events

The University must be notified of serious adverse events immediately the incident occurs. Where the adverse event is unexpected and serious, the Chair or Deputy Chair will decide whether the study should be terminated pending the opinion of an independent expert (a detailed report from the Principal Investigator shall be requested as part of this process). The adverse event will be considered at the next meeting of the Ethics Committee and a decision made as to the need to change the participant information sheet and/or study protocol.

Non-serious Adverse Events

The Principal Investigator should inform the Chair of the University Research Ethics Committee within ten days of an adverse incident occurring and provide a written report detailing the nature and consequences of the event. The report should include any proposed amendments to the participant information sheet, study protocol and/or other study materials. Examples that may constitute a non-serious adverse event include the unintended recruitment of study participants outside of the specified age range in the approved study or other deviations in the study protocol. The Chair of the University Research Committee will confirm that the incident is non-serious and report to the Committee at its next meeting. The final view of the Committee will be communicated to the Principal Investigator.

Contact

Research and Innovation Services, 1st Floor, Exchange Station, Tithebarn St, Liverpool, L2 2QP

Email: researchethics@ljmu.ac.uk

Tel: 0151 904 6467