Adverse events

An adverse event includes any event which results in or had the potential to cause (a near miss or undesired circumstance), injury, ill health, harm to animals, harm to the environment or harm to the reputation of the University.

In the first instance, the PI or supervisor should consider an emergency response which includes taking prompt emergency action (for example first aid) or contact 2222), make the area safe (in some cases this may need to be done first) and report the adverse event to the person responsible for health and safety (this person will be the supervisor/line manager in the area where the adverse event occurred) and the LJMU Research Governance Manager. Additionally, the PI or supervisor should consider whether there is potential for harm to individuals, animals, the environment or the reputation of the University if the project/data collection continues. Having considered these issues, in consultation with line managers, the research ethics manager, research integrity team as required, the PI or supervisor should decide whether to suspend the project immediately.

An adverse event that occurs during the course of a research or knowledge exchange project must be reported in accordance with the LJMU Health and Safety Code of Practice SCP7 Reporting and Investigating of Adverse Events. An adverse event involving a research or knowledge exchange project must also be reported by the principal investigator or supervisor to the LJMU Research Governance manager (ResearchGovernance@ljmu.ac.uk) in accordance with the LJMU Research Ethics and Governance Standard Operating Procedures. Adverse events that occur during a project involving the NHS must be reported in accordance with the HRA Safety Requirements and Governance Handbook for LJMU Sponsored Health and Social Care Research.

Breach of research ethics and governance SOPs

A breach of research ethics and governance SOPs (for example projects conducted without research governance approval, a favourable ethics opinion in place, not in accordance with the ethics application that received a favourable ethics opinion or a personal data breach) must be reported to the Director of School, for undergraduate and PGT student projects and to the LJMU Research Governance manager (ResearchGovernance@ljmu.ac.uk) for staff and PGR student projects.

In addition, a personal data breach must be reported immediately to the LJMU Data Protection Officer (DPO) using the Personal Data Breach Form. A personal data breach, as defined by regulations like GDPR, is a security incident that results in the accidental or unlawful destruction, loss, alternation, unauthorised disclosure of or access to, personal data. This includes breaches that are the result of both accidental and deliberate causes. It also means that a breach is more than just about losing personal data. Please visit the Information Commissioner’s Office (ICO) for further information.

Further information

Further information is available in the LJMU Research Ethics and Governance Standard Operating Procedures.