Ethics and integrity process for studies involving human participants
The University recognises the need for fostering a positive culture in relation to research ethics and integrity amongst students and staff in order to facilitate high quality research that is safe for both participants and researchers, whilst also mitigating the risk for the University and ensuring freedom of speech.
Research that involves recruitment of human participants will require ethics review and this is a requirement of the University of Birmingham’s Code of Practice for Research. The Code of Practice also sets out how the University handles allegations relating to those requirements not being adhered to.
The University currently has two central Research Ethics Committees (RECs) that support the research ethics review process for staff and PGR student projects, and report to the Research Governance, Ethics and Integrity Committee:
- HaSS supporting the College of Arts and Law and the College of Social Sciences.
- STEM supporting the College of Life and Environmental Sciences, the College of Engineering and Physical Sciences, and the College of Medicine and Dentistry.
The central Research Ethics, Governance and Integrity (REGI) Team in the Research Strategy and Services Division manages the research ethics review process through the online Ethics Review Manager (ERM) system.
For research that requires review by a University Research Ethics Committee, the REGI Team works in close collaboration with academic colleagues, who are appointed by the Pro-Vice-Chancellor (Research) as members of the University RECs. Current ethics review process are based on the complexity of ethics issues and risk:
Self certification: No ethical issues raised, PI self-certifies.
Abstract only: Project involves human participants but ethical issues are minimal, PI is asked to provide a brief abstract rather than a full application.
Full application (low/medium/high risk): Project involves human participants and/or ethical issues considered of low, medium or high risk. The level of scrutiny of these applications is stratified on the basis of the level of risk involved. Low risk projects will be reviewed by a member of the REGI Team and a REC Chair, while medium and high risk projects will go to the REC and a lay reviewer will be included.
Research that requires review by an external research ethics committee will follow external review process requirements such as the Health Research Authority. Researchers are supported by members of the REGI Team for these submissions.
Oversight for high-risk clinical trials is provided by the Clinical Trial Oversight Committee and the Human Tissue Oversight Committee. Both report to the Research Governance, Ethics and integrity Committee chaired by the PVC.