University Research Ethics and Integrity Processes for studies that involve human participants

The University is committed to maintaining the highest standards of scholarly and scientific integrity in its research. It expects all students, members of staff, and other researchers using University facilities or researching under the auspices of the University of Birmingham to work to these standards.

The Pro-Vice-Chancellor (Research), is the named person within the University responsible for research integrity. The administrative lead for research integrity matters is Dr Birgit Whitman, Head of Research Governance & Integrity. The University Research Committee maintains oversight of ethical issues in research, primarily through the Research Governance Ethics and Integrity Committee.

Processes for research that involves 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 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.