On behalf of the University Research Ethics Committee, the Faculty Research Ethics Committees audit a proportion of research projects each year. Research projects are selected at random and the purpose of the audit is to establish whether the research is being carried out in line with the ethics application.
Researchers are expected to keep a record of all approved documentation, as well as documents such as consent forms, and other documents relating to the study in case the project is selected for audit.
Researchers often need to make changes to the methodology during the course of the research project. Please notify the committee if you intend to make any amendments to the original research as submitted at date of approval, including changes to recruitment methodology. All changes must receive ethical approval prior to implementation.
Researchers will be notified in advance of the date of the audit if their project is selected. The auditors will visit the department and will assess the following:
- Study documentation and study files;
- Amendments to the study;
- Whether the study is being conducted according to what was approved.
The process is also an opportunity for researchers to ask questions or comment on their experience of the ethical review process.
Examples of good and bad practice auditors have come across during ethics audits:
- Clear record of correspondence related to applying for ethical review.
- Clear record of amendments applied for.
- Data is stored securely, in line with University of Leeds policies and as per your ethics application form.
- FREC/ School REC recommendations had been acted upon.
- Signed consent forms unavailable, eg if stored away from University of Leeds premises.
- Consent forms for both parents and children stored in an unsystematic manner, for example so that it is difficult to establish whether consent has been obtained from both.
- Ethics approval not sought for all amendments.
If you have any questions about the University’s research ethics audit protocol please contact the Senior Research Ethics Administrator.
“My initial reaction when I received an email notification that my research project had been randomly chosen to be audited was concern that it would delay my research or worse still that I might need to radically adjust my research plans. I emailed with my research supervisor, Professor Jouni Paavola and his response was positive; this was a learning opportunity. The audit process itself was a constructive discussion about my research administration, e.g. filing fieldwork assessments and ethics approvals, data storage, and on my research methodology. My supervisor and I had opportunity to ask questions and were provided with advice. An outcome of the audit was I had to submit an ethics amendment. It was simple to do and it was approved swiftly. Through the audit and amendments (I now have two) I have established a more constructive dialogue with research ethics. My advice to others is engage with research ethics early and when new queries and issues arise as they have the expertise to help.”
Dr Rosalind Bark, School of Earth and Environment, August 2016
Dealing with allegations of unethical research practice
Should you wish to report concerns of an ethical nature relating to research being undertaken by the University of Leeds please contact ResearchEthics@leeds.ac.uk.