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Understand your responsibilities following ethical approval, including how to apply for amendments or extensions, reporting adverse events, and annual reporting.
Ethics considerations and responsibilities do not stop after the project receives ethical approval; they are a key part of the project lifecycle. Below are key processes and responsibilities Principal Investigators (PIs) need to be aware of once approval has been granted.
PI responsibilities following approval
Amendments or extensions
If you need to make changes to your project, you will need to amend your ethical approval. Any proposed changes require review and approval by the approving Research Ethics Committee (REC) unless urgent changes need to be made to address immediate hazards to researchers or participants. The REC should be notified as soon as possible in these instances.
If you have low-risk ethical approval from a Local Research Ethics Committee (LREC), contact your LREC Chair or administrator for advice on applying for an amendment.
- Projects approved in ethics@ucl
If you submitted your research ethics application through ethics@ucl you should submit your amendment in the system. Step-by-step guidance on how to submit an amendment via ethics@ucl can be found on our Using ethics@ucl page.
- Projects approved via other routes
Ethics approvals submitted using the Word ethics application form will not be migrated to ethics@ucl. Applications submitted to the UCL Research Ethics Service or an LREC before the implementation of the ethics@ucl system will continue to be processed outside of the system until their ethical approval expires. You should continue to submit amendments and details of adverse events to ethics@ucl.ac.uk or your LREC as per your approval letter.
To submit an amendment, complete and submit the amendment request form below to ethics@ucl.ac.uk, with your ethics ID number and whether your original application was high- or low-risk in the subject line, e.g., '12345.001 Amendment request for high-risk application [date]'.
When completing the above form, you should include the following information in a combined PDF document:
- A clear description of, and justification for, your proposed changes
- An outline of the ethical issues or considerations raised by your proposed changes
- An updated version of your ethics application form, including any previous amendments and highlighting the proposed changes. This helps the reviewer identify the changes you wish to make in the context of the original approval and ensures the REC has an up-to-date overview of your study
- Appendix documents such as participant information sheets, consent forms, interview topic guides, and recruitment adverts highlighted to reflect all changes.
Major modifications will require a new research ethics application to be submitted, explaining what changes are being made. Examples of major modifications include substantial changes to the study aims or methodology, the addition of an overseas location, or any changes where the risks and ethical issues are vastly increased.
If you need to extend your ethical approval you need to complete and submit the Amendment Request Form before the current ethical approval expires.
Reporting adverse events
Any adverse events (both non-serious and serious) involving risk to participants or others must be reported promptly to the approving ethics committee.
- Projects approved in ethics@ucl
For ethics applications submitted through ethics@ucl you can add any adverse events in the system. Visit our Using ethics@ucl page for step-by-step guidance on reporting an adverse event via ethics@ucl.
- Projects approved via other routes
For existing approvals, you should continue to submit any adverse events to ethics@ucl.ac.uk or your LREC. You should provide a full written report with any amendments to the participant information sheet and study protocol.
Annual reporting
If required by the approving ethics committee, the PI will need to report on the progress of the research on an annual basis (or more frequently as deemed necessary) by completing and submitting the continuing review approval form below.