Understand what your responsibilities are 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 has been ethically approved, but are part of the project lifecycle. Below are key processes and responsibilities Principal Investigators need to be aware of once ethical approval has been granted.
Key responsibilities of the Principal Investigator (PI) following approval
Applying for amendments or extensions to approval
If you need to make changes to your project, you will need to amend your ethical approval. Please note that any proposed changes should not be initiated without prior review and approval by the approving REC. The only exception would be if urgent changes are necessary to address immediate hazards to researchers and/or participants; the REC must always be notified at the earliest possible opportunity in these instances.
If you obtained low risk ethical approval from a Local Research Ethics Committee (LREC), please consult your LREC Chair or administrator for advice on applying for an amendment.
For those with ethical approval from the UCL Research Ethics Committee (UCL REC), please complete and submit the amendment request form linked below to firstname.lastname@example.org. In the subject line, please include your ethics ID number from our database and whether your original application was high or low risk e.g., '12345.001 Amendment request for high risk application [date]'.
Our standard practice is to issue ethical approval for up to five years. The current version of the amendment request form (2021) states that the total duration of a project, including any extensions, cannot exceed six years. At this point, we will require a new application to be submitted providing full details of the research, protocols, and the latest versions of the participant documentation. Please find the latest version of the application form here under Step 5.
When completing the above form, please include in a combined pdf:
- 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, with proposed changes highlighted. This allows the reviewer to identify the changes you wish to make in the context of the original approval and ensures that 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 cannot be reviewed by amendment request and require a new application to be submitted, making it clear what the changes are. 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 the length of ethical approval you also need to complete the Amendment Request Form. Please note, extension requests must be submitted 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 in the form of a full written report that should include any amendments to the participant information sheet and study protocol.
If required by the approving ethics committee, the Principal Researcher is required to report on the progress of the research on an annual basis (or more frequently as deemed necessary by the ethics committee) through completion and submission of the continuing review approval form below.