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Responsibilities after ethical approval

Ethical considerations and responsibilities do not end after approval; they are a key part of the project lifecycle. Understand your responsibilities following ethical approval.

Below are key processes and responsibilities Principal Investigators (PIs) need to be aware of once ethical approval has been granted.

Amendments and 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 are needed 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.

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

Applications submitted to the UCL Research Ethics Service or an LREC before the implementation of ethics@ucl will continue to be processed outside the system until their ethical approval expires. You should continue to submit amendments and details of adverse events to the Research Ethics Service following the instructions below or your LREC as per your approval letter.

Submitting an amendment to the Research Ethics Service

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.

Reporting adverse events


Any adverse events (both non-serious and serious) involving risk to participants or others need to be reported promptly to the approving ethics committee. 

Projects approved in ethics@ucl

Adverse events relating to ethics applications submitted through ethics@ucl can be added directly in the system. 

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.