Responsibilities after approval
Key Responsibilities of the Principal Researcher following Approval
The following are the responsibility of the Principal Researcher.
Applying for amendments or extension to approval
If you need to make changes to your project you will need to amend your ethical approval in order to include these changes. Please note that any proposed changes should not be initiated without prior review and approval by the approving REC. The only exception would be when changes would be necessary to address immediate hazards to the participants. For those with ethical approval from the UCL REC you will need to use the following Amendment Request Form. To assist reviewers in assessing the proposed changes, a revised version of the approved application, and any affected documents (e.g. recruitment documentation) should also be submitted.
Major modifications - These major modifications cannot be reviewed via this route and require a new application to be submitted; making clear what the changes are. Examples of major modifications includes substantial changes to the study aims or methodology, addition of an overseas location or any changes where the risks and ethical issues are vastly increased.
Extension requests - If you need to extend the length of ethical approval you also need to complete the Amendment Request Form. Please note, that this needs to be submitted before the current ethical approval expires.
Reporting adverse events
Any adverse events (both non-serious and serious adverse ) 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. events must be reported.
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.
Page last updated: September 2021