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Post Approval Reporting & Amendments

Post Approval Reporting

There are three post approval reports that researchers may require after they have received their ethics approval and their study/data collection has begun, as follows:

  • Requesting an Amendment, an extension and/or adding a new researcher to an approved study.
  • Reporting an unexpected adverse event.
  • Submitting an End of Study Report.

Amending an approved study

Requests are at the discretion of the Chair of the relevant committee. Depending on the nature of the request some amendments may require a full review by Committee.

Researchers are required to request, in writing, permission to make any alterations or significant changes to their approved study. This is applicable to both approved and low risk study submissions for both the HREC and the AREC. Researchers must notify the Chair of the relevant committee of the decision to amend the study and provide justification as to why the amendment is required.

How to Request an Amendment, Extension, or add a New Researcher:

For HREC studies complete the HREC Amend Extend Request Form and submit it along with the cover letter and any supporting documents to hrec@ucd.ie

For AREC studies please click here.

 TIP:

Always use your reference in your email marked as an amendment request. Researchers who do not use their reference number in the subject line of their email experience longer delays in getting their request processed. 

What to do if you need to pause your research

  • If your research is put on hold you must, where possible, inform your participants.
  • If you are halting the research and/or issuing an update to participants, you do not need to submit an amendment. You may wish to detail the steps you took at a later stage either when submitting for an amendment or in your End of Study Report.
  • Please note that all face-to-face research should cease. This includes any research that involves going to people‚Äôs homes especially the elderly.

Reporting an Unexpected Adverse Event

This refers to any unexpected adverse event or outcome experienced by any participant or researcher, which exceeds the risk that participants were informed of prior to consent or during debriefing. 

You must report all unforeseen adverse events whether minor or major.  Please submit a covering letter to the Chair of the relevant committee (quoting your research ethics reference number) with the following Report to hrec@ucd.ie.

HR5 Adverse Event Report - this is for Human Research only.

The AREC version of the form is available here.

Failure to submit a report at the time of the adverse event could cause a delay to the completion of your study and may result in a halt to the research or future publications.  It is the duty of the researcher to ensure that their research is managed efficiently at all times.

Documents that Researchers should retain for their records

There are a number of documents associated with your ethical review which you are strongly advised to retain. They are as follows:

  • Approved final version of the Application Form;
  • Copies of all supporting documents.  For human research the researcher should keep the latest version of the supporting documents template as this will be required for requesting any amendments to the study;
  • Copy of the Approval Letter from the UCD Research Ethics Committee (AREC, HS or LS);
  • Copies of any correspondence approving amendments or extensions or permissions relevant to your research project.

PLEASE NOTE: The Office of Research Ethics does not act as a repository for your research project documents and cannot be held responsible for the retention of your documentation.

Contact UCD Office of Research Ethics

UCD Research, Tierney Building, Belfield, Dublin 4.
E: research.ethics@ucd.ie