Human Research Ethics Reporting

Researchers must immediately report via email to the HREC Secretariat anything which might warrant review of ethical approval including:

• serious or unexpected adverse effects on participants or others involved in the project
• unforeseen events that might affect continued ethical acceptability of the project

It is a condition of ethics approval that researchers report anything which might warrant review of ethical approval including proposed changes to the application form or study protocol, participant documents, investigator team, etc. Amendments must be submitted to the HREC for approval prior to proceeding with any changes.

To submit an amendment:

• Please email hrec@adelaide.edu.au with your ethics approval number in the subject line.
• Include a covering letter/email clearly outlining the summary of changes and justification for the change.
• Please attach ALL study documentation as a full resubmission (even if the changes do not apply to all documents).
• Ensure tracked changes are present to clearly highlight the changes. Please note highlights can no longer be accepted in the interest of making the review process more efficient and transparent for the Committee.

If the above points are not addressed, the application may be returned in the case the Committee do not have enough context or information they need to make a determination.

Please note that amendments can take anywhere from 2-6 weeks to approve, depending on the scale of the amendment and the availability of reviewers or the need for full Committee review.

It is a condition of ethics approval and the University's insurance policy that researchers undertake timely reporting. Ethics approval is granted for a period of five years subject to providing a satisfactory Annual Report on Project Status form outlining the project's progress and the researcher's adherence to proper ethical standards.

The annual report on project status form should be used for reporting.

To submit the annual report:

• Save the entire file (including any supplementary information) as one PDF document
• Email the PDF document to hrec_report@adelaide.edu.au

It is a condition of approval that researchers inform the HREC, giving reasons, if the project is discontinued before the expected date of completion.

Researchers are also required to inform the HREC when a project is completed.

If a project is completed or discontinued, researchers should submit an annual report on project status form to the HREC Secretariat.