Reporting Requirements

Any changes to the project which might affect its continued ethical acceptability will invalidate the project's approval. It is a condition of both ethics approval and the University's insurance policy that researchers undertake timely reporting. All reports are to be submitted using the Ethics Renewal and Project Status Report.

Adverse events

It is a condition of approval that researchers immediately report 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.

Annual progress report

From 1 January 2012, ethics approval is granted for a period of three years subject to providing a satisfactory annual report on the researchers' progress and their adherence to proper ethical standards.

Discontinuation and completion of project

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

On completion of the project, researchers are required to submit a brief final report to the HREC highlighting issues of ethical interest.