Step 6: Compliance after approval

The HREC is responsible for monitoring approved research to establish that ethical standards of research are maintained in compliance with the National Statement on Ethical Conduct in Human Research.

Researchers should note that the following reporting requirements are a condition of HREC approval and any failure to report may result in approval being suspended or withdrawn.

Annual / final project reports

Ethics Approval is contingent upon the submission of an HRE Final Project Report within one month of the completion/discontinuation of the project. HRE Annual Project Reports must also be submitted if the duration of the project exceeds twelve months.

It is the responsibility of researchers to take note of the report dates on the approval notification and submit as due. Failure to submit reports is a breach of compliance and project approval, which may result in ethics approval lapsing.

Abandoned / discontinued project

If a decision is made to discontinue a project researchers must complete an HRE Final Report form and submit this to the Ethics Officer within one month of the decision to abandon.

Reporting adverse or unforeseen effects and events

The Principal Researcher is responsible for reporting any serious or unexpected adverse effects of the research on participants, and any problems relating to the conduct of the project. Failure to do so may result in discontinuation of approval and/or disciplinary action.

Complete an HREC Incident report form and submit this to the Ethics Officer within one month of the occurrence of the event.

Reporting proposed amendments

A formal request must be submitted to the HREC for consideration and approval for any amendments or modifications to an HREC approved project using one of the following amendment applications:

Project amendment:

Change of personnel:

Any change of Supervision or personnel to be added or removed from the research project must be advised.

Extension request:

Apply at least one month prior to the anticipated completion date for an extension to ensure ongoing approval is obtained, as retrospective approval will not be approved.