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requirements are a condition of HREC approval and any failure to report may result in approval being suspended or withdrawn.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:
- For any change to recruitment methods, data collection, numbers of participants, location of interviews, dissemination of results, approval must be sought.
- When requesting approval for amendments, researchers should read through the original approved application to ensure that the proposed amendments will not affect responses given in the original application.
- Give attention to implications for compliance with legislative requirements including, the Guidelines Approved under Section 95A of the Privacy Act 1988, and the Statutory Guidelines on Research Issued for the Purposes of Health Privacy Principles.
Any change of Supervision or personnel to be added or removed from the research project must be advised.
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.