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Monitoring and reporting for Riverland Academy of Clinical Excellence research
In accordance with the National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research (2023), the institution, the lead HREC and investigators must ensure that research continues to conform to approved ethical standards and adhere to institutional requirements.
Progress reports to HREC
It is the responsibility of the site Principal Investigator (PI) to complete a progress report for each research project regardless of the progress of the research or whether it has commenced. Progress reports are due on the anniversary of the reviewing Human Research Ethics Committee (HREC) approval, or the date specified by lead HREC.
Continuation of ethics approval and governance authorisation is contingent on submission of annual progress reports. Failure to comply will result in the suspension or termination of HREC approval or Research Governance Officer (RGO) authorisation.
The HREC email the site PI to acknowledge receipt and acceptance of the progress report. Any further actions that may be required will be detailed in that email.
Final reports to HREC
It is the responsibility of the site PI to complete a final report at the completion of their research project. Completion of the project is defined as the time when all participants have completed any study related activity and all access to medical records has ceased.
The HREC will email the site PI to acknowledge receipt and acceptance of the final report. Any further actions that may be required will be detailed in that email.
Monitoring and reporting templates are available and submitted within the SA Health research governance and ethics management system (Research GEMS) for projects that are submitted initially via GEMS. For lower risk projects that used expedited ethics approval outside of Research GEMS, contact the approving HREC for access to monitoring and reporting forms.
Reporting to RMCLHN
The site Principal Investigator (PI) is required to complete and submit an annual report to the Riverland Mallee Coorong Local Health Network (RMCLHN) for each project that has commenced (and until project closure). This report will include a self-audit tool (see link below). Report templates are available from the RMCLHN Research Unit and are due annually by 30 June. The RMCLHN Research Unit will email the site PI to acknowledge receipt and acceptance of the report.