For the duration of an approved research project, the reviewing Human Research Ethics Committee (HREC) is responsible for monitoring the ethical conduct and safety of the research. This involves verification that the conduct of the research conforms to the approved project.
In Victoria, all reporting to the reviewing HREC aligns with the guidance of the National Health and Medical Research Council (NHMRC) – Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods (NHMRC, 2016). In this guidance, the responsibility of reporting to the reviewing HREC is assigned to the sponsor of the research project. The sponsor may be an institution, investigator, collaborative group or commercial company.
For more information refer to the Standard Operating Procedures.
Reporting to the Human Research Ethics Committee (HREC)
The sponsor has reporting responsibilities to a Victorian HREC. These are:
- Reporting on an approved research project using the forms available below (Safety report; Annual safety report form; Amendment request form; Progress report – project form (HREC); Project final report/site closure report (HREC); Protocol deviation or violation report.)
- Completing the required reporting form(s) for the research project (single-site or multi-site project)
- Submitting the required reporting form(s) to the reviewing HREC.
Reporting to the site Research Governance Officer (RGO)
Each site Principal Investigator has responsibility for:
- Reporting to the site RGO according to local policy using the forms available below (Progress report – site form (RGO); Site audit report for research; Complaint report)
- Completing the required reporting form(s) for the site
- Submitting the required reporting form(s) to the site RGO.
The post-approval safety reporting policy is in line with the National Statement on Ethical Conduct in Human Research (NHMRC, 2007) and Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods (NHMRC, 2016).
Projects that received ethics approval or research governance authorisation prior to the release of Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods (NHMRC, 2016) do not require any retrospective change to their existing approval or authorisation documentation. A standard letter from the Department of Health and Human Services confirms this guidance. The letter is available below and can be filed with project documentation.
Standard forms must be used for reporting to the reviewing HREC and/or the site RGO.
Use ERM to complete and submit all post approval forms. Access the report forms below only if directed by the research office at your organisation.