Post Approval and Monitoring

Once a research project has been ethically approved, any change to its design or conduct must be approved by the reviewing Human Research Ethics Committee (HREC). This Ethics Amendment request must be completed and submitted to the reviewing HREC on Ethical Review Manager.

An amendment to a research project may also impact research governance/site specific assessment (SSA). The Research Office must be notified of any ethically approved amendment, using a Site Governance Amendment form.

An amendment must not be implemented at SWH until the HREC has granted approval of the amendment and (if applicable) the RGO has granted authorisation of the site governance amendment.

Monitoring of research refers to the process of verifying that the conduct of research conforms to the approved proposal. Monitoring occurs through:

• Reports from researchers;
• Reports from independent agencies (such as a data and safety monitoring board);
• Review of adverse event reports;
• Audit involving random inspections of research sites, data, or consent documentation; and
• Interviews with research participants or other forms of feedback from them.

Researchers are required to submit project progress report, or final report depending if the project is ongoing or has been completed/ abandoned, at least annually. All reports must be summited by the anniversary of the initial ethics approval for project via Ethics Review Manager (ERM). For high risk projects reports can be requested at frequent intervals. Researchers should provide information on:

• Progress to date, or outcome in the case of completed/ abandoned research;
• Maintenance and security of records;
• Compliance with the approved proposal; and
• Compliance with any conditions of approval.

The progress report must have summary of progress and any supporting documents or manuscripts. The final report must have summary of the outcomes and / or any supporting documents or manuscripts.

All reports will be reviewed by SWH HREC and acknowledged via ERM. SWH HREC or the Research Office can request for any additional information. The granting of extension of ethical approval for a research project must be on the condition that the researchers submit a satisfactory progress report.

SWH participates in interventional studies and /or multi-site studies approved by a certified HRECs under National Mutual Acceptance scheme.

The Principal Investigators must report any ethical issues to the Coordinating Principal Investigator, sponsor and reviewing HREC.

The reporting to the reviewing HREC must align with the guidance of the National Health and Medical Research Council (NHMRC) – Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods (NHMRC, 2016).

The Principal Investigator must adhere to the Monitoring and Reporting Matrix, and should provide:

• Site Governance Amendment Request
• Site Progress and Final Report
• Non-serious Breach/Deviation Report
• Site Audit Report
• Complaint Report
• Safety Reports

All submissions should be made using the site notification form on ERM.

The progress report is due on the anniversary of HREC approval.

In addition, a comprehensive final report should be submitted to the RGO upon completion of the project. Continued research governance authorisation is contingent on receipt of an annual report submitted to the Research Office via ERM.