The NHMRC National Statement on Ethical Conduct in Human Research (2007) requires institutions to monitor research projects to ensure they are conducted in compliance with the ethics approval provided. Internal audit of research projects is an important means by which Western Health ensures research conducted under its auspices is conducted in accordance with good clinical practice (GCP) and approved ethical guidelines. Office for Research instigated Audits including; Self, Desktop and Onsite Audits. All projects (QA, Low Risk & Governance) undertaken at Western Health may be subjected to audits.
Annual Self Audits
A self-audit form is to be completed annually (for all approved projects being conducted at Western Health. The self-audit form has also been incorporated into the WH Progress report template. Office for Research may also require other individual Self-audits to be completed for other selected projects upon request.
It is the responsibility of the Principal Investigator to complete an annual progress report & self-audit form to maintain and ensure ongoing ethics and governance approvals. Any reminder emails sent from the Office for Research are a courtesy only, and is not the responsibility of the Office for Research to follow-up with Research personnel to maintain their progress reporting.
Failure to provide a satisfactory annual progress report and self-audit will trigger a short audit.
Short Audits (Desktop Only)
Short audits (Desktop Only) will be completed by researchers on request from the Office for Research. Short audits are requested if a satisfactory progress report or annual self-audit has not be completed or provided.
The Principal Investigator will be notified when a desktop audit is required to be completed and submitted to the Office for Research.
This will involve the following:
- If not already provided, a completed progress report and self-audit form
- Detailed review of selected study documents as requested by the Office for Research (e.g. study protocol, original ethics submission and approval or post approval documents).
- Electronic documents are to be sent to the Office for Research when requested.
Failure to provide satisfactory short audit documents or if critical findings have been noted, an onsite audit may occur.
Onsite Audits
Research Governance Auditors from the Office for Research will regularly conduct onsite audits of a range of research projects including all SSA, low risk and QA projects. This will involve meeting with researchers to; examine all relevant documentation, compliance to GCP, check on the arrangements to protect privacy and confidentiality of participant data and check data storage and security practices.
Study documents will be reviewed in the researcher's department. It is expected that the Principal Investigator attend the audit opening and closing meetings. The Principal Investigator will be notified prior to the audit to identify a mutually convenient time for the audit and forwarded the Audit review rubric to assist in the researcher's preparation for the audit.
At the conclusion of the onsite audit, the Audit findings will be discussed with the researchers. A detailed audit report will also be sent to researchers with the audit findings and the actions that need to be addressed.
The Office for Research will conduct a Follow up Audit at a later date to verify the completion and effectiveness of these actions noted in the original Audit Report. This will involve an onsite Study File Review from a selection of previously audited or any other Projects within the Department. Auditors may also request further meetings with the Principal Investigator/s if required.
How are projects selected for an audit?
A project may be selected for an onsite audit for a number of reasons:
- For cause:
- At the request of the Human Research Ethics Committee, following a protocol violation or following a significant change in classification of risk;
- Following a complaint;
- Insufficient Progress Reports being submitted on an annual basis;
- Failure to provide a satisfactory self-audit or short audit details.
- No cause:
Scope
The scope of audit includes all project documentation for compliance with applicable Western Health policies, guidelines and SOPs, regulations and legislation including:
- ICH GCP E6 R2
- NHMRC Australian Code for the Responsible Conduct of Research (2018).
- NHMRC National Statement on Ethical Conduct in Human Research (2007)
- Western Health Research Policy
- Western Health Research Code of Conduct 2023
- All relevant WH Office for Research GCP SOPs
