Apply for authorisation
Use this pathway to seek authorisation for quality improvement/quality assurance (QI/QA) activities and clinical audits at Macquarie University Health (MUH).
This process is underpinned by the NHMRC Ethical Considerations in Quality Assurance and Evaluation Activities (2014).
Determining whether an activity is QI/QA or research is ultimately the responsibility of the applicant, with input from the Clinical Innovation, Research and Audit (CIRA) Governance Unit and (where required) Macquarie University HREC.
If you intend to publish or present externally, you are responsible for ensuring publication requirements are met and for justifying why the activity was not research requiring HREC approval. HREC approval cannot be provided retrospectively.
Where an activity is determined to be QI/QA, the CIRA Governance Unit will issue a formal letter confirming the activity has been considered by the CIRA Committee and is regarded as exempt from HREC review (noting this may or may not meet journal/publisher requirements, and the institution is not liable for external determinations).
Review triggers
Triggers that may warrant ethical review (this list is not exhaustive):
- collecting information beyond routine care (including biospecimens or additional investigations)
- comparison of cohorts
- potential infringement of privacy or professional reputation of participants, providers or organisations
- randomisation or use of control groups/placebos
- secondary use of data (using QA/evaluation data or analysis for another purpose)
- targeted analysis involving minority/vulnerable groups separated from the main dataset
- testing non-standard/innovative protocols or equipment (if aligned to innovation, discuss with CIRA Governance Unit as it may fall under the Clinical Innovation pathway).
Examples (2025)
- Implementing postoperative patient-reported outcome and experience measures (PROMs/PREMs) (Allied Health)
- Outcomes of transcatheter aortic valve implantation in an Australian cohort (Cardiology)
- Medium to long-term outcomes following breast implant surgery (Plastic and Reconstructive Surgery)
If you need advice, contact the Clinical Research Manager: clinical.innovation@mqhealth.org.au.
Authorisation and reporting process
Apply (REDCap)
- Complete the Quality Improvement/Clinical Audit Application Form in REDCap.
- Download your completed PDF copy (a copy will be emailed to you when you click 'Save work and close' on the final page). Note: this does NOT submit the application for review.
- Collect all required signatures (hard-copy or electronic).
- Some applications may require support from the Clinical Discipline Head (or Clinical Program Head if the applicant is the Discipline Head). Where required, this will be sought/confirmed by the CIRA Governance Unit as a part of the review process.
- Submit the signed application and any required supporting documents to the CIRA Governance Unit via clinical.innovation@mqhealth.org.au with the email subject 'Quality Assurance/Clinical Audit Application' plus a reference keyword.
Supporting documents may include (as applicable):
- copies of data collection instruments
- Data Management Plan (DMP).
Review
Upon receipt of all required documentation, the CIRA Governance Unit will pre-review your application and send you an acknowledgement email. Additional information may be requested before the application proceeds to panel review.
Following review by the CIRA Committee, you may be asked to provide further information or clarification. Once the review is finalised, the CIRA Governance Unit will issue an authorisation letter. Authorisation is valid for 12 months.
Important: The activity should not commence without formal notification of authorisation from the CIRA Governance Unit.
Indicative timeline: Up to 15 working days.
CIRA Committee reporting
Authorisation is typically subject to reporting conditions via:
- clinical discipline governance structures (eg M&M or other discipline forum) and
- reporting to the CIRA Governance Unit on:
- each anniversary of your project authorisation date and/or
- when your project finishes (if it finishes within a year of authorisation) and/or
- as advised in your final authorisation letter.
You will be prompted by the CIRA Governance Unit/REDCap when reporting is due, and you will need to complete the report in REDCap.