Apply for authorisation of clinical innovations
Use this pathway to seek authorisation to implement a new interventional procedure or clinical practice innovation within Macquarie University Health (MUH) Clinical Services.
Health service organisations such as MUH require robust processes to assess the safety, value and sustainability implications of new procedures and innovations. At MUH, this is overseen by the Clinical Innovation, Research and Audit (CIRA) Governance Unit, the CIRA Committee and Executive Group, and MUH Clinical Services Executive.
What is a clinical innovation?
Clinical innovations in scope include surgical, medical, biological, diagnostic or therapeutic procedures, and software as a medical device, that have not been previously undertaken or used within MUH (Clinical Services). This can include:
- new techniques for established procedures
- procedures/practices new to MUH (even if used elsewhere)
- trialling new equipment or approaches.
This process excludes research and clinical trials, which require formal research ethics and site-specific governance review.
Clinical innovations being implemented under Special Access or Authorised Prescriber Schemes may require additional governance and ethical review.
Examples (2025)
- A novel transcatheter valve leaflet replacement system for mitral regurgitation (Cardiology)
- An electrical stimulation system (shoulder pacemaker) for shoulder instability (Physiotherapy)
- Image-integrated robotic-assisted bronchoscopy for pulmonary lesion assessment (Respiratory)
If you need advice, contact the Clinical Research Manager: clinical.innovation@mqhealth.org.au.
Authorisation and reporting process
Apply (REDCap)
- Complete the Clinical Innovation 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 any required signatures (hard-copy or electronic).
- Support from the Clinical Discipline Head (or Clinical Program Head if the applicant is the Discipline Head) is required, and will be confirmed by the CIRA Governance Unit as 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 'Clinical Innovation Application' plus a reference keyword.
Supporting documents may include (as applicable):
- Data Management Plan (DMP)
- evidence of financial approval from MUH Clinical Services Executive (if required)
- Patient Information Statement and Consent Form (PISCF).
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 clinical innovation must not be implemented without formal notification of authorisation from the CIRA Governance Unit.
Indicative timeline: Up to 15 working days. If financial review is required, or the application needs to be considered at an executive meeting, the timeline may be longer.
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 (for example, after a specified number of cases have been performed).
You will be prompted by the CIRA Governance Unit/REDCap when reporting is due and you will need to complete the report in REDCap.