For Montu, a large Australian health technology platform operating in medicinal cannabis, governance is increasingly being treated as an operational consideration rather than background compliance. Through its organisation-wide Research Governance Framework (RGF), the company has formalised ethical oversight, research integrity and transparency across its research activities.
Presented publicly at the International Society for Quality of Life Research (ISOQOL) Annual Conference, the framework is intended to support engagement with clinicians, regulators and research partners, while also reducing avoidable risk in a sector under growing scrutiny.
Why governance matters now
In fast-evolving therapeutic sectors, trust often shapes whether innovation is accepted or challenged.
“From a government, regulator and patient perspective, trust is the licence to operate,” says Jodie Thomas, Vice President of Corporate Affairs and Patient Advocacy at Montu. “It determines whether an emerging therapeutic sector is viewed as a credible contributor to health system reform, or as a risk requiring heightened scrutiny.”
In medicinal cannabis, research activity has expanded rapidly as clinical use grows. However, across the market, ethical oversight, data controls and methodological consistency have not always developed at the same pace. That gap can create uncertainty for clinicians and regulators and contribute to uneven confidence in the evidence base.
From ad hoc research to structured stewardship
Jeremy Fox, General Manager of Medical Affairs at Montu, says the decision to invest in a dedicated framework followed internal reflection on how research was being conducted and governed.
“Across the sector, we were seeing increasing research activity, but without a consistent, organisation-wide governance architecture to support it,” he explains. “Variability in ethical oversight, protocol design and data controls introduces avoidable risk to data integrity, clinical confidence and the translational value of findings.”
The RGF establishes a unified, auditable approach to research oversight across the organisation, aligned with the National Statement on Ethical Conduct in Human Research (2025). It applies a proportionate review model for quality improvement and low-risk research, supported by formal policies, standard operating procedures and standardised templates.
A multidisciplinary Research Governance Committee sits at the centre of the model, including internal and external expertise across research ethics, clinical governance, legal, compliance and consumer representation.
“Research oversight across the sector has historically been fragmented frequently operating at the individual site or sponsor level,” Fox says. “For Montu, what was important was the development of an integrated, organisation-wide governance structure capable of setting methodological standards, ensuring consistency of practice, and providing transparent, auditable accountability across all research programs.”
Governance as an enabler, not a brake
Montu is positioning governance as an enabler of scale, collaboration and credibility, rather than a defensive function.
“The framework represents a shift from isolated research activity to structured research stewardship,” Fox says. “It allows us to move beyond individual studies toward a coordinated, longitudinal evidence program governed by consistent ethical, scientific and operational standards. This materially strengthens the credibility, reliability and clinical relevance of the evidence we generate for the broader health system.”
For healthcare institutions, strong governance is often the entry ticket to partnership.
“Within the Australian healthcare system, strong governance is the gateway to trusted collaboration,” Thomas says. “It enables engagement with public hospitals, primary care networks, universities and government-funded research bodies that operate to nationally mandated standards.”
The company also notes that alignment with recognised ethical frameworks can facilitate participation in international research initiatives, particularly in real-world evidence generation.
“Embedding governance at this level positions Montu to generate research that is both nationally policy-relevant and globally credible,” Thomas adds.
Meeting clinician and regulator expectations
For clinicians and regulators, confidence in research often hinges on assurance that studies are well designed, independently reviewed and appropriately monitored.
“Clinicians and regulators consistently seek assurance around the quality, integrity and independence of research,” Fox says.
“The framework directly addresses these expectations by embedding standardised, auditable processes for ethical review, protocol governance, data oversight and continuous monitoring, all aligned with the National Statement on the Ethical Conduct in Human Research. This provides clear, documented assurance that research activity is being conducted to nationally recognised standards.”
External expertise has been deliberately incorporated into the model.
“The inclusion of external experts brings essential independence to this process – providing objective scrutiny, challenging internal assumptions, and ensuring ongoing alignment with contemporary academic, clinical and regulatory expectations,” Fox explains.
Building scalable real-world evidence
One of the first major applications of the RGF will be Montu’s upcoming 12-month prospective mixed-methods observational study examining patient-reported outcomes, adherence behaviours and real-world patient experiences with medicinal cannabis.
The study will operate under a single governance framework with predefined endpoints, standardised eligibility criteria and structured monitoring across participating sites.
“This establishes the structural conditions for sustained, high-quality real-world evidence generation,” Fox says. “Governance is what allows evidence to travel – from clinic to policy to practice.”
A signal to the wider sector
For Montu, the RGF is positioned as part of medicinal cannabis’ broader shift towards established, evidence-based care.
“Strong governance is how emerging therapeutic sectors earn their place alongside mature areas of medicine,” Thomas says. “By investing at this level, Montu is helping set the benchmark for what responsible leadership in the medicinal cannabis space should look like.”
As scrutiny increases across health innovation, governance is becoming less of a background function and more of a visible capability, one that shapes trust, collaboration and long term system integration.
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