ACTA, with the research sector and consumers, explored the one-size-fits-all approach to obtaining clinical trial consent. This can present challenges in the context of certain trial types, such as comparative effectiveness research. ACTA proposes the application of a more proportionate and risk-adjusted approach to trial consent within existing national frameworks and guidance.
The feasibility report illustrates international consent policy that supports proportionate consent for comparative effectiveness trials, and clarifies whether similar initiatives are permitted by the Australian regulatory and ethical frameworks.
To support this, we have produced guidance on how to apply a proportionate approach to consent in comparative effectiveness trials conducted within Australia.
Resource Documents
Report on the feasibility of a proportionate approach for comparative effectiveness research in Australia
Applying a proportionate approach to consent in comparative effectiveness trials: Guidance for researchers