Applying a simplified consent approach for low-risk clinical trials webinar

Join ACTA and a panel of experts, including researchers and consumers, on 28 July 2021 (11-12pm AEST) as we share our work on applying a simplified (integrated) consent approach in the context of low-risk clinical trials. We will discuss why a one-size-fits-all approach to obtaining clinical trial consent presents challenges, particularly for low-risk, pragmatic comparative effectiveness trials.

The webinar aims to:

  • Increase awareness of the feasibility of applying proportionate consent approaches to low-risk comparative effectiveness research within the existing Australian regulatory and ethical framework.
  • Describe when simplified (integrated) approaches may be appropriate.
  • Describe the value of working in partnership with consumers to help design and implement proportionate approaches to consent for low-risk, comparative effectiveness research.

As proportionate (risk-based) consent approaches are established in other regions, ACTA commissioned a feasibility report that examined international best practice and the use of more flexible approaches to consent. Importantly, these approaches are already supported by the National Statement. ACTA has published a discussion paper that provides advice on simplified consent for low-risk pragmatic trials, so that trial consent is more feasible at point-of-care.

We look forward to connecting with everyone to explore this topic, including how this resource is being implemented in practice.

Latest Resources