Applying a proportionate approach to consent in low-risk trials webinar success

Patien Consent


Over 180 participants joined us in a webinar on 28 July 2021 where we launched a series of resources related to simplified consent in comparative effectiveness trials (CETs). These resources are an outcome of an ACTA project to aid the investigator-led sector by developing more proportionate, risk-adjusted approaches to consent.

The webinar was presented by ACTA’s Project and Engagement Manager, Nicola Straiton, Tanya SymonsA/Prof Steven Tong and consumers who shared their work on applying a simplified (integrated) consent approach in the context of low-risk clinical trials.

A/Prof Tong described how they utilised ACTA's integrated (simplified) consent approach during the design of the investigator-initiated SNAP clinical trial (a study exploring the most effective treatments for Staphylococcus aureus bloodstream infection).  The research team, which included consumers created a short, tiered participant information sheet and consent form (PICF), to make this trial more accessible to end-users and ensure effective and efficient recruitment of participants.

We have produced a number of resources as part of this project including a discussion paper that describes how consent could be better integrated into clinical care. The discussion paper was informed by a feasibility report that confirms the National Statement both permits and encourages a flexible approach to consent. Finally to illustrate integrated consent, we have developed an example participant information sheet template which can be adapted for use in other studies.