Accessible informed consent: A mixed methods study of Australian clinical research staff perspectives

Accessible and inclusive informed consent processes are crucial for ethical clinical research, yet little is known about how research staff implement these practices in Australia. This study aimed to explore current practice and perspectives of staff involved in informed consent processes for clinical research in Australia, including perceived barriers and enablers to facilitating accessible informed consent. To address this aim, we conducted a convergent parallel, mixed-methods study involving an online survey and semi-structured interviews (August to December 2024). Quantitative data were reported descriptively, while qualitative data were analysed using content analysis, with barriers and facilitators mapped to the Theoretical Domains Framework. Findings show that staff are motivated to employ a range of strategies to support their informed consent practice. The most frequently perceived facilitator to practice was providing information in varied formats, including the availability of video, audio, and language translations. However, there are challenges in offering information in multiple accessible formats due to limited skills, capability and resources (e.g. time, funding) to produce them. Industry leaders, regulators, funders and research organisations must lead and resource the delivery of accessible informed consent with focussed research staff training, funding accessibility, simplifying materials, promoting alternative formats, updating ethics guidance and convening shared-learning collaboratives with research participants to build sector confidence and ensure equitable, empowered consent.