Rebecca Soole1, 2, 3, Urska Arnautovska1, 2, 3, Nicole Korman1,2, Andrea Baker3, Dan Siskind1, 2, 3
1Faculty of Medicine, University of Queensland, Brisbane, Australia
2Metro South Addiction and Mental Health Services, Brisbane, Australia
3Queensland Centre for Mental Health Research, Brisbane, Australia
Informed consent is a cornerstone of self-determination of consumers receiving health and mental health services. Ensuring that potential participants understand the research study they are entering and voluntarily agree to participate is imperative to uphold ethical and regulatory standards of research activities. Patient Information and Consent Forms (PICFs) have faced criticism as potential barriers to valid consent due to their length and complexity. These barriers can be especially challenging for individuals with schizophrenia, who may face cognitive and motivational difficulties such as shorter attention and difficulties in executive functioning.
It is crucial that the very documents designed to facilitate informed consent are tailored to the unique needs of the population to ensure both ethical compliance and meaningful informed consent. To address these challenges, we conducted two participatory co-design sessions at a Brisbane psychosocial rehabilitation facility with individuals living with schizophrenia. The goal was to gather consumer insights on various aspects of our research teams current PICF—specifically its length, the use of visual prompts, and alternative ways to present content. This approach allowed us to gain invaluable insights from those who have firsthand experience with the challenges of navigating consent materials.
What we learned from consumers
The feedback from these sessions was clear: consumer representatives expressed preference for a shorter PICF, one that incorporated visual prompts as anchors to guide reading and facilitate initial discussions about the study. This approach was deemed more user-friendly, less overwhelming, and more motivating for individuals first learning about the research.
However, consumer representatives also recognised the need for a longer, more detailed text-based PICF for those who wanted or valued more in-depth information. To cater to this, our final design included both a short, icon-based PICF for initial conversations and a more detailed, text-based version for deeper engagement. To bridge these two versions, consumer representatives suggested the use of consistent visual icons to help readers navigate between the short and long PICFs.
To further enhance readability, a question-and-answer format was adopted for each paragraph in both versions. This format allows readers to quickly find the information that is most relevant to them. Additionally, consumer representatives provided valuable feedback on improving the overall aesthetics of the PICF, identifying jargon that could be simplified to improve accessibility, as well as language modifications to better emphasise autonomy.
Integrating consumer feedback into our practice
The insights gained from our co-design sessions have already begun to shape our research practices. The newly designed short and long-form PICFs received ethical clearance for use in our established schizophrenia platform trial. By incorporating lived experience into the design process, we are making strides toward more inclusive and accessible research practices.
Conclusion: Towards More Ethical and Effective Research
Traditional PICFs can inadvertently act as barriers to valid consent, particularly in populations with cognitive challenges. Our research underscores the importance of customising consent forms to meet the diverse needs of potential participants who may be interested in participating in research. By integrating the perspectives of those with lived experience, we made these materials more accessible and effective, promoting informed decision-making and enhancing the ethical conduct of schizophrenia research.
Impact and Future Directions
These adaptations are a critical step towards promoting informed decision-making in health-related research participation and meaningful and equitable engagement with individuals affected by schizophrenia. By tailoring PICFs to better serve individuals with schizophrenia, we empower this often-marginalised group to make informed choices, thus supporting their autonomy and reducing the stigma associated with schizophrenia. Our approach intends to not only facilitate greater access to research but also hopes to foster a more inclusive and respectful environment for participants of research studies and lived experience colleagues.
If you are interested in learning more about our co-designed PICFs or considering them for your research, please reach out to us at r.soole@uq.edu.au. Our dedicated team at the Physical and Mental Health Stream, University of Queensland, is committed to enhancing research accessibility for individuals living with schizophrenia, both in Australia and worldwide.
