Redesigning Consent to Research.
Simplifying Participant Information and Consent Forms
Deciding whether to participate in research should be supported by information that is clear, simple and easy to navigate. Yet current Participant Information and Consent Forms (PICFs) are often the opposite: long, complex, and difficult to understand. The CT:IQ InFORMed Project is developing templates and guidance to assist in the creation of more participant-centric PICFs.
CT:IQ (Clinical Trials: Impact & Quality) is a collaborative group of stakeholders with the aim of improving the impact and quality of clinical trials in Australia. CT:IQ comprises more than 50 member organisations and individuals who come together to pursue projects that will promote efficient, effective, and participant-centred, clinical trials. Initiated in 2021, the InFORMed project team is made up of 35 stakeholders from across the research sector, including consumer representatives, sponsors, Human Research Ethics Committee members, governance offices and research sites.
The evidence
To provide an evidence-base for reform, the team conducted surveys, gathering feedback from over 700 respondents (consumers and other stakeholders) on issues with current PICFs and areas for improvement. The survey results provide widespread support for change, including towards simpler, less legalistic and more visually engaging forms. Literature and best practice reviews further support the need for simpler, PICFs, favouring a tiered or layered approach. That is, where key information for decision making about study entry is contained in a concise, well laid out PICF, written in simple language, supplemented by more detailed information for those who seek it out.
The draft template was tested in three demonstration projects based on real studies from different types of research involving consumers with lived experience of the disease or condition being studied. Recommendations from the consultation report have been incorporated into the template and user guide.
What’s next?
Consultation on the template and user guide will be open through 2023. You can provide feedback through the dedicated portal.
We would love to hear experiences from researchers, sites, sponsors and HRECs who have sought to apply the InFORMed template and user guide to their research projects.
We are also especially interested in consumer views on whether the template would meet their needs in deciding whether to participate in a research project.
This feedback will be instrumental to refining the template and user guide in early 2024 before seeking endorsement from the National Health and Medical Research Council.
