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 February 2021, A committed group of 35 project team members worked alongside CT:IQ Project Manager Sonia Harvey to bring this vision into reality. The team undertook an extensive development process, including:
Background research on what makes a useful PICF
Surveys with consumers and research staff to understand issues with current PICFs and areas for improvement
A partnership with HeSANDA to develop a national data sharing statement and privacy language for the PICF template
Three consumer focus groups, conducted by Dr Tanya Symons and supported by Medicines Australia and Bellberry Ltd, to understand consumer values and preferences regarding PICFs
A six-month beta-testing process to gather feedback from a diverse range of stakeholders on draft PICF template and user guide.
CT:IQ and the project team are proud to release the InFORMed template and user guide for use by the Australian health and medical research sector.
We invite you to review the dedicated project website for additional information, including FAQs and resources. You can also watch a webinar where frequent questions about the InFORMed template were answered by experts in their fields.
