Learn about the InFORMed Participation Information Consent Form (PICF) template, which helps health and medical researchers design consent forms that are clear, consistent and easy for participants to understand. Developed by CT:IQ (Clinical Trials: Impact and Quality) and supported by the ARDC through the Health Studies Australian National Data Asset (HeSANDA) program, the resource supports better communication about clinical research participation and data sharing.
By the end of reading this resource, you should be able to:
Informed consent is the foundation of ethical health and medical research. It ensures that participants understand what a study involves, what will happen to their data and samples, and the potential risks and benefits of taking part. This allows participants to make an informed and voluntary decision about participation.
The Participant Information and Consent Form (PICF) is central to this process. It is a written document that explains the study, records participants’ agreement to take part, and outlines their rights, including how their data may be used, stored and shared in future.
However, PICFs can often be complex and lengthy. Many researchers use PICF templates developed over a decade ago, which are often more than 25 pages and written in highly technical language.
Feedback from researchers and participants indicates these forms are too long and difficult to understand, creating barriers to truly informed participation in clinical trials and other medical research. Recognising the need for change, CT:IQ, supported by the ARDC, initiated the InFORMed project to modernise consent templates and support a more participant-centred, transparent approach to informed consent.
The InFORMed PICF provides a clear, participant-centred template that uses plain language, logical structure and consistent design to help study participants make more informed decisions. It is a freely accessible document that clearly outlines the requirements, purpose, benefits and risks of participating in a study. It can be easily adapted to suit a variety of research trials.
The InFORMed PICF project was a national collaboration led by a team of 35 representatives across the medical research sector, including representatives from research, contract research organisations, consumers, Human Research Ethics Committee members, government departments, and more.
The team undertook extensive research and consultation to ensure the new template reflects the needs and values of participants and researchers. These activities confirmed the need for clearer, shorter, and more engaging consent documents.
To develop the PICF, the InFORMed team:
Using the InFORMed PICF template helps:
The InFORMED PICF template has been adopted nationally through the National Mutual Acceptance (NMA) Jurisdictional Working Group. The NMA is a national system for mutual acceptance of scientific and ethical review of multi-centre human research projects conducted in publicly funded health services across jurisdictions.
The InFORMED PICF template is already used by NSW Health, SA Health’s Southern Adelaide Local Health Network (SALHN), Bellberry Ltd and others, and will now be rolled out nationally. In March 2026, InFORMED PICF was endorsed by the NHMRC.
Download the editable InFORMed PICF template from the InFORMed website.
Explore and download the InFORMed PICF materials via the official InFORMed website. The site includes:
The CT:IQ hosted a webinar in May 2024 with a panel of experts to explore the pathways forward in Australia to promote participant-centered consent to research. Watch the recording below.
