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A new nationally endorsed template aims to simplify and streamline Participant Information and Consent Forms for researchers and participants.
For the Australian health sector to deliver the outcomes that Australians expect, we need a vibrant medical research sector. Medical research is strongest when people from a wide range of backgrounds participate.
Before taking part in a health and medical research project, potential participants must decide if the project is right for them. Participant Information and Consent Forms (PICFs) are meant to provide people with the information they need to make these decisions. However, over time PICFs have become increasingly complex and legalistic, which makes it difficult for people to understand important information.
This has now changed with national endorsement of the CT:IQ InFORMed PICF template by the NHMRC and all Australian health departments.
PICFs: The challenges and opportunities
Extensive research has documented the length and complexity of PICFs in Australia and internationally. In one study by Biggs & Marchesi, the 86 PICFs submitted to an Australian HREC in the year 2012-13 reportedly varied in length from one to 35 pages. Only six of the PICFs satisfied the Grade 8 reading level recommended by the NHMRC. A 2012 analysis of the readability of PICFs used in anaesthesia research in Australia and New Zealand reported that readability scores typically exceeded grade 11 reading levels.
This length and complexity makes it hard for the approximately 44% of Australians who have a reading level below the grade 11 or 12 level to understand the information in many PICFs. Even people with high literacy may find it hard to understand the information if it is provided at a time of vulnerability, such as soon after being diagnosed with a serious health condition.
In recent years, researchers have identified strategies to improve understanding of PICFs. As well as making them shorter and easier to read, PICFs can benefit from the inclusion of multimedia informational aids such as videos and slideshows with voiceovers. An important innovation is the concept of layered consent, which streamlines PICFs by only including the information that is crucial for participant decision-making in the main body of the PICF, and providing access to optional information for those participants who want to know more.
Yet, until now, these innovations were not incorporated into Australia’s nationally endorsed PICF templates.
The InFORMed Project
The CT:IQ InFORMed Project commenced in 2021 as an initiative to develop a national, participant-centred, simpler PICF for Australian health and medical research. CT:IQ is a member-based not for profit organisation hosted by Bellberry. CT:IQ is dedicated to continually improving the Australian clinical trials landscape through supporting efficient, effective and patient-centred clinical trials.
To develop a template that would be acceptable across the health and medical research sector, CT:IQ set up a multisectoral project team. This included representatives of sponsor companies, researchers, sites, consumers, and human research ethics committee members. The project team identified emerging best practices in PICF development and surveyed consumers and other interest-holders on their PICF experiences and preferences. Survey findings showed a widespread desire for PICFs to be more concise and less legalistic. A clear message that came through was that ‘shorter isn’t always better’. Instead, people wanted a form that was easy to navigate, visually appealing, and provided only the information they needed to know to make an informed decision about participation.
CT:IQ developed a draft template and tested it through a series of dedicated consumer workshops. CT:IQ worked closely with the study team for three research projects — a cardiovascular device trial, a kidney disease drug trial, and a survey on body image involving young people — to develop a study-specific PICF based on the InFORMed template. We then recruited workshop participants who met the study eligibility criteria to see if the PICF would meet their needs. Feedback from these workshops were incorporated into the InFORMed template, including simplifying the privacy language and including information about research benefits as well as risks.
One of the most ethically and legally complex aspects of PICFs is requests for future use of participants’ data and biological samples. In partnership with the Australian Research Data Commons (ARDC), CT:IQ set up a dedicated team to develop a National Data Sharing Statement to develop clear and accurate language to support such consents.
After a further round of consultation, the InFORMed template and an associated User Guide were launched in June 2024. The template encourages users to:
- write in a clear, direct and conversational way;
- keep information short, simple and relevant, including through the use of layered consent strategies;
- make the layout easy to navigate and include visual and other multimedia aides; and
- involve consumers in developing PICFs.
Meaningful change will require thoughtful implementation
In February 2026, the NHMRC updated its website to endorse the use of the InFORMed template for Australian human research.
National endorsement of the InFORMed template positions Australia well when it comes to genuinely consumer-centred PICFs. However, it’s important to remember that the template is just a tool and not an end in and of itself.
For meaningful change to take place, all involved in health and medical research must commit to thoughtful adoption. Ways to do this include:
- Engaging with people with lived experience early and often. This is crucial for understanding what information is meaningful to include in the PICF and the language in which it should be expressed.
- Adapting the template in ways that work for their study, including by adding plain language descriptions of research interventions. A number of tools are available to help with this process, such as the Sydney Health Literacy Lab, which includes an online health literacy editor.
- Considering the creation of multimedia and other innovative approaches to providing participants with information in ways that best suit their needs. This may include electronic consent platforms, videos, comics, and many more options.
Dr Lisa Eckstein is the CT:IQ Director and Ethics Specialist for Bellberry. She holds an adjunct position as Senior Lecturer in the Faculty of Law at the University of Tasmania.
The statements or opinions expressed in this article reflect the views of the authors and do not necessarily represent the official policy of the AMA, the MJA or InSight+ unless so stated.
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