The InFORMed template has been developed by CT:IQ to support a participant-centred, simplified Participant Information and Consent Form (PICF) for Australian health and medical research. Background to the project and its core principles can be found in this webinar, held on 17 May 2024.

The InFORMed template was developed by a project team of 35 individuals, including representatives of sponsors, sites, researchers, contract research organisations, consumers, Human Research Ethics Committee members, government departments, and more. The team undertook consumer surveys and consumer focus groups to understand what information consumers wanted in PICFs and how they wanted the information presented. CT:IQ partnered with the Australian Research Data Commons to develop privacy law information and a national data sharing statement as a component of the InFORMed template. Australian health and medical research stakeholders were given an opportunity to provide feedback on a beta-testing version of the template. The template has undergone a plain language review as well as a legal review.

It is important to remember that more words on a page doesn’t necessarily mean more information is being provided or that potential participants are gaining more understanding from the PICF. The opposite can be true when long and complex PICFs obscure material information. In addition, consent should be seen as a process rather than a form, and we anticipate that with many research projects the information in the template will be supported by an opportunity to discuss the research project with a team member.

The InFORMed template has been reviewed by the project team for compliance with the National Statement on Ethical Conduct in Human Research (2023) and Australian privacy laws. (Noting that we do not recommend the template at this stage for genomics research, which raise additional ethical and legal issues that the template does not at this stage address.)

The InFORMed template is suitable for use with either paper-based or eConsent (including dynamic consent). If eConsent is being used, researchers should liaise with reviewing Human Research Ethics Committees to ensure the consent process and documentation satisfies regulatory requirements.

Absolutely. The InFORMed template is designed to facilitate the development concise, consumer-focused PICFs. We think that the black text will be relevant for many/most research projects, but you may still wish to make changes to some of the content or language to best suit your research or consumer group. Text is in orange when we think it will need to be changed to suit most research projects. Either way, the wording is intended to provide researchers with a starting point—not a pre-determined conclusion.

The InFORMed template has been developed to be used for most types of research. It is deliberately flexible, to allow it to be adapted for different research contexts.

There are some specialised areas of research for which the InFORMed template is not presently suitable. In particular, for research involving predictive or diagnostic genetic testing, we recommend that templates recently developed by Australian Genomics should be used to ensure all relevant legal and ethical considerations are addressed. 

The InFORMed template has been designed to contain the key important information that a potential participant should need to decide whether to participate in a research study. The project team has sought to make the information concise, simple, and easy to navigate.

The template encourages researchers to focus the PICF on the key information that a potential participant would need to make a decision. Additional information that is not likely to be required to make that decision (e.g., a detailed study schedule or lengthy privacy policy) can be provided as supplementary information for participants who choose to seek it out. This ensures that important information is not obscured by unnecessary detail. The InFORMed user guide provides additional information on how to assess whether information should be included in the main body of the PICF or in supplementary information. We recommend that researchers seek feedback from relevant consumers to understand what information they consider to be material for decision making.

The InFORMed template is designed to be flexible. We would encourage researchers to use it as a starting point but recognise that not all of the headings and suggested text may be applicable to all research projects. If certain headings and text are not relevant to your project, feel free to delete them. The InFORMed template should be seen as a tool rather than a requirement. If the template does not fit the research project you are undertaking, you may decide to use the layout and language of the template as inspiration rather than direction.

The InFORMed template focuses on shortening and simplifying the PICF, which we believe will assist in decision making for persons not fluent in reading English, including culturally and linguistically diverse participants. We also recommend using pictures and diagrams as a supplement written information to improve comprehension and understanding.  Project teams could also consider developing narrated versions of the PICF.

For research targeting specific participant populations, such as Aboriginal and Torres Strait Islander peoples and communities, we encourage those developing the PICF to consult with representative consumer groups to ensure that the content, language, and visuals are culturally appropriate.

Some PICFS have a summary page setting out key information about the research project. These can be very useful for long and complex PICFs. Given the InFORMed template is designed to produce a concise, well laid out and easy to understand PICF, we have not recommended the use of a summary page. If, even after using the InFORMed principles, your PICF is long and complex, you may consider adding a summary page.

Given most research participants withdraw from research without using a withdrawal form (e.g., by contacting the principal investigator), we have not included one in the template.   

Yes, any consumer facing information will need to be reviewed by an HREC, including supplementary material.  

We have sought to ensure that the InFORMed template is consistent with the requirements set out in relevant Australian laws and regulations, including Commonwealth, state and territory privacy requirements and the NHMRC National Statement on Ethical Conduct in Human Research. We have received a legal review of the template and consulted with persons with legal and ethical expertise. Reviewing HRECs and research governance officers may advise of information specific to a jurisdiction or a site that should be included in addition to the standard InFORMed template.

We would note, however, that the aim of the InFORMed project is ensure that PICFs meet their primary purpose: to provide consumers with the information that they need to decide whether to participate in a research project. We heard from consumers that PICFs are often intimidating and legalistic, which can make it harder for them to understand the information they need to know.   

CT:IQ is in ongoing discussions with the National Health and Medical Research Council and Australian government departments to progress implementation of the InFORMed template. Further information will be made available as discussions progress. The implementation process is anticipated to include the development of a suite of more specific templates, including for paediatric research and medical treatment decision makers consenting on behalf of a trial participant.

We will be publishing examples of PICFs that have been developed using the InFORMed template as they become available.