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 very 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.  

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 highlighted in yellow 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 designed to contain the key important information that a potential participant should need to make a decision 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 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 those who choose to seek it out. This ensures that important information is not obscured by unnecessary detail.

It will be helpful to get feedback from relevant consumers on 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 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 to better display information to improve comprehension and understanding.  Project teams could also consider developing narrated versions of the PICF.

We would love to showcase examples of translations or other modifications of the InFORMed template to improve clinical trial diversity. If this is something that you are interested in doing, please get in touch with the project team.

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 could consider a summary page.

Absolutely! We have provided a formatted template template for those people who don’t have the time, resources or inclination to create their own.  We have also provided an unformatted template, so that you can use whatever colours or icons that fit with your study. 

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

Yes, any consumer facing information will need to be reviewed by an HREC. During the consultation period, we will be engaging with HRECs to ensure that the review process works as smoothly as possible. 

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 a number of persons with legal and ethical expertise. If you believe that there are legal or ethical requirements that are not addressed by the template, please give us your feedback so we can review them as a part of our broader feedback process.

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.