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Trial planning

Participant recruitment and consent

As part of the clinical trial team, you’ll require a range of recruitment materials to ensure participants give their informed consent.

Participant recruitment and consent is an important part of the project plan for clinical trials. In the planning stage, trial personnel create the Participant Information Sheet and Consent Form (PICF) and a range of recruitment materials.

The clinical trial project plan outlines procedures and guidelines for the recruitment stage. As the first step in this process, the research team will draft and seek input for a range of participant-facing resources, including a Participant Information Sheet and, separately or as part of the same document, a Consent Form (collectively known as a PICF or PISCF).

The research team will also develop a range of recruitment materials, including offline and online materials. These resources give potential participants the information and support they need to give their informed consent.

Here’s what you’ll need to do in the participant recruitment and consent stage of your clinical trial:

draft a Patient Information Sheet and Consent Form with essential information about the trial, including its purpose, the steps involved, and potential risks and benefits for participants
ensure the PICF meets the requirements of good clinical practice and ethical guidelines, and if needed, seek additional approval from a Human Research Ethics Committee (HREC)
before finalising the PICF, seek input from consumers; this may involve consulting participant experience surveys from previous trials or making resources available in different formats and languages
develop and seek the required approval for recruitment materials, which may include a range of offline and online materials such as flyers, emails, landing pages, videos or social media posts.