NSW Health has released the revised Human Research Ethics Committees – Standardised Participant Information and Consent Form (PICF) Guideline [GL2025_019], marking a major step toward participant-centred research. This update simplifies the consent process, making research participation clearer, more inclusive, and easier to navigate for participants and NSW Health staff.
The new Guideline introduces plain language, layered structure and shorter documentation that empowers participants to make informed decisions about their involvement in clinical trials. By prioritising clarity and flexibility, it ensures that consent is not just a formality but a meaningful process.
The Guideline adopts the InFORMed PICF Template, User Guide, and Withdrawal Form which were developed by CT:IQ with support from the Office for Health and Medical Research (OHMR). These resources were co-designed by CT:IQ with input from over 700 stakeholders, including researchers, clinicians, ethics committees, governance staff, and consumers. OHMR led an extensive 18-month consultation across the sector, engaging Chief Executives, Human Research Ethics Committees, researchers, and industry representatives, shaping a model that meets ethical and legal standards while improving usability.
A priority of ours is to make research participation clear and accessible. The feedback from our final consultation confirmed we’re on the right track, with stakeholders strongly supporting the move toward a simpler, participant-focused approach. Co-design was critical to this success. By working alongside researchers, clinicians and consumers, we’ve created a framework that genuinely reflects the needs of those involved. This Guideline will empower people to make informed choices and ensure clinical trial participation is easier to understand and navigate.
This initiative highlights our commitment to implementing the NSW Research and Innovation Strategy outcomes. By building on national resources and fostering partnerships, we are demonstrating how collaborative reform can deliver practical benefits for participants and researchers alike.
The revised guideline generated strong interest and positive feedback from the sector at the recent ACTA conference, where Senior Policy Officer Ambika Murthy showcased OHMR’s pivotal role in making research participation clearer, more inclusive, and easier to navigate.
Implementation planning is now underway across NSW public health organisations, supported by structured evaluation and feedback processes. This work reflects a shared commitment to making research participation accessible, transparent, and participant-focused.