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Additional file 2. Draft Participant Information Sheet. consent form removed.

Additional file 3. Final Participant Information Sheet Approved by the Ethics Committee Reviewing the SNAP Trial. consent form removed.

Additional file 1. Semi-Structured Moderator’s Guide. Used for the focus groups and interviews conducted in the study.

Background: Embedding trials into the health system requires risk-based approaches to their conduct. This includes streamlined ways to obtain consent when patients participate in trials. Risk-based approaches to consent can improve trial efficiency, but it is unclear whether the models used internationally can be adopted in Australia. Objectives: This thesis aims to contribute to evidence on risk-based consent to support the embedding of trials in the health system and to contribute to the implementation of risk-based consent models through the development of evidence-based guidelines. Method: A literature review and analysis of regulatory frameworks was conducted to clarify international frameworks for the use of risk-based consent in a learning healthcare system context, and to confirm patient perspectives on their use. Studies were conducted to quantify the length and complexity of PICFs in Australia and to gather consumer perspectives on a novel intervention to simplify consent documents, known as integrated consent. Findings: Several factors support the embedding of trials and risk-based consent, including supportive governance frameworks and greater engagement of clinicians, who are the linchpin for increased trial activity. A range of consent models are feasible in Australia, but further work is required before they can be fully implemented. Conclusion: Waiver of consent and verbal consent are feasible, but requires explicit clarification in the National Statement that they can be used for trials. Although international evidence suggests patient support for these models, Australian research would facilitate implementation. Integrated consent, which provides participant information in layers, is supported by patients and is a promising intervention to improve written trial consent. Privacy law may also support a no-consent model for some trials that are considered quality improvement research.