SIMPLY-SNAP: Evaluating the impact of a SIMPlified Layered consent process versus a conventional informed consent form on recruitment of potential participants to a large platform clinical trial: a pragmatic nested randomized controlled trial

We are enrolling potential SNAP trial participants to this sub-study to test out different consent processes and their impact on recruitment, participant understanding, and participant satisfaction.

• Existing clinical trial consent forms are long and complicated, and patients can be overwhelmed with too much information. This can lead to counter-productive effects such as deterring patients from participating in a clinical trial, or unintentionally discriminating against patients with less privileged educational or socio-economic backgrounds.
• In this study, we are evaluating the use of a novel simplified layered consent process, where summarized information is provided in a 4-page concise participant information sheet, with links to additional information that can be accessed separately for participants who wish to read more.
• We are comparing this to the conventional informed consent form where all information is provided upfront, and assessing if there is any difference in recruitment, participant satisfaction, and participant understanding of the clinical trial with these two different consent methods.