Informed consent is a cornerstone of ethical medical practice, ensuring that participants are fully aware of the risks and benefits associated with treatments in clinical research studies. This presentation explores the critical role of clear communication in conveying safety and contraception information within informed consent documents. We will examine regulatory and ethical frameworks, effective risk mitigation strategies, and practical communication techniques.

We will summarise the process of continuous safety updates within clinical development and demonstrate how Lay Language Medical Writers can extend this process to integrate regular safety updates into Informed Consent Forms. We will describe how to extract and convert relevant information for potential clinical study volunteers. Examples will be provided to illustrate how safety language can be simplified to be both acceptable to researchers and understandable to participants. Additionally, we will discuss the evolution of safety content from early investigational drugs to approved medicines on the market, including adjustments for communicating safety to children and adolescents.

By sharing feedback from patients, doctors, sites, and ethics committees, we will highlight the challenges of implementing clear communication of safety and contraception information. Attendees will gain insights into overcoming common challenges and implementing best practices to enhance patient understanding and decision-making.