The revised Common Rule included a new requirement for researchers to provide a concise and focused summary of key information about the study to potential subjects prior to presenting the full Informed Consent Document. This presentation will explore the regulatory requirement, including the justification for this change and how to determine what to include as key information based on the study and the subject population. Attendees will consider the subject perspective as they draft a key information summary for a fictitious study protocol. Attendees will be able to apply the content of the presentation to assist them in writing clear and concise summaries of key information for their own research studies.

Pre-registration is recommended.