Options for Exchange of Information
OPTION 1: Verbal Exchange
A verbal exchange of information can occur at a study visit or in a phone conversation with the content of the conversation documented in a research record. Information should only be shared in this way if it does not affect risk to subject.
OPTION 2: Informational Sheet
An informational sheet is as it sounds. The content includes the new information in a medium that the subject can reference. The informational sheet does not require a subject signature, but investigators need to document that the sheet was provided to the subject in a research record. Information shared in this way typically does not substantially affect risk to subject. IRB review and approval of the informational sheet is required prior to distributing to research subjects.