General Guidance - Protocol Design

Investigators must include in their protocols a thorough description of the process by which potential subjects will be asked to participate in their research study. The protocol must describe a process that allows potential subjects sufficient time to consider participation; removes any impediments to the autonomy of the individuals as they ponder participation; and includes procedures that evaluate a potential subject’s understanding of study procedures, risks, and benefits. In some cases a third party is included in the consent process to serve as a witness or as a surrogate decision-maker. After agreeing to participate, subjects are typically asked to sign a consent form. Consent forms must contain specific information and be written in a style that is readily understandable to subjects.