Informed Consent: Overview

Informed Consent: Overview

Signed consent

The default is signed, written consent; the IRB expects that written consent will be obtained from all participants, unless a justification is provided.

The regulations require that the following information must be conveyed to each subject:


Written consent forms can be created with the help of the Consent Form Wizard.  Be sure to proofread and edit the drafts generated from the Consent Form Wizard.

For questions or more information regarding the requirement of informed consent, please consult IRB Guidance: Informed Consent