Do research participants have to sign a consent document?
The IRB may waive the requirement to obtain written documentation of informed consent if the research meets certain conditions. See “CHECKLIST: Waiver of Written Documentation of Consent (HRP-411)” for the criteria the IRB uses to determine whether a waiver of written documentation of consent is acceptable. If the IRB grants a waiver of documentation of consent, you are still responsible for incorporating all of the principles of informed consent and conducting a comprehensive verbal consent process to obtain the voluntary consent of participants. Once consent is obtained, the consent process should be documented within the research record.
Include study-specific information in your protocol to support your request for a waiver of documentation of consent. A participant or Legally Authorized Representative must sign a consent document if the IRB has not waived the requirement to obtain written documentation of informed consent.