Waiver of the Requirement to Obtain Written Documentation of the Consent Process (Option #2) Checklist
D) Waiver of the Requirement to Obtain Written Documentation of the Consent Process (Option #2) Checklist: All conditions must be met:
D) Waiver of the Requirement to Obtain Written Documentation of the Consent Process (Option #2): All conditions must be met:
(1) The research presents no more that minimal risk of harm to participants.
(2) The research involves no procedures for which written documentation of the consent process is normally required outside of the research context.
(3) The investigator has provided a script of the consent discussion that meets the requirements for the consent process and includes all required and appropriate additional elements of consent disclosure.
(4) The IRB has considered whether the investigator is to provide written information to the participant that includes all required and appropriate additional elements of consent disclosure. Required?