COMPLETING THE WAIVER OF CONSENT APPLICATION
OVERVIEW
This Quickguide provides instructions for completing the Waiver of Consent (WoC) Application.
BEFORE YOU BEGIN
- Consider printing a copy of the Waiver of Consent Request Supplemental Form to use as reference as you complete the Application in IRBManager.
- Review the Determining Waiver of Consent Requirements Quickguide to determine if a waiver of consent is appropriate.
INSTRUCTIONS
The investigator or designee answers all questions on the CIRB Waiver of Consent Application.
COMPLETE THE WAIVER OR ALTERATION OF REGULATORY ELEMENTS OF INFORMED CONSENT QUESTIONS
- Question 1: Select the type of waiver requested. For more information on this determination, refer to the Determining Waiver of Consent (Woc) Quickguide. If a waiver or alteration of the required elements of consent is requested, use the checkboxes to select the elements being waived or altered. Use the text box to provide a description of research activities and a rationale for waiving or altering the selected elements.
- Questions 2-6: These questions are used to document the regulatory criteria necessary for approval of a waiver or alteration of the elements of informed consent. Answer each question and use the text box to provide the details of research activities or rationale as requested.
COMPLETE WAIVER OF DOCUMENTATION OF INFORMED CONSENT QUESTIONS
- Questions 1-4: These questions are used to document the regulatory criteria necessary for approval of a waiver of documentation of consent. Answer each question and use the text box to provide the details of research activities or rationale as requested.