Completing The Assent Waiver Worksheet

Completing The Assent Waiver Worksheet

OVERVIEW

This Quickguide provides instructions for completing the Assent Waiver Worksheet.

BEFORE YOU BEGIN

  • Review the Determining Assent Requirements Quickguide to determine if assent is required by the CIRB.
  • If assent is required, but the child is unable to provide assent, then request an assent waiver prior to enrolling the child in the study.
  • You’ll need an active Cancer Therapy Evaluation Program (CTEP) Identity and Access Management (IAM) account to access RUMS on the CTSU website and you must have an assigned role on the CIRB roster for your Signatory Institution to view the CIRB roster in RUMS. For more information, go to Individual Roles within the CIRB. If you are a Consortia site, go to Navigating the CIRB as a Consortia Site for information on how processes vary for you.

INSTRUCTIONS

The investigator or designee answers all questions on the Assent Waiver Worksheet.

Steps

COMPLETE THE REQUESTING AN ASSENT WAIVER WORKSHEET QUESTIONS

  • Question 1: The submitting user information is auto-populated. Use the Cancer Trials Support Unit (CTSU) Roster Update Management System (RUMS) to change the auto-populated information relating to the person submitting and the name of the institution. For more information, go to Updating Your CIRB Person Roster Using RUMS.  
  • Question 2: Enter the complete study ID number.  For example, you must enter NRG-GY004 and not just GY004.
  • Questions 3-4: These fields are used to record the name and email address of the enrolling investigator or PI for the study requesting the assent waiver.
  • Question 5: Attach the letter signed by the enrolling investigator or the PI for the study requesting the assent waiver. The letter should contain the following information:
    • A study ID or unique anonymous identifier for the specific child
    • The age of the child
    • An explanation of why the child cannot provide assent
    • The signature of the enrolling investigator or the PI for the study
  • Question 6: Select the institution associated with this submission. In most cases, only one is available in the dropdown selection.  If the submitter of the Worksheet is associated with more than one institution, be sure to select the one associated with this submission.
  • Questions 7-9: From the letter attached in Question #5, enter the age of the child, the Participant Registration Number or another unique anonymous identifier assigned to the child, and the reason the child cannot provide assent.
  • Question 10: Attach any other supporting document you feel the CIRB would need to complete the review.

USEFUL TIPS

If you feel you have questions completing this Worksheet, contact the CIRB Helpdesk.

Posted: December 20, 2017