Age of Majority Consent for the Research Database

Centers should make every attempt to contact recipients to obtain the age of majority consent. A process in place will ensure that consent is obtained in a timely manner. If the recipient has declined or if unable to re-consent, centers should still update the status in the Consent Tool. If you have additional questions, please consult your center’s IRB specialist.
Using the Consent Tool in FormsNet3, centers should ADD a new record when reporting a recipient’s age of majority consent.

Process for ADDING the age of majority consent date:

Select Add New Consent

  • If Q1 = Yes
    • Answer Q2,3, and 6
    • Q6 = Site Initiated Consent
  • If Q1 = No
    • Answer Q4, and 6
    • Q6 = Withdrawn

Examples

If age of majority consent is not obtained before a form is submitted, and the form is now past due (other than the 100d), the site should use the Survival Tool to report the survival status of the recipient for that visit.

  • ALLO recipient on TED track: if the consent has not yet been obtained, centers should continue to submit forms as required for SCTOD reporting (applies to US patients only).
  • ALLO recipient on CRF track: if the consent has not yet been obtained but the recipient has been contacted for age of majority consent, centers should update the form status from DUE to SUR using the Survival Tool. The form will not be made DUE again once consent is obtained and reported in the Consent Tool. Data reported on the SUR form will be captured on the recipient’s next follow up form.
  • Auto recipients (CRF or TED): if the consent has not yet been obtained but the recipient has been contacted for age of majority consent, centers should update the form status from DUE to SUR using the Survival Tool. The form will not be made DUE again once consent is obtained and reported in the Consent Tool. Data reported on the SUR form will be captured on the recipient’s next follow up form.
Last modified: May 12, 2021