Entering a New Consent for Age of Majority

Process for ADDING the Age of Majority (AOM) Consent Date

Using the Consent Tool in FormsNet3, centers should ADD a new record to report a recipient’s age of majority reconsent.

Select Add New Consent

• If Q1 = Yes
  • Answer Q2 Future Research Consent, Q3 Date Signed
  • Q9 Reason for Change should be answered “Site Initiated Reconsent”
• If Q1 = No
  • Answer Q4 Date Approached
  • Q9 Reason for Change should be answered “Withdrawn”

Reporting Follow-Up Data Without AOM Consent

For U.S. allogeneic patients on TED track, follow-up data can be submitted normally as required for SCTOD reporting because the consent status does not change the reporting expectation.

For all other patients (non-U.S., autologous, CRF), if age of majority consent is not obtained before a form is expected for CPI, the center should use the Survival Tool to report the survival status of the recipient for that visit. The form will not be made DUE again. Any clinical data that would have been reported on the SUR form should be reported on the recipient’s next follow-up form.

!NOTE: If the recipient declines consent or the age of majority consent could not be obtained, the Consent Tool will automatically update the follow-up forms to align with the new consent status. ALLO patients will be dropped to TED track and AUTO patients will have follow-up forms removed.

FormsNet Automated Update (Reconsent Pending Status) – U.S. Centers Only

If AOM reconsent has not been reported by the patient’s 19th birthday, CIBMTR will insert a “Reconsent Pending” row to quarantine that patient’s data from research until a new consent has been obtained.

When the reconsent has been obtained, centers should update the reconsent pending record in the Consent tool to provide the new consent.

Edit Reconsent Pending Record

• Answer Q1 Consent Status with new consent response
  • Answer questions 2-7, as applicable. FN3 will enable to correct questions based on the response in Q1.
  • Q9 Reason for Change should be answered “Site Initiated Reconsent”

!NOTE: If the new consent date provided is still prior to the patient’s 18th birthday, then a new reconsent pending record will be inserted in the next month’s update.

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CIBMTR® (Center for International Blood and Marrow Transplant Research) is a research collaboration between the Medical College of Wisconsin and NMDP.