Entering a New Consent for Age of Majority

Age of Majority Consent for the Research Database

*Age of Majority Consent definition – each U.S. state has its own age of majority which is the legally defined age at which a person is considered an adult, with all the attendant rights and responsibilities of adulthood. The age of majority is defined by state laws, which vary by state, but is typically 18 in most states. The definition of Age of majority may be defined differently in other countries.

*Centers under oversight of the NMDP IRB are required to obtain Age of Majority Reconsent for participants to continue on-study. If your center uses their local IRB for this study, please confirm with your IRB if Age of Majority Reconsent is required. If your IRB has approved a waiver of Age of Majority Reconsent, please send a copy of the approval to DatabaseIRB@nmdp.org

Centers should make every attempt to contact recipients to obtain the age of majority consent. Having a process in place will ensure that consent is obtained in a timely manner. If the recipient has declined or is unable to reconsent, 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.

!NOTE: If the recipient declines to be consented or the age of majority consent is not obtained, the Consent Tool will change ALLO (related and unrelated) recipients from the CRF track to the TED track.

Process for ADDING the Age of Majority Consent Date

Select Add New Consent

• If Q1 = Yes
  • Answer Q2, Q3 and Q9
  • Q9 = Site Initiated Reconsent
• If Q1 = No
  • Answer Q4, and Q9
  • Q9 = Withdrawn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.
  

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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.