When is reconsent required?
Age of majority reconsent will be continuously required for all participants enrolled to the CIBMTR Research Outcomes Database Protocol under minor consent. Centers under the oversight of the NMDP IRB are required to follow the NMDP IRB’s guidelines which require this at age of majority. If your center is under oversight of your local IRB, the center must follow their guidance. If your local IRB has approved a waiver of consent, send the waiver to DatabaseIRB@nmdp.org to maintain a record of this waiver.
When was this change implemented?
As of July 28, 2023, CIBMTR began identifying recipients turning 18 at US centers and updating their consent status to Reconsent Pending. This process is completed monthly.
What about patients who reached Age of Majority prior to July 2023?
The NMDP IRB has granted a waiver of data use on these participants until August 17, 2024. The CIBMTR will continue utilizing data for research regardless of Age of Majority reconsent status until that date. Note, participants who were appropriately approached with reconsent after age of majority, and declined, will NOT have data used for research.
Centers should begin making attempts to reconsent these patients at their next follow up visit or sooner. After August 17, 2024 the CIBMTR will provide further communication regarding disposition for any participants that have not yet been reconsented.
This decision by the NMDP IRB applies to centers under the NMDP IRB and centers under the oversight of their local IRB. For centers under the oversight of their local IRB, a local determination may be substituted for the NMDP IRB’s decision. This documentation must be provided to DatabaseIRB@nmdp.org
Why was this change implemented?
Age of Majority reconsent is a critical component of the informed consent process. The CIBMTR is committed to ensuring that our participants’ right to consent is provided to them once they have reached their age of majority.
What are transplant centers expected to do?
Centers are expected to monitor recipients who were consented using a minor consent (i.e., < 18 years old). Once a recipient reaches the age of majority, the center will be required to reconsent the recipient using the current version of the study informed consent forms.
What should centers do if reconsent cannot be obtained?
If the recipient cannot be reached for reconsent via in-person or remote consent, the reconsent status can be updated accordingly and the recipient will be exited from the study. Data required for reporting purposes will be collected on the appropriate track, based on the infusion.
How long should centers try to obtain reconsent?
The Reconsent Pending status will automatically protect a recipient’s data from being used for research. We understand that follow-up schedules can vary. We expect recipients will be reconsented at their next follow-up visit.
What will happen to the submitted data if reconsent cannot be obtained?
Data that has already been submitted will remain in the database but will not be available for use in research.
What will happen to the forms if reconsent cannot be obtained? Will forms still come due?
If reconsent cannot be obtained, the consent status should be updated to No or Not approached (review instructions below on when to use these options) within the consent tool. FormsNet3SM will update the recipient’s track accordingly once the update has been submitted within the consent tool.
Can centers still complete and submit data while trying to obtain reconsent?
Centers can still be complete and submit data while reconsent is trying to be obtained; however, the data submitted will not be used for research when the consent status is Reconsent Pending.
Can centers still complete and submit data if reconsent cannot be obtained?
Centers can continue to complete and submit data, however, without reconsent, the data will not be used for research.
Who should the center contact with questions regarding Age of Majority?
Submit any questions through CIBMTR Center Support (FormsNet3 > Consent Tool)
When should each option in the consent tool be used for the reconsent status?
Select Yes if the recipient has been approached and signed a new consent form, indicating they agree to participate in the Research Database.
Select No in the following scenarios:
- The recipient has been approached with a new consent form but declined to participate in the Research Database
- The center contacted the recipient with the new consent form but the recipient did not respond
Select Not approached if the recipient is unable to be located or contacted for reconsent and no further attempts will be made.
Can remote consent be used to obtain Age of Majority reconsent?
Yes. The CIBMTR understands that it may not be feasible to reconsent all patients in-person. Therefore, we encourage sites to utilize remote consent if that is an available option at your center.
- For centers under NMDP IRB, remote consents must be done in compliance with Section 10 of the NMDP IRB SOP S00045 General Consenting Requirements.
- For centers under Local IRB, remote consents must be conducted in compliance with your local institutional guidelines.