When is reconsent required?
Age of majority reconsent will be continuously required for all participants enrolled to the CIBMTR Research Outcomes Database Protocol via 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.
As of October 25, 2024, this update will occur on the patient’s 19th birthday instead to allow centers a year to reconsent the patient before the quarantine is effective.
As of October 24, 2025, this update will return to 18 years and be extended to all active patients, even if those patients turned 18 prior to July 2023.
What about patients who reached age of majority prior to July 2023?
For patients who reach the age of 18 and if that patient has not yet provided consent as an adult to participate in the Research Database Protocol, the NMDP IRB has granted a 2 year Waiver of Data Use allowing continued use of their data collected under the minor consent previously provided. The 2 year waiver commences on their 18th birthday. Centers should begin making attempts to reconsent these patients at their next follow up visit or sooner. CIBMTR will continue utilizing data for research regardless of age of majority reconsent status until 2 years after the patient birthdate OR if adult consent has been provided. Note, patients who were appropriately approached to reconsent after age of majority, and declined, will NOT have data used for research.
CIBMTR expects centers to reconsent these AOM patients at their next visit to ensure uninterrupted reporting. 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. 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 participation in Research Database research activities. Data required for reporting purposes will be collected on the appropriate track, based on the infusion.
How long should centers try to obtain reconsent?
Centers have up to 2 years after the patient’s 18th birthday to obtain the adult consent.
What will happen to the submitted data if reconsent cannot be obtained?
Data is available to be used for until 2 years after the patient’s 18th birthday. If the center is actively submitting data to CIBMTR, the reason they are unable to reconsent the patient should be provided. If the center is no longer actively submitting data, consideration to move the record status to lost to follow up should be considered
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. FormsNet3 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 continue to complete and submit data, however, without reconsent, the data can only be used for research for up to 2 years after the patients AOM date.
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. CIBMTR understands that it may not be feasible to reconsent all patients in-person. Therefore, we encourage sites to utilize remote consent if possible 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.
Do I have to reconsent a patient if they have transferred to my center?
Yes. If your center is actively reporting data on a patient, your center should have approached that patient about consenting for the research database and provided their response in FormsNet.