Minors Reaching the Legal Age of Consent While Enrolled in a Study

Long-term studies may involve subjects who are minors at the time of enrollment but who reach the legal age of consent (18 years of age) while study or follow-up procedures are still ongoing. The UI IRB considers on a study-by-study basis whether obtaining new consent from each subject is required or whether a waiver of consent may be granted.  If there is continued interaction with subjects who were first enrolled as minors, the IRB typically requires researchers to obtain a new consent when a subject reaches the legal age of consent.


If a subject reaches the age of consent while still participating in research interactions, then the Investigator will need to detail the plan to reconsent this subject in HawkIRB question VII.D.29 of the HawkIRB application. Ideally, this plan would be in place when the study is first approved by the IRB. But it could be added later, prior to the first subject reaching the age of majority.

Depending on the nature of the study, the consent process may be conducted by one or more of the following methods:

  • In-person
  • By mail
  • By email (with a pdf. version of the consent form to ensure that the signed document includes the IRB approval stamp), or
  • eConsent process (see guidance on the Educational Tools page)

All materials utilized to obtain the new consent, such as a letter, phone script, or email explaining the requirement, should be attached to the HawkIRB application.

Waiver of Consent

If the investigator will not have any interaction with the subject after they turn 18, but there is ongoing data analysis or data collection from the medical record, either describe the plan to obtain a new consent in Section VII.D.29 or request a waiver of consent for these subjects in Section IV.3-19.

With proper justification, the IRB may approve a waiver of consent for ongoing data collection from the medical record after the subject reaches the legal age of consent under 45 CFR 46.116(d).

IRB Policy

For additional guidance, see the UI IRB Standard Operating Procedures and Researcher Guide, Section  II, Part 17.A.ii (Minors aging up process).