North Texas Regional Institutional Review Board
University of North Texas Health Science Cent
er
Guidance and Procedures for Investigators
Topic: When Minors become Adults (during a research study)
In studies involving children (generally speaking, anyone under age 18), the parent gives
permission for the child to participate via a Parental Permission Form, and the child must also
“assent” to be in that research project, again via a Child/Adolescent Assent Form. In some cases,
the study continues long enough for that child to turn age 18 or otherwise become an adult
(marriage, enlistment in armed forces, etc.). When a child research subject becomes an adult,
and is still involved in that research study, regulations require that former child (now an adult) to
“re-consent,” now as an adult, to continue to participate in research. Usually this is done with a
re-consenting process using an adult consent form, indicating that the child-now-adult has full
legal decision-making authority and responsibility for their involvement in the project.
Below are some guidance points and suggestions for managing this transition from child subject
to adult subject.
Statement to include in Protocol Synopsis
Re-Consenting Minors
“Participants enrolled in this study as minors will be re-consented as adults when they turn 18
years old if they are still actively participating in this study. Re-consenting will occur at the next
available opportunity (i.e. next study visit, contact point, intervention, etc.) upon reaching
majority.
Statement for Parental Permission Form
“If your child becomes an adult (turns 18 years old) while they are still actively participating in
this research, we will request that he or she provide their consent (agreement) to continue their
participation in this study.
Statement for Adolescent Assent Form
If you become an adult (turn 18 years old) during this study, we will ask you if you want to
continue to be in this study as an adult.
Created January 20
10; Revised February 2018
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