Turning 18 During an Amendment Re-Consent
A 16-year-old, Maya, enrolled 5 months ago in a pediatric asthma trial. Her mother signed the parental permission form and Maya signed the assent form. The IRB recently approved an amendment that adds an optional bronchoscopy with bronchoalveolar lavage at week 24 and a separate genetic substudy. The amendment requires re-consent of all active participants and states that subjects who reach the age of majority must sign an adult consent form; parental permission is no longer valid. Maya turned 18 two weeks ago. At the re-consent visit, her mother signs the amended parental permission and says, 'I decide what she does; she is still in high school.' Maya says she wants to stay in the study but does not want the bronchoscopy or genetic testing. The next scheduled study visit is in 10 days. The protocol says the bronchoscopy is optional, but the genetic substudy has separate consent.
1. Who must sign which consent documents, and what can Maya decline?
Read the worked answer
Maya is 18 and legally an adult, so she, not her mother, must sign the adult consent form for continued participation. The mother's parental permission is no longer valid for any study procedure after Maya's birthday. The coordinator should give Maya a private, unhurried re-consent discussion, use teach-back, and document it. The bronchoscopy is optional and the genetic substudy has separate consent; Maya can decline either without being withdrawn from the main study, provided the main study consent is signed. Check whether the IRB-approved main consent allows continued participation without the optional procedures. If Maya signs the main adult consent and declines optional parts, record her choices on the correct signature or checkbox pages. Do not let the mother sign for her or pressure her. If Maya had impaired decision-making, follow the IRB's legally authorized representative process, but there is no evidence of that here.
2. How should the coordinator handle the mother's insistence and protect Maya's voluntariness?
Read the worked answer
Meet Maya alone first, explain that her mother can remain for support only if Maya wants, and clarify confidentiality: her study choices are hers to make. Acknowledge the mother's concerns and explain that once a participant turns 18 the IRB requires adult consent; this is not a judgment about the family. Avoid framing the optional bronchoscopy as needed to stay in the study. Ask Maya open-ended questions about her understanding of risks, alternatives, and voluntariness. If she declines the genetic substudy, do not send her sample or collect it. Document the private discussion and Maya's choices. If the mother becomes coercive, pause and reschedule; do not obtain a signature under pressure. Notify the PI if family conflict is affecting voluntariness. The coordinator should not act as a family mediator but must ensure the signature reflects Maya's own decision.
3. What if Maya declines the amendment re-consent entirely but wants to keep coming to visits?
Read the worked answer
If Maya declines the amendment re-consent entirely, the site cannot continue study procedures under the old consent after the IRB-required re-consent date. The coordinator should explain the consequences, ask whether she will consent to continued safety follow-up if the protocol and IRB permit a separate consent, and arrange a safe withdrawal from study intervention with the PI. Do not continue dispensing investigational product or performing research procedures without valid consent. Document the refusal, the discussion, and the withdrawal plan; notify the sponsor and IRB as required. If Maya later changes her mind, re-consent can be revisited, but only voluntarily. The reasoning is that re-consent is not a clerical update: when risks or procedures change, continued participation requires valid, current consent from the now-adult participant.