Adolescent Self-Report, Proxy Consent, and a Safety Alert

Adolescent ePRO requires separate attention to legal consent, developmental assent, and confidentiality. The caregiver may give permission, but the adolescent's assent must be documented in a way the adolescent can understand, and the adolescent should be told who can see the diary and under what circumstances. Using the caregiver's phone does not make the caregiver the data subject. If the adolescent completes entries on a shared family device, privacy is compromised unless the app has a private session, a passcode, and a clear logout, or the participant is offered a provisioned device. The caregiver's request to see entries should not be granted automatically. Check the protocol, consent forms, and local law: some jurisdictions give adolescents confidentiality rights for certain health information, and safety limits may require disclosure. The site should explain to the caregiver what will and will not be shared before enrollment, not after a request. Switching the mood item to paper may reduce digital access but creates a visible paper trail in the home, which may be worse for privacy. Fix the digital privacy controls first.

An alert that lands in an unmonitored inbox is not a functioning safety workflow. The protocol requires follow-up within 24 hours, so the workflow must specify who is responsible at all times, including weekends and holidays. Options include a rotating on-call site clinician, a central triage service with escalation to the site, or a documented next-business-day rule only if the protocol and safety team have accepted it. The alert should contain the minimum necessary information, not the full diary, and should be delivered through a monitored channel with acknowledgement. The site must document the time the alert was received, the time of contact, the outcome, and any escalation. A score of 3 should trigger a clinical conversation, not an automated message to the participant. The vendor and sponsor should test the workflow end-to-end before the next participant enrolls. The three existing scores need retrospective review now, with documented follow-up even if late, and the deviation should be reported through the appropriate safety and monitoring channels.

Respond to the caregiver with the confidentiality rules that were explained at assent, not with the diary content. The coordinator can acknowledge the caregiver's concern, explain that the adolescent's answers are kept private within the limits described in the assent, and offer a clinical discussion with the adolescent present if there is a safety concern. If local law or the consent form gives the caregiver access, that must be stated clearly and applied consistently; it should not be invented at the moment of request. For the shared tablet, offer a provisioned device or a private app session with a passcode, and confirm that the adolescent can complete entries without others seeing them. Do not switch the mood item to paper without assessing whether a paper form in the home is more or less private; in many households, paper is more discoverable. Any change to the mode of administration would also need protocol and ethics review. Document the caregiver request, the response, and the privacy remediation.