Re-contacting minors enrolled in research upon their reaching the age of majority or maturity to seek their autonomous consent to continue their participation is considered an ethical requirement. This issue has generally been studied in the context of minors who are actively involved in the research. However, what becomes of this issue when the minor has been withdrawn from the research or has been lost to follow-up? May researchers re-contact the minor at the age of majority or maturity under these (...) circumstances to seek the consent of the minor to re-join the research? In this paper, we explore the ethical permissibility of recontacting minors whose participation in research has ended, once they have reached the age of majority or maturity. In particular, we identify scenarios in which the participation of a minor in a research project may end and discuss factors that can help determine such an ethical permissibility. Finally, we discuss the practical and ethical challenges of re-contact and present re-consent models that may be used by researchers. (shrink)

Children’s preferences about medical treatment—like the preferences of other patients—hold moral weight in decision-making that is independent of considerations of autonomy or best interests. In light of this understanding of the moral value of patient preferences, the American Academy of Pediatrics could strengthen the ethical foundation for its formal guidance on pediatric assent.

Background Deep brain stimulation is approved for treating refractory obsessive-compulsive disorder in adults under the US Food and Drug Administration Humanitarian Device Exemption, and studies have shown its efficacy in reducing symptom severity and improving quality of life. While similar deep brain stimulation treatment is available for pediatric patients with dystonia, it is not yet available for pediatric patients with obsessive-compulsive disorder, although soon could be. The prospect of growing indications for pediatric deep brain stimulation raises several ethical concerns relating (...) to bodily integrity, the ability to offer informed assent, and the role pediatric patients play in the decision-making process. Objective The aim of this study is to solicit and assess the views of stakeholders (children, parents, clinicians) on pediatric assent, autonomy, and bodily integrity in the context of potential pediatric deep brain stimulation for obsessive-compulsive disorder. Methods Semi-structured interviews were conducted with pediatric obsessive-compulsive disorder patients ( n = 21), caregivers of pediatric obsessive-compulsive disorder patients aged 14–18 ( n = 19), and clinicians with experience treating refractory obsessive-compulsive disorder ( n = 25). Interviews were transcribed and coded in MAXQDA 2018 and 2020 software and processed for thematic content analysis to isolate and compare specific themes. Results A majority of respondents (74%, 48/65) across all three stakeholder groups voiced that the decision-making process should be collaborative and involve everyone (clinicians: 84% or 21/25, caregivers 71% or 15/21, and patients 63% or 12/19). We identified a split between respondents’ views on who should have the final say in the event of disagreement (38% or 25/65 favored the patient versus 35% or 23/65 favoring caregivers). A split between respondents also emerged concerning the maturity relevant for deep brain stimulation decision-making, with 45% (29/65) favoring developmental maturity (age/physiological development) and 45% (29/65) favoring decisional maturity (capacity to understand and weigh information). A majority of clinicians indicated that they would not move forward with deep brain stimulation without securing patient assent (80% or 20/25), with some stating the only exception is if patient quality of life was very poor and/or they lacked insight. Both caregivers and patients expressed a significant respect for the patient's right to bodily integrity, with 67% of caregivers (14/21) and 68% of patients (13/19) justifying patient involvement in decision-making specifically with reference to infringements of bodily integrity. Conclusion Our findings demonstrate that despite broad agreement across stakeholders that the decision-making process for pediatric deep brain stimulation for obsessive-compulsive disorder should be collaborative and somehow involve pediatric patients, there is disagreement about what this process entails and what factors determine patient involvement in the process. However, there is agreement that children have a right to bodily and brain integrity, which should only be infringed upon in rare circumstances. (shrink)