IRB: Ethics & Human Research

Recontacting Pediatric Research Participants for Consent When They Reach the Age of Majority

by Bartha Maria Knoppers, Karine Sénécal, Joanne Boisjoli, Pascal Borry, Martina C. Cornel, Conrad V. Fernandez, Jasjote Grewal, Ingrid A. Holm, Erin Nelson, Wim Pinxten, Mahsa Shabani, Anne Marie Tassé, Ma’n Zawati, and Ellen Wright Clayton, on behalf of the P3G International Paediatric Research PlatformPublished Volume: 38 | Issue: 6

Abstract:

Because children are presumed to have insufficient cognitive ability to consent to participate in research, pediatric research raises particular ethical and legal issues. For children who have not reached the age of consent stipulated by law or policy, parents (or legal guardians) must authorize their participation. This paper explores the issue of whether, to satisfy the ethical and legal norms of consent for research, participants in pediatric studies who attain the age of majority after their parents or guardians enrolled them in a study should be “recontacted” to obtain their consent to remain in the study. Using three different contexts (longitudinal studies, clinical trials, and newborn screening), we argue that distinctions should be made between the risks and benefits involved in recontacting for consent before determining the potential duties of researchers. An obligation to recontact should always be balanced with the feasibility and cost of such efforts in each particular research context and with consideration for the existence or lack of an ongoing relationship with the participant.

Key words: pediatric research, pediatric longitudinal studies, pediatric clinical trials, newborn screening, informed consent, age of majority, risks and benefits of research, recontact for consent, researcher obligation and recontact for consent