"Everyone is Responsible for Their Own Life": Views on Research Participation Decision-Making Among Adolescents and Guardians Within Uganda's Rakai Community Cohort Study.

Abstract

Background: Ensuring the ethical inclusion of adolescents in biomedical trials is crucial to advancing critical health efforts, such as HIV prevention. One key consideration is who makes the decision for adolescent participants to participate. Yet, little is known about what adolescents, and their guardians believe about who should decide if an adolescent participates in health research.

Methods: Adolescents and their guardians were recruited from the Rakai Community Cohort Study in rural Uganda between 2020-2021. We conducted and analyzed in-depth interviews with 24 adolescent-guardian dyads about who they believed should make decisions for adolescents to participate in research. In addition, we examined responses from adolescents (N = 80) to a single question from the MacArthur Competence Assessment Tool for Clinical Research. Transcripts were analyzed to understand the range of perspectives on research participation decision-making among adolescents of different ages and between adolescent-guardian dyads.

Results: Adolescents and guardians evidenced diverse perspectives on who should decide about research participation. Just over half of adolescents reported they should be the primary decision-maker. As a 16-year-old girl explained, "this is about someone's life, everyone is responsible for their own life." Others identified their guardian as the primary decision-maker, because, as one 14-year-old girl noted, guardians "have nurtured them up to where they are, and paid school fees." Many adolescents across all age groups also endorsed joint decision-making. A late-adolescent girl reported, "Parents can help [children] and decide for them. In this case, they discuss about it and mutually agree on their decision." Guardians' perspectives varied; some believed adolescents should decide, given their involvement with sex and other proscribed behaviors. Many guardians endorsed adolescent autonomy and joint decision-making. Parents and adolescents often agreed and disagreed about consent processes.

Conclusion: Consent policies for research should balance respect for adolescent autonomy with the often-diverse perspectives of adolescents and parents on decision-making.