Capacity to Consent to Research Among Adolescent-Parent Dyads in Rakai, Uganda - 17/06/23
, Susie Hoffman, DrPH 1, 2, William Ddaaki, MSc 3, Neema Nakyanjo, MA 3, Esther Spindler, MS 4, Charles Ssekyewa, BA 3, Dauda Isabirye, BA 3, Rosette Nakubulwa, BA 3, Nabakka Proscovia, BA 3, Lee Daniel, MPH 5, Nao Haba, MD, MPH 4, Mahlet Maru, MPH 5, Julia Thompson, MS 6, Ivy S. Chen, MPH 6, Fred Nalugoda, PhD 3, Robert Ssekubugu, MSPH 3, Tom Lutalo, PhD 3, Mary A. Ott, MD, MA 7, John S. Santelli, MD, MPH 4Abstract |
Objectives |
To assess the cognitive capacity of early, middle, and late adolescents and their parents or guardians to provide informed consent to a population-based cohort study.
Study design |
Adolescent-parent/guardian dyads including 40 early (n = 80; 10-14 years), 20 middle (15-17 years), and 20 late (18-19 years) adolescents were recruited from the Rakai Community Cohort Study, an open demographic cohort in Uganda. Participants were administered the MacArthur Competence Assessment Tool for Clinical Research, a structured open-ended assessment; interviews were recorded and transcribed. Twenty transcripts were scored independently by two coders; the intraclass correlation coefficient was 0.89. The remaining interviews were scored individually. We compared mean scores for early and middle/late adolescents using a one-sided t test and score differences between parent/guardian and adolescent dyads using two-sided paired t tests.
Results |
Early adolescents (mean score, 28.8; 95% CI, 27.1-30.5) scored significantly lower (P < .01) than middle/late adolescents (32.4; 31.6-33.1). In paired dyad comparisons, we observed no statistically significant difference in scores between parents/guardians and middle/late adolescents (difference, −0.2; 95% CI, −1.0-0.6). We found a statistically significant difference in scores between parents/guardians and early adolescents (difference, 3.0; 95% CI, 1.2-4.8).
Conclusions |
The capacity of adolescents—of different ages and in diverse settings—to comprehend risks, benefits, and other elements of informed consent is a critical but understudied area in research ethics. Our findings support the practice of having middle and late adolescents provide independent informed consent for sexual and reproductive health studies. Early adolescents may benefit from supported decision-making approaches.
Le texte complet de cet article est disponible en PDF.Keywords : cognitive capacity, informed consent, MacCAT-CR, adolescents, minors, Eastern and Southern Africa, sexual and reproductive health
Abbreviations : HIC, LMIC, MacCAT-CR, RCCS, SES, SRH, UNCST
Plan
| Supported by a grant from the National Institute of Child Health and Human Development and a Bioethics Supplement (R01HD091003-03S1, PI J.S.). In addition, P.K.’s contribution was supported by grants from the National Institute of Mental Health (K01MH122319, PI P.K.; T32 MH019139, PI Sandfort) and an award to the HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University (P30MH43520, PI Remien). M.O. is on the Editorial Board for The Journal of Pediatrics. The authors declare no conflicts of interest. |
Vol 257
Article 113271- juin 2023 Retour au numéro
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