Abstract
For research on sensitive topics like HIV, it is critical to understand the capacity of adolescents to provide
informed consent, as parental consent has been identified as the greatest barrier to adolescent participation in
biomedical research. In many countries including low-and middle-income countries, where 90% of adolescents
live, adolescents can consent to sexual and reproductive healthcare but require parent/guardian permission to
participate in research before age 18 – leading to adolescent underrepresentation and systematic exclusion from
biomedical and behavioral studies. Among adults, research has identified effective biomedical HIV prevention
tools such as pre-exposure prophylaxis (PrEP) that have successfully decreased HIV transmission. Youth in
East and Southern Africa have the highest HIV incidence in the world, yet less than 1% of biomedical HIV
prevention trials include minor adolescents. Thus, developmentally tailored HIV prevention and care research
for adolescents and young adults is urgently needed.
Improving understanding of Capacity to consent to sensitive biomedical Research among adolescents in Rakai
Uganda (ICARE) will leverage The Rakai Community Cohort Study (RCCS) to test adolescent capacity to
consent to biomedical research, identify differences in developmental decision-making, characterize eligibility
for, beliefs about and interest in oral and injectable pre-exposure prophylaxis (PrEP), and construct a digital
toolkit for including adolescents in biomedical research. The RCCS presents a unique opportunity to compare
cognitive capacity to consent for biomedical research among adolescents with and without prior research
experience at three developmental stages – early (10-14 years), middle (15-17 years), and late (18-19 years) –
with the cognitive capacity of their parents/guardians. Limited data are available on adolescents’ actual capacity
to consent, particularly in low- and middle-income countries and low resource, high HIV prevalence settings.
Findings will contribute to addressing a major barrier to research participation through an examination of the
capacity of adolescents to comprehend risks, benefits, and the other elements of informed consent and,
therefore, to provide informed consent to biomedical research. ICARE has the potential to offer guidance for
ethical boards seeking to harmonize adolescent treatment and prevention with research procedures, thus
addressing disparities in research by age and facilitating studies that prioritize adolescents to end the HIV
epidemic.
