Inclusion of Adolescents in STI/HIV Biomedical Prevention Trials: Autonomy, Decision Making, and Parental Involvement

In order to develop new methods for prevention and treatment of sexually transmitted infection (STI) and human immunodeficiency virus (HIV), clinical trials must be conducted in relevant populations. In the U.S., half of all STI incident infections are among 15-24 year olds (Satterwhite et al., 2013), making healthy adolescents a highly relevant population. The inclusion of adolescents in STD/HIV prevention research is critical for developing appropriate strategies to promote adolescent sexual health. Results from adult studies may not generalize to adolescents, given their biological and psychosocial developmental status (Hwang et al., 2009). In order to understand the extent to which these differences are applicable to safety, efficacy, and acceptability, the products must be tested in minors. Enrolling adolescents who have not reached the legal age of majority in sexual health research, though, poses legal and ethical challenges. Investigators have been described as facing moral conflict between their responsibility to protect the scientific rigor of the study and the well-being of the participants (Merritt, 2005). Institutional Review Boards (IRBs) must balance the interests of minors, their parents, and the institution (Knopf et al., 2016). Data suggest that adolescents are under-represented in biomedical trials of HIV and STD prevention (Tolley et al., 2014; Hoffman et al., 2016). We propose that the inclusion of these adolescents in sexual health research is not only ethically permissible but is ethically required