IRB: Ethics & Human Research
Pregnancy Testing of Adolescents during Clinical Research: Managing the Process
Pregnancy testing is often required for participation in clinical research, but little published literature addresses the special issues that arise when adolescents who are not legal adults are eligible to participate in such research. Finding the appropriate balance between autonomy and protection (respect for persons and beneficence) can be challenging when conducting pregnancy testing in adolescents involved in clinical research. Focusing on the challenges that arise when the testing is conducted in the course of research unrelated to sexual or reproductive health, this article sets forth a framework for how such testing should be managed, drawing on considerations of ethics, law, and adolescents’ developmental cognitive capacity to make decisions about research participation and medical care. We recommend, among other things, that, in the interest of respecting the privacy and maximizing the autonomy of adolescents, those who are potential research participants should routinely speak with a member of the study team without their parents early in the consent-assent process.
Keywords: research on adolescents, pregnancy testing in clinical trials, pregnancy testing of adolescent research subjects, research ethics, confidentiality