Adolescent Female Assent in Clinical Trials: A Model Assent Process

Abstract

Multiple issues concerning the assent process for adolescent female participation in clinical trials are present in a process that has historically been based on an adult developmental and cognitive perspective. Adolescents are experiencing physiological and psycho-social, sexual growth and, therefore, should not be approached as though they are adults. This paper addresses important assent elements from the unique developmental perspective of female adolescents including sexual activity, birth control, privacy rights, confidentiality, and pregnancy. A proposed assent process and model assent form addressing these important issues are presented.

PAeDS-MoRe: A framework for the development and review of research assent protocols involving children and adolescents

“…Once confident that the child is ready to engage in the discussion about the key aspects of the study, the researcher should present the research opportunity in a developmentally appropriate manner and in a familiar environment to promote optimal child receptiveness (Johnston, 2006; O’Lonergan and Forster-Harwood, 2006). Ideally, the assent and consent discussion should be done with the parent present (Mattison et al, 2002). In this way, the researcher can discuss key elements of the informed consent form with both the parent and child, and the parent can help translate complex aspects of the study.…”

“…Documenting assent via the signature of the child is generally recommended where possible (Mattison et al, 2002). Inviting a child to sign or print his name to indicate assent is empowering and may serve to reinforce autonomy and the voluntary nature of participation (Helseth and Slettebo, 2004).…”

“…The researcher may ask if the child assents to participate after mitigating undue influence and ensuring that appropriate conditions are met (Fusaro and Harris, 2008). Documenting assent via the signature of the child is generally recommended where possible (Mattison et al, 2002). Inviting a child to sign or print his name to indicate assent is empowering and may serve to reinforce autonomy and the voluntary nature of participation (Helseth and Slettebo, 2004).…”