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.
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Mattison, D., VandenBosch, T.M., Soskolne, E. et al. Adolescent Female Assent in Clinical Trials: A Model Assent Process. Ther Innov Regul Sci 36, 21–30 (2002). https://doi.org/10.1177/009286150203600106
- Female adolescents
- Clinical trials