Pediatric oncologists' attitudes towards involving adolescents in decision-making concerning research participation

Abstract

Background: Various regulations and guidelines stipulate the importance of involving adolescents in decision-making concerning research participation. Several studies have shown that in the context of pediatric oncology this involvement is difficult to achieve due to emotional stress, the complexity of research protocols and limited time. Still, up to 80% of adolescents with cancer enter onto a trial during their illness. The aim of this study was to determine clinicians' views and attitudes towards enrolling adolescents in research, considering the difficulties surrounding their involvement in decision-making.

Methods: A qualitative multicenter study was performed, using in-depth semi-structured interviews on the informed consent process with 15 pediatric hemato-oncologists.

Results: Four central themes emerged that characterize clinicians' attitudes towards involving adolescents in the decision-making process: (1) clinicians regard most adolescents as not capable of participating meaningfully in discussions regarding research; (2) clinicians do not always provide adolescents with all information; (3) proxy consent from parents is obtained and is deemed sufficient; (4) clinician-investigator integrity: clinicians judge research protocols as not being harmful and even in the best interest of the adolescent.

Conclusions: Clinicians justify not involving adolescents in research discussions by referring to best interest arguments (adolescents' incompetence, proxy consent, and investigator integrity), although this is not in line with legal regulations and ethical guidelines.