Navigating ethical challenges in the FORTEe randomised controlled trial: a multi-centre staff survey on exercise intervention for children and adolescents undergoing cancer treatment

Abstract

The FORTEe randomised controlled trial (NCT05289739) investigates an exercise intervention for children and adolescents undergoing cancer treatment. Conducting research with this vulnerable population poses unique ethical challenges, including participant burden, child autonomy, and parental decision-making. This study explored the ethical experiences of healthcare professionals (HCPs) involved in the trial. The trial's ethical climate was largely perceived as positive, though emotional and logistical burdens were noted. Reports of emotional discomfort and moral distress among staff highlight the ethical tensions between research integrity and individual well-being. Furthermore, divergent views on children’s capacity to give consent suggest the need for clearer guidance on paediatric autonomy and shared decision-making.