What information and the extent of information to be provided in an informed assent/consent form of pediatric drug trials

Abstract

Background This study aimed to determine the elements and the extent of information that child participants and their parents would like to read in an informed assent form (IAF)/informed consent form (ICF) of a pediatric drug trial. Methods A descriptive survey was conducted to determine the perceived importance of each element of the ICF content from child participants and their parents who underwent informed assent/consent of a multi-center pediatric drug trial. The respondents were asked to indicate the level of importance of each item in a questionnaire, by giving a rating scale from 1 (not important) to 5 (very important). Results A total of 22 families, 17 child participants with the diagnosis of hematology or oncology diseases and 27 parents, were enrolled. Among 30 items, risk–benefit aspects (i.e., direct health benefit [mean: 4.71 for child respondents, 4.89 for parent respondents], indirect/societal benefit [mean: 4.65, 4.85], major foreseeable risk [mean: 4.47, 4.78], post-trial benefit/provision [mean: 4.59, 4.74], and all adverse effects of the drug including uncommon adverse effects [mean: 4.53, 4.74]) were perceived to be of most concerning items from both child participants’ and parents’ viewpoint. None of the items were considered ‘slightly important’ or lower by more than 20% of the respondents. Conclusions For pediatric drug trials, risk–benefit information (including direct health benefit, indirect/societal benefit, and post-trial benefit/provision, as well as major foreseeable risk and adverse effects of the drug) should be made a salient feature of an IAF/ICF. This empirical data could help related stakeholders arrange essential information in order of importance and tailor an IAF/ICF to better suit child participants’ and parents’ needs, particularly for pediatric drug trials involving children with the diagnosis of hematology or oncology diseases.

Consideraciones claves en el proceso de asentimiento en niños, niñas y adolescentes: revisión integrativa

“…Se seleccionaron científicos, doce eran estudios cuantitativos [22][23][24][25][26][27][28][29][30][31][32][33] ocho cualitativos [34][35][36][37][38][39][40][41] . Los lugares de origen de los estudios fueron Estados Unidos 26,27,[29][30][31]39 , Brasil 28,34,40 , Tailandia 24 , Jordania 37,38 , Malawi 41 , Europa 22,23,25,32,33,35,36,39 .…”

“…La literatura encontrada no permite determinar claramente a partir de qué edad un niño puede tomar decisiones válidas y consentir sobre su participación en una investigación 34,41 . Sin embargo, los factores que más influye en la competencia de los NNA para consentir sería su desarrollo cognitivo 23,31,34 , madurez 41 , sistemas sociales 34 , normativas legales, aspectos culturales, religiosos y educativos 22,24,37,38 .…”

Research ethics committee members’ perspectives on paediatric research: a qualitative interview study

“…Deciding on the depth and width of information required to make an informed and voluntary decision, without overwhelming children and parents, can be a difficult task. Health benefits and side-effects related to trial participation have been reported to be the most valued and relevant information for families considering participation in drug trials (Koonrungsesomboon et al, 2022).…”

Ethical frameworks of informed consent in the age of pediatric precision medicine

“…For patients, age-appropriate models may be needed to help minors and their substitute decision-makers understand the concept of assent and their roles in the process (Weisleder, 2020 ). Maximizing the relevant, lay information necessary to understand the risk–benefit profiles of planned medical procedures coupled with novel communication mediums (Koonrungsesomboon et al, 2022 ), such as using age-appropriate multimedia assent documents (Wongthai et al, 2022 ), are one step toward addressing this need for patient education. Third, there can exist exceptional scenarios where seeking assent from children with developing capacity may be overridden if there exists a significant benefit to the child and their wellbeing would be jeopardized otherwise (Moran et al, 2011 ).…”