Journal Article

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

Fanhchaksai, Kanda, Morakote, Nimit, Sakuludomkan, Wannachai, Charoenkwan, Pimlak, Koonrungsesomboon, Nut, Natesirinilkul, Rungrote

2022

Overview

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. Key points Informed assent/consent remains one of the most challenging issues in pediatric drug trials, with no trustworthy clue or guidance to determine what type of information and the extent of information to be provided in an informed assent/consent form. Based on our empirical data, risk–benefit aspects related to trial participation were perceived to be more important than general information or technical details of the trial, although all the elements are deemed useful, to a certain degree, to both child participants and their parents. Both child participants and their parents did not want to read an unduly long form, with the maximum acceptable page length of no more than 5–8 pages.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Assent / Children / Clinical trials / Consent forms / Diseases / Education / Enrollments / Ethical aspects / Ethics / Ethics in Biomedical Research / Hematology / Informed consent / Informed consent (Medical law) / Medical ethics / Outpatient care facilities / Parental consent / Parents / Parents & parenting / Pediatrics / Philosophy / Philosophy of Medicine / Questionnaires / Research Article / Surveys / Theory of Medicine/Bioethics