Children's Competence for Assent and Consent: A Review of Empirical Findings

Abstract

This narrative review summarizes the empirical literature on children's competence for consent and assent in research and treatment settings. Studies varied widely regarding methodology, particularly in the areas of participant sampling, situational context studied (e.g., psychological versus medical settings), procedures used (e.g., lab-based vs. real-world approaches), and measurement of competence. This review also identifies several fundamental dilemmas underlying approaches to children's informed consent. These dilemmas, including autonomy versus best interest approaches, legal versus psychological or ethical approaches, child- versus family-based approaches, and approaches that emphasize consent versus those that emphasize assent, have implications for the measurement of children's competence and interpretation of findings. Recommendations for future research in the area of children's informed consent include the use of diverse samples and control groups, development of multidimensional and standardized measures of competence, utilization of multidimensional and standardized measures of competence, utilization of observational methods and longitudinal designs, examination of noncognitive aspects of children's competence and comparison of children's competence for treatment and research decisions.

Quality assurance of ethical issues and regulatory aspects relating to good clinical practices in the HELENA Cross-Sectional Study

“…For several reasons, it was important to inform the adolescents who were screened for the HELENA-CSS that this research had no direct benefit to their health or well-being, although they would be given data about their health status. The information letter took into account the limited capacity of the adolescents to understand all the scientific objectives and details of the study design, [10][11][12][13][14] and assumed that the parents or guardians would act in the best interest of the adolescents when deciding to participate in the research. For these reasons, the information letter was written in the local language using adapted explanations and vocabulary to avoid misunderstanding and to allow the adolescents and their parents or guardians to understand the difference between research and medical care.…”

“…15 Such letters need to take into account the potential low educational level or understanding about terminology relating to biomedical research. 11 To facilitate the participants' understanding of the information provided, two forms of the information letter were first written in English: one written for the adolescents and the other for the parents. The two forms were then translated into the national language and adapted to comply with the local regulatory demands.…”

Children as Research Subjects: The Ethical Issues

“…The application of general principles indicates that, where children have "sufficient understanding and intelligence to understand what is proposed", it is they and not their parents whose consent is required by law 13 .…”

Å forske på barns premisser

“…Evnen til forståelse er individuell. Studier viser at alder, leseferdigheter og tidligere erfaringer med sykdom og sykehus spiller en rolle for å forstå hva forskning innebaerer (16). Abstrakt informasjon som studiens hensikt, risiko, fordeler og rett til å trekke seg fra studien, blir forstått i henhold til alder.…”