Background: Knowledge about assent or dissent of children to non-therapeutic research is poor.Objectives: To assess sociodemographic characteristics in healthy children and adolescents who were invited to participate in non-therapeutic research, to evaluate their motives for assent or dissent and their understanding of the information given.Methods: A total of 1281 healthy children and adolescents six to sixteen years of age were invited to participate in a non-therapeutic study and a questionnaire.Results: Assenting children were motivated by a desire to help sick children (...) and to gain experience with participating in a research study . Dissenting children made their decision because of worries about having a blood or a urine sample taken or because of worries about a doctor’s examination . Fewer children in the assent group than in the dissent group worried about the doctor’s examination . In the assent and dissent group, 568 and 343 children, respectively, said they were able to understand some or all of the written information , and 650 and 330 , respectively, were able to understand some or all of the verbal information .Conclusions: Sociodemographic characteristics may not influence healthy children’s decision to volunteer for non-therapeutic research. Assenting children have altruistic and educational motives, whereas worries about procedures may cause children to dissent. A great majority of school children and adolescents feel capable of understanding and giving assent or dissent to non-therapeutic research. (shrink)

In Spain, any person under the age of 18 is a minor. Generally, minors lack the legal capacity to take legally binding actions because they are deemed incapable of legally binding consent. Spanish civil law recognises, however, that the child, in accordance with the law and being sufficiently mature, may act for himself. It stands, then, that consent, as expressed by the “sufficiently mature” minor, should be legally valid.

Book reviewed in this article: Principles of Biomedical Ethics. By Tom L. Beauchamp and James F. Childress.

This study ascertained reports of assent (affirmative agreement) and permission (agreement by an adult fully capable of being informed) in 114 children's research articles in 1990 in Child Development (CD), Journal of Consulting and Clinical Psychology (JCCP), Journal of Pediatric Psychology, and Journal of Clinical Child Psychology. Of the research projects, 43% failed to specify permission, and 68.5% failed to specify assent. JCCP reported assent significantly more than CD. Assent was reported significantly more in research with older children than with (...) younger children. This lack of sensitivity to assent and permission suggests that many authors, reviewers, and editors consider reporting assent and permission unessential. We recommend specifying assent and permission in all manuscripts, highlighting children's research issues in graduate training, and using specific safeguards when conducting research with children. (shrink)

The U.S. federal regulations require investigators conducting nonbeneficial research to obtain the assent of children who are capable of providing it. Unfortunately, there has been no analysis of which children are capable of assent or even what abilities ground the capacity to give assent. Why should investigators be required to obtain the positive agreement of some children, but not others, before enrolling them in research that does not offer a compensating potential for direct benefit? We argue that the scope of (...) children's research decision making should be based on the principles of respect for autonomy and nonmaleficence. These principles imply that the threshold for assent should be fixed at 14 years of age, and a dissent requirement should be adopted for all children in the context of nonbeneficial research. (shrink)

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 identified several fundamental dilemmas underlying approaches to children's informed consent. These dilemmas, including autonomy versus best interests 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 observational methods and longitudinal designs, examination of noncognitive aspects of children's competence, and comparison of children's competence for treatment and research decisions. (shrink)

This study examined the quality of children's assent to a clinical trial. In subjects younger than 9 years of age, understanding of most aspects of the study was found to be poor to non-existent. Understanding of procedures was poor in almost all subjects. In addition, voluntariness may have been compromised in many subjects by their belief that failure to complete the study would displease others. If the fact that a child's assent has been obtained is used to justify the exposure (...) of that child to the potential harm of a non-therapeutic blood sample, the assent must be meaningful. In the nutrition study observed here, the quality of the assent of children younger than 9 years of age was very poor. The assent therefore did not provide a valid justification for requesting a blood sample from these children. This study indicates that most children younger than 9 years of age cannot be expected to consent or assent to clinical research in a meaningful way. The current age of 7 years for initiating assent (in addition to parental consent) is possibly not appropriate and should be reconsidered. (shrink)

In a Norwegian study on how children aged 7-12 years cope during a period of serious illness within the family and on their quality of life at this time, several ethical questions became apparent. These were mainly concerned with the vulnerability of children during research, with their ability to make autonomous decisions, and with considerations regarding how to respect their right to confidentiality during the research process. In this article we approach these questions using our experience from this previous study, (...) discussing them within the framework of theories of ethics and relevant research ethical guidelines. Finally, we discuss our experience in the light of the overall purpose of this article: how to deal with the ethical dilemmas that may appear during research involving young children. (shrink)