1. Introduction
Based on international ethical standards, the literature argues that minors have the right to be heard and to give their opinion, which should be taken into consideration progressively, according to their age, degree of maturity and discernment. Minors are thus increasingly considered to have rights and the capacity for self-determination as expressed in the United Nations Convention on the Rights of the Child of 20 November 1989 [
1].
However, most parents and practitioners argue that the great majority of children will experience limitations in decision making. To account for these limitations, the term “informed assent” introduces a broader view on the capacity of decision making, recognizing that children to some extent should participate in decision making and that they can agree with treatment or participation in research without precisely understanding all of its consequences or without complying with all aspects of full consent [
2].
This study appears as a method of deepening ethical knowledge regarding the recognition for the decision making capacity of minors concerning their participation in research studies, based on the notion of human vulnerability and the imperative need to create mechanisms that guarantee the protection of children to ensure respect for their dignity as human beings and care for their best interests.
It is also considered that this study can contribute to the enhancement of the health professionals’ approach to vulnerable populations, in particular children, in the design of strategies conducive to their empowerment and involvement in the decision making process.
The literature notes the importance of asking children for their assent, especially when they are enrolled in research. However, in order to comply with the best practices, assent should be requested whenever it is necessary to make a decision involving the health and well-being of the minor. In this study, we agreed with this assumption and argued that in research the assent is of utmost importance because frequently children do not benefit directly from the results obtained.
It is ethically and legally accepted that, in addition to the agreement of the parents regarding the inclusion of their children in medical programs, the minor should also express his willingness to participate, i.e., he must give his assent [
3]. This request for assent represents a challenge related to the ability of minors to understand and make decisions since this is not a fixed phenomenon but a process that matures with time and experience. It should be noted that age alone does not indicate the ability of a child to understand, considering that factors such as knowledge, health status, anxiety, values, cultural, family, and religious contexts, for example, play an important role in their ability to understand and make decisions [
4]. According to the authors, assent is about respecting children’s developing capacity, which means assisting them in understanding their condition and treatment at a developmentally appropriate level and involving them in appropriate decision making tasks [
4].
As such, all aspects of the assent process should be clarified to avoid possible doubts about what is being questioned and to what extent the minor’s response will be respected [
5]. These assumptions require the practitioner to master a set of high-quality communication skills due to the need to present an individualized communication appropriate to the child’s developmental stage, which constitutes personalized assent [
6,
7].
Technically, the assent is a document that explains to the child in the language she/he can understand the essence of what is planned in the research, as well as the fact that she/he can say ‘no’ or can change his/her mind midway through the research [
3]. Accordingly, ‘Assent’ is a term used to express the willingness to participate in research by persons who are, by definition, too young to give informed consent but who are old enough to understand the proposed research in general, its expected risks and possible benefits and the activities expected of them as subjects. However, assent by itself is not sufficient. If assent is given, informed consent must still be obtained from the subject’s parents or guardian.
“Informed consent” is the voluntary agreement of an individual or his or her authorized representative who has the legal capacity to give consent and who exercises free power of choice without undue inducement or any other form of constraint or coercion to participate in research. The individual must have sufficient knowledge and understanding of the nature of the proposed research, the anticipated risks and potential benefits and the requirements of the research to be able to make an informed decision [
8].
Therefore, child assent must be linked to a protective mechanism such as parental permission, even if the requirement for parental permission has been waived. The linked requirement for parental permission means that we do not need to burden child assent with the same informational and decision making standards as adult informed consent [
9].
Regarding the importance of parents, the American Academy of Pediatrics Committee on Bioethics states that decision making by children and adolescents is usually influenced by their parents’ point of view and may not be entirely voluntary or autonomous. Unless there is significant coercion perceived by clinicians, this situation is not unacceptable because medical decision making cannot and should not occur in a vacuum isolated from all other concerns. Medical decision making is not a discrete event but evolves over time among the health care team, family and pediatric patient as new information becomes available [
10].
Thus, based on ensuring compliance with the ethical standards in force, the assessment of the decision making capacity of the child should include the following: a review of the legal context consistent with the principles of the Convention on the rights of the child; the existence of an empathic relationship between the child and the team/researcher; respect for the child’s abilities and stage of development; the inclusion, if relevant, of relatives, experts, teachers and/or health and social professionals with their consent; the control of any type of coercion or other social forces that may influence their decision and, finally, the existence of a deliberative evaluation on the criteria of the adolescent’s decision making process [
11,
12].
The Teachers College Institutional Review Board of Columbia University states that the assent procedure should reflect a reasonable effort to enable the child (youth or adolescent) to understand, to the degree they are capable, what their participation in research involves. Assenting also involves researchers actively observing verbal and non-verbal cues that the youth does not want to participate (e.g., crying, fussing, throwing a tantrum, hesitation, distraction, discomfort, etc.). Researchers should pause (or stop) the study if they observe any signs of resistance the youth may express [
13].
In addition to these aspects, the UK Royal College of Pediatrics stipulates “school-age” as a milestone from which the child is involved in decision making. Additionally, in the USA, the National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research advocates the involvement of minors from the age of seven years old, which is a decision that is also supported by the American Academy of Pediatrics [
14].
Some studies argue that the lack of involvement can have negative consequences, such as increased fears and anxieties, reduced self-esteem, depersonalization and lack of preparation for the procedures [
15]. In the opinion of Coyne et al. [
15], children who are not involved may assume that their opinions are not important or relevant and may not seek to share them in the future.
In this sense, Rippen [
16] argues the importance of being aware that children have the right to the best possible medical care, the best information and education in comprehensive language suited to their age and a patient-oriented approach. If these aspects are considered, children generally feel better when they become involved in health care decisions and emotional problems and disorders in the development of the child can be prevented. However, Baines (2011) argues that assent is emphasized in research but is largely ignored in medical treatment for children. In this case, the child’s medical treatment may proceed with consent from the parents but the child’s participation in research requires both consent from the parents and the assent of the child and this may result in a practical problem if the parent and child provide incompatible responses when asked to consent and assent [
17].
On the other hand, a double consent procedure will do justice to both developmental aspects of children and the specific characteristics of the parent-child dyad. The parental role offers extra protection by creating the context for the child’s competent decision making and by facilitating the child’s long-term autonomy. In general, the perspective and attitudes of the adults (both parents and clinician) towards the child may be an important predisposing factor in order to stimulate the highest competence in the child [
18].
We must also consider the balance between the autonomy of the child versus the approach based on her best interest, the legal aspects versus the ethical and psychological aspects, the will of the child versus the will of the family and approaches that emphasize assent versus those that emphasize consent given by the child [
19]. It should be noted that for a complete assent process, certain key elements must be considered, namely the explanation given by the participant about his understanding of the study, the risks and benefits involved, the alternatives to his participation, the potential consequences of participating or not, his understanding of the voluntary nature of his participation and the possibility of withdrawing from the study at any time [
6].
However, even though the assent may empower the child to the extent that they are capable, Unguru [
4] argues that parents should decide to what extent the child is in fact capable. In the point of view of Breeuwesma and van Geert [
2], the easiest method to solve this problem is to accept parents or other caregivers of the child-patient as the main actors when it comes to making medical decisions. Regardless, the Belmont Report states that the requirement for parental permission and child assent is an application of utmost importance when regarding the general principle of respect for all persons [
20].
Therefore, if the patient is a child, the family play an extra important role if the goal is to provide child and family centered care. In the opinion of Rippen [
16], information sharing and communication with the patient and their loved ones on the decision making process are the key elements in applying true family-centered care. Furthermore, this author states that family integrated care not only means children and parents should be at the center but also actively involved in the care process, in decision making and regarded as equals.
The ruling of the parents is very important in this process because some children prefer a passive role in shared decision making because they are too ill or distressed by the treatments. Likewise, some children prefer to hear information from their parents especially if it is ‘bad’ news or, for example, about treatment side effects [
21].
Children’s behavior varies constantly in terms of their involvement in the shared decision making process. Therefore, health professionals need to be attentive to the children’s need to ask questions by themselves. Children in the study of Beresford and Sloper [
22] described how their parents dominated consultations, making it difficult for them to contribute to the interaction. Some children also described trying to ask questions to health professionals and being told to stay quiet by the parent. This points to the importance that health professionals need to take every opportunity to talk with children about their hopes and worries, their wants and needs, their ideas, goals and their decisions [
2].
In summary, measuring children’s competence to make health care decisions raises a set of problems because decision making competence does not increase linearly with age but can vary greatly between moments and contexts. In this case, health professionals need to look at every child individually and accept that medical decision making is an ongoing process that varies depending on many factors. Therefore, considering the child’s best interest, parents should be involved in decision making and, alongside children, should act as collaborators with shared interests.
The purpose of this study was to evaluate the comprehension capacity of minors regarding the information given to them and to ultimately help health professionals better understand the importance of including children in the decision making and, at the same time, attempting the implementation of an informed assent model in Portugal’s pediatric health care. The aims of the study are as follows: (a) adapt the Quality of Informed Consent Questionnaire (QuIC) for a pediatric population; (b) evaluate the ability of children to understand the information made available to them regarding the request for assent to perform the exercise echocardiogram and for their inclusion in the study; (c) develop an informed assent model for pediatric population; (d) evaluate the opinion of their parents related to the child’s importance of assent to better accept the medical procedure.
4. Discussion
The results of this study show that minors can understand the information given to them by health professionals. However, where children are concerned, we do not know when exactly they can decide on medical issues in a meaningful manner [
24].
Our findings show that some children have difficulty in understanding a few aspects related to diagnostic procedures and other aspects of the study procedures. In this sense, Roth-Cline and Nelson [
9] argue that the amount of information that a child must comprehend to provide meaningful and developmentally appropriate child assent (or dissent) should be allowed to vary with the age and maturity of the child. Thus, the child’s inability to understand otherwise important informational elements of informed consent, such as any reasonably foreseeable risks, does not establish that a child is incapable of agreeing or disagreeing to research participation [
9].
The existing literature demonstrates the difficulty in deciding clearly from what age a minor can make valid decisions. In this sense, Grootens-Wiegers et al. [
25] point that in the clinical research context children of 11.2 years and above were generally competent. In the treatment context, initial indications point into the direction of comparable age limits for alleged competence, which is around the age of 12.
The comprehension capacity is directly related to the manner by which the health professional transmits the information to the child. In this case, Burke et al. [
26] emphasized that if the information is adapted to the age of the children, they can understand potentially difficult and complex concepts regarding their participation in biomedical research from the age of 6 years old.
Based on this consideration of age as a decisive factor for assenting, we present the results of another study for which its objective was to evaluate the key factors for the child’s competence to consent to participate in clinical research studies, which consisted of a sample of 161 children aged between 6 and 18 years old. The results showed a strong correlation between competence to decide and age [
27].
The skills necessary to understand relevant information are usually acquired at 11 or 12 years of age when the individual’s thinking begins to function within models of verbal ideation and becomes capable of performing abstraction and logical operations [
1]. These findings agree with the results obtained in our study, which showed a high ability to understand the information made available to them with a positive relationship between both forms of information, i.e., the greater the ability to understand objective information, the greater the ability to understand subjective information.
A study conducted by Grooten-Wiegers et al. (2017) with minors aged between 12 and 17 years old on their perspective regarding their involvement in research found that all the participants showed a good ability to understand [
25].
Another study conducted by Grady et al. (2014) aimed at understanding the importance given by adolescents to their involvement in the decision making process found that 98% of the 177 adolescents between 13 and 17 years of age in their study reported wanting to sign an informed assent form and that it was easy to read and understand what they received in writing [
28].
A previous study by Hein et al. (2015) reported similar findings as to that of our own reported here [
29].
In sum, it can be concluded that there are no statistically significant differences between the two groups of children (10 years old and <14 years old and 14 years old and <18 years old) regarding their ability to understand the information. The children aged between 10 and 17 years showed high understanding ability related to the information that was made available to them to obtain assent to the medical procedure. However, there is the possibility that some children answered the questions based on what adults expected from them. Nonetheless, they considered their involvement in decision making a determining factor for reducing anxiety and increasing the sense of maturity and responsibility. There are no statistically significant differences between the female children compared to the male children regarding the ability to understand the information made available to them in the context of assent. The parents considered the implementation of the assent as a fundamental step to the child’s acceptance of health care.
5. Conclusions
Based on findings from previous studies as well as our own, we can conclude that decision making competence is a process and not a fixed phenomenon. Therefore, the confirmed potential for competence combined with the influence of other factors affecting it enables us to recommend a double consent procedure (child and parent) for minors from the age of 12 until 18. A double consent procedure will do justice for both developmental aspects of children and the specific characteristics of the parent-child dyad [
25].
Thus, the literature shows that the ability of minors to assent is not based only on age but also on the ability of the child to understand and weigh the options and consequences of their involvement in the process and other factors, such as the objective of the study, the methods to be used and the type of information to be collected, may interfere with the decision making ability of the child and may have a weight greater than that of their age [
30].
As a recommendation resulting from these results, we emphasize the need and relevance of the widespread application of child assent models.
As limitations, we emphasize that this is a convenience sample of small size. To expand our findings, we would need a large sample size (which we did not have) followed by an exploratory factor analysis.
The measurement instrument was not originally developed for use with children, which prevents us from finding studies that can serve as a comparison for the present study.
Cronbach’s alpha is an index of the consistency of a scale-reliability, i.e., it refers to the degree to which a scale correlates with its own “true” score and uncorrelates with extraneous random factors. A “high” value for alpha does not imply that the measure is unidimensional. In our case the internal consistency of the items is acceptable because α is over 0.65. To provide evidence that the scale in question is unidimensional, an exploratory factor analysis must be considered.
There was no objective validation of the understanding demonstrated by the minors regarding the information made available to them, for example, through an interview where they had to describe what was explained to them.
Another limitation might be that the same version of the QuIC was administered to the whole range of children aged 10 to 17.
Practice Implications
Improving the knowledge of health professionals about the ability of minors to understand the information made available to them can improve children’s participation in healthcare situations and contribute to accomplishing true child and family centered care.
Health professionals must inform parents of the benefits of involving minors in the decision making process. Therefore, they should encourage the adoption of a more open communication style by involving the whole family.
Parents should be encouraged to participate in the decision making process involving assent because of their enhanced ability to interpret the behavior and statements of their children and to better define whether they will expresses assent or dissent.
Parents play an important role in helping children recognize their abilities and responsibilities as key actors in the actual assent process.
Depending on the child’s reading ability and comprehension, the researcher may read the form to or with the child. The child must be given the opportunity to ask questions and the researcher should have the opportunity to explain anything that is not clear.
For older minors, a written assent form is desirable. The researchers should consider the children’s reading level and adapt the language accordingly. It may require more concise explanations or the use of pictures or videos to better explain the study procedures.