10 May 2022

CDBIO(2022)8

CDENF(2022)09

STEEring committee for human rights

in the fields of biomedicine and health (CDBIO)

Steering committee for the rights of the child (CDENF)

Draft Guide to good practice concerning the participation of children

in the decision-making processes on matters

regarding their health

 

Prepared by the BIO/ENF-CP Drafting Group

in cooperation with Annagrazia Altavilla, Consultant

and the support of the Secretariat

Introduction

Children, defined as any person under the age of 18 years[1], have a right to participate in decisions about their lives concerning relevant issues that affect them, including but not limited to their health, education, social and democratic life, and the environment. This is enshrined in Article 12 of the United Nations Convention on the Rights of Child (UNCRC, 1989), which requires that:

-       all children capable of forming their own views, have the right to express their views freely in all matters affecting them;

-       that children’s views be given due weight in accordance with their age and maturity.

The recognition of this, along with greater acknowledgement of children’s evolving capabilities, has led to an increasing awareness that children’s views must be given value in European and national policies.

The Committee of Ministers Recommendation (2012)2 on the participation of children and young people under the age of 18^[2] establishes guidelines on the implementation of active and meaningful child participation. Importantly, it defines child participation as “a process where children and young people have the right, the means, the space, the opportunity and, where necessary, the support to freely express their views, to be heard and to contribute to decision-making on matters affecting them, their views being given due weight in accordance with their age and maturity”.

The right to participate is important [not only as a right and a general principle but also] because taking children’s views into account in decisions and actions that affect them brings significant immediate and long-term benefits for them. Children have unique knowledge about their lives, needs and concerns. Using this knowledge, their ideas and views can lead to more improved individual decisions for children, and enhanced fulfilment of children’s rights. Children are entitled to choose whether or not to express their views or participate in decision making on issues that affect them.

In the health field, when considering the participation of children in decision-making processes relevant to them, a distinction needs to be made between participation of a child in an individual health-care decision and children’s collective involvement in the development of health policies and services[3].

The provisions of the Council of Europe Convention on Human Rights and Biomedicine (Oviedo Convention, 1997), namely in its Article 6, are consistent with Article 12 of the UNCRC[4] about the participation of a child in a decision-making process regarding an intervention to be carried out on him or her. In accordance with Article 6 of the Oviedo Convention, the opinion of a minor, who according to law is considered not able to consent, shall be taken into consideration as a an increasingly determining factor in proportion to his or her age and degree of maturity.

The participation of children in their own health care is essential for ensuring children’s access to health care and optimal health outcomes.[5] Children’s rights, needs and resources have to be placed at the centre of relevant healthcare activities, taking into account their family and social environment. Policies to deliver child-oriented services, based on child-specific developmental needs and evolving capacities are to be promoted, ensuring children’s participation at every level of decision making, in accordance with their age and degree of maturity.

Through the Strategy for the Rights of the Child[6] and the Strategic Action Plan on Human Rights and Technologies in Biomedicine, the Council of Europe is promoting such child-friendly health care approach, rooted in the UNCRC, the European Convention for Human Rights and the Oviedo Convention^[7].

Scope and aim of the guide

This Guide is intended to provide a practical tool based on concrete examples of good practices addressed to the target audience directly concerned.

To that end, and while acknowledging the importance of promoting the participation of children in the development of health policies and services, it will focus on individual health-care decision making.

It aims to support those concerned in engaging with children in individual decision-making processes, including those that, in accordance with domestic legislation, have the right to give their own consent to treatment and interventions. The guide will also consider how children’s opinions may be used to facilitate and improve such processes.

Specifically, the objectives of the Guide are:

·         To highlight relevant international frameworks and standards;

·         To provide examples of national legislation and good practices;

·         To provide practical guidance on how professionals can improve their practices when involving children in individual decision-making processes affecting their health;

·         To identify other measures that healthcare and other relevant institutions may apply to advance and facilitate such involvement.

This guide is primarily targeted at health professionals and others working with or for children in healthcare. It will also contribute to increase the awareness of parents and children’s legal representatives, as well as other relevant stakeholders.

This guide was developed through a multi-step research process involving a review of international and European standards relevant for the field of the study, a literature review, consultations with experts and main stakeholders and a series of survey and questionnaires administered by the Council of Europe. Children have also provided their views on the content of this guide.

The importance of the participation of children in individual health care decision-making processes

Giving children a voice and involving them in individual health care decision-making processes is every child’s right. But, enabling the participation of children is not only a right, it also has significant immediate and long-term benefits.

Children who participate in individual decision-making processes on issues relevant to their health are likely to be more informed, feel more prepared, to learn how to better manage their condition and treatments on their own and experience less anxiety about the unknown.

Allowing children to participate in decisions regarding their health may help them develop competence, confidence, and responsibility, leading to their empowerment and greater participation in their own lives. In turn, this contributes to fostering their self-esteem, develop self-caring and participation skills that are necessary for long-term self-management as well as to promote health-seeking behaviour, satisfaction, health-related quality of life and overall welfare[8].

Participating in medical decision-making processes can instil children with a sense of control, which results in increased cooperation with procedures, better adjustment to and compliance with treatment, which helps to reduce conflicts that may arise during these processes.

Overall, such participation contributes to improving practices by developing more effective partnerships with healthcare professionals.

Figure 1. Benefits of children's participation in health decision-making processes

 

Children’s participation is not a one-off event. Participation is a rolling process and does not stop with children’s views being expressed, it involves adults and children co-producing decisions. Understanding participation in this way encourages children and adults to work together for a meaningful participation. Furthermore, the right to participation does not contradict the right to protection. Indeed, protection benefits from participation^[9].

Example: Benefits for children with chronic and long-term illnesses, when involved in their own health Involving children in decision-making processes, starting with providing them appropriate information about their condition, is particularly important for those who live with chronic or other long-term conditions. In such situations, the involvement of children in their care will have concrete and long-term benefits in helping them to understand and cope with their condition in daily life and in the future. Living with a chronic disease imposes various challenges such as a child’s evolving capacities, how to weigh his/her growing experience with living with a chronic condition, and the different possible dynamics and stages of the illness. For critically ill children, uncertainty regarding diagnosis and prognosis makes it harder to decide for all stakeholders to decide which treatment option is in the child’s best interest. In case of rare diseases, serial misdiagnosis and difficulties in early therapeutic management have also to be faced. All these challenges are more relevant especially for children who because of their ethnicity or demographic characteristics are disproportionally at risk of being affected by acute, chronic or rare diseases.

Challenges concerning children’s participation

Although children’s right to participation is enshrined in legislation and policies, there are a number of challenges that may hinder the effective implementation of this right and children’s experiences in decision-making processes. These challenges may include, among other:

·         Children may be listened to, but only when the issue is trivial. The more serious the situation, the less likely that the child’s view may be considered – especially if it is different from the view of adults.

·         There is a discrepancy between existing policies, knowledge and practice of professionals, as well as the experiences of children and of their parents concerning the implementation of the right to informed consent.[10]

·         Lack of training on children’s rights in health care, in particular how these translate into practice. Specific training could include, for example, how to understand and respect the individuality of children and families, but also culture-specific parenting beliefs and expectations; how to effectively communicate with children, in accordance to their evolving capacities; and how to enable children to make informed choices in relation to their lifestyle, among other.

·         The complexity of a decision-making process, in particular, when difficult decisions need to be made, which may lead to conflict between parents and children or parents, children and health professionals.

·         Some groups may have more difficulty to participate, due to their background, characteristics, beliefs or other reasons.

I.                   Background

A.                Principles governing children’s participation

The UNCRC has identified four guiding principles for the implementation of all rights of the Convention:

Guiding principles of the UNCRC

Article 2. The obligation to respect and ensure the rights to each child without discrimination of any kind.

Article 3(1): the best interests of the child as a primary consideration in all actions concerning children.

Article 6. the child’s inherent right to life and the obligation to ensure to the maximum extent possible the survival and development of the child.

Article 12. the child’s right to express his or her views freely in “all matters affecting the child”, those views being given due weight.

In simple terms, this means that all children have the right to participate regardless of age or other characteristics, taking into account their best interests and what is necessary for their well-being and development. This means that decision-making processes must be a balance between what the child wants, what is needed to secure the child’s health, including their survival, life and development, what other stakeholders want (parents and health professionals) and what is genuinely in the best interest of each child. In the context of practical health care, this includes consideration of the negative effects of not enabling participation too. For example, non-compliance with treatment, inability of a child to identify alert symptoms in case of a chronic illness or other.

National example: Assessing a child’s best interests during health care decision-making processes “An assessment of best interests will include what is clinically indicated in a particular case. You should also consider: the views of the child or young person, so far as they can express them, including any previously expressed preferences the views of parents the views of others close to the child or young person the cultural, religious or other beliefs and values of the child or parents4 the views of other healthcare professionals involved in providing care to the child or young person, and of any other professionals who have an interest in their welfare which choice, if there is more than one, will least restrict the child or young person’s future options. This list is not exhaustive. The weight you attach to each point will depend on the circumstances, and you should consider any other relevant information. You should not make unjustified assumptions about a child or young person’s best interests based on irrelevant or discriminatory factors, such as their behaviour, appearance or disability.” In UK General Medical Council. Guidance for practitioners, available at: Assessing best interests - GMC (gmc-uk.org)

B.                 International frameworks setting standards on children’s participation in health

In 1989, with the adoption of the UNCRC, a fundamental value underpinning children’s rights was put forward: the vision that children must be agents in their own lives, in particular, through Article 12, which sets out that children’s views must be taken into account considered and given due weight in a manner consistent with their evolving capacities. This article later became known as “children’s right to participation”.

The respect for the child’s right to express his or her views and to participate applies to individual health-care decisions, as well as to children’s involvement in the development of health policy and services aimed at promoting the healthy development and well-being of children.

Conditions for the effective implementation of the “children rights to participation” according to the General Comment 12[11]  ü  Children should be provided with information about proposed treatments and their effects and outcomes, including in formats appropriate and accessible to children with disabilities ü  Physicians and health-care facilities should also provide clear and accessible information to children on their rights concerning their participation in paediatric research and clinical trials ü  Where fixed age at which the right to consent transfers to the child is established, children above this age have an entitlement to give consent without the requirement for any individual professional assessment of capacity after consultation with an independent and competent expert ü  Where a younger child can demonstrate capacity to express an informed view on her or his treatment, this view is given due weight ü  Access to confidential medical counselling and advice without parental authorisation should be ensured, irrespective of the child’s age, where this is needed for the child’s safety or well-being ü  Measures enabling children to contribute their views and experiences to the planning and programming of services for their health and development should also been introduced.

At European level, the Oviedo Convention^[12], the only international legally binding instrument on the protection of human rights in the biomedical field, lays down the general rule that an intervention in the health field may only be carried out after the person concerned has given free and informed consent to it. This person shall beforehand be given clear and suitably worded information as to the purpose and nature of the intervention as well as on its consequences and risks. Furthermore, consent may be freely withdrawn at any time (art.5). The respect for the child’s right to express his or her views clarifying conditions to implement this right is reaffirmed in art.6.

Relevant Oviedo Convention provisions Chapter II – Consent Article 5 – General rule: An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it. This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks. The person concerned may freely withdraw consent at any time. Article 6 – Protection of persons not able to consent (...) 2. Where, according to law, a minor does not have the capacity to consent to an intervention, the intervention may only be carried out with the authorisation of his or her representative or an authority or a person or body provided for by law. The opinion of the minor shall be taken into consideration as an increasingly determining factor in proportion to his or her age and degree of maturity.

It is also clarified that in certain situations which take account of the nature and seriousness of the intervention as well as the minor's age and ability to understand, the minor's opinion should increasingly carry more weight in the final decision. This could even lead to the conclusion that the consent of a minor should be necessary, or at least sufficient for some interventions^[13].

While the UNCRC and the Oviedo Convention provide the basis for children’s right to participation, legislation, policies and practices have evolved significantly beyond, including European legislation on clinical trials and national legislations on children’s right to informed consent.

Example: Relevant provisions of the EU Regulation on clinical trials At European level, in the context of research, the EU Regulation 536/2014 on clinical trials, which came into force on 31 January 2022, establishes that a clinical trial on minors may be conducted only if the “informed consent of their legally designated representative” has been obtained. Nevertheless, a minor who is capable of forming an opinion and assessing the information given to him or her, should himself or herself assent in order to participate in a clinical trial. The relevant provisions of the EU Regulation on clinical trials include: ·         The minor shall take part in the “informed consent procedure” in a way adapted to his or her age and mental maturity ·         The explicit wish of a minor who is capable of forming an opinion and assessing the information, to refuse participation in, or to withdraw from, the clinical trial at any time, is respected by the investigator ·         If during a clinical trial the minor reaches the age of legal competence to give informed consent as defined in the law of the Member State concerned, his or her express informed consent shall be obtained before that subject can continue to participate in the clinical trial (art.32)

C. National legislation concerning children’s participation in health

The right for children to participate in treatment and research decisions is recognised at national level, but substantial differences exist among national laws. Across Europe, the statutory age at which a child is considered able to consent varies from 12 years to 18 years.

• In some countries, the legal age for consent to a medical intervention corresponds to the age of legal majority, and children under this age will require authorisation from their legal representatives before an intervention can be carried out. However, some national laws recognise the need for informing minors and taking their will into account, according to their cognitive capacity.
• In other countries, children younger than the age of legal majority can give consent without their parents’ or carers’ authorisation, either according to their maturity and competence in relation to the nature of the health issues concerned or from a fixed age.^[14]

Examples of national legislation and related criteria Belgium, France, Finland, Germany, Hungary, Italy and Monaco The right to receive information and/or to express his/her will, is recognised on the basis of evolving capacities / (the evaluation of the degree of maturity / or of the capacities / or of the level of development of the child) Austria, Bulgaria, Ireland, Italy, the Netherlands, Norway, Portugal and Ukraine The exercise of the right to receive information or to express his/her will is recognised once the child reaches the minimum age set by legislators. The age ranges vary from 7 to 16 years and are combined with different conditions (see Annexe Tables 1 and 2)

Children’s competency: The notion of children’s competency was first discussed in a case brought to court in the UK in 1986[15]. The so-called Gillick competency grew in importance and is increasingly recognised as a determining factor for giving children the right to consent to treatment. For example, the Scottish Age of Legal Capacity Act (1991) states that:

“a person under the age of 16 years shall have legal capacity to consent on his own behalf to any surgical, medical or dental procedure or treatment where, in the opinion of a qualified medical practitioner attending him, he is capable of understanding the nature and possible consequences of the procedure or treatment.”[16]

Remember: It is important to know legislation applicable in your own setting and validated tools to reliably assess children’s competency or capacity to be implemented in your practice.

D. The role of parents, children and healthcare professionals

1.      The role of parents

Parents and other carers are natural and essential partners in any process concerning children’s health, well-being and development. The experiences of parents and the extent to which they are able to influence their child's health care varies across countries. Some parents are not involved or listened to and thus may feel powerless and uncertain about their child's health care. This heightens parent’s and children’s stress in an already demanding situation and can limit parent’s coping strategies and their ability to support their child[17]^,[18]. Parents need appropriate information about their child's health problem, disease and the different options for treatment in order to be able to participate in decisions related to their child's health care[19]^,[20].

Parents are dependent on if, how and when healthcare professionals involve them in decision making about their child's health care

Actions to be undertaken ü  Speak in a language and way that parents understand and avoid medical jargon; ü  Repeat the same information in different moments, if necessary; ü  Complement oral information with written one where possible and appropriate; ü  Coordinate with other health professionals to avoid that parents and children receive contradictory information; ü  Advise and guide parents on how they can support their children’s participatory efforts; ü  Take time to encourage parents to ask questions and answer to them.

Information to parents shall always include            i.    the purpose and the nature of the intervention           ii.    the extent and duration of the procedures involved          iii.    its consequences, risks and burdens         iv.    available preventive, diagnostic and therapeutic procedures and alternatives          v.    any information collected about children’s health         vi.    arrangements to ensure respect for private life and ensure the confidentiality of personal data        vii.    any foreseen potential further uses, including commercial uses, of personal data or biological materials In the case of research it shall also include : i.      the arrangements for responding to adverse events or the concerns of research participants ii.     the source of funding of the research project iii.    the arrangements for fair compensation in the case of damage iv.   arrangements for access to information relevant to the participant arising from the research and to its overall results

Parental rights, duties and responsibilities to provide “appropriate direction and guidance” diminish in the light of the child’s evolving capacities. However, it is still important to recognise the importance of parents and to respect the wishes of those children who wish for their parents to be as involved in the decisions to be taken as possible.

2.         The role of children

Children are recognised as rights-holders and not merely as persons in need of protection. They are the key agent in the health care partnerships. Children’s views should be obtained and respected as much as possible prior to take decisions. Children’s right to express their views “is not dependent upon their capacity to express a mature view; it is dependent only on their ability to form a view, mature or not.”  Children should thus be provided with adequate and appropriate information in order to understand the situation and all the relevant aspects in relation to their interests, and be allowed, when possible, to give their consent in an informed manner. 

There is no minimum age for the right to express one’s views. A child’s stage of maturity does not determine whether the individual has rights, but rather what weight is given to the child’s view. Children often express that they want the opportunity to provide input and want to feel heard but do not want the burden of having to make the final decision. Sometimes, adults may have a final say in making decisions and they would and could overrule their choices at the condition to have included children in the decision process. Being asked to express one’s views also implies a greater responsibility for the child, which not all children would like or feel ready for. Therefore, deciding that the adults should make the major decisions is also participation in decision-making.

The level of involvement can differ from child to child and from circumstances. Information‐sharing involving the child thus requires that the child is included, and duly guided by adults with the opportunity to enhance their competences, while giving due weight to the child’s perspective [21].

Actions to be undertaken to effectively implement the child’s right to participation         i.        Adequately inform children on the possibility for partaking in decision-making regarding health care and interventions      ii.        Support children and invite them into a dialogue about to what extent they wish to participate, in what way and when     iii.        Contribute in increasing awareness of own situation making children more competent in decision-making

3.      The role of healthcare professionals

Healthcare professionals have a central role in ensuring that children have opportunities and spaces for participation and, additionally, in creating security for children in uncomfortable situations and in empowering them to take control of their own health[22].

Healthcare professionals also have an essential role in providing patients and other persons involved in the decision‑making process with the necessary medical information and in facilitating parents' active involvement in children's health care decisions. Healthcare professional may contribute to strengthen both children’s and parent's sense of coherence and in improving their ability to cope with the situation they are experiencing. These processes in turn help to increase parents' and children’s competencies and engagement in children’s care and ensure the quality and provision of child-friendly health care.

Training for healthcare professionals ü  Professionals in direct contact with children should be trained in communicating with children of all ages and stages of development, and with children in situations of particular vulnerability ü  Training should include an increased awareness of children’s individual needs, capacities, and preferences and learning about strategies to involve them according to these abilities and wishes ü  Training should focus on professionals’ attitudes and practices, aiming at the improvement of communication with parents and children ü  Training may be especially challenging within diseases or other settings where families feel that standardised protocols leave them little room for choice[23] ü  Regular refresher training should also be held to equip professionals with new skills and to share experiences

Remember: There may be organisational aspects, such as available resources, the allocation of time to communicate with children and parents and other possible constraints that influence the quality and effectiveness of decision-making processes. These constraints should be identified and addressed by both institutions and professionals.

II.                 Fulfilling children’s right to participation in health care

The involvement of children in their care should be seen as a progressive process involving four levels of participation: (1) being informed, (2) expressing a view, (3) influencing a decision, and (4) being the main decision-maker, for example, giving consent to a treatment or intervention.[24] In turn, children’s level of participation should be informed by both their abilities and preferences^[25].

1.            Informing children

Appropriate and accessible information is an important pre-requisite for the ability to speak out, express views and discuss decisions. Adults have a responsibility to find ways in which to enable children to communicate their views, concerns or ideas.

Providing children with information regarding treatments (including the accompanying risks and benefits, diseases’ peculiarities or research practices) aids children’s understanding of the process and implications[26]. A lack of information increases children’s fears and anxiety surrounding treatments, causing them to feel unprepared for procedures and reduces self-esteem[27].

Remember

ü  information must be sufficiently clear and suitably worded, for example, avoid medical jargon and include terms that children can understand;

ü  enable children to understand how to weigh the aim and methods, the necessity or usefulness of the intervention against its risks and the discomfort or pain it will cause;^[28]

ü  make sure to tell children they can ask questions at any time;

ü  adequately answer to requests of children for additional information, also according to circumstances;

Child-friendly information material in relation to different relevant topics should be prepared and made available to children to complement the communication of information between healthcare providers and children. Information materials that may be useful may include, among other:

·         Children’s rights in general;

·         Children’s right to participation in decision-making processes in particular;

·         Information related to specific categories of diseases (e.g. oncology, acute, chronic, rare etc);

·         Other, as appropriate.

Child-friendly information material helps to support the communication and mutual understanding of children and service providers. It also helps children to reflect on the information they received orally and to identify questions for a follow-up conversation with the healthcare professionals. Medical conditions and the diversity of the groups are important aspects to be taken into account in developing materials.

Examples of formats of Child-friendly information material ü  Brochures to be distributed to children, ü  Leaflets, ü  Videos, ü  Information accessible through social media, specific websites or applications ü  Other printed or digital material

Examples of existing brochures or Charter’s on Children’s rights in health care?

Health education is an important component of the treatment plan for most children, including learning about their rights and how to get their needs met.  Information, communication and education, combining strategies, approaches and methods that enable children, families to play active roles in achieving, protecting and sustaining their own health, should be promoted.

2.           Expressing a view

A trustful relationship with healthcare professionals is a prerequisite for increasing children’s opportunities to be active in their own care. The rights of children should be reflected in the entire health care process, from the moment they call to make an appointment, to the built environment where they access care, to the interactions with all staff, including clinicians, to the treatment plan, and finally to any follow-up care. By empowering children at every stage in this process and by giving children a voice in the design and implementation of these processes, healthcare professionals can create a collaborative process that improves outcomes[29].

The ability of children to express their views Children’s ability to express their views and opinions is influenced by a number of factors, including: ü  Their age and maturity ü  Their decision-making capacities ü  Prior experience of participation either in health care or other relevant decision-making processes (at home, school or other) ü  The extent to which they understand their situation (illness, consequences of the treatment or long-term illness, etc) ü  How comfortable and engaged they feel within the decision-making process ü  Cultural background and health literacy

To help children expressing their views, healthcare professionals need to remain alert to their changing health care needs. They need to follow children closely, constantly assessing, reflecting, learning, and innovating, always with the children at the centre. This attitude with sensitivity, humane treatment and compliance with the principles of transparency and honesty in the exchange of information could help in generating a great degree of trust, bolstering both parties so that they can better achieve their common goal: providing the child with the best possible care[30].

Privacy is an important issue to take into account when working children, especially when sharing or discussing information concerning their own health. Thus, it is critical to discuss confidentiality issues with children, at the outset and allow them time to ask questions. It is also important to have time alone with the child to provide space for children to discuss whatever matters to them.[31]

Healthcare professionals and institutions also need to be attuned to whether their physical space is one that both encourages children to feel welcome and empowered to exercise their right to be heard and enables clinicians and staff to respond to children in a way that makes youth participation meaningful. Being attuned to the culture of children and acknowledging what matters to them healthcare settings can foster trust, promote participation, and alleviate fears and anxiety.

Actions to help children to express their views   ü  Have time alone with the child to provide space for children to discuss whatever matters to them ü  Both active questioning and active listening are essential. In all interactions, especially with adolescents, avoiding judgment is critical. ü  Check that the child understands the information that has been given ü  Ask the child what they think (don’t assume a child will feel able to give their thoughts voluntarily) ü  Allow more time for a child to think, if they want and need it ü  Reassure the child that his/her opinions and thoughts are important – whether those are about big things or small things (sometimes small things can be very important)

3.           Influencing a decision

When, by national legislation, children are not able to give their consent to a treatment or intervention, their views and opinions should nevertheless genuinely influence a decision. This means that their views and opinions should be taken seriously and given due weight in the final decision. Where the final decision does not reflect the child’s wishes, it should be properly explained why another decision was taken and not the one they preferred.

Children should be able to influence a decision in accordance to their evolving capacities. The evolving capacities of the child is a very important concept to be taken into account when working with and for children. It recognises children’s developmental characteristics and needs, their competencies and emerging personal autonomy.[32] This means that, as children grow, they should be more involved in decisions. Children’s age, maturity, but also their life experiences should be taken into account when enabling a child to participate and deciding the extent to which they should participate.

Secondly, the principle of the best interest of the child is crucial in any decision that concerns children. This principle places children at the centre of the decision-making process, looking at what is best for each single child, taking into account their age, maturity, personal characteristics, but also the short, medium and long-term consequences of a given treatment and intervention to the life of that particular child. The best interest of the child considers the opinion of those close to the child, such as the parents, and other important dimensions of the child’s life, including culture and religion. All these aspects should be given due weight and help professionals to make the best possible decision for the child.

Remember: Childhood is not a single, fixed, universal experience. At different stages in their lives, children require different degrees of protection, provision, prevention, information and participation. Children’s wishes should be considered seriously, most of all in the field of health care and biomedical research.

The principle of assent Recognising the role that children should play in decisions concerning their own health, the principle of assent was introduced. The terms assent and dissent generally describe when children give their agreement or disagreement to a treatment, in cases where they do not yet have a right to give their consent to treatment, in accordance to the law. Giving children the possibility to assent and dissent to treatment is important because it involves children more directly in the decision-making process and prepares them for taking responsibility in similar processes in the future.

4.           Giving consent to treatment

Giving consent to treatment is the final stage in the individual process of decision-making. Free and informed consent is the decision, taken freely after being duly informed of the nature, significance, implications and risks of an intervention (including all medical acts, in particular interventions performed for the purpose of prevention, diagnosis, treatment, rehabilitation or research) by any child capable of giving consent. This would equally apply to the authorisation given by the child’s legal representative, where, according to national legislation, the child is not able of giving consent.

Remember: It is important to verify the national legislation and guidelines applicable in your own setting regarding the need to obtain consent from children or authorisation from parents.  

In order to ensure that children exercise their right to consent, hospitals and other health services should put in place different measures, including:

·         Adopt a hospital or health service consent policy, reflecting national legislation;

·         Ensure that health professionals are aware of the policy;

·         Promote capacity building of professionals to ensure they have the knowledge and competencies to engage and involve children in the decision-making process in a meaningful way and that they ask for their consent to treatment whenever it is required;

·         Engage with children regularly to assess existing policies and practices, as a way to improve them and children’s experiences of care.

[To include example of a hospital consent policy concerning children] …

III.              Engaging with children as a means to improve individual decision-making processes

As described earlier in the guide, international child rights standards emphasise that children’s right to participation in health care includes both their participation in decisions affecting their own health, but also their participation in the development, assessment and improvement of healthcare services. The latter may be described as collective or group participation. Similarly, to the elements identified for the individual processes, children participating in collective decision-making processes need to be empowered adequately to be able to fully participate.[33] 

Children may participate collectively to improve the policies of healthcare institutions and practices of professionals on a number of issues.[34] In the specific case of the participation of children in individual decision-making processes, children may help to:

·         Assess current practices by professionals in a given healthcare service, for example, the extent to which they are able to provide information in an effective manner;

·         Identifying ways to improve existing policies and practices in hospitals and health services;

·         Design specific information and materials targeting children;

·         Help designing better policies on individual participation of children in individual decision-making processes.

Engaging children in an evaluation of existing processes can identify opportunities to further improve current practices.

Collective actions to be undertaken to implement of individual decision-making processes: ü  Developing adequate policies ü  Creating appropriate environment, spaces and opportunities ü  Building staff capacity and training health professionals/families ü  Supporting advisory groups, consultative bodies and collective self-advocacy initiatives ü  Promoting age-tailored information, training and “play to learn” activities ü  Developing evaluation mechanisms ü  Setting up child friendly complaints

Children may provide their views on services through different ways, for example, feedback or satisfaction questions, surveys or research studies. Children’s collective or group participation may also be institutionalised in hospitals or other health services, for example, by setting up children’s councils, advisory groups or other initiatives.

Young Persons Advisory Groups (YPAGs) YPAGs, have already been set up across Europe and at international level to underpin clinical trials. The YPAGs include young people aged between 8-19 years (although some groups have older young adults up to the age of 21) who are patients, regular attenders at hospital, and/or healthy young people having an interest in science and healthcare. YPAGs are predominantly facilitated by a professional involved in a clinical research facility, children’s hospital, or academic institution. They are recruited by means of schools, associations, hospitals and the patients’ and families associations, and were selected according to their motivation and interest in being involved in this kind of empowerment activities. YPAGs provide a platform for children and young people to have a voice, share their opinions, and apply their experience to a variety of issues relevant for biomedical research.

Research project on eHealth as an aid for facilitating and supporting self-management for children in Sweden The multidisciplinary research project on eHealth as an aid for facilitating and supporting self-management for children with long-term childhood illness – development, evaluation and implementation in clinical practice. The overall aim of the project is to 1)Evaluate, advance and implement models of eHealth to improve self-management for children and adolescents with or at risk for long-term illness and their families for better allocation of family-, health care- and societal resources; Increase the knowledge of cultural factors and implementation strategies to facilitate implementation processes in general, and more specifically generate theoretical and methodological models on how to successfully implement eHealth in paediatric care; Enhance the translation and integration of new research findings within eHealth into care services and the wider society by supporting healthcare professionals in their provision of evidence-based care and by translating and communicating research results to them as well as stakeholders and families. The project focus is on the needs of children and families and how they participate in care and decisions when a child is ill, focusing on transitions in pediatric care, for example to home care and how the family can be supported with the help of various e-health interventions. It also focus on measures that prevent ill health in the family and interventions that support and develop the child's and family's health, for example in areas such as obesity and physical activity. The research generates knowledge about the whole family when a child in the family becomes chronically ill, how care and treatment affect the family's daily life and what effects it has over time.

Definitions:

For the purpose of the present guide:

§  “Child” refers to any person under the age of 18 years

§  “Participation” is about individuals and groups of individuals having the right, the means, the space, the opportunity and, where necessary, the support to freely express their views, to be heard and to contribute to decision making on matters affecting them, their views being given due weight in accordance with their age and maturity. Participation is also an ongoing process of children’s expression and active involvement in decision-making at different levels in matters that concern them. It requires information-sharing and dialogue between children and adults based on mutual respect^[35]

§  “Parent” is understood as an “individual biologically and/or emotionally linked to the child”, which typically includes “the provision of care, concern and affection”. For the purpose of this guide, the term “parent” is used in relation to the “legal parent”, i.e. the person holding parental responsibility, unless stated otherwise. Where a parent does not or no longer hold parental responsibility, the term may need to be defined specifically in terms of biological or social and affective parenthood

§  “Holder of parental responsibility”refers to parents and other persons or bodies entitled to exercise some or all parental responsibilities

§  “Parental responsibility” refers to all rights and duties relating to the person or the property of a child, which are given to a natural or legal person by a decision, by law or by an agreement having legal effect, including the right and duty to complement the limited legal capacity of the child and rights of access[36].

§  “Relevant information” refers to information that is given to the child to enable the child to exercise his or her rights fully unless the provision of such information were contrary to the [best interests] of the child[37].

§  “Informed Consent” is a process enabling a person able to consent to take an informed decision on an intervention after being duly informed of its nature, significance, implications and risks. With regard to consent to certain interventions, additional elements are required. For example, informed consent to participate in a research project has to be given expressly, specifically and be written, dated and signed; if the person concerned is unable to write, oral consent in the presence of at least one witness may be given in exceptional cases, as provided for in national legislation.

Where the person concerned is, according to national law, not capable of giving consent, the authorisation of his or her legal representative, or of the authority, the person or body designated by law, is required for any intervention on the person concerned. The legal representative, the authority, the person or body concerned shall be given the information referred to in the previous paragraph.  

§  To empower is to help children exercise their rights and develop and voice their opinions[38]

ANNEX 1

National legislations implementing the right of children to participate in decisions regarding their health

The right of the child to receive information and/or to express his/her will, is recognised on the basis of evolving capacities / (the evaluation of the degree of maturity / or of the capacities / or of the level of development of the child) is recognised in Italy, Belgium, France, Germany, Finland, Hungary and Monaco. In Spain, different provisions exist according to the autonomous communities’ laws.

Specificities in national legislations §  In France, healthcare professionals do not have to obtain the parent’s or carer’s consent when medical treatments are necessary to safeguard the health of a minor or when the minor expressly refuses the consultation of the holders of parental authority. §  In Belgium the minor can independently exercise their rights if he/she can be considered as being able to reasonably assess his/her interest.

The exercise of the right to receive information or to express his/her will is recognized once the child reached the minimum age set by legislators in Austria, Bulgaria, Italy, Norway, Ireland, Portugal, the Netherlands, Ukraine and Denmark. The age ranges vary from 7 to 16 years and are combined with different conditions (see Tables 1 and 2).

Specificities in national legislations §  In Italy, the minor or the person must receive information concerning their choices with regard to their health in a way that is appropriate to their capacities, so as to being in proper conditions to express their wishes. Furthermore, not specifically for the healthcare sector, it is specified that the minor from the age of 12, or even younger where capable of understanding, has the right to be heard in all matters and procedures that concern him or herself. §  In Austria, it is assumed that a child older than 14 years is capable of making decisions. Nevertheless, in case a child capable of making decisions gives its consent to a medical treatment, which normally induces severe and enduring physical or psychological damage, such medical treatment may only be administered if the legal representative gives his consent as well. §  In Norway, the child who is able to form his/her own opinions has the right to receive information and give opinion from 7 years. From 12 child has the right to refuse to inform parents about his/her health and from 16 the child can give consent, unless special provisions, or where the nature of measures dictate otherwise. §  In Ukraine, children from 14 years have the right to choose a doctor and treatment methods according to the doctor’s recommendation. Medical treatment shall be provided upon his / her written consent as well as that of his/her legal representative. Nevertheless, if a child from 14 is required to consent to medical intervention he/she can receive information only from the age of 18.

              

Table 1. Ages set by legislator to recognise the child able to take a decision

Age	Country
7	Norway *
12	Netherlands (child can be associated to decisions) Italy (right to be heard not only in the healthcare sector)
14	Austria*, Ukraine *
15	Denmark (right to consent/refuse)
16	Bulgaria, Ireland*, Norway* Netherlands* Portugal (regardless of level of education literacy/cultural characteristics)
16 or judged to be Gillick competent[39]	UK & Scotland minor patients from 16 years of age or judged to be “Gillick competent” are commonly granted the right to consent to treatment but not to refuse it

*Conditions for including the child in decision process according to the age (See Table 2)

Table 2. Conditions for including the child in decision process according to the age

Country	Conditions for including the child in decision process according to the age
Austria	Even in case a child capable of making decisions gives its consent to a medical treatment, which normally induces severe and enduring physical or psychological damage, such medical treatment may only be administered, if the legal representative gives his consent as well
Ireland	Specific conditions for treatment/diagnostic with increased risk
Netherlands	Above 16 years of age the child can decide on her/his own and can also decide that the legal carer will not be informed
Norway	From 7 or younger, if the child is able to form this/her own opinions, right to receive information and give an opinion From 12 right to refuse to inform parents about his/her health From 16 right to give consent unless special provisions or the nature of measures dictate otherwise
Ukraine	From 14 children must consent to medical intervention but receive information from the age of 18 (normative dissonance)