Eléments de la prise de décision
Determining a child’s best interests
Reaching any decision concerning a child’s care must be based on what is in the best interests of the child. Assessment and determination of the child's best interests must be centred on the individual child and include consideration of the child’s health needs, their own views, safety, protection, care and overall well-being.
Many aspects should be given due weight to assess and determine a child’s best interests. However, there is no fixed recipe for every situation. Respect for the best interests of the child and, indeed, respect for children’s participation requires a balance between what professionals (ideally all professionals working in a multidisciplinary team with an integrated approach to care) and parents consider to be the best for the child, given the illness or health problem, available treatments, effects and so on; and the child’s views on what is ‘best’ for them. Exploring children’s preferences, family culture (including participation culture), past experiences and other factors will help professionals support and facilitate the best possible decision for the child. Consideration must also be given to the children’s right to an open future, meaning that preference should be given, when possible, to options which least restrict their future choices.
The notions of consent, assent and dissent
For certain treatments or interventions, through protocols specified by law, professionals will need to obtain the formal agreement of parents or of the child him/herself.
According to the Oviedo Convention, the term “consent” is used when the formal agreement is given by the person concerned by treatment or act, whereas the term “authorisation” refers to the formal agreement given by the parents/legal representatives or body provided by law.
According to the World Health Organization (WHO), informed consent “relates to the formally expressed (usually written) agreement or permission for any health intervention, such as vaccination, effective surgery, choosing or terminating a treatment. ”
As mentioned in section II.b., in national legislations, children’s right to informed consent to treatment can be based on age criteria. Additionally, another concept has emerged, that of children’s competencies. The notion of children’s competency was discussed in a case brought to court in the UK in 1986, where the court’s ruling stated that “whether or not a child is capable of giving the necessary consent will depend on the child’s maturity and understanding and the nature of the consent required. The child must be capable of making a reasonable assessment of the advantages and disadvantages of the treatment proposed, so the consent, if given, can be properly and fairly described as true consent.” 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. Assessing competency is left to the health care professionals and there is no universally agreed-upon method to do so. However, guidance will usually include assessing children’s ability to understand their situation, to weigh the different options available to them and to understand the consequences of each.
The emergence of methods and practices to assess competency have been intended to increase child inclusion, participation and rights in decision-making. This places a duty on health professionals to ensure that children are given appropriate information in a way that is understandable to them in order to facilitate their competence. It also requires that health professionals recognise that some children may require information in different ways in order to achieve the same level of understanding and competence.
Examples of guidance on assessing a child’s competency
From Cheshire West & Chester Council, Young People and Consent Guidance Notes :
To be considered competent, a child should have:
- The ability to understand that there is a choice and that choices have consequences
- The ability to weigh the information and arrive at a decision
- To communicate that decision
- A willingness to make a choice (including the choice that someone else should make the
- An understanding of the nature and purpose of the proposed intervention
- An understanding of the proposed intervention’s risks and side effects
- An understanding of the alternatives to the proposed intervention and the risks attached to them
- Freedom from undue pressure
- The ability to retain the information
WHO guidance on assessing the competence of children
Pocket book of primary health care for children and adolescents: guidelines for health promotion, disease prevention and management from the newborn period to adolescence. Copenhagen: WHO Regional Office for Europe; 2022. Licence: CC BY-NCSA 3.0 IGO. Page 666
Children can also, according to national legislation, provide their assent or express their dissent. The terms assent and dissent generally describe when children give their agreement or disagreement to a treatment, in situations where they do not yet have a legal right to give their consent.
If children are considered capable of assent, their assent should be sought in addition to parental authorisation.
In many European countries, written authorisation of parents in addition to the child’s own assent is required.
In order to ensure that children can exercise their right to consent or assent, hospitals and other health services should put in place different measures, including:
Adopting a hospital or health service consent policy, reflecting national legislation
Ensuring that health professionals are aware of this policy;
Promoting 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;
Engaging with children regularly to assess existing policies and practices, as a way to improve these and also children’s experiences of care.
Cultural differences may lead to misunderstandings. Where appropriate a translator and/or a cultural mediator should be available during the process of information and consent/assent and in the planning of the research. This person should be familiar with medical terminology, experienced in the language, social habits, culture, traditions, religion, and particular ethnic differences. This person may need to be available throughout the medical intervention and/or clinical trial, e.g. to facilitate exchanges, adverse events reporting.
Taking into account the national legal framework, seeking agreement should put in balance the emerging capacity of an adolescent for independent decision-making with the need for continued special protection as provided by the parents/legally designated representative in compliance with national laws. The specific aspects of disclosure to parents of information concerning adolescents should be made clear to the adolescent concerned.
For younger or non-verbal children who are not able to raise or express verbal objections, any signs of resistance or protest should be identified and discussed with the parents to assess and recognise whether the behaviour is merely an expression of an acceptable burden or can be considered a concern on intervention continuation. It should also be recognised that for many children, the people best placed to understand or interpret non-verbal indications will be the parents.
In all circumstances, and regardless of the outcome or direction of a decision, the conclusions of any decisions made should be carefully and kindly explained to the child.
Managing disagreements and conflicts
Inevitably, situations will arise when there is a difference of opinion or disagreement. This may typically be between children and their parents, or children and health professionals, or both. It is important to support and manage disagreements with care and according to rights-based principles, so as to enable the best decisions to be made, to protect the ongoing relationships that are often vital to children’s continuing health care, and to enable all parties to move forward beyond the current situation.
The role of health professionals to protect, facilitate and advocate for each child’s right to participate remains unchanged in any circumstance. However, that does not imply that health professionals should agree with or take sides in any disagreement, it is about ensuring that the child is supported to express their opinion, and to ensure that this opinion is considered properly and with due weight in accordance with their rights. Each situation brings its own challenges for health professionals to try to navigate in order to support each child to achieve this right to the greatest extent; whilst enabling the important supportive relationships between the child, parents, and health professionals to remain intact.
Situations of disagreement may test the willingness and skills of health professionals to promote children’s right to participate, who may also worry about damaging relationships with those in disagreement. But the protection of this right is a central duty of health professionals and the principles for meaningful participation referred to in section IIc can help.
Similarly, whilst health professionals have a duty to support and enable children’s rights to participation, they should not be expected to go beyond the laws of their own country. Therefore, it is important for health professionals to know the legal parameters in their country.
Episodes where there may be different views, or where children may express disagreement with a proposed action, range across a wide spectrum of focus and severity. Scenarios where there may be different views and disagreement occur in all areas of health care:
1. Disagreements may arise in situations where no procedure as such is involved, such as in areas of information-giving
For example, a child may wish to take part in a health survey or needs assessment, and the parents may disagree. In such circumstances, any reasons for parental reluctance should be explored and where possible, any unfounded fears met with reassurance where possible (for example about how information is used or how data is stored). However, when assessing ‘best interests’, health professionals also need to remain objective and open to the possibility that in some circumstances (for example, violence in the home), parents may seek to block their child from disclosing concerns and needs; in which case the child’s ‘best interests’ may lie in advocating internally for a way to enable this child to participate, assuming this is possible within the legal framework of the country.
2. In primary health care, immunisation can also be a controversial issue within some families
In primary health care, immunisation can also be a controversial issue within some families, and it is not uncommon for children or adolescents to want a vaccination and the parent be reluctant, for example for COVID-19 or for HPV. This can be a reflection of parent’s own concerns and sometimes be the result of misunderstanding or misinformation.
Providing accurate and clear information about the purpose of the intervention is important and can be reassuring and helpful, ensuring that this is objective and not directive. Similarly, explaining to parents about the rights that their child has and why these are important can be helpful, as parents are sometimes not aware of these or may be sceptical.
Sometimes, moral, religious or cultural beliefs contribute to conflict around medical decisions. Such concerns should be identified and addressed in a respectful manner as early as possible and discussions should be truthful and transparent, always assuming that the primary focus of decision-making remains the child patient’s best interests. Getting the support and mediation of a trusted religious or community leader where available, can be helpful.
3. In situations requiring urgent decisions or actions
Such as procedures to insert an intravenous cannula to give medicines to treat a serious infection or take blood for an important test, it is not uncommon for children to initially refuse or not to want this, particularly being young.
In such circumstances, the conclusion may be non-negotiable and that it is in the child’s best interests to have the treatment. However, this should be explained kindly and carefully to the child concerned, and the child concerned should still be given choices that enable some sense of control and influence on other elements of the care provided, such as sitting position, which arm/hand is used, etc. It is also important to choose the least intrusive treatments possible and to seek alternatives that would be acceptable to the child.
4. There are some situations where the physical holding of a child who resists a procedure may be required to provide health care or to prevent greater harm to the child
These typically occur with young children requiring urgent care, as described in the paragraphs above, and sometimes in complex mental health care settings. Situations like these often create ethical conflicts for health professionals and challenge the application of children’s rights. Physical holding should only occur when there is serious risk to the child’s health if the intervention is not performed, if proactive and preventive strategies have been exhausted. The legal guardians would as a main rule need to approve of the action. The action must be justified and proportionate to the health risk one is seeking to mitigate, and there are legal requirements for this that will vary between member states. All efforts should in any case be made to reduce the level and intensity of this situation and the degree of force should be confined to only what is necessary to hold the child for the shortest amount of time whilst minimising injury to all involved. Decisions to use any form of restrictive physical intervention must be based on the assessment that no other method is available and that its use will cause less harm than not intervening. Even if the necessity has been explained before the intervention, it should always be followed by a discussion where the professional explains why this has been necessary and the child should be given an opportunity to debrief, including emotionally.
5. Differing views may also arise in situations relating to sexual and reproductive issues
For example if an adolescent seeks advice or health care in relation to concerns about a sexually transmitted disease and does not wish to tell their parents. The child's right to confidentiality and access to counselling is important and should be respected. In such circumstances, health professionals may encourage children to open up to their parent(s) and offer support and mediation between the child and the parent(s) if necessary.
In parallel, health professionals also have a duty to assess the circumstances to consider if the child is in an abusive situation and needs protection, or if the child's mental and physical wellbeing is at risk. These and other factors need to be balanced by health professionals in determining the 'best interests' of the child and whether parents should be informed.
6. There are some situations where the focus of disagreements has particularly serious implications
For example, disagreements between children and parents or health professionals about whether to continue active treatment or interventions when there is little hope of recovery (maybe in the case of continuing treatment for cancer, after previous treatments have failed).
In such cases proposed intervention should be delayed while an attempt at resolution is made. Such situations are always very emotive and health professionals should be compassionate but objective in supporting every effort to understand and respect differences of opinion between the children and their parents/legally designated representative. Objections from children, capable of forming an opinion, should be advocated for and respected; and the opinion of legal representatives should be taken into account in interpreting the wishes of children.
Enabling open communication is often key to resolving issues. However, sometimes serious disagreements over what are the children’s best interests remain among parents, children and health care professionals, even after a collaborative decision-making process. It is part of the health professional’s role to mediate and help to restore positive relationships following this.
- Children, parents/legal representatives and health care professionals should be helped to clearly identify the values contributing to conflict and discuss the goals of the proposed treatment/research ;
- Early discussion around the expectations, limitations and uncertainties of treatment options and outcomes may help establish mutually agreeable treatment/research plans;
- Cases should be discussed within multidisciplinary teams ;
- Further discussions and/or referral for a second, independent medical opinion, should be promoted;
- Consulting with and mediation support from a spiritual care leader, social worker, relevant peers, patient relations expert, bioethicist or a bioethics committee, or with institutional or personal legal counsel ;
- In very serious or complicated situations (when the child’s life is at risk or where a severe permanent injury can occur) a court can be asked to decide whether it is right to proceed with a particular treatment.
Examples of guidance / national guidelines on how to manage conflicting views between children, parents and healthcare professionals:
Refusal of care expressed by the minor (section 2-4) – Guidance by the Ministry of Health (France)
2-4-Refusal of care expressed by the minor
The minor's participation in the decision and the collection of his or her point of view cannot take precedence over the decision of the holders of parental authority.
Minors may not refuse hospitalisation.
When a minor expresses a refusal out of weariness, fear of pain or even in the event of irreversible consequences, appropriate dialogue will be required. The medical team, in conjunction with the family, should try to convince the minor.
When the medical acts performed on the minor are not necessary for his or her health, the child has a right of veto prohibiting the holders of parental authority from imposing the act in question. This applies to bone marrow collection for the benefit of a family member or participation in biomedical research.
2-5-Refusal of care expressed by one or more holders of parental authority
It may happen that the parents or legal representatives of minors object to treatment or surgery being carried out or that they decide to take the child out of the health establishment against the advice of the doctors.
The question is to what extent hospital staff can intervene to protect the child against the parents' wishes.
The law states that the doctor must respect the parents' wishes after having informed them of the consequences of their choice.
When the health or physical integrity of the minor is in danger of being compromised by the refusal of the minor's legal representative or the impossibility of obtaining the latter's consent, the doctor must inform the doctor in charge of the service who may refer the matter to the public prosecutor in order to initiate educational assistance measures enabling him or her to provide the necessary care.
In the event of extreme urgency, the law requires the doctor to provide essential care, i.e. that which will protect the young patient from serious consequences for his health. In this case, the doctor will decide to intervene after consulting another doctor and will then draw up a certificate of the urgency of the situation, without waiting for an educational assistance measure from the public prosecutor.
In the absence of an emergency, if the parents or legal representative refuse to sign the authorisation for care or if their consent cannot be obtained, no act of care can be carried out, they must sign a certificate of refusal of care. The parents may avail themselves of the provisions of the Public Health Code when the care does not significantly affect the minor's state of health or if the abstention from care is in keeping with the family's cultural background and its own health beliefs.
If there is no emergency but the medical or surgical procedure is essential, the doctor must inform the director who will alert the public prosecutor so that an educational assistance measure can be taken. The duty public prosecutor should be contacted.
- The doctor should mention in the medical file the need for the treatment, the proportionality of the procedure, the impossibility of obtaining the agreement of the holders of parental authority and the means used to change their minds.
- The decision to operate must be signed by the doctor and co-signed by a representative of the hospital administration or by a doctor with no hierarchical link (check feasibility)
2-6-The case of refusal of blood transfusion
In case of emergency, the parents must be informed of the risk to the child if he/she is not transfused.
If the opposition persists, an educational assistance procedure must be initiated by the public prosecutor's office to lift parental authority.
The doctor then takes the decision to transfuse the child because of the urgency of the situation. If the blood transfusion is not essential for the child's survival and the parents or legal representative refuse it, they must sign a certificate of refusal of care.
Source: Fiche n°3: Information et consentement aux soins d’un mineur - Direction générale de l'offre de soins (DGOS) -ONVS Observatoire nationale des violences en milieu de santé
Italian Children’s Hospital sets up Clinical Ethics Committee to advise and resolve conflicts, Italy
In 2016, the Ospedale Pediatrico Bambino Gesu’(Rome) set up a Bioethics Function, a Clinical Ethics Service and in 2021 it established a Clinical Ethics Committee with the aim of providing advice and specialist training in Clinical Ethics for children.
The purpose of Clinical Ethics consultancy is to identify, analyse and propose solutions to ethical problems and conflicts that arise in patient care.
There were 12 cases involving children brought to the attention of the Committee in 202, 15 cases in 2022, and 11 cases between January and July 2023. The numbers include all the ethical consultancy of Bioethics Resource some of which were discussed and evaluated together with the Committee.
Clinical cases are analyzed using four criteria: 1. Indications for medical intervention: what is the medical problem and how can it be solved; 2. Patient preferences: what the parents want and, when the child can express himself, what the patient prefers; 3. Quality of life: compared to the present conditions, how can the future life of the patient be improved; 4. Contextual aspects: for example the needs of siblings, closeness or distance from the hospital, economic or social problems.
The main and frequent ethical questions raised to the Bioethics Resource and to the Committee of Ethics concerns therapeutic obstinacy. Above all in paediatrics, clinical persistence and experimental obstinacy are often practiced because almost instinctively, even at the request of parents (due to understandable emotional feelings), the physician is inclined to do as the parents wish and do everything possible (both pharmacologically and technologically) to preserve the child’s life, without considering the negative effects in terms of outcomes and further pain and suffering. Sometimes, clinical persistence is consciously practiced as a defence against any possible accusations of failure to provide medical assistance or active interruption of care or life-sustaining treatments (the so called ‘defensive medicine’). In the majority of cases, clinical persistence is accompanied by the use of often sophisticated technologies. For this reason, the term "clinical persistence" is also associated with "technological obstinacy". Issues involving clinical persistence in paediatrics need to be addressed on a case by case analysis which takes into account the specific circumstances prevailing in the different concrete realities: An increase of these situations is foreseeable in paediatrics environment given the rapid developments in science and technology.
The main ‘lessons learnt’ in the Committee in this context are the following:
In the first place, the need for the identification of clinical obstinacy through scientific and medical elements that describe the patient's clinical condition, as in paediatrics the subjective elements that refer to the patient's experience are often lacking. In the case of children, there is a lack of a sufficiently conscious participation in the choice, as they may not be able to express themselves because of their age or immaturity, or in any case be in a condition incompatible with autonomy or full awareness. The description of the clinical condition is necessary in order to justify a possible gradual suspension of an ongoing medical treatment in children with a negative prognosis and in conditions of limited life expectancy, excluding any reasonable possibility of recovery and improvement of the clinical conditions, but only increasing the pain and suffering of the child. The reality is often even more complex: some children do not have a diagnosis (as, for example, is the case with rare diseases); others have a diagnosis but not a prognosis. It should always be considered that in children the unpredictability of the evolution of the clinical framework calls for special attention in careful consideration of each term used ; even the reference to "incurability" is dynamic, revisable in relation to the evaluation moment by moment of the evolution of the pathology, of the rapid progress of medical science; even more so with the expressions 'terminality' or 'imminence of death' which are temporally and clinically vague given the prognostic difficulty. And even pain and suffering are not easily detectable and still difficult to measure above all in children. The best interest of the child should be the inspiring criterion in the situation and should be defined starting from the contingent clinical condition. Doctors should avoid implementing ineffective and disproportionate clinical pathways only in order to comply with parental requests and/or to meet defensive medicine criteria. The Committee helps doctors and parents (often through hearings and direct dialogue during meetings) to base their reflection on the best interest of the child.
A second important element is communication. The decision of the medical team should necessarily be made by involving the parents in the cure and care of the children, devoting particular attention to the empathic understanding of the dramatic situation that the parents are facing and guaranteeing them time and space in communication. Information to parents should be provided by a multi-specialist medical team, of variable composition in relation to the typology of the child's illness, the examination of the possible clinical implications associated with it, the risks and benefits of treatments and their burden. It should be kept in mind that the information cannot always have clear and definitive contents, given the complexity, uncertainty and unpredictability of the condition. However, the information should be continuous for the duration of the entire therapeutic process, also through the elaboration of shared treatment plans or decisions, according to the evolution of the child's conditions in the context of a care relationship, which contributes to the construction of a climate of trust between doctors and family. Often in the process psychologists need to be involved to support both the parents and the children. The quality of life of both the children and parents should be considered, as well as the context (cultural, socio-demographic conditions).
A third element is the need to implement the training of doctor and healthcare personnel, to create a core group of professionals (together with social workers, psychologists, bioethics experts, family associations) able to support parents on an emotional and practical level and accompany them in the difficult path given by the conditions of illness and vulnerability of the child in extremely precarious clinical conditions. There should also be recognition of the important role of the Associations of the parents of sick children in order to consolidate the networks for joint support from parents and from society itself.