The main provisions of international law
The United Nations Convention on the Rights of the Child (UNCRC)
In 1989, with the adoption of the United Nations Convention on the Rights of the Child (UNCRC), a fundamental value underpinning children’s rights was put forward: the vision that children, defined as any person under the age of 18 years This definition is in line with the provisions of Article 1 of the UNCRC. Article 6 (2) of the Convention on Human Rights and Biomedicine, refers to the term “minor”. For the purposes of this guide, the term “child” is used, unless direct reference is made to provisions using different terminology., must be agents in their own lives, in particular, through Article 12, which sets out the right of all children to be heard and taken seriously, in a manner consistent with their evolving capacities:
Article 12: “1. States Parties shall assure to the child who is capable of forming his or her own views the right to express those views freely in all matters affecting the child, the views of the child being given due weight in accordance with the age and maturity of the child."
The right granted by this article later became known as “children’s right to participation”.
Through its General Comment No.12 (2009) - The right of the child to be heard , the Committee on the Rights of the Child provides guidance on how to interpret children’s right to participate in different areas of life.
Regarding the provision of health care, it states the following:
- “Children, including young children, should be included in decision-making processes, in a manner consistent with their evolving capacities. They should be provided with information about proposed treatments and their effects and outcomes, including in formats appropriate and accessible to children with disabilities”.
- “States parties need to introduce legislation or regulations to ensure that children have access to confidential medical counselling and advice without parental consent, irrespective of the child’s age, where this is needed for the child’s safety or well-being. Children may need such access, for example, where they are experiencing violence or abuse at home, or in need of reproductive health education or services, or in case of conflicts between parents and the child over access to health services. The right to counselling and advice is distinct from the right to give medical consent and should not be subject to any age limit”.
- “Physicians and health-care facilities should provide clear and accessible information to children on their rights concerning their participation in paediatric research and clinical trials. They have to be informed about the research, so that their informed consent can be obtained in addition to other procedural safeguards.”
- Where fixed age at which the right to consent transfers to the child is established, children above that 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 “
- Where a younger child can demonstrate capacity to express an informed view on her or his treatment, this view is given due weight.
Article 12 of the UNCRC, or the right of all children to be heard and taken seriously as a general principle, is linked to the other general principles of the ConventionSuch as the right to non-discrimination (article 2), the right to life, survival and development (article 6) , and, in particular, is interdependent with primary consideration of the best interests of the child (article 3). It should therefore also be considered in the interpretation and implementation of all other rights.
The UN Convention makes no distinction based on age or other characteristics: all children have the right to receive appropriate information and to express their views, and therefore participate in the decision-making process, taking into account their best interests and what is necessary for their well-being and development.
The Oviedo Convention
At the European level, the Council of Europe Convention on Human Rights and Biomedicine (Oviedo Convention, 1997) , 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, based on prior relevant information (article 5). An intervention on a child who cannot consent requires the authorisation of his/her representative, usually a parent, but his/her opinion shall be taken into consideration as an increasingly determining factor in proportion to his or her age and degree of maturity and, as a general rule, an intervention can only be carried out if it is for the child’s direct benefit (article 6).
The Explanatory Report to the Convention specifies that:
- situations should take account of the nature and seriousness of the intervention as well as the child's age and ability to understand, and that the child's opinion should increasingly carry more weight in the final decision. It states that in some cases, this could even lead to the conclusion that the consent of a child should be necessary, or at least sufficient for some interventions (para. 45).
- In some very specific situations and under some very strict conditions in the context of medical research and the removal of regenerative tissue respectively, the rule of direct benefit of the person may be waived.” (Articles 17 and 20 of the Convention (para.44)
Additional international legal instruments apply more specifically to specific health situations or to specific groups of children and re-affirm and/or complement the principles laid down by the two conventions cited above.
Children’s participation in biomedical research
Children’s participation in biomedical research, including clinical trials, is subject to the general principles cited above but also to additional safeguards.
In particular, research cannot be carried out if a child explicitly objects to it. Even if the legal representatives provide their authorisation, a child’s refusal or the revocation of their acceptance cannot be overruled.
This is reflected at European level, in the Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research (CETS No. 195) that stipulates that research must not be carried out if a person who is not able to consent to research objects to it.
CHAPTER V – Protection of persons not able to consent to research
Article 15 – Protection of persons not able to consent to research
1. Research on a person without the capacity to consent to research may be undertaken only if all the following specific conditions are met:
- i) the results of the research have the potential to produce real and direct benefit to his or her health;
- ii) research of comparable effectiveness cannot be carried out on individuals capable of giving consent;
- iii) the person undergoing research has been informed of his or her rights and the safeguards prescribed by law for his or her protection, unless this person is not in a state to receive the information;
- iv) the necessary authorisation has been given specifically and in writing by the legal representative or an authority, person or body provided for by law, and after having received the information required by Article 16, taking into account the person’s previously expressed wishes or objections. An adult not able to consent shall as far as possible take part in the authorisation procedure. The opinion of a minor shall be taken into consideration as an increasingly determining factor in proportion to age and degree of maturity;
- v) the person concerned does not object.
Within the European Union, EU Regulation 536/2014 on clinical trials on medicinal products for human use establishes that 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 to be respected by the investigator.
Article 32 Clinical trials on minors
1. A clinical trial on minors may be conducted only where, in addition to the conditions set out in Article 28, all of the following conditions are met:
- (a) the informed consent of their legally designated representative has been obtained;
- (b) the minors have received the information referred to in Article 29(2) in a way adapted to their age and mental maturity and from investigators or members of the investigating team who are trained or experienced in working with children;
- (c) the explicit wish of a minor who is capable of forming an opinion and assessing the information referred to in Article 29(2) to refuse participation in, or to withdraw from, the clinical trial at any time, is respected by the investigator; (…)
2. The minor shall take part in the informed consent procedure in a way adapted to his or her age and developmental maturity.
3. 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.
The The Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Genetic Testing for Health Purposes (CETS No. 203) provides that “Where, according to law, a minor does not have the capacity to consent, a genetic test on this person shall be deferred until attainment of such capacity unless that delay would be detrimental to his or her health or well-being” (article 10). And in any case, “(w)here, according to law, a minor does not have the capacity to consent to a genetic test, that test 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” (article 12).
In emergency situations, health professionals may be faced with a conflict of duties between their obligations to provide care and to seek the patient's consent. The law provides for conditions under which medical decisions may be taken without the authorisation of the child’s legal representative.
Articles 8 and 9 of the Oviedo Convention allow the practitioner to act immediately in such situations without the consent of the patient, under certain conditions.
This possibility to act without the authorisation of the legal representative is restricted to :
- emergencies which prevent the practitioner from obtaining the appropriate consent and is limited solely to medically necessary interventions which cannot be delayed. Interventions for which a delay is acceptable are excluded;
- the intervention must be carried out for the immediate benefit of the individual concerned;
- in emergency situations health care professionals must make every reasonable effort to determine what the patient would want;
- when persons have previously expressed their wishes, these shall be taken into account. Nevertheless, taking previously expressed wishes into account does not mean that they should necessarily be followed;
- these provisions apply both to persons who are capable and to persons who are unable either de jure or de facto to give consent.
The EU Regulation 536/2014 on clinical trials also provides for specific rules concerning informed consent in emergency situations (art.35).
Where, due to the urgency of the situation, caused by a sudden life-threatening or other sudden serious medical condition, the subject is unable to provide prior informed consent and to receive prior information on the clinical trial, and it is not possible to obtain informed consent prior to the intervention, patients may be enrolled in the clinical trial under the following conditions:
- the clinical trial relates directly to the medical condition because of which it is not possible within the therapeutic window to obtain prior informed consent from the subject or from his or her legally designated representative;
- there are scientific grounds to expect that participation of the subject in the clinical trial will have the potential to produce a direct clinically relevant benefit for the subject resulting in a measurable health-related improvement;
- the clinical trial poses a minimal risk to, and imposes a minimal burden on, the subject in comparison with the standard treatment of the subject's condition.
Any previously expressed objection by the patient should be respected, and informed consent from the subject or from his/her legally designated representative should be sought without undue delay and the information shall be given as soon as possible to the subject and to his/her legally designated representative.
Children with disabilities
The Convention on the Rights of Persons with Disabilities (UNCRPD) reflects the right to child participation in Article 7.3 whereby “States Parties shall ensure that children with disabilities have the right to express their views freely on all matters affecting them, their views being given due weight in accordance with their age and maturity, on an equal basis with other children, and to be provided with disability and age-appropriate assistance to realize that right”.
Through its General comment No. 20 (2016) on the implementation of the rights of the child during adolescence, the Committee on the Rights of the Child, reaffirms the right to child participation in general by stressing that “adolescents with disabilities should, in addition, be provided with opportunities for supported decision-making in order to facilitate their active participation in all matters concerning them.” (paragraph 32).
Every child has the right to be informed and listened to before any health intervention.
The weight given to the views of the child increases with age and maturity.
Decisions should be taken in the best interests of the child.
Medical research may not be carried out on a child if they explicitly object to it, even when the legal representatives have provided authorisation.
Genetic testing on a child must in principle be deferred unless the deferral would be detrimental to their health.
Children with disabilities enjoy this right on an equal basis with other children, and they must be supported to realize that right.