Eur J Pediatr (2003) 162: 629–633

DOI 10.1007/s00431-003-1193-z

O R I GI N A L P A P E R

Maria De Lourdes Levy Æ Victor Larcher Æ Ronald Kurz

the members of the Ethics Working Group of the CESP

Informed consent/assent in children. Statement of the Ethics

Working Group of the Confederation of European Specialists
in Paediatrics (CESP)

Received: 22 October 2002 / Accepted: 28 January 2003 / Published online: 19 July 2003
Ó Springer-Verlag 2003

Abstract Informed consent means approval of the legal measures and research. Children may effectively refuse
representative of the child and/or of the competent child treatment or procedures which are not necessary to save
for medical interventions following appropriate infor- their lives or prevent serious harm. Where treatment is
mation. National legal regulations differ in regard to the necessary to save a life or prevent serious harm, the
question when a child has the full right to give his or her doctor has the duty to act in the best interest of the child.
autonomous consent. Informed assent means a child’s However, parents may also refuse to consent and in this
agreement to medical procedures in circumstances where case national laws and legal mechanisms for resolving
he or she is not legally authorised or lacks sufficient disputes may be used.
understanding for giving consent competently. Doctors
should carefully listen to the opinion and wishes of Keywords Children Æ Ethics Æ Informed consent
children who are not able to give full consent and should
strive to obtain their assent. Doctors have the respon-
sibility to determine the ability and competence of the Introduction and nature of consent/assent
child for giving his or her consent or assent. All children,
even those not judged as competent, have a right to re- Informed consent means approval of the legal repre-
ceive information given in a way that they can under- sentative of the child or of the competent child for
stand and give their assent or dissent. This consent/ medical interventions following appropriate informa-
assent process must promote and protect the dignity, tion. There are differences in national legal regulations
privacy and confidentiality of the child and his or her when a child has the full right to give his or her auton-
family. Consent or assent is required for all aspects of omous consent. Informed assent means a child’s agree-
medical care, for preventive, diagnostic or therapeutic ment for medical procedures in circumstances where he
or she is not legally authorised or has insufficient
Members of the Ethics Working Group of the CESP are: Timothy L. understanding to be competent to give full consent.
Chambers (UK), Francis P. Crawley (Belgium), Denis Gill (Ireland), Consent/assent as applied to medical treatment in-
Milena LoGiudice (Italy), Stefan Grosek (Slovenia), Ronald Kurz,
Chairman (Austria), Maria de Lourdes Levy (Portugal), Staffan volves more than mere agreement that a diagnostic test
Mjönes (Sweden), Andreas Constantopoulos (Greece), Armido or a therapeutic procedure shall be done. Consent/assent
Rubino (Italy), Pieter J. J. Sauer (Netherlands), Martti Siimes is a more active process and involves a patient receiving
(Finland), Michael Weindling (UK) and Maximilian Zach (Austria). information about the proposed procedure at a pace and
Approved by the CESP, May 4th, 2002
a level which they can comprehend and the ability to use
that information to make a voluntary choice as to
R. Kurz (&) whether to undergo that procedure. Consent/assent
Ethics Working Group of the CESP, emphasises the qualities of partnership, mutual under-
Department of Paediatrics, standing, respect and trust which underline the doctor-
University Hospital Graz, Auenbrugger-Platz 30,
8036, Graz, Austria patient relationship. An essential element in consent/
E-mail: ronald.kurz@kfunigraz.ac.at assent is that informed choices are freely made without
M. De Lourdes Levy
coercion or force.
University Clinic of Pediatrics, The legal purpose of consent of the patient is to
Hospital de Santa Maria, Lisbon, Portugal safeguard his or her autonomy or right to self-determi-
V. Larcher nation but also gives licence for the physician and others
Queen Mary’s School of Medicine and Dentistry, to do things to patients which would otherwise be illegal.
London, UK However, doctors should also carefully listen to the
630

opinion and wishes of children who are not able to give must not ignore children’s interests. On the contrary
full consent and should obtain their assent. The doctor they, in partnership with parents, have a duty to en-
has a high responsibility because he has to determine the hance, encourage, protect and promote children’s
ability and competence of the child to give his or her development from the dependency of infancy to the
consent or assent under the conditions of the national autonomy of adults.
law. Parents are given the ethical and legal responsibility
Although consent/assent is often perceived as one-off to make decisions for children provided that they do so
event, it is better regarded as a continuing process. in the best interest of the child (United Nations Con-
vention of Rights of the Child). However, the UN
Convention, which has been ratified by all EU states and
Ethical justifications for consent/assent which defines the child as being a person also under the
age of 18, provides a mechanism for children’s views to
Seeking consent/assent for medical treatment is justified be heard. Article 12 provides that the states ‘‘shall assure
by the application of traditional moral theory or prin- the child who is capable of forming his or her own view,
ciples. the right to express those views freely in all matters
Firstly, seeking a person’s consent/assent respects affecting the child, the view of the child being given due
their basic right to self-determination (autonomy). weight in accordance with the age and maturity of the
Individuals are best placed to determine what is their child’’. As a consequence, ‘‘children shall be provided
best interests and the only justification for infringing this with the opportunity to be heard in any judicial or
right is to prevent harm to others. Secondly, obtaining administrative proceeding affecting the child directly’’.
consent/assent involves treating others in a way in which Whilst this does not explicitly refer to medical treatment,
we would expect to be treated ourselves. The universal there is no doubt that this is what is intended. The
need to obtain consent/assent also involves treating Convention also provides that children should have ac-
people justly. Thirdly, obtaining consent/assent protects cess to the best available standards of health care, the
patients from the physical and psychological harms right to information, the right not to be subjected to
which may occur as a result of illness or its treatment. inhuman or degrading treatment and the right to pri-
Fourthly, obtaining consent/assent confers benefit by vacy. Children are right owners, even if they are not able
encouraging active participation of individuals in to express their rights. Everyone dealing with such rights
investigation and treatments which are intended to re- has the duty to promote them, to give voice to them and
store their health. As a consequence, compliance for to become a true child advocate.
treatment is often improved. Wider social benefits from
consent/assent include the fostering of a doctor-patient
relationship which is based on partnership, mutual trust, The role of law in disputes about consent
understanding and respect.
Traditional moral theories have to do with adults As indicated above, disputes about consent/assent and
who are usually regarded as sentient rational beings refusal may require legal intervention. The role of law in
without having the obligation to prove it. Increasingly, ethical decision-making is to: (1) provide a framework
doctors actively involve children in making decisions within which to resolve difficult ethical issues, (2) pro-
about their own health care to an extent which would vide safeguards in response to controversial issues viz (a)
have been unlikely in the past. This greater involvement absolute prohibition- even with consent, e.g. circumci-
implies some changes in our attitudes to the moral status sion, (b) procedural hurdles, e.g. regulation of fertility
of children and the moral claims which they may make treatments, (3) provide a mechanism for resolving
on society. intransigent disputes fairly and (4) to protect weak and
vulnerable individuals, e.g. infants.
Controversies, which may arise, are likely to relate to
The moral status of children the age at which children and young people are regarded
as competent to refuse treatment, which health care
According to Article 1 of the Declaration of Human professionals believe to be in their best interests. Al-
Rights, the child must be recognised as a person with the though it is logical to assume that if children are com-
basic rights of all human beings to be free and equal in petent to consent to a procedure, they are also
dignity and rights. Therefore, the principal attitude or competent to refuse it, there may be difficulties with this
doctors must be dedicated to the respect of the life and approach. Many jurisdictions are reluctant to permit
dignity of the child as an entity of full value at each stage children to refuse life-saving treatment, even when they
of development. The more children are dependent on the are felt to be competent to consent to it, e.g. treatment
protection and the support of their parents and other for anorexia nervosa, blood transfusions and treatment
adults because of the lower status of their development, of leukaemia in Jehovah’s Witnesses. The general over-
the more the attention and empathy of doctors should riding principle of law is usually that the best interests
be focused on the needs of children. Therefore doctors of the child or young person are a major factor in
should not only concentrate on the view of parents and deciding what should be done. This is in keeping with
 631

the provisions of the UN Convention on the Rights or assent. However, valid consent/assent requires not
of the Child, which has been widely ratified and in only competence but also the adequate information and
decisions by the European Court of Human Rights. the obtaining of the consent/assent without duress or
constraint.

The question of age

Assessing competence
Under the UN Convention all children have rights
irrespective of their age or maturity and these rights Competence is the ability to perform the task in ques-
confer certain obligations on society and individuals in tion. In this case, it involves the ability to make decisions
their treatment of children. The Convention does not about health care. Whether a child may make such
define when the wishes of a child become determinative decisions, depends on the national law and on the
rather than merely need to be taken into account. Thus judgement of the doctor on the developmental skills of
the Convention does not determine when children be- the child to be able to make autonomous decisions. The
come competent to make decisions for themselves. Par- child therefore needs to show that he or she can (1)
ents are acknowledged as being the most important understand the information which is given to them, (2)
decision-makers for incompetent children although there believe that information applies to them, (3) use the
may be other complex circumstances where other information to make a free choice and (4) make the
agencies, e.g. the law court, may be involved. choice in question.
In law, if not ethically, it has been traditional to re- Competence depends on the context which may in-
gard competence as a function of age. Thus the age at volve the physical surroundings of the child. It also de-
which children may ride motor cycles, drive automobiles pends on the relationship between the child, the parents
or drink alcohol has been defined by relevant law in and the health professionals and must be seen within the
European states. However this notion of age-related child’s experience of their illness. Competence also varies
competence has been increasingly questioned in relation over time and with the state of the illness. For example a
to such personal matters as making decisions about child who is in severe pain may not be competent to
health care. This questioning has begun to find expres- make decisions which they could otherwise make.
sion in national laws or their application in relation to a Broadly speaking, children need to show understand-
child’s competence to consent/assent or refuse medical ing of the nature of their illness, why treatment is neces-
treatment. In EU countries, the age of majority is gen- sary, understanding of the treatment which is proposed
erally 18 years although exceptions exist. At this age any and what risks are entailed and understanding of the
competent person is legally able to refuse treatment as implications of treatment or non-treatment on themselves
well as consent to it. or on their families. The more impact a treatment is likely
Younger children may, according to laws of individ- to have, the greater understanding they will need to
ual states, be able to consent to treatment especially if demonstrate, especially if they wish to refuse it. There is a
they have enough maturity and ability to understand the complex relationship between competence and informa-
benefits and risks of the proposed treatment and its tion. It would be difficult for a child to be competent if they
alternatives. The concept of a ‘‘mature minor’’ has been had not been adequately informed. Therefore, all chil-
introduced by some authorities to include groups of dren, even those not judged as competent, have the right
children whose age ranges in most EU countries from 14 to receive information given in the way they can under-
to 18 years and who are often regarded as being mature stand and to give their assent or dissent.
enough to give their own consent to treatment. In some
countries the age at which children are considered to be
potentially competent is even lower. In some jurisdic- Information
tions competent minors can give their consent without
the involvement of parents, assuming the decision is It is doubtful if fully informed consent/assent is ever
beneficial for the adolescent and he/she does not want possible. Therefore the information which needs to be
the parents involved. divulged needs to be adequate in quantity and quality.
Competence has often been associated with cognitive
capacity, rationality and age. However, it is now re-
garded to be also a function of a child’s experience of the Quality of information
illness in question. For example a 12-year-old adolescent
with a second relapse of leukaemia has a unique expe- It is most important that all information should be in
rience of the illness on which to base his or her decisions conformity with the capacity of the child to understand.
about future treatment. Very young children may have a Language and communication should be adapted to the
clear understanding of death although they may lack capacity of the child to understand and make decisions.
understanding of the likely effect of their death on their Both parents and children should have sufficient time and
families. In any case, doctors should always question space to reflect upon the information which has been given
themselves if the child is mature enough to give consent to them to use it to make a choice. For special cases e.g.
632

cardiac, oncological and other diseases, clinical centres sent in which an individual is specifically asked to con-
usually provide supporting written information. Addi- sent/assent to the procedure in question, e.g.
tional drawings which illustrate medical interventions are appendectomy for acute appendicitis. Consent may be
useful means of information. However, the personal and implied when an individual presents themself or is pre-
lingual communication between the doctor and the par- sented for a procedure to which general agreement has
ents and child-patients is mandatory for the informed been agreed or implied. For example, a child’s presen-
consent/assent process. tation by a parent for immunisation as a result of a letter
The content of information which needs to be given of invitation is often taken as being implied consent/
should include the following: assent for this procedure. Nevertheless, information
about benefits and risks should be regarded as manda-
1. What is going to be done?
tory.
2. Why is it going to be done?
Consent may be written or verbal. Written consent
3. What is the intended outcome?
provides some kind of record that the procedure has
4. What are the benefits and risks of the treatment
been discussed but may have no more legal force in some
proposed?
countries than verbal consent. Nevertheless, it is essen-
5. What are the alternatives including benefits and risks?
tial to provide a written account of the information
6. What will happen if nothing is done?
which is being given to obtain consent. Assent may be
These questions deal in broad terms with the quality given verbally.
of information which should be given. They do not
consider how much information should be given.
In what circumstances is consent/assent unnecessary?

Quantity of information Medical treatment may take place without consent/as-

sent when the indication to intervene overrides the
Previously, professionals revealed as much information as practicalities of obtaining consent/assent. Doctors need
they thought was necessary; this often provided insuffi- to satisfy themselves that either the child’s life would be
cient information. The minimum information which in danger or there is a serious risk to the physical or
should be provided is that which a reasonable or average mental health of the child if treatment is not given. A
parent or child might want in order to make a decision doctor has a duty to act in the child’s best interest and
about whether to undergo a procedure in similar cir- would need to show that is what he or she had done. It
cumstances. A more stringent standard is to provide the would be wise to have the written support of a colleague
information which this individual parent or child might that the child’s life would be in danger if treatment were
actually require to make the decision in question. What- not given. A record of the steps taken to try to obtain
ever standard is chosen there is a duty to answer all consent/assent should be kept. In most circumstances
questions that the child or parents may have unless the parents would be available to give consent but if they
doctor feels that to do so would be so harmful that he or refuse to do so, e.g. in the case of a child who requires a
she feels that it cannot be given. These circumstances are blood transfusion but whose parents are Jehovah’s
exceptionally rare. Without sufficient information neither Witnesses, then legal intervention may be necessary if
children nor parents can be competent to make decisions. there is sufficient time to do so.

Voluntariness Refusal of treatment

The consent/assent process must promote and protect the It is logical to assume that a child who is competent to
dignity, privacy and confidentiality of the child and his or assent to treatment is also able to refuse treatment even
her family. The consent/assent must be obtained without if doctors feel that it is in the child’s interest. However,
forced or undue influence and should not take place under thus is not necessarily the case in law whose function in
duress. There may be circumstances, e.g. an acute emer- this instance is to protect the child or others from harm.
gency, where time constraints apply. The power imbal- Children may refuse treatment or procedures which
ance in the doctor-patient relationship can also be a factor are not necessary to safe their lives or prevent serious
in reducing voluntariness. harm, e.g. blood tests or minor dental procedures. At-
tempts should be made to persuade them that the pro-
cedure is in their best interests but in general, the
In what situations is informed consent/assent treatment should be postponed until the child is able to
necessary? agree to it.
Where treatment is necessary to save life or prevent
Consent or assent is required for all medical care, for harm, the doctor has a duty to act in the best interest of
preventive, diagnostic or therapeutic measures and the child. In these circumstances the consent of the
research. Usually it is necessary to obtain express con- parents is usually obtained and in law is often regarded
 633

as sufficient. However, parents may also refuse to con- national and international law on this matter are often
sent and in this case national laws and legal mechanisms unclear.
for resolving the dispute may be used. In general children should give their consent/assent to
Children may also refuse treatment if mental illness be involved in research also when the parents have given
renders them incompetent to consent/assent to treat- consent. This is especially so if children are involved in
ment which is otherwise in their best interest, e.g. an projects which carry no tangible benefit to them e.g. the
adolescent with anorexia nervosa who refuses feeding provision of blood samples to obtain controlled data of
support. Although treatment may proceed with parental normal population value.
consent or by invoking appropriate medical health leg- Guidelines for the process of obtaining informed
islation, it is good to listen carefully to children and consent/assent in biomedical research involving children
explain to them why their wish to refuse treatment is are laid down by a separate document of the ethics
going to be overruled. Very rarely children may consent working group of the CESP.
to treatment which is in their best interest but also
dangerous or experimental and to which their parents
refuse. If they are competent to understand fully the Further reading
nature and purpose of what is involved, then their choice
should generally be respected. 1. Alderson P (1990) Choosing for children: parents’ consent to
Many disputes about consent/assent and refusal can surgery. Oxford University Press, Oxford
2. Alderson P, Montgomery J (1996) Healthcare choices. Making
be resolved by devoting time and energy to discussions decisions with children. Institute of Public Policy Research,
with parents and children by perhaps involving advo- London
cates, religious advisers etc. However, in cases where 3. Devereux JA, Jones DH, Dickenson DI (1993) Can children
resolution cannot be achieved, the appropriate legal withhold consent to treatment? BMJ 303:1459–1461
steps are taken. Such documentation should include 4. Doyal L (1993) Needs, rights and the moral duties of clinicians.
In: Gillon R (ed) Principles of health care ethics. Wiley,
clear justification as to why a child’s right might be in- London, pp 217–230
fringed. 5. Ethics Working Group of the Confederation of European
Specialists in Paediatrics (CESP) (2003). Guidelines for in-
formed consent in biomedical research involving paediatric
populations as research participants. Eur J Pediatr 162:455–458
Research 6. Foreman DM (1999) The family rule. A framework for
obtaining ethical consent for medical interventions from chil-
Research involving children is important in terms of the dren. J Med Ethics 25:491–496
benefits which it may provide to both individual chil- 7. Gillon R (1991) Philosophical medical ethics. Wiley, Chichester
8. King NMP, Cross AW (1996) Children as decision makers.
dren, children in general and to society. However, all Guidelines for paediatricians. J Pediatr 115:10–16
research must fulfill strict ethical criteria and must be 9. Kurz R, Ethics Working Group of the CESP (2001) Decision
subject to valid consent/assent. All research proposals making in extreme situations involving children: withholding of
should be subject to evaluation by research ethics com- withdrawal of life supporting treatment in paediatric care.
Statement of the ethics working group of the Confederation of
mittees/review boards which will usually require that: the European Specialists of Paediatrics (CESP). Eur J Pediatr
1. The research proposed will answer a valuable scien- 160: 214–216
10. Lansdown R (1998) Listening to children; have we gone too far
tific question. (or not far enough)? J Roy Soc Med 91: 457–461
2. The research needs to be done in children. 11. Nuffield Council on Bioethics (1995) Human tissue and legal
3. The research has a favourable risk-benefit ratio. issues. Nuffield Council on Bioethics, London
4. A written information leaflet will be given. 12. Ondrusek N, Abramowitch R, Pencharz P, Koren G (1998)
Empirical examination of the ability of children to consent to
5. A written consent will be obtained. clinical research. J Med Ethics 24: 158–165
6. Adequate time is provided for consent. 13. Pearce J (1994) Consent to treatment during childhood: the
7. Withdrawal of consent may occur at any time with- assessment of competence and the avoidance of conflict. Br
out any consequences for patients or parents. J Psychiatry 165: 1–16
8. The person obtaining consent/assent will be the per- 14. Sauer PPJ, Ethics Working Group of the CESP (2002) Re-
search in children. Report on behalf of the Ethics Working
son who is carrying out the research project. Group of the Confederation of European Specialists in Paedi-
atrics. Eur J Paediatr 161: 1–5
Studies suggest that children over 9 years of age can 15. United Nations Children’s Fund (1995) The Convention of the
understand quite complex metabolic projects but Rights of the Child. UK Committee for UNICEF, London