WHO/IVB/14.

04
Considerations regarding consent
in vaccinating children and adolescents
between 6 and 17 years old

© C. McNab

Introduction
Around the world, immunization programmes are It provides information that should be considered
increasingly including, in their national immuniza- when preparing guidance notes on the consent
tion schedules, vaccines that target age groups process, or for clarifying questions from the health
beyond infancy and early childhood. This docu- workers who provide the vaccinations. The docu-
ment is aimed at programme managers who are ment is all the more important because this popu-
planning to introduce vaccines for older children lation group may present for vaccination without
and adolescents aged between 6 and 17 years.1 an accompanying parent or legal guardian.

1. According to the Convention on the Rights of the Child (1989), childhood ends upon reaching 18 years of age. In most countries
in the world, this is often considered the age at which legal adulthood, the age of majority, is reached.
 © Ammad Khan

The principleS of consent and assent

Consent Assent
Consent is the principle wherein individuals must Assent refers to the process of children’s and
give their permission before receiving a medical adolescents’ participation in the decision-making
intervention or procedure. According to the laws on vaccination (or other medical interventions).
and regulations in place in most countries, consent Assent is not regulated in law like consent, and
is required for a range of medical interventions is sometimes referred to as a moral obligation
or procedures, from a simple blood test to organ closely linked to good practice in dealing with
donation, and including vaccinations. In only very patients. International law provides strong support
few, well-described circumstances, such as life- for children’s rights to participate in decisions
threatening emergencies, may consent be waived. about their health and health care, and also in the
Consent derives from the principle of autonomy planning and provision of health services relevant
and forms an important part of medical and public- to them and based on their evolving capacity.3
health ethics, as well as international law.2 For
consent to be valid, it must be informed, understood
and voluntary, and the person consenting must
have the capacity to make the decision.

For consent to
be valid, it must
Legal age of consent
be informed, In most country’s legal systems, the legal age In a growing number of countries, the age of
understood and of consent tends to coincide with the age of consent for medical interventions is set below the
majority. This is 18 years in most countries. It age of majority. This allows adolescents to provide
voluntary, and the follows, therefore, that a child or adolescent in consent for specific interventions, such as access
person consenting the age group 6 to 17 years cannot provide consent to contraceptives or HIV testing. Some countries
must have the to vaccination and so consent is normally required have fixed the age of consent specifically to allow
capacity to make from their parent or legal guardian. HPV vaccination at 12 years.

the decision.

2. Convention on the Rights of the Child, General Comment No. 4 (CRC/C/GC/4, 1 July 2003) and No. 15 (CRC/C/GC/15, 17 April 2013).
3. CRC/C/GC/4, 1 July 2003 states that “adolescents need to have a chance to express their views freely and their views should be
2 given due weight, in accordance with article 12 of the Convention.”
Common approaches for obtaining consent
for vaccination
Current practices of obtaining informed consent for vaccination vary Approaches to
among countries, but can be broadly categorized into three approaches. obtain informed
consent:
1. A formal, written consent process is Implied consent procedures are common practice 1. Written consent
used, particularly in middle- and high-income in many countries. However, when children present
countries that have a higher percentage of literate for vaccination unaccompanied by their parents, 2. Verbal consent
populations and a longer history of providing it is challenging to determine whether parents
vaccination to older age groups.4 Vaccination indeed provided consent. Therefore, countries 3. Implied consent
of this target group may be delivered through are encouraged to adopt procedures that ensure
school health services. Health authorities inform that parents have been informed and agreed to
the parents about the vaccination and written the vaccination. Comprehensive data on whether
consent from the parent is required to opt-in, i.e. the approach countries use to deal with consent
give permission for the older child/adolescent has changed or evolved over the last decades is
to be vaccinated. Alternatively, a written form is not available.
used to allow parents to express non-consent (or
refusal) to vaccination of their child. This is known
as an opt-out procedure.

2. A verbal consent process, whereby

consent is given verbally by the parent after being
duly informed about the vaccination. However,
this approach can only be used when parents
accompany the child to the vaccination.

3. An implied consent  process by which

parents are informed of imminent vaccination
through social mobilization and communication,
sometimes including letters directly addressed to
the parents. Subsequently, the physical presence
of the child or adolescent, with or without an
accompanying parent at the vaccination session, is
considered to imply consent. This practice is based
on the opt-out principle and parents who do not
consent to vaccination are expected implicitly to
take steps to ensure that their child or adolescent
does not participate in the vaccination session. This
may include not letting the child or adolescent
attend school on a vaccination day, if vaccine
delivery occurs through schools.
© C. McNab

4. A WHO survey in 2012 in 34 selected countries from four regions on consent procedures for vaccination in 6–17 year-olds, found
that approximately half of the respondent countries use written consent for vaccination in this age group.
3
Mandatory vaccination does not always overrule
the need for consent
Based on concepts of vaccines as a public good,
or on public-health goals of disease elimination
and outbreak control, some countries identify one
or more vaccines as mandatory in law, or in their
policies. Vaccination may, for example, be made
a condition for entry into preschool or primary
school, or to enable access to welfare benefits.
Whether consent is needed for mandatory
vaccination depends on the legal nature of the
regulations. When mandatory vaccination is
established in relevant provisions in law, consent
may not be required. If the mandatory nature of
vaccination is based on policy, or other forms of
soft law, informed consent needs to be obtained
as for any other vaccines. Some countries allow
individuals to express non-consent (opt-out) and
obtain an exemption for mandatory vaccines. This
may come with certain conditions, like barring
unvaccinated children from attending school
during disease outbreaks.

© WHO

SchoolS and communities can authorize, not give consent

When vaccination is carried out in schools, local In a legal sense, school or local welfare or other
or national school authorities normally authorize community authorities, do not have the capacity
the intervention to take place at their premises. to consent to medical interventions on behalf of
This authorization is needed for planning and the children in their care. Exceptions, stipulated in
implementing the vaccination sessions in schools. local laws and regulations, may exist in defined,
The same applies when community or traditional special situations. In some countries, there may be
leaders are asked for permission for vaccination to be tension between cultural or customary practices
carried out in their communities. This authorization, surrounding community consent, and the formal
however, does not imply informed consent by the requirements for consent in laws and regulations.
individuals in that school or community.

4
Practical challenges
There are two main areas in which the vaccination of older children
and adolescents presents challenges for the informed consent process.

Non-accompanied persons
Older children and adolescents may attend a
vaccination session without a parent. This situation
arises when vaccination is school-based, but may
also occur when adolescents visit a health facility
to be vaccinated without their parents. In such
situations, obtaining consent from parents before
vaccination becomes a challenge, and careful
planning is needed to enable them to provide
consent prior to the vaccination of their child. This
is especially true for school-based vaccination
programmes. Countries that use implied consent
for childhood vaccination, consider the parent
bringing the child for vaccination as an expression
of informed consent. To allow parents to express
consent, when vaccination of their child takes
place in their absence, special procedures need
to be put in place. Planning for vaccination must © WHO

take into account the informed consent process.

If written consent (or non-consent) is required for
school-based vaccination, sufficient time needs to
be allowed for the consent forms to be provided on the part of the health worker to ensure that the Health workers
child/adolescent agrees to the intervention. While
to parents and to be returned to the school prior
the views of the child/adolescent and parents
need to know and
to the vaccination session.
on vaccination will concur in most situations, be able to apply the
Evolving capacities of the child
sometimes they may be different. A parent may correct procedure
want their adolescent to be vaccinated but the to follow, according
The capacities of older children and adolescents adolescent refuses, or the reverse when the
evolve towards independent decision-making as adolescent wants to be vaccinated but the parent to national or
they mature. This principle of “evolving capacity”’ does not give permission. It is important that local laws and
outlined in the Convention on the Rights of the health workers understand the rights of parents regulations.
Child (Art. 5),5 combined with the obligation to and children in such cases, and are able to weigh
“respect the views” (Art. 12) and securing the “best these rights based on guiding principles that
interests of the child” (Art. 3), implies that older govern such situations in the country context.6
children and adolescents should have a say in She/he also needs to know, and apply the correct
the consenting process. Formally, this is known as procedure to follow, according to national or local
“assent”, which is interpreted as a moral obligation laws and regulations.

5. Convention on the Rights of the Child. UNGA resolution 44/25 (1989).

6. Convention on the Rights of the Child, General Comment No. 4, 2003 (CRC/GC/2003/4) states: “Before parents give their consent,
adolescents need to have a chance to express their views freely and their views should be given due weight, in accordance with
article  12 of the Convention. However, if the adolescent is of sufficient maturity, informed consent shall be obtained from the
adolescent her/himself, while informing the parents if that is in the ‘best interest of the child’ (Art. 3)” (para. 32–33).
5
 Exceptional
situations and
© Ammad Khan
emancipated minors
Specific situations, living conditions or status of children and adolescents, may affect informed consent.
In a growing Among others, these may include certain groups including adolescents in boarding school. This is
number of like orphans, child-headed households, adolescents also called “third party consent”. In such cases,
living on the streets or married adolescents. In some these third parties can provide consent for
countries, the of these cases, when the parent or legal guardian is medical care, including vaccination of specific,
age of consent absent, such children are considered emancipated individual children.
for medical children or minors. Specific regulations may govern
~~In some African countries, with many HIV/
consent in such situations.
interventions is AIDS orphans and child-headed households,
set below the age ~~In some countries, laws and regulations are the oldest child as of a specific age (e.g. 16 years
in place that identify school- or social-services of age), is empowered by law to consent to
of majority. officials as appointed guardians for children medical interventions for themselves and their
and adolescents not living with their parents, younger siblings.

Consent and immunization coverage

A common concern is that consent procedures vaccination for 13 year-olds, found that more liberal
affect vaccine acceptance and coverage. When opt-out exemption policies were associated with
comparing data from countries using written 5% lower coverage.7 Another country that had
consent and those using informal, verbal or introduced HPV vaccination using written, opt-in
implied consent processes, comparable levels consent forms for parents, had lower coverage
for vaccination can be seen in both settings. initially but coverage levels improved when it
This suggests that the association between the switched to a written, opt-out procedure. While
informed consent procedure that a country uses, better advance planning with the opt-in form could
and actual levels of immunization coverage, is have contributed to better coverage levels, the
not strong. Other factors, such as accessibility, experience confirms evidence from other fields,
acceptance and cost of vaccines, have been seen like HIV,8 national organ-donation programmes
to have more impact on coverage. A study in and behavioural economics,9 which suggests that
the United States of America, which compared opt-out procedures are associated with higher
vaccination coverage among states in the coverage levels than opt-in approaches.
country with mandatory hepatitis B and varicella

7. Olshen E et al (2007). The impact of state policies on vaccine coverage by age 13 in an insured population. Journal of Adolescent
Health. 40;5:405–411.
8. Baisley K et al (2012). Uptake of voluntary counselling and testing among young people participating in an HIV prevention trial:
comparison of opt-out and opt-in strategies. PLoS One. 7(7):e42108.d.
6 9. Kahneman D. Thinking, fast and slow. New York: Farrar, Strauss and Giroux;2011.
Programmatic considerations
Immunization programmes planning to amend or introduce new consent Understanding
procedures for the vaccination of older children and adolescents, are encouraged benefits and risks
to consider the following. of vaccination is
a central aspect
~~Informed consent is required for medical in higher acceptance of an intervention, than of informed
interventions, including vaccination. using opt-in. consent and
~~Where parental consent is required, health work- ~~Increasingly, vaccines are part of integrated
assent. Therefore,
ers should allow older children and adolescents approaches11 and may be delivered alongside communication
to provide assent to the vaccination. other health interventions, such as deworming. strategies and
~~Understanding the benefits and risks of
Hence, there may be a need to harmonize materials need
consent procedures that are currently used for
vaccination is a central aspect of informed different interventions and establish a single, to cater not only
consent and assent. Hence, communication common, informed consent procedure. to parents but also
strategies and materials need to cater not
only to parents but also to older children and
to older children
adolescents. The level of information provided and adolescents.
to the child should be compatible with their
evolving mental capacities and with the level
of their mental maturity.

~~Making changes to consent procedures for

vaccination requires a clear and well-targeted
communication strategy to ensure public
acceptance.10 In countries where written consent
is not common practice in routine vaccination,
the community may associate written consent
with research. In particular, communities may
interpret the introduction of a new vaccine
in combination with a new informed consent
process, as an experiment.

~~Resource requirements (materials, planning

and time) for written consent, particularly for
active opt-in approaches, are often higher than
for other consent strategies.

~~Evidence suggests that consent procedures

based on opt-out approaches are likely to result © Ezequil Rocha Barreto

10. For example, using the principles from: Communication for development. Strengthening the effectiveness of the United
Nations. UNDP; 2011.
11. For example, WHO guidance note on: Comprehensive cervical cancer prevention and control: a healthier future for girls
and women. Geneva: WHO; 2013.
7
Country responsibility
To ensure that national immunization
programmes use informed consent
procedures that are programmatically
feasible and in line with national
and local laws and regulations,
as well as international human
rights principles, vaccination
programmes and regulatory
agencies are encouraged to: © WHO

~~collect information about the (legal) require- and the implications for informed consent
ments for informed consent for medical inter­ process, when vaccinating older children and
ventions (including age of consent and assent) adolescents;
at national, subnational and institutional levels;
~~develop an informed consent procedure that is
~~collect information on public-health laws, adapted to the local situation, to the capacity of
including provisions related to mandatory the health system and, if relevant, school system,
vaccinations and relevant non-compliance in a way that optimizes use of resources and
measures; public-health outcomes while respecting the
~~ collect information about authorization process- rights of individuals;
es in institutions involved in vaccinating older ~~provide guidance to, and build the capacity
children, such as educational establishments; of health workers to implement, informed
~~become familiar with international human rights consent procedures for vaccination and deal
principles and rights of parents and children, appropriately with any special situations.12

12. CRC/C/GC/15 (17 April 2013) states: “it is therefore essential that supportive policies are in place and that children, parents
and health workers have adequate rights-based guidance on consent, assent and confidentiality.”

For further information

• Convention on the Rights of the Child available at: [Link]
• Informed consent procedures for vaccinating non-accompanied children and adolescents. Background document, World Health Organization (2013).
• adolescent hiv testing, counselling and care – Implementation guidance for health providers and planner. World Health Organization, 2013. Section on
‘Informed consent and HIV testing’ available at: [Link]

© World Health Organization 2014.

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