Research involving children & young people

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KING’S COLLEGE LONDON (KCL) COLLEGE RESEARCH ETHICS
COMMITTEE (CREC) GUIDANCE DOCUMENT
RESEARCH INVOLVING CHILDREN & YOUNG PEOPLE
Summary: This document is intended to provide guidance to researchers who wish to
undertake research with children and/or young people as participants. Research involving
children and young people is subject to the same ethical and governance requirements as
any other research project involving human participants. However, the inclusion of children
and young people as participants can also raise specific ethical issues, risks and
governance requirements. It is these issues that this document addresses.
Definitions: What do we mean by the term ‘children and young people’?
For the purposes of this document, and for applications being made to the King’s College
London College Research Ethics Committees (CREC: which incorporates the Research
Ethics Subcommittees (RESCs) and Research Ethics Panels (REPs)), we will use the
following definitions:
Children & Young People: All individuals under the age of 18. For clarity, throughout this
document the acronym ‘CYP’ will be used to stand for ‘children & young people’. The word
‘child’ will be used to refer to an individual child or young person.
Adults: All individuals aged 18 or over.
Parent(s): The person(s) with parental responsibility for the child.
Responsible others: Those who have responsibility for the welfare and well-being of the
child, e.g. teachers, social workers.
Gatekeepers: Individuals or bodies (such as local authorities, schools, care homes)
through whom children might be contacted and in whose setting the research might take
place.
Key principles:
Research involving CYP should only be conducted where:
1. The research is responsive to the needs and/or priorities of this population or
community and there is a reasonable likelihood that this population or community
stands to benefit from the results of the research;
2. The research might not equally well be carried out with adults;
3. The study methods are appropriate for CYP; and
4. The circumstances in which the research is conducted provide for the physical,
emotional and psychological safety of the child.
When should CYP be considered as ‘vulnerable’?
If you are making an application to the KCL College Research Ethics Committees (CREC),
as part of your application you will need to decide whether or not your research
participants could be deemed to be vulnerable. It is important to note that the assumption
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should not be made that all CYP are vulnerable. Whether a child is considered to be
‘vulnerable’ depends on several factors. These will include the child’s circumstances, their
susceptibility to coercion, the type of research being undertaken and how and where the
research is being undertaken. Researchers must therefore take all of these factors into
consideration when assessing whether CYP identified as potential research participants
should be deemed to be ‘vulnerable’ (in some cases this will determine the application
procedure/route you will need to take when making an application to CREC for ethical
approval. See here:
www.kcl.ac.uk/innovation/research/support/ethics/applications/briefingpage.aspx ).
What do we mean by ‘vulnerable’?
Vulnerability should not be determined only by reference to the age of an individual.
Rather, it can be defined as relating to whether or not an individual is more susceptible to
coercion, pressure, emotional, psychological or physical humiliation. Vulnerability may also
relate to a person’s ability to take care of him or herself, or ability to protect him or herself
against significant harm or exploitation. This vulnerability in turn could be the result of
mental or other disabilities, illness, their relationship to the researcher or other participants,
and/or personal circumstances, and a myriad of other factors.
With relation to CYP in research settings, there are many circumstances where CYP can
voluntarily give their informed consent to take part in a research project without there being
an increased likelihood of them being susceptible to coercion or pressure to participate
such that they need be considered to be vulnerable. CYP have the right to be properly
informed and, where possible, their fully informed consent must be obtained.
In situations where there is a need to gain the consent of the parent of a child for that
child’s participation in a research project, this should not be taken to mean that the child is
vulnerable, or not competent to give informed consent themselves. However the
involvement of CYP in research needs to be balanced with the fact that CYP are often less
able to understand and comprehend fully the implications inherent in participating in a
research project. As such, concurrent parental consent is justified by reference to the fact
that the parent has a legal and moral responsibility to ensure the child’s welfare.
Consent:
Research involving very young children and CYPs unable to give informed consent:
In some cases a child is unable to understand the research project and what
participation would mean. For research involving very young children or CYPs with
severe learning disabilities, it is not possible to gain informed consent from the child
themselves, as they are not competent to give consent and so sole parental
consent is necessary. In these circumstances the parent is giving consent for you to
undertake the research involving the child as long as the child remains co-operative
and accepting of the research activities involved. As such you will need to
constantly monitor the child throughout the data collection to ensure the child
remains happy to take part. For research with very young infants who cannot
vocalise their consent, the researcher should be sensitive to other non-verbal cues
and clues to whether the child is happy to take part throughout any data collection
with the child. Ordinarily if a child does not wish to take part, they should not be
made to do so, even if the parent wishes them to do so. However there are
exceptional cases where a research project involves medical treatments or
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procedures such that the parental consent may overrule a child’s objections. For
further guidance please see Sections 4 & 5 of the Medical Research Council
guidance document:
http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC002430
Research involving CYP under 16 years of age (where they are able to give
informed consent):
For such research the consent of the parent should ordinarily be obtained in addition
to that of the child. Where possible, in the first instance consent should be obtained
from the parent. After such consent has been obtained, the child themselves should
be approached and their consent obtained. It is key to note that while parental
consent is required, a parent cannot consent on behalf of their child. If either the
child or the parent does not give their consent, the child must not participate.
However there are exceptional circumstances where it may be more appropriate not
to approach parents for their consent for CYPs under the age of 16. The NCB
guidelines give various circumstances where this may be the case (see page 30):
http://www.ncb.org.uk/media/434791/guidelines_for_research_with_cyp.pdf .
It is important to note that the circumstances mentioned are the exceptions to the
rule. If you wish to undertake research with CYP under the age of 16 without
approaching parents about their child’s involvement, you will need to ensure you
have a thorough justification for this, and that appropriate procedures/measures are
in place.
Research involving CYP who are 16-17 years old:
It is not usually necessary to gain parental consent for research with CYP who are
16-17 years old. However again there are situations where parental consent might
be appropriate in addition to the 16-17 year old themselves giving consent. See
Section 3.4.1 of the NCB guidelines for more details on when this may be the case:
http://www.ncb.org.uk/media/434791/guidelines_for_research_with_cyp.pdf .
Recruitment documents (Information Sheets, consent forms, handouts, posters etc):
When creating recruitment documents, such as Information Sheets, it is key that these
documents are tailored specifically towards the different participant groups at which they
are aimed. Careful attention needs to given by researchers to devising ways of enabling
CYP to access the information required for consent. This should take account of factors
such as level of reading ability and attention span. The use of visual imagery (such as
cartoon characters), spaced out text rather than long paragraphs, and generally simplified
wording on the documents to be seen by CYP, can be very helpful in this regard. The
primary aim is to keep such documents as clear and concise as possible to ensure the
child is fully informed and understanding of what the project will involve. There are various
reading age tests/tools available online where you can check the readability of the
documents you intend to use during a study.
It should usually be the case that separately worded Information Sheets and consent
forms are used for parents and for child participants. This is because in most cases the
child is the participant, while the parent is not. As such, the wording on the different
documents should reflect this.
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Methods of obtaining consent:
For research involving CYP it should usually be the case that written consent is taken
through the use of a physical consent form (one for parents to give their consent for the
child to take part (for CYP under 16 years of age) and one for the child themselves to give
consent to take part. It should be noted that written consent for very young children is often
not appropriate and can be replaced with oral consent where necessary).
Ethics committees recognise that for research involving classroom observations it may be
not be feasible to gain written consent from every parent. In such cases, where justifiable,
an ‘opt-out’ procedure for parents can be used.
The opt-out consent process for parents is only acceptable for passive classroom
observations where there is no disruption to normal classroom activity, there are no
sensitive topics involved and there is no intervention. In cases where teachers are working
with their own students an intervention is only if they change their daily teaching. This
applies to all researchers and not only those who are observing their own class.
Opt-out involves the parent being informed of the study and asked to respond using an
‘opt-out’ form, the receipt of which means that the particular child will not then be included
in the study. If such a form was not then received by the research team, the consent of the
parent would be taken as assumed. This in itself is potentially problematic, as there may
be situations where the parent/carer did not receive the information about the project in
time to then submit the opt-out form, so factors such as this will need to be carefully
considered should an opt-out process be used. Such an opt-out procedure needs to be
managed carefully ensuring that forms are received by parents with time to be submitted.
More generally however, and for the majority of projects involving CYP, ‘opt-in’ consent
procedures are preferred and should be the ‘default’ option of gaining consent. Opt-in
consent procedures allow parents and CYP to make a positive step towards agreeing to
be involved in the project. This method ensures that only parents, and CYP, who do wish
to take part will be recruited into the project.
Key points on consent:
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As a researcher, you will need to gain initial consent from parents, (and if
necessary) the agreement of responsible others with a duty of care for the child.
This will nearly always be necessary for CYP under the age of 16. CYP over the
age of 16 can usually give consent to take part in research without their parent
being involved or informed.
In some situations you may also be required to gain permission from ‘gatekeeper’
organisations, such as schools, charities, local authorities. This will depend on the
nature of the project and how participants are being identified and recruited.
Active consent should be sought from each child individually – not from CYP as a
group (because individuals in the group could feel pressured to take part against
their wishes).
As a general rule, remember that the child is the participant, not the parent or
gatekeeper, and, therefore ethics principles about consent should always apply to
the child. As with adults, start from a position of assuming competence; do not
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assume that CYP are incompetent, but recognise the need to adapt your methods
for seeking consent to their level of understanding.
Safeguarding requirements:
When undertaking research with CYP there may be specific safeguarding requirements
and governance responsibilities that the researcher will need to take into account.
Child protection issues/limits to confidentiality:
Researchers have a legal and moral duty to respect the rights of participants for
their participation and data to remain confidential. However, there are some
circumstances where a disclosure might be made by a participant, or evidence may
come to light of a child protection issue. In such circumstances, the researcher may
have a legal, professional or moral duty to breach the confidentiality of participants
and inform a third party outside of the researcher team, such as a relevant authority
(e.g. the Children’s services department of the local authority/social services, a
school/educational establishment, the police etc). It is crucial that all such
possibilities are considered by the researcher prior to the project taking place, with
appropriate procedures put in place. Parents and CYP should be made aware on
the Information Sheet that there may be limits to confidentiality, and that certain
situations would mean that the researcher has a duty to inform a relevant authority
outside of the research team. An example of wording which may be used is as
follows: ‘Everything you say will be treated as confidential, unless I am worried that
there is a risk of harm to you or another young person, in which case I will inform
your teacher/ social worker’ (or adapted for younger children).
CRB checks:
Information regarding CRB clearance can be found on the website of the Criminal
Records Bureau www.direct.gov.uk/crb and the Independent Safeguarding
Authority website http://www.isa-gov.org.uk/ .
If you think Criminal Records Bureau clearance might be necessary for your project,
ensure you have contacted the Criminal Records Bureau directly to confirm whether
or not this is the case. You will need to ensure you have the appropriate and
necessary Criminal Records Bureau clearance for your study prior to commencing
recruitment or data collection. You may wish to consult with the relevant
‘gatekeeper’ organisation with which you are undertaking the study with respect to
this issue.
Note that individuals cannot apply for a CRB check directly. You will have to have a
CRB check carried out through the College or by the organization where you are
carrying out the research, if they request it. Be aware that your department in the
College may have a specific procedure for CRB applications, and you should check
with an appropriate member of staff before applying centrally.
The College policy on CRB checks can be found at the following link:
http://www.kcl.ac.uk/college/policyzone/index.php?id=270 .
Other issues:
Non-participating CYP in group settings:
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Where a research project will involve groups of CYP (perhaps where a whole class
or year at a specific school are being approached for a study), it is important for the
researcher to take into consideration the possible effects the project might have on
those individuals who do not participate in the project. There are various
circumstances where an individual child might not take part (e.g. where there is a
medical, social, cultural or religious reason for non-participation) and researchers
must be sensitive to this. Where this is the case there is a potential for the nonparticipating CYP to be labelled or stigmatised as a result of their non-participation.
This risk needs to be addressed and resolved in the application for ethical approval
It may also be the case that the non-participation of some CYP could lead to them
being disadvantaged compared to participating CYP, or vice versa. To take
observation studies as an example, where this will involve video recording of
classroom activities. Some CYP will not wish to be video recorded, and might opt
not to take part in the research for this reason. Where this is the case, the child
should ideally not be disadvantaged by them missing the lesson in question. In such
a case, liaising closely with the gatekeeper organisation about provisions for nonparticipants would be crucial.
The NCB guidelines provide some useful guidance on different methodological
issues for research involving CYP. See section 3.3:
http://www.ncb.org.uk/media/434791/guidelines_for_research_with_cyp.pdf .
Incentives and compensation:
Where you intend to offer incentives or compensation to CYP for taking part in a
project, it is crucial that consideration is given to the appropriateness of doing so,
and also of the kind of incentive/compensation to be offered. For example, offering
sweets to CYP would usually be advised against where a healthier alternative might
be available. Similarly, what you offer should also be appropriate for all CYP
involved, regardless of their religion, cultural background, or medical status. It may
be advisable to consult with parents/carers beforehand for advice on this. It is good
practice to offer vouchers rather than cash where possible, in order that the
incentive can be tailored toward an appropriate, specific area.
Dissemination of findings/results:
As with all research, consideration must be given as to how the results and findings
of the project might be disseminated and communicated to the participants. The
method through which this is achieved will depend on the nature of the project and
the participants, but wall-charts, posters, websites, child-friendly pamphlets, or even
events (such as workshops) based on the findings of the project are all possible
ways of disseminating findings back to the child participants.
Useful resources and guidelines:
There is a wealth of useful resources and guidelines for researchers undertaking projects
involving CYP. In the first instance the researcher should consult the professional
guidelines and codes of practice specific to their area of research; e.g. psychologists
should consult the British Psychological Society guidelines on research, and the specific
recommendations made for working with CYP.
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As well as this there are guidelines from organisations and bodies that have specific
expertise with respect to CYP.
National Children’s Bureau (NCB):
http://www.ncb.org.uk/media/434791/guidelines_for_research_with_cyp.pdf
British Educational Research Association (BERA):
http://www.bera.ac.uk/publications/ethical-guidelines
Medical Research Council:
http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC002430
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