Children and young people must be understood within the context of their stage of growth and development. It is often not scientific or ethical to apply findings from research with adults to them, for example adult drug formulations are often inappropriate for children. Children also require special protection because they:
- are less likely than adults to be able to express their needs or defend their interests
- may not have the capacity to give consent
Key challenges to undertaking research with children include:
- their potential vulnerability
- issues of capacity
- legal protections
- the need to adapt study designs and outcome measures for this age-group
Above all, research with children involves a partnership with both the child and their family.
Research with children, as with all research involving human participants, must ensure that:
- there is an acceptable balance of risk and benefit
- approval is obtained from an independent research ethics committee
- informed consent is taken from participants
Specific ethics principles apply to research with children:
- research should only include children where the relevant knowledge cannot be obtained by research in adults
- research aims must be relevant to child health or wellbeing
- assent from children is needed
- researchers should involve parents or guardians in the decision to participate wherever possible, and always if the child is not yet competent
- a child’s refusal to participate or continue should always be respected
- the child and family should be kept informed and have the opportunity to consent to separate stages of the project
UKRI expects researchers who are undertaking research projects that involve working with children to:
- seek research ethics approval
- include children in decisions to participate and obtain their assent
- provide adequate age-appropriate information about the research to elicit informed decisions about participation
- inform children and families about the balance of benefits and risk
- ensure that appropriate child protection or safeguarding measures are in place at study outset
- observe relevant legal requirements for working with children
- ensure that any incentives and compensation for participation are age appropriate and not coercive
- involve children in co-production, public and participant involvement or engagement (PPIE) opportunities to support and inform the research project