Guidance for Research Participants Under the Age of 18

Including children as participants in social research raises many ethical dilemmas for researchers. Legal responsibilities to uphold children’s rights within the research process, enshrined in the UN Convention on the Rights of the Child, sit alongside researcher obligations to respect the principles of justice, consent, confidentiality and avoiding doing harm to child participants. Researchers must find the balance between protection and participation to enable children to be heard – without exploiting or distressing them – and protected, without silencing and excluding them (Alderson & Morrow, 2004).

Article 12 of the UN Convention on the Rights of the Child states that all children who are capable of forming their own views, have a right to express those views freely in all matters affecting them, with the views of the child being given due weight in accordance with their age and maturity.  This right has been translated into Irish law through Article 42A of the Irish Constitution and into policy and practice by Tusla, through its development of a Participation Strategy for children and young people[1]. This policy is underpinned the Lundy model (Lundy 2007) which outlines four chronological steps to be followed in the realisation of children and young people’s participation.

1. ‘space’: children must be provided with the opportunity to express a view in a space that is safe and inclusive.
2. ‘voice’: children must be facilitated to express their view.
3.  ‘audience’: the view must be listened to.
4. ‘influence’: the view must be acted upon as appropriate and the reasons for the decision taken must be communicated to the child

National policy published by the Department of Children and Youth Affairs’ National Strategy on Children and Young People's Participation in Decision-making (2015-2020) and Better Outcomes, Brighter Futures:  The National Policy Framework for Children and Young People 2014-2020 also advocate for children and young people to be listened to on matters affecting their lives.

Guidelines produced by the UK-based National Children’s Bureau Research Centre (2011:4) noted that ‘we not only seek to involve children and young people in research because they have a right to be involved but also to improve the quality of the research itself’. It is vital to ensure children’s right to participate in matters that affect them (Graham et al 2013) is upheld in the research process.

Involving research participants under the age of 18 in research, can provide a range of benefits to research participants, researchers, policymakers, service providers, funders, and the wider community.

• It can enhance the validity of research findings and inform practice (Salveron, Finan & Bromfield 2013)
• Children can meaningfully contribute to studies on a range of sensitive issues including homelessness, well-being, illness, pain and poverty using age appropriate methods and tools (Moore, Saunder & McArthur, 2011; Nobe- Carr, 2006; Peterson & Biggs, 1997; Punch, 2002)
• Studies have consistently found that young people want to be asked their opinion and be involved in decisions affecting them (e.g. Tierney et al 2018)
• There are benefits for researchers too. Involving children in research develops a greater understanding about lived experience and a deeper appreciation for the challenges, concerns and implications that particular issues have on their lives and those of their families and communities (Moore, Saunders et al. 2011).

The following concluding points are highlighted by DCYA in the their guidance for research involving children[2] Research with, and for, children (defined in Ireland as people below the age of 18) is necessary and beneficial, but particular ethical concerns arise in relation to children’s involvement in research and these must be addressed.

Basic ethical principles apply to all research, and these include a commitment to the well-being, protection and safety of participants; a duty to respect the rights and wishes of those involved; a responsibility to conduct high-quality scientific research; and a commitment to disseminate and communicate the results to stakeholders.

In addition to core ethical principles, research with children requires legal and policy commitments. National and international child protection policies and guidelines, must be applied to ensure that a child-centred, inclusive approach to research is adopted.

HSE National Policy for Consent in Health and Social Care Research outlines the requirements for obtaining consent for research involving children under 18 years. The key points are summarised below but it is recommended that all applicants read Section 5 of the policy.

• A parent or other legally appointed guardian must provide consent on behalf of the child to participate in research. In all research circumstances, parental/legal guardian consent is required for the processing of the participant’s personal data if they are aged under 18 years.
• A parent or legal guardian who provides consent on a child’s behalf should be given the opportunity, to a reasonable extent, to be present and to observe the research as it proceeds.
• The child’s assent to participate, and for the processing of their data for research purposes, should also be obtained. Even in cases where children are not able to formally assent, their opinions and wishes should be considered and respected.  Information should be presented to children in a tailored, developmentally appropriate manner. The child’s assent, or decision not to assent, should be documented.
• Withdrawing Consent and Assent:  Parent(s)/legal guardian(s) and the child should be informed that they may choose to withdraw from the research at any stage, and that it will not impact on their clinical care or service provision. They should also be appropriately informed that while it would be possible to withdraw the child from secondary research, it may not be possible to delete previously acquired research data.
• Confidentiality is key to research practice, but a limitation exists in child-related research if a child protection issue arises and this restriction in relation to confidentiality must be explained when obtaining consent and assent.
• Researchers must complete appropriate child protection training (e.g. mandatory Tusla Training) and need to have evidence of current Garda Vetting before coming in contact with children. These certificates and a Child Safeguarding Statement should also be submitted to the REC with the research application.
•  In the case of professionals who have a professional regulatory registration body, registration with this body, and adherence to the associated professional guidelines/codes of conduct, is required.
• Every effort should be made to actively involve children as participants in the research process and care must be taken to protect the rights of all children, as well as specific groups of children, in research activity.
• We also recommend that applicants consider Public and Patient Involvement (PPI) in research and how input from children and young people if applicable might inform their research project.
• We also recommend that applicants have gatekeepers[3] in place prior to submitting their application to support them with recruitment of research participants.

Children in Care

Consent to participate in research may need to be provided by the parents and/or Tusla, depending on the type of care arrangement. Consent protocols to participate in research will be reviewed and approved and/or declined by Tusla’s independent REC. Tusla National Research Office can provide advice.  Tusla’s independent REC can seek legal advice from Tusla’s Office of Legal Services and Tusla’s Data Protection Unit on a researcher’s behalf.

The participation of children in care in research may need to be considered on a case-by-case basis.

Care order:

As parents still retain some rights of guardianship, Tusla continues to have obligations to ensure sufficient consultation with the parents.  Researchers will require consent from parents and, generally, the child’s social worker for the child to participate in research, as well as the child’s assent.

Interim care order and voluntary care agreement:

Tusla will need to be involved in addition to the birth parents.  However, Tusla does not have control over the child as if it were the child’s parent. Accordingly, in addition to consultation, the consent of the parent will be required.  If a social worker/clinician believes that a child would benefit from participation in a research study, and if parental consent is not forthcoming, it is possible to apply to the District Court for an order under Section 47 of the Child Care Act, 1991. Where children are the subject of ongoing and current court proceedings (in camera rule), the Court should always be told of any intended participation in research and may need to approve the children’s participation in the proposed research study[4] .

Unwell children and Neonates:

Valid consent from parent(s)/legal guardian(s) is also required where the research involves children who may be acutely unwell, and parents are in a heightened situation of distress.

For research involving full-term or preterm neonates or babies, the decision to consent to participate in research rests with their parent(s)/legal guardian(s) and, in general, the same rules apply.