Guidance for Research Participants Under the Age of 18

Introduction

The inclusion of Including children as participants in health and social care 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 are combined with 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.

Legal and policy framework

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. This policy is underpinned by the Lundy model of participation (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 Disability and Equality The National Framework for Children and Young People’s Participation in Decision-making   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 all matters affecting their lives including as research participants and collaborators.

The benefits of involving children and young people as research participants

Involving children and young people as research participants, can provide a range of benefits to research participants, researchers, policymakers, service providers, funders, and the wider community.

• Studies have consistently found that children and young people want to be asked their opinion
• Children and young people can meaningfully contribute to studies on a range of sensitive issues
• Participation can enhance the validity of research findings and inform practice
• There are benefits for researchers too. Involving children in research develops a greater understanding about their lived experience and a deeper appreciation for the challenges they face, and implications that particular issues have on their lives and those of their families and communities

The ethical implications of involving children and young people as research participants

Research with, and for, children and young people (defined in Ireland as people below the age of 18) is necessary and beneficial, but particular ethical and legislative concerns arise in relation to children and young people’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 those who can use this knowledge’.

In addition to core ethical principles, research with children and young people 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.

Under Schedule 1, Children First Act 2015, any research involving children as participants will require:

• A child safeguarding statement (CSS)
• 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 and young people under 18 years. These certificates and a Child Safeguarding Statement should also be submitted with a research application to Tusla Research Ethics Committee (REC) on application for approval.

Obtaining consent and assent from children and young people participating in research

The HSE National Policy for Consent in Health and Social Care Research outlines the requirements for obtaining consent for research involving children under 16 years. The key points are summarised below, but it is recommended that all applicants read Section 5 of the policy.

The HSE Consent for Health and Social Care Research Policy (2024), defines consent as

“Informed and explicit agreement of a prospective research participant to take part in a research study and, when relevant, to the use of their personal data for such research.  The agreement for both must be ethically obtained, recorded, and retained; the proposed consent protocol must be approved by an appropriate Research Ethics Committee (REC) and, when applicable, comply with Irish data protection legislation.”

• 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 if they are aged under 16 years.
• A young person aged 16 or 17 years old can consent to participate in health and social care research and can consent to the processing of their data.
• 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.
• As with adults, a young person may lack decision-making capacity to make a particular decision at one time but may have the capacity to do so at another time. If a young person is found to lack decision-making capacity to consent based on a functional assessment, the approach to seeking consent for research under this policy should include the same safeguards as research involving children. It is essential to encourage and facilitate the young person to participate as fully as possible in decision-making.  When assessing a person’s capacity to make a specific decision, the person assessing capacity is considering whether the person is able to:
  • Understand information and facts relevant to the decision;
  •  Retain that information long enough to make a voluntary choice;
  • Use and weigh that information as part of the process of making the decision;
  • Communicate the decision. The healthcare worker must assess and document each of the above elements. If the person does not meet one or more of these elements the person lacks capacity to make that particular decision at that time (National Consent Policy, see page 33). Also see Section 3 of the Assisted Decision-Making (Capacity) Act, ‘Person’s capacity to be construed functionally’, https://www.irishstatutebook.ie/eli/2015/act/64/section/3/enacted/en/html#sec3)

• Withdrawing Consent and Assent:  Parent(s)/legal guardian(s) and the child/young person 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.

Other ethical considerations

• 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. Confidentiality of information provided cannot always be guaranteed by researchers and can only be protected within the limitations of the law, namely the Data Protection Acts 1998 to 2018.
• 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. https://coru.ie/social-care-workers/resources-for-social-care-workers/social-care-workers-code-of-professional-conduct-and-ethics/
• Every effort should be made to actively involve children and young people 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 their research and how input from children and young people, if applicable, might inform their research project throughout the research stages. See more here and resources which may be helpful
• We also recommend that applicants have gatekeepers in place prior to submitting their research ethics application to support them with recruitment of research participants. A gatekeeper is someone at a research site who provides access to the site and to the research participants.

Considerations when involving Children in Care as participants in research

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 or young person’s social worker for the child or young person 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 or young person 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.

Involving Unwell children and Neonates in research:

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.

For more information see The HSE National Policy for Consent in Health and Social Care Research Section 5.

For more on doing ethical research with children and young people watch this presentation by Dr Edel Tierney to learn more about the importance of including children and youth in research, understand the legislative and policy context for research with children and young people, identify key requirements for ethical research with children and young people and to learn more about the role of children and youth as collaborators in research.

See here for more information on Tusla Research Ethics Committee.