A child-rights approach to involving children and young people in the design and conduct of clinical studies

My Research

Whilst policy and evidence strongly support the active involvement of patients and the public in the design and delivery of health research, it is more difficult to define how this is realised in practice, especially where children and young people are concerned. Until fairly recently most of the issues highlighted in the literature focus on work with adult patients and members of the public and pays very little attention to developing clinical studies in partnership with children and young people. More importantly what is missing from this discourse are the perspectives of children and young people themselves. Recent literature has called for more research to address this deficit of understanding to strengthen and standardise monitoring and evaluation processes to track children and young people’s participation, explore the quality and value (i.e., outcomes and impact of such practice), and share lessons learned.

Understanding the experiences and views of children and young people will give us a better understanding of what ‘meaningful’ participation means to them and will inform the development of more rigorous child-rights informed research methodology that captures the outcomes and impact of participatory practice in the design and conduct of conduct of clinical studies in children.

Aims and objectives

The research has two aims:

1) To gain insights into the motivations, experiences, and outcomes of participation for children, young people, families, and those who work with them in the design and conduct of clinical studies in children;

2) To use participatory research methods to develop a monitoring and evaluation tool that takes account of children’s and young people’s voices.

The objectives of the research include:

To understand how children, young people and families are currently involved in the design and conduct of clinical studies in children.
To understand the motivations of participation from the perspective of children, young people, families, and those who work with them.
To explore what meaningful participation means to children, young people, families, and those who work with them.
To explore the perceived outcomes and impact(s) of participation on children, young people, families, and those who work with them.
To explore how to empower children, young people, families, and those who work with them to self-reflect on participatory practice to inform ‘meaningful’ participation in the design of clinical studies in children

Co-creating research with children and young people

Children and young people in this study are understood to be competent participants and as valuable contributors in research. Children and young people (aged 8-18 years) will be involved as research partners (Young Peer Researchers) and research respondents. The research will adopt a mixed methods design (informed by the Young Peer Researchers), using both quantitative (surveys) and qualitative (individual semi-structured interviews and focus groups) methods.

What has been done so far?

Stage 1 – Scoping review of how PPI with children and young people is reported

One task part of the first stage of my research was to explore how PPI with children and young people is reported in NIHR funded research projects.

The aim was to examine in detail the reports that are completed by researchers about involvement activities with CYP. The review focused on the sections of reports that describe the involvement of CYP in these types of activities, not adult involvement (parents and other stakeholders). The focus was on the following questions:

What opportunities are offered to CYP, including levels and stages of involvement?
Who is involved and how?
What are the reported outcomes and impacts of PPI with CYP?
How do CYP support the dissemination of research findings?
What are the reported challenges and facilitators to involvement?

A summary of reported CYP involvement activities can be found in this poster. It builds a picture of how NIHR funded researchers are conducting and reporting PPI with CYP. I acknowledge that documentary evidence is not a proxy for actual PPI practice, and it is not my intention to offer judgements about practice or individuals responsible for writing the reports. A paper will be published in the coming months.