45 - Including Young People in Research: A Toolkit to Support the Intentional Inclusion of Youth Perspectives in Pediatric Clinical Trials & Product Development

Background:
We posit it is an ethical imperative to mindfully, intentionally and representatively include the voices of young people throughout the clinical research/product development lifecycle. While gaining traction in research involving adults, pediatric engagement remains uncommon. The clinical research enterprise and all phases of product development—inclusive of planning, conducting, and return of results--would be strengthened ethically and operationally if young people’s perspectives were routinely solicited and integrated.

Methods:
We developed a toolkit (and companion how-to video), Including Young People in Research, that offers tools, checklists, and considerations to support the intentional inclusion of youth perspectives throughout all phases of pediatric clinical trials and product development. These materials assist investigators, IRBs, sponsors, and others working with children/adolescents to engage youth respectfully and thoughtfully, ensuring their perspectives are valued, gathered, weighted, integrated, and responded to. Tools are adaptable to different ages, local contexts, and study needs.

Conclusion:
We argue that children, parents, and their allies should be respected participant partners in clinical research/product development. Authentic engagement requires time, effort, resources, flexibility, knowledge, and tools that are appropriately adapted to the age and situation.

Those who work with youth in a research setting need to plan, approach, and engage with children and adolescents in clinical research; they will benefit from review and use of the toolkit. The tools created support those working with young people, strengthening their ability to listen to children, adolescents, and parents respectfully, adjust their communication styles, and create a safe communication environment, including:

* A parental/guardian consent and pediatric assent form for non-research activities such as materials review
* A guide for initiating conversations with young people, their parents/guardians, and caregivers to gain insights into young people’s thoughts, beliefs, and experiences
* A guide to assist adults with engaging youth throughout the product lifecycle to garner the youth perspective
* An offering of various considerations to aid decisions around planning for youth engagement such as approach, representative participation, questions to address, and potential methodology.

The array of considerations offered encourage flexibility to accommodate differences in the youth’s age, ability, language, literacy, context, and culture. Researchers are guided to lessen perceived power imbalances and overcome barriers to participation through respectful communication throughout the engagement. Closing the communication loop includes sharing study results and defining the end of collaboration with processes that respect the youth’s dignity, individuality, and the contributions made.

Limitations:

Limitations include operational barriers to incorporating youth engagement in clinical research/product development lifecycle. Further, attitude and process shifts are needed to accommodate the additional time, effort, and resources required, along with acceptance that youth can be true agents of change. Differing opinions between parents and children about research participation must be addressed within the assent/consent process, and accounting for nuances of culture, individual circumstances and the capacity of each individual child are further potential limitations.

Discussion:
This toolkit discussion highlights multiple opportunities for researchers to attend to the unique needs of children and adolescents in clinical research/product development. Many such opportunities involve mindful and respectful communication with the trial participants and their families, flexibility and adaptability with modes of information transmission, transparency and reciprocity in communication, and respect for children as persons with agency. Dissemination through multiple channels will be critical to ensure uptake and implementation.

Next steps:

We acknowledge the need and utility of conducting an assessment of this toolkit and remain open to the option of developing a pre/post assessment tool to include in subsequent iterations of the toolkit.