Topic: Biobanking with Children

Overview

Biobanking that includes children is an imperative resource to advance paediatric medical research and to better understand health conditions that affect young people. It is already known that research findings from adult populations don’t necessarily apply to children. It is therefore important to view them as a distinct population and to ensure that they are given the opportunity to participate in biobanking, with the end goal being to improve paediatric health outcomes.

There are however distinct challenges when involving children given that they are still in the process of growing and developing, which includes physically, cognitively and emotionally. This makes them more vulnerable. As a result, additional safeguards are required to ensure that their interests are protected, particularly as children will have limited ability to communicate their needs and limited capacity to give informed consent.

Biobanks have a key role to protect the rights of children, whilst involving them and their families as active participants. In practice, this means that biobanks should be vigilant in ensuring that they have the necessary safeguards and oversight processes in place that protect the interests of young people as they grow and mature. This requires understanding children within the context of their specific developmental stage, adjusting procedures and practices accordingly as they grow, and involving them in an age-appropriate manner.

Key Ethical, Legal and Societal Issues

Biobanking and research with minors, namely children and young people, raises various ethical, legal and societal issues, which should be addressed. Key issues include:

Informed Consent

Due to their age, children are generally considered unable to provide legally valid consent. It is therefore important that biobanks obtain consent from parents or guardians with regards to their child’s participation in the biobank.

However, as minors grow, their ability to understand and make decisions about their own participation also increases. As a result, biobanks should additionally involve minors in decision-making processes, providing age-appropriate information, and respecting their wishes and opinions as to whether or not they wish to participate. This requires taking a more dynamic approach in order to ensure that children are actively engaged concerning their involvement in biobanking.

It is also good practice that biobanks regularly inform the child and family about biobanking activities, giving them the possibility to modify their preferences as various stages. This is especially relevant when reaching adulthood, when they are able to give their own consent to continued participation in the biobank.

Privacy and Confidentiality

Given that biobanking involves collecting and storing sensitive personal information, such a genetic data and health records, maintaining privacy and confidentiality of minors’ data is crucial. Robust safeguards must be in place to maintain the privacy and confidentiality of such information both from a policy and operational standpoint, with strict security measures in place.

Benefit – Risk Assessments

Biobanks should inform children and their families about the balance of benefits and risks involved in biobanking in a comprehensive manner.  Although there is generally minimal physical risk, there other associated risks, and these need to be communicated. Given that biobanks often store samples and data for future unspecified research purposes, one such risk involves knowledge of predisposition to certain diseases. Such risks should be carefully weighed, particularly considering the vulnerability and limited understanding of minors, who should not be exposed to any undue risk that detrimentally affects their quality of life.

Return of Individual Results

Biobanking research can generate individual findings, including incidental findings. Biobanks should have appropriate policies and procedures in place to determine whether and which findings should be returned to minors or their parents/guardians. Furthermore, biobanks and researchers should carefully consider how findings are communicated and ensure that appropriate support systems are in place for children and their families.

Note: To learn more about incidental findings, click here.

Governance

Robust governance frameworks, including ethical review processes, policies, and oversight frameworks are necessary to protect the rights and interests of minors in biobanking research.

Additionally, biobanking involving minors may be subject to specific legal requirements and regulations, which can vary across different jurisdictions.

Relevant EU Legislation

General Data Protection Regulation (GDPR)

The GDPR provides a regulatory framework for lawfully processing personal data, including genetic data and any other health information.  While the GDPR does not directly address the management of incidental findings, it does nevertheless apply upon their discovery, given that incidental findings constitute sensitive personal data.

EU Clinical Trials Regulation (No. 536/2014)

The EU Clinical Trials regulates the processes for clinical trials throughout the EU. Article 32 focuses on minors in clinical trials, explicitly requiring children and young people be involved during consent process.

BBMRI Resources

ELSI Dialogues Webinar: Biobanking with Children

This webinar gives an outline of the regulatory background and an overview of key ethical issues relevant to paediatric biobanking, highlighting the need to actively involve all relevant players.

External Resources

The below resources have been developed outside of the BBMRI network:

ECRIN Paediatric Tools: Tools for the Empowerment of Paediatric Community

by ECRIN – European Clinical Research Infrastructure Network

ECRIN has developed a series of tools and procedures to support the setup and management of multinational neonatal and paediatric clinical trials in Europe.

EPTRI Webinars

by EPTRI – European Paediatric Translational Research Infrastructure

EPTRI has webinars on various topics concerning paediatric research, ranging from regulations, clinical case studies and patient involvement, as well as other relevant topics.

ERIC Ethical Guidance for Research

by ERIC – Ethical Research Involving Children

The ERIC Ethical Guidance focuses on four key areas when it comes to research involving children, namely harms and benefits; privacy and confidentiality; informed consent; and payment and compensation.

ERIC Reflexive Tool

by ERIC – Ethical Research Involving Children

This reflexive tool is designed for researchers, as well as other stakeholders, encouraging them to reflect on relevant ethical issues at each stage of the research process.

Enpr-EMA Priority Activities

by the European Medicines Agency

The European Network of Paediatric Research at the European Medicines Agency (Enpr -EMA) focuses on enabling studies in order to increase the availability of medicines for children. Enpr-EMA serves a platform for sharing good practices with regards to research on medicines for children, with a number of priority tasks, some of which are listed below:

Principles on the involvement of young patients/consumers within EMA activities

by the EMA (May 2017)

This document set out the key principles when involving of young patients, as well as their carers.

Preparedness of medicines’ clinical trials in paediatrics – Recommendations by the Enpr-EMA Working Group on Trial Preparedness

by Enpr-EMA (August 2020)

This document by the European Network of Paediatric Research at the European Medicines Agency set out sets out recommendations for discussions concerning clinical trial preparedness in paediatrics. The Recommendations highlight the need to integrate perspectives of participants, along with their families and how their involvement can ultimately improve the trial designs.

Assent / Informed Consent Guidance for Paediatric Clinical Trials with Medicinal Products in Europe

developed by the Working Group on Ethics, Enpr-EMA (January 2021)

This document provides an overview of assent/informed consent forms for all stakeholders (such as patients, sponsors and investigators) to support the conduct of high quality paediatric clinical trials in Europe.

Informed Consent for Paediatric Clinical Trials in Europe 2015

developed by the Working Group on Ethics, Enpr-EMA (June 2023)

This document focuses on informed consent procedures for children across Europe.

Note: Whilst some resources may focus on clinical trials, they are nevertheless important as they provide overarching principles that are relevant in the context of paediatric biobanking and research.

Guiding Examples

Below are guiding examples of that illustrate how paediatric patients and their families have been involved in biobanking and research.

EPTRI Toolkit for Patients and Families

This toolkit educates paediatric patients about their involvement in basic research. It includes a videos explaining translational research, as well as resources on various topics such as basic research, animal testing, and sample donations.

ERIC Case Studies

by ERIC – Ethical Research Involving Children

Researchers share a spectrum of case studies about ethical issues that arise in the context of research involving children. From different international contexts, as well as research fields, the case studies focus on the process for developing ethical thinking and improving practice in research with children.

Kids Barcelona

KIDS Barcelona is part of the global project “Kids and Families Impacting Disease Through Science (KIDS)” within the International Children’s Advisory Network (Ican). It showcases how children and their families are involved within the project, from how they communicate with different age groups, as well as how children are involved as intrinsic partners within the research process.

Relevant Publications

‘How-To Guide: Next Generation Biobanking / Biobanking with the Next Generation (V1.0)’

by Casati, S. and Ellul, B.

Zenodo (2024)

‘ELSI challenges with children in Translational Medicine’. Contemporary Issues in Clinical Bioethics – Medical, Ethical and Legal Perspectives.

by Casati, S. and Ellul, B.

IntechOpen (2024)

Peadiatric Biobanking for Health: The Ethical, Legal and Societal Landscape

by Casati, S., Ellul, B., Mayrhofer, M., et al.

Frontiers Public Health (2022)

Acknowledgements: The work done stems from the assistance of TNGB – Telethon Network of Genetic Biobanks, which is network of 11 Italian Rare Disease Biobanks and is funded by Fondazione Telethon Italy. We would also like to acknowledge the Kids Barcelona is the Young Person’s Advisory Group (YPAG) at Sant Joan de Déu Barcelona Children’s Hospital, along with the TEARDRoP Consortium.

Last Updated: July 2024