Key aspects for a step-by-step engagement process with minors in biobanking #

Step 1 – Design research with children, not merely on children #

The engagement process begins before recruitment. Researchers and biobanks should recognise children as a distinct population with specific biological, developmental, psychological, and social characteristics. Research protocols should therefore be designed to address children’s health needs and include age-appropriate engagement strategies from the outset.

Step 2 – Prepare an age-appropriate information strategy #

Before recruitment, information materials should be developed for different developmental stages. Information should:

• be understandable for the child’s age and level of maturity;
• explain what a biobank is;
• explain why samples and data are collected;
• describe future research uses;
• explain rights, including withdrawal;
• use child-friendly language and visual aids where appropriate.

Step 3 – Obtain parental permission #

Because children generally lack legal capacity to provide consent, the legally authorised representative provides permission for participation.

Parents or guardians should receive comprehensive information regarding:

• the purpose of the biobank;
• storage of biological materials;
• future research uses;
• privacy safeguards;
• possible return of results;
• withdrawal procedures.

Parental permission authorises participation but does not replace the child’s own involvement, as parents are gatekeepers—not the research participants.

Step 4 – Seek the child’s assent #

Whenever the child has sufficient maturity to understand the research, researchers should actively seek the child’s assent, which must be informed; appropriate to the level of development of the child; viewed as an ongoing dialogue rather than a signed document.

Researchers should be trained in communicating with children and adolescents.

Step 5 – Respect the child’s wishes #

The child should have genuine opportunities to express views, ask questions, and voice concerns.

Researchers should respect disagreement and periodically revisit the discussion as maturity develops.

Step 6 – Conduct research within an empowerment framework #

Engagement continues throughout participation in the biobank.

Researchers and biobanks should maintain communication with children and families.

Step 7 – Protect privacy throughout childhood #

Children’s biological materials and associated data require enhanced safeguards.

Biobanks should ensure pseudonymisation where appropriate; secure storage; GDPR-compliant governance in place and transparent information on data processing;

Step 8 – Revisit participation as the child matures #

As children develop cognitive and emotional maturity, researchers should provide updated information; verify continuing willingness to participate and document evolving preferences where feasible.

Step 9 – Obtain reconsent at the age of majority #

When participants reach the legal age to provide independent consent, reasonable efforts should be made to obtain their own informed consent for continued storage and use of their biological materials and data.

Step 10 – Promote long-term partnership #

Modern paediatric biobanking encourages lifelong relationships between participants and research infrastructures through ongoing communication and opportunities for public engagement