Biobanking “with” children: a step-by-step engagement process
Pediatric biobanking is essential to provide tailored diagnostic and therapeutic answers and identify correctly potential participants for a clinical trial in a unique population such as children.
Children are a unique population because of their specific developmental and physiological differences compared to adults. Therefore, a key issue in the process of progressive minor people’s involvement in research, both translation and biomedical, and healthcare choice is:
including their views, experiences, and participation, within a new deal of promoting research with and for them, designed specifically for children/adolescent people.
Ethically, we can observe an immense change of pace from the parents’/guardians’ consent as a sine qua non condition for a research study to a positive minor’s agreement (a practical/ethical consent): the child is the participant, not the parents, who are only the gatekeepers.
Within an ELSI horizon, it represents a significant challenge in terms of the engagement of a participant, the minor, who progressively acquires decision-making competence and legal capacity.
This means deeply rethinking issues of assent and consent, moving toward dynamic and participatory models of regulation and interpretation. Moreover, growing and acquiring capabilities, minors highlight the direct link between reconsenting, follow-up, and engagement that is critical for a sustainable, fair biobanking for our future.
There is a paradigm shift at stake which over time has permeated our regulatory framework as well.
It has been being a not obvious process, deconstructing patterns, a long journey of inclusion and recognition of the minor as a participant, whose opinion must be considered and whose dissent must be respected. At the same time, it outlines the path of making researchers and biobankers aware of their own role, in increasing the risk of vulnerability and discrimination of minors involved in biobank-based research, if not acted upon responsibly, inclusive, and guarantor of empowerment, capability settings.
Two warnings:
- the regulatory framework revolves primarily around clinical trials, biomedical research in the strict sense. In fact, only in 2006, the Council of Europe will publish the first recommendation on biobanking, on research on biological material of human origin.
- The regulatory framework has been built up over 50 years basically thanks to soft laws, which promote and recommend but do not impose good practices and fairness.
Fifty years, to deconstructing the paternalistic paradigm, to include the minor, the most protected subject, to respect him/her by providing and encouraging processes and tools of self-determination, such as assent, dissent/disagreement, and reconsent are.
And that is precisely the European Regulation on clinical trials makes the difference.
The Regulation explicitly requires that children and young people should “take part” in the consent process: the minor participates while the legally designated representatives authorize his/her participation.
The Regulation is also crucial clearly articulating how informed consent is a process configured by researchers or research team members trained or experienced in working with children. This is a pillar: informed consent can only be shared with/by competent and qualified personnel.
Article 32 – Clinical trial (on) minors
1 (b) the minors have received the information referred to in Article 29(2) in a way adapted to their age and mental maturity and from investigators or members of the investigating team who are trained or experienced in working with children;
1 (c) the explicit wish of a minor who is capable of forming an opinion and assessing the information referred to in Article 29(2) to refuse participation in, or to withdraw from, the clinical trial at any time, is respected by the investigator;
2 The minor shall take part in the informed consent procedure in a way adapted to his or her age and mental maturity”
The minor should be adequately informed, respected, and involved in the decision-making process.
The updated Recommendation for biobank-based research, in dialogue with the content of the Oviedo Convention and its additional protocols, highlights this change of pace: ¡
Article 12 – Biological materials from persons not able to consent
“4… If the person not able to consent is a minor, his or her opinion should be taken into consideration as an increasingly determining factor in proportion to age and degree of maturity. Any objection by the person not able to consent should be respected. Any wishes previously expressed by such a person should be taken into account.
5. Where a person not able to consent, whose biological materials have been stored for future research,attains or regains the capacity to consent, reasonable efforts should be made to seek the consent of that person for continued storage and research use of his or her biological materials.”
In fact, this article clearly statutes that any objection from the minor should be respected also in biobanking and that reconsent is needed for continued biobanking.
This change based on the inclusion and engagement of children becomes a matter of fact, pervasive:
The Council for International Organizations of Medical Sciences (CIOMS) together with the World Health Organization (WHO) suggest not only that:
Children and adolescents must be included in health-related research unless a good scientific reason justifies their exclusion.
But that before undertaking research involving children and adolescents, the researcher and the research ethics committee (and we add biobanks/biobankers) must ensure that:
the agreement (assent) of the child or adolescent has been obtained in keeping with the child’s or adolescent’s capacity, after having been provided with adequate information about the research tailored to the child’s or adolescent’s level of maturity.
The General Data Protection Regulation is in agreement with this. Processing data concerns the minor. In fact, where processing is addressed to a child, any information and communication should be in such a plain language that the child can easily understand. Article 12 adds that:
The information shall be provided in writing, or by other means, including, where appropriate, by electronic means.” Orally if requested.
But the article 8 states that:
for use of digital services offered directly to a child, age of child not requiring parental consent cannot be less than 13 years, but is set by state between 13 and 16 years.
