Children and biobanks: a review of the ethical and legal discussion

Abstract

The use of tissue samples from children is vital to genetic research. Collections of such tissue, in so-called biobanks, can take the form of large-scale prospective cohort studies or disease-specific studies using tissue of children with that specific disease. Collections of samples gathered in a diagnostics context, such as blood spot cards, can also be used for genetic research. Research on stored tissue samples from children poses ethical questions that are different from those posed by the use of samples from adults. Also, the ethical questions raised by the participation of children in biobanks are not analogous to those raised by the participation of children in clinical trials. In this review we first give an overview of the international ethical guidelines and legal regulations concerning biobanking and minors. Next, we review the different themes that occur in the ethical literature on this subject. Specifically we focus on questions of risk and benefit, consent and assent and the return of individual results. We also discuss the concept of solidarity, which is a relatively new concept in the context of children and biomedical research. To conclude, we discuss the gaps and questions raised by the review.

Clarifying ethical responsibilities in pediatric biobanking

“…Some go as far as suggesting that "there can be no reason, apart from the convenience of the researchers, to renounce withdrawability at the proxy consent stage" (Holm 2005, 21À22). Considerable importance is placed on children's ability to renew their consent when they reach the age of competence and their ability to withdraw from research (Hens, Levesque, and Dierickx 2011;Holm 2005). What this all boils down to in the pediatric context is that parents need to understand exactly what they are consenting to on behalf of their child.…”

“…We can ask adults whether they want to receive information that may emerge about their health, and they can elect to be informed or they can choose not to know. Where children are concerned, it is not clear that parents should be provided all information about their child that becomes available (e.g., the child's genetic makeup) or that parents should have the right to say they do not want to receive results that could contain information that is of benefit to their child (Hens, Levesque, and Dierickx 2011).…”

Biobanking strategies and regulative approaches in the EU: recent perspectives

“…Today, it is widely acknowledged that the ability of minors to assess information about a treatment or a research project does not depend primarily on their age, but on their maturity and competence in understanding its meaning, scope, and possible side effects. 50 In the case of diminished capacity or incompetence, parents or guardians must decide for the minor. However, overly strict or demanding requirements for the IC of research participants can exclude whole populations from innovative research projects.…”

ELSI challenges and strategies of national biobank infrastructures

“…When biobanks contain collections derived from a variety of studies that have banked samples, it can be difficult to determine from the original consents which sets of human biological samples and associated data may come under the auspices of the national biobank infrastructure and the specific research purposes for which they can be used and shared. This issue also applies to the use of samples from deceased individuals and children when these samples become part of a biobank and regulation may not provide sufficient guidance (17,18).…”