Developing a policy for paediatric biobanks: principles for good practice

Abstract

The participation of minors in biobank research can offer great benefits for science and health care. However, as minors are a vulnerable population they are also in need of adequate protective measures when they are enrolled in research. Research using biobanked biological samples from children poses additional ethical issues to those raised by research using adult biobanks. For example, small children have only limited capacity, if any, to understand the meaning and implications of the research and to give a documented agreement to it. Older minors are gradually acquiring this capacity. We describe principles for good practice related to the inclusion of minors in biobank research, focusing on issues related to benefits and subsidiarity, consent, proportionality and return of results. Some of these issues are currently heavily debated, and we conclude by providing principles for good practice for policy makers of biobanks, researchers and anyone involved in dealing with stored tissue samples from children. Actual implementation of the principles will vary according to different jurisdictions.

Clarifying assent in pediatric research

“…[9][10][11] Also, the European Society of Human Genetics (ESHG) considers assent an important condition for the inclusion of a child's material in biobanks, as they put forward in a recent policy statement. 12 With regard to the different types of pediatric biobanks, the prevailing view is that assent should be obtained when possible. 3,[13][14][15][16][17][18][19] However, though many emphasize the importance of assent, few explain how they understand the concept and few have elaborated on the underlying grounds of assent and its role in pediatric biobanks.…”

Ethics of children’s participation in a Saudi biobank: an exploratory survey

“…2,3 One distinct challenge is related to a child's ability to make a decision with regard to participating in medical research and sharing the information. There has been much discussion about the validity of parental consent and/or child assent, 4-6 the most suitable age for accepting child consent, 7 child withdrawal, 2,6,8,9 and reconsent when a child reaches adulthood. 2 Questions also have been asked about the right to share a child's information and whether there is any difference between medical and genetic information in relation to confidentiality.…”

Confidentiality, informed consent and children's participation in the Saudi biobank governance: a comparative study

“…Other conditions for children's participation in research include: minimizing risks to the child; considering the best interest of the child; obtaining the guardian's consent and-when appropriate, based upon the age of the child-the child's assent as well (46)(47)(48). Many researchers distinguish between research on children and research on samples taken from children, especially regarding the issue of minimalizing risks (49,50).…”