Ethical and deontological aspects of pediatric biobanks: the situation in Italy

Nunzia Cannovo,Rosa Guarino,Piergiorgio Fedeli

doi:10.1007/s10561-020-09833-4

Nunzia Cannovo, Rosa Guarino + Show 1 more

Open Access

https://doi.org/10.1007/s10561-020-09833-4

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Abstract

While pediatric biobanks are a precious resource for scientific research to improve our understanding of genetic pathologies, the value of these studies should be considered together with the value of the privacy rights of pediatric donors, as they are particularly vulnerable and in many cases unable to discern the meaning of the donation of biological material and the related implications of the research. Thus this work calls for reflection on the numerous ethical and legal issues involved in the development and regulation of these biobanks. In particular, it explores what form of consent best balances the intangible rights of the minor, on the one hand, and the development of technological progress and scientific research, on the other, and examines the implications of the collection of biological material of minors in biobanks. It focuses on solutions to bridge the gaps in current Italian legislation, especially in light of the current lack of attention to the interests of fragile subjects. In addition, this work presents an overview of the pediatric biobanks in Italy.

Highlights

Biological material stored in biobanks, in relation to the progress in research on the identification of genes and diseases, has made it possible to ascertain the causes of hereditary pathologies in family units, to learn about specific mutations, to prepare diagnostic tests to identify those with the disease and those who are bearers (Wright et al 2018), to evaluate the risk of procreating, and to make possible prenatal diagnosis (Dagna Bricarelli 2011)
It should be noted that research on pediatric biological material does not always directly benefit the minor donor, and it is not possible to use the same precautions dictated for recruiting minors for clinical trials (EU Regulation n. 536/2014)
As minor donors come of age, they should be contacted through new computer technologies to obtain their informed consent to the donation of biological material that their parents or legal representatives had authorized

Summary

Introduction

Biobanks are an important resource for research, and in particular, pediatric ones can provide useful information for understanding the interactions between genetics and the onset of certain pathologies, enabling the development of studies about multifactorial pathologies and the achievement of personalized medicine (Brothers 2011). 8/2016), in particular when particular or exceptional factors make it impossible to inform the donors, or demand a disproportionate effort, or risk gravely compromising or even rendering impossible the achievement of the research goals It follows that those responsible for pediatric biobanks (guarantors or curators) must develop procedures and appropriate instruments for contacting donors when they come of age, so the latter can obtain adequate information, gain access to the samples and data, and if they so desire, rescind the consent, have the samples destroyed and/or have the information eliminated (National Bioethics Committee 2014). Congenital diseases are the third cause of hospitalization of minors in Italy (Corsello et al 2013), where between 2003 and 2008, every year on average there were 164 diagnoses of malignant tumor for every million children (0–14 years old) and 269 cases for every million adolescents (ages 15–19) (https://www.airc.it/pediatrici)

Conclusions

Compliance with ethical standards