Pediatric Biobanking: A Pilot Qualitative Survey of Practices, Rules, and Researcher Opinions in Ten European Countries

Abstract

Ethical, legal, and social issues related to the collection, storage, and use of biospecimens and data derived from children raise critical concerns in the international debate. So far, a number of studies have considered a variety of the individual issues crucial to pediatric biobanking such as decision making, privacy protection, minor recontact, and research withdrawal by focusing on theoretical or empirical perspectives. Our research attempted to analyze such issues in a comprehensive manner by exploring practices, rules, and researcher opinions regarding proxy consent, minor assent, specimens and data handling, and return of results as faced in 10 European countries. Because of the lack of comparative analyses of these topics, a pilot study was designed. Following a qualitative methodology, a questionnaire draft mostly including open-ended queries was developed, tested, and sent by e-mail to a selected group of researchers dealing with pediatric biobanking (n=57). Returned questionnaires (n=31) highlighted that the collection, storage, distribution, and use of biospecimens and data from children were widely practiced in the contacted laboratories. In most cases, pediatric biobanking was subjected to national or local regulations covering adult biobanks (n=26). Informed consent was generally given by parents or legal representatives (n=17). Children's opinions were frequently sought and taken into account (n=16). However, minors were usually not recontacted at the age of maturity to express their own choices (n=26). Based on the collected data, dedicated recommendations are needed to govern unique ethical and regulatory issues surrounding pediatric biobanking.

Scientists’ perspectives on consent in the context of biobanking research

“…[9][10][11][12][13] The ethical and legal appropriateness of different consent models is one of the most divisive topics with the absence of a consensus among academic scholars, 6 research policies, 14 and public opinion data. 15 While the bulk of research studies focus on capturing the perceptions of the general public and patients on research ethics issues related to biobanking, [16][17][18] only a few have focused on understanding the views of scientists who may manage biobanks [19][20][21][22][23][24][25] and even fewer concentrate on scientists' perceptions of informed consent. 26,27 It is important to capture the opinions of scientists as they run biobanks and are the end users of biorepository samples and information and thus have first-hand knowledge on biobank functions.…”

Clarifying assent in pediatric research

“…[1][2][3][4][5] A biobank can be defined as a collection of human biological samples stored for medical-scientific research purposes, usually linked to phenotypic data in one way or another. [6][7][8] Hence, the primary goal of biobanks is to facilitate research, not to provide medical care.…”

Returning Results: Let's Be Honest!

“…An example is the Biobank Ireland Trust that has decided to adopt an organization where results will not be returned (Mee et al, 2013). Special problems exist concerning pediatric biobanks, as most of them do not recontact children at the age of maturity to ask for their choices and address updates (Salvaterra et al, 2012).…”