Pediatric biobanking: a pilot qualitative survey of practices, rules, and researcher opinions in ten European countries.
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.
1 Unit of Bioethics, Scientific Institute "E. Medea," Associazione La Nostra, Famiglia, via Don L. Monza, Bosisio Parini (LC), Italy .
Elena
E
Salvaterra
Roberto
R
Giorda
Maria T
MT
Bassi
Renato
R
Borgatti
Lisbeth E
LE
Knudsen
Andrea
A
Martinuzzi
Maria
M
Nobile
Uberto
U
Pozzoli
Gian P
GP
Ramelli
Gianl L
GL
Reni
Damiano
D
Rivolta
Maria A
MA
Stazi
Sandra
S
Strazzer
Carel
C
Thijs
Virgilia
V
Toccaceli
Antonio
A
Trabacca
Anna C
AC
Turconi
Sergio
S
Zanini
Claudio
C
Zucca
Nereo
N
Bresolin
Leonardo
L
Lenzi On Behalf Of The Pediatric Biobank Elsi Working Group