Pediatric biobanking: a pilot qualitative survey of practices, rules, and researcher opinions in ten European countries

Elena Salvaterra; Roberto Giorda; Maria T Bassi; Renato Borgatti; Lisbeth E. Knudsen; Andrea Martinuzzi; Maria Nobile; Uberto Pozzoli; Gian P Ramelli; Gianl L Reni; Damiano Rivolta; Maria A Stazi; Sandra Strazzer; Carel Thijs; Virgilia Toccaceli; Antonio Trabacca; Anna C Turconi; Sergio Zanini; Claudio Zucca; Nereo Bresolin; Leonardo Lenzi On Behalf Of The Pediatric Biobank Elsi Working Group

doi:10.1089/bio.2011.0037

Pediatric biobanking: a pilot qualitative survey of practices, rules, and researcher opinions in ten European countries

Elena Salvaterra, Roberto Giorda, Maria T Bassi, Renato Borgatti, Lisbeth E. Knudsen, Andrea Martinuzzi, Maria Nobile, Uberto Pozzoli, Gian P Ramelli, Gianl L Reni, Damiano Rivolta, Maria A Stazi, Sandra Strazzer, Carel Thijs, Virgilia Toccaceli, Antonio Trabacca, Anna C Turconi, Sergio Zanini, Claudio Zucca, Nereo BresolinLeonardo Lenzi On Behalf Of The Pediatric Biobank Elsi Working Group

16 Citationer (Scopus)

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.

Originalsprog	Engelsk
Tidsskrift	Biopreservation and Biobanking
Vol/bind	10
Udgave nummer	1
Sider (fra-til)	29-36
Antal sider	8
ISSN	1947-5535
DOI	https://doi.org/10.1089/bio.2011.0037
Status	Udgivet - 1 feb. 2012

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10.1089/bio.2011.0037

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Salvaterra, E., Giorda, R., Bassi, M. T., Borgatti, R., Knudsen, L. E., Martinuzzi, A., Nobile, M., Pozzoli, U., Ramelli, G. P., Reni, G. L., Rivolta, D., Stazi, M. A., Strazzer, S., Thijs, C., Toccaceli, V., Trabacca, A., Turconi, A. C., Zanini, S., Zucca, C., ... Lenzi On Behalf Of The Pediatric Biobank Elsi Working Group, L. (2012). Pediatric biobanking: a pilot qualitative survey of practices, rules, and researcher opinions in ten European countries. Biopreservation and Biobanking, 10(1), 29-36. https://doi.org/10.1089/bio.2011.0037

Salvaterra, E, Giorda, R, Bassi, MT, Borgatti, R, Knudsen, LE, Martinuzzi, A, Nobile, M, Pozzoli, U, Ramelli, GP, Reni, GL, Rivolta, D, Stazi, MA, Strazzer, S, Thijs, C, Toccaceli, V, Trabacca, A, Turconi, AC, Zanini, S, Zucca, C, Bresolin, N & Lenzi On Behalf Of The Pediatric Biobank Elsi Working Group, L 2012, 'Pediatric biobanking: a pilot qualitative survey of practices, rules, and researcher opinions in ten European countries', Biopreservation and Biobanking, bind 10, nr. 1, s. 29-36. https://doi.org/10.1089/bio.2011.0037

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title = "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.",

author = "Elena Salvaterra and Roberto Giorda and Bassi, {Maria T} and Renato Borgatti and Knudsen, {Lisbeth E.} and Andrea Martinuzzi and Maria Nobile and Uberto Pozzoli and Ramelli, {Gian P} and Reni, {Gianl L} and Damiano Rivolta and Stazi, {Maria A} and Sandra Strazzer and Carel Thijs and Virgilia Toccaceli and Antonio Trabacca and Turconi, {Anna C} and Sergio Zanini and Claudio Zucca and Nereo Bresolin and {Lenzi On Behalf Of The Pediatric Biobank Elsi Working Group}, Leonardo",

year = "2012",

month = feb,

day = "1",

doi = "10.1089/bio.2011.0037",

language = "English",

volume = "10",

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journal = "Biopreservation and Biobanking",

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T1 - Pediatric biobanking

T2 - a pilot qualitative survey of practices, rules, and researcher opinions in ten European countries

AU - Salvaterra, Elena

AU - Giorda, Roberto

AU - Bassi, Maria T

AU - Borgatti, Renato

AU - Knudsen, Lisbeth E.

AU - Martinuzzi, Andrea

AU - Nobile, Maria

AU - Pozzoli, Uberto

AU - Ramelli, Gian P

AU - Reni, Gianl L

AU - Rivolta, Damiano

AU - Stazi, Maria A

AU - Strazzer, Sandra

AU - Thijs, Carel

AU - Toccaceli, Virgilia

AU - Trabacca, Antonio

AU - Turconi, Anna C

AU - Zanini, Sergio

AU - Zucca, Claudio

AU - Bresolin, Nereo

AU - Lenzi On Behalf Of The Pediatric Biobank Elsi Working Group, Leonardo

PY - 2012/2/1

Y1 - 2012/2/1

N2 - 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.

AB - 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.

U2 - 10.1089/bio.2011.0037

DO - 10.1089/bio.2011.0037

M3 - Journal article

C2 - 24849751

SN - 1947-5535

VL - 10

SP - 29

EP - 36

JO - Biopreservation and Biobanking

JF - Biopreservation and Biobanking

IS - 1

ER -

Pediatric biobanking: a pilot qualitative survey of practices, rules, and researcher opinions in ten European countries

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