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Informed consent, and an ethico- legal framework for paediatric observational research and biobanking: the experience of an Italian birth cohort study

An Erratum to this article was published on 25 April 2016

Abstract

Birth cohort studies are important tools for life-course epidemiology, given the spectrum of the environmental, behavioural, and genetic factors that should be considered when making judgements on human health. Biobanks are valuable components of studies designed to investigate the genetic variability of diseases and improve phenotypic characterisation. In studies involving vulnerable populations and biobanks, it is essential to provide ethical reasoning and analyse the legal requirements. We describe the processes and the tools used in the iterative design of an appropriate informed consent model and the ethico-legal framework of the Piccolipiù study. The Piccolipiù study is a prospective population-based study funded by the Italian Ministry of Health that intends to enrol 3,000 newborns and their mothers in five Italian cities, and to store biological samples for future use. To realise these objectives, we performed a thorough evaluation of the literature, of national and international guidelines, and of the impact of the Italian legal requirements for research biobanking. Discussions among stakeholders facilitated the design of the informed consent and the ethico-legal framework. Several topics are addressed, including the suitability of a broad informed consent for paediatric biobanks, infant vulnerability, access to and sharing of data, and the disclosure of individual’s genetic results. Discussion of the ethical and legal procedures adopted in epidemiological biobanking might be a fruitful ground for comparison both at the national level, where standardization and homogeneity are lacking, and at the international level, where different regulatory issues are often in the background and might hamper research biobanks networking.

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Acknowledgments

The authors are grateful to Cristina D’Ippolito and Miriam Salemi (Genetic Epidemiology Unit, Centre of Epidemiology, Surveillance and Health Promotion, Istituto Superiore di Sanità, Rome) for their technical assistance. The Piccolipiù study was funded by the National Centre for Disease Prevention and Control (CCM) of the Italian Ministry of Health (No. T7A, 2010).

Conflict of interest

The authors have no conflicts of interest to declare.

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Correspondence to Virgilia Toccaceli.

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And the Piccolipiù Working Group.

See “Appendix” section for the members of the Piccolipiù Working Group.

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Appendix

Appendix

Members of the Piccolipiù Working Group: D. Di Lallo, S. Farchi, and M. Culasso (Public Health Agency, Lazio region, Rome, Italy); L. Richiardi, F. Merletti, A. Rasulo, L. M. Fiorini, C. Grasso, and M. Trevisan (Department of Medical Sciences, University of Turin and CPO-Piemonte, Turin, Italy); T. Todros, G. Garofalo, and S. Parisi (Department of Surgical Sciences, University of Turin, Italy); L. Ronfani, L. Vecchi Brumatti, P. Volpi, E. Piscianz, V. Tognin, and M. Bin (Institute for Maternal and Child Health-IRCCS “Burlo Garofolo”, Trieste, Italy); F. Rusconi, V. Montelatici, G. Poggesi, and G. Rapisardi (Meyer Children’s University Hospital, Florence, Italy); I. Mugelli and A. Frizzi (Ospedale Santa Maria Annunziata, Ponte a Niccheri, Italy); L. Gagliardi (Department of Women’s and Children’s Health, Ospedale Versilia, Viareggio, Italy); V. Martini, P. De Bartoli, and G. Baccaro (“Città di Roma” Clinic, Rome, Italy); S. Ferrazzani, T. Bernardini, L. Di Franco, and M. Badaloni (Cristo Re Hospital, Rome, Italy); F. Forastiere and D. Porta (Department of Epidemiology, Lazio Regional Health System, Rome, Italy); and M. A. Stazi, L. Nisticò, L. Penna, S. Brescianini, V. Toccaceli, and E. Medda (Genetic Epidemiology Unit, Centre of Epidemiology, Surveillance, and Health Promotion, National Institute of Health, Rome, Italy).

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Toccaceli, V., Serino, L. & Stazi, M.A. Informed consent, and an ethico- legal framework for paediatric observational research and biobanking: the experience of an Italian birth cohort study. Cell Tissue Bank 15, 579–590 (2014). https://doi.org/10.1007/s10561-014-9431-3

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Keywords

  • Population-based biobanks
  • Informed consent
  • Vulnerability
  • Genetic test results
  • Privacy
  • Access to data