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      The general data protection regulation, the clinical trial regulation and some complex interplay in paediatric clinical trials

      review-article
      European Journal of Pediatrics
      Springer Berlin Heidelberg
      GDPR, CTR, Paediatric clinical trials

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          Abstract

          Although a number of authors have commented upon the impact of the GDPR on clinical trial conduct, few have examined the specific setting of paediatric trials. Whilst the general principles are the same as those for adults, some additional considerations arise. The ages of consent relating to data privacy and clinical trial participation are different in a number of countries, but the distinction is often not recognised in non-drug trials. Accidental pregnancies in clinical trials always raise complexities, but these are amplified when the trial subject is a minor, and the processes described in clinical trial protocols rarely take account of GDPR requirements. This paper describes approaches which can be taken to ensure the rights of children are respected.

          Conclusion: The conduct of paediatric clinical trials within GDPR requirements is quite possible provided authors think carefully when drafting protocols.

          What is Known:

          GDPR is applicable to clinical trials, including paediatric trials.

          A number of challenges at the interface between the GDPR and CTR have been described.

          What is New:

          The application of the GDPR to certain specific situations in paediatric trials does not appear to have been explored.

          Three such situations are described and solutions offered.

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          Most cited references5

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          Ethical Considerations for the Participation of Children of Minor Parents in Clinical Trials

          Children of minor parents are under-represented in clinical trials. This is largely because of the ethical, legal, and regulatory complexities in the enrolment, consent, and appropriate access of children of minor parents to clinical research. Using a case-based approach, we examine appropriate access of children of minor parents in an international vaccine trial. We first consider the scientific justification for inclusion of children of minor parents in a vaccine trial. Laws and regulations governing consent generally do not address the issue of minor parents. In their absence, local community and cultural contexts may influence consent processes. Rights of the minor parent include dignity in their role as a parent and respect for their decision-making capacity in that role. Rights of the child include the right to have decisions made in their best interest and the right to the highest attainable standard of health. Children of minor parents may have vulnerabilities related to the age of their parent, such as increased rates of poverty, that have implications for consent. Neuroscience research suggests that, by age 12–14 years, minors have adult-level capacity to make research decisions in situations with low emotion and low distraction. We conclude with a set of recommendations based on these findings to facilitate appropriate access and equity related to the participation of children of minor parents in clinical research.
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            Ethical and deontological aspects of pediatric biobanks: the situation in Italy

            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.
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              Regulating biobanking with children's tissue: a legal analysis and the experts' view.

              Many current paediatric studies concern relationships between genes and environment and discuss aetiology, treatment and prevention of Mendelian and multifactorial diseases. Many of these studies depend on collection and long-term storage of data and biological material from affected children in biobanks. Stored material is a source of personal information of the donor and his family and could be used in an undesirable context, potentially leading to discrimination and interfering with a child's right to an open future. Here, we address the normative framework regarding biobanking with residual tissue of children, protecting the privacy interests of young biobank donors (0-12 years). We analyse relevant legal documents concerning storage and use of children's material for research purposes. We explore the views of 17 Dutch experts involved in paediatric biobank research and focus on informed consent for donation of leftover tissue as well as disclosure of individual research findings resulting from biobank research. The results of this analysis show that experts have no clear consensus about the appropriate rules for storage of and research with children's material in biobanks. Development of a framework that provides a fair balance between fundamental paediatric research and privacy protection is necessary.
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                Author and article information

                Contributors
                dalrympleharris@prahs.com
                Journal
                Eur J Pediatr
                Eur J Pediatr
                European Journal of Pediatrics
                Springer Berlin Heidelberg (Berlin/Heidelberg )
                0340-6199
                1432-1076
                18 January 2021
                18 January 2021
                2021
                : 180
                : 5
                : 1371-1379
                Affiliations
                Centre For Pediatric Clinical Development, PRA Health Sciences, 500 South Oak Way, Green Park, Reading, RG2 6AD UK
                Author notes

                Communicated by Gregorio Paolo Milani

                Author information
                http://orcid.org/0000-0002-6044-0863
                Article
                3933
                10.1007/s00431-021-03933-3
                8032631
                33462697
                87376d0b-e9c8-418a-a8d3-902024260b71
                © The Author(s) 2021

                Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

                History
                : 11 June 2020
                : 29 December 2020
                : 5 January 2021
                Categories
                Review
                Custom metadata
                © Springer-Verlag GmbH Germany, part of Springer Nature 2021

                Pediatrics
                gdpr,ctr,paediatric clinical trials
                Pediatrics
                gdpr, ctr, paediatric clinical trials

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