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The Best Interests of the Child and the Return of Results In Zawati et al. BMC Medical Ethics 2014, 15:72 http://www.biomedcentral.com/1472-6939/15/72 DEBATE Open Access The best interests of the child and the return of results in genetic research: international comparative perspectives Ma’n H Zawati*, David Parry and Bartha Maria Knoppers Abstract Background: Paediatric genomic research raises particularly challenging questions on whether and under what circumstances to return research results. In the paediatric context, decision-making is guided by the best interests of the child framework, as enshrined in the 1989 international Convention on the Rights of the Child. According to this Convention, rights and responsibilities are shared between children, parents, researchers, and the state. These “relational” obligations are further complicated in the context of genetic research. Discussion: A comparative review of international, regional and national documents on the return of research results reveals that there is a dearth of normative documents in the paediatric context. The best interests of the child framework is increasingly complicated by a growing appreciation of pediatric autonomy and the development thereof; parental rights (particularly when parents are affected by the genomic information of their children); and the right not to know. Summary: This comparative analysis reveals that policy-makers and legislators have responded to the above challenges in different ways. Nevertheless, in Europe as well as in Canada, there is an emerging trend towards making the return of certain results mandatory in the paediatric context, should this course of action prove to be in the best interests of the child. Keywords: Return of research results, Best interests of the child, Paediatrics, Genomic research, Convention on the Rights of the Child, Children’s rights Background research, or to the complex dynamics of decision-making An “individual research result” is defined as “a finding in this context. Indeed, while the ‘best interests of the concerning an individual research participant that has child’ (‘BIC’) framework remains the foundation for potential health or reproductive importance or personal decisions concerning children in research, these decisions utility and is discovered in the course of research […]in are shared between 1) parents, who, as a matter of law, meeting the project’s research aims” [1]. In recent years, are authorized to speak for their children, guide their discussions surrounding the topic of the return of such actions and determine their healthcare; 2) researchers, results in genetic research have mainly focused on whether who have an obligation to conduct research according to individual findings should be returned to participants and, professional norms; 3) children, whose views become if so, under what conditions [2]. The increasing availability increasingly important as they mature; and finally, 4) the and affordability of next-generation sequencing has made State, which has the power to intervene in cases of neglect this debate all the more pressing [3]. and to legislate on matters relating to the participation of That being said, little attention has been given to the children in research. In the case of paediatric genetics, challenging issue of return of results in paediatric genetic where research results may not be actionable during childhood or may have implications for parents, siblings and other relatives, the best interests of the child * Correspondence: [email protected] Centre of Genomics and Policy, McGill University, 740 Dr. Penfield Avenue, framework is all the more complicated. What role do Suite 5200, Montreal, Quebec H3A 0G1, Canada the aforementioned stakeholders play in the decision © 2014 Zawati et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Zawati et al. BMC Medical Ethics 2014, 15:72 Page 2 of 13 http://www.biomedcentral.com/1472-6939/15/72 to return paediatric research findings? What are the Discussion general principles that guide such decision-making International norms: general principles processes? What are the responsibilities of the various There is a dearth of international normative literature actors involved? on return of results in the paediatric context [6]. Existing Despite the fact that children have been involved policies and/or guidelines are primarily concerned with in medical research for hundreds of years, pediatric adult-level participation, and are extremely broad in participation has been consistently overlooked in both scope and application [4]. That being said, however, guidelines and policy-related documents [4]. In recent several important principles can be distilled from these years, however, the international community has reached normative documents that are highly relevant to the issue a consensus [4] on the importance of including children of return of results in paediatric research. For example, in research. Accordingly, this text will undertake a UNESCO’s1997Universal Declaration on the Human comparative analysis of international norms relating Genome and Human Rights sets out ‘[t]he right of each to the return of results in paediatric genomic research. individual to decide whether or not to be informed of First, this text will examine general principles as enshrined the results of genetic examination and the resulting in the 1989 Convention on the Rights of the Child [5] consequences should be respected’ [7], despite the fact (“CRC”) (Section II.A). Second, it will review principles in that it does not explore the nature of this right in the regional (European) normative documents as well as paediatric context. professional norms (Section II.B). These norms, when In international law, the BIC is the central ethos for adopted by professional bodies, often play a role in decisions concerning children participating in genomic determining standard of care. Findings from Sections research. Consequently, the CRC can be viewed as a II.A and II.B will allow us to comprehend how these “cornerstone” document; with the dual distinction of principles and professional norms are applied to the (1) having been unanimously approved by the UN’s return of research results in paediatrics for select common General Assembly; and (2) being the most universally rati- and civil law countries (UK, France, the Netherlands, fied UN treaty to date [8], the CRC offers a comprehensive Spain and Canada)a (Section II.C). Finally, we return to statement on paediatric human rights. Article 3 of the our international comparison in order to critically evaluate CRC enshrines the BIC as a general principle, which has the future of the return of results in the context of since been reinforced by a number of international paediatric research (Section II.D). normative documents. The CRC also enshrines other important paediatric Methodology rights. Notably, for our purposes, these include the child’s The international documents referenced in this text were ‘right to be heard’ [5] and right to enjoy ‘the highest collected using the HumGen International Database attainable standard of health’ [5]. Though the CRC is not (http://www.humgen.org), a database of international, specific to paediatric research (and, in fact, this paper national, and regional guidelines and policies specific acknowledges that research is fundamentally different to human genetic research. In order to narrow our from clinical care), the driving spirit of this convention search, the keywords “minor/child” and “communication can be applied to the debate surrounding paediatric of results” were used to identify those documents that research. In point of fact, since the CRC came into force, were most relevant and important. Keywords such as scholarship on this convention has focused on the rights “research result” or “incidental findings” were not avail- of autonomy and participation in the paediatric context, able. All organizations were selected, and no limitations and decisions affecting these rights [9]. were set as to jurisdiction. This provided a large selection Importantly, the rights spelled out in the CRC exist of documents. Only English documents dating from 1990 ‘independently of […] parents and are enforceable by to 2013 were queried. This search generated 145 results, children over against their parents through the medium of which approximately 20 were selected based on their of the state’ [10]. This is significant both because it level of relevance to this text. has altered the rights and responsibilities of those Case law was retrieved using Quicklaw, a legal database. who share in decision-making surrounding children (i.e., For the purposes of our research, the keywords “research” parents, researchers, children, and the State), but also and “best interests of the child” were used. This search because children are seen to have independent legal generated 933 results; these results were then narrowed rights (albeit usually exercised via a court-appointed based on their relevance to the best interests of the child in tutor). Moreover, this duality begs the question of how to medicine. Legal doctrine was retrieved using
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