Living tissue and organ donation by minors : suggestions to improve the regulatory framework in Europe

Whether living tissue and donation by minors is acceptable is the subject of considerable debate. In view of the vulnerable position of minors, the risks involved in the medical procedure, and the possible conflict of interests on the part of the parents, the legal approach in Europe has traditionally been very restrictive. However, this approach may raise concerns when a situation would arise where donation by a minor would still be in that person’s best interests. Moreover, a very restrictive approach may be difficult to reconcile with the requirement to give due weight to the views of minors in accordance with their age and maturity. In the light of these considerations, this article examines whether there is room to improve the way in which living tissue and organ donation by minors is currently regulated across Europe. We first sketch the debate about the acceptability of using minors as living donors and explore its potential clinical need. Subsequently, we assess whether international legal instruments and guidelines offer any guidance to address the issues raised. This is followed by an analysis of the legal situation in the United States. Finally, we examine in detail the legal situation in Europe. To that aim, relevant regulations were compiled, translated, and analyzed in close cooperation with national legal experts. By way of conclusion, we compare the legal approach followed in the great majority of European countries with the one preferred in the United States and make suggestions to amend European transplant regulations to better protect the interests of minors

Legal approaches regarding health-care decisions involving minors: implications for next-generation sequencing

The development of next-generation sequencing (NGS) technologies are revolutionizing medical practice, facilitating more accurate, sophisticated and cost-effective genetic testing. NGS is already being implemented in the clinic assisting diagnosis and management of disorders with a strong heritable component. Although considerable attention has been paid to issues regarding return of incidental or secondary findings, matters of consent are less well explored. This is particularly important for the use of NGS in minors. Recent guidelines addressing genomic testing and screening of children and adolescents have suggested that as ‘young children' lack decision-making capacity, decisions about testing must be conducted by a surrogate, namely their parents. This prompts consideration of the age at which minors can provide lawful consent to health-care interventions, and consequently NGS performed for diagnostic purposes. Here, we describe the existing legal approaches regarding the rights of minors to consent to health-care interventions, including how laws in the 28 Member States of the European Union and in Canada consider competent minors, and then apply this to the context of NGS. There is considerable variation in the rights afforded to minors across countries. Many legal systems determine that minors would be allowed, or may even be required, to make decisions about interventions such as NGS. However, minors are often considered as one single homogeneous population who always require parental consent, rather than recognizing there are different categories of ‘minors' and that capacity to consent or to be involved in discussions and decision-making process is a spectrum rather than a hurdle

UIML based design of multimodal interactive applications with strict synchronization requirements

As the variety in network service platforms and end user devices grows rapidly, content providers must constantly adapt their production system to support these new technologies. In this paper, we present a middleware platform for deploying highly interactive (television)applications over a diverse collection of networks and end user devices. As the user interface of such interactive applications may vary depending on the capabilities of the different target devices, our middleware uses UIML for the description of generic user interfaces. Our middleware platform also provides a pluggable support for new networks. A factor that highly complicates the design is the need for strict synchronization between an interactive application and video or audio data that is broadcasted. In order to support a maximum of functionality, downloadable application logic is used to provide the interactive services. As a test case, an evaluation setup was built, targeting both set-top boxes and mobile phones

Living Organ Donation by Minors: An Analysis of the Regulations in EU Member States

Living organ donation (LD) is an increasingly established practice. Whereas in the U.S. and Canada LD by minors has occasionally been reported, LD by minors seems to be largely absent in the European Union. It is currently unclear whether this is the result of a different legal approach. This study is the first to systematically analyze the regulations of EU Member States, Norway and Iceland towards LD by minors. Relevant regulations were identified by searching government websites, translated, compared and sent for verification to national legal experts. We identified five countries where LD by minors is allowed. In two of these (Belgium and the UK) some minors may be deemed sufficiently mature to make an autonomous decision regarding LD. By contrast, in the three other countries (Luxembourg, Norway and Sweden), LD by minors is only allowed subject to parental permission and the assent (or absence of objection) of the donor. Where allowed, regulations differ significantly with regard to the substantive and procedural safeguards in place. In view of the controversial nature of the procedure, as illustrated by recent reports and surveys, we argue for a very cautious approach and greater harmonization in countries where LD by minors is allowed. This article is protected by copyright. All rights reserved.status: publishe

Should minors and young adults qualify as potential live kidney donors? The views of international transplant professionals

Although live kidney donation (LD) has become an increasingly common procedure, European and US transplant centres disagree as to whether minors and young adults should qualify as donor candidates. Therefore, we aimed to better understand the attitudes and viewpoints of transplant professionals. We conducted fourteen in-depth interviews with a purposive sample of international transplant professionals from various professional backgrounds. Data analysis was guided by QUAGOL, a systematic approach based on the constant-comparative method. Professionals expressed a cautionary view, worrying about the uncertain long-term medical and psychosocial consequences of LD at a young age. They also worried that young individuals' decisions are more likely to be influenced by their psychosocial developmental stage or family pressure. As these concerns were more significant for minors as compared to young adults, minors were deemed ineligible for LD except for in highly exceptional circumstances. Professionals' attitudes were also influenced by the expected benefits for the recipient and the availability of therapeutic alternatives, as well as the strength of the donor-recipient relationship. More prospective research on the long-term medical and psychological outcomes in young adult donors is likely to shed more light on the acceptability of LD by adolescents and young adults.status: publishe

Living Tissue and Organ Donation by Minors: Suggestions to Improve the Regulatory Framework in Europe

© SAGE Publications. Whether living tissue and donation by minors is acceptable is the subject of considerable debate. In view of the vulnerable position of minors, the risks involved in the medical procedure, and the possible conflict of interests on the part of the parents, the legal approach in Europe has traditionally been very restrictive. However, this approach may raise concerns when a situation would arise where donation by a minor would still be in that person's best interests. Moreover, a very restrictive approach may be difficult to reconcile with the requirement to give due weight to the views of minors in accordance with their age and maturity. In the light of these considerations, this article examines whether there is room to improve the way in which living tissue and organ donation by minors is currently regulated across Europe. We first sketch the debate about the acceptability of using minors as living donors and explore its potential clinical need. Subsequently, we assess whether international legal instruments and guidelines offer any guidance to address the issues raised. This is followed by an analysis of the legal situation in the United States. Finally, we examine in detail the legal situation in Europe. To that aim, relevant regulations were compiled, translated, and analyzed in close cooperation with national legal experts. By way of conclusion, we compare the legal approach followed in the great majority of European countries with the one preferred in the United States and make suggestions to amend European transplant regulations to better protect the interests of minors.status: publishe

Legal approaches regarding health-care decisions involving minors: implications for next-generation sequencing

The development of next-generation sequencing (NGS) technologies are revolutionizing medical practice, facilitating more accurate, sophisticated and cost-effective genetic testing. NGS is already being implemented in the clinic assisting diagnosis and management of disorders with a strong heritable component. Although considerable attention has been paid to issues regarding return of incidental or secondary findings, matters of consent are less well explored. This is particularly important for the use of NGS in minors. Recent guidelines addressing genomic testing and screening of children and adolescents have suggested that as 'young children' lack decision-making capacity, decisions about testing must be conducted by a surrogate, namely their parents. This prompts consideration of the age at which minors can provide lawful consent to health-care interventions, and consequently NGS performed for diagnostic purposes. Here, we describe the existing legal approaches regarding the rights of minors to consent to health-care interventions, including how laws in the 28 Member States of the European Union and in Canada consider competent minors, and then apply this to the context of NGS. There is considerable variation in the rights afforded to minors across countries. Many legal systems determine that minors would be allowed, or may even be required, to make decisions about interventions such as NGS. However, minors are often considered as one single homogeneous population who always require parental consent, rather than recognizing there are different categories of 'minors' and that capacity to consent or to be involved in discussions and decision-making process is a spectrum rather than a hurdle.European Journal of Human Genetics advance online publication, 15 June 2016; doi:10.1038/ejhg.2016.61.status: publishe