A Unified European Approach on Tissue Research and Biobanking? A Comparison

Beier, Katharina; Lenk, Christian

doi:10.1007/978-94-007-1673-5_10

Cited by 6 publications

(16 citation statements)

References 10 publications

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“…With regard to its ethical and legal implications, however, commercialization of biobank research, ie, "the transfer of property on body material in exchange for financial rewards", 63 is controversial. Although this debate is global, 64 the European discourse displays some special features.…”

Section: Commercializationmentioning

confidence: 99%

“…However, some of the EU's conventions and directives impact member states' regulative approaches. 42,63 The European Convention on Human Rights and Biomedicine, referred to in the following as the OC, 51 which was ratified by the majority of European countries, contains several provisions that are relevant for biobank research. For one, the OC stipulates that IC is a general rule for research (article 16) and requires a subject's renewed (secondary) consent if her samples will be used for purposes that were not covered by her initial consent (article 22).…”

Section: Regulation At the Eu Levelmentioning

confidence: 99%

“…42 For this reason, an analysis of the European context in terms of groups of countries seems most useful. 63 Whether the research use of human tissues is regulated by laws passed specifically to control such activities, nonspecific existing laws, or means of soft law varies from country to country. Against this background, we can classify countries into three regulatory groups: countries with a specific law, countries with composite regulations of laws, often accompanied by soft law (eg, ethical guidelines), and countries with no domestic regulation where transnational provisions provide guidance (Table 3).…”

Section: A Typology Of Regulative Approachesmentioning

confidence: 99%

“…[65][66][67][68] In fact, the gradual introduction of commercialization can already be observed insofar as bodily materials can be procured, exchanged, and traded in several European countries as long as these activities produce no financial gain. 63,69 Moreover, several biobank networks charge researchers fees beyond what is needed to recover their costs. 15 The no-commercialization principle will definitely become obsolete in Europe if human biological materials are turned into products.…”

mentioning

confidence: 99%

“…Given the complex relationships between bodily materials and their human sources and the increasing forms of commercial activity, it is important to consider these issues adequately in public discussion and in crafting legal provisions. 63 Moreover, the dichotomous conception of bodily materials as belonging to either the sphere of donation or the sphere of the market is outdated and must be replaced by more nuanced models. 72 For example, the not-for-profit status of charitable institutions and public-private partnerships could, together with public funding, help to ensure the financial sustainability of biobanks.…”

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confidence: 99%

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Biobanking strategies and regulative approaches in the EU: recent perspectives

Beier¹,

Lenk²

2015

BSAM

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Biobanks, ie, systematic collections of human biological materials and associated clinical and lifestyle data, provide an indispensable infrastructure for modern research. Although biobank research takes place on a global scale, there is no internationally binding framework for its ethical and legal regulation yet. A better understanding of existing regulative approaches is an important prerequisite for its ethical and legal harmonization and, thus, for improving the interoperability of biobank-based research in the future. This review focuses on biobanking strategies, regulative approaches, and recent developments in Europe. Specifically, we discuss selected ethical and legal issues in research biobanking in the European context by looking at population biobanks, new participation models, the cross-border sharing of samples, the participation of minors, the handling of incidental health findings, whole genome sequencing, and commercialization. We also provide an overview of regulations on biobank research in the EU and member states and highlight commonalities and differences. Although several common trends can be identified across Europe, we acknowledge the importance of national research traditions that cannot easily be set aside. Thus, harmonization, rather than a complete unification, of approach seems to be the most realistic vision for future biobank research in Europe.

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Section: Commercializationmentioning

confidence: 99%

Section: Regulation At the Eu Levelmentioning

confidence: 99%

Section: A Typology Of Regulative Approachesmentioning

confidence: 99%

mentioning

confidence: 99%

mentioning

confidence: 99%

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Biobanking strategies and regulative approaches in the EU: recent perspectives

Beier¹,

Lenk²

2015

BSAM

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Is the commercialisation of human tissue and body material forbidden in the countries of the European Union?

Lenk

Beier

2011

J Med Ethics

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The human body and its parts are widely perceived as matters beyond commercial usage. This belief is codified in several national and European documents. This so-called 'no-property rule' is held to be the default position across the countries of the European Union. However, a closer look at the most pertinent national and European documents, and also current practices in the field, reveals a gradual model of commercialisation of human tissue. In particular, we will argue that the ban on commercialisation of body material is not as strict as it may appear at first sight, leaving room for the commercial practice of tissue procurement and transfer. We argue for more transparent information for patients and tissue donors, an intensified ethical debate on commercialisation practices, and a critical review of current normative principles.

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International requirements for consent in biobank research: qualitative review of research guidelines

2014

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Several stakeholders in the field of biobank research are currently developing and evaluating innovative consent procedures, and in doing so refer to national and international guidelines that regulate biomedical research. The objectives of this study were to present (1) a synthesis of all consent issues mentioned or required in guidelines that are of potential relevance to biobank research and (2) a detailed overview of similarities and differences between these guidelines. This analysis considered a purposive sample of the nine most internationally recognised research guidelines plus a national checklist for developing consent forms. The synthesis of all included research guidelines found 41 issues of potential relevance to consent procedures in biobank research. The guidelines differ substantially with respect to (1) how comprehensively they address these consent issues, (2) their definition and explanation of the issues and (3) how directly or indirectly the issues are mentioned. The set of 41 consent issues presented in this paper should be further developed in a continuous process. Our findings on the differences among major research guidelines also raise the issue of a more systematic development and revision process for these guidelines. The presented set of content issues potentially relevant to consent in biobank research can inform the balanced development or evaluation of consent forms, as well as the development and revision of corresponding research guidelines.

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A Unified European Approach on Tissue Research and Biobanking? A Comparison

Cited by 6 publications

References 10 publications

Biobanking strategies and regulative approaches in the EU: recent perspectives

Biobanking strategies and regulative approaches in the EU: recent perspectives

Is the commercialisation of human tissue and body material forbidden in the countries of the European Union?

International requirements for consent in biobank research: qualitative review of research guidelines

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