© Springer Science+Business Media Dordrecht 2015Deborah Mascalzoni (ed.)Ethics, Law and Governance of BiobankingThe International Library of Ethics, Law and Technology1410.1007/978-94-017-9573-9_11
Governing Biobanks Through a European Infrastructure
Ethical, Legal and Social Implications
Université Le Mirail, Genetics and Society Platform, Toulouse, France
DR CNRS, Unité INSERM 558, Toulouse, France
In the framework of the 2007 call to support the preparatory phase of the European biobank infrastructures, the European Commission funded a specific project aiming to prepare a pan-European Biobanking and Biomolecular Resources Research Infrastructure (BBMRI) for biomedical and biological research in Europe and worldwide (Yuille et al. 2008). This infrastructure, which was to be built on new and existing national networks, resources and technologies, would be specifically complemented by innovative components and would be properly embedded into European ethical, legal and societal frameworks.
The project had four main objectives:
to benefit European health-care, medical research and, ultimately, the health of the citizens in the European Union (EU);
to create a sustainable legal and financial conceptual framework for a pan-European biobank infrastructure;
to increase scientific excellence and the efficacy of European research in the life sciences, especially in biomedical research; and
to expand and secure the competitiveness of European research and the industry in a global context, especially in the field of medicine and biology.
The infrastructure was to include samples from patients and healthy persons, representing different European populations (with links to epidemiological and healthcare information), molecular genomics resources, and biocomputational tools to optimally resource for exploit this global biomedical research.
The key components of the BBMRI included comprehensive collections of biological samples from different (sub-)populations in Europe, of which some could be linked to continuously updated data on the health status, lifestyle and environmental exposure of the sample donors. Other kinds of biobanks and biomolecular tools were also envisioned in addition to longitudinal, population-based biobanks; patient-based collections, tumour banks, and molecular reagents, for example, were to be well characterised. These different categories of resources and their variants were addressed in three work packages (WP2, 3, 4).
This could only be achieved by the federated network of centres that had been established in most, if not all, European Member States.
Therefore, the format of the BBMRI was to follow a distributed hub structure in which the hubs coordinate the activities, including the collection, exchange and analysis of samples and data for the main domains. The biobanks, biomolecular resources and technology centres that are members of the BBMRI were each to be associated with a specific domain hub. Furthermore, a variety of public and private institutions1 (e.g., universities, hospitals, companies) were to provide biological samples, data, technologies or services, with the possibility of being associated with certain BBMRI members. This structure provides great flexibility, allowing new participants to be connected at any time, and can be easily adapted to the emerging needs of biomedical research.
The preparatory phase for the BBMRI project has focused on technical, governance, and financial issues in WP5 (information technology), WP7 (financial aspects) and WP1 (coordination and governance), and has developed the ethical, legal and social implications (ELSI) platform in order to identify key issues relating to the networks used by biobanks, to provide schema and tools, and to trigger a stakeholder forum with various inputs.
Developing an infrastructure that is “properly embedded into European ethical, legal and societal frameworks” requires specific preparation, both on operational questions that deal with the immediate feasibility of the endeavour and on more fundamental questions. This preparation was intended to help the understanding of how these issues could impact on the organisation of the future BBMRI, and the public’s perception of the BBMRI and their engagement with it. Both aspects had to be addressed first in the preparatory phase, by means of coordination activities; WP6 was in charge of this task. The respective groups worked in two directions: (1) rapid operationality based on existing frameworks, resulting in practical tools, and (2) preparatory steps for the long-term, solid foundation of the ELSI of the BBMRI, resulting in background papers, proposals and some level of piloting of approaches and methodologies.
This section presents the work done by the BBMRI ELSI group to highlight the key challenges in building such an infrastructure and to evaluate the results for improving the translation from research activities to clinical or health system application.
The general objective of the ELSI working group was to design an agreed, harmonised and implementable ethical, legal and social framework for the establishment of a biobanking and biomolecular European infrastructure and to propose corresponding strategies and scenarios as a basis for the operational concept and contractual agreements.
The specific objectives were to manage and to oversee the ethical and corresponding legal aspects in practice in the BBMRI preparatory phase; to develop an online platform on the legal aspects of uploading and validating existing legal documents in use by BBMRI members and partners; to work out the concept of harmonising, as compared to standardising, the ethics and to present practical mechanisms for achieving this in the context of the BBMRI; to provide mechanisms for the BBMRI to interact openly and transparently with the European citizenry and the means for assessing the debate regarding such an infrastructure in the population and among the relevant stakeholders in the different countries; to define, describe and demonstrate an integrated conceptual and operational model for the ELSI of the BBMRI; and to prepare proposals for training in the domain of ELSI relevant to the BBMRI in Europe.
The competencies and experience represented by the four partners of this working party have allowed access to a large network of experts in each of the main domains and disciplines involved (ethics and bioethics, law, and social sciences); this core group has interacted frequently and in a dynamic way with a group of about 20 experts from 17 countries covering these three domains.
The core group has produced background documents, in particular in the fields of ethics (1) and public consultations (2), templates, and methodological considerations for each of the specific questions requiring an answer before the BBMRI can be launched; these documents are being used to assess the existing situation and to identify gaps through expert consultation, and are systematically communicated to the other functional bodies of the BBMRI preparatory phase for comments and integration. For legal aspects, a bottom-up approach has been set up through an on-line wiki-platform, a web-based tool providing administrative information to researchers who want to exchange samples across borders, and a proposal to trace and assess the uses of bio-collections (3). Based on this previous work, we are now ready to set up governance rules for the implementation of the European biobanks infrastructure (4).
Among the topics to be addressed when constructing a network of entities across borders, in this case a network of biobanks, the harmonisation of the related ethics is particularly complex. The issue is: on the one hand, ethics is seen as a cultural aspect of the Member States, which could induce strong differences between them about the way to address life sciences; on the other hand, in view of the globalisation of research and the subsequent increased collaboration between teams, research ethics should not be seen as hampering scientific collaboration. This paradox has been addressed through Ruth Chadwicks’ paper (Chadwick and Strange 2009), in which she identifies various processes and the corresponding ethical theories, as follows:
The harmonisation of a process is a consistent, universal, global system based on concepts and/or principles. Is this possible and/or desirable in ethics?
The standardisation of a process is less burdensome, as standards are often established without requiring full-blown harmonisation.
Standardisation alone, whilst practical, is probably not sufficient in this instance.
These processes rely on conceptual theories (Fleischacker 1999) that can be summarised through the following models.
The Necessary Conditions model: this is a philosophical approach used to identify cross-cultural ethical features and to produce abstract, descriptive principles. The success of this model is limited because of cultural bias.
The Human Rights model: this is a political/legal approach which can be functional but minimal. Its abstract nature fails to account for a multitude of perspectives, and it is more akin to standardisation.
The Cultural Dialogue approach: this requires comprehensive, continual, inter-cultural discussion and aims to discover parallel norms and to produce a concrete, global ethic.
As a result, it has been suggested that what is commonly intended in the context of the BBMRI by the term ‘harmonisation’ of ethics, namely common values, might better be regarded as the establishment of common standards. However, that is not sufficient. Agreement on the ethical credentials of the initiative itself is a prerequisite. Beyond that, harmonisation is indeed necessary, but not as an end point, rather as an ongoing process—the interplay of different voices in relation to the ‘text’ of the standards in question. The voices in question must also include the voices that are heard less often.
To illustrate this conceptual approach, a survey was conducted as part of WP6 among national ethics committees (NECs) and other official bodies across the member and partner countries of the BBMRI to obtain their opinions on biobanks. The aim of this analysis was to highlight the similarities and differences regarding ethical questions on biobanks. Twenty-five countries have been studied.2 The report consists of an overview and analyses of the current opinions of national ethics committees or the opinions adopted by public authorities (e.g. the Ministry of Research) or professional societies among the BBMRI partners and members. In order to identify the relevant texts regarding ethical views, our research encompassed the following categories: formal and national bodies (opinions issued by NECs), more specific institutional advice (public institutes or universities) and advice from legal and ethical experts when no texts were available or accessible. With regard to the extent and diversity of the ethical issues dealt with in these diverse opinions, and considering the goal of the BBMRI, we focused on and addressed specific relevant ethical issues.
Studying these diverse opinions highlighted important ethical issues which weren’t necessarily identified as such in the first attempt to list the aspects to be explored and compared. For example, the question of further use of biological matter needed to be treated separately, and not as belonging within the category of informed consent.
The following six ethical issues were finally derived:
Definitions of biobanks and their scope of application
Exchanges between centres
Public or private sectors
These issues have been discussed in comparison to the concept of standardisation to propose recommendations for implementing them in the context of the BBMRI.
Analysis of the results showed that all the participant NECs thought that biobanks and biomolecular resources raised ethical issues. Two attitudes can be pinpointed in analysing the spirit of these opinions.
For some NECs, ethics was seen as a governance tool. Opinions were built on general ethical values and the objective of these NECs was to enlighten the researcher on the ethical issues that should be taken into account in the biobank research field.
Other NECs insisted on specific procedures to be respected by researchers and provided guidelines in order to outline a code of conduct for professionals; for these NECs, ethics was seen as a standardising tool.