Ethical and Societal Issues

Leaders: Anne Cambon-Thomsen, Bartha Maria Knoppers, Jennifer Harris

Population-based biobanks engender a host of scientific and ethical challenges. While the scientific challenges are met by rapid integration of new methodologies into labs worldwide, the picture is quite different regarding the ethical challenges. Socio-ethical and governance procedures for the establishment and use of biobanks have not kept pace with the rapid technological advances that have increased the demand for biobank studies. It is often the case that ethical protocols are not unified between projects within the same country or between countries. Rather, each country grapples with the same sets of questions (e.g. consent, data confidentiality, transfer of biological samples), and then adopts their own solutions. This situation poses clear hindrances to the growing interest in internationally coordinated biobank initiatives where ethical procedures have implications for nearly all key components of collaboration (e.g. data collection, analysis, sharing and storage of data). An increasingly common scenario is that researchers developing international projects are confronted with complex information regarding ethics regulations, which they are ill-equipped to interpret and coordinate. Accordingly, the success of European multinational biobank initiatives will hinge on the coordination and harmonization of ethical-legal and governance issues.

Aims and Objectives
The goal of this workpackage is to increase the scientific value and the various usages of pre-existing and planned population-based genetic databases and biobanks through coordination and harmonization activities that will establish a basis for a platform of the ethical-legal and governance criteria.

The work subsumed under the WP can be broadly divided into two phases

Phase I consists of developing tools (lexicon, grid) and mapping extant database activities related to the major ethical questions raised by these projects. This includes compiling information related to the major to consultation of stakeholders and/or population before projects, transparency, consent, recruitment, controlled access by 3^rd parties, data sharing, role of oversight bodies, identifiability and privacy protection, commercialisation, participant rights to withdraw, destruction of data, data confidentiality, and informing participants of results. A number of issues are already quite developed through other projects like GenomEUtwin or ELSAGEN and are being addressed in other initiatives such as P3G and ESTO report (IPTS). An effort will be made to build on already produced documents and to coherently connect the work completed. The work undertaken in this WP will involve:

collecting and analyzing normative documents of relevance
Describing ethical issues specific to various population study designs and development of corresponding grid
Cataloguing protocols and discerning governance models in selected projects

We will focus more specifically on important aspects that are insufficiently addressed thus far including: a) definitions to clarify the degree to which the identification of persons through samples and data are qualified and named; b) issues related to children in long-term biobanking projects. We have already contacted Dr L Knudsen (Copenhagen) in order to use the documents available from the EU funded CA (5FP) ChildrenGenoNetwork in which a specific workshop on ethical issues in research with children was held in December 2003); and c) special issues associated with ethnicity and isolated populations including parameters used in biobanks: definitions, usages, legal aspects and how the legal situation influences the construction of the projects involving population or specific closed populations. The work will be highly interactive with the other PHOEBE WPs (WP1 for ELSI characterization of large projects, WP2 for ELSI unique to isolates, WP3 for lexicon and database ELSI and WP4 to build public understanding of the role of large-scale genotyping studies). A main objective under the Phase I mapping effort is to generate an easily readable matrix of information to guide the development of recommendations under Phase II. This will require integrating information from diverse fields of expertise including bioethics and law and sociology of sciences. Therefore, this aspect of the WP will involve a strong partnership between the Genetics and Society platform in genopole Toulouse and the Genetics and Society Project (GSP) at the Centre de recherche en droit public (CRDP), University of Montreal.

Phase II of this workpackage is a consensus building process. Information will be distilled from the phase I work to generate recommendations associated with creating a platform of ethical-legal and governance criteria that is consistent with international norms and will enable sharing data and samples for the research purposes within a defined ethical framework for Europe. It is critical to coordinate this consensus finding effort with activities underway at the various projects associated with this CA. Specifically, P³G, together with other international bodies (e.g. UNESCO, WHO, CE, OECD, HUGO and HGVS) are developing a common taxonomy/nomenclature for biobanks with particular emphasis placed on an overarching ethical framework. This work strives towards maximum harmonization of ethical review methodologies used to evaluate population research protocols. This work would help the EC organizing the relevant ethical reviews of such projects in the context of the R&D frameworks. For example, current approaches are built upon the ethics of protecting the individual and do not sufficiently address population research or even group benefits (promotion/prevention/protection) but only group “harms”. Building such an understanding and consensus on norms and methodology requires networking and education, both of which are critical elements of this WP. An advantage to conducting this work through the present CA is to be able to take into account the actual empirical experience of several large projects on such issues. To help inform the produced recommendations a conference will be organized on the theme of ‘Translational Medicine and Public Health Policy: Lessons form Biobank ELSI. In coordination with training efforts and the exchange program of P3G, this WP will also develop a component of the PHOEBE training program.

Deliverables
D1       Preliminary planning, strategy setting and identification of full expert groups for all
           workpackages at Initial PHOEBE Conference
           Time: 6 months
D 2      Debriefing, presentation and discussion of final reports, and discussion of future
           strategy with all workpackages at the Concluding PHOEBE Conference.
           Time: 35 months
D 3      Final report to be posted on worldwide web.
           Time: 36 months
D 24    Interim report on ethical definitions and practices in Europe, Canada and other
           countries (including concordance tables and lexicon)
           Time: 18 months
D 25    Organization of conference ‘Translational medicine and public health policy: lessons
           from biobank ELSI’.
           Time: 22 months
D 26    Develop ELSI training component of PHOEBE in conjunction with the P3G training and
           exchange program.
           Time 30 months
D 27    Final consensus report describing the basis and tools necessary for an internationally
           consistent legal-social-ethical and governance platform.
           Time: 33 months

Milestones
The sole ”decision point” will occur at the Initial PHOEBE Conference when we will determine the full composition of the expert groups. Time: 6 months

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