EMBL Forum Lectures
Thursday, 20 September 2012, 16:00, Small Operon, EMBL Heidelberg
Anne Cambon-Thomsen, CNRS Director of Research
Sharing bioresources and data: ethical aspects, incentives and evolving framework
With the development of large scale biology in the –omics era, many bioresources are being created. Bioresources are of different kinds: collections of biological samples with associated data [biobanks], databases independent of physical samples and other biomolecular and bioinformatics research tools. An increasing portion of scientific research relies on the use of biobanks and databases. Sharing such bioresources is essential for optimizing knowledge production. Although many aspects of the sharing of bioresources apply to all domains of biology we shall concentrate on examples of bioresources dealing with human data and samples, as specific regulations and issues exist and the implications for society have specific features to be considered. There are ethical imperatives to share biological samples, data and tools to use and analyse such data. A number of issues do not facilitate such sharing at various levels (technical aspects, intellectual property aspects, recognition of the tasks leading to sharing in the evaluation of research activity as well as ethical aspects). Search for solutions is underway. Some of these obstacles are actually associated to the protection of human persons and data especially with informed consent aspects and heterogeneity in national legal frameworks. More generally speaking there is the need, not only of a better harmonisation of ELSI policies, but also of a higher coordination of the ELSI research at international level. An initiative (ELSI 2.0 for genomics and society, http://www.elsi2.net/ ) will be presented (Science, 2012, 336, 673-4).
We shall then address the frameworks at international and European levels, both legally binding and non binding reference texts, at UNESCO, HUGO and OECD as well as Council of Europe and EU levels. The Open access policies and the governance of bioresources and community resources show recent evolution, and examples will be taken in FP7 projects and infrastructures (e.g. BBMRI: biobanking and biomolecular resources research infrastructure, http://www.bbmri.eu/, ESGI: European sequencing and genotyping infrastructure, http://www.esgi-infrastructure.eu/, GEN2PHEN (genotype to phenotype) http://www.gen2phen.org/, and BioSHaRE-eu http://www.bioshare.eu/ ).
A major obstacle is the lack of recognition of efforts paid to elaborate and share such resources. We shall present the initiative towards the development of a Bioresource Research Impact Factor (BRIF http://www.gen2phen.org/groups/brif-bio-resource-impact-factor ) that aims to document: 1. the quantitative use of a bioresource, 2. the importance of research results involving it, 3. the efforts of those who made available a valid bioresource and 4. recognition for their institution. Central to BRIF’s goals is the construction of a relevant quantitative parameter along with guidance for optimizing recognition of bioresources sharing worldwide (Nat genet, 2003, 34, (1) : 25-26 and2011, 43: 503-4). An international working group has been established and specific tasks assigned to sub-groups. This seminar will provide the foundations for such work and will describe elements of guidelines in order to foster discussion on policies in this domain within the biomedical and biotechnology community.
Anne Cambon-Thomsen, MD, is Director of Research in CNRS (French national centre for scientific research). Specialist in human immunogenetics, holding also a degree in health ethics, she presently leads a multidiciplinary research team on “Genomics, biotherapies and public health”, involving human and social sciences as well as health sciences, in the context of research in epidemiology and public health at Inserm (National Institute for Health and Medical Research), and University of Toulouse III Paul Sabatier, joint Unit 1027) at the Faculty of Medicine Toulouse-Purpan. She also leads a “Genetics and Society” platform at the Toulouse-Midi-Pyrénées Genopole. She is involved in several EU projects in genomic sciences, public health genomics and biobanks, where she is responsible of ethical, legal and social aspects. She has been rapporteur of an EU expert group on ethical, legal and social aspects of genetic testing; she sits in several scientific advisory boards of international projects and is member of the scientific council of Inserm and of the board of the European and French Societies of Human Genetics. She is a former member of the CCNE (French national advisory bioethics committee, 2002-2005) and of the European Group on ethics of science and new technologies (2005-2010) and has Chaired the Life sciences operational ethics committee in CNRS (2006-2011). She worked in recent years on societal aspects of biobanks, biotherapies and genetic testing.www.u1027.inserm.fr ; http://societal.genotoul.fr/