Nordic committee on bioethics – workshop at the 2017 NeIC conference
New technologies enable the accumulation of large amounts of genetic data, biometric data, health records and socio-economic data about individuals. These data are increasingly being gathered and mined by companies for research and commercial purposes. The proper handling, security and use of such data is important to protect individuals while enabling the use of the data for the benefits of society, research or business. This workshop aims to investigate key ethical and societal issues concerning the large-scale collection, storage and sharing of data about individuals.
This workshop will feature presentations by invited speakers, and short summary discussion.
More information about the Nordic committee on bioethics: http://ncbio.org/english/
Chair: Arnar Pálsson
Kjetil Rommetveit – Centre for the Study of the Sciences and the Humanities, University of Bergen.
Daniela Cutas – Department of Historical, Philosophical and Religious Studies, Umea University, and Department of Philosophy, Linguistics and Theory of Science, University of Gothenburg.
Kimmo Pitkänen - The Helsinki Biobank.
Elisabeth Engberg – Centre for Demographic and Aging Research, Umeå University.
Chair: Isabelle Sylvie Budin Ljøsne
Einar Arnason – Faculty of Life- and Environmental Sciences, University of Iceland.
Mette Hartlev – Faculty of Law, University of Copenhagen.
Deborah Mascalzoni – Centre for Research Ethics & Bioethics, Uppsala University.
This is the second workshop that Nordic committee on bioethics organizes at a NeIC conference, see information on the NeIC 2015 Bioethics Workshop.
Kjetil Rommetveit – Centre for the Study of the Sciences and the Humanities, University of Bergen.
Since the inception of the human genome project, systematic and institutional efforts have been in place to regulate the collection, storage and processing of health information for purposes of research and health care delivery. Such efforts have always been subject to conflicting demands: on the one hand responding to rapid technological innovation in fields such as bioinformatics and ‘post-genomics’; on the other hand trying to anchor and legitimate such innovations by recourse to the institutional demands of law and ethics. In this talk I trace some main configurations of large-scale databanks with ethical and legal efforts towards regulation: whereas initial approaches turned on individual consent, the severe problems encountered by (individual) consent resulted in a ‘communitarian turn’ in which collective interests seem to trump individual rights of patients and research subjects. I argue that the bioethical debate has been epistemologically and institutionally insufficient for dealing with the problems, and I point to new developments in the EU General Data Protection Regulation that could possibly remedy some of the shortcomings. Yet, even as the new Regulation remains to be implemented, it seems clear that also this effort will run into difficulties. Hence, more than anything, the governance of large-scale databanks remains a protracted problem in need of critical scrutiny and public debate.
Elisabeth Engberg – Centre for Demographic and Aging Research, Umeå University.
POPLINK is a multigenerational population database constructed to overcome two main obstacles which long has obstructed and delayed the effective use of the unique Swedish registers for large-scale studies and multigenerational research: a poor access to 20th century micro-data, before the 1950-60s when modern registers were introduced, and a lacking coordination between population- and research registers. The POPLINK database covers >20 selected parishes in northern Sweden, where a large part of the population - up to 100 percent in certain age groups - is previously included in prospective biobank cohorts. Methods for secure linkage to biobank data and other civil registration based registry resources have been drawn up, tested and evaluated in close cooperation with Statistics Sweden. This presentation will discuss the ethical issues involved when setting up this kind of infrastructure and the experiences from disseminating data to researchers. It will also give some examples of projects where population data has been linked to biobanks and research registers, to study the interaction between different risk factors over long time periods as well as intergenerational patterns of disease.
Einar Arnason – Faculty of Life- and Environmental Sciences, University of Iceland.
Public goods and public interests are tied together. The public goods model exemplified by the UK Biobank contrasts with the commercial model of the deCODE Biobank in Iceland. I will examine the case of deCODE. I follow the trail of the money from deCODE’s founding (1996) through its bankruptcy (2009), re-emergence under almost the same name and its acquisition by Amgen (2012). I will examine deCODE’s evolving business plan of biobanking and research plan from linkage analysis and positional cloning, to genome wide association studies (GWAS), and whole genome sequencing (WGS). I will discuss the shortcomings of commercial biobanks as a model of the public interest. The deCODE method of consent raises at least two ethical issues, first about imputed genotypes and second about actionable and non-actionable incidental findings. I will focus on these consent issues and the issue of fair compensation.
Mette Hartlev - Faculty of Law, University of Copenhagen.
The Danish regulation of health data and biobanks, and the use of data and tissue samples for various purposes (treatment, research, and quality control and development), is to a large degree structured by categories and distinctions such as treatment/research, public/private, “dry” data/tissue samples and national/international. E.g., the relation between the researcher and the research subject is considered to of a different kind than the doctor-patient relationship, requiring somehow special concerns and regulation. Similarly, data management in the public sector is governed by principles, which differ from those applying in the private sector. This presentation will explore how NGS and personalized medicine challenges these distinctions and blur the boundaries between established legal categories. It will also look into which topics should be considered to establish a new, and robust, legal and ethical infrastructure for data sharing in the future.