Abstract
Biobank operations started officially in Finland in 2013 when the Biobank Act defining and regulating biobank operations came into force. Since then, ten biobanks have been established and they have started to collect new prospective samples with broad consent. The main corpus of biobank samples, however, consists of approximately 10 million “legacy samples”. These are old diagnostic or research samples that were transferred to biobanks in accordance with the Biobank Act. The focus of this article is on ambiguities concerning these legacy samples and their transfer in terms of legality, human rights, autonomy, and social sustainability. We analyse the Finnish biobank operations in the context of international regulation, such as the European Convention of Human Rights, the Oviedo Convention, European Charter of Fundamental Rights, the GDPR, and EU Clinical Trials Regulation, and show that the practice of using legacy samples is at times problematic in relation to this regulatory framework. We argue that the prevailing interpretations of these regulations as translated into the Finnish biobank practices undermine the autonomy of individuals by not giving individuals a right to consent or an actionable right to opt-out of the transfer of these legacy samples to the biobank. This is due to the fact that individuals are not given effective notification of such transfers. Thus, issues regarding the legal status of the biobank samples and the social sustainability of biobank operations remain a challenge for biobanks in Finland despite governmental efforts to create pioneering, comprehensive, and enabling legislation.
Highlights
During the first decade of this millennium, biobank legislation was prepared in Finland
Finnish biobank legislation (Biobank Act 688/2012) entered into force in September 2013 and was celebrated as the first comprehensive modern biobank law to enable recontacting of donors and enhance the autonomy and privacy of individuals (Soini 2013; Tupasela 2015; MSAH 2016; Snell and Tarkkala 2019)
At the same time, when it became possible to start the collection of prospective samples, a transfer of the existing diagnostic sample collections in public hospitals, research collections in universities, and the epidemiological research collections of the National Institute of Health and Welfare (THL) into biobanks became possible without informed consent. It is the ambiguities concerning these older legacy samples and their transfer—both legally and in terms of social sustainability—that we examine in this article
Summary
During the first decade of this millennium, biobank legislation was prepared in Finland. The explanatory report of the Protocol on Biomedical research states that if there is an intention to utilize biological materials or personal data obtained during a medical intervention for research purposes after the medical intervention, it is good practice to obtain a specific consent for such research uses not related to the medical intervention.17 This principle is confirmed in the EU Clinical Trials Regulation (No 536/2014 EU), which explicitly requires a separate consent for subsequent research use of trial data.18 these principles are elementary both for the legacy samples based on clinical collections of hospitals, and the ones based on research projects.
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