- Open Access
The social dimension of biobanking: objectives and challenges
© The Author(s). 2017
- Received: 11 July 2016
- Accepted: 8 August 2017
- Published: 13 September 2017
The present article allows to explore, analyze and reflect on the consequences and problems posed by biobanks and attempts to prove the need of social and humanitarian support in establishing and functioning of biobanks as a new type of scientific institutions. The basis of the article is the latest publications devoted to social and humanitarian aspects of biobanking and Russian experience of the initial formation of this subject domain (before the first professional biobanks were established in Russia in the 2010-s, the only highly specialized collections of bio-samples had been registered). The article marks and classifies different aspects of biobanking that objectively demands the participation of specialists in ethics and social sciences. The cases of biobanking development and risks are estimated; the objective need of applied ethics and social sciences specialists’ participation in biobanking is proved.
- Society social and humanitarian support biobank biobanking social technologies bioethics biotechnologies
The development of individual and translational medicine as well as a still unsolved issue of conceptual interpretation of the human genome make modern research in biological chemistry, molecular, cell biology, and other allied scopes impossible without collecting, storing and using different types of biological material. Establishing banks-depositories of biomaterials of any type, and especially of the human material kind is connected with the need of solving a range of complicated social and humanitarian issues.
Biobank activities, ultimately, are the transformation of individual bodies into biological data, in other words, conversion of the unique, individual and – in the case of human being – personal into typical (serial), representative, species. In the case of banks storing human biological samples and data, this function objectively needed for a modern complex of biological sciences and technologies is associated with serious difficulties of the ethic and social, in general. The first ethic problem arisen was the fact that a new kind of natural resources – human biological material – is inside the human being body, in other words, in creatures being personalities that have certain inalienable rights. Secondly, alliance of biotechnology with informational and communicational technologies discovered the human body represented as the data, which provoked the concerns for the data protection, confidentiality and privacy. Thirdly, taking into consideration potential economic, technological and scientific value of the human being biological material and bio-information correlated to it, politicians were concerned about “genes’ theft” or unauthorized bio-surveillance over incompetent individuals (Karlsen & Strand 2009, 576).
Hereinafter, we analyze consequently the key directions of the biobank development that demand social and humanitarian support due to various reasons. Not all of them are recognized as demanding the participation of experts in social sciences. And many of them are considered as the domain of independent professional competence of sellers and consumers of the biobank services. Further, we address to Russian experience (that is limited yet because of the initial stage of biobanking in Russia), show the challenges the biobank development faces in Russia and the need of social and humanitarian support in this sphere today.
Biobank development analysis shows that we deal with the object which is not completely formed. This object is heterogeneous and highly complicated, it includes technical, economic, communicational, law, ethic, social and political components and each of them has its own issues demanding an integrated mutually agreeable solution in terms of each specific bank. Herewith, a range of questions inevitably arising in the process of the biobank activity depending on decisions that go beyond technical competence of subject specialist (technologists, medical professionals, biologists, lawyers etc.) and demanding a wide-range inter-sector discussion with the assistance of social sciences specialists.
Unlike western countries, where the process of biobanks’ establishment began at least in the 1990-s, biobanking in Russia is a new phenomenon that is at the stage of formation. At the moment, a few big biobanks function in Russia – the bank of biomaterials of the Federal State Budgetary Institution “East-Siberian Scientific Center of Human Ecology” (Siberian Branch of the Russian Academy of Medical Sciences), in 2012 the biobank of V.A. Almazov North-Western Federal Medical Research Center started functioning. At the EuroQSAR symposium in March 2014, the successful start of the first commercial biobank in Russia called “NBS” (National Bio Service) was announced.
The Russian Federation is the participant of the international project on establishing the biobank studying thyroid cancer. The event encouraged this project was the tragedy of Chernobyl Nuclear Plant in 1986. The exhaust and formation of radionuclide of iodine caused mass radiation exploration of the thyroid in Ukraine, Russia, Belorussia. In 1998, the European Commission, World Health Organization, National Cancer Institute and Sasakawa Memorial Health Foundation came forward with an initiative of the international project of establishing the Chernobyl bank of thyroid tissues, blood, nucleic acids and data base. The activity field of this bank would be collecting unique material and information that is significantly important for health gain of future generations. The foundation of the bank was supported by Belorussia, Ukraine and Russia. The locations of the bank are Minsk, Kiev and Obninsk.
At the present time, the foundation of a biobank that would focus on collecting materials of “all the living organisms on Earth” is a scientific project of Lomonosov Moscow State University. This project is symbolically titled “Noah’s Ark” (National Depositary Bank of Living Systems). This project should lay foundation for forming unique policy of biobanking development based on interdisciplinary specificity having a wide range of research goals. So, Moscow State University serves as a scientific center having the key objective of elaborating scientific basics of biobanking.
However, there are other aspects of biobanking development besides scientific purposes. This fact is determined by heterogeneous concept of the biobank. And the aspect of law regulations of biobanking is of crucial importance.
When speaking about peculiarities of biobanks’ regulations in Russia, we note that biobanks’ activities are regulated by separate laws and subordinate acts. There is no special law created in accordance with the new Constitution.
The law basis forming in Russia is built on international law acts such as the Universal Declaration of Human Genome and Human Rights (UNESCO, 1997), the International Declaration on Human Genetic Data (UNESCO, 2003), Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine; World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects; International Guiding Principles for Biomedical Research Involving Human; the Universal Declaration on Bioethics and Human Rights etc. But the norms of these acts serve only as guidelines and do not determine the specific aspects of everyday biobanking’s practice.
Among main federal laws that can be potentially recognized as the platform when implementing the project of Moscow State University “Noah’s Ark” are the Federal Law of 27/07/2006 # 152 “On personal data”. This law is the important guarantee of the constitutional right of the individual for non-interference in privacy from third parties; the Federal Law of 03/12/2008 # 242 “On the Government Genome Registration in the Russian Federation”; the Federal Law of 05/07/1996 # 86 “On the Government Control in Gene Engineering Activity”. Among subordinate acts, the following should be mentioned: the Russian Federation Government Edict of 28/12/2012 “On Adopting the Strategy of Medical Science in the Russian Federation for the Period up to 2025”, the Order of the Ministry of Health of the Russian Federation of 30/04/2013 #281 “On Adopting the Scientific Foundations of Medical Science”, the Order of the Federal Agency on Technical Regulating and Metrology of 14/04/2014 #472 “On Establishing a Technical Committee of Standardization of Biotechnology” and the Draft Regulation of the Russian Federation Government “On the Program of Fundamental Scientific Research in the Russian Federation in a Long-Run Period”.
It is to be noted that in the nearest time, a law gap will be partly filled, because, on the 23/06/2016, the President of the Russian Federation endorsed the law #180-FL “On the Biological Cell Products”. This law will take effect on the 1st of January, 2017. This law regulates the relations including those of “storage and transport of biological materials”.
Consequently, law regulations of biobanks are fragmentary. At the moment, unlike a range of western countries, there is no unique law regulating biobanks’ activities from the stage of establishment to the stage of sampling, storage and possible transfer of biomaterials.
The example of Russia, where organization, law and media fields of professional biobanks’ activity are forming intensively, clearly demonstrates heterogeneous character of biobanking that function “at the edge of genomics, ethics, social and law profit”.3 When having no set system of normative and law regulations and interpretation of biobanking at the level of public opinion, practically all key aspects of biobank activities – form of informed consent, principles of interactions with donors, policy of providing users with materials’ collections, selective policy in the case of national bio-depositories of the “Noah’s Ark” kind, information policy etc. demonstrate the presence of social implications closely connected to the questions of biopolitics and “social interests”.
For instance, one of the most promising directions of biobanking application is the development of personalized medicine (Eropkin 2015, 11). Personalized medicine is considered to be a step in the direction of high value medicine and one of the ways to economy of knowledge. However, along with impressive advantages of individual adjustment of diagnostics and pharmacology, there are rather impressive risks of regeneration of eugenics and different forms of discrimination on biomarkers’ grounds – beginning from changes in cost of medical insurances to forming new tools of the state biopolitics and population government. These risks are integral parts of biobanking institute development and they demand participation of specialists in social sciences.
When having pragmatic advantages connected with local engineering (research) purposes, final outcomes of biobank activities, including those of social consequences, are determined by implicit target-setting and ethics principles. The choice of these principles cannot be made in automatic mode. This choice cannot be also trusted in full to engineers, businessmen and natural scientists. The experts in social and humanitarian support should participate at all stages inasmuch as we deal with a new fundamental social institute formation.
Exploring brand new space and territories, new types of products and services, production and economic exchange, practices of consuming and life styles can model the new market forms and, potentially, new anthropology corresponding to them.
In connection to biobank industry development, it is possible to speak about developing new strategy forms intended to “invade” into the individuality of human being body at the deepest (polymorphous and molecular unique) level, using available individual biomaterial samples as new bearing points and new biotechnologies as new tools for providing their own performative efficiency.4
Although, at the moment, the application field and approbate opportunities of biobanks are not used at the global level, they are not totally controlled and they are also far from changing biological nature of the human being, a relevant opportunity is implied by the structure of the research, engineering and technical practices that were produced and used by biobanks. The development of biotechnologies and genomics can be examined as a part of social and technical regime, whose center is the new biological knowledge of the human being body (Hedgecoe & Martin 2008, 819). It should be taken into consideration that this regime can cross the borders of the industry generated it and be the basis of not only biomedical but also social and political technologies.
The analysis of biobanks’ development objectives should include the discussion about the consequences of the possibility connected with the fact that, at the basis of biobanks, the projects of eugenic kind (technical, “scientific” constructing of the “healthy and happy” body that has no physical (and, probably, other) sufferings) and the ideas of naturalization of social inequality and hierarchy regimes can reappear. At a time when technological breakthrough, local efficiency of tools and decisions are taking place, such kind of projects and ideas can possibly seem “natural” and “progressive” for at least a part of social groups.
So called “social and humanitarian support” of biobanks became a separate intellectual research abroad long time ago (primarily, in the EU and North America). From the research legitimacy and possible practical contribution point of view, it depends on understanding the complexity and heterogenic character of the biobank, comprehending the fact that biobanks are not just places to keep, store and produce the knowledge. The biobank functioning activates and assembles (borrowing the term from Deleuze and Latour5) different “elements” (“scientific”, “technological”, “economic”, “ethic”, “law”, “social”, “anthropological”, “ideological” etc.). The element assembles are extremely variable and changeable to much extent.6
The biobank is an object being at the stage of formation. Possible trajectories of its development are able to be a stake in multiple and diverse social conflicts about biobanks taking place between social agents and their specific interests (scientists, doctors, states, investors, donors, groups of civil activists).
In this context, social and humanitarian support of the biobank is crucially needed. The body and personality, biological and social in the human being, individual and social do not belong to different reality. Something that happens to one component has an essential impact on another. When investing in biotechnologies’ development, it should be remembered that biotechnologies are always social technologies and they have social consequences, because their source and object is not an abstract “biological body” but the human being having the whole variety of features, forms and definitions.
At the beginning of modern clinical medicine, clinic patients are considered the “material” for searching means of treatment for the “society” (humanity). In this sense, personal recovery and, in general, personal destiny of certain patient was interesting just in terms of its contribution to the fundamental clinical presentation promoting the investigation of a disease and, in perspective, victory over it for the “public good”. As the director of one of the first European maternity hospitals said – the obstetrical hospital of Gottingen University (Germany, founded in 1751): “The Pregnant Women are here for the Sake of the Teaching Institution” (cit. ex: (Shlumbohm 2008, 78)).
A special problem arisen by biobanking in a new way is intellectual property rights. Ref.: (Hawkins 2015).
The quotation educes one from four fundamental aspects of defining biobanking suggested by professor Akim Abayomi from Stellenbosch University (Capetown, RSA) in Geneva at conference for biobanking in connection with epidemic Ebola on 13 of May, 2015.
The notions of biopolitics and biopower commonly used as research tools in the works devoted to biobanks and biobanking (for instance, (Ducournau, Cambon-Thomsen 2009) and (Karlsen et al. 2011)) originated from Michel Foucault’s intellectual heritage. The biopower is the total of mechanisms by which something that determining biological features of the human kind can penetrate into politics, political strategies, into the general strategy of power (Foucault 2009). Anyway, the subjects of donors’ informed consent (at the moment, an irremovable procedure in biobank functioning and the subject of continuing debates) and confidence in biobanks as new biotechnological institutions (Starkbaum 2014) (confidence is frequently declared a necessary condition in biobank activities) are naturally fit into Foucault’s discourse of liberal ruling regimes based not so much on radical physical violence and/or economic expropriation, but delicate mechanisms of producing consent and recognition (Karlsen et al. 2011, Mascalzoni 2015)).
The term “assemblage” is incorporated into intellectual discourse by J. Deleuze and F. Guattari (Deleuze & Guattari 2004). Because of their context complexity, we take the explanation from H. Watson-Verran and D. Turnbull: the assemblage is similar to the episteme complemented by technologies. However, the “assemblage” connotes situational ad hoc contingency of collage in terms of its capability to cover a wide range of inconsistent components. Moreover, the advantage of the term “assemblage” is connotations of active practices but not passive static strictures (Watson-Verran & Turnbull 1995). Ref. also important explanations in John Law (Law 2004).
The inevitable methodological complexities are caused by that. How to construct the biobank as a research object, taking into consideration its complicated nature? Basically, there is no answer to this question. The diversity of research methods and subjects of their application in social and humanitarian support of biobanking is great. The system analysis (bearing the postulates of the object entirety and its hierarchy structure organization) is not the only methodological opportunity that modern social research represents. For example, conceptual and descriptive resources of so-called «Science Technology Studies» (STS) and actor-network approaches elaborated for description, primarily, scientific and technical innovations demand detailed examination. One of theoretical functions of the “net” notion is demonstration of certain irregularity of segregating the system from the environment implied by the system method when analyzing complicated processes and objects of modern techno-science. (Ref. to STS and actor-network theory (Hedgecoe & Martin 2008), (Latour 1987) and (Latour 2005). It is significant that the representative actor-network – Latour’s “Pasteurization of France” (Latour 1988) – is devoted to the research of the biotechnological innovation – Pasteur’s invention of anthrax bacterin).
The Authors would like to thank the colleagues of Lomonosov Moscow State University working on the project developing the ideas of the biobank’s establishing and functioning in Russia. We are grateful, in particular, to Dr. Vladimir Mironov (Doctor of Philosophical Sciences, the Dean of Philosophical Faculty of Lomonosov Moscow State University) and Dr. Dmitry Stambolsky (PhD in Biology, the Leading Researcher of the Laboratory of Gene and Cell Technology Department of the Faculty of Fundamental Medicine of Lomonosov Moscow State University) for their precious recommendations on earlier drafts of this paper. We also would like to thank Dr. Ludmila Ogorodova (Doctor of Medical Sciences, Associate Member of Russian Academy of Sciences, the Head of the Department of Intermediate Level Pediatrics with the Course of Child Diseases of the Faculty of General Medicine of Siberian State Medical University) and Dr. Pavel Tischenko (Doctor of Philosophical Sciences, the Head of the Department of Humanitarian Expertise and Bioethics of Institute of Philosophy of Russian Academy of Sciences) for their important comments given upon some aspects of the article. Any remaining errors, omissions and mistakes remain the sole responsibility of the Authors.
The research is accomplished using the grant of the Russian Scientific Fund (the project # 14–50-00029).
The authors contributed equally to this work. All authors read and approved the final manuscript.
The Authors declare that they have no competing interest.
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- Deleuze G, Guattari F. A thousand plateaus: Capitalism and schizophrenia. Minneapolis: University of Minnesota Press; 1987.Google Scholar
- Ducournau P, Cambon-Thomsen А. Users and Uses of the Biopolitics of Consent: A Study of DNA Banks. The Ethics of Research Biobanking. Solbakk JH, Holm S, Hofmann B, editors. New York – London: Springer; 2009: 33–48.Google Scholar
- Elger B, Biller-Andorno N. Biobanks and Research: Scientific Potential and Regulatory Challenge. The International Library of Ethics, Law and Technology. Vol. 8. Biobanks and Tissue Research. The Public, the Patient and the Regulation. 2010; 37–52.Google Scholar
- Eropkin M. Biobanks and their role in the Systems of Biosecurity, public health service, biotechnology, environment and “economy of knowledge”. 2015Google Scholar
- Foucault, M.2009 Security, territory, population. In The lecture course given in college de France in 1977–1978. N.Y: Picador.Google Scholar
- Giesbertz, N, A Bredenoord, J Van Delden. 2014. Clarifying assent in pediatric research. Eur J Hum Genet 22(2): 266–269.View ArticleGoogle Scholar
- Hedgecoe А, Martin P. Genomics, STS, and the making of Sociotechnical futures. The handbook of science and technology studies, 3 ed. 2008;817–840.Google Scholar
- Hawkins N. Intellectual Property and Biobanks. The International Library of Ethics, Law and Technology. Ethics, Law and Governance of Biobanking. National, European and International Approaches. Dordrecht – Heidelberg – London – New York: Springer, 2015;14:39–52Google Scholar
- Hofmann B, Solbakk JH, Holm S. Consent to Biobank Research: One Size Fits All? The Ethics of Research Biobanking. Solbakk JH, Holm S, Hofmann B, editors. New York – London: Springer; 2009; 3–24.Google Scholar
- International Declaration on Human Genetic Data. http://portal.unesco.org/en/ev.php-URL_ID%3D17720%26URL_DO%3DDO_TOPIC%26URL_SECTION%3D201.html
- Karadi S. The Concepts of Common Good and Public Interest: From Plato to Biobanking. Cambridge Quarterly of Healthcare Ethics. 2011;(20):554–562.Google Scholar
- Karlsen JR, Strand R. Annexation of Life: The Biopolitics of Industrial Biology. The Ethics of Research Biobanking. Solbakk JH, Holm S, Hofmann B, editors. N.Y. and L.; 2009. pp. 315–330.Google Scholar
- Karlsen, JR, JH Solbakk, S Holm. 2011. Ethical endgames: Broad consent for narrow interests; open consent for closed minds. Camb Q Healthc Ethics 20(4): 572–583.View ArticleGoogle Scholar
- Latour B. Science in action: How to follow scientists and engineers through society. Cambridge, MA: Harvard University Press; 1987.Google Scholar
- Latour B. Pasteurization of France. Cambridge, MA: Harvard University Press; 1988.Google Scholar
- Latour B. Reassembling the social: An introduction to actor-network-theory. Oxford: Oxford University Press; 2005.Google Scholar
- Law J. After method: Mess in social science research. Oxford: Taylor & Francis; 2004.Google Scholar
- Mascalzoni D. Ethics law and governance of biobanking: A very complex normative puzzle. The international library of ethics, law and technology. Vol. 14. Ethics, law and governance of biobanking. National, European and international approaches. Springer: Dordrecht - Heidelberg - London - New York; 2015. pp. 1-14.Google Scholar
- Master, Z, L Campo-Engelstein, T Caulfield. 2015. Scientists’ perspectives on consent in the context of biobanking research. Eur J Hum Genet 23: 569–574.View ArticleGoogle Scholar
- Shlumbohm, J. The pregnant women are here for the sake of the teaching institution. Disease health: new approaches to the history of medicine. Saint-Petersburg: Aleteya: 2008;73–103.Google Scholar
- Serepkaite, J, Z Valuckiene, E Gefenas. 2014. ‘mirroring’ the ethics of biobanking: What should we learn from the analysis of consent documents? Sci Eng Ethics 20(4): 1079–1093.View ArticleGoogle Scholar
- Shaw DM, Elger BS, F. Colledge, What is a biobank? Differing definitions among biobank stakeholders. Clinical Genetics: 2014;85(3):223-227Google Scholar
- Starkbaum, J, H Chen, H Gottweis. 2014. Publics and biobanks in China and Europe: A comparative perspective. Asia Europe Journal 12: 345–359.View ArticleGoogle Scholar
- Tallacchini М. A participatory space beyond the “autonomy versus property” dichotomy. The international library of ethics, law and technology. Vol 14. Ethics, law and governance of biobanking. National, European and international approaches. Springer: Dordrecht - Heidelberg - London - New York; 2015: pp. 21-38.Google Scholar
- Togni, E, K Dierickx, C Porteri. 2014. Participation in biobanks for research by incapacitated adults: Review and discussion of current guidelines. Int J Geriatr Psychiatr 29(7): 670–681.View ArticleGoogle Scholar
- Universal Declaration of Human Genome and Human Rights. http://www.unesco.org/new/en/social-and-human-sciences/themes/bioethics/human-genome-and-human-rights/
- Watson-Verran H, Turnbull D. Science and other indigenous Knowedge systems. In The handbook of science and technology studies. London: Sage. 1995;115–139.Google Scholar