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Population Biobanking and International Collaboration

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Abstract

Population-based biobanks promise to be important resources for genetic research. However, the study of normal genomic variation across populations requires the collection of data and biological samples from individuals on a large scale. While international collaboration has become both a scientific and an ethical imperative, international sharing of data and samples poses many challenges. Significant variation persists among the legal and ethical norms governing population biobanks in different jurisdictions. Many of these norms do not clearly provide for international access. To illustrate these problems, we collected and compared applicable legislative instruments, as well as ethical guidelines issued by national, regional, and international bodies. In addition, harmonization is faced with important limitations and may not be sufficient to ensure effective international sharing. Population biobanks are therefore looking for new ways to promote sharing and improve interoperability. The formation of biobank networks and the development of common governance tools are two approaches that are setting the groundwork for international collaboration in genetic research. © 2015 S. Karger AG, Basel.
... Heterogeneity and a lack of standardization attributed to normative and legal aspects for majority of the established biobanks is currently what affects sharing of samples and data for research between biobanks [14][15][16][17]. A sound quality management system (QMS) is imperative in ensuring that services and products provided by a biobank are fit for purpose [18]. ...
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The National Biobank of the National Health Laboratory Service (NHLS) is a national treasure established to serve as support infrastructure for the provision of high quality human biological materials for research purposes and it represents the first of its kind in South Africa. This article aims to demonstrate the alignment of the NHLS Biobank to international best practices and guidelines with reference to the 13 sections of the International Society of Biological and Environmental Repositories (ISBER) Best Practices for Repositories (4th ed.). The NHLS Biobank has implemented procedures and management strategies that are technical best practices covering the lifecycle of biobanking (collection, processing, storage and dissemination of human biological materials) while having respect for ethical and regulatory processes, upholding the interest of the donors. ISBER best practices are invaluable sources of guidance and benchmarking on the guiding principles has enabled the NHLS Biobank to develop into an entity with infrastructure and operational activities that support its short-term and long-term objectives that are set out in the business plan.
... Several studies illustrate variations among the legal and ethical norms governing biobanks in different jurisdictions (Kinkorová 2016). Although harmonization of biobank Standard Operating Procedures (SOPs), best practices and governance is an essential tool for sharing of biobank samples and data, the concept is context specific and relates to the compatibility of methods and approaches to facilitate synergy (Harris et al. 2012;Zawati et al. 2015). The major hurdle with harmonizing legislation is due to the extent of variation that exists between different government systems. ...
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It is common practice for biobanks and biobank researchers to seek funding from agencies that are independent of the biobank that often stipulate conditions requiring researchers to grant access and share biomaterials and data as part of the agreement, in particular, in international collaborative health research. As yet, to the author’s knowledge, there has been no study conducted to examine whether these conditions could result in the commercialization of biomaterials and data and whether such practice is considered ethical. This paper therefore seeks to answer the question of whether such sharing of biomaterials and data for biobank research in exchange for funding from sponsors and funders in collaborative health research is ethically justified. The central idea of this paper is based on an argument against commodification of the body and its parts, which includes biomaterials and data and holds that it is ethically wrong to commodify humans and their body parts. The arguments against commodification of biomaterials and data explored are the Kantian approach argument as it relates to interference of commodification with human dignity which is linked to a diminished sense of personhood, an argument against commodification that is based on a dilution of altruism and lastly the communitarian approach anti-commodification argument which emphasizes a social responsibility to the common good. Arguments in support of commodification based on liberal individualism and consequentialism are also discussed.
... 46,47 In most countries BCNet is involved in guidelines that are the primary means for governing biobanking and research involving human samples. 48 In some of these countries there is high-level legislation dealing with human research, but it tends to focus more on clinical trials and the establishment of ethics review committees. 49 This legislation has usually been drafted before the potential for research on human samples was recognized. ...
Article
Biomedical research based on the sharing and use of ever larger volumes of samples and data is increasingly becoming an essential component of scientific discovery. The success of biobanking and genomic research is dependent on the broad sharing of resources for use by investigators. However, important ethical challenges need to be addressed for the sample and data sharing to be successful. Despite low- and middle-income countries (LMICs) carrying a higher burden of disease, biomedical research conducted to date has mainly focused on high-income countries. In order for LMICs to benefit from the advances in such research, normative documents (such as laws and guidelines) play a significant role in allowing LMIC projects to partake and be represented in global biomedical research. The administration and management of the ethical aspects of biobanking, including informed consent, are key components in ensuring that samples and data can legally and ethically be used and shared. As part of its support to the LMIC biobanks, the International Agency for Research on Cancer (IARC) established a biobank and population cohort building network (BCNet) in 2013 with the aims of providing support (including education and training) and facilitating the development and improvement of biobanking infrastructure in LMICs. A comparative analysis of the laws and guidelines in BCNet countries was completed to highlight some of the ethical and legal issues related to biobanking in LMICs and to identify examples of effective systems of governance already in operation.
... La colaboración local y extranjera resultan fundamentales para crecer en número de datos y así obtener mejores conclusiones. Esta cooperación también ofrece una oportunidad de consensuar protocolos e intercambiar formación de recurso humano que permita garantizar la calidad del funcionamiento de un biobanco 29,30 . ...
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The concept "Biobank" is relatively new in the scientific literature, and is not yet consensually defined, even for the World Health Organization (WHO). However, the use of human samples in biomedical research is a very old activity. The organized development of Biobanks in different places has grown in the last decade. The experience in different countries and continents has been diverse. In this special article we intend to summarize, organize and communicate to the national medical and scientific community, (i) the concept of Biobank, (ii) the international experience and a map of the Research Biobanks working in Chile, (iii) the basic biomedical and essential operational aspects to manage a Biobank for Research and (iv) the impact of a National Network of Biobanks implementation in the Chilean Health System. Ethical and regulatory aspects will not be included, given their intrinsic complexity, which should be discussed elsewhere. (Rev Med Chile 2019; 147: 901-909)
... La colaboración local y extranjera resultan fundamentales para crecer en número de datos y así obtener mejores conclusiones. Esta cooperación también ofrece una oportunidad de consensuar protocolos e intercambiar formación de recurso humano que permita garantizar la calidad del funcionamiento de un biobanco 29,30 . ...
Article
The concept "Biobank" is relatively new in the scientific literature, and is not yet consensually defined, even for the World Health Organization (WHO). However, the use of human samples in biomedical research is a very old activity. The organized development of Biobanks in different places has grown in the last decade. The experience in different countries and continents has been diverse. In this special article we intend to summarize, organize and communicate to the national medical and scientific community, (i) the concept of Biobank, (ii) the international experience and a map of the Research Biobanks working in Chile, (iii) the basic biomedical and essential operational aspects to manage a Biobank for Research and (iv) the impact of a National Network of Biobanks implementation in the Chilean Health System. Ethical and regulatory aspects will not be included, given their intrinsic complexity, which should be discussed elsewhere. (Rev Med Chile 2019; 147: 901-909)
... The national law of Iceland asserts that the government has custodial rights of the physical samples themselves while the donors retain ownership rights (Nwabueze, 2008;The Icelandic Data Protection Authority, 2000). Estonia, conversely, awards ownership of the biobank samples to the government while granting a strong protection of donor rights (Nwabueze, 2008;Priisalu & Ottis, 2017;Zawati, Knoppers, & Thorogood, 2014). In Sweden, personal information regarding the donors is not considered part of the biobank. ...
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Introduction: Distributed Research Infrastructures are becoming increasingly more salient as science expands and universities continue to look for new means to cooperate and share expertise and expenses on large-scale projects. One area which has seen much development in recent years is biobanking, as there have been numerous attempts to harmonise the different biobanking standards over the years, none of which have been entirely successful. BBMRI.se was an EU-initiative that sought to harmonise the biobanks nationwide. BBMRI.se, was thus selected as a case for studying how a distributed Research Infrastructure was set up. At the time of its creation, the organisation constituted the largest investment ever made by the Swedish Research Council in a medical Research Infrastructure. The organisation involved all Swedish universities with a medical faculty, in addition to two other universities. However, the organisation was marred by a number of controversies and would eventually fold in 2018. Aim: This dissertation is to elucidate the mechanisms involved in the construction of a medical large-scale distributed Research Infrastructure, and to understand the motivations and rationale of the experts who activate themselves in constructing it. Thus, the overall aim of this doctoral thesis is to identify the benefits and constraints of forming a large-scale medical, distributed Research Infrastructure. Specifically, this dissertation looks at a real-life case while comparing it to the available literature covering the development of Research Infrastructures as well as some of the theories covering mindsharing and collective entrepreneurship. The ambition is to contribute knowledge on the determining factors in bringing a large-scale infrastructure together as well as the risks associated with it. Hence, this dissertation asks the following research question: What are the principal lessons for researchers, entrepreneurs and funders that can be inferred from the formation of a large-scale distributed Research Infrastructure towards securing more sustainable prospects for similar, future endeavours? More precisely, this dissertation seeks to determine what the most debated topics are within the academic discourse on Research Infrastructures (study I), after which it looks at the factors involved in constructing shaping a distributed Research Infrastructure (study II). The study then endeavours to looks at some of the pitfalls and how managerial self-governance affects organisational failure (study III). The study then seeks to investigate the mind-set of the managers/pioneers involved in setting up BBMRI.se and if they perceive the organisation in a similar fashion for the other managers (study IV) and how they have reasoned behind their motivations for joining the initiative in the first place (study V). The overall results have endeavoured to elucidate what components are at work when forming such an infrastructure at an organisational level, but also to understand the reasoning and motivation that the individuals responsible in setting up the infrastructure might have had, and how their visions and/or actions may have impacted on the organisation. Method: Some various designs and data collection methods were used in this dissertation. Study I was a literature study carried out as a narrative review using the PRISMA statements as a guideline. Both the Web of Science (WOS) and PubMed databases were scoured for articles. Study II-V used qualitative, semi-structured interviews with BBMRI.se managers. All of these studies took on the form of iterative, directed content analyses, with the exception of study III, which was an inductive, directed content analysis. Results: Study I found that the most commonly discussed topics concerned the need for developing and expanding the use of “infrastructures”. The findings indicated that the future of scientific research calls for a deeper and more widespread multidisciplinary forms of collaboration. Study II found that it is crucial to identify the potential collaborative and deliberative organisational elements of organisational team building already at the outset of establishing a distributed Research Infrastructure. The study also found that, contrary to suggestions of extant literature, the establishment of a distributed Research Infrastructure does not necessarily counteract organisational fragmentation. Study III identified that an organisation with high levels of task uncertainty and low levels of organisational integration will suffer from organisational fragmentation. The type of fragmentation manifested in BBMRI.se is best identified as a “fragmented adhocracy”. This means that the organisation’s mission statement is subject to diverse views, leading to goals that are separate, unstable and sometimes even conflicting, while also lacking in co-ordination. The study also found that the organisation lacked a “liaison device” and instead depended on a more traditional model of planning and control systems through its reliance on strategy documents and interim evaluation reports. This was in spite of the fact that this model is better suited for a more vertical organisational structure. Study IV investigated how managers/associates of BBMRI.se perceived the organisation’s brand and the role of “mindsharing”. The results showed that mindsharing occurred throughout the initial two stages (“Brand Strategic Analysis” and “Brand Identity”), but would dissipate throughout the remaining two final stages (“Brand Operationalising”, and “Post-Implementation Reflections”). This resulted in a fragmented brand perception, which resulted in the failure of generating a “pull-effect” for the BBMRI.se brand. Study V looked at how collective entrepreneurial team cognition of the instigators behind BBMRI.se changes throughout the process of establishing the organisation. The study devised a new “action phase model”, known as the “4 I’s” of entrepreneurship, where each “I” elaborated on the entrepreneurial rationale behind the various stages of the creation process. These were “Intention”, “Initiation”, “Implementation” and “Introspection”. The results illustrated that the respondents agreed that there was a need for BBMRI.se, while disagreeing on what the organisation should be doing and what its challenges consisted of. The homogenous mind-set would begin to dissipate once the “Initiation” stage was reached, declining further throughout the Implementation stage. Conclusion: The overall conclusions from study I-V have shown that distributed Research Infrastructures carries potential to form a platform to pool scientific research in the face of the ever-expanding sciences, where the demands of co-financing and scientific co-operation are becoming ever so pressing. In addition, distributed Research Infrastructures have the benefit of utilising initial synergy effects and using multidisciplinary teams. In line with the contention of Gibbons et al. (1994), this carries the potential of opening up new possibilities of scientific knowledge production. Provided there is a political incentive in place to allocate the necessary funding, the process of establishing a distributed Research Infrastructure can be done in a considerably swift timespan. However, there are several inherent risks. Most notably, there was a lack of “infrastructuring”, as defined by Star and Bowker (2002). This means that scientists as well as the policy-makers should gradually learn together through a learning process about how to creating an effective large-scale infrastructure. This may have prevented mindsharing from becoming consolidated throughout the formation process (Aaker, 1996; Acuña, 2012; Azevedo, 2005; J. Griffin, 2009; Holt, 2016; Krishnan, Sullivan, Groza, & Aurand, 2013; Stevens, 2003). This, in turn, would also put an end to the collective entrepreneurship that had up till that point characterised BBMRI.se, in which the motivations and drivers of the initiators/managers, as well as their respective recollections of the same, were instrumental features (Cardon, Post, & Forster, 2017; Czarniawska-Joerges & Wolff, 1991; Sakhdari, 2016). Moreover, the integration of autonomous “National Champions” (leading scientists within their field) carries a risk of the “principal-agent” problem, which in turn can lead to “moral hazard” as the “National Champion(s)” may elect to undertake added risks, since someone else bears the cost of those risks (Holmstrom, 1982; Laffont & Martimort, 2002; Steets, 2010). There is also an overwhelming risk of organisational fragmentation, which, coupled with managerial neglect, may cause the eventual failure of the organisation.
... 2 The current demands for data of adequate volume, veracity and validity to make sound scientific associations between the human genome and disease are far greater than any one scientist or institution can meet alone. [3][4][5] An ethical imperative to share genomic and associated clinical data complements this scientific rationale. Participants accept informational risk(s), albeit minor, as part of their involvement in genetic/genomic research. ...
Article
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Clinical research and health information data sharing are but ripples in a growing wave of reimagined applications of distributed ledger technologies beyond the digital marketplace for which they were originally created. This paper explores the use of distributed ledger technologies to facilitate single institutional ethics review of multi-site, collaborative studies in the data- intensive sciences such as genetics and genomics. Immutable record-keeping, automatable protocol amendments and direct connectivity between stakeholders in the research enterprise (e.g., researchers, research ethics committees, institutions, funders and regulators) comprise several of the conceptual and technological advantages of distributed ledger technologies to research ethics review. This novel-use proposal dovetails recent policy reforms to research ethics review across North America that mandate a single ethics review for any study that takes place across more than one research site. Such reforms in the United States, Canada and Australia replace prior institution-by-institution approval mechanisms that contributed to significant research delays and duplicative procedures for collaborative research worldwide. While this paper centers on the Common Rule revision in the United States, the single ethics review mandate is a noteworthy example of regulation evolving in parallel with advances in the data- intensive sciences it governs. The informational exchange capacities of distributed ledger technologies align well with the procedural goals of streamlining the ethics review system under the new Common Rule ahead of its official implementation on January 19, 2020. The ethical, legal and social implications of applying such technologies to ethics review will be explored in this concept paper. Namely, the paper proposes how administrative data from research ethics committees (REC) could be protected and shared responsibly, as well as inter- institutional cooperation negotiated within a centralized network of research ethics committees using the blockchain.
Chapter
The many ethical challenges in biobanking include management of biobanks with quality issues and benefit sharing, consent issues related to autonomy of the donors, data storage, and privacy as well as the sources and use of samples and data. Thus, one side of the coin is the many potential health benefits, such as biomarkers for clinical purposes, which makes the development of biobanks containing human samples with linkable health data ethically justifiable. The other side of the coin is the ethical costs in the form of potential loss of autonomy depending on the consent practice, unknown or even unlawful use of tissues, and their future use in ways unacceptable to people. People, in general, are interested in genetic data and willing to donate samples and data to scientific research. It is important to cherish research integrity and listen to people’s opinions to retain trust. In addition to public discussion, education of both scientists and lay people, and advanced legislation are important for the ethically good long-term development for the biobanking field.
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The concept “Biobank” is relatively new in the scientific literature, and is not yet consensually defined, even for the World Health Organization (WHO). However, the use of human samples in biomedical research is a very old activity. The organized development of Biobanks in different places has grown in the last decade. The experience in different countries and continents has been diverse. In this special article we intend to summarize, organize and communicate to the national medical and scientific community, (i) the concept of Biobank, (ii) the international experience and a map of the Research Biobanks working in Chile, (iii) the basic biomedical and essential operational aspects to manage a Biobank for Research and (iv) the impact of a National Network of Biobanks implementation in the Chilean Health System. Ethical and regulatory aspects will not be included, given their intrinsic complexity, which should be discussed elsewhere.
Chapter
Genomic medicine aims to optimize medical interventions by exploiting the patients' genetic information. However, there are often major discrepancies in the pace of implementation of genomic medicine between different countries worldwide. In other words, and contrary to the majority of developed countries in Europe and the United States, implementation of genomic medicine in low-resource environments and developing nations proceeds at a much slower pace as a result of poor capacity building, lack of dedicated infrastructure, insufficient genetic literacy of healthcare professionals, and poor or even lack of reimbursement policies for genetic testing and legislation governing the use of genetic testing. Nevertheless, there are several examples of successful implementation of genomic medicine in resource-limited environments in Asia, Latin America, and Africa that are outlined in this chapter. Also, formation of large multinational networks among researchers from developing countries can also expedite genomic medicine implementation efforts. These examples of successful implementation of genomic medicine interventions can be replicated by other developing countries selectively, according to their needs.
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Population biobanks are research facilities that store human biological material and health data of thousands of participants to facilitate research in the field of personalized medicine. To achieve this goal, biobanks usually collect samples and data from research participants through the process of broad consent. This type of research consent request permission to use data and biological samples collected from a wide range of research projects that are not specifically identified in the consent form (e.g. for genetic research). This article aims to determine if the trend supported by research funding agencies, to require broad consent from biobank participants, meets current Canadian legal and ethical standards. Based on our research, it appears of paramount importance that the requirements of funding agencies could be better harmonized with the current legal and ethical framework. The lack of synchronization identified could have negative impacts on research and the realization of legal objectives. Ideally, rules governing consent in this area of research will have to evolve in order to better respond to the objectives and challenges of contemporary biomedical research. Meanwhile, funding agencies involved in biobank research should make a greater effort to reconcile their scientific requirements with current ethics and legal rules.
Article
Biobanking has long generated a host of challenging ethical and legal issues, particularly in relation to consent. A topic at the heart of current debates is the acceptability of the use of 'broad' consent in place of more specific and conventional consent approaches. In this paper, the justifications for the move toward broad consent are analysed and critiqued. It is concluded that all of the justifications - such as concern for costs, the desire to do research in the public good and the concept of minimal risk - remain contentious and seem insufficient, at least on their own, to stand as a rationale for a move away from traditional notions of consent.
Article
Third Edition [Formula: see text] [Box: see text] Printed with permission from the International Society for Biological and Environmental Repositories (ISBER) © 2011 ISBER All Rights Reserved Editor-in-Chief Lori D. Campbell, PhD Associate Editors Fay Betsou, PhD Debra Leiolani Garcia, MPA Judith G. Giri, PhD Karen E. Pitt, PhD Rebecca S. Pugh, MS Katherine C. Sexton, MBA Amy P.N. Skubitz, PhD Stella B. Somiari, PhD Individual Contributors to the Third Edition Jonas Astrin, Susan Baker, Thomas J. Barr, Erica Benson, Mark Cada, Lori Campbell, Antonio Hugo Jose Froes Marques Campos, David Carpentieri, Omoshile Clement, Domenico Coppola, Yvonne De Souza, Paul Fearn, Kelly Feil, Debra Garcia, Judith Giri, William E. Grizzle, Kathleen Groover, Keith Harding, Edward Kaercher, Joseph Kessler, Sarah Loud, Hannah Maynor, Kevin McCluskey, Kevin Meagher, Cheryl Michels, Lisa Miranda, Judy Muller-Cohn, Rolf Muller, James O'Sullivan, Karen Pitt, Rebecca Pugh, Rivka Ravid, Katherine Sexton, Ricardo Luis A. Silva, Frank Simione, Amy Skubitz, Stella Somiari, Frans van der Horst, Gavin Welch, Andy Zaayenga 2012 Best Practices for Repositories: Collection, Storage, Retrieval and Distribution of Biological Materials for Research INTERNATIONAL SOCIETY FOR BIOLOGICAL AND ENVIRONMENTAL REPOSITORIES (ISBER) INTRODUCTION T he availability of high quality biological and environmental specimens for research purposes requires the development of standardized methods for collection, long-term storage, retrieval and distribution of specimens that will enable their future use. Sharing successful strategies for accomplishing this goal is one of the driving forces for the International Society for Biological and Environmental Repositories (ISBER). For more information about ISBER see www.isber.org . ISBER's Best Practices for Repositories (Best Practices) reflect the collective experience of its members and has received broad input from other repository professionals. Throughout this document effective practices are presented for the management of specimen collections and repositories. The term "Best Practice" is used in cases where a level of operation is indicated that is above the basic recommended practice or more specifically designates the most effective practice. It is understood that repositories in certain locations or with particular financial constraints may not be able to adhere to each of the items designated as "Best Practices". Repositories fitting into either of these categories will need to decide how they might best adhere to these recommendations within their particular circumstances. While adherence to ISBER Best Practices is strictly on a voluntary basis, it is important to note that some aspects of specimen management are governed by national/federal, regional and local regulations. The reader should refer directly to regulations for their national/federal, regional and local requirements, as appropriate. ISBER has strived to include terminology appropriate to the various specimen types covered under these practices, but here too, the reader should take steps to ensure the appropriateness of the recommendations to their particular repository type prior to the implementation of any new approaches. Important terms within the document are italicized when first used in a section and defined in the glossary. The ISBER Best Practices are periodically reviewed and revised to reflect advances in research and technology. The third edition of the Best Practices builds on the foundation established in the first and second editions which were published in 2005 and 2008, respectively.
Article
Given the burgeoning of genetic research and proliferation of human genetic databases, especially in the biomedical sphere, this paper explores whether the existing laws and regulatory structures for governing genetic databases in England and Wales are adequate. Through a critical survey of relevant rules, bodies and practices, it argues that the current UK framework is far from ideal in at least five major areas: (1) forms and styles of law used, especially the separate legislative regimes for physical biomaterial and data; (2) core definitions; (3) formal regulatory bodies, licensing and notification requirements; (4) ethics committees and other advisory panels; and (5) enforcement powers and sanctions. Such shortcomings could have major implications for stakeholders, hamper efforts to achieve European or international harmonisation of genetic database principles and practices, and undermine the UK’s standing as a world leader in genetics and biotechnology. Drawing on comparative analysis of governance strategies adopted in Estonia, Iceland and Sweden, the paper identifies alternative options and lessons from experiences abroad, suggesting possible avenues for reform that may warrant serious consideration in the UK.
Chapter
As is by now a well-investigated fact that human tissue research and biobanking is not regulated by a common legal framework in Europe so far, this article aims to step beyond this rather descriptive finding. By focussing on central issues of biobank research, the authors do not only highlight common trends and perspectives in the regulation of human tissue research across the countries of the European Union and Switzerland but also identify the ethical and legal foundations for some of the persisting differences in this field. Their analysis bears on the premise that certain countries hold similar research traditions and are united by common ethical and legal pathways for regulating research. Based on their distinction of seven country groups and their respective regulatory frameworks, the authors finally draw some overall conclusions regarding the future regulation and potential legal harmonization of this field within the European Union.
Article
In terms of sample exchange, international collaborations between biobanks, or between biobanks and their research partners, have two important aspects. First, the donors' consent usually implies that the scope and purpose of any sample transfer to third parties is subject to major constraints. Since the legal, ethical and political framework of biobanking may differ substantially, even between countries of comparable jurisdictional systems, general rules for the international sharing of biomaterial are difficult, if not impossible, to define. Issues of uncertainty include the right to transfer the material, the scope of research allowed, and intellectual property rights. Since suitable means of international law enforcement may not be available in the context of biobanking, collaborators are advised to clarify any residual uncertainty by means of bilateral contracts, for example, in the form of material transfer agreements. Second, biobank partners may rightly expect that the biomaterial they receive for further analysis attains a certain level of quality. This implies that a biobank has to implement stringent quality control measures covering, in addition to the material transfer itself, the whole process of material acquisition, transport, pre-analytical handling and storage. Again, it may be advisable for biobank partners to claim contractual warranties for the type and quality of the biomaterial they wish to acquire.
Article
There are currently multiple international bodies suggesting legal and ethical frameworks for regulating international biobank research. One will for obvious reasons find inconsistencies in terminology and differences in procedures suggested for biobank research among all those guidelines, emanating from many different moral and legal traditions. A central question is whether this constitutes a threat to making progress in international biobank research, as some have argued. In this book, Chapter 1 suggests that there are sufficient and well-established instruments and ethical principles available to guide research in this area. Basically I argue that there is no need for a top-down superstructure of detailed rules and guidelines to be imposed on biobank researchers. With the existing ethical review boards (ERBs) playing a central role guided by well-established ethical guidelines (e.g., the Helsinki Declaration) and solutions to specific ethical problems suggested in the literature, self-regulation by researchers providing arguments for balancing of interests in association with different research initiatives and protocols will be sufficient. Traditional information and consent procedures suffice and data protection implies a sovereign right of the individual citizen to grant the use of biobank material and personal data that is needed for biobank research. Clearly, there may still be inconsistencies in terminology when researchers of different nationalities meet in common enterprises, but both they and the ERBs are well equipped to sort out what is actually meant and propose different instruments for, for example, coding following recently established nomenclatures. The existing ERBs should play the key role, guided by the sound argumentation of the researchers in their applications to the board.