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Background: The emergence of "multi-omics" and "multi-parametric" types of analysis based on a high number of biospecimens enforces the use of a great number of high-quality "Biological Materials and Associated Data" (BMaD). To meet the demands of biomedical research, several Biological Resource Centers (BRCs) or Biobanks world-wide have implemented a specific Quality Management System (QMS) certified ISO 9001:2015 or accredited by CAP9 ISO 20387:2018. For the first time, ISO, with the support of several Biobanking experts, issued the ISO 20387:2018 which is the first ISO norm specific for Biobanks. The fundamental difference with present certification/accreditation standards is that the ISO 20387:2018 focuses not only on the operational aspects of the Biobank, but also on the "competence of the Biobank to carry our specific Biobanking tasks". Methods: The accreditation process for ISO 20387:2018 required the definition of: (1) objectives, goals and organizational structure of the Biobank, including procedures for governance, confidentiality and impartiality policies; (2) standard operating procedures (SOPs) of all activities performed, including acquisition, analysis, collection, data management, distribution, preparation, preservation, testing facility and equipment maintenance, calibration, and monitoring; (3) procedures for control of documents and records, the identification of risks and opportunities, improvements, corrective actions, nonconforming records and evaluation of external providers (4) an internal audit and management reviews, verification of QMS performance, monitoring of quality objectives and personnel qualification and competency in carrying out specific Biobanking tasks. Results: The accreditation process is performed by an independent authorized organization which certifies that all processes are performed according to the QMS, and that the infrastructure is engineered and managed according to the GDP and/or GMP guidelines. Conclusion: Accreditation is given by an accreditation body, which recognizes formally that the Biobank is "competent to carry out specific Biobanking tasks". [ABSTRACT FROM AUTHOR]

Biobanks emerged in the early 2000s, and now facilitate scientific research through the provision of resources for research that requires a large scale of biospecimens and data. Biobank projects have also become intertwined with complicated socio-economic initiatives to boost economic development or to shape community identity. While legislators continue to debate the ethical and regulatory challenges associated with biobanks, the federal regulation over research involving human subjects, the Common Rule, is based on a traditional research model that fails to address the complex challenges unique to biobanking. Through an examination of the proposed revisions to the Common Rule concerning research using biospecimens and ethical controversies regarding informed consent, privacy, ownership and benefit-sharing, this article highlights a participatory aspect of biobanking that calls for public engagement with respect to both ethics and norms. Many biobank projects try to appeal to a sense of civic engagement whereby citizens have rights as well as responsibilities with respect to participation in collaborative scientific projects. Domestic and international guidelines describe incorporating public engagement with biobanking as an essential means of protecting research participants and achieving good governance. International experiences with various approaches of public engagement have also proven that involving the general public is feasible. Moreover, the principle of democratic deliberation, which was proposed by the Presidential Commission for the Studies of Bioethical Issues to be aguiding principle for bioethics policy decisions, further underscores the criticality of public engagement in biobanking. [ABSTRACT FROM AUTHOR]

The article provides a comprehensive comparison between concurrent offset schemes in New South Wales (NSW), Australia: the biobanking scheme and the negotiation of offsets within the traditional development control and planning system. In an attempt to improve the protection of biodiversity values in NSW, the Parliament adopted in 2006 an offset scheme (biobanking) that aims to better integrate biodiversity values into development projects. Rather than making it mandatory, the scheme works in parallel with the existing negotiation of biodiversity offsets under the traditional assessment and approval process. As the biobanking scheme is voluntary, its effectiveness depends in part on its attractiveness as compared with the alternative route. While the article helps to better understand how the biobanking scheme operates in theory and in practice, its teachings are particularly useful in the European Union context, with the European Commission currently developing a no net loss policy (action 7b of the 2020 Biodiversity Strategy) and several Member States adopting habitat banking and offset policies. The NSW experience highlights the importance of carefully integrating banking and offset schemes within the existing legal framework for assessing and approving impacts on biodiversity. It also highlights the need to establish common decision-making and offset standards applicable to all developers, whether they compensate on a case-by-case basis or through the use of biodiversity credits. [ABSTRACT FROM AUTHOR]

The article discusses the South Korean government's regulation of biobanks through the country's 2005 Bioethics and Biosafety Act, including its initial impact on limiting genetic testing. The role that the aforementioned law plays in protecting human research subjects is discussed. The law's requirement that research organizations have institutional review boards (IRBs), including their role in validating informed consent, is also discussed.

The article provides a comparative analysis of the biobanking and privacy laws of 20 countries as of 2016, and it mentions the ethical aspects of biobanking, as well as information about a European Union (EU)-U.S. Safe Harbor agreement. The Human Genome Project is addressed, along with the legal aspects of research involving human subjects, data security, and human biological materials. Autonomy and self-determination are examined, along with biobank research ethics.

The article discusses various aspects of the biobanking industry in Great Britain as of 2016, and it mentions the healthcare that is provided by the British National Health Service, as well as the efforts to link health data to genomic and biomedical research. The UK Biobank Ltd. population research entity is examined, along with the legal aspects of biobanks and privacy rights in Great Britain. European Union regulations and laws are assessed, along with the British Data Protection Act.

The article discusses the legal aspects of biobanking, privacy rights, and the regulation of biomedical research in the U.S. as of 2016, and it mentions the guidelines for sharing biological samples and health information in America. Technological innovations are addressed in relation to the creation and storage of personal- and health-related data. The internal governance of biobanks is examined, along with informed consent and confidentiality and human subjects protections.

The article discusses the European Union's (EU's) laws regarding privacy rights involving genomic databases and biobanking as of 2016, and it mentions the efforts to harmonize the laws of EU Member States in order to create a single market. The Council of Europe is addressed, along with human rights, democracy, and the rule of law in the EU. Law reform efforts in the EU are examined, as well as informed consent, data protection laws, and legal judgments by EU courts.

The article discusses the legal aspects of the regulation of privacy rights and biobanks in the Netherlands as of 2016, and it mentions the country's Authority over Bodily Material Act, human rights protections, and the laws governing research involving human biological materials and personal data. The Dutch health care system is examined, along with the Netherlands' constitutional monarchy form of government and the nation's Constitution. Scientific progress-related rights are assessed.

The article discusses various aspects of the legal regulation of biobanks in Mexico as of 2016, and it mentions the country's population, political system, and Mexico's General Health Law which governs health research in the nation. Problems with Mexico's National Health System are addressed, along with legal protections for genomic databases and regulations regarding the sanitary disposal of human organs, tissues, and corpses. The ethical aspects of biomedical research are also assessed.

The article discusses the legal aspects of biobanking and a right to privacy in India, and it mentions the globalization of science and technology, as well as India's regulation and governance of biomedical research. Emerging technologies are addressed, along with ethical conflicts involving research and development (R&D) and clinical trials. Millennium Development Goals (MDGs) are examined, along with the Indian Council for Medical Research and health research, and non-communicable diseases.

The article discusses the relationships between privacy and biobanking laws in the Federal Republic of Germany (Germany) as of 2016, and it mentions the German health and biomedical research systems, as well as the doctrine of informational self determination and judgments issued by the German Constitutional Court. German constitutional rights are assessed, as well as human rights and Germany's parliamentary democracy form of government. Germany's Biobank Act is also examined.

The article discusses the legal aspects of biobanking in Finland as of 2016, and it mentions Finnish growth and genomic strategies, as well as the efforts to balance privacy rights and innovation. An independent parliamentary democracy in Finland is examined, along with the country's health care system, a Nordic Welfare State, and Finland's cultural, economic, and political research environment. Finland's Biobank Act and Personal Data Act are examined, along with genomic research laws.

The article discusses various aspects of the biobanking industry in the Republic of Estonia (Estonia) as of 2016, and it mentions the Estonian Genome Center (EGCUT) biobank and the efforts to collect data on the Estonian population. Estonia's democratic, parliamentary republic form of government is examined, along with information about the Constitution of Estonia, the country's health care system, and the legal aspects of biobanking. Informed consent and privacy rights are assessed.

The article discusses the right to privacy in Canada in relation to the legal aspects of the country's biobanking industry as of 2016, and it mentions fundamental legal rights and the nation's Health Canada federal government agency which is responsible for national public health in Canada. The Canadian Charter of Rights and Freedoms is examined, as well as Canadian common law and various criminal law-related litigation matters. The constitutional laws in Canada are also assessed.

The nature of the relationship between the donor and donee within a biobanking framework is complex and dynamic. Issues such as ownership, rights and benefits often influence outcomes and access for researchers. In New Zealand, a raft of soft and hard law measures exist unconvincingly to govern this relationship. This article examines the current legislative provisions in New Zealand and explores possible avenues such as dynamic and broad consent, equity and contract that may provide a more appropriate framework for biobanking donors and donees. [ABSTRACT FROM AUTHOR]

Nigeria's commitment to genomic research and biobanking is beyond dispute. Proof, if there is need for one, is that the country is one of only six nations (others are Canada, China, Japan, the United Kingdom, and the United States) involved in the International HapMap Project. The HapMap Project is an innovative enterprise aimed at developing a haplotype map of the human genome, a tool that is helpful to studying the genetic basis of disease as well as the genetic or hereditary factors that contribute to variation in response to environmental factors, in susceptibility to infection, and in the effectiveness of, and adverse responses to, drugs and vaccines. In addition, the country is home to H3Africa biobank (with 45, 358 human samples in storage), affiliated with the Institute of Human Virology of Nigeria (IHVN), and several others. Benefits accruing from genomic research and biobanking are enormous; so also is protection of research subjects. The protection envisaged centers primarily on, inter alia, securing informed consent, safeguarding privacy and maintaining confidentiality of health information - all of which are enshrined in ethicolegal regimes in Nigeria. But whether these frameworks are consistent with international best practices is not at all clear, hence the need for this paper. [ABSTRACT FROM AUTHOR]

The availability of biological samples and data is critical for the establishment of biobanks for health research purposes. Such availability should be ensured in accordance with relevant national legislation and ethical principles. In this article, we consider the extent to which the current legal and ethical regulatory frameworks in South Africa are capable of governing the use of stored biological samples in a manner that facilitates health research while at the same time protecting the interests of sample donors. These two attributes are essential for establishing biobanks in the country. Our evaluation of the frameworks is based on desk review of the current literature with a special focus on oversight mechanisms in place that ensure compliance with national legislation and ethical review processes to facilitate future and secondary uses of data, the extent to which informed consent policies foster sharing of research samples, data and protocols as well as mechanisms for safeguarding confidentiality. We established that there is an urgent need to streamline South Africa's legal and ethical frameworks because they are currently ambiguous and disjointed. There is equally a need to bring the frameworks in line with the current developments at the national and international levels. [ABSTRACT FROM AUTHOR]

The Spanish legal framework for the processing of samples and data with biomedical research purposes has sought to encourage scientific research, protect the right to freedom of research, and guarantee the interests of donors. The pillars of this legal framework are firstly, the duty to inform the donor in order to ensure that he or she is aware of the importance and the consequences of the donation; secondly, the control by ethics committees (RECs and External Ethics Committees of biobanks); and third, the supplementary application of the general rules on data protection. There are three different possibilities for processing samples (project, collection, and biobanks) - each one reinforcing specific consent or requiring other added guarantees. This system, which is applied consistently in the entire national territory, is producing very satisfactory results. However, there are some issues that need further policies or legal development, as the specific conditions and procedures for the international transfer of samples and data with research purposes. [ABSTRACT FROM AUTHOR]

This paper introduces legal framework and governance structure in relation to the management and development of biobanks in Taiwan. At first, we briefly describe Taiwan's population, political system and health care system. Secondly, this research introduces biobanking framework of Taiwan including 25 biobanks established with the approval of the Ministry of Health and Welfare. In those biobanks, 'Taiwan Biobank' is the first and the largest government-supported biobank which comprises population-based cohort study and disease- oriented study. Since the collection of information, data, and biological specimen of biobanks often involve highly sensitive personal information, in the legal framework of Taiwan, there is a specific regulation, 'Human Biobank Management Act' (HBMA), which plays an important role in regulating biobanks in Taiwan. HBMA, the Personal Information Act and other regulations constitute a comprehensive legal and regulatory privacy framework of biobanks. Through the introduction and analysis of the current legal framework applicable to biobanks, we found that there are several challenges that need to be solved appropriately that involve duplicate review systems, the obstacles in the international collaboration, and data sharing between biobanks in Taiwan. [ABSTRACT FROM AUTHOR]

Biobanks are a key emerging biomedical research infrastructure. They manifest the turn towards greater global sharing of genomic and health-related data, which is considered by many to be an ethical and scientific imperative. Our collective interests lie in improving the health and welfare of individuals, communities, and populations; improving health and welfare requires access to, and use of, widely dispersed quality data. But sharing these individual and familial data requires in turn that due thought be given to the ethical and legal interests at stake. Most critically, data sharing must occur in an environment whereby privacy interests are safeguarded throughout the lifecycle of biobank initiatives, and regardless of the locations where the data are stored, to which they are sent, and where they are ultimately processed. In this article, I outline the complex dimensions of data privacy regulation that challenge data sharing within the biobanking context. I discuss how harmonization may be a remedy for the gaps and marked differences of approach in data privacy regulation. Finally, I encourage the development of foundational responsible data sharing principles set within an overarching governance framework that provides assurance that reasonable expectations of privacy will be met. [ABSTRACT FROM AUTHOR]

This article reviews international privacy norms governing human genomic biobanks and databases, and how they address issues related to consent, secondary use, de- identification, access, security, and governance. A range of international instruments were identified, varying in substance - e.g., human rights, data protection, research ethics, biobanks, and genetics - and legal character. Some norms detail processes for broad consent, namely, that even where potential participants cannot consent to specific users and uses, they should be given clear information on access policies, procedures, and governance structures. Some also give guidance about the conditions under which secondary use of data and samples without consent is appropriate, e.g., where consent is impracticable. International norms exhibit a confusing range of terminology relating to de-identification. They also continue to rely heavily on consent and anonymity as the basis for privacy protection, though governance is becoming more prominent. It may not be fatal that such a plurality of norms apply to biobanking; what is essential is that governance be built on shared values, our common interest in the success of genomic research, and practical tools that incentivize responsible, global sharing. [ABSTRACT FROM AUTHOR]

Australian biobanks are largely autonomous and funded by local health care institutions, although some biobanks also receive funding from the National Health and Medical Research Council (NHMRC). There is no formal biobank legislation, but the NHMRC has developed biobanking guidelines. The regulation of biobanks is mainly through privacy laws and human research ethics committees. Australia is moving toward the use of broad consent for biobanking. International data sharing is permitted. [ABSTRACT FROM AUTHOR]

This article analyzes the current regulatory framework for biobanking, genomic research, and protection of privacy in Brazil. It is divided in four parts. The first describes the biobanking context in Brazil and its evolution in recent years. In the second, the entire regulatory framework on biobanking and genomic research is analyzed. The third part focuses on the critical evaluation of this regulatory framework, specifically on some major ethical dilemmas in biobanking. The fourth part describes the characteristics of the Brazilian biobanking and human research governance system, known as the CEP/CONEP system. Finally, the conclusion summarizes the information in the article and its contribution to the study of the biobanking ethical challenges, especially the protection of privacy. It is highlighted that biobanking regulatory harmonization among countries is necessary, since it increases scientific possibilities that can come from broader cooperation among biobanks and several research centers on the national and international levels. [ABSTRACT FROM AUTHOR]

Disease-based biobanks have operated in hospitals and research institutes in China for decades, and China has recently embarked on a plan to establish further biobank networks with the aim of promoting data sharing among the existing biobanks. Although the Chinese Constitution has only recently begun to recognize individual privacy as a distinct and independent constitutional right, biobanking in China has been loosely regulated under a patchwork of sometimes overlapping laws (such as the Interim Measures for the Administration of Human Genetic Resources) and regulatory instruments, as well as and the policies of individual biobanks and networks of biobanks (such as the Shanghai Biobank Network Guidelines). A Draft Ordinance on Human Genetics Resources is currently being developed that will deal in more detail than previous laws with issues such as management measures, legal liability, and punishment for violations. International data sharing will be tightly regulated under this new law, and individual biobanks' policies such as the Shanghai Guidelines may choose to regulate such sharing even more. In contrast with national regulatory instruments, the Shanghai Guidelines also contain detailed de-identification policies, and explicitly endorse broad consent. [ABSTRACT FROM AUTHOR]

Biobanking in Denmark is regulated via patients' rights laws, data protection laws, and research ethics reviews. Danish law recognizes tissue samples as personal data for purposes of the data protection laws, meaning research with tissue samples may be subject to research ethics review, data protection laws, and patients' rights requirements depending on the circumstances of collection. However, research on information gained through whole genome sequencing is subject only to data protection laws, despite the similarity in the nature of the information. The regulatory framework treats biobank samples collected from patients differently than samples collected from research participants, particularly with respect to autonomy. Importantly, biobanks established for future unspecified research are not subject to research ethics review. Biobank-based research has gained more prominence on the national level recently, and the potential for a less fragmented and more consistent regulatory approach may emerge from this attention. [ABSTRACT FROM AUTHOR]

The privacy of biobank research participants in France is protected by a combination of bioethics laws, research laws, and data protection laws. Although the law has attempted to facilitate research by creating an opt-out regime for research with pre-existing samples, other aspects of the law hinder research. The requirement for multiple consents throughout the process of biobank sample collection and use, the lack of acceptance of a broad consent for biobanking, and genetic exceptionalism in the law all complicate biobank research. With IRB approval, opt-out consent may be used for genetic research using human tissue collected for other purposes, but express consent is still required for research with the associated genetic data. Among the important issues remaining to be addressed are harmonizing and simplifying the various informed consent processes. [ABSTRACT FROM AUTHOR]

Large-scale biobanks represents an important scientific and medical as well as a commercial opportunity. However, realizing these and other prospects requires social, legal, and regulatory conducive climate, as well as a capable scientific community and adequate infrastructure. Israel has been grappling with the appropriate approach to establishing such a repository, and debates over the governance, structure, finance, and mode of operation shed a bright light on the underlying social norms, civic engagement and scientific clout in steering a governmental response to pressing medical needs. The article presents the backdrop of the Israeli scene, and explores the reasons and forces at work behind the current formulation of the Israeli National Biobank, MIDGAM. [ABSTRACT FROM AUTHOR]

With the progress in bioinformatics, genomics, and epidemiology, biobanks, as repositories of populations’ biological samples as well as of personal and medical information, are becoming an essential research tool. Despite the potential benefits biobanks may bring and the options presented by some of the current biobanks’ consent policies, there remain ethical concerns regarding the autonomy and dignity of research participants if consent is not fully informed as dictated in the terms of traditional informed consent. This article aims at providing an overview of the approaches taken by the main international norms with respect to informed and broad consent and how well these norms are integrated by biobanks or biobank consortia. We conclude that broad consent could be an important tool to achieve the benefits of large-scale biobanks projects. If it is to be accepted, its regulation and implementation need to be mindful of the participant’s dignity and autonomy and sensitive to the need for international coherence and harmonization. [ABSTRACT FROM AUTHOR]

The article offers information on the European Biobank regulations that regulate issues related to biomedicine and compare them with the current South African Biobank regulatory tools. Topics discussed include biobank as a facility procuring and distributing biological materials and associated data under governance structures and procedures, two regulations in the South African Government Gazette and the European Union Tissue & Cells Directives issued under the Human Tissue Regulations 2007.

To understand the causes of disease and improve diagnosis and treatment regimes, biomedical researchers need access to large numbers of well-characterized data and samples. Over the past decade, biobanks have been established across Europe to collect and manage access to data and samples. The challenge that we face is how to develop the tools and collaborations to enable researchers to access samples and data from a network of biobanks, rather than applying to individual biobanks. One of the perceived stumbling blocks to achieving this is represented by the different legal requirements in each country. The aim of the BioSHaRE-European Union (EU) project is to address these challenges by developing tools and methods for researchers to access and use pooled data from different cohort and biobank studies. The purpose of this article is to identify and compare the key legal requirements regarding research use of data across biobanks based in Finland, Germany, the Netherlands, Norway and the UK. Our investigation starts with the analysis of the key differences for the use of data between these countries. As a result, we identified three key areas where legal requirements differ across the five BioSHaRE-EU jurisdictions, namely, in the definition of personal data, the requirements regarding pseudonymization and processing for medical research purposes. This article provides an overview of these differences and describes them in the light of the proposed EU regulation on data protection. [ABSTRACT FROM PUBLISHER]

The article examine the emergence of biobank governance in Europe and lessons that may be learned for Africa and need to enhance the research process by facilitating collaborations between researchers in Africa.

While there is widespread agreement on the broad aspects of what constitutes a biobank, there is much disagreement regarding the precise definition. This research aimed to describe and analyze the definitions of the term biobank offered by various stakeholders in biobanking. Interviews were conducted with 36 biobanking stakeholders with international experience currently working in Switzerland. The results show that, in addition to the core concepts of biological samples and linked data, the planned use of samples (including sharing) is held to be a key criterion. It also emerges that some researchers avoid the term in order to circumvent certain regulatory guidelines, including informed consent requirements. Developments in the field of biobanking will be complicated if researchers are unaware, or deny that their collection is a biobank. A clear definition of the term is therefore an important step towards fostering collaboration amongst researchers, enabling them to more easily identify potential sources of samples. [ABSTRACT FROM AUTHOR]

The article discusses the principle of autonomy in relation to a physician's duty to inform, the legal aspects of population biobanks, and information sharing in Canada as of 2014. Patients' legal protections are addressed, along with disclosure of information laws and medical decision making. Other topics include Canadian courts, medical consent, and various legal proceedings which deal with a duty to inform in non-therapeutic research cases. Human genome sequencing is also assessed.

The article focuses on the biobanking of blood and bone marrow in Australia. Topics include the challenges faced by custodians of public resources, the Australian Bone Marrow Donor Registry (ABMDR), the use of biospeciment repositories for medical research, and their right to share information with other biobanks for research purposes.

Finland has enacted a Biobank Act that will come into force on 1 September 2013. Finland is regarded as a highly successful environment for medical research using population samples and data for many reasons. One of the rationales behind the new legislation was to solve the problems due to the overly strict informed consent doctrine hindering access to old samples and data and asking for multi-purpose consents. Yet although consent is the primary justification to use biobank samples and data, the Biobank Act allows asking for a consent for several unspecified future research purposes. The guiding principles of the Biobank Act are promotion of trust, equal access to data and samples, protection of privacy, acceleration of innovation activities, and bringing biobank activities under public scrutiny. To the author's knowledge, this is the first "all purpose" Biobank Act in Europe applied to all biobanks in one country. [ABSTRACT FROM AUTHOR]

The article provides analysis on the Italian legal framework in the international and European law context with regard to several topics. One topics discusssed is the juridical nature of human tissue sample and the distinction betwen biological materials and personal data about health and generation information. Another are the property right and the right to privacy and the ownership of human tissue sample and data unavailability.

Complex problems and emerging technologies challenge the public health system and create both opportunities and risks for population health. Risk governance is an appropriate tool with which public health practitioners can maximize benefit and minimize risk to the public's health. To date, there is no risk governance framework that is robust, rigorous, and applicable to population health. This article first explores existing risk governance frameworks and discusses their potential applicability to population health challenges. It then explains specifically how biobanks, which have great potential to improve the population's health, but threaten individual interests, could benefit from the application of a risk governance framework. [ABSTRACT FROM AUTHOR]

Bioethics in global biobanking touches upon several internationally accepted fundamental rights and values, namely the sample donor's right of privacy, the patient's right to health, and - at least implicitly - scientific freedom. From the perspective of fundamental rights, however, there are very few internationally applicable rules as to the enforcement of these rights at the administrative level. Instead, the combination of the practical need for common rules and the lack of political will and/or legislative competence within the international community or the European Union (EU) seems to have paved the way for soft law. Further, the role of courts in the area of bioethics and biobanking, nationally as well as internationally, is limited. The implementation of administrative rules at the national or regional levels is carried out by research committees and research funding institutions, usually with limited or no right to appeal to the general court system. Consequently, the traditional mechanisms of political and judicial control to a large extent are unavailable. The question raised here is whether the theories connected to global administrative law can be of any guidance in developing a legitimate regulatory regime for international biobanking. Can principles of participation, transparency, and reasoned decisions be of relevance in this area of law? [ABSTRACT FROM AUTHOR]

New opportunities for large-scale data linkage and data-mining have rendered biobanks one of the core resources of medical research in the twenty-first century. At the same time, research biobanking has been seen to pose particular ethical and legal challenges pertaining to, for example, data protection, and the minimisation of other risks for participants. These measures have in turn led to heavy administrative, logistical, and financial costs and attracted criticism for unduly impeding disease research. Based on a newly formulated approach to solidarity, we propose an approach to governance that recognises people's willingness to participate in a public research biobank, and poses stronger emphasis on harm mitigation. We argue that such a model avoids some of the pitfalls of previous approaches. It also allows moving beyond overly restrictive and burdensome, exclusively autonomy-based governance towards governance that is reflective of people's willingness to accept costs to assist others. [ABSTRACT FROM AUTHOR]

The article discusses a right to privacy in relation to Canadian paediatric biobanks, and it mentions the legal efforts to control access to and the use of personal information. Privacy legislation and policies are addressed, along with legislative reform and the Supreme Court of Canada's definition of information privacy. Public trust and the legal aspects of third parties are examined, along with the use and transfer of a child's data and the Canadian Charter of Rights and Freedoms.

An essay is presented on biobanks and their impact on tissue donation, public health, and personalized medicine as of September 2012. An increase in government investments in biobanks is noted, especially from countries such as the U.S. Several lawsuits involving biobanks and human tissue are also mentioned, including Moore v. Regents of the University of California and Greenberg v. Miami Children's Hospital Research Institute, Inc.

According to estimates more than 400 biobanks currently operate across Europe. The term 'biobank' indicates a specific field of genetic study that has quietly developed without any significant critical reflection across European societies. Although scientists now routinely use this phrase, the wider public is still confused when the word 'bank' is being connected with the collection of their biological samples. There is a striking lack of knowledge of this field. In the recent Eurobarometer survey it was demonstrated that even in 2010 two-thirds of the respondents had never even heard about biobanks. The term gives the impression that a systematic collection of biological samples can constitute a 'bank' of considerable financial worth, where the biological samples, which are insignificant in isolation but are valuable as a collection, can be preserved, analysed and put to 'profitable use'. By studying the practices of the numerous already existing biobanks, the authors address the following questions: to what extent does the term 'biobank' reflect the normative concept of using biological samples for the purposes of biomedical research? Furthermore, is it in harmony with the so far agreed legal -- ethical consensus in Europe or does it deliberately pull science to the territory of a new, ambiguous commercial field? In other words, do biobanks constitute a medico-legal fiction or are they substantively different from other biomedical research protocols on human tissues? [ABSTRACT FROM AUTHOR]

This paper examines, from an Australian and international perspective, the phenomenon of population ‘biobanks’ (research platforms comprising collections of human genetic samples or ‘biospecimens’ and relevant personal information) and the legal challenges that this development presents. In particular, the paper focuses on the legal concept of consent and the tensions on the traditional understanding of consent that large-scale, long-term population biobanks exert. The aim of the paper is to review the operation of consent principles as they apply to population biobanks and to propose a way forward for how the consent concept can be reconceptualised to meet their demands. In particular, the paper argues for a more liberal approach which allows for ‘broad’ (or ‘enlarged’ or ‘open’) consent in circumstances where permission is sought for future use of samples in, as yet unspecified, genetic research. In pursuing this aim, the objectives underlying this paper are to ensure that unnecessary impediments to research are removed and, at the same time, to facilitate research participation and respect for autonomous choices by research subjects. [ABSTRACT FROM AUTHOR]

This article focuses on the Human Biobank Management Act of 2010, a Taiwanese law regarding community benefit-sharing. Topics covered include Article 21, Paragraph 1 of the Act on benefit-sharing for the commercial use of human biobanks, the statement on benefit-sharing by the Human Genome Organization, and the adoption of such statement by the United Nations Educational, Scientific and Cultural Organization (UNESCO). Also mentioned is UNESCO's International Declaration on Human Genetic Data.

The article examines two cases of violation of research ethics and the protection of group interest in Taiwan in light of the passage of the country's Human Biobank Management Act. It cites the 2007 collection of saliva samples from some Kebalan people without complete disclosure of the research use's purpose and the 2010 patenting of research outcome without prior consent from the Tayal tribe. It also discusses the principle of informed consent and the definition of group and group consent.

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The use of tissue samples from children is vital to genetic research. Collections of such tissue, in so-called biobanks, can take the form of large-scale prospective cohort studies or disease-specific studies using tissue of children with that specific disease. Collections of samples gathered in a diagnostics context, such as blood spot cards, can also be used for genetic research. Research on stored tissue samples from children poses ethical questions that are different from those posed by the use of samples from adults. Also, the ethical questions raised by the participation of children in biobanks are not analogous to those raised by the participation of children in clinical trials. In this review we first give an overview of the international ethical guidelines and legal regulations concerning biobanking and minors. Next, we review the different themes that occur in the ethical literature on this subject. Specifically we focus on questions of risk and benefit, consent and assent and the return of individual results. We also discuss the concept of solidarity, which is a relatively new concept in the context of children and biomedical research. To conclude, we discuss the gaps and questions raised by the review. [ABSTRACT FROM AUTHOR]

Although a few jurisdictions around the world have legislated in response to the phenomenon of biobanking, the far more common response has been policy led with funders and other stakeholders initiating multi-level policy initiatives to guide biobanking practice. An example of this is UK Biobank which has developed and operates according to an Ethics and Governance Framework. Such an instrument has no basis in law and yet it has played a crucial role in the set up and ongoing management of the resource. It will continue to do so, as related policies emerge, such as access and intellectual property policies. Numerous biobanking initiatives have similar high-level policy documents that guide decisions and practice. These are often framed as a commitment to participants, researchers and society more broadly and invoke notions such as the public good and the public interest. As such, they serve as a benchmark against which to measure a biobank's performance. Moreover, policies become an important means by which biobankers are held accountable. This article critically analyses this policy-driven phenomenon asking how effectively policy-often as an alternative to law-serves to police and to promote biobanking. It argues that a policy of reflexive governance-defined and developed herein-can best meet the challenges faced by many biobanks and without the need for recourse to law. [ABSTRACT FROM AUTHOR]

Genetic research gained new momentum with the completion of the Human Genome Project in 2003. Formerly centered on the investigation of single-gene disorders, genetic research is increasingly targeting common complex diseases and in doing so is studying the whole genome, the environment and its impact on genomic variation. Consequently, biobanking initiatives have emerged around the world as a tool to sustain such progress. Whether they are small scale or longitudinal, public or private, commercial or non-commercial, biobanks should consider the possibility of closure. Interestingly, while raising important ethical issues, this topic has hardly been explored in the literature. Indeed, ethical issues associated with sale, insolvency, end of funding, or transfer of materials to other entities (which are all issues either related to or possible consequences of closure) are seldom the subject of discussion. In an attempt to fill this gap, this paper will discuss-using population and direct-to-consumer (DTC) genetic testing companies' biobanks as case studies-(1) international and national normative documents addressing the issue of closure and (2) the internal policies of population biobanks and DTC genetic testing companies. The analysis will inform the debate on biobank closure and elucidate the underlying ethical issues, which include, but are not limited to informed consent, storage and privacy. [ABSTRACT FROM AUTHOR]