| Soto-Gómez1
|
Mexico |
2014 |
Legal hermeneutics |
To identify, analyse and compare the normative frameworks of biobanks in Mexico and the European Union. |
Mexico and the EU share an international regulation, given by rules from the UN, WHO, PAHO, WMA and CIOMS, although individual countries have harmonised their domestic systems in different ways. After analysing the cases of France, England and Mexico, it concluded that there is a lack of legal regulation in Mexico. |
| Laurence2
|
Mexico |
2018 |
Legal hermeneutics |
Gives an overview of the Oviedo Convention and presents current issues. |
This international instrument, designed to guarantee protection for human dignity and human rights within the scope of biomedicine, came into being in response to two needs: to protect people from improper use of science and to provide a common framework for protecting human rights. |
| Garza-Rodríguez et al.3
|
Mexico |
2016 |
Document review |
To determine the importance of biobanks in medical sciences. |
Identified their importance in various facets of health, such as basic and clinical research, formation of research networks and care and teaching. |
| Lee4
|
Finland |
2018 |
Document review |
To identify the types of link between biobanks and artificial intelligence as regards personalised medicine. |
The entry of AI into biobanks centres on methods of automatic learning and natural language processing techniques by extracting information from structured data, such as images, genetic data and unstructured data. In the biobanks’ processes, it acts on bioresource collection and management (criteria for specifying and measuring the quality of biospecimens). |
| Benítez-Arvizu et al.5
|
Mexico |
2014 |
Document review |
To examine trunk cell biobanks from a global perspective, emphasising the case of Mexico. |
Identified the types of trunk cell worldwide that can be stored, which facilitates their transport in biobank networks. In that connection, it emphasised the existence of international certifying authorities that standardise processes as regards their infrastructure and sample management, information and data management and legal, ethical and social concerns. |
| Bernal-Gómez and Bernal-Gómez6
|
Colombia |
2017 |
Document review |
Considers the consequences of biomedical research and biobanks from a Colombian perspective. |
In economic terms, biobanks opened up a new world market determined by the industrialisation of, and trade in, new techniques. Nonetheless, their availability depends on each country’s economic development, leading to industrial, IT and biotechnological dependence for the poorer countries. |
| Instituto de Salud Carlos III7
|
Spain |
2007 |
Document review |
To provide recommendations on biobanks to encourage responsible deliberation. |
Drawing on the experience of biobanks in Spain and Italy, the working group proposed 19 recommendations addressing organisation, degree of specimen identification, management guarantees, consent, right to know and not to know, consent, specimen harvesting in the deceased, management of pre-existing biospecimen collections, title and commercialisation and payback benefiting the community. |
| Chen and Pang8
|
WHO |
2015 |
Document review |
To identify the ethical, social and legal problems connected with biobanks’ cross-border activities. |
Identified practices, differentiated by countries’ incomes, as regards the number of biobanks, experience and normative frameworks. Cross-border issues involving Latin America and Asia included inadequate participant protection, unfair distribution of risks and benefits, biopiracy, lack of direct benefits to individuals or communities, reported benefits to only the authors or research centres, i.e., financial benefits, personal recognition, commercialisation of products by patenting. These were found to lead to relations of exploitation and mistrust. |
| Marodin et al.9
|
PAHO |
2012 |
Document review |
To set out and problematise Brazil’s legal frameworks for biobanks and biorepositories, and to examine their ethical and operational consequences. |
The difference between a biobank and a biorepository is that the former is an institutional installation for the systematic collection of biological material with a view to various future studies, while a biorepository is designed for the collection of biological material for some specific current investigation. That difference entails, in turn, different ethical and operational treatments. |
| Luna-González et al.10
|
Spain |
2016 |
Document review |
To identify the data harmonisation and standardisation challenges facing biobanks. |
There were two main challenges: linkage among networks of biobanks, because the harmonisation and standardisation reported was at only the regional or State level (BBMRIERIC in Europe, BBRB and CAP in the USA and Canada and CCB in England), and improving interoperability of biodata in order to develop robust, flexible and secure bioinformatics platforms and to foster socialisation of the related knowledge. |
| Mendy et al.11
|
WHO-IARC |
2017 |
Document review |
To establish a series of guidelines and recommendations for biobanks from a study of validated, evidence-based guidelines. |
Guidelines and recommendations for biobanks are designed to increase their interoperability and foster open access to samples and data. The guidelines cover: a) ethical, legal and social issues and governance structures, b) informed consent, c) data privacy and protection, d) feedback of findings, e) sharing of data and samples, f) creation of biobanks, g) informatics system, h) disaster recovery plan and i) record management system. |
| Martínez et al.12
|
Colombia |
2012 |
Document review |
To examine the most important aspects of the development of biobanks in Colombia. |
After examining the composition of biobanks, sample storage procedures and regulations on sample conservation, there was found to be a need to introduce an international regulatory framework in order to homogenise practices and boost development. |
| Capron et al.13
|
USA |
2009 |
Interviewed 42 experts in an international cohort. |
To conduct an international study of ethical standards and international governance of genetic data bases. |
The findings were: a) views on ownership of genetic samples and data were divergent and confused as to the interests and objectives of “ownership”; b) multilateral trade agreements were generally regarded as an effective vehicle for ensuring responsible management of samples and data; and c) the experts’ views differed on how to assure respect for groups’ interests. |
| Brena-Sesma14
|
Mexico |
2010 |
Document review |
To set out the overall ethical and legal panorama of biobanks of human biological material destined for research. |
Legislation is sparse in some Latin American countries, contains legal gaps and needs to be harmonised with international instruments. The study suggested strengthening the functions of research ethics committees, because when they fulfil their duties they prevent data bases’ being formed on commercial criteria and establish measures for redistributing individual and collective benefits. |
| Marodin et al.15
|
Brazil |
2013 |
Document review by interdisciplinary group. |
To describe the relationship between democracy and biobanks in Brazil. |
Concluded that the dynamics of science modifies social paradigms and, as a consequence, social group morals shape ethical precepts and regulatory frameworks. It highlights Brazil’s role in Latin America as regards normative regulation of biobanks. |
| Gottweis and Lauss16
|
Germany |
2012 |
Document review |
To compare biobank governance structures and present a participatory governance structure. |
Biobank governance is a mosaic strategy for organising a network of field interactions (scientific-technological, medical-health, industrial-economic, legal-ethical and socio-political). The funding models were: entrepreneurial, biosocial and public. The study suggested a network of participants that is open and not designed top-down, so as to assure participation by all of society, which does not entail democratising the process, but rather developing plural, inclusive political structures. |
| Paskal et al.17
|
Netherlands |
2018 |
Comprehensive review |
To describe and classify biobanks, standard operating systems, informatics systems and ethical and legal dilemmas. |
Described and proposed a classification of: biobanks; standard operating systems (SOPs); and informatics systems. Divided the ethical and legal dilemmas into relating to ownership, limitations in informed consent, sample storage, protection of privacy and anonymity, accessibility and the function of the knowledge produced. |
| Serrano-Díaz et al.18
|
Colombia |
2016 |
Document review |
To conduct a critical review of biobanks and of the protocols and rules of the Cardiecol Programme. |
Offered two classifications of biobanks, by purpose and scope. The critical analysis of international protocols and standards highlighted how biobanks influence both translational research and the application of scientific and technological advances in innovation. |
| Milanovic et al.19
|
Great Britain |
2018 |
Document review |
To explore how biobanks of human biological material reconfigure human life and socialisation. |
Biobanks are spaces where the links between life and technical processes are restructured, because they introduce a new signification of living beings guided by utilitarian and aesthetic criteria, erasing the ontological distinction between living being and artefact. This has led to the emergence of bio-artefacts defined by the triangulation among three types of process: life, technical and social. Social processes have made it possible to set up power institutions and new relations of bio-socialisation and bio-capital. |
| Ommen et al.20
|
Great Britain |
2015 |
Document review |
To describe the fundaments of Expert Centres and illustrate the new operating model with examples. |
Expert Centres are grounded in public-private (replacing academic-industrial) participation and in the international standardisation of biological sample analysis. The rationale for their creation rests is twofold: access to and availability of data and availability of samples to industry. Both reasons derive from biobanks’ economic success in the biotechnology industry, the market for pharmaceuticals and biomarkers, and in the diagnostics industry market. |
| Godard et al.21
|
Great Britain |
2003 |
Interviews of 50 experts from 12 countries and consensus-building workshop |
To examine the social, ethical and legal problems of biobanks of human DNA for biomedical research. |
It is a consensus that consent is required for later use of identifiable samples. Nonetheless, there is disagreement as to what consent is required when samples are anonymised for retrospective or prospective studies, because of the ambiguities in: type of sample and control of, and authorisation for, access to and sharing of samples. They stressed that, in biomedical research today, samples and data are not freely transferred. To solve that, they identified a need for an organisation to take the lead internationally. |
| Bryzgalina et al.22
|
Great Britain |
2017 |
Document review |
To examine and think about the consequences and problems posed by biobanks as politico-scientific institutions. |
In relation to the biobank industry, it is possible to speak of the development of new kinds of strategy designed to "invade" the individuality of the human body to generate more efficient performance. In that regard, biobanks are biomedical-social-political technologies, political institutions with divergent (scientific, economic, ethical, legal, social, anthropological and other) components. The risks associated with biobanks are: eugenic (“healthy and happy body”) projects and a naturalisation of social inequality. |
| Villarroel23
|
Chile |
2013 |
Document review |
To examine the ethical difficulties of biobanks in view of Michel Foucault’s “biopolitics”. |
Studied from the philosophical perspective of Michel Foucault, biobanks reveal the linkages among science, power and capital, where scientific knowledge is also an economic value that deploys a logic of power through an instrumental rationality. From this perspective, biobanks serve as instrumental technical tools that extract information from human beings on their biological, social and symbolic existence. The study proposed drafting broad legislation as a solution. |
| De Souza and Greenspan24
|
Great Britain |
2013 |
Systematic review |
To discuss and characterise the history of biobanks. |
Considering the taxonomy of biobanks, the study identified their complexity and the following evolution: a) an early stage dating over 100 years during which samples were conserved for specific studies; b) a second stage moving to larger scale involving technological advances; c) a third stage characterised by biorepositories; and d) a fourth stage involving the emergence of virtual biobanks. |
| Domaradzki and Pawlikowski25
|
Switzerland |
2019 |
Systematic review |
To provide an overview of existing research into social attitudes to biobanks. |
Identified a generalised lack of information about biobanks, although there was also a willingness to donate, determined especially by knowledge about biobanks, the type of tissue donated, the purpose of the research, data security concerns, the preferred type of consent and trust in biobanks. |
| Kinkorová and Topolčan26
|
Switzerland |
2018 |
Systematic review |
To identify the social challenges and projects connected with biobanks in Horizon 2020. |
Identified the main challenges in 2020: health, demographic change, wellbeing, food security, sustainable agriculture, marine and maritime research, bioeconomy, climate action and efficiency in resources and raw materials. To tackle these challenges as regards biobanks, they recommended: a multidisciplinary approach, international collaboration and education and research programmes. |
| Nemogá-Soto27
|
Colombia |
2012 |
Document review |
To examine protection for individual and collective rights in Colombia with the establishment of human genetic biobanks. |
No appropriate framework has been put in place to regulate constitutional guarantees for individual and collective human rights. This makes authors more likely to participate irregularly in international projects as simple providers of biological samples and related data. For research in indigenous communities or groups, in addition to free and informed consent, there should be prior consultations based on the culture and cultural context. |
| Domaradzki28
|
Poland |
2019 |
Document review |
To set out and examine the concept of geneticisation and related social problems. |
Geneticisation is an excessive generalisation of genetics-related ways of thinking, which can be subdivided into: genetic reductionism, genetic determinism, genetic essentialism and genetic fatalism. The related social problems are: creation of a single genotype, geneticisation of diagnosis, risk of genetic discrimination, commercialisation of genetics and genetic patenting. |
| Hamilton29
|
Great Britain |
2008 |
Document review |
To examine biopiracy and its relation to intellectual property rights and the bioeconomy. |
The components of biopiracy are: cultural knowledge, intellectual property rights and genetic resources. Biopiracy entails a semantic and conceptual combination that resignifies the relation between Nature (genetic resource) and Culture (traditional knowledge). Two trends are identified: when the interpretation leans towards Nature, the debate is between discovery and invention, while when it inclines towards Culture, the debate is about ownership. |
| Brochhausen et al.30
|
Great Britain |
2019 |
Founding open biological and biomedical ontologies. |
To develop an ontology of biobanks that extends data integration so as to permit data analysis and sample sharing. |
Fostering semantic data integration for the greatest possible number of users and consumers is connected with the possible merging of two or more ontologies. The study showed that it is possible to merge two ontologies - OMIABIS and BO - because both are based on the principles of the Open Biological and Biomedical Ontologies (OBO) Foundry, they share a common design methodology and they extend the same Upper Ontology and Reference Ontology. |
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Source: Elaborated by the authors.
Source: Elaborated by the authors.