Abstract

Biobanks are multidisciplinary infrastructures and, accordingly, this integrative research seeks to bring out the concept of biobank in the various sciences that construct and interpret it, so as to arrive at a holistic understanding of its essential components. This integrative review - guided by PRISMA and with quality assessment following CASPe - resulted in a selection of 30 articles. Data were analysed by Aristotelian categories and the results were interpreted on the complexity paradigm of Edgar Morin. The biobank concept was clarified by considering it to be the representation of a biological, social and cultural phenomenon in which knowledge and practices from diverse scientific fields enter into complementary, antagonistic and ambiguous types of relationship. This network of signification, analysed here using categories from Aristotelian philosophy, has impacts on the construction of subjectivity and forms of socialisation.

Key words:
Multidisciplinary research; Genbank; Genetic databases; Bank; Biological sample

Introduction

Biobanks are infrastructure designed for the collection, recording and storage of human and non-human biological samples together with the related data¹1 Soto-Gómez L. Regulating Mexican Biobanks for Human Biomedical Research: What can be Learned from the European Experience? Mex Law Rev 2014; 7(1):31-55.

2 Laurence L. Convention on Human Rights and Biomedicine: The Oviedo Convention. In: Brena IS, Ruíz de Chávez MH, coordinadores. Bioética y derechos humanos. México: IIJ-UNAM; 2018.

3 Garza-Rodríguez ML, Pérez-Maya AA, Monsivais-Ovalle DE, Velázquez-Vadillo JF, Barrera-Saldaña, HA. El Biobanco Institucional como pilar de las ciencias médicas. Salud Publica Mex 2016; 58(4):483-489.

4 Lee J. Artificial Intelligence in the Future Biobanking: Current Issues in the Biobank and Future Possibilities of Artificial Intelligence. Biomed J Sci Tech Res 2018; 7(3):5937-5939.

5 Benítez-Arvizu G, Palma-Lara I, Alcántara-Quintana L. Biobancos de células troncales para terapia celular. Una realidad en México. Rev Med Inst Mex Seguro Soc 2014; 52(3):244-247.

6 Bernal-Gómez BM, Bernal-Gómez DR. Investigación Biomédica y Biobancos: Una Reflexión para su Implementación. Principia Iuris 2018; 16(29):128-143.

7 Instituto de Salud Carlos III, Comité de Ética del Instituto de Investigación de Enfermedades Raras (IIER). Recomendaciones sobre los aspectos éticos de las colecciones de muestras y bancos de materiales humanos con fines de investigación biomédica. Rev Esp Salud Publica 2007; 81(2):95-111.

8 Chen H, Pang T. A call for global governance of biobanks. Bull WHO 2015; 93(2):113-117.

9 Marodin G, França P, Rocha JCC, Campos AH. Biobanking for health research in Brazil: Present challenges and future directions. Rev Panam Salud Publica 2012; 31(6):523-528.

10 Luna-González ML, Guío-Mahecha E, Becerra-Bayona S, Serrano-Díaz N. La gestión de los datos, un proceso esencial para el desarrollo del Biobanco. Rev Univ Ind Santander Salud 2016; 48(4):548-553.

11 Mendy M, Caboux E, Lawlor RT, Wright J, Wild CP. Common mínimum technical standards and protocols for biobanks dedicated to cancer research. Lyon: Int Agency Res Cancer; 2017.

12 Martínez JC, Briceño I, Alejandra H, Gómez A. Biobancos. Una estrategia inteligente y esencial para la conservación de muestras biológicas. Acta Med Colomb 2012; 37(3):158-162.

13 Capron AM, Mauron A, Elger BS, Boggio A, Ganguli-Mitra A, Biller-Andorno N. Ethical norms and the international governance of genetic databases and biobanks: findings from an international study. Kennedy Inst Ethics J 2009; 19(2):101-124.

14 Brena-Sesma I. Biobancos, un asunto pendiente de legislar. Bol Mex Der Comp 2010; 43(129):1055-1079.

15 Marodin G, Salgueiro JB, Motta ML. Pacheco-Santos LM. Brazilian guidelines for biorepositories and biobanks of human biological material. Rev Assoc Med Bras 2013; 59(1):72-77.

16 Gottweis H, Lauss G. Biobank governance: heterogeneous models of ordering and democratization. J Community Genet 2012; 3(2):61-72.

17 Paskal W, Paskal AM, Debski T, Gryziak M, Jaworowski J. Aspects of Modern Biobank Activity - Comprehensive Review. Pathol Oncol Res. 2018; 24(4):771-785.

18 Serrano-Díaz N, Páez-Leal MC, Luna-González ML, Guío-Mahecha E. Biobanco: Herramienta fundamental para la investigación biomédica actual. Rev Univ Ind Santander Salud 2016; 48(2):97-117.

19 Milanovic F, Merleau-Ponty N, Pitrou P. Biobanks and the reconfiguration of the living. New Genetics Soc 2018; 37(4):285-295.

20 Ommen GV, Törnwall O, Bréchot C, Dagher G, Galli J, Hveem K, Landegren U, Luchinat C, Metspalu A, Nilsson C, Solesvik OV, Perola M, Litton J, Zatloukal K. BBMRI-ERIC as a resource for pharmaceutical and life science industries: the development of biobank-based Expert Centres. Eur J Hum Genet 2015; 23(7):893-900.

Godard B, Schmidtke J, Cassiman JJ, Ayme S. Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A profesional perspective. Eur J Hum Genet 2003; 11(Supl. 2):S88-122.

22 Bryzgalina E, Alasania KY, Varkhotov T, Gavrilenko SM, Shkomova, EM. The social dimension of biobanking: objectives and challenges. Life Sci Soc Policy 2017; 13(1):1-11.

23 Villarroel R. Biopolitical administration within Biobanks. Acta Bioethica 2013; 19(1):39-47.

24 De Souza YG, Greenspan JS. Biobanking past, present and future: responsibilities and benefits. AIDS 2013; 27(3):303-312.

25 Domaradzki J, Pawlikowski J. Public Attitudes toward Biobanking of Human Biological Material for Research Purposes: A Literature Review. Int J Environ Res Public Health 2019; 16(12):2209.

26 Kinkorová J, Topolcan O. Biobanks in Horizon 2020: sustainability and attractive perspectives. EPMA J 2018; 9(4):345-353.

27 Nemogá-Soto G. Dilemas sobre Biobancos: asuntos éticos y jurídicos. Pensamiento Jurídico 2012; 35:195-230.

28 Domaradzki J. Geneticization and biobanking. Polish Sociological Review 2019; 205(1):103-117.

29 Hamilton C. Intellectual property rights, the bioeconomy and the challenge of biopiracy. Genom Soc Policy 2008; 4(3):26-45.^-3030 Brochhausen M, Zheng J, Birtwell, D, Williams H, Masci AM, Ellis HJ, Stoeckert CJ Jr. OBIB-a novel ontology for biobanking. J Biomed Semantics 2016; 7(1):23.. Both biobanks and biorepositories are institutional installations for the systematic collection of biological material and data, the difference between them being that the former intends these for future research and the latter, for specific current studies⁷7 Instituto de Salud Carlos III, Comité de Ética del Instituto de Investigación de Enfermedades Raras (IIER). Recomendaciones sobre los aspectos éticos de las colecciones de muestras y bancos de materiales humanos con fines de investigación biomédica. Rev Esp Salud Publica 2007; 81(2):95-111..

Historically, the development of biobanks can be classified into the following stages: a) they emerged as public projects linking biological samples with related data¹⁵15 Marodin G, Salgueiro JB, Motta ML. Pacheco-Santos LM. Brazilian guidelines for biorepositories and biobanks of human biological material. Rev Assoc Med Bras 2013; 59(1):72-77.^,1616 Gottweis H, Lauss G. Biobank governance: heterogeneous models of ordering and democratization. J Community Genet 2012; 3(2):61-72.^,1818 Serrano-Díaz N, Páez-Leal MC, Luna-González ML, Guío-Mahecha E. Biobanco: Herramienta fundamental para la investigación biomédica actual. Rev Univ Ind Santander Salud 2016; 48(2):97-117.; b) sample collection, besides becoming massive and systematic, was conducted with a view to specific current research²²22 Bryzgalina E, Alasania KY, Varkhotov T, Gavrilenko SM, Shkomova, EM. The social dimension of biobanking: objectives and challenges. Life Sci Soc Policy 2017; 13(1):1-11.; c) collection then targeted specific geographical areas, giving rise to population biobanks¹⁵15 Marodin G, Salgueiro JB, Motta ML. Pacheco-Santos LM. Brazilian guidelines for biorepositories and biobanks of human biological material. Rev Assoc Med Bras 2013; 59(1):72-77.^,1919 Milanovic F, Merleau-Ponty N, Pitrou P. Biobanks and the reconfiguration of the living. New Genetics Soc 2018; 37(4):285-295.; d) there followed massive, systematic collection with a view to future research¹⁵15 Marodin G, Salgueiro JB, Motta ML. Pacheco-Santos LM. Brazilian guidelines for biorepositories and biobanks of human biological material. Rev Assoc Med Bras 2013; 59(1):72-77.; e) then massive, systematic collection coupled with BigData¹⁵15 Marodin G, Salgueiro JB, Motta ML. Pacheco-Santos LM. Brazilian guidelines for biorepositories and biobanks of human biological material. Rev Assoc Med Bras 2013; 59(1):72-77.; e) massive samples and data which are stored and delivered for commercial research²⁰20 Ommen GV, Törnwall O, Bréchot C, Dagher G, Galli J, Hveem K, Landegren U, Luchinat C, Metspalu A, Nilsson C, Solesvik OV, Perola M, Litton J, Zatloukal K. BBMRI-ERIC as a resource for pharmaceutical and life science industries: the development of biobank-based Expert Centres. Eur J Hum Genet 2015; 23(7):893-900.; and f) lastly, collaboration between biobanks and between the public and private sectors¹⁸18 Serrano-Díaz N, Páez-Leal MC, Luna-González ML, Guío-Mahecha E. Biobanco: Herramienta fundamental para la investigación biomédica actual. Rev Univ Ind Santander Salud 2016; 48(2):97-117.^,2222 Bryzgalina E, Alasania KY, Varkhotov T, Gavrilenko SM, Shkomova, EM. The social dimension of biobanking: objectives and challenges. Life Sci Soc Policy 2017; 13(1):1-11..

Biobanks are decisively important to the life and health sciences, because they facilitate both basic and clinical research. Such studies include prominently: the Framingham Heart Study (1948)¹⁵15 Marodin G, Salgueiro JB, Motta ML. Pacheco-Santos LM. Brazilian guidelines for biorepositories and biobanks of human biological material. Rev Assoc Med Bras 2013; 59(1):72-77.^,1616 Gottweis H, Lauss G. Biobank governance: heterogeneous models of ordering and democratization. J Community Genet 2012; 3(2):61-72.^,1818 Serrano-Díaz N, Páez-Leal MC, Luna-González ML, Guío-Mahecha E. Biobanco: Herramienta fundamental para la investigación biomédica actual. Rev Univ Ind Santander Salud 2016; 48(2):97-117.; the AIDS Specimen Bank (1982)²²22 Bryzgalina E, Alasania KY, Varkhotov T, Gavrilenko SM, Shkomova, EM. The social dimension of biobanking: objectives and challenges. Life Sci Soc Policy 2017; 13(1):1-11.; the Avon Study of Parents and Children (ALSPAC) and European Longitudinal Study of Pregnancy and Childhood (ELSPAC) (1990)¹⁵15 Marodin G, Salgueiro JB, Motta ML. Pacheco-Santos LM. Brazilian guidelines for biorepositories and biobanks of human biological material. Rev Assoc Med Bras 2013; 59(1):72-77.^,1919 Milanovic F, Merleau-Ponty N, Pitrou P. Biobanks and the reconfiguration of the living. New Genetics Soc 2018; 37(4):285-295.; the European Prospective Investigation into Cancer and Nutrition (1993)¹⁵15 Marodin G, Salgueiro JB, Motta ML. Pacheco-Santos LM. Brazilian guidelines for biorepositories and biobanks of human biological material. Rev Assoc Med Bras 2013; 59(1):72-77.; the Chernobyl Tissue Bank (1998)²²22 Bryzgalina E, Alasania KY, Varkhotov T, Gavrilenko SM, Shkomova, EM. The social dimension of biobanking: objectives and challenges. Life Sci Soc Policy 2017; 13(1):1-11.; the National Cancer Human Biobank (2002)²²22 Bryzgalina E, Alasania KY, Varkhotov T, Gavrilenko SM, Shkomova, EM. The social dimension of biobanking: objectives and challenges. Life Sci Soc Policy 2017; 13(1):1-11.; the UK Biobank (2005)¹⁵15 Marodin G, Salgueiro JB, Motta ML. Pacheco-Santos LM. Brazilian guidelines for biorepositories and biobanks of human biological material. Rev Assoc Med Bras 2013; 59(1):72-77.; the Danish National Biobank (2012)²²22 Bryzgalina E, Alasania KY, Varkhotov T, Gavrilenko SM, Shkomova, EM. The social dimension of biobanking: objectives and challenges. Life Sci Soc Policy 2017; 13(1):1-11.; and the BBMRI-ERIC Expert Centre (2013)¹⁸18 Serrano-Díaz N, Páez-Leal MC, Luna-González ML, Guío-Mahecha E. Biobanco: Herramienta fundamental para la investigación biomédica actual. Rev Univ Ind Santander Salud 2016; 48(2):97-117..

Biobanks bring together a multiplicity of agents, including researchers, universities, national and international companies, States and international organisations, while the sample and data collection, filing and storage activities involve practitioners of the life, health, exact and social sciences and the humanities. In view of these characteristics, a number of studies have considered biobanks to involve multi- and interdisciplinary endeavours, regarding either their object, activity or integration. However, there are no reviews that contribute to a multidisciplinary construction of the concept.

That given, an integrative review on the subject is both useful and necessary, because it offers wide-ranging information and permits in-depth understanding of the biobank concept on the basis of a multidisciplinary approach that analyses and synthesises both its most important characteristics and aspects and those that are open to debate, so as to highlight the network or fabric of scientific and human knowledge and practices that converge in the conceptualisation of the biobank and how these influence the construction of its constituent categories.

Methods and materials

Methods

This integrative literature review investigated the biobank concept on a multidisciplinary approach via Aristotelian categories. An integrative review allows the findings of diverse studies and types of source to be analysed and synthesised so as to provide a broad, holistic understanding of a health phenomenon or problem³¹31 Whittemore R, Knafl K. The integrative review: updated methodology. J Adv Nurs 2005; 52(5):546-553.. This is done by a rigorous, systematic, inclusive process of approximation for the purpose of reducing error and bias³²32 Souza MT, Silva MD, Carvalho RD. Integrative review: what is it? How to do it? Einstein (São Paulo) 2010; 8(1):102-106.. The analysis and synthesis identified not only the characteristics of the phenomenon or problem, but revealed the gaps in knowledge, as well as debatable points, thus helping to clarify the issue and support future research. Methodologically, it followed the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)³³33 Urrútia G, Bonfill X. Declaración PRISMA: una propuesta para mejorar la publicación de revisiones sistemáticas y metaanálisis. Med Clin (Barc) 2010; 135(11):507-511..

Search strategy

The data bases were searched using the descriptor biobanco/biobank, from 6 March to 5 May 2019, without Boolean Operators, so as to include the largest possible number of studies from diverse sciences and thus perform a multidisciplinary integrative review. The search included publications in English, Portuguese and Spanish in the following data bases: Medical Literature Analysis and Retrieval System Online (PubMed-MedLine), Latin American and Caribbean Literature in Health Sciences (LILACS), Network of Scientific Journals from Latin America and the Caribbean, Spain and Portugal (REDALyC), Education Resources Information Center (ERIC), PAHO-BIREME Virtual Health Library (VHL Regional Portal), WHO Institutional Repository for Information Sharing (IRIS), Science Direct, JSTOR, Scientific Electronic Library Online (SciELO), Digital Repository of the Economic Commission for Latin America and the Caribbean (ECLAC Digital Repository), Dialnet, World Wide Science and Latindex.

Eligibility criteria

The inclusion criteria were: original articles, systematic, comprehensive literature reviews, editorials and book chapters, published between 2003 and 2019, in Spanish, English or Portuguese, originating in the health, life, exact or social sciences and humanities, using qualitative or mixed methodologies and with open access. It was decided to set the cut-off date at 2003, because that was when UNESCO adopted the International Declaration on Human Genetic Data, which regulated respect for human dignity in the collection, processing, use and storage of human genetic data, human proteomic data and biological samples, resulting in its implementation worldwide¹1 Soto-Gómez L. Regulating Mexican Biobanks for Human Biomedical Research: What can be Learned from the European Experience? Mex Law Rev 2014; 7(1):31-55.^,22 Laurence L. Convention on Human Rights and Biomedicine: The Oviedo Convention. In: Brena IS, Ruíz de Chávez MH, coordinadores. Bioética y derechos humanos. México: IIJ-UNAM; 2018.^,66 Bernal-Gómez BM, Bernal-Gómez DR. Investigación Biomédica y Biobancos: Una Reflexión para su Implementación. Principia Iuris 2018; 16(29):128-143.^,77 Instituto de Salud Carlos III, Comité de Ética del Instituto de Investigación de Enfermedades Raras (IIER). Recomendaciones sobre los aspectos éticos de las colecciones de muestras y bancos de materiales humanos con fines de investigación biomédica. Rev Esp Salud Publica 2007; 81(2):95-111.^,1414 Brena-Sesma I. Biobancos, un asunto pendiente de legislar. Bol Mex Der Comp 2010; 43(129):1055-1079.^,1515 Marodin G, Salgueiro JB, Motta ML. Pacheco-Santos LM. Brazilian guidelines for biorepositories and biobanks of human biological material. Rev Assoc Med Bras 2013; 59(1):72-77.^,2727 Nemogá-Soto G. Dilemas sobre Biobancos: asuntos éticos y jurídicos. Pensamiento Jurídico 2012; 35:195-230.. The exclusion criteria were: theses, monographs, dissertations and abstracts published prior to 2003.

Data extraction

The electronic search of the above data bases yielded 1794 publications meeting the inclusion criteria. Each document was then reviewed to ensure that it matched at least two Aristotelian categories, leaving 625. The studies were then reviewed again to assure that their content met the eligibility criteria, which left 62 documents. At this point, a critical reading was made of the documents (by GS, OC, HA and BR) with the aid of the CASPe guides, resulting in a total of 30 publications. That result was discussed and a consensus arrived at, so that the decisions involved no disagreement or stalemate (Figure 1).

Quality assessment

Four authors (GS, OC, HA and BR) performed the assessment by applying the guide to critical reading of qualitative studies of the quality assessment instrument produced by the Critical Appraisal Skills Programme, CASPe³⁴34 Cano-Arana A, González-Gil T, Cabello-López JB. Plantilla para ayudarte a entender un estudio cualitativo. In: CASPe. Guías CASPe de Lectura Crítica de la Literatura Médica. Alicante: CASPe; 2010. p. 3-8., then discussed the results and arrived at a consensus.

Sample size calculation

Given the nature of the study, sample size was not calculated, because the selection had to meet the eligibility criteria during the search period.

Data synthesis

For data extraction, two standardised forms were designed in MS Excel. The first contained the criteria year of publication, country of publication, type of publication, plus the questions answered with respect to biobanks. The second contained author, place of publication, type of research, objectives and findings (Chart 1).

Data analysis

The data were analysed and summarised by applying Aristotelian logical categories so as to ascertain the attributes and conceptual network of the object “biobank”³⁵35 Aristóteles. Tratados de lógica: el Organon. Larroyo F. México: Porrúa; 1993.. Five categories were used: definitory, action/teleological, subjective, structural and legal. These categories were analysed and applied to biobanks, then later discussed until a consensus was reached on their properties:

Results

Selection of studies

The result was 30 texts: 18 original articles¹1 Soto-Gómez L. Regulating Mexican Biobanks for Human Biomedical Research: What can be Learned from the European Experience? Mex Law Rev 2014; 7(1):31-55.^,66 Bernal-Gómez BM, Bernal-Gómez DR. Investigación Biomédica y Biobancos: Una Reflexión para su Implementación. Principia Iuris 2018; 16(29):128-143.^,88 Chen H, Pang T. A call for global governance of biobanks. Bull WHO 2015; 93(2):113-117.^,1212 Martínez JC, Briceño I, Alejandra H, Gómez A. Biobancos. Una estrategia inteligente y esencial para la conservación de muestras biológicas. Acta Med Colomb 2012; 37(3):158-162.

13 Capron AM, Mauron A, Elger BS, Boggio A, Ganguli-Mitra A, Biller-Andorno N. Ethical norms and the international governance of genetic databases and biobanks: findings from an international study. Kennedy Inst Ethics J 2009; 19(2):101-124.

14 Brena-Sesma I. Biobancos, un asunto pendiente de legislar. Bol Mex Der Comp 2010; 43(129):1055-1079.

15 Marodin G, Salgueiro JB, Motta ML. Pacheco-Santos LM. Brazilian guidelines for biorepositories and biobanks of human biological material. Rev Assoc Med Bras 2013; 59(1):72-77.^-1616 Gottweis H, Lauss G. Biobank governance: heterogeneous models of ordering and democratization. J Community Genet 2012; 3(2):61-72.^,1818 Serrano-Díaz N, Páez-Leal MC, Luna-González ML, Guío-Mahecha E. Biobanco: Herramienta fundamental para la investigación biomédica actual. Rev Univ Ind Santander Salud 2016; 48(2):97-117.^,2020 Ommen GV, Törnwall O, Bréchot C, Dagher G, Galli J, Hveem K, Landegren U, Luchinat C, Metspalu A, Nilsson C, Solesvik OV, Perola M, Litton J, Zatloukal K. BBMRI-ERIC as a resource for pharmaceutical and life science industries: the development of biobank-based Expert Centres. Eur J Hum Genet 2015; 23(7):893-900.

Godard B, Schmidtke J, Cassiman JJ, Ayme S. Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A profesional perspective. Eur J Hum Genet 2003; 11(Supl. 2):S88-122.

22 Bryzgalina E, Alasania KY, Varkhotov T, Gavrilenko SM, Shkomova, EM. The social dimension of biobanking: objectives and challenges. Life Sci Soc Policy 2017; 13(1):1-11.

23 Villarroel R. Biopolitical administration within Biobanks. Acta Bioethica 2013; 19(1):39-47.^-2424 De Souza YG, Greenspan JS. Biobanking past, present and future: responsibilities and benefits. AIDS 2013; 27(3):303-312.^,2727 Nemogá-Soto G. Dilemas sobre Biobancos: asuntos éticos y jurídicos. Pensamiento Jurídico 2012; 35:195-230.

28 Domaradzki J. Geneticization and biobanking. Polish Sociological Review 2019; 205(1):103-117.

29 Hamilton C. Intellectual property rights, the bioeconomy and the challenge of biopiracy. Genom Soc Policy 2008; 4(3):26-45.^-3030 Brochhausen M, Zheng J, Birtwell, D, Williams H, Masci AM, Ellis HJ, Stoeckert CJ Jr. OBIB-a novel ontology for biobanking. J Biomed Semantics 2016; 7(1):23., 4 comprehensive and systematic review articles⁴4 Lee J. Artificial Intelligence in the Future Biobanking: Current Issues in the Biobank and Future Possibilities of Artificial Intelligence. Biomed J Sci Tech Res 2018; 7(3):5937-5939.^,1717 Paskal W, Paskal AM, Debski T, Gryziak M, Jaworowski J. Aspects of Modern Biobank Activity - Comprehensive Review. Pathol Oncol Res. 2018; 24(4):771-785.^,2525 Domaradzki J, Pawlikowski J. Public Attitudes toward Biobanking of Human Biological Material for Research Purposes: A Literature Review. Int J Environ Res Public Health 2019; 16(12):2209.^,2626 Kinkorová J, Topolcan O. Biobanks in Horizon 2020: sustainability and attractive perspectives. EPMA J 2018; 9(4):345-353., 2 special articles or collaborations³3 Garza-Rodríguez ML, Pérez-Maya AA, Monsivais-Ovalle DE, Velázquez-Vadillo JF, Barrera-Saldaña, HA. El Biobanco Institucional como pilar de las ciencias médicas. Salud Publica Mex 2016; 58(4):483-489.^,77 Instituto de Salud Carlos III, Comité de Ética del Instituto de Investigación de Enfermedades Raras (IIER). Recomendaciones sobre los aspectos éticos de las colecciones de muestras y bancos de materiales humanos con fines de investigación biomédica. Rev Esp Salud Publica 2007; 81(2):95-111., 2 editorials⁵5 Benítez-Arvizu G, Palma-Lara I, Alcántara-Quintana L. Biobancos de células troncales para terapia celular. Una realidad en México. Rev Med Inst Mex Seguro Soc 2014; 52(3):244-247.^,1919 Milanovic F, Merleau-Ponty N, Pitrou P. Biobanks and the reconfiguration of the living. New Genetics Soc 2018; 37(4):285-295., 1 technical note¹⁰10 Luna-González ML, Guío-Mahecha E, Becerra-Bayona S, Serrano-Díaz N. La gestión de los datos, un proceso esencial para el desarrollo del Biobanco. Rev Univ Ind Santander Salud 2016; 48(4):548-553., 1 standards protocol¹¹11 Mendy M, Caboux E, Lawlor RT, Wright J, Wild CP. Common mínimum technical standards and protocols for biobanks dedicated to cancer research. Lyon: Int Agency Res Cancer; 2017., 1 current issues article⁹9 Marodin G, França P, Rocha JCC, Campos AH. Biobanking for health research in Brazil: Present challenges and future directions. Rev Panam Salud Publica 2012; 31(6):523-528. and 1 book chapter²2 Laurence L. Convention on Human Rights and Biomedicine: The Oviedo Convention. In: Brena IS, Ruíz de Chávez MH, coordinadores. Bioética y derechos humanos. México: IIJ-UNAM; 2018..

General characteristics of the studies

The study summarised information published in 12 countries and by 3 international organisations, as follows: 7 studies from Great Britain¹⁹19 Milanovic F, Merleau-Ponty N, Pitrou P. Biobanks and the reconfiguration of the living. New Genetics Soc 2018; 37(4):285-295.

20 Ommen GV, Törnwall O, Bréchot C, Dagher G, Galli J, Hveem K, Landegren U, Luchinat C, Metspalu A, Nilsson C, Solesvik OV, Perola M, Litton J, Zatloukal K. BBMRI-ERIC as a resource for pharmaceutical and life science industries: the development of biobank-based Expert Centres. Eur J Hum Genet 2015; 23(7):893-900.

Godard B, Schmidtke J, Cassiman JJ, Ayme S. Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A profesional perspective. Eur J Hum Genet 2003; 11(Supl. 2):S88-122.^-2222 Bryzgalina E, Alasania KY, Varkhotov T, Gavrilenko SM, Shkomova, EM. The social dimension of biobanking: objectives and challenges. Life Sci Soc Policy 2017; 13(1):1-11.^,2424 De Souza YG, Greenspan JS. Biobanking past, present and future: responsibilities and benefits. AIDS 2013; 27(3):303-312.^,2929 Hamilton C. Intellectual property rights, the bioeconomy and the challenge of biopiracy. Genom Soc Policy 2008; 4(3):26-45.^,3030 Brochhausen M, Zheng J, Birtwell, D, Williams H, Masci AM, Ellis HJ, Stoeckert CJ Jr. OBIB-a novel ontology for biobanking. J Biomed Semantics 2016; 7(1):23., 5 from Mexico¹1 Soto-Gómez L. Regulating Mexican Biobanks for Human Biomedical Research: What can be Learned from the European Experience? Mex Law Rev 2014; 7(1):31-55.

2 Laurence L. Convention on Human Rights and Biomedicine: The Oviedo Convention. In: Brena IS, Ruíz de Chávez MH, coordinadores. Bioética y derechos humanos. México: IIJ-UNAM; 2018.^-33 Garza-Rodríguez ML, Pérez-Maya AA, Monsivais-Ovalle DE, Velázquez-Vadillo JF, Barrera-Saldaña, HA. El Biobanco Institucional como pilar de las ciencias médicas. Salud Publica Mex 2016; 58(4):483-489.^,55 Benítez-Arvizu G, Palma-Lara I, Alcántara-Quintana L. Biobancos de células troncales para terapia celular. Una realidad en México. Rev Med Inst Mex Seguro Soc 2014; 52(3):244-247.^,1414 Brena-Sesma I. Biobancos, un asunto pendiente de legislar. Bol Mex Der Comp 2010; 43(129):1055-1079., 4 from Colombia⁶6 Bernal-Gómez BM, Bernal-Gómez DR. Investigación Biomédica y Biobancos: Una Reflexión para su Implementación. Principia Iuris 2018; 16(29):128-143.^,1212 Martínez JC, Briceño I, Alejandra H, Gómez A. Biobancos. Una estrategia inteligente y esencial para la conservación de muestras biológicas. Acta Med Colomb 2012; 37(3):158-162.^,1818 Serrano-Díaz N, Páez-Leal MC, Luna-González ML, Guío-Mahecha E. Biobanco: Herramienta fundamental para la investigación biomédica actual. Rev Univ Ind Santander Salud 2016; 48(2):97-117.^,2727 Nemogá-Soto G. Dilemas sobre Biobancos: asuntos éticos y jurídicos. Pensamiento Jurídico 2012; 35:195-230., 2 from Switzerland²⁵25 Domaradzki J, Pawlikowski J. Public Attitudes toward Biobanking of Human Biological Material for Research Purposes: A Literature Review. Int J Environ Res Public Health 2019; 16(12):2209.^,2626 Kinkorová J, Topolcan O. Biobanks in Horizon 2020: sustainability and attractive perspectives. EPMA J 2018; 9(4):345-353., 2 from Spain⁷7 Instituto de Salud Carlos III, Comité de Ética del Instituto de Investigación de Enfermedades Raras (IIER). Recomendaciones sobre los aspectos éticos de las colecciones de muestras y bancos de materiales humanos con fines de investigación biomédica. Rev Esp Salud Publica 2007; 81(2):95-111.^,1010 Luna-González ML, Guío-Mahecha E, Becerra-Bayona S, Serrano-Díaz N. La gestión de los datos, un proceso esencial para el desarrollo del Biobanco. Rev Univ Ind Santander Salud 2016; 48(4):548-553., 1 from Brazil¹⁵15 Marodin G, Salgueiro JB, Motta ML. Pacheco-Santos LM. Brazilian guidelines for biorepositories and biobanks of human biological material. Rev Assoc Med Bras 2013; 59(1):72-77., 1 from Germany¹⁶16 Gottweis H, Lauss G. Biobank governance: heterogeneous models of ordering and democratization. J Community Genet 2012; 3(2):61-72., 1 from Chile²³23 Villarroel R. Biopolitical administration within Biobanks. Acta Bioethica 2013; 19(1):39-47., 1 from Finland⁴4 Lee J. Artificial Intelligence in the Future Biobanking: Current Issues in the Biobank and Future Possibilities of Artificial Intelligence. Biomed J Sci Tech Res 2018; 7(3):5937-5939., 1 from Netherlands¹⁷17 Paskal W, Paskal AM, Debski T, Gryziak M, Jaworowski J. Aspects of Modern Biobank Activity - Comprehensive Review. Pathol Oncol Res. 2018; 24(4):771-785., 1 from Polonia²⁸28 Domaradzki J. Geneticization and biobanking. Polish Sociological Review 2019; 205(1):103-117., 1 from USA¹³13 Capron AM, Mauron A, Elger BS, Boggio A, Ganguli-Mitra A, Biller-Andorno N. Ethical norms and the international governance of genetic databases and biobanks: findings from an international study. Kennedy Inst Ethics J 2009; 19(2):101-124., 1 from WHO⁸8 Chen H, Pang T. A call for global governance of biobanks. Bull WHO 2015; 93(2):113-117., 1 from PAHO⁹9 Marodin G, França P, Rocha JCC, Campos AH. Biobanking for health research in Brazil: Present challenges and future directions. Rev Panam Salud Publica 2012; 31(6):523-528. and 1 from WHO-IARC¹¹11 Mendy M, Caboux E, Lawlor RT, Wright J, Wild CP. Common mínimum technical standards and protocols for biobanks dedicated to cancer research. Lyon: Int Agency Res Cancer; 2017.. By year of publication, there were: 3 from 2019²⁵25 Domaradzki J, Pawlikowski J. Public Attitudes toward Biobanking of Human Biological Material for Research Purposes: A Literature Review. Int J Environ Res Public Health 2019; 16(12):2209.^,2828 Domaradzki J. Geneticization and biobanking. Polish Sociological Review 2019; 205(1):103-117.^,3030 Brochhausen M, Zheng J, Birtwell, D, Williams H, Masci AM, Ellis HJ, Stoeckert CJ Jr. OBIB-a novel ontology for biobanking. J Biomed Semantics 2016; 7(1):23., 5 from 2018²2 Laurence L. Convention on Human Rights and Biomedicine: The Oviedo Convention. In: Brena IS, Ruíz de Chávez MH, coordinadores. Bioética y derechos humanos. México: IIJ-UNAM; 2018.^,44 Lee J. Artificial Intelligence in the Future Biobanking: Current Issues in the Biobank and Future Possibilities of Artificial Intelligence. Biomed J Sci Tech Res 2018; 7(3):5937-5939.^,1717 Paskal W, Paskal AM, Debski T, Gryziak M, Jaworowski J. Aspects of Modern Biobank Activity - Comprehensive Review. Pathol Oncol Res. 2018; 24(4):771-785.^,1919 Milanovic F, Merleau-Ponty N, Pitrou P. Biobanks and the reconfiguration of the living. New Genetics Soc 2018; 37(4):285-295.^,2626 Kinkorová J, Topolcan O. Biobanks in Horizon 2020: sustainability and attractive perspectives. EPMA J 2018; 9(4):345-353., 3 from 2017⁶6 Bernal-Gómez BM, Bernal-Gómez DR. Investigación Biomédica y Biobancos: Una Reflexión para su Implementación. Principia Iuris 2018; 16(29):128-143.^,1111 Mendy M, Caboux E, Lawlor RT, Wright J, Wild CP. Common mínimum technical standards and protocols for biobanks dedicated to cancer research. Lyon: Int Agency Res Cancer; 2017.^,2222 Bryzgalina E, Alasania KY, Varkhotov T, Gavrilenko SM, Shkomova, EM. The social dimension of biobanking: objectives and challenges. Life Sci Soc Policy 2017; 13(1):1-11., 3 from 2016³3 Garza-Rodríguez ML, Pérez-Maya AA, Monsivais-Ovalle DE, Velázquez-Vadillo JF, Barrera-Saldaña, HA. El Biobanco Institucional como pilar de las ciencias médicas. Salud Publica Mex 2016; 58(4):483-489.^,1010 Luna-González ML, Guío-Mahecha E, Becerra-Bayona S, Serrano-Díaz N. La gestión de los datos, un proceso esencial para el desarrollo del Biobanco. Rev Univ Ind Santander Salud 2016; 48(4):548-553.^,1818 Serrano-Díaz N, Páez-Leal MC, Luna-González ML, Guío-Mahecha E. Biobanco: Herramienta fundamental para la investigación biomédica actual. Rev Univ Ind Santander Salud 2016; 48(2):97-117., 2 from 2015⁸8 Chen H, Pang T. A call for global governance of biobanks. Bull WHO 2015; 93(2):113-117.^,2020 Ommen GV, Törnwall O, Bréchot C, Dagher G, Galli J, Hveem K, Landegren U, Luchinat C, Metspalu A, Nilsson C, Solesvik OV, Perola M, Litton J, Zatloukal K. BBMRI-ERIC as a resource for pharmaceutical and life science industries: the development of biobank-based Expert Centres. Eur J Hum Genet 2015; 23(7):893-900., 2 from 2014¹1 Soto-Gómez L. Regulating Mexican Biobanks for Human Biomedical Research: What can be Learned from the European Experience? Mex Law Rev 2014; 7(1):31-55.^,55 Benítez-Arvizu G, Palma-Lara I, Alcántara-Quintana L. Biobancos de células troncales para terapia celular. Una realidad en México. Rev Med Inst Mex Seguro Soc 2014; 52(3):244-247., 3 from 2013¹⁵15 Marodin G, Salgueiro JB, Motta ML. Pacheco-Santos LM. Brazilian guidelines for biorepositories and biobanks of human biological material. Rev Assoc Med Bras 2013; 59(1):72-77.^,2323 Villarroel R. Biopolitical administration within Biobanks. Acta Bioethica 2013; 19(1):39-47.^,2424 De Souza YG, Greenspan JS. Biobanking past, present and future: responsibilities and benefits. AIDS 2013; 27(3):303-312., 4 from 2012⁹9 Marodin G, França P, Rocha JCC, Campos AH. Biobanking for health research in Brazil: Present challenges and future directions. Rev Panam Salud Publica 2012; 31(6):523-528.^,1212 Martínez JC, Briceño I, Alejandra H, Gómez A. Biobancos. Una estrategia inteligente y esencial para la conservación de muestras biológicas. Acta Med Colomb 2012; 37(3):158-162.^,1616 Gottweis H, Lauss G. Biobank governance: heterogeneous models of ordering and democratization. J Community Genet 2012; 3(2):61-72.^,2727 Nemogá-Soto G. Dilemas sobre Biobancos: asuntos éticos y jurídicos. Pensamiento Jurídico 2012; 35:195-230., 1 from 2010¹⁴14 Brena-Sesma I. Biobancos, un asunto pendiente de legislar. Bol Mex Der Comp 2010; 43(129):1055-1079., 1 from 2009¹³13 Capron AM, Mauron A, Elger BS, Boggio A, Ganguli-Mitra A, Biller-Andorno N. Ethical norms and the international governance of genetic databases and biobanks: findings from an international study. Kennedy Inst Ethics J 2009; 19(2):101-124., 1 from 2008²⁹29 Hamilton C. Intellectual property rights, the bioeconomy and the challenge of biopiracy. Genom Soc Policy 2008; 4(3):26-45., 1 from 2007⁷7 Instituto de Salud Carlos III, Comité de Ética del Instituto de Investigación de Enfermedades Raras (IIER). Recomendaciones sobre los aspectos éticos de las colecciones de muestras y bancos de materiales humanos con fines de investigación biomédica. Rev Esp Salud Publica 2007; 81(2):95-111. and 1 from 2003²¹Godard B, Schmidtke J, Cassiman JJ, Ayme S. Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A profesional perspective. Eur J Hum Genet 2003; 11(Supl. 2):S88-122..

Study quality was evaluated using the quality assessment instruments of the Critical Appraisal Skills Programme (CASPe)³⁴34 Cano-Arana A, González-Gil T, Cabello-López JB. Plantilla para ayudarte a entender un estudio cualitativo. In: CASPe. Guías CASPe de Lectura Crítica de la Literatura Médica. Alicante: CASPe; 2010. p. 3-8., which assesses three aspects - rigour, credibility and relevance - by way of “Yes”, “No” or “Can’t tell” responses to 10 questions. The first three questions evaluate the objectives, methodology and the relation between the two and, in the 30 studies selected, the answers were “Yes”. Accordingly, the studies were evaluated by the other 7 questions, which address: participant selection strategies, data collection techniques, reflexiveness, ethical concerns, rigorous data analysis, whether the findings are set out clearly and how applicable they are.

As the objective of this review was a multidisciplinary approach to the biobank concept based on a synthesis of a general approximation from various sciences and sources, studies that elicited a “No” to some of the questions were not excluded³⁶36 Thomas J, Harden A. Methods for the thematic synthesis of qualitative research in systematic reviews. BMC Med Res Methodol 2008; 8:45., in the following cases: a) those that did not address the participant selection question, because most were document-based or theoretical qualitative studies, except for two that used interviews¹³13 Capron AM, Mauron A, Elger BS, Boggio A, Ganguli-Mitra A, Biller-Andorno N. Ethical norms and the international governance of genetic databases and biobanks: findings from an international study. Kennedy Inst Ethics J 2009; 19(2):101-124.^,21Godard B, Schmidtke J, Cassiman JJ, Ayme S. Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A profesional perspective. Eur J Hum Genet 2003; 11(Supl. 2):S88-122.; b) those that did not explicitly state their method, although it was implicit in the study process, especially in studies originating in the social sciences and humanities¹1 Soto-Gómez L. Regulating Mexican Biobanks for Human Biomedical Research: What can be Learned from the European Experience? Mex Law Rev 2014; 7(1):31-55.^,22 Laurence L. Convention on Human Rights and Biomedicine: The Oviedo Convention. In: Brena IS, Ruíz de Chávez MH, coordinadores. Bioética y derechos humanos. México: IIJ-UNAM; 2018.^,66 Bernal-Gómez BM, Bernal-Gómez DR. Investigación Biomédica y Biobancos: Una Reflexión para su Implementación. Principia Iuris 2018; 16(29):128-143.^,1010 Luna-González ML, Guío-Mahecha E, Becerra-Bayona S, Serrano-Díaz N. La gestión de los datos, un proceso esencial para el desarrollo del Biobanco. Rev Univ Ind Santander Salud 2016; 48(4):548-553.^,1414 Brena-Sesma I. Biobancos, un asunto pendiente de legislar. Bol Mex Der Comp 2010; 43(129):1055-1079.^,1616 Gottweis H, Lauss G. Biobank governance: heterogeneous models of ordering and democratization. J Community Genet 2012; 3(2):61-72.^,1919 Milanovic F, Merleau-Ponty N, Pitrou P. Biobanks and the reconfiguration of the living. New Genetics Soc 2018; 37(4):285-295.^,2020 Ommen GV, Törnwall O, Bréchot C, Dagher G, Galli J, Hveem K, Landegren U, Luchinat C, Metspalu A, Nilsson C, Solesvik OV, Perola M, Litton J, Zatloukal K. BBMRI-ERIC as a resource for pharmaceutical and life science industries: the development of biobank-based Expert Centres. Eur J Hum Genet 2015; 23(7):893-900.^,2222 Bryzgalina E, Alasania KY, Varkhotov T, Gavrilenko SM, Shkomova, EM. The social dimension of biobanking: objectives and challenges. Life Sci Soc Policy 2017; 13(1):1-11.^,2323 Villarroel R. Biopolitical administration within Biobanks. Acta Bioethica 2013; 19(1):39-47.^,2727 Nemogá-Soto G. Dilemas sobre Biobancos: asuntos éticos y jurídicos. Pensamiento Jurídico 2012; 35:195-230.^,2828 Domaradzki J. Geneticization and biobanking. Polish Sociological Review 2019; 205(1):103-117.; c) those that were proposals to regulate standards, guidelines or protocols which also did not state their method explicitly, but used the legislative technique⁷7 Instituto de Salud Carlos III, Comité de Ética del Instituto de Investigación de Enfermedades Raras (IIER). Recomendaciones sobre los aspectos éticos de las colecciones de muestras y bancos de materiales humanos con fines de investigación biomédica. Rev Esp Salud Publica 2007; 81(2):95-111.^,1111 Mendy M, Caboux E, Lawlor RT, Wright J, Wild CP. Common mínimum technical standards and protocols for biobanks dedicated to cancer research. Lyon: Int Agency Res Cancer; 2017.; and d) those that were expert opinions or contributions, such as special articles, editorials or current affairs studies³3 Garza-Rodríguez ML, Pérez-Maya AA, Monsivais-Ovalle DE, Velázquez-Vadillo JF, Barrera-Saldaña, HA. El Biobanco Institucional como pilar de las ciencias médicas. Salud Publica Mex 2016; 58(4):483-489.^,55 Benítez-Arvizu G, Palma-Lara I, Alcántara-Quintana L. Biobancos de células troncales para terapia celular. Una realidad en México. Rev Med Inst Mex Seguro Soc 2014; 52(3):244-247.^,77 Instituto de Salud Carlos III, Comité de Ética del Instituto de Investigación de Enfermedades Raras (IIER). Recomendaciones sobre los aspectos éticos de las colecciones de muestras y bancos de materiales humanos con fines de investigación biomédica. Rev Esp Salud Publica 2007; 81(2):95-111.^,99 Marodin G, França P, Rocha JCC, Campos AH. Biobanking for health research in Brazil: Present challenges and future directions. Rev Panam Salud Publica 2012; 31(6):523-528.^,1919 Milanovic F, Merleau-Ponty N, Pitrou P. Biobanks and the reconfiguration of the living. New Genetics Soc 2018; 37(4):285-295..

Qualitative summary of the findings

The data summary using Aristotelian categories and their properties yielded the following information (Figure 2):

None of the normative instructions were applied 100%, mainly because of States’ normative sovereignty in entering into international treaties, i.e., they are free to accede to rights and obligations with other States or regional and international organisations. This in turn leads to normative conflicts which authors propose to solve by setting up an international authority and introducing global governance¹1 Soto-Gómez L. Regulating Mexican Biobanks for Human Biomedical Research: What can be Learned from the European Experience? Mex Law Rev 2014; 7(1):31-55.

2 Laurence L. Convention on Human Rights and Biomedicine: The Oviedo Convention. In: Brena IS, Ruíz de Chávez MH, coordinadores. Bioética y derechos humanos. México: IIJ-UNAM; 2018.

3 Garza-Rodríguez ML, Pérez-Maya AA, Monsivais-Ovalle DE, Velázquez-Vadillo JF, Barrera-Saldaña, HA. El Biobanco Institucional como pilar de las ciencias médicas. Salud Publica Mex 2016; 58(4):483-489.

4 Lee J. Artificial Intelligence in the Future Biobanking: Current Issues in the Biobank and Future Possibilities of Artificial Intelligence. Biomed J Sci Tech Res 2018; 7(3):5937-5939.^-55 Benítez-Arvizu G, Palma-Lara I, Alcántara-Quintana L. Biobancos de células troncales para terapia celular. Una realidad en México. Rev Med Inst Mex Seguro Soc 2014; 52(3):244-247.^,88 Chen H, Pang T. A call for global governance of biobanks. Bull WHO 2015; 93(2):113-117.^,1010 Luna-González ML, Guío-Mahecha E, Becerra-Bayona S, Serrano-Díaz N. La gestión de los datos, un proceso esencial para el desarrollo del Biobanco. Rev Univ Ind Santander Salud 2016; 48(4):548-553.

11 Mendy M, Caboux E, Lawlor RT, Wright J, Wild CP. Common mínimum technical standards and protocols for biobanks dedicated to cancer research. Lyon: Int Agency Res Cancer; 2017.

12 Martínez JC, Briceño I, Alejandra H, Gómez A. Biobancos. Una estrategia inteligente y esencial para la conservación de muestras biológicas. Acta Med Colomb 2012; 37(3):158-162.

13 Capron AM, Mauron A, Elger BS, Boggio A, Ganguli-Mitra A, Biller-Andorno N. Ethical norms and the international governance of genetic databases and biobanks: findings from an international study. Kennedy Inst Ethics J 2009; 19(2):101-124.

14 Brena-Sesma I. Biobancos, un asunto pendiente de legislar. Bol Mex Der Comp 2010; 43(129):1055-1079.

15 Marodin G, Salgueiro JB, Motta ML. Pacheco-Santos LM. Brazilian guidelines for biorepositories and biobanks of human biological material. Rev Assoc Med Bras 2013; 59(1):72-77.

16 Gottweis H, Lauss G. Biobank governance: heterogeneous models of ordering and democratization. J Community Genet 2012; 3(2):61-72.

17 Paskal W, Paskal AM, Debski T, Gryziak M, Jaworowski J. Aspects of Modern Biobank Activity - Comprehensive Review. Pathol Oncol Res. 2018; 24(4):771-785.

18 Serrano-Díaz N, Páez-Leal MC, Luna-González ML, Guío-Mahecha E. Biobanco: Herramienta fundamental para la investigación biomédica actual. Rev Univ Ind Santander Salud 2016; 48(2):97-117.

19 Milanovic F, Merleau-Ponty N, Pitrou P. Biobanks and the reconfiguration of the living. New Genetics Soc 2018; 37(4):285-295.

20 Ommen GV, Törnwall O, Bréchot C, Dagher G, Galli J, Hveem K, Landegren U, Luchinat C, Metspalu A, Nilsson C, Solesvik OV, Perola M, Litton J, Zatloukal K. BBMRI-ERIC as a resource for pharmaceutical and life science industries: the development of biobank-based Expert Centres. Eur J Hum Genet 2015; 23(7):893-900.

Godard B, Schmidtke J, Cassiman JJ, Ayme S. Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A profesional perspective. Eur J Hum Genet 2003; 11(Supl. 2):S88-122.

22 Bryzgalina E, Alasania KY, Varkhotov T, Gavrilenko SM, Shkomova, EM. The social dimension of biobanking: objectives and challenges. Life Sci Soc Policy 2017; 13(1):1-11.

23 Villarroel R. Biopolitical administration within Biobanks. Acta Bioethica 2013; 19(1):39-47.

24 De Souza YG, Greenspan JS. Biobanking past, present and future: responsibilities and benefits. AIDS 2013; 27(3):303-312.

25 Domaradzki J, Pawlikowski J. Public Attitudes toward Biobanking of Human Biological Material for Research Purposes: A Literature Review. Int J Environ Res Public Health 2019; 16(12):2209.

26 Kinkorová J, Topolcan O. Biobanks in Horizon 2020: sustainability and attractive perspectives. EPMA J 2018; 9(4):345-353.

27 Nemogá-Soto G. Dilemas sobre Biobancos: asuntos éticos y jurídicos. Pensamiento Jurídico 2012; 35:195-230.

28 Domaradzki J. Geneticization and biobanking. Polish Sociological Review 2019; 205(1):103-117.

29 Hamilton C. Intellectual property rights, the bioeconomy and the challenge of biopiracy. Genom Soc Policy 2008; 4(3):26-45.^-3030 Brochhausen M, Zheng J, Birtwell, D, Williams H, Masci AM, Ellis HJ, Stoeckert CJ Jr. OBIB-a novel ontology for biobanking. J Biomed Semantics 2016; 7(1):23..

From the analysis and summary of the categories and properties that constitute a biobank, it can be deduced that it is a complex weave of heterogeneous but inseparably associated elements, i.e., it is a concept that represents a complex phenomenon³⁷37 Morin E. Introducción al pensamiento complejo. Barcelona: Gedisa; 1994.. In this respect, from the standpoint of the complexity paradigm (distinction-conjunction), it is a bio-socio-cultural phenomenon, characterised by simultaneous relationships of three types: complementary, antagonistic and ambiguous³⁸38 Morin E. El paradigma perdido. Barcelona: Kairos; 2005.. These relations stem from the practices and knowledge of the scientific fields that shape biobanks, in the following manner:

This tangle of significations has had an impact on how Humanity and the human world are conceived. New problems were pointed up by Philosophy, including the Ontology of Being through subjectivity (genetic reductionism, determinism, essentialism and fatalism) and Ontology of the World (bioartefacts); by Ethics, questioning the criteria (utility, justice, law and so on) for setting guidelines and determining what is good; and lastly, by Political Philosophy, debating State sovereignty and cosmopolitanism and pointing to global governance, as well as the problems arising from multi- and pluri-culturality.

Discussion

Summary of the evidence

Definitory category

From the analysis and systematisation of the preceding information, it was possible to identify recurrent elements, from which the following definition was proposed¹1 Soto-Gómez L. Regulating Mexican Biobanks for Human Biomedical Research: What can be Learned from the European Experience? Mex Law Rev 2014; 7(1):31-55.

2 Laurence L. Convention on Human Rights and Biomedicine: The Oviedo Convention. In: Brena IS, Ruíz de Chávez MH, coordinadores. Bioética y derechos humanos. México: IIJ-UNAM; 2018.

3 Garza-Rodríguez ML, Pérez-Maya AA, Monsivais-Ovalle DE, Velázquez-Vadillo JF, Barrera-Saldaña, HA. El Biobanco Institucional como pilar de las ciencias médicas. Salud Publica Mex 2016; 58(4):483-489.

4 Lee J. Artificial Intelligence in the Future Biobanking: Current Issues in the Biobank and Future Possibilities of Artificial Intelligence. Biomed J Sci Tech Res 2018; 7(3):5937-5939.

5 Benítez-Arvizu G, Palma-Lara I, Alcántara-Quintana L. Biobancos de células troncales para terapia celular. Una realidad en México. Rev Med Inst Mex Seguro Soc 2014; 52(3):244-247.

6 Bernal-Gómez BM, Bernal-Gómez DR. Investigación Biomédica y Biobancos: Una Reflexión para su Implementación. Principia Iuris 2018; 16(29):128-143.

7 Instituto de Salud Carlos III, Comité de Ética del Instituto de Investigación de Enfermedades Raras (IIER). Recomendaciones sobre los aspectos éticos de las colecciones de muestras y bancos de materiales humanos con fines de investigación biomédica. Rev Esp Salud Publica 2007; 81(2):95-111.

8 Chen H, Pang T. A call for global governance of biobanks. Bull WHO 2015; 93(2):113-117.

9 Marodin G, França P, Rocha JCC, Campos AH. Biobanking for health research in Brazil: Present challenges and future directions. Rev Panam Salud Publica 2012; 31(6):523-528.

10 Luna-González ML, Guío-Mahecha E, Becerra-Bayona S, Serrano-Díaz N. La gestión de los datos, un proceso esencial para el desarrollo del Biobanco. Rev Univ Ind Santander Salud 2016; 48(4):548-553.

11 Mendy M, Caboux E, Lawlor RT, Wright J, Wild CP. Common mínimum technical standards and protocols for biobanks dedicated to cancer research. Lyon: Int Agency Res Cancer; 2017.

12 Martínez JC, Briceño I, Alejandra H, Gómez A. Biobancos. Una estrategia inteligente y esencial para la conservación de muestras biológicas. Acta Med Colomb 2012; 37(3):158-162.

13 Capron AM, Mauron A, Elger BS, Boggio A, Ganguli-Mitra A, Biller-Andorno N. Ethical norms and the international governance of genetic databases and biobanks: findings from an international study. Kennedy Inst Ethics J 2009; 19(2):101-124.

14 Brena-Sesma I. Biobancos, un asunto pendiente de legislar. Bol Mex Der Comp 2010; 43(129):1055-1079.

15 Marodin G, Salgueiro JB, Motta ML. Pacheco-Santos LM. Brazilian guidelines for biorepositories and biobanks of human biological material. Rev Assoc Med Bras 2013; 59(1):72-77.

16 Gottweis H, Lauss G. Biobank governance: heterogeneous models of ordering and democratization. J Community Genet 2012; 3(2):61-72.

17 Paskal W, Paskal AM, Debski T, Gryziak M, Jaworowski J. Aspects of Modern Biobank Activity - Comprehensive Review. Pathol Oncol Res. 2018; 24(4):771-785.

18 Serrano-Díaz N, Páez-Leal MC, Luna-González ML, Guío-Mahecha E. Biobanco: Herramienta fundamental para la investigación biomédica actual. Rev Univ Ind Santander Salud 2016; 48(2):97-117.

19 Milanovic F, Merleau-Ponty N, Pitrou P. Biobanks and the reconfiguration of the living. New Genetics Soc 2018; 37(4):285-295.

20 Ommen GV, Törnwall O, Bréchot C, Dagher G, Galli J, Hveem K, Landegren U, Luchinat C, Metspalu A, Nilsson C, Solesvik OV, Perola M, Litton J, Zatloukal K. BBMRI-ERIC as a resource for pharmaceutical and life science industries: the development of biobank-based Expert Centres. Eur J Hum Genet 2015; 23(7):893-900.

Godard B, Schmidtke J, Cassiman JJ, Ayme S. Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A profesional perspective. Eur J Hum Genet 2003; 11(Supl. 2):S88-122.

22 Bryzgalina E, Alasania KY, Varkhotov T, Gavrilenko SM, Shkomova, EM. The social dimension of biobanking: objectives and challenges. Life Sci Soc Policy 2017; 13(1):1-11.

23 Villarroel R. Biopolitical administration within Biobanks. Acta Bioethica 2013; 19(1):39-47.

24 De Souza YG, Greenspan JS. Biobanking past, present and future: responsibilities and benefits. AIDS 2013; 27(3):303-312.

25 Domaradzki J, Pawlikowski J. Public Attitudes toward Biobanking of Human Biological Material for Research Purposes: A Literature Review. Int J Environ Res Public Health 2019; 16(12):2209.^-2626 Kinkorová J, Topolcan O. Biobanks in Horizon 2020: sustainability and attractive perspectives. EPMA J 2018; 9(4):345-353.^,2828 Domaradzki J. Geneticization and biobanking. Polish Sociological Review 2019; 205(1):103-117.

29 Hamilton C. Intellectual property rights, the bioeconomy and the challenge of biopiracy. Genom Soc Policy 2008; 4(3):26-45.^-3030 Brochhausen M, Zheng J, Birtwell, D, Williams H, Masci AM, Ellis HJ, Stoeckert CJ Jr. OBIB-a novel ontology for biobanking. J Biomed Semantics 2016; 7(1):23.: a biobank is the physical space that houses human samples (DNA, RNA, cells, fluids, tissues and organs) and non-human (plant and animal) samples, necessarily linked to a virtual space where its data base is hosted associating the biological information sample (biological data) with donor information (patient data), such as clinical history, geographical location, ethnicity, lifestyle, labour history, personality and environment.

The various sciences characterised biobanks as, among other things, rational, systematic, not-for-profit and guided by solidarity (regarding the community payback principle). As regards their objects and purposes:

- Health sciences emphasised research and experimentation, personalised medicine, pharmacogenetics and others³3 Garza-Rodríguez ML, Pérez-Maya AA, Monsivais-Ovalle DE, Velázquez-Vadillo JF, Barrera-Saldaña, HA. El Biobanco Institucional como pilar de las ciencias médicas. Salud Publica Mex 2016; 58(4):483-489.^,55 Benítez-Arvizu G, Palma-Lara I, Alcántara-Quintana L. Biobancos de células troncales para terapia celular. Una realidad en México. Rev Med Inst Mex Seguro Soc 2014; 52(3):244-247.

6 Bernal-Gómez BM, Bernal-Gómez DR. Investigación Biomédica y Biobancos: Una Reflexión para su Implementación. Principia Iuris 2018; 16(29):128-143.^-77 Instituto de Salud Carlos III, Comité de Ética del Instituto de Investigación de Enfermedades Raras (IIER). Recomendaciones sobre los aspectos éticos de las colecciones de muestras y bancos de materiales humanos con fines de investigación biomédica. Rev Esp Salud Publica 2007; 81(2):95-111.^,1212 Martínez JC, Briceño I, Alejandra H, Gómez A. Biobancos. Una estrategia inteligente y esencial para la conservación de muestras biológicas. Acta Med Colomb 2012; 37(3):158-162.^,1313 Capron AM, Mauron A, Elger BS, Boggio A, Ganguli-Mitra A, Biller-Andorno N. Ethical norms and the international governance of genetic databases and biobanks: findings from an international study. Kennedy Inst Ethics J 2009; 19(2):101-124.^,1515 Marodin G, Salgueiro JB, Motta ML. Pacheco-Santos LM. Brazilian guidelines for biorepositories and biobanks of human biological material. Rev Assoc Med Bras 2013; 59(1):72-77.^,1717 Paskal W, Paskal AM, Debski T, Gryziak M, Jaworowski J. Aspects of Modern Biobank Activity - Comprehensive Review. Pathol Oncol Res. 2018; 24(4):771-785.

18 Serrano-Díaz N, Páez-Leal MC, Luna-González ML, Guío-Mahecha E. Biobanco: Herramienta fundamental para la investigación biomédica actual. Rev Univ Ind Santander Salud 2016; 48(2):97-117.

19 Milanovic F, Merleau-Ponty N, Pitrou P. Biobanks and the reconfiguration of the living. New Genetics Soc 2018; 37(4):285-295.

20 Ommen GV, Törnwall O, Bréchot C, Dagher G, Galli J, Hveem K, Landegren U, Luchinat C, Metspalu A, Nilsson C, Solesvik OV, Perola M, Litton J, Zatloukal K. BBMRI-ERIC as a resource for pharmaceutical and life science industries: the development of biobank-based Expert Centres. Eur J Hum Genet 2015; 23(7):893-900.^-21Godard B, Schmidtke J, Cassiman JJ, Ayme S. Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A profesional perspective. Eur J Hum Genet 2003; 11(Supl. 2):S88-122.^,2525 Domaradzki J, Pawlikowski J. Public Attitudes toward Biobanking of Human Biological Material for Research Purposes: A Literature Review. Int J Environ Res Public Health 2019; 16(12):2209.^,2626 Kinkorová J, Topolcan O. Biobanks in Horizon 2020: sustainability and attractive perspectives. EPMA J 2018; 9(4):345-353.^,3030 Brochhausen M, Zheng J, Birtwell, D, Williams H, Masci AM, Ellis HJ, Stoeckert CJ Jr. OBIB-a novel ontology for biobanking. J Biomed Semantics 2016; 7(1):23..

- The exact sciences stressed their virtual space, data bases and technology⁴4 Lee J. Artificial Intelligence in the Future Biobanking: Current Issues in the Biobank and Future Possibilities of Artificial Intelligence. Biomed J Sci Tech Res 2018; 7(3):5937-5939.^,77 Instituto de Salud Carlos III, Comité de Ética del Instituto de Investigación de Enfermedades Raras (IIER). Recomendaciones sobre los aspectos éticos de las colecciones de muestras y bancos de materiales humanos con fines de investigación biomédica. Rev Esp Salud Publica 2007; 81(2):95-111.^,1010 Luna-González ML, Guío-Mahecha E, Becerra-Bayona S, Serrano-Díaz N. La gestión de los datos, un proceso esencial para el desarrollo del Biobanco. Rev Univ Ind Santander Salud 2016; 48(4):548-553.^,1212 Martínez JC, Briceño I, Alejandra H, Gómez A. Biobancos. Una estrategia inteligente y esencial para la conservación de muestras biológicas. Acta Med Colomb 2012; 37(3):158-162.^,1414 Brena-Sesma I. Biobancos, un asunto pendiente de legislar. Bol Mex Der Comp 2010; 43(129):1055-1079.^,1515 Marodin G, Salgueiro JB, Motta ML. Pacheco-Santos LM. Brazilian guidelines for biorepositories and biobanks of human biological material. Rev Assoc Med Bras 2013; 59(1):72-77.^,2626 Kinkorová J, Topolcan O. Biobanks in Horizon 2020: sustainability and attractive perspectives. EPMA J 2018; 9(4):345-353.^,3030 Brochhausen M, Zheng J, Birtwell, D, Williams H, Masci AM, Ellis HJ, Stoeckert CJ Jr. OBIB-a novel ontology for biobanking. J Biomed Semantics 2016; 7(1):23..

- The social sciences highlighted the applicable legal norms; human rights and intellectual property rights; regional and global political agendas; control, authority and global governance; social problems, such as stigmatisation or discrimination by ethnic origin; economic problems, such as conflicts of interest; sociological and anthropological problems, such as the new forms of socialisation processes with regard to bio-objects; and others¹1 Soto-Gómez L. Regulating Mexican Biobanks for Human Biomedical Research: What can be Learned from the European Experience? Mex Law Rev 2014; 7(1):31-55.^,22 Laurence L. Convention on Human Rights and Biomedicine: The Oviedo Convention. In: Brena IS, Ruíz de Chávez MH, coordinadores. Bioética y derechos humanos. México: IIJ-UNAM; 2018.^,66 Bernal-Gómez BM, Bernal-Gómez DR. Investigación Biomédica y Biobancos: Una Reflexión para su Implementación. Principia Iuris 2018; 16(29):128-143.^,77 Instituto de Salud Carlos III, Comité de Ética del Instituto de Investigación de Enfermedades Raras (IIER). Recomendaciones sobre los aspectos éticos de las colecciones de muestras y bancos de materiales humanos con fines de investigación biomédica. Rev Esp Salud Publica 2007; 81(2):95-111.^,1010 Luna-González ML, Guío-Mahecha E, Becerra-Bayona S, Serrano-Díaz N. La gestión de los datos, un proceso esencial para el desarrollo del Biobanco. Rev Univ Ind Santander Salud 2016; 48(4):548-553.^,1313 Capron AM, Mauron A, Elger BS, Boggio A, Ganguli-Mitra A, Biller-Andorno N. Ethical norms and the international governance of genetic databases and biobanks: findings from an international study. Kennedy Inst Ethics J 2009; 19(2):101-124.

14 Brena-Sesma I. Biobancos, un asunto pendiente de legislar. Bol Mex Der Comp 2010; 43(129):1055-1079.^-1515 Marodin G, Salgueiro JB, Motta ML. Pacheco-Santos LM. Brazilian guidelines for biorepositories and biobanks of human biological material. Rev Assoc Med Bras 2013; 59(1):72-77.^,1919 Milanovic F, Merleau-Ponty N, Pitrou P. Biobanks and the reconfiguration of the living. New Genetics Soc 2018; 37(4):285-295.^,21Godard B, Schmidtke J, Cassiman JJ, Ayme S. Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A profesional perspective. Eur J Hum Genet 2003; 11(Supl. 2):S88-122.^,2323 Villarroel R. Biopolitical administration within Biobanks. Acta Bioethica 2013; 19(1):39-47.^,2727 Nemogá-Soto G. Dilemas sobre Biobancos: asuntos éticos y jurídicos. Pensamiento Jurídico 2012; 35:195-230.

28 Domaradzki J. Geneticization and biobanking. Polish Sociological Review 2019; 205(1):103-117.^-2929 Hamilton C. Intellectual property rights, the bioeconomy and the challenge of biopiracy. Genom Soc Policy 2008; 4(3):26-45..

- The humanities pointed to concerns with bioethics, philosophy of science and technology, ontology, political philosophy, artificial intelligence, biological and technological determinism and others¹1 Soto-Gómez L. Regulating Mexican Biobanks for Human Biomedical Research: What can be Learned from the European Experience? Mex Law Rev 2014; 7(1):31-55.

2 Laurence L. Convention on Human Rights and Biomedicine: The Oviedo Convention. In: Brena IS, Ruíz de Chávez MH, coordinadores. Bioética y derechos humanos. México: IIJ-UNAM; 2018.

3 Garza-Rodríguez ML, Pérez-Maya AA, Monsivais-Ovalle DE, Velázquez-Vadillo JF, Barrera-Saldaña, HA. El Biobanco Institucional como pilar de las ciencias médicas. Salud Publica Mex 2016; 58(4):483-489.

4 Lee J. Artificial Intelligence in the Future Biobanking: Current Issues in the Biobank and Future Possibilities of Artificial Intelligence. Biomed J Sci Tech Res 2018; 7(3):5937-5939.

5 Benítez-Arvizu G, Palma-Lara I, Alcántara-Quintana L. Biobancos de células troncales para terapia celular. Una realidad en México. Rev Med Inst Mex Seguro Soc 2014; 52(3):244-247.

6 Bernal-Gómez BM, Bernal-Gómez DR. Investigación Biomédica y Biobancos: Una Reflexión para su Implementación. Principia Iuris 2018; 16(29):128-143.

7 Instituto de Salud Carlos III, Comité de Ética del Instituto de Investigación de Enfermedades Raras (IIER). Recomendaciones sobre los aspectos éticos de las colecciones de muestras y bancos de materiales humanos con fines de investigación biomédica. Rev Esp Salud Publica 2007; 81(2):95-111.

8 Chen H, Pang T. A call for global governance of biobanks. Bull WHO 2015; 93(2):113-117.

9 Marodin G, França P, Rocha JCC, Campos AH. Biobanking for health research in Brazil: Present challenges and future directions. Rev Panam Salud Publica 2012; 31(6):523-528.

10 Luna-González ML, Guío-Mahecha E, Becerra-Bayona S, Serrano-Díaz N. La gestión de los datos, un proceso esencial para el desarrollo del Biobanco. Rev Univ Ind Santander Salud 2016; 48(4):548-553.

11 Mendy M, Caboux E, Lawlor RT, Wright J, Wild CP. Common mínimum technical standards and protocols for biobanks dedicated to cancer research. Lyon: Int Agency Res Cancer; 2017.

12 Martínez JC, Briceño I, Alejandra H, Gómez A. Biobancos. Una estrategia inteligente y esencial para la conservación de muestras biológicas. Acta Med Colomb 2012; 37(3):158-162.

13 Capron AM, Mauron A, Elger BS, Boggio A, Ganguli-Mitra A, Biller-Andorno N. Ethical norms and the international governance of genetic databases and biobanks: findings from an international study. Kennedy Inst Ethics J 2009; 19(2):101-124.

14 Brena-Sesma I. Biobancos, un asunto pendiente de legislar. Bol Mex Der Comp 2010; 43(129):1055-1079.

15 Marodin G, Salgueiro JB, Motta ML. Pacheco-Santos LM. Brazilian guidelines for biorepositories and biobanks of human biological material. Rev Assoc Med Bras 2013; 59(1):72-77.

16 Gottweis H, Lauss G. Biobank governance: heterogeneous models of ordering and democratization. J Community Genet 2012; 3(2):61-72.

17 Paskal W, Paskal AM, Debski T, Gryziak M, Jaworowski J. Aspects of Modern Biobank Activity - Comprehensive Review. Pathol Oncol Res. 2018; 24(4):771-785.

18 Serrano-Díaz N, Páez-Leal MC, Luna-González ML, Guío-Mahecha E. Biobanco: Herramienta fundamental para la investigación biomédica actual. Rev Univ Ind Santander Salud 2016; 48(2):97-117.

19 Milanovic F, Merleau-Ponty N, Pitrou P. Biobanks and the reconfiguration of the living. New Genetics Soc 2018; 37(4):285-295.

20 Ommen GV, Törnwall O, Bréchot C, Dagher G, Galli J, Hveem K, Landegren U, Luchinat C, Metspalu A, Nilsson C, Solesvik OV, Perola M, Litton J, Zatloukal K. BBMRI-ERIC as a resource for pharmaceutical and life science industries: the development of biobank-based Expert Centres. Eur J Hum Genet 2015; 23(7):893-900.

Godard B, Schmidtke J, Cassiman JJ, Ayme S. Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A profesional perspective. Eur J Hum Genet 2003; 11(Supl. 2):S88-122.

22 Bryzgalina E, Alasania KY, Varkhotov T, Gavrilenko SM, Shkomova, EM. The social dimension of biobanking: objectives and challenges. Life Sci Soc Policy 2017; 13(1):1-11.

23 Villarroel R. Biopolitical administration within Biobanks. Acta Bioethica 2013; 19(1):39-47.

24 De Souza YG, Greenspan JS. Biobanking past, present and future: responsibilities and benefits. AIDS 2013; 27(3):303-312.

25 Domaradzki J, Pawlikowski J. Public Attitudes toward Biobanking of Human Biological Material for Research Purposes: A Literature Review. Int J Environ Res Public Health 2019; 16(12):2209.

26 Kinkorová J, Topolcan O. Biobanks in Horizon 2020: sustainability and attractive perspectives. EPMA J 2018; 9(4):345-353.

27 Nemogá-Soto G. Dilemas sobre Biobancos: asuntos éticos y jurídicos. Pensamiento Jurídico 2012; 35:195-230.

28 Domaradzki J. Geneticization and biobanking. Polish Sociological Review 2019; 205(1):103-117.

29 Hamilton C. Intellectual property rights, the bioeconomy and the challenge of biopiracy. Genom Soc Policy 2008; 4(3):26-45.^-3030 Brochhausen M, Zheng J, Birtwell, D, Williams H, Masci AM, Ellis HJ, Stoeckert CJ Jr. OBIB-a novel ontology for biobanking. J Biomed Semantics 2016; 7(1):23..

Also striking was that the meaning of the scientific definitions (discourses and practices) and the uses of technology varied by socioeconomic group. For example, the private sector directed definitions towards pathology, pharmacogenomics, genomic aesthetics, transgenic research in plants and animals²⁰20 Ommen GV, Törnwall O, Bréchot C, Dagher G, Galli J, Hveem K, Landegren U, Luchinat C, Metspalu A, Nilsson C, Solesvik OV, Perola M, Litton J, Zatloukal K. BBMRI-ERIC as a resource for pharmaceutical and life science industries: the development of biobank-based Expert Centres. Eur J Hum Genet 2015; 23(7):893-900.^,2626 Kinkorová J, Topolcan O. Biobanks in Horizon 2020: sustainability and attractive perspectives. EPMA J 2018; 9(4):345-353.^,2828 Domaradzki J. Geneticization and biobanking. Polish Sociological Review 2019; 205(1):103-117.^,2929 Hamilton C. Intellectual property rights, the bioeconomy and the challenge of biopiracy. Genom Soc Policy 2008; 4(3):26-45., while the public sector was oriented towards achieving the public good and public health⁷7 Instituto de Salud Carlos III, Comité de Ética del Instituto de Investigación de Enfermedades Raras (IIER). Recomendaciones sobre los aspectos éticos de las colecciones de muestras y bancos de materiales humanos con fines de investigación biomédica. Rev Esp Salud Publica 2007; 81(2):95-111.^,99 Marodin G, França P, Rocha JCC, Campos AH. Biobanking for health research in Brazil: Present challenges and future directions. Rev Panam Salud Publica 2012; 31(6):523-528.^,2525 Domaradzki J, Pawlikowski J. Public Attitudes toward Biobanking of Human Biological Material for Research Purposes: A Literature Review. Int J Environ Res Public Health 2019; 16(12):2209. and the social sector moved by collective interests²²22 Bryzgalina E, Alasania KY, Varkhotov T, Gavrilenko SM, Shkomova, EM. The social dimension of biobanking: objectives and challenges. Life Sci Soc Policy 2017; 13(1):1-11.^,2828 Domaradzki J. Geneticization and biobanking. Polish Sociological Review 2019; 205(1):103-117. looked to pathologies associated with specific social groups or connected with social struggles¹⁶16 Gottweis H, Lauss G. Biobank governance: heterogeneous models of ordering and democratization. J Community Genet 2012; 3(2):61-72..

From the analysis and systematisation of the documents, the following typology of biobanks was established¹1 Soto-Gómez L. Regulating Mexican Biobanks for Human Biomedical Research: What can be Learned from the European Experience? Mex Law Rev 2014; 7(1):31-55.

2 Laurence L. Convention on Human Rights and Biomedicine: The Oviedo Convention. In: Brena IS, Ruíz de Chávez MH, coordinadores. Bioética y derechos humanos. México: IIJ-UNAM; 2018.

3 Garza-Rodríguez ML, Pérez-Maya AA, Monsivais-Ovalle DE, Velázquez-Vadillo JF, Barrera-Saldaña, HA. El Biobanco Institucional como pilar de las ciencias médicas. Salud Publica Mex 2016; 58(4):483-489.

4 Lee J. Artificial Intelligence in the Future Biobanking: Current Issues in the Biobank and Future Possibilities of Artificial Intelligence. Biomed J Sci Tech Res 2018; 7(3):5937-5939.

5 Benítez-Arvizu G, Palma-Lara I, Alcántara-Quintana L. Biobancos de células troncales para terapia celular. Una realidad en México. Rev Med Inst Mex Seguro Soc 2014; 52(3):244-247.

6 Bernal-Gómez BM, Bernal-Gómez DR. Investigación Biomédica y Biobancos: Una Reflexión para su Implementación. Principia Iuris 2018; 16(29):128-143.

7 Instituto de Salud Carlos III, Comité de Ética del Instituto de Investigación de Enfermedades Raras (IIER). Recomendaciones sobre los aspectos éticos de las colecciones de muestras y bancos de materiales humanos con fines de investigación biomédica. Rev Esp Salud Publica 2007; 81(2):95-111.

8 Chen H, Pang T. A call for global governance of biobanks. Bull WHO 2015; 93(2):113-117.

9 Marodin G, França P, Rocha JCC, Campos AH. Biobanking for health research in Brazil: Present challenges and future directions. Rev Panam Salud Publica 2012; 31(6):523-528.

10 Luna-González ML, Guío-Mahecha E, Becerra-Bayona S, Serrano-Díaz N. La gestión de los datos, un proceso esencial para el desarrollo del Biobanco. Rev Univ Ind Santander Salud 2016; 48(4):548-553.

11 Mendy M, Caboux E, Lawlor RT, Wright J, Wild CP. Common mínimum technical standards and protocols for biobanks dedicated to cancer research. Lyon: Int Agency Res Cancer; 2017.

12 Martínez JC, Briceño I, Alejandra H, Gómez A. Biobancos. Una estrategia inteligente y esencial para la conservación de muestras biológicas. Acta Med Colomb 2012; 37(3):158-162.

13 Capron AM, Mauron A, Elger BS, Boggio A, Ganguli-Mitra A, Biller-Andorno N. Ethical norms and the international governance of genetic databases and biobanks: findings from an international study. Kennedy Inst Ethics J 2009; 19(2):101-124.

14 Brena-Sesma I. Biobancos, un asunto pendiente de legislar. Bol Mex Der Comp 2010; 43(129):1055-1079.

15 Marodin G, Salgueiro JB, Motta ML. Pacheco-Santos LM. Brazilian guidelines for biorepositories and biobanks of human biological material. Rev Assoc Med Bras 2013; 59(1):72-77.

16 Gottweis H, Lauss G. Biobank governance: heterogeneous models of ordering and democratization. J Community Genet 2012; 3(2):61-72.

17 Paskal W, Paskal AM, Debski T, Gryziak M, Jaworowski J. Aspects of Modern Biobank Activity - Comprehensive Review. Pathol Oncol Res. 2018; 24(4):771-785.

18 Serrano-Díaz N, Páez-Leal MC, Luna-González ML, Guío-Mahecha E. Biobanco: Herramienta fundamental para la investigación biomédica actual. Rev Univ Ind Santander Salud 2016; 48(2):97-117.

19 Milanovic F, Merleau-Ponty N, Pitrou P. Biobanks and the reconfiguration of the living. New Genetics Soc 2018; 37(4):285-295.

20 Ommen GV, Törnwall O, Bréchot C, Dagher G, Galli J, Hveem K, Landegren U, Luchinat C, Metspalu A, Nilsson C, Solesvik OV, Perola M, Litton J, Zatloukal K. BBMRI-ERIC as a resource for pharmaceutical and life science industries: the development of biobank-based Expert Centres. Eur J Hum Genet 2015; 23(7):893-900.

Godard B, Schmidtke J, Cassiman JJ, Ayme S. Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A profesional perspective. Eur J Hum Genet 2003; 11(Supl. 2):S88-122.

22 Bryzgalina E, Alasania KY, Varkhotov T, Gavrilenko SM, Shkomova, EM. The social dimension of biobanking: objectives and challenges. Life Sci Soc Policy 2017; 13(1):1-11.

23 Villarroel R. Biopolitical administration within Biobanks. Acta Bioethica 2013; 19(1):39-47.

24 De Souza YG, Greenspan JS. Biobanking past, present and future: responsibilities and benefits. AIDS 2013; 27(3):303-312.

25 Domaradzki J, Pawlikowski J. Public Attitudes toward Biobanking of Human Biological Material for Research Purposes: A Literature Review. Int J Environ Res Public Health 2019; 16(12):2209.

26 Kinkorová J, Topolcan O. Biobanks in Horizon 2020: sustainability and attractive perspectives. EPMA J 2018; 9(4):345-353.

27 Nemogá-Soto G. Dilemas sobre Biobancos: asuntos éticos y jurídicos. Pensamiento Jurídico 2012; 35:195-230.

28 Domaradzki J. Geneticization and biobanking. Polish Sociological Review 2019; 205(1):103-117.

29 Hamilton C. Intellectual property rights, the bioeconomy and the challenge of biopiracy. Genom Soc Policy 2008; 4(3):26-45.^-3030 Brochhausen M, Zheng J, Birtwell, D, Williams H, Masci AM, Ellis HJ, Stoeckert CJ Jr. OBIB-a novel ontology for biobanking. J Biomed Semantics 2016; 7(1):23.:

Action category

The analysis and systematisation identified two major types of process¹1 Soto-Gómez L. Regulating Mexican Biobanks for Human Biomedical Research: What can be Learned from the European Experience? Mex Law Rev 2014; 7(1):31-55.

2 Laurence L. Convention on Human Rights and Biomedicine: The Oviedo Convention. In: Brena IS, Ruíz de Chávez MH, coordinadores. Bioética y derechos humanos. México: IIJ-UNAM; 2018.

3 Garza-Rodríguez ML, Pérez-Maya AA, Monsivais-Ovalle DE, Velázquez-Vadillo JF, Barrera-Saldaña, HA. El Biobanco Institucional como pilar de las ciencias médicas. Salud Publica Mex 2016; 58(4):483-489.

4 Lee J. Artificial Intelligence in the Future Biobanking: Current Issues in the Biobank and Future Possibilities of Artificial Intelligence. Biomed J Sci Tech Res 2018; 7(3):5937-5939.

5 Benítez-Arvizu G, Palma-Lara I, Alcántara-Quintana L. Biobancos de células troncales para terapia celular. Una realidad en México. Rev Med Inst Mex Seguro Soc 2014; 52(3):244-247.

6 Bernal-Gómez BM, Bernal-Gómez DR. Investigación Biomédica y Biobancos: Una Reflexión para su Implementación. Principia Iuris 2018; 16(29):128-143.

7 Instituto de Salud Carlos III, Comité de Ética del Instituto de Investigación de Enfermedades Raras (IIER). Recomendaciones sobre los aspectos éticos de las colecciones de muestras y bancos de materiales humanos con fines de investigación biomédica. Rev Esp Salud Publica 2007; 81(2):95-111.

8 Chen H, Pang T. A call for global governance of biobanks. Bull WHO 2015; 93(2):113-117.

9 Marodin G, França P, Rocha JCC, Campos AH. Biobanking for health research in Brazil: Present challenges and future directions. Rev Panam Salud Publica 2012; 31(6):523-528.

10 Luna-González ML, Guío-Mahecha E, Becerra-Bayona S, Serrano-Díaz N. La gestión de los datos, un proceso esencial para el desarrollo del Biobanco. Rev Univ Ind Santander Salud 2016; 48(4):548-553.

11 Mendy M, Caboux E, Lawlor RT, Wright J, Wild CP. Common mínimum technical standards and protocols for biobanks dedicated to cancer research. Lyon: Int Agency Res Cancer; 2017.

12 Martínez JC, Briceño I, Alejandra H, Gómez A. Biobancos. Una estrategia inteligente y esencial para la conservación de muestras biológicas. Acta Med Colomb 2012; 37(3):158-162.

13 Capron AM, Mauron A, Elger BS, Boggio A, Ganguli-Mitra A, Biller-Andorno N. Ethical norms and the international governance of genetic databases and biobanks: findings from an international study. Kennedy Inst Ethics J 2009; 19(2):101-124.

14 Brena-Sesma I. Biobancos, un asunto pendiente de legislar. Bol Mex Der Comp 2010; 43(129):1055-1079.

15 Marodin G, Salgueiro JB, Motta ML. Pacheco-Santos LM. Brazilian guidelines for biorepositories and biobanks of human biological material. Rev Assoc Med Bras 2013; 59(1):72-77.

16 Gottweis H, Lauss G. Biobank governance: heterogeneous models of ordering and democratization. J Community Genet 2012; 3(2):61-72.

17 Paskal W, Paskal AM, Debski T, Gryziak M, Jaworowski J. Aspects of Modern Biobank Activity - Comprehensive Review. Pathol Oncol Res. 2018; 24(4):771-785.

18 Serrano-Díaz N, Páez-Leal MC, Luna-González ML, Guío-Mahecha E. Biobanco: Herramienta fundamental para la investigación biomédica actual. Rev Univ Ind Santander Salud 2016; 48(2):97-117.

19 Milanovic F, Merleau-Ponty N, Pitrou P. Biobanks and the reconfiguration of the living. New Genetics Soc 2018; 37(4):285-295.

20 Ommen GV, Törnwall O, Bréchot C, Dagher G, Galli J, Hveem K, Landegren U, Luchinat C, Metspalu A, Nilsson C, Solesvik OV, Perola M, Litton J, Zatloukal K. BBMRI-ERIC as a resource for pharmaceutical and life science industries: the development of biobank-based Expert Centres. Eur J Hum Genet 2015; 23(7):893-900.

Godard B, Schmidtke J, Cassiman JJ, Ayme S. Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A profesional perspective. Eur J Hum Genet 2003; 11(Supl. 2):S88-122.^-2222 Bryzgalina E, Alasania KY, Varkhotov T, Gavrilenko SM, Shkomova, EM. The social dimension of biobanking: objectives and challenges. Life Sci Soc Policy 2017; 13(1):1-11.^,2424 De Souza YG, Greenspan JS. Biobanking past, present and future: responsibilities and benefits. AIDS 2013; 27(3):303-312.

25 Domaradzki J, Pawlikowski J. Public Attitudes toward Biobanking of Human Biological Material for Research Purposes: A Literature Review. Int J Environ Res Public Health 2019; 16(12):2209.

26 Kinkorová J, Topolcan O. Biobanks in Horizon 2020: sustainability and attractive perspectives. EPMA J 2018; 9(4):345-353.

27 Nemogá-Soto G. Dilemas sobre Biobancos: asuntos éticos y jurídicos. Pensamiento Jurídico 2012; 35:195-230.

28 Domaradzki J. Geneticization and biobanking. Polish Sociological Review 2019; 205(1):103-117.

29 Hamilton C. Intellectual property rights, the bioeconomy and the challenge of biopiracy. Genom Soc Policy 2008; 4(3):26-45.^-3030 Brochhausen M, Zheng J, Birtwell, D, Williams H, Masci AM, Ellis HJ, Stoeckert CJ Jr. OBIB-a novel ontology for biobanking. J Biomed Semantics 2016; 7(1):23., the first relating to the biological samples, here termed the Biological Process, and second, relating to the data extracted from the samples and the systematisation of information, termed the Bioinformatics Process.

The purposes of the Biological Process were to preserve, identify, classify and safeguard the sample and, when appropriate, transfer it in part or whole. In this connection, an international endeavour is underway to homogenise both techniques and procedures. The stages into which the process was divided depend on the type and characteristics of the biological material, but generally speaking they can be considered to be the following¹1 Soto-Gómez L. Regulating Mexican Biobanks for Human Biomedical Research: What can be Learned from the European Experience? Mex Law Rev 2014; 7(1):31-55.

2 Laurence L. Convention on Human Rights and Biomedicine: The Oviedo Convention. In: Brena IS, Ruíz de Chávez MH, coordinadores. Bioética y derechos humanos. México: IIJ-UNAM; 2018.

3 Garza-Rodríguez ML, Pérez-Maya AA, Monsivais-Ovalle DE, Velázquez-Vadillo JF, Barrera-Saldaña, HA. El Biobanco Institucional como pilar de las ciencias médicas. Salud Publica Mex 2016; 58(4):483-489.

4 Lee J. Artificial Intelligence in the Future Biobanking: Current Issues in the Biobank and Future Possibilities of Artificial Intelligence. Biomed J Sci Tech Res 2018; 7(3):5937-5939.

5 Benítez-Arvizu G, Palma-Lara I, Alcántara-Quintana L. Biobancos de células troncales para terapia celular. Una realidad en México. Rev Med Inst Mex Seguro Soc 2014; 52(3):244-247.

6 Bernal-Gómez BM, Bernal-Gómez DR. Investigación Biomédica y Biobancos: Una Reflexión para su Implementación. Principia Iuris 2018; 16(29):128-143.

7 Instituto de Salud Carlos III, Comité de Ética del Instituto de Investigación de Enfermedades Raras (IIER). Recomendaciones sobre los aspectos éticos de las colecciones de muestras y bancos de materiales humanos con fines de investigación biomédica. Rev Esp Salud Publica 2007; 81(2):95-111.

8 Chen H, Pang T. A call for global governance of biobanks. Bull WHO 2015; 93(2):113-117.

9 Marodin G, França P, Rocha JCC, Campos AH. Biobanking for health research in Brazil: Present challenges and future directions. Rev Panam Salud Publica 2012; 31(6):523-528.

10 Luna-González ML, Guío-Mahecha E, Becerra-Bayona S, Serrano-Díaz N. La gestión de los datos, un proceso esencial para el desarrollo del Biobanco. Rev Univ Ind Santander Salud 2016; 48(4):548-553.

11 Mendy M, Caboux E, Lawlor RT, Wright J, Wild CP. Common mínimum technical standards and protocols for biobanks dedicated to cancer research. Lyon: Int Agency Res Cancer; 2017.

12 Martínez JC, Briceño I, Alejandra H, Gómez A. Biobancos. Una estrategia inteligente y esencial para la conservación de muestras biológicas. Acta Med Colomb 2012; 37(3):158-162.

13 Capron AM, Mauron A, Elger BS, Boggio A, Ganguli-Mitra A, Biller-Andorno N. Ethical norms and the international governance of genetic databases and biobanks: findings from an international study. Kennedy Inst Ethics J 2009; 19(2):101-124.

14 Brena-Sesma I. Biobancos, un asunto pendiente de legislar. Bol Mex Der Comp 2010; 43(129):1055-1079.

15 Marodin G, Salgueiro JB, Motta ML. Pacheco-Santos LM. Brazilian guidelines for biorepositories and biobanks of human biological material. Rev Assoc Med Bras 2013; 59(1):72-77.

16 Gottweis H, Lauss G. Biobank governance: heterogeneous models of ordering and democratization. J Community Genet 2012; 3(2):61-72.

17 Paskal W, Paskal AM, Debski T, Gryziak M, Jaworowski J. Aspects of Modern Biobank Activity - Comprehensive Review. Pathol Oncol Res. 2018; 24(4):771-785.

18 Serrano-Díaz N, Páez-Leal MC, Luna-González ML, Guío-Mahecha E. Biobanco: Herramienta fundamental para la investigación biomédica actual. Rev Univ Ind Santander Salud 2016; 48(2):97-117.

19 Milanovic F, Merleau-Ponty N, Pitrou P. Biobanks and the reconfiguration of the living. New Genetics Soc 2018; 37(4):285-295.

20 Ommen GV, Törnwall O, Bréchot C, Dagher G, Galli J, Hveem K, Landegren U, Luchinat C, Metspalu A, Nilsson C, Solesvik OV, Perola M, Litton J, Zatloukal K. BBMRI-ERIC as a resource for pharmaceutical and life science industries: the development of biobank-based Expert Centres. Eur J Hum Genet 2015; 23(7):893-900.

Godard B, Schmidtke J, Cassiman JJ, Ayme S. Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A profesional perspective. Eur J Hum Genet 2003; 11(Supl. 2):S88-122.^-2222 Bryzgalina E, Alasania KY, Varkhotov T, Gavrilenko SM, Shkomova, EM. The social dimension of biobanking: objectives and challenges. Life Sci Soc Policy 2017; 13(1):1-11.^,2424 De Souza YG, Greenspan JS. Biobanking past, present and future: responsibilities and benefits. AIDS 2013; 27(3):303-312.

25 Domaradzki J, Pawlikowski J. Public Attitudes toward Biobanking of Human Biological Material for Research Purposes: A Literature Review. Int J Environ Res Public Health 2019; 16(12):2209.

26 Kinkorová J, Topolcan O. Biobanks in Horizon 2020: sustainability and attractive perspectives. EPMA J 2018; 9(4):345-353.

27 Nemogá-Soto G. Dilemas sobre Biobancos: asuntos éticos y jurídicos. Pensamiento Jurídico 2012; 35:195-230.

28 Domaradzki J. Geneticization and biobanking. Polish Sociological Review 2019; 205(1):103-117.

29 Hamilton C. Intellectual property rights, the bioeconomy and the challenge of biopiracy. Genom Soc Policy 2008; 4(3):26-45.^-3030 Brochhausen M, Zheng J, Birtwell, D, Williams H, Masci AM, Ellis HJ, Stoeckert CJ Jr. OBIB-a novel ontology for biobanking. J Biomed Semantics 2016; 7(1):23.:

The purposes of the Bioinformatics Process were to acquire, record, organise, analyse, interpret, store and distribute the biological data or information extracted directly from the samples, patients or donors and/or authors, which entailed producing data bases, algorithms, statistical tools and software to permit experimentation in silico (simulators, such as digital sequencing). For these purposes, biobanks had four 4 protocols, covering data base, data base security, catalogue formation and data access and sharing. The stages common to all biobanks were¹1 Soto-Gómez L. Regulating Mexican Biobanks for Human Biomedical Research: What can be Learned from the European Experience? Mex Law Rev 2014; 7(1):31-55.

2 Laurence L. Convention on Human Rights and Biomedicine: The Oviedo Convention. In: Brena IS, Ruíz de Chávez MH, coordinadores. Bioética y derechos humanos. México: IIJ-UNAM; 2018.

3 Garza-Rodríguez ML, Pérez-Maya AA, Monsivais-Ovalle DE, Velázquez-Vadillo JF, Barrera-Saldaña, HA. El Biobanco Institucional como pilar de las ciencias médicas. Salud Publica Mex 2016; 58(4):483-489.

4 Lee J. Artificial Intelligence in the Future Biobanking: Current Issues in the Biobank and Future Possibilities of Artificial Intelligence. Biomed J Sci Tech Res 2018; 7(3):5937-5939.

5 Benítez-Arvizu G, Palma-Lara I, Alcántara-Quintana L. Biobancos de células troncales para terapia celular. Una realidad en México. Rev Med Inst Mex Seguro Soc 2014; 52(3):244-247.

6 Bernal-Gómez BM, Bernal-Gómez DR. Investigación Biomédica y Biobancos: Una Reflexión para su Implementación. Principia Iuris 2018; 16(29):128-143.

7 Instituto de Salud Carlos III, Comité de Ética del Instituto de Investigación de Enfermedades Raras (IIER). Recomendaciones sobre los aspectos éticos de las colecciones de muestras y bancos de materiales humanos con fines de investigación biomédica. Rev Esp Salud Publica 2007; 81(2):95-111.

8 Chen H, Pang T. A call for global governance of biobanks. Bull WHO 2015; 93(2):113-117.

9 Marodin G, França P, Rocha JCC, Campos AH. Biobanking for health research in Brazil: Present challenges and future directions. Rev Panam Salud Publica 2012; 31(6):523-528.

10 Luna-González ML, Guío-Mahecha E, Becerra-Bayona S, Serrano-Díaz N. La gestión de los datos, un proceso esencial para el desarrollo del Biobanco. Rev Univ Ind Santander Salud 2016; 48(4):548-553.

11 Mendy M, Caboux E, Lawlor RT, Wright J, Wild CP. Common mínimum technical standards and protocols for biobanks dedicated to cancer research. Lyon: Int Agency Res Cancer; 2017.

12 Martínez JC, Briceño I, Alejandra H, Gómez A. Biobancos. Una estrategia inteligente y esencial para la conservación de muestras biológicas. Acta Med Colomb 2012; 37(3):158-162.

13 Capron AM, Mauron A, Elger BS, Boggio A, Ganguli-Mitra A, Biller-Andorno N. Ethical norms and the international governance of genetic databases and biobanks: findings from an international study. Kennedy Inst Ethics J 2009; 19(2):101-124.

14 Brena-Sesma I. Biobancos, un asunto pendiente de legislar. Bol Mex Der Comp 2010; 43(129):1055-1079.

15 Marodin G, Salgueiro JB, Motta ML. Pacheco-Santos LM. Brazilian guidelines for biorepositories and biobanks of human biological material. Rev Assoc Med Bras 2013; 59(1):72-77.

16 Gottweis H, Lauss G. Biobank governance: heterogeneous models of ordering and democratization. J Community Genet 2012; 3(2):61-72.

17 Paskal W, Paskal AM, Debski T, Gryziak M, Jaworowski J. Aspects of Modern Biobank Activity - Comprehensive Review. Pathol Oncol Res. 2018; 24(4):771-785.

18 Serrano-Díaz N, Páez-Leal MC, Luna-González ML, Guío-Mahecha E. Biobanco: Herramienta fundamental para la investigación biomédica actual. Rev Univ Ind Santander Salud 2016; 48(2):97-117.

19 Milanovic F, Merleau-Ponty N, Pitrou P. Biobanks and the reconfiguration of the living. New Genetics Soc 2018; 37(4):285-295.

20 Ommen GV, Törnwall O, Bréchot C, Dagher G, Galli J, Hveem K, Landegren U, Luchinat C, Metspalu A, Nilsson C, Solesvik OV, Perola M, Litton J, Zatloukal K. BBMRI-ERIC as a resource for pharmaceutical and life science industries: the development of biobank-based Expert Centres. Eur J Hum Genet 2015; 23(7):893-900.

Godard B, Schmidtke J, Cassiman JJ, Ayme S. Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A profesional perspective. Eur J Hum Genet 2003; 11(Supl. 2):S88-122.^-2222 Bryzgalina E, Alasania KY, Varkhotov T, Gavrilenko SM, Shkomova, EM. The social dimension of biobanking: objectives and challenges. Life Sci Soc Policy 2017; 13(1):1-11.^,2424 De Souza YG, Greenspan JS. Biobanking past, present and future: responsibilities and benefits. AIDS 2013; 27(3):303-312.

25 Domaradzki J, Pawlikowski J. Public Attitudes toward Biobanking of Human Biological Material for Research Purposes: A Literature Review. Int J Environ Res Public Health 2019; 16(12):2209.

26 Kinkorová J, Topolcan O. Biobanks in Horizon 2020: sustainability and attractive perspectives. EPMA J 2018; 9(4):345-353.

27 Nemogá-Soto G. Dilemas sobre Biobancos: asuntos éticos y jurídicos. Pensamiento Jurídico 2012; 35:195-230.

28 Domaradzki J. Geneticization and biobanking. Polish Sociological Review 2019; 205(1):103-117.

29 Hamilton C. Intellectual property rights, the bioeconomy and the challenge of biopiracy. Genom Soc Policy 2008; 4(3):26-45.^-3030 Brochhausen M, Zheng J, Birtwell, D, Williams H, Masci AM, Ellis HJ, Stoeckert CJ Jr. OBIB-a novel ontology for biobanking. J Biomed Semantics 2016; 7(1):23.:

Subjective category

Diverse agents intervene in the creation, administration and regulation of biobanks, but it was a consensus that States¹1 Soto-Gómez L. Regulating Mexican Biobanks for Human Biomedical Research: What can be Learned from the European Experience? Mex Law Rev 2014; 7(1):31-55.

2 Laurence L. Convention on Human Rights and Biomedicine: The Oviedo Convention. In: Brena IS, Ruíz de Chávez MH, coordinadores. Bioética y derechos humanos. México: IIJ-UNAM; 2018.

3 Garza-Rodríguez ML, Pérez-Maya AA, Monsivais-Ovalle DE, Velázquez-Vadillo JF, Barrera-Saldaña, HA. El Biobanco Institucional como pilar de las ciencias médicas. Salud Publica Mex 2016; 58(4):483-489.

4 Lee J. Artificial Intelligence in the Future Biobanking: Current Issues in the Biobank and Future Possibilities of Artificial Intelligence. Biomed J Sci Tech Res 2018; 7(3):5937-5939.

5 Benítez-Arvizu G, Palma-Lara I, Alcántara-Quintana L. Biobancos de células troncales para terapia celular. Una realidad en México. Rev Med Inst Mex Seguro Soc 2014; 52(3):244-247.

6 Bernal-Gómez BM, Bernal-Gómez DR. Investigación Biomédica y Biobancos: Una Reflexión para su Implementación. Principia Iuris 2018; 16(29):128-143.

7 Instituto de Salud Carlos III, Comité de Ética del Instituto de Investigación de Enfermedades Raras (IIER). Recomendaciones sobre los aspectos éticos de las colecciones de muestras y bancos de materiales humanos con fines de investigación biomédica. Rev Esp Salud Publica 2007; 81(2):95-111.

8 Chen H, Pang T. A call for global governance of biobanks. Bull WHO 2015; 93(2):113-117.

9 Marodin G, França P, Rocha JCC, Campos AH. Biobanking for health research in Brazil: Present challenges and future directions. Rev Panam Salud Publica 2012; 31(6):523-528.

10 Luna-González ML, Guío-Mahecha E, Becerra-Bayona S, Serrano-Díaz N. La gestión de los datos, un proceso esencial para el desarrollo del Biobanco. Rev Univ Ind Santander Salud 2016; 48(4):548-553.

11 Mendy M, Caboux E, Lawlor RT, Wright J, Wild CP. Common mínimum technical standards and protocols for biobanks dedicated to cancer research. Lyon: Int Agency Res Cancer; 2017.

12 Martínez JC, Briceño I, Alejandra H, Gómez A. Biobancos. Una estrategia inteligente y esencial para la conservación de muestras biológicas. Acta Med Colomb 2012; 37(3):158-162.

13 Capron AM, Mauron A, Elger BS, Boggio A, Ganguli-Mitra A, Biller-Andorno N. Ethical norms and the international governance of genetic databases and biobanks: findings from an international study. Kennedy Inst Ethics J 2009; 19(2):101-124.

14 Brena-Sesma I. Biobancos, un asunto pendiente de legislar. Bol Mex Der Comp 2010; 43(129):1055-1079.

15 Marodin G, Salgueiro JB, Motta ML. Pacheco-Santos LM. Brazilian guidelines for biorepositories and biobanks of human biological material. Rev Assoc Med Bras 2013; 59(1):72-77.

16 Gottweis H, Lauss G. Biobank governance: heterogeneous models of ordering and democratization. J Community Genet 2012; 3(2):61-72.

17 Paskal W, Paskal AM, Debski T, Gryziak M, Jaworowski J. Aspects of Modern Biobank Activity - Comprehensive Review. Pathol Oncol Res. 2018; 24(4):771-785.

18 Serrano-Díaz N, Páez-Leal MC, Luna-González ML, Guío-Mahecha E. Biobanco: Herramienta fundamental para la investigación biomédica actual. Rev Univ Ind Santander Salud 2016; 48(2):97-117.

19 Milanovic F, Merleau-Ponty N, Pitrou P. Biobanks and the reconfiguration of the living. New Genetics Soc 2018; 37(4):285-295.

20 Ommen GV, Törnwall O, Bréchot C, Dagher G, Galli J, Hveem K, Landegren U, Luchinat C, Metspalu A, Nilsson C, Solesvik OV, Perola M, Litton J, Zatloukal K. BBMRI-ERIC as a resource for pharmaceutical and life science industries: the development of biobank-based Expert Centres. Eur J Hum Genet 2015; 23(7):893-900.

Godard B, Schmidtke J, Cassiman JJ, Ayme S. Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A profesional perspective. Eur J Hum Genet 2003; 11(Supl. 2):S88-122.

22 Bryzgalina E, Alasania KY, Varkhotov T, Gavrilenko SM, Shkomova, EM. The social dimension of biobanking: objectives and challenges. Life Sci Soc Policy 2017; 13(1):1-11.

23 Villarroel R. Biopolitical administration within Biobanks. Acta Bioethica 2013; 19(1):39-47.

24 De Souza YG, Greenspan JS. Biobanking past, present and future: responsibilities and benefits. AIDS 2013; 27(3):303-312.

25 Domaradzki J, Pawlikowski J. Public Attitudes toward Biobanking of Human Biological Material for Research Purposes: A Literature Review. Int J Environ Res Public Health 2019; 16(12):2209.

26 Kinkorová J, Topolcan O. Biobanks in Horizon 2020: sustainability and attractive perspectives. EPMA J 2018; 9(4):345-353.

27 Nemogá-Soto G. Dilemas sobre Biobancos: asuntos éticos y jurídicos. Pensamiento Jurídico 2012; 35:195-230.

28 Domaradzki J. Geneticization and biobanking. Polish Sociological Review 2019; 205(1):103-117.

29 Hamilton C. Intellectual property rights, the bioeconomy and the challenge of biopiracy. Genom Soc Policy 2008; 4(3):26-45.^-3030 Brochhausen M, Zheng J, Birtwell, D, Williams H, Masci AM, Ellis HJ, Stoeckert CJ Jr. OBIB-a novel ontology for biobanking. J Biomed Semantics 2016; 7(1):23. and universities¹1 Soto-Gómez L. Regulating Mexican Biobanks for Human Biomedical Research: What can be Learned from the European Experience? Mex Law Rev 2014; 7(1):31-55.

2 Laurence L. Convention on Human Rights and Biomedicine: The Oviedo Convention. In: Brena IS, Ruíz de Chávez MH, coordinadores. Bioética y derechos humanos. México: IIJ-UNAM; 2018.

3 Garza-Rodríguez ML, Pérez-Maya AA, Monsivais-Ovalle DE, Velázquez-Vadillo JF, Barrera-Saldaña, HA. El Biobanco Institucional como pilar de las ciencias médicas. Salud Publica Mex 2016; 58(4):483-489.

4 Lee J. Artificial Intelligence in the Future Biobanking: Current Issues in the Biobank and Future Possibilities of Artificial Intelligence. Biomed J Sci Tech Res 2018; 7(3):5937-5939.

5 Benítez-Arvizu G, Palma-Lara I, Alcántara-Quintana L. Biobancos de células troncales para terapia celular. Una realidad en México. Rev Med Inst Mex Seguro Soc 2014; 52(3):244-247.

6 Bernal-Gómez BM, Bernal-Gómez DR. Investigación Biomédica y Biobancos: Una Reflexión para su Implementación. Principia Iuris 2018; 16(29):128-143.

7 Instituto de Salud Carlos III, Comité de Ética del Instituto de Investigación de Enfermedades Raras (IIER). Recomendaciones sobre los aspectos éticos de las colecciones de muestras y bancos de materiales humanos con fines de investigación biomédica. Rev Esp Salud Publica 2007; 81(2):95-111.

8 Chen H, Pang T. A call for global governance of biobanks. Bull WHO 2015; 93(2):113-117.

9 Marodin G, França P, Rocha JCC, Campos AH. Biobanking for health research in Brazil: Present challenges and future directions. Rev Panam Salud Publica 2012; 31(6):523-528.

10 Luna-González ML, Guío-Mahecha E, Becerra-Bayona S, Serrano-Díaz N. La gestión de los datos, un proceso esencial para el desarrollo del Biobanco. Rev Univ Ind Santander Salud 2016; 48(4):548-553.

11 Mendy M, Caboux E, Lawlor RT, Wright J, Wild CP. Common mínimum technical standards and protocols for biobanks dedicated to cancer research. Lyon: Int Agency Res Cancer; 2017.

12 Martínez JC, Briceño I, Alejandra H, Gómez A. Biobancos. Una estrategia inteligente y esencial para la conservación de muestras biológicas. Acta Med Colomb 2012; 37(3):158-162.

13 Capron AM, Mauron A, Elger BS, Boggio A, Ganguli-Mitra A, Biller-Andorno N. Ethical norms and the international governance of genetic databases and biobanks: findings from an international study. Kennedy Inst Ethics J 2009; 19(2):101-124.

14 Brena-Sesma I. Biobancos, un asunto pendiente de legislar. Bol Mex Der Comp 2010; 43(129):1055-1079.

15 Marodin G, Salgueiro JB, Motta ML. Pacheco-Santos LM. Brazilian guidelines for biorepositories and biobanks of human biological material. Rev Assoc Med Bras 2013; 59(1):72-77.

16 Gottweis H, Lauss G. Biobank governance: heterogeneous models of ordering and democratization. J Community Genet 2012; 3(2):61-72.

17 Paskal W, Paskal AM, Debski T, Gryziak M, Jaworowski J. Aspects of Modern Biobank Activity - Comprehensive Review. Pathol Oncol Res. 2018; 24(4):771-785.

18 Serrano-Díaz N, Páez-Leal MC, Luna-González ML, Guío-Mahecha E. Biobanco: Herramienta fundamental para la investigación biomédica actual. Rev Univ Ind Santander Salud 2016; 48(2):97-117.

19 Milanovic F, Merleau-Ponty N, Pitrou P. Biobanks and the reconfiguration of the living. New Genetics Soc 2018; 37(4):285-295.

20 Ommen GV, Törnwall O, Bréchot C, Dagher G, Galli J, Hveem K, Landegren U, Luchinat C, Metspalu A, Nilsson C, Solesvik OV, Perola M, Litton J, Zatloukal K. BBMRI-ERIC as a resource for pharmaceutical and life science industries: the development of biobank-based Expert Centres. Eur J Hum Genet 2015; 23(7):893-900.

Godard B, Schmidtke J, Cassiman JJ, Ayme S. Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A profesional perspective. Eur J Hum Genet 2003; 11(Supl. 2):S88-122.^-2222 Bryzgalina E, Alasania KY, Varkhotov T, Gavrilenko SM, Shkomova, EM. The social dimension of biobanking: objectives and challenges. Life Sci Soc Policy 2017; 13(1):1-11.^,2424 De Souza YG, Greenspan JS. Biobanking past, present and future: responsibilities and benefits. AIDS 2013; 27(3):303-312.

25 Domaradzki J, Pawlikowski J. Public Attitudes toward Biobanking of Human Biological Material for Research Purposes: A Literature Review. Int J Environ Res Public Health 2019; 16(12):2209.

26 Kinkorová J, Topolcan O. Biobanks in Horizon 2020: sustainability and attractive perspectives. EPMA J 2018; 9(4):345-353.

27 Nemogá-Soto G. Dilemas sobre Biobancos: asuntos éticos y jurídicos. Pensamiento Jurídico 2012; 35:195-230.

28 Domaradzki J. Geneticization and biobanking. Polish Sociological Review 2019; 205(1):103-117.

29 Hamilton C. Intellectual property rights, the bioeconomy and the challenge of biopiracy. Genom Soc Policy 2008; 4(3):26-45.^-3030 Brochhausen M, Zheng J, Birtwell, D, Williams H, Masci AM, Ellis HJ, Stoeckert CJ Jr. OBIB-a novel ontology for biobanking. J Biomed Semantics 2016; 7(1):23. intervene.

There are national biobank networks, as in Spain, and regional networks involving groups of States, as in the LatinBanks (Germany, Argentina, Brazil, Chile, Colombia, Costa Rica, Spain, France, Mexico and Portugal)⁶6 Bernal-Gómez BM, Bernal-Gómez DR. Investigación Biomédica y Biobancos: Una Reflexión para su Implementación. Principia Iuris 2018; 16(29):128-143., the Red de Biobancos de América Latina y el Caribe (REBLAC)¹⁰10 Luna-González ML, Guío-Mahecha E, Becerra-Bayona S, Serrano-Díaz N. La gestión de los datos, un proceso esencial para el desarrollo del Biobanco. Rev Univ Ind Santander Salud 2016; 48(4):548-553. and the BBMRI-ERIC in the EU, which brings together 19 countries and an international agency, WHO-IARC, and has established sharing of knowledge and experience¹¹11 Mendy M, Caboux E, Lawlor RT, Wright J, Wild CP. Common mínimum technical standards and protocols for biobanks dedicated to cancer research. Lyon: Int Agency Res Cancer; 2017.^,1717 Paskal W, Paskal AM, Debski T, Gryziak M, Jaworowski J. Aspects of Modern Biobank Activity - Comprehensive Review. Pathol Oncol Res. 2018; 24(4):771-785. on ethical, legal and social issues (ELSI), information technologies (IT) and quality management (QM).

In the private sector, there are national, international and even transnational agents that intervene in biobanks. Prominent among these are pharmaceutical corporations, such as Hoffman, Roche Laboratories, Pfizer, Johnson & Johnson, GlaxoSmithKline, Siemens Healthcare and others; genomic medical care firms such as Decode, Navigenics, 23andMe, Illumina and others; banks and insurers in the United Kingdom, Taiwan, Korea and China; software firms, such as BC Platforms, NorayBio, Alatel, Dataworks, Thermo Fisher, LabWare, Krishagni Product, oBiBa and CBSR; and practitioners’ associations, such as the World Medical Association (WMA), Council for International Organisations of Medical Sciences (CIOMS) and the Human Genome Organisation (HUGO) International¹⁰10 Luna-González ML, Guío-Mahecha E, Becerra-Bayona S, Serrano-Díaz N. La gestión de los datos, un proceso esencial para el desarrollo del Biobanco. Rev Univ Ind Santander Salud 2016; 48(4):548-553.^,1111 Mendy M, Caboux E, Lawlor RT, Wright J, Wild CP. Common mínimum technical standards and protocols for biobanks dedicated to cancer research. Lyon: Int Agency Res Cancer; 2017.^,1717 Paskal W, Paskal AM, Debski T, Gryziak M, Jaworowski J. Aspects of Modern Biobank Activity - Comprehensive Review. Pathol Oncol Res. 2018; 24(4):771-785.^,1919 Milanovic F, Merleau-Ponty N, Pitrou P. Biobanks and the reconfiguration of the living. New Genetics Soc 2018; 37(4):285-295.^,2020 Ommen GV, Törnwall O, Bréchot C, Dagher G, Galli J, Hveem K, Landegren U, Luchinat C, Metspalu A, Nilsson C, Solesvik OV, Perola M, Litton J, Zatloukal K. BBMRI-ERIC as a resource for pharmaceutical and life science industries: the development of biobank-based Expert Centres. Eur J Hum Genet 2015; 23(7):893-900.^,21Godard B, Schmidtke J, Cassiman JJ, Ayme S. Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A profesional perspective. Eur J Hum Genet 2003; 11(Supl. 2):S88-122..

Recently, the EU has promoted the BBMRI-ERIC Expert Centre and Trusted Partner as a new public-private model for analysing samples and generating data in countries of origin under internationally standardised conditions. In 2019 there were two recognised centres: a) in Austria, the CBmed gained recognition as an expert centre linking the public sector with private pharmaceutical corporations and diagnostic and IT centres; and b) the ATMA-EC Platform in Italy, which links the public and private sectors, has centred on developing a platform to verify and validate biomarkers and is improving and expediting communication between academic and pharmaceuticals sectors²⁰20 Ommen GV, Törnwall O, Bréchot C, Dagher G, Galli J, Hveem K, Landegren U, Luchinat C, Metspalu A, Nilsson C, Solesvik OV, Perola M, Litton J, Zatloukal K. BBMRI-ERIC as a resource for pharmaceutical and life science industries: the development of biobank-based Expert Centres. Eur J Hum Genet 2015; 23(7):893-900.. Lastly, in Spain, the Centro Nacional de Análisis Genómico - Instituto de Análisis Genómico (CNAG-CRG) is in the process of being recognised as an expert centre for its outstanding quality management (ISO 9001: 2015 certification, ISO 17025: 2017 accreditation, Illumina and Agilent Exome Sequencing service provider certificates and membership of the Roche Sequencing Solutions Technical Certification Programme)²⁰20 Ommen GV, Törnwall O, Bréchot C, Dagher G, Galli J, Hveem K, Landegren U, Luchinat C, Metspalu A, Nilsson C, Solesvik OV, Perola M, Litton J, Zatloukal K. BBMRI-ERIC as a resource for pharmaceutical and life science industries: the development of biobank-based Expert Centres. Eur J Hum Genet 2015; 23(7):893-900..

Lastly, the subject essential to the biobank process is the human participant from whose body a biological sample is taken and who is legally entitled to a series of rights guaranteed by the declaration of informed consent¹1 Soto-Gómez L. Regulating Mexican Biobanks for Human Biomedical Research: What can be Learned from the European Experience? Mex Law Rev 2014; 7(1):31-55.

2 Laurence L. Convention on Human Rights and Biomedicine: The Oviedo Convention. In: Brena IS, Ruíz de Chávez MH, coordinadores. Bioética y derechos humanos. México: IIJ-UNAM; 2018.

3 Garza-Rodríguez ML, Pérez-Maya AA, Monsivais-Ovalle DE, Velázquez-Vadillo JF, Barrera-Saldaña, HA. El Biobanco Institucional como pilar de las ciencias médicas. Salud Publica Mex 2016; 58(4):483-489.

4 Lee J. Artificial Intelligence in the Future Biobanking: Current Issues in the Biobank and Future Possibilities of Artificial Intelligence. Biomed J Sci Tech Res 2018; 7(3):5937-5939.

5 Benítez-Arvizu G, Palma-Lara I, Alcántara-Quintana L. Biobancos de células troncales para terapia celular. Una realidad en México. Rev Med Inst Mex Seguro Soc 2014; 52(3):244-247.

6 Bernal-Gómez BM, Bernal-Gómez DR. Investigación Biomédica y Biobancos: Una Reflexión para su Implementación. Principia Iuris 2018; 16(29):128-143.

7 Instituto de Salud Carlos III, Comité de Ética del Instituto de Investigación de Enfermedades Raras (IIER). Recomendaciones sobre los aspectos éticos de las colecciones de muestras y bancos de materiales humanos con fines de investigación biomédica. Rev Esp Salud Publica 2007; 81(2):95-111.

8 Chen H, Pang T. A call for global governance of biobanks. Bull WHO 2015; 93(2):113-117.

9 Marodin G, França P, Rocha JCC, Campos AH. Biobanking for health research in Brazil: Present challenges and future directions. Rev Panam Salud Publica 2012; 31(6):523-528.

10 Luna-González ML, Guío-Mahecha E, Becerra-Bayona S, Serrano-Díaz N. La gestión de los datos, un proceso esencial para el desarrollo del Biobanco. Rev Univ Ind Santander Salud 2016; 48(4):548-553.

11 Mendy M, Caboux E, Lawlor RT, Wright J, Wild CP. Common mínimum technical standards and protocols for biobanks dedicated to cancer research. Lyon: Int Agency Res Cancer; 2017.

12 Martínez JC, Briceño I, Alejandra H, Gómez A. Biobancos. Una estrategia inteligente y esencial para la conservación de muestras biológicas. Acta Med Colomb 2012; 37(3):158-162.

13 Capron AM, Mauron A, Elger BS, Boggio A, Ganguli-Mitra A, Biller-Andorno N. Ethical norms and the international governance of genetic databases and biobanks: findings from an international study. Kennedy Inst Ethics J 2009; 19(2):101-124.

14 Brena-Sesma I. Biobancos, un asunto pendiente de legislar. Bol Mex Der Comp 2010; 43(129):1055-1079.

15 Marodin G, Salgueiro JB, Motta ML. Pacheco-Santos LM. Brazilian guidelines for biorepositories and biobanks of human biological material. Rev Assoc Med Bras 2013; 59(1):72-77.

16 Gottweis H, Lauss G. Biobank governance: heterogeneous models of ordering and democratization. J Community Genet 2012; 3(2):61-72.

17 Paskal W, Paskal AM, Debski T, Gryziak M, Jaworowski J. Aspects of Modern Biobank Activity - Comprehensive Review. Pathol Oncol Res. 2018; 24(4):771-785.

18 Serrano-Díaz N, Páez-Leal MC, Luna-González ML, Guío-Mahecha E. Biobanco: Herramienta fundamental para la investigación biomédica actual. Rev Univ Ind Santander Salud 2016; 48(2):97-117.

19 Milanovic F, Merleau-Ponty N, Pitrou P. Biobanks and the reconfiguration of the living. New Genetics Soc 2018; 37(4):285-295.

20 Ommen GV, Törnwall O, Bréchot C, Dagher G, Galli J, Hveem K, Landegren U, Luchinat C, Metspalu A, Nilsson C, Solesvik OV, Perola M, Litton J, Zatloukal K. BBMRI-ERIC as a resource for pharmaceutical and life science industries: the development of biobank-based Expert Centres. Eur J Hum Genet 2015; 23(7):893-900.

Godard B, Schmidtke J, Cassiman JJ, Ayme S. Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A profesional perspective. Eur J Hum Genet 2003; 11(Supl. 2):S88-122.

22 Bryzgalina E, Alasania KY, Varkhotov T, Gavrilenko SM, Shkomova, EM. The social dimension of biobanking: objectives and challenges. Life Sci Soc Policy 2017; 13(1):1-11.

23 Villarroel R. Biopolitical administration within Biobanks. Acta Bioethica 2013; 19(1):39-47.

24 De Souza YG, Greenspan JS. Biobanking past, present and future: responsibilities and benefits. AIDS 2013; 27(3):303-312.

25 Domaradzki J, Pawlikowski J. Public Attitudes toward Biobanking of Human Biological Material for Research Purposes: A Literature Review. Int J Environ Res Public Health 2019; 16(12):2209.

26 Kinkorová J, Topolcan O. Biobanks in Horizon 2020: sustainability and attractive perspectives. EPMA J 2018; 9(4):345-353.

27 Nemogá-Soto G. Dilemas sobre Biobancos: asuntos éticos y jurídicos. Pensamiento Jurídico 2012; 35:195-230.

28 Domaradzki J. Geneticization and biobanking. Polish Sociological Review 2019; 205(1):103-117.

29 Hamilton C. Intellectual property rights, the bioeconomy and the challenge of biopiracy. Genom Soc Policy 2008; 4(3):26-45.^-3030 Brochhausen M, Zheng J, Birtwell, D, Williams H, Masci AM, Ellis HJ, Stoeckert CJ Jr. OBIB-a novel ontology for biobanking. J Biomed Semantics 2016; 7(1):23.. For proper protection, the competent authority of the biobank has to evaluate whether the type of informed consent is appropriate to the research. The main types of informed consent include consent waiver, consent opt out, consent opt in (subtypes: specific consent and specific and broad consent), broad consent, re-consent and dynamic consent⁷7 Instituto de Salud Carlos III, Comité de Ética del Instituto de Investigación de Enfermedades Raras (IIER). Recomendaciones sobre los aspectos éticos de las colecciones de muestras y bancos de materiales humanos con fines de investigación biomédica. Rev Esp Salud Publica 2007; 81(2):95-111..

Standing in opposition to this individualistic view of Humanity is the historical and community perspective, from which there emerges a collective subject formed from an accumulation of individuals who share culture and are thus bound together by identity, values, traditions and history. In this case, the human rights of peoples and communities have been protected by the declaration of collective or community informed consent⁶6 Bernal-Gómez BM, Bernal-Gómez DR. Investigación Biomédica y Biobancos: Una Reflexión para su Implementación. Principia Iuris 2018; 16(29):128-143.^,1212 Martínez JC, Briceño I, Alejandra H, Gómez A. Biobancos. Una estrategia inteligente y esencial para la conservación de muestras biológicas. Acta Med Colomb 2012; 37(3):158-162.^,1313 Capron AM, Mauron A, Elger BS, Boggio A, Ganguli-Mitra A, Biller-Andorno N. Ethical norms and the international governance of genetic databases and biobanks: findings from an international study. Kennedy Inst Ethics J 2009; 19(2):101-124.^,1616 Gottweis H, Lauss G. Biobank governance: heterogeneous models of ordering and democratization. J Community Genet 2012; 3(2):61-72.^,1919 Milanovic F, Merleau-Ponty N, Pitrou P. Biobanks and the reconfiguration of the living. New Genetics Soc 2018; 37(4):285-295.^,2828 Domaradzki J. Geneticization and biobanking. Polish Sociological Review 2019; 205(1):103-117.^,2929 Hamilton C. Intellectual property rights, the bioeconomy and the challenge of biopiracy. Genom Soc Policy 2008; 4(3):26-45.. Note that, in spite of various cases (India, Brazil, Kenya, Bolivia, Japan, Malaysia, China and others), the form and content of collective consent has not been standardised, except that it should feature three components: a) the collectivity should understand the research; b) the authority representing the group should give authorisation; and c) the process should comprise three stages: prior consent, assent and permission¹¹11 Mendy M, Caboux E, Lawlor RT, Wright J, Wild CP. Common mínimum technical standards and protocols for biobanks dedicated to cancer research. Lyon: Int Agency Res Cancer; 2017.^,1313 Capron AM, Mauron A, Elger BS, Boggio A, Ganguli-Mitra A, Biller-Andorno N. Ethical norms and the international governance of genetic databases and biobanks: findings from an international study. Kennedy Inst Ethics J 2009; 19(2):101-124.^,21Godard B, Schmidtke J, Cassiman JJ, Ayme S. Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A profesional perspective. Eur J Hum Genet 2003; 11(Supl. 2):S88-122..

The issues raised in the subjective category were, firstly, emerging or developing countries’ technological dependence on developed countries: the countries with most biobanks and samples are located geographically in the EU⁶6 Bernal-Gómez BM, Bernal-Gómez DR. Investigación Biomédica y Biobancos: Una Reflexión para su Implementación. Principia Iuris 2018; 16(29):128-143.^,88 Chen H, Pang T. A call for global governance of biobanks. Bull WHO 2015; 93(2):113-117.. Secondly, the benefit payback principle is not applied in emerging or developing countries where human and non-human biological samples are collected: most of the resources produced return to Europe⁸8 Chen H, Pang T. A call for global governance of biobanks. Bull WHO 2015; 93(2):113-117.^,2020 Ommen GV, Törnwall O, Bréchot C, Dagher G, Galli J, Hveem K, Landegren U, Luchinat C, Metspalu A, Nilsson C, Solesvik OV, Perola M, Litton J, Zatloukal K. BBMRI-ERIC as a resource for pharmaceutical and life science industries: the development of biobank-based Expert Centres. Eur J Hum Genet 2015; 23(7):893-900.^,21Godard B, Schmidtke J, Cassiman JJ, Ayme S. Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A profesional perspective. Eur J Hum Genet 2003; 11(Supl. 2):S88-122.. Some of the causes identified in countries of Asia, Africa and Latin America⁸8 Chen H, Pang T. A call for global governance of biobanks. Bull WHO 2015; 93(2):113-117. were: economic poverty, digital poverty and lack of legal regulation of medical research and/or patents. Thirdly, biopiracy has been reported in these countries⁸8 Chen H, Pang T. A call for global governance of biobanks. Bull WHO 2015; 93(2):113-117.^,1010 Luna-González ML, Guío-Mahecha E, Becerra-Bayona S, Serrano-Díaz N. La gestión de los datos, un proceso esencial para el desarrollo del Biobanco. Rev Univ Ind Santander Salud 2016; 48(4):548-553.^,1212 Martínez JC, Briceño I, Alejandra H, Gómez A. Biobancos. Una estrategia inteligente y esencial para la conservación de muestras biológicas. Acta Med Colomb 2012; 37(3):158-162.

13 Capron AM, Mauron A, Elger BS, Boggio A, Ganguli-Mitra A, Biller-Andorno N. Ethical norms and the international governance of genetic databases and biobanks: findings from an international study. Kennedy Inst Ethics J 2009; 19(2):101-124.^-1414 Brena-Sesma I. Biobancos, un asunto pendiente de legislar. Bol Mex Der Comp 2010; 43(129):1055-1079.^,1616 Gottweis H, Lauss G. Biobank governance: heterogeneous models of ordering and democratization. J Community Genet 2012; 3(2):61-72.^,1919 Milanovic F, Merleau-Ponty N, Pitrou P. Biobanks and the reconfiguration of the living. New Genetics Soc 2018; 37(4):285-295.^,21Godard B, Schmidtke J, Cassiman JJ, Ayme S. Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A profesional perspective. Eur J Hum Genet 2003; 11(Supl. 2):S88-122.^,2222 Bryzgalina E, Alasania KY, Varkhotov T, Gavrilenko SM, Shkomova, EM. The social dimension of biobanking: objectives and challenges. Life Sci Soc Policy 2017; 13(1):1-11.^,2525 Domaradzki J, Pawlikowski J. Public Attitudes toward Biobanking of Human Biological Material for Research Purposes: A Literature Review. Int J Environ Res Public Health 2019; 16(12):2209.

26 Kinkorová J, Topolcan O. Biobanks in Horizon 2020: sustainability and attractive perspectives. EPMA J 2018; 9(4):345-353.

27 Nemogá-Soto G. Dilemas sobre Biobancos: asuntos éticos y jurídicos. Pensamiento Jurídico 2012; 35:195-230.^-2828 Domaradzki J. Geneticization and biobanking. Polish Sociological Review 2019; 205(1):103-117.^,2929 Hamilton C. Intellectual property rights, the bioeconomy and the challenge of biopiracy. Genom Soc Policy 2008; 4(3):26-45.. There are two senses of biopiracy: the first connected with obtaining a biological sample without permission, as with genetic samples in China given to foreign academics and pharmaceutical corporations, and the second relating to illegal access, appropriation, use or exploitation of biological resources and/or their derivatives, such as indigenous peoples’ or communities’ knowledge by way of forms of intellectual property, such as patents, a situation that has often occurred in Latin America, as well as in Egypt and India⁸8 Chen H, Pang T. A call for global governance of biobanks. Bull WHO 2015; 93(2):113-117.^,1313 Capron AM, Mauron A, Elger BS, Boggio A, Ganguli-Mitra A, Biller-Andorno N. Ethical norms and the international governance of genetic databases and biobanks: findings from an international study. Kennedy Inst Ethics J 2009; 19(2):101-124.^,1111 Mendy M, Caboux E, Lawlor RT, Wright J, Wild CP. Common mínimum technical standards and protocols for biobanks dedicated to cancer research. Lyon: Int Agency Res Cancer; 2017.^,1919 Milanovic F, Merleau-Ponty N, Pitrou P. Biobanks and the reconfiguration of the living. New Genetics Soc 2018; 37(4):285-295..

Structural category

A biobank’s structure refers to its constituent elements or components and their relations and disposition, i.e., its organic structure, which should not be confused with the form of organisation, which tends towards global governance (be it processual-normative, corporative-managerial, market-competition or network) nor with the form of funding, which tends to mixed participation.

Biobanks can comprise a diversity of elements or components, but the data analysis warranted proposing the following committees as essential¹1 Soto-Gómez L. Regulating Mexican Biobanks for Human Biomedical Research: What can be Learned from the European Experience? Mex Law Rev 2014; 7(1):31-55.

2 Laurence L. Convention on Human Rights and Biomedicine: The Oviedo Convention. In: Brena IS, Ruíz de Chávez MH, coordinadores. Bioética y derechos humanos. México: IIJ-UNAM; 2018.

3 Garza-Rodríguez ML, Pérez-Maya AA, Monsivais-Ovalle DE, Velázquez-Vadillo JF, Barrera-Saldaña, HA. El Biobanco Institucional como pilar de las ciencias médicas. Salud Publica Mex 2016; 58(4):483-489.

4 Lee J. Artificial Intelligence in the Future Biobanking: Current Issues in the Biobank and Future Possibilities of Artificial Intelligence. Biomed J Sci Tech Res 2018; 7(3):5937-5939.

5 Benítez-Arvizu G, Palma-Lara I, Alcántara-Quintana L. Biobancos de células troncales para terapia celular. Una realidad en México. Rev Med Inst Mex Seguro Soc 2014; 52(3):244-247.

6 Bernal-Gómez BM, Bernal-Gómez DR. Investigación Biomédica y Biobancos: Una Reflexión para su Implementación. Principia Iuris 2018; 16(29):128-143.

7 Instituto de Salud Carlos III, Comité de Ética del Instituto de Investigación de Enfermedades Raras (IIER). Recomendaciones sobre los aspectos éticos de las colecciones de muestras y bancos de materiales humanos con fines de investigación biomédica. Rev Esp Salud Publica 2007; 81(2):95-111.

8 Chen H, Pang T. A call for global governance of biobanks. Bull WHO 2015; 93(2):113-117.

9 Marodin G, França P, Rocha JCC, Campos AH. Biobanking for health research in Brazil: Present challenges and future directions. Rev Panam Salud Publica 2012; 31(6):523-528.

10 Luna-González ML, Guío-Mahecha E, Becerra-Bayona S, Serrano-Díaz N. La gestión de los datos, un proceso esencial para el desarrollo del Biobanco. Rev Univ Ind Santander Salud 2016; 48(4):548-553.

11 Mendy M, Caboux E, Lawlor RT, Wright J, Wild CP. Common mínimum technical standards and protocols for biobanks dedicated to cancer research. Lyon: Int Agency Res Cancer; 2017.

12 Martínez JC, Briceño I, Alejandra H, Gómez A. Biobancos. Una estrategia inteligente y esencial para la conservación de muestras biológicas. Acta Med Colomb 2012; 37(3):158-162.

13 Capron AM, Mauron A, Elger BS, Boggio A, Ganguli-Mitra A, Biller-Andorno N. Ethical norms and the international governance of genetic databases and biobanks: findings from an international study. Kennedy Inst Ethics J 2009; 19(2):101-124.

14 Brena-Sesma I. Biobancos, un asunto pendiente de legislar. Bol Mex Der Comp 2010; 43(129):1055-1079.

15 Marodin G, Salgueiro JB, Motta ML. Pacheco-Santos LM. Brazilian guidelines for biorepositories and biobanks of human biological material. Rev Assoc Med Bras 2013; 59(1):72-77.

16 Gottweis H, Lauss G. Biobank governance: heterogeneous models of ordering and democratization. J Community Genet 2012; 3(2):61-72.

17 Paskal W, Paskal AM, Debski T, Gryziak M, Jaworowski J. Aspects of Modern Biobank Activity - Comprehensive Review. Pathol Oncol Res. 2018; 24(4):771-785.

18 Serrano-Díaz N, Páez-Leal MC, Luna-González ML, Guío-Mahecha E. Biobanco: Herramienta fundamental para la investigación biomédica actual. Rev Univ Ind Santander Salud 2016; 48(2):97-117.

19 Milanovic F, Merleau-Ponty N, Pitrou P. Biobanks and the reconfiguration of the living. New Genetics Soc 2018; 37(4):285-295.

20 Ommen GV, Törnwall O, Bréchot C, Dagher G, Galli J, Hveem K, Landegren U, Luchinat C, Metspalu A, Nilsson C, Solesvik OV, Perola M, Litton J, Zatloukal K. BBMRI-ERIC as a resource for pharmaceutical and life science industries: the development of biobank-based Expert Centres. Eur J Hum Genet 2015; 23(7):893-900.

Godard B, Schmidtke J, Cassiman JJ, Ayme S. Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A profesional perspective. Eur J Hum Genet 2003; 11(Supl. 2):S88-122.

22 Bryzgalina E, Alasania KY, Varkhotov T, Gavrilenko SM, Shkomova, EM. The social dimension of biobanking: objectives and challenges. Life Sci Soc Policy 2017; 13(1):1-11.

23 Villarroel R. Biopolitical administration within Biobanks. Acta Bioethica 2013; 19(1):39-47.

24 De Souza YG, Greenspan JS. Biobanking past, present and future: responsibilities and benefits. AIDS 2013; 27(3):303-312.

25 Domaradzki J, Pawlikowski J. Public Attitudes toward Biobanking of Human Biological Material for Research Purposes: A Literature Review. Int J Environ Res Public Health 2019; 16(12):2209.

26 Kinkorová J, Topolcan O. Biobanks in Horizon 2020: sustainability and attractive perspectives. EPMA J 2018; 9(4):345-353.

27 Nemogá-Soto G. Dilemas sobre Biobancos: asuntos éticos y jurídicos. Pensamiento Jurídico 2012; 35:195-230.

28 Domaradzki J. Geneticization and biobanking. Polish Sociological Review 2019; 205(1):103-117.

29 Hamilton C. Intellectual property rights, the bioeconomy and the challenge of biopiracy. Genom Soc Policy 2008; 4(3):26-45.^-3030 Brochhausen M, Zheng J, Birtwell, D, Williams H, Masci AM, Ellis HJ, Stoeckert CJ Jr. OBIB-a novel ontology for biobanking. J Biomed Semantics 2016; 7(1):23.:

Note that, in the EU¹¹11 Mendy M, Caboux E, Lawlor RT, Wright J, Wild CP. Common mínimum technical standards and protocols for biobanks dedicated to cancer research. Lyon: Int Agency Res Cancer; 2017.^,1616 Gottweis H, Lauss G. Biobank governance: heterogeneous models of ordering and democratization. J Community Genet 2012; 3(2):61-72.^,21Godard B, Schmidtke J, Cassiman JJ, Ayme S. Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A profesional perspective. Eur J Hum Genet 2003; 11(Supl. 2):S88-122.^,2222 Bryzgalina E, Alasania KY, Varkhotov T, Gavrilenko SM, Shkomova, EM. The social dimension of biobanking: objectives and challenges. Life Sci Soc Policy 2017; 13(1):1-11.^,2626 Kinkorová J, Topolcan O. Biobanks in Horizon 2020: sustainability and attractive perspectives. EPMA J 2018; 9(4):345-353., it is recommended that a public participation committee be constituted to learn public opinion with regard to the biobank’s activities, specifically its objectives or research projects. That committee also engages in scientific publication and national and/or international public policy activities, as well as advisory activities. Examples are the participation committee of adolescents (UK Biobank Ethics and Governance Council, 2009) of the Avon Longitudinal Study of Parents and Children (ALSPAC) and also the subcommittee of the NIH Precision Medicine Initiative Cohort Program (2015)¹¹11 Mendy M, Caboux E, Lawlor RT, Wright J, Wild CP. Common mínimum technical standards and protocols for biobanks dedicated to cancer research. Lyon: Int Agency Res Cancer; 2017..

Legal category

From the analysis and systematisation of the information, three types of legal norms applicable to biobanks emerged. By their content, they regulate: a) human rights; b) practices and processes by standardisation; and c) private property and trade.

Human rights: the main normative instructions and guidelines that protect life, human dignity and health, internationally and regionally, were described in Chart 2.

Standardisation of biological and bioinformatics processes: the main norms for standardising and/or certifying biobank processes originate from the Human Genome Organisation (HUGO)⁴4 Lee J. Artificial Intelligence in the Future Biobanking: Current Issues in the Biobank and Future Possibilities of Artificial Intelligence. Biomed J Sci Tech Res 2018; 7(3):5937-5939.^,77 Instituto de Salud Carlos III, Comité de Ética del Instituto de Investigación de Enfermedades Raras (IIER). Recomendaciones sobre los aspectos éticos de las colecciones de muestras y bancos de materiales humanos con fines de investigación biomédica. Rev Esp Salud Publica 2007; 81(2):95-111.^,88 Chen H, Pang T. A call for global governance of biobanks. Bull WHO 2015; 93(2):113-117.^,1010 Luna-González ML, Guío-Mahecha E, Becerra-Bayona S, Serrano-Díaz N. La gestión de los datos, un proceso esencial para el desarrollo del Biobanco. Rev Univ Ind Santander Salud 2016; 48(4):548-553.

11 Mendy M, Caboux E, Lawlor RT, Wright J, Wild CP. Common mínimum technical standards and protocols for biobanks dedicated to cancer research. Lyon: Int Agency Res Cancer; 2017.

12 Martínez JC, Briceño I, Alejandra H, Gómez A. Biobancos. Una estrategia inteligente y esencial para la conservación de muestras biológicas. Acta Med Colomb 2012; 37(3):158-162.

13 Capron AM, Mauron A, Elger BS, Boggio A, Ganguli-Mitra A, Biller-Andorno N. Ethical norms and the international governance of genetic databases and biobanks: findings from an international study. Kennedy Inst Ethics J 2009; 19(2):101-124.^-1414 Brena-Sesma I. Biobancos, un asunto pendiente de legislar. Bol Mex Der Comp 2010; 43(129):1055-1079.^,1616 Gottweis H, Lauss G. Biobank governance: heterogeneous models of ordering and democratization. J Community Genet 2012; 3(2):61-72.

17 Paskal W, Paskal AM, Debski T, Gryziak M, Jaworowski J. Aspects of Modern Biobank Activity - Comprehensive Review. Pathol Oncol Res. 2018; 24(4):771-785.^-1818 Serrano-Díaz N, Páez-Leal MC, Luna-González ML, Guío-Mahecha E. Biobanco: Herramienta fundamental para la investigación biomédica actual. Rev Univ Ind Santander Salud 2016; 48(2):97-117.^,2020 Ommen GV, Törnwall O, Bréchot C, Dagher G, Galli J, Hveem K, Landegren U, Luchinat C, Metspalu A, Nilsson C, Solesvik OV, Perola M, Litton J, Zatloukal K. BBMRI-ERIC as a resource for pharmaceutical and life science industries: the development of biobank-based Expert Centres. Eur J Hum Genet 2015; 23(7):893-900.^,21Godard B, Schmidtke J, Cassiman JJ, Ayme S. Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A profesional perspective. Eur J Hum Genet 2003; 11(Supl. 2):S88-122.^,2626 Kinkorová J, Topolcan O. Biobanks in Horizon 2020: sustainability and attractive perspectives. EPMA J 2018; 9(4):345-353.

27 Nemogá-Soto G. Dilemas sobre Biobancos: asuntos éticos y jurídicos. Pensamiento Jurídico 2012; 35:195-230.^-2828 Domaradzki J. Geneticization and biobanking. Polish Sociological Review 2019; 205(1):103-117.^,3030 Brochhausen M, Zheng J, Birtwell, D, Williams H, Masci AM, Ellis HJ, Stoeckert CJ Jr. OBIB-a novel ontology for biobanking. J Biomed Semantics 2016; 7(1):23., the HUGO Committee on Ethics, Law and Society (CELS)⁷7 Instituto de Salud Carlos III, Comité de Ética del Instituto de Investigación de Enfermedades Raras (IIER). Recomendaciones sobre los aspectos éticos de las colecciones de muestras y bancos de materiales humanos con fines de investigación biomédica. Rev Esp Salud Publica 2007; 81(2):95-111.^,1010 Luna-González ML, Guío-Mahecha E, Becerra-Bayona S, Serrano-Díaz N. La gestión de los datos, un proceso esencial para el desarrollo del Biobanco. Rev Univ Ind Santander Salud 2016; 48(4):548-553.

11 Mendy M, Caboux E, Lawlor RT, Wright J, Wild CP. Common mínimum technical standards and protocols for biobanks dedicated to cancer research. Lyon: Int Agency Res Cancer; 2017.

12 Martínez JC, Briceño I, Alejandra H, Gómez A. Biobancos. Una estrategia inteligente y esencial para la conservación de muestras biológicas. Acta Med Colomb 2012; 37(3):158-162.

13 Capron AM, Mauron A, Elger BS, Boggio A, Ganguli-Mitra A, Biller-Andorno N. Ethical norms and the international governance of genetic databases and biobanks: findings from an international study. Kennedy Inst Ethics J 2009; 19(2):101-124.^-1414 Brena-Sesma I. Biobancos, un asunto pendiente de legislar. Bol Mex Der Comp 2010; 43(129):1055-1079.^,1616 Gottweis H, Lauss G. Biobank governance: heterogeneous models of ordering and democratization. J Community Genet 2012; 3(2):61-72.

17 Paskal W, Paskal AM, Debski T, Gryziak M, Jaworowski J. Aspects of Modern Biobank Activity - Comprehensive Review. Pathol Oncol Res. 2018; 24(4):771-785.^-1818 Serrano-Díaz N, Páez-Leal MC, Luna-González ML, Guío-Mahecha E. Biobanco: Herramienta fundamental para la investigación biomédica actual. Rev Univ Ind Santander Salud 2016; 48(2):97-117.^,2020 Ommen GV, Törnwall O, Bréchot C, Dagher G, Galli J, Hveem K, Landegren U, Luchinat C, Metspalu A, Nilsson C, Solesvik OV, Perola M, Litton J, Zatloukal K. BBMRI-ERIC as a resource for pharmaceutical and life science industries: the development of biobank-based Expert Centres. Eur J Hum Genet 2015; 23(7):893-900.^,21Godard B, Schmidtke J, Cassiman JJ, Ayme S. Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A profesional perspective. Eur J Hum Genet 2003; 11(Supl. 2):S88-122.^,2626 Kinkorová J, Topolcan O. Biobanks in Horizon 2020: sustainability and attractive perspectives. EPMA J 2018; 9(4):345-353.

27 Nemogá-Soto G. Dilemas sobre Biobancos: asuntos éticos y jurídicos. Pensamiento Jurídico 2012; 35:195-230.^-2828 Domaradzki J. Geneticization and biobanking. Polish Sociological Review 2019; 205(1):103-117.^,3030 Brochhausen M, Zheng J, Birtwell, D, Williams H, Masci AM, Ellis HJ, Stoeckert CJ Jr. OBIB-a novel ontology for biobanking. J Biomed Semantics 2016; 7(1):23., the World Medical Association (WMA)¹1 Soto-Gómez L. Regulating Mexican Biobanks for Human Biomedical Research: What can be Learned from the European Experience? Mex Law Rev 2014; 7(1):31-55.^,88 Chen H, Pang T. A call for global governance of biobanks. Bull WHO 2015; 93(2):113-117.^,1111 Mendy M, Caboux E, Lawlor RT, Wright J, Wild CP. Common mínimum technical standards and protocols for biobanks dedicated to cancer research. Lyon: Int Agency Res Cancer; 2017.^,1717 Paskal W, Paskal AM, Debski T, Gryziak M, Jaworowski J. Aspects of Modern Biobank Activity - Comprehensive Review. Pathol Oncol Res. 2018; 24(4):771-785.^,21Godard B, Schmidtke J, Cassiman JJ, Ayme S. Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A profesional perspective. Eur J Hum Genet 2003; 11(Supl. 2):S88-122.^,2727 Nemogá-Soto G. Dilemas sobre Biobancos: asuntos éticos y jurídicos. Pensamiento Jurídico 2012; 35:195-230. and the Council for International Organisations of Medical Sciences (CIOMS)¹¹11 Mendy M, Caboux E, Lawlor RT, Wright J, Wild CP. Common mínimum technical standards and protocols for biobanks dedicated to cancer research. Lyon: Int Agency Res Cancer; 2017.^,1515 Marodin G, Salgueiro JB, Motta ML. Pacheco-Santos LM. Brazilian guidelines for biorepositories and biobanks of human biological material. Rev Assoc Med Bras 2013; 59(1):72-77.^,1717 Paskal W, Paskal AM, Debski T, Gryziak M, Jaworowski J. Aspects of Modern Biobank Activity - Comprehensive Review. Pathol Oncol Res. 2018; 24(4):771-785.^,21Godard B, Schmidtke J, Cassiman JJ, Ayme S. Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A profesional perspective. Eur J Hum Genet 2003; 11(Supl. 2):S88-122.^,2626 Kinkorová J, Topolcan O. Biobanks in Horizon 2020: sustainability and attractive perspectives. EPMA J 2018; 9(4):345-353.^,2727 Nemogá-Soto G. Dilemas sobre Biobancos: asuntos éticos y jurídicos. Pensamiento Jurídico 2012; 35:195-230.^,3030 Brochhausen M, Zheng J, Birtwell, D, Williams H, Masci AM, Ellis HJ, Stoeckert CJ Jr. OBIB-a novel ontology for biobanking. J Biomed Semantics 2016; 7(1):23..

Private property and trade: in biobanks, assignment of property rights is rendered complex not just by the existence of two levels of legal regulation (State and international), but by the plurality of elements that converge in biological and bioinformatics processes, because on the one hand are the donors’ property rights to their biological material and the related data and, on the other hand, are the intellectual and industrial property rights in favour of authors and, where appropriate, the public or private institutions that finance the research, such as universities and pharmaceutical corporations.

The organisations that play a role in regulating authors’ biobanks are: a) the World Intellectual Property Organisation (WIPO)²⁹29 Hamilton C. Intellectual property rights, the bioeconomy and the challenge of biopiracy. Genom Soc Policy 2008; 4(3):26-45.; b) the Organisation for Economic Cooperation and Development (OECD)⁶6 Bernal-Gómez BM, Bernal-Gómez DR. Investigación Biomédica y Biobancos: Una Reflexión para su Implementación. Principia Iuris 2018; 16(29):128-143.^,99 Marodin G, França P, Rocha JCC, Campos AH. Biobanking for health research in Brazil: Present challenges and future directions. Rev Panam Salud Publica 2012; 31(6):523-528.^,1111 Mendy M, Caboux E, Lawlor RT, Wright J, Wild CP. Common mínimum technical standards and protocols for biobanks dedicated to cancer research. Lyon: Int Agency Res Cancer; 2017.^,1717 Paskal W, Paskal AM, Debski T, Gryziak M, Jaworowski J. Aspects of Modern Biobank Activity - Comprehensive Review. Pathol Oncol Res. 2018; 24(4):771-785.^,1818 Serrano-Díaz N, Páez-Leal MC, Luna-González ML, Guío-Mahecha E. Biobanco: Herramienta fundamental para la investigación biomédica actual. Rev Univ Ind Santander Salud 2016; 48(2):97-117.^,2020 Ommen GV, Törnwall O, Bréchot C, Dagher G, Galli J, Hveem K, Landegren U, Luchinat C, Metspalu A, Nilsson C, Solesvik OV, Perola M, Litton J, Zatloukal K. BBMRI-ERIC as a resource for pharmaceutical and life science industries: the development of biobank-based Expert Centres. Eur J Hum Genet 2015; 23(7):893-900.^,21Godard B, Schmidtke J, Cassiman JJ, Ayme S. Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A profesional perspective. Eur J Hum Genet 2003; 11(Supl. 2):S88-122.^,2727 Nemogá-Soto G. Dilemas sobre Biobancos: asuntos éticos y jurídicos. Pensamiento Jurídico 2012; 35:195-230.^,2828 Domaradzki J. Geneticization and biobanking. Polish Sociological Review 2019; 205(1):103-117.; c) the World Trade Organisation (WTO)¹¹11 Mendy M, Caboux E, Lawlor RT, Wright J, Wild CP. Common mínimum technical standards and protocols for biobanks dedicated to cancer research. Lyon: Int Agency Res Cancer; 2017.^,1717 Paskal W, Paskal AM, Debski T, Gryziak M, Jaworowski J. Aspects of Modern Biobank Activity - Comprehensive Review. Pathol Oncol Res. 2018; 24(4):771-785.^,21Godard B, Schmidtke J, Cassiman JJ, Ayme S. Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A profesional perspective. Eur J Hum Genet 2003; 11(Supl. 2):S88-122.^,2727 Nemogá-Soto G. Dilemas sobre Biobancos: asuntos éticos y jurídicos. Pensamiento Jurídico 2012; 35:195-230.^,2929 Hamilton C. Intellectual property rights, the bioeconomy and the challenge of biopiracy. Genom Soc Policy 2008; 4(3):26-45.; and d) the International Standards Organisation (ISO)¹1 Soto-Gómez L. Regulating Mexican Biobanks for Human Biomedical Research: What can be Learned from the European Experience? Mex Law Rev 2014; 7(1):31-55.^,33 Garza-Rodríguez ML, Pérez-Maya AA, Monsivais-Ovalle DE, Velázquez-Vadillo JF, Barrera-Saldaña, HA. El Biobanco Institucional como pilar de las ciencias médicas. Salud Publica Mex 2016; 58(4):483-489.

4 Lee J. Artificial Intelligence in the Future Biobanking: Current Issues in the Biobank and Future Possibilities of Artificial Intelligence. Biomed J Sci Tech Res 2018; 7(3):5937-5939.^-55 Benítez-Arvizu G, Palma-Lara I, Alcántara-Quintana L. Biobancos de células troncales para terapia celular. Una realidad en México. Rev Med Inst Mex Seguro Soc 2014; 52(3):244-247.^,1010 Luna-González ML, Guío-Mahecha E, Becerra-Bayona S, Serrano-Díaz N. La gestión de los datos, un proceso esencial para el desarrollo del Biobanco. Rev Univ Ind Santander Salud 2016; 48(4):548-553.^,1111 Mendy M, Caboux E, Lawlor RT, Wright J, Wild CP. Common mínimum technical standards and protocols for biobanks dedicated to cancer research. Lyon: Int Agency Res Cancer; 2017.^,1717 Paskal W, Paskal AM, Debski T, Gryziak M, Jaworowski J. Aspects of Modern Biobank Activity - Comprehensive Review. Pathol Oncol Res. 2018; 24(4):771-785.^,2424 De Souza YG, Greenspan JS. Biobanking past, present and future: responsibilities and benefits. AIDS 2013; 27(3):303-312.^,2626 Kinkorová J, Topolcan O. Biobanks in Horizon 2020: sustainability and attractive perspectives. EPMA J 2018; 9(4):345-353.^,2727 Nemogá-Soto G. Dilemas sobre Biobancos: asuntos éticos y jurídicos. Pensamiento Jurídico 2012; 35:195-230., to avert technical obstacles to trade and facilitate legal harmonisation.

In addition to the foregoing are studies and guidelines signed by the WTO, WHO and WIPO to regulate intellectual property rights in health, to promote access to technologies and innovation and to regulate health from three perspectives - as part of public law (public health), private law (intellectual property) and mercantile law (trade) - resulting in the signing of the Doha Declaration on the TRIPS and public health agreement (2001) and the Hong Kong Ministerial Declaration on TRIPS and public health (2005).

Limitations and strong points

This review has limitations, of course: temporal, language-related, limited open access, geographical and cultural. It endeavoured to identify studies originating in a variety of fields of knowledge so as to produce a multidisciplinary panorama. Despite the best efforts, however, not all could be included. The PRISMA criteria guarantee a certain quality to the research, while the CASPe quality assessment criteria were applied to all the selected studies. Nonetheless, in studies from the social sciences and humanities and in the normative projects, methodologies and data collection techniques tend to be implicit in the article and not to involve participant selection. Note that, from the search for instruments for measuring research quality, the CASPe guide proved the best suited to the diversity of sources and methodologies that the study worked with. Risks and possible biases were minimised by eliminating the grey literature and by the four authors’ (GS, OC, HA and BR) working independently. The study’s strengths include its originality: as far as is known to the authors and in view of the bibliographical search, no studies were found to take a multidisciplinary approach to biobanks. The findings summarise the general and most relevant information from a diversity of sciences and, as such, may serve other studies.

References

Publication Dates

History