Biobanking Spotlight on Europe,Middle East,and Africa: Presenting the Collective Experience of the ISBER-EMEA Regional Ambassadors

Abstract

Introduction

A regional ambassador program was initiated by _ISBER in December 2018 to help the organization better understand local/national issues and requirements, and to help expand the reach of the work.¹ One of these regions is the EMEA region, comprised of Europe, Middle East, and Africa—a very large geographical area with diverse populations, needs, and challenges. The regional ambassadors were selected by a dedicated ISBER committee and are considered the regional thought-leaders in biobanking within their regions. ISBER members can self-nominate and apply to become a regional ambassador online at www.isber.org/page/ISBERregionalambassa

In this article, ISBER-EMEA regional ambassadors, working in conjunction with the EMEA Director-at-Large, highlight according to their personal views and the lens of human biobanking the challenges and achievements that remain at the top of the agenda for the ISBER-EMEA region. Following is a selection of responses on

(1)

the existing challenges in sharing samples and data and: whether there is an expectation that the challenges will be addressed in some way, locally or internationally for the region;

(2)

the biobanks' impact assessment: how biobanks in the region are expected to deliver impactful work and how that is measured; and

(3)

the two highest priority issues in their respective region with regard to biobanking.

Nassimbwa S, Uganda

Sharing samples and data

Research, partnerships, and collaborations have been taking place in Uganda consistently for the last 40 years, involving the sharing of samples and data across Africa and globally.² The import and export of human biospecimens for biomedical research are preauthorized, controlled, and supervised at the governmental level through the Ugandan Ministry of Health (MoH), Uganda National Council for Science and Technology (UNCST), and National Drug Authority (NDA). The lists of export and import approvals (∼120 per year, averaged across the last 5 years) granted by the Ugandan UNCST, NDA, and MOH evidence the regular occurrence of crossborder exchange of biospecimens.

Local/national networking and collaboration between research organizations and biobanks inside Uganda are not well supported due to the minimal public awareness/biobanking knowledge within the local community and the lack of visibility for the impact of biobanking activities. However, a significant boost was received in 2019 from the UNCST, which now recognizes biobanking as a specialty and supports the development of biobanking in Uganda as central to research.³ Fostering the exchange of biospecimens and promoting good practices in biobanking are among the UNCST-stated goals.

Some of the challenges in sample and data sharing include the following: (i) the need to clarify the intellectual property rights over samples by the donors. According to the UNCST guidelines, the sample source retains ownership of the physical samples, while the registered organizations have custodianship over such samples; (ii) the need to clarify further aspects of intellectual property such as limitations/restrictions for third-party uses where sample and/or derivatives are involved; (iii) sample data are governed by the Data Protection and Privacy Act 2019 enacted by the Ugandan government.⁴ Other International regulations such as General Data Protection Regulation (GDPR), the Common Rule and Nagoya protocol, also affect collaborations, and the limited in-country knowledge of some of these regulations produce additional challenges; (iv) research and technology are governed by UNCST.⁵ While MTAs and shipments out of the country get clearance from UNCST, imports are not documented and receiving them is not regulated. This situation calls for the establishment of a regulatory body or procedure, especially for genetic research and permissions for further future use.⁶

Biobank impact assessment

Small and isolated biobanks have existed within Uganda since the mid-2000s. At present there is rapid development in biobanking with three major human biobanks recognized and operating to support clinical and basic research. While plant and animal biobanks do exist to support science, agriculture, and fisheries, they are not well mapped. Depending on their operational model and affiliation, they provide services either directly to the institution to which they belong or to national and/or international research consortia, and their impact(s) are assessed differently.

Specializations of active biobanks vary from public- to private-institutional settings to dedicated clinical based, fertility, research, animal breeding, and plants. These biobanks support national public health, agricultural, and research concerns in four ways: (i)

the future development of the Ugandan National Biobanking guidelines;

i) the provision of research samples required for translational research from biobanks within research settings;

ii) networking and collaborations such as the opportunities from the H3Africa consortium, increasing capacity for genomic research⁷; and

v) supporting surveillance as in the case of the Ugandan National Health Laboratory Services Biorepository (UNHLSB) and the direct association with the national Human Immunodeficiency Virus Drug Resistance Program (HIVDR), and Prevention of mother-to-child transmission programs (PMTCT).⁸

Current challenges

(A) Certification/Accreditation. There is currently no certifying body that can review the setting up and operation of biobanks. As a result biobanks are mushrooming often with poor outcomes, as the expertise and support are unavailable. This seems to be the case in Uganda and throughout Africa at large. UNHLB is currently developing a certification checklist to address this challenge.

(B) Education and training. A shortage of suitable education and training has led to a lack of qualified and trained personnel in biobanking operations. The globally available courses are not easily accessible and those that are accessible are expensive, with no available scholarships. As a result only a few people have done biobanking as part of their Continuing Medical Education training (CME) in Uganda. The educational system does not have any existing curriculum for biobanks, although UNHLS is now developing one. There needs to be a better orchestrated approach to harness expertise and develop biobanking as a discipline in Uganda, and support and increase the awareness of biobanking in the community.

Anisimov SV, Russian Federation

Sharing samples and data

Russia is one of the countries with strict governmental control over the import and export of human biospecimens collected for research purposes. The State body (Roszdravnadzor—Federal Service for Surveillance in Health care) authorizes, controls, and supervises the import and export of biospecimens collected over the course of both clinical trials (representing the majority of biospecimens leaving Russia) and other types of collaborations such as research agreements between Russian and foreign universities, companies, biobanks. Scientific exchange of biospecimens across borders is possible as evidenced by the lists of export and import approvals granted by Roszdravnadzor and published bimonthly on its website.⁹ However, the requirement to obtain export/import approvals is one potential complication for any potential research collaboration with Russian organizations. It is not expected that this requirement will be waived, or that application procedures will be simplified in the foreseeable future. But the process adds a beneficial degree of traceability, which is important for many users of biospecimens who wish to make sure that biospecimens have been collected and exported legally.

Local/national networking and collaboration between biobanks inside Russia have received a boost after the National Association of Biobanks and Biobanking Specialists (NASBio) was established in early 2019.¹⁰ Fostering exchange of biospecimens and promoting good practices in biobanking are among the important stated goals of NASBio.

Biobank impact assessment

Since 2010, biobanking has developed rapidly in Russia, and ∼30 research biobanks are currently operating nationally, in addition to a few clinical biobanks.^11–14 Depending on the model and affiliation, they provide services either directly to the institution to which they belong or to a research consortium at a national or international level. Specializations of active Russian research biobanks vary from population-based to dedicated specific clinical areas (e.g., immunology or age-related disorders), as well as those covering multiple clinical domains. Therefore, these biobanks are able to support a variety of research projects. A few clinical biobanks exist, representing either commercial umbilical cord blood/stem cell collection and storage, or institutional clinical biobanks specializing in cardiology (isolation, storage, and transplantation of heart valve homograft), traumatology (ligaments and bones), etc. Persisting challenges include the acute deficit of qualified and trained personnel and difficulties in reaching self-sustainment. Nevertheless, the rapid development of Russian biobanks illustrates the growth based on the needs of the research community, as well as the ongoing State support.

Current challenges

(A) Governance framework. Recently there have been activities directed at developing and implementing a Federal Law on Biobanking in Russia. Various groups are involved in preparing the draft of this document, and the Russian biobanking society is generally optimistic that experts have been invited to participate at the drafting stage. There is no doubt that if accepted, this law will have a major effect on the fields of biobanking and of biomedical research in Russia.

(B) Standardization. While no official national standard currently exists in Russia in biobanking, there are discussions aimed at creating a Russian State Standard that aligns with existing national legislations, and is based on EU norms and the ISO 20387:2018 standard. The creation of National State Standards aligned with international ones is a common policy for many countries including the Russian Federation. It is hoped that NASBio will actively participate in developing such a standard, but the process of establishing it is as yet undecided.

Kinkorova J, Czech Republic/European Union

Sharing samples and data

Europe is a very diverse and fragmented region regarding biomedical research and biobanking. The European Union (EU) considers the member states as world leaders in the development of biobanking infrastructure to support research, making huge investments each year to such initiatives. The development of biobanking was stated as a key challenge in the last two decades in the EU, and the support, development, and functioning of biobanks in Europe were key funded actions in the 7th Framework program (FP7) and subsequently in the Horizon 2020 funding framework programs.^15,16

To overcome this rapidly expanding, yet highly fragmented, situation the biggest European infrastructure for biobanking, Biobanking and Biomolecular resources Research Infrastructure–European Research Infrastructure Consortium (BBMRI-ERIC), was funded, based initially on a project from the FP7 in 2008.¹⁷ The aim of the infrastructure is to bring together main players in biobanking in Europe to boost biomedical research. Hence, quality management services, ethical, legal, and social support, and other online tools are offered. Currently, the increasing perceived value of samples and data in national biobanks does not correspond with an adequate increase in sample/data sharing and sample/data access. To facilitate efficient sample/data sharing, IT solutions and tools were developed by BBMRI-ERIC and offered to users: the Negotiator and Locator.¹⁷ The Negotiator is an online tool for users to negotiate access to samples and datasets located within European biobanks. The Negotiator focuses on making communication between a high number of requesters and biobanks as efficient as possible. The Locator is an online tool to locate samples and datasets hosted by biobanks that are of interest to the requesters. The Locator allows for detailed, privacy-preserving, multicriteria search of samples and datasets, while also respecting the degree of control required by the biobank infrastructure operators. In addition, working groups developed supportive materials such as the Minimum Information About Biobank Data Sharing (MIABIS)¹⁸ and MIABIS 2.0.¹⁹ These represent the minimum information required to initiate collaborations between biobanks and to enable the exchange of biological material, following adherence to the GDPR, protecting identifiable or potentially identifiable information.

Biobanks impact assessment

Biobanking activity has increased dramatically in Europe during the last two decades, and research involving biobanks as active, key contributors of samples and data is developed at several levels, from small national and regional research programs, collaborations between institutions in different EU states focused on rare diseases, cancer, neurodegenerative diseases, diabetes and obesity and many others, to wide international collaborations. The crossborder collaborative project Biobank Research on Telemedical Approaches for Human Biobanks in a European Region (BRoTHER)²⁰ between the Bavarian Region and Czech Republic is an example of a small bilateral bottom-up evolving project in the center of Europe. The impact(s) of these initiatives are assessed usually in terms of scientific output and knowledge transfer, most EU member states following the example provided by the EU research funding assessment mechanisms.

Current challenges

(A) The GDPR entered into force on May 24, 2016.²¹ GDPR is binding in its entirety and directly applicable in all member states from May 25, 2018. Europe is characterized by the great diversity in personal data and information collection, protection, storing, and sharing, thus sharing them was almost impossible. To overcome the crucial problem, GDPR was developed and approved by all member states; however, the implementation is still ongoing among different EU states.

(B) Education and training. Different education and training systems at all levels relevant to biobanking staff complicate international collaboration and even staff exchange. There are insufficient and inadequate compulsory/optional subjects/courses at universities and high schools. This situation occurs not only at medical faculties but also includes courses on data and information management as related to biobanking, biostatistics, and big data. A focus on crossdisciplinary, comprehensive, and innovative approaches for future biobanking education is needed. International societies and associations such as BBMRI-ERIC, the International Society for Biological and Environmental Repositories (ISBER),²² and the European, Middle Easter and African Society for Biopreservation and Biobanking (ESBB)²³ have an important role to play in training and education to further the discipline of biobanking.

Marrs S, South Africa

Sharing samples and data

Even though major international studies have included and taken place within South Africa for many years, there is still no clear indication or documentation of how the international sharing of samples has benefitted the South African population or participants. The South African Department of Health (DoH) has to give express permission for specimens to leave the country—a process that has not always been followed. Recently guidelines have been introduced to ensure that any such procedures are ethically and legally compliant; however, there are no specific regulations relating to biobanks. As a result biobanks tend to operate in isolation, address challenges in isolation, and focus increasingly on servicing local research needs that can have a direct positive impact on the local population.

There have been instances in the past where data and samples have been crossing borders, but there have not been any tangible local health care benefits noted. As a consequence, such arrangements have raised community and ethical concerns, in particular as the training of staff to only satisfy a snapshot or research activity with a lack of follow-on activities has denied the country of potentially beneficial skills and training relating to samples and data collection. There are also infrastructure challenges that make the growth of the biobanking field particularly difficult, such as irregular electricity supply and variable supply of consumables.^24,25 As a result, the cost of creating and maintaining a biobank remains prohibitively high, as long-term operations are associated with high operational risks. Furthermore, the lack of clear long-term financial support from governmental agencies confounds the sustainability aspects. Thus biobanks continue to operate mainly focusing on short-term collaborations and international research opportunities.

In addition, most of the equipment and software are to be found only internationally, requiring lengthy import processes. Finally, some local biobanks do not have proper disaster management plans, which given the above constraints puts them at risk. However the picture is clearer in the many environmental/biodiversity biobanks in South Africa, where a longer experience in collecting samples has led to better organized systematic networking and communication between these facilities. For example, those facilities operated under the National Zoological Gardens of South Africa, where samples are utilized for research linked to biodiversity conservation and where pathways for data sharing were defined some years earlier.²⁶

Biobanks impact assessment

Some of the human biobanks rely on standardized organizational risk assessment to look at their impact (provided for or based on their institutional templates). On specific clinical research, the challenges are that the international funders would preferably fund the research of their own interest and not necessarily of the country's priority list. This appears as detrimental to the impact assessment, operating only as a “sample supplier” with no further added value. Furthermore, often such international collaborative studies place requirements by international funders for specimens to be shipped to their own country for analysis, without either helping the local institution with equipment for analysis or finding and training the local laboratory to do this analysis themselves. As such the local impact of the biobanks is minimized. It has to be noted that biobanking is still a novel engagement, and as such being able to demonstrate full impact will take some time.

Current challenges

(A) Certification/Accreditation. There is currently only one biobank in South Africa that has achieved ISO9001 certification, the NHLS Biobank. Other biobanks do not have internationally recognized certifications/accreditations in place (AABB, CAP, or others). South Africa still has to adopt ISO 20387 and train the auditors assessing successful implementation of the standard, before it can be implemented. The cost of attaining certification/accreditation also needs to be taken into consideration. It is hoped that the acquisition of certification will allow a closer link between biobanks and other established, governmentally run institutions, therefore contributing to the potential long-term sustainability of the biobanking sector.

(B) Education and training. There are currently no directly registered courses for biobanking in South Africa, or southern Africa, contributing to the lack of appropriately trained and qualified staff. As such online available international courses for certificates on biobank processes are followed where possible. The high cost of further education, and the necessity of that taking place abroad, denies other interested people to pursue such options.

Afifi NM, Qatar

Sharing samples and data

The Qatar Biobank (QBB) is a not-for-profit organization but does implement a cost-recovery strategy to help cover the operating costs only. It means that researchers' samples and data can be shared, but the cost of accessing data, including genomic data and biological samples, can be limited to only scientists who can obtain grants. QBB is collaborating with many academic research institutes to offer solutions to the restrictive cost of accessing data and samples.²⁷ It is a requirement for undergraduate students in health science fields to complete a research project as part of their final project. QBB has agreed to cover the data and sample costs (excluding genomic data) up to an agreed number of required subjects, to ensure that students engaging in research are not negatively impacted through a lack of budget. Grants are available from the Qatar National Research Fund, an organization designed to support local and international research projects. The Path toward Precision Medicine grant is designed specifically to support genomic research using QBB and Qatar Genome Project data and samples with more focus on innovative projects aimed at translating basic research into clinical interpretation.^28,29 The national priorities research program (NPRP) grant scheme is also available from QNRF, which selects research projects that aim to address national priorities.³⁰

Biobanks impact assessment

The work of the QBB is impacting health initiatives within the country, and QBB staff are part of three new national surveillance committees, which have been created. The surveillance committees focus on three of the most urgent chronic health problems affecting the local population: diabetes, dementia, and cardiovascular disease with diabetes. Information programs promoting healthy lifestyle choices are easily accessible for the population, and there is good governmental support and public recognition of the impact of the QBB on health research in general.

Current challenges

(A) Governance framework. This remains a burning issue, and highlights the lack of a national framework of regulations for data sharing and specifically the ownership of genetic data. The Ministry of Public Health has published guidelines for Human Subject Research, created from many commonly used publications such as The Belmont Report, World Medical Association and Declaration of Helsinki. However the local guidelines do not address data sharing. Individual research and academic institutes have set their own guidelines for the sharing of data and samples, which results in confusion for researchers and lack of consistency. QBB has made provisions within the consent procedure, which informs participants that their biological samples will be kept and used in Qatar only.

(B) Certification/Accreditation. This aspect is very important to QBB as it offers customers assurances about the quality of services provided. The quality of data and samples provided to researchers has a direct impact on the outcome of the research being conducted. QBB has addressed quality challenges through the use of the ISO 9001: 2015 standard and to ensure quality standards are set and maintained within the laboratory setting. The QBB is working toward achieving the College of American Pathologists (CAP) Laboratory Accreditation for testing human specimens.

Aguilar-Quesada R, Spain

Sharing samples and data

The main challenge in sharing human samples and data for research is achieving standardization in sample collection, processing, and preservation, and to have available common clinical information, avoiding preanalytical bias. The Spanish Biobank Network is working to address this and the access to multiple human biological samples by means of a catalog of collections. The Spanish Biobank Network is a public national initiative formed currently by 39 biobanks, which provides an added value to the Spanish biobanking activity through joint actions such as innovative projects, public–private collaborations, dissemination, and educational activities.³¹ In addition, the National Stem Cell Bank is a public network structure with the goal and legal mandate of preserving and distributing pluripotent stem cell lines. This includes human embryonic and human-induced pluripotent stem cell lines produced in the Spanish laboratories for their use in biomedical research,³² promoting the quality and safety of the corresponding procedures. One of the objectives of the national legislation published in 2011 to establish the basic requirements for the authorization and functioning of research biobanks in Spain was to guarantee the controlled circulation of human biological samples. In relation to import and export of biological samples, national legislation published in 2006 indicates the necessary requirements.

Biobanks impact assessment

The impact of the Spanish biobanks is measured by acknowledgment in publications. Despite clauses in Material Transfer Agreements, researchers using biobanked samples often do not indicate the exact sample provenance impeding the capture of this metric. Individual biobanks are mainly focused on local projects as they are considered to be part of the service platform within their center. Inclusion in the Spanish Biobank Network gives them opportunities to be included in wider private and public, national and international research. Many researchers still work without the support and guarantees offered through biobanks to avoid presumed higher costs or administrative burden.

Current challenges

(A) Sustainability. Although a cost-recovery policy may be available to cover some of the costs of collection, processing, and sending of samples, it does not provide full financial sustainability. Charging the costs reflecting the actual biobank costs in full would be impractical and unaffordable to the researchers. Different models of partnerships have been proposed by some authors to address this funding gap.³³ Institutional support remains necessary to assure the survival of biobanks, and it must be envisaged as a government strategy promoting the quality of research and protecting the rights of citizens who donate samples for research.

(B) Education and training. Through the Spanish Biobank Network a Masters Degree in Biobanks has been organized for biobank-related staff with several student cohorts having completed the course. However, despite the efforts invested in the dissemination of the biobanking career opportunities, a poor awareness remains in society at present. Because biobanking is a young discipline, further actions with educational institutions are necessary to include this field in the undergraduate and university levels to achieve wider professional recognition.

Conclusion

It becomes evident from the above contributions, summarized in Table 1, that even though biobanking as a field has experienced sustained growth, this growth is very much dependent on central government support, and on the appropriate legal and ethical frameworks being defined. This in turn presumes that the local authorities would be informed about biobanking, its functions and potentials, so that the appropriate support becomes available and operational. As highlighted by the expert contributors, in the cases where centralized, governmental support was provided to biobanking, the field was able to grow and contribute to the research development locally and often internationally. However the overall visibility of biobanking remains low, and further actions are necessary, so that it becomes identified as a crucial part of the health care research environment. Enhancing the general knowledge and awareness of biobanking serves as essential means to grant such sustained governmental support.

Table 1.

Summary by Geographical Location and Theme, of the Views Highlighted in the Manuscript

	Uganda	Russian Federation	Czech Republic	South Africa	Qatar	Spain
Sharing samples and data	There is a recent legal framework for operations. An overseeing authority is also needed to regulate the creation of new biobanks.	There is an established legal framework for the import/export of samples operating for many years.	The EU has invested on BBMRI-ERIC to provide guidance on these aspects and in relation to recent laws (GDPR).	Past experiences where samples left the country without any benefits in return have raised ethical concerns for sharing. Better experiences have been documented for enviro-bio biobanks.	National grant schemes are built on the basis of accessing/sharing data. However the cost of doing so without dedicated funding can be a limiting factor.	The Spanish Biobank Network and more recently the National Stem Cell Bank have been harmonizing the aspects of sharing samples and data across Spain.
Biobank impact assessment	Dependent on the consortium or affiliated institution	Dependent on the consortium or affiliated institution	Different assessment mechanisms followed across the EU	The impact is usually assessed according to the funders' priorities and not the nations	The impact is assessed based on its alignment to the national research priorities	Measured by the mention in publication, but not adhered to by all researchers.
Education and training	Courses are too far and generally inaccessible	Educational opportunities are limited; a National Association of Biobanks now exists	Different educational systems and training opportunities exist, but are not comparable yet	Courses are too far and generally inaccessible	There is availability of skilled staff; however, further educational opportunities are commonly abroad.	There are options for Master's level courses, but options need to be created as part of undergraduate studies.
Challenges	Improved mapping of biobanks (human and enviro-bio) operating in the country	The creation of a “biobank-specific” legal framework and of a national standard based on ISO	The EU-wide GDPR legislation is being implemented across the EU in different ways.	The cost of certification/accreditation is considerable resulting in a slow uptake currently.	The alignment of the local guidelines for sharing data and samples needs to be strengthened.	The sustainability of biobanks remains the major challenge, as they are heavily dependent on one source (institution).

The overall impression is that biobanking, once appreciated, is viewed as an essential infrastructure. However, the impact of that infrastructure on the delivery of better local research and the development of health care solutions is identified, measured, and acknowledged very differently across EMEA, reflecting the priority setting of the different research agendas between wide geographical areas. This complicates the efforts of providing comparable success stories across wide geographical areas, and echoes the still existing underlying challenges of harmonization and standardization in the field. Similarly, though accreditation and certification exist, these are interpreted differently by the different areas in terms of staff expectations and the needs they satisfy.

Finally, the critical experts' contributions highlight the need for education in biobanking. There is the acknowledgment that options for attending courses and further education do exist; however, these are few and not necessarily accessible. Alternative options would need to be created by either institutions or international organizations to strengthen the provision of educational resources across EMEA and to create cohorts of young biobanking professionals and subsequently define their career path better. It is hoped that the new online Qualification in Biorepository Science (www.isber.org/page/qualification) will provide an internationally accessible course to further the field of biobanking science and the education of biobankers.

Footnotes

Acknowledgments

The authors thank their colleagues and ISBER for their support and trust in becoming regional ambassadors for EMEA.

Disclaimer

Where authors are identified as personnel of the International Agency for Research on Cancer/WHO, the authors alone are responsible for the views expressed in this article and they do not necessarily represent the decisions, policy, or views of the International Agency for Research on Cancer/WHO.

Author Disclosure Statement

No conflicting financial interests exist.

Funding Information

No direct funding was received for this project.

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