Practical Approach to Biobanking in Zimbabwe: Establishment of an Inclusive Stakeholder Framework

Abstract

The growing need for biobanks in health research presents an opportunity for building capacity in developing countries. In Zimbabwe, there is limited knowledge and awareness about biobanking. As such we report the proceedings of a biobanking course, which included research scientists, healthcare professionals, and regulatory authorities as a start to developing a framework for biobanking practice. The aim was to educate stakeholders about biobanking and to understand the current and future regulatory and infrastructure requirements for biobanking. Using an inclusive stakeholder approach, we sought to articulate the strengths, weaknesses, opportunities, and threats. This report highlights a practical method to providing basic education to stakeholders, building awareness and consensus about building capacity for biobanking in a developing country.

Introduction

Biobanking is increasingly becoming an important component of biomedical research and health innovations accompanied by technological applications in genomics and bioinformatics to understand human population diversity and clinical development of diagnostic tools and medicines. In this study, we define biobanks as repositories of human tissue often connected to databases containing clinical and biological personal health information for purposes of diagnostic procedures, surgical treatment, education, or research.^1,2 Biobanks may be population, hospital, or disease-based depending on the scope and use, and have varying legal, ethical, and governance structures.³ Population-based prospective biobanks largely focus on the study of the development of common complex diseases over time, mainly based on blood and nucleic acid collections (DNA) for genomic research. Disease- or clinical-based biobanks focus on tissue samples and clinical data.

As we make an attempt to understand the status and level of biobanking in Zimbabwe and sub-Saharan Africa, we acknowledge the existing biobanks and sample collections at academic and research institutions where biobanking may be rudimentary in comparison to levels in developed countries. Most of these activities have been carried out as isolated individual efforts and sometimes without adequate ethical, legal, and governance frameworks and limited scientific and technical knowledge and expertise. These considerations highlight the need for capacity building through collaboration, networking, building awareness, stakeholder engagement, education, and leadership, as well as infrastructure development and funding.

Several initiatives which include the Human Heredity and Health in Africa (H3Africa), championed by the African Society for Human Genetics (AfSHG) in partnership with the Wellcome Trust, UK and National Institutes of Health (NIH), United States, are currently supporting the establishment of biobanking activities in Africa primarily in support of health-related genomic research.^4,5 The varying views and levels of biobanking challenges and limitations in biobanking faced by low- and middle-income countries (LMICs), such as South Africa and Nigeria, were reported through the European, Middle East, and African Society for Biobanking and Biopreservation (ESBB) Working Group.^6,7 A survey indicated the need to develop biobank frameworks to support the existing structures through collaborations, networks, education and training, and funding resources.⁸ In addition, country-specific needs should be established to tailor biobanking approaches at the local level. Therefore, the LMICs Biobank and Cohort Building Network (BCNet) was set up to address some of these challenges.⁹ Another initiative is Bridging Biobanking and Biomedical Research across Europe and Africa (B3Africa), which will support activities to harmonize the ethical and legal framework, biobank data representation, and bioinformatic pipelines for data and knowledge sharing across biobanks.¹⁰ In addition, B3Africa will implement an education and training system for biobanking capacity building.

In Zimbabwe, the initiation of the African Pharmacogenomics Consortium in 2002 and the subsequent establishment of the Biobank and Pharmacogenetics Database of African populations were a significant start to a collaborative network to support human genomic research in African countries.¹¹ However, its utility has been limited due to the slow development of human genomic research in Africa and unclear frameworks for biobanking and sharing of samples and data. Although unreported, biobanking for clinical research exists in national health programs and primarily support infectious disease surveillance and drug clinical trial research in Zimbabwe. Private and public research institutions, such as the African Institute of Biomedical Science and Technology (AiBST), University of Zimbabwe College of Health Sciences (UZCHS), Biomedical Research and Training Institute (BRTI), and University of Zimbabwe-University of California San Francisco Collaborative Partnership (UZ-UCSF), are active in clinical research from large-scale studies to student projects, which involve biospecimen collection and storage. There are also opportunities to develop registry-linked biobanks such as the Zimbabwe Cancer Registry to support research by providing biospecimens from a population where little is known about epidemiological risk factors and molecular epidemiology. Health professionals and research scientists at these institutions could benefit from biobank education and support the development of a biobank framework in collaboration with the regulatory authorities, which will strengthen health research capacity.

Biobanking, in conjunction with clinical and epidemiological studies, provides value in clinical and translational research while advancing public health.^12,13 However, some of the challenges include lack of awareness of these values and opportunities among stakeholders, absence of coordinated efforts, competing national and health priorities, limited funding, as well as inadequate education and training specific for biobanking. Tackling these challenges requires a multidisciplinary coordinated strategic framework for education, infrastructure, governance, and funding. We proposed an educational course as a means to start addressing the highlighted gaps within the prevailing health and research environment, political and economic systems, and legislative framework under which biobanking would be facilitated in Zimbabwe.

By taking a leading role in driving the biobank agenda forward in Zimbabwe through stakeholder engagement and education, the African Institute of Biomedical Science and Technology (AiBST) hosted a biobank course. In this study, we report the course activities and discussions held during the “Biobanking and Biomedical Research Course” held from November 24–28, 2014. A total of 18 participants attended the course from the following institutions: University of Zimbabwe College of Health Sciences (UZCHS), Medicines Control Authority of Zimbabwe (MCAZ), Medical Research Council (MRCZ), Research Council of Zimbabwe (RCZ), National Blood Transfusion Services (NBTS), and Medical Laboratory and Clinical Scientists Council of Zimbabwe (MLCSCZ). The participants included key stakeholders such as policy-makers, regulatory and ethics personnel, and clinical and biomedical scientists. The tutors included biobank experts from the Karolinska Institute Biobank (Sweden), as well as national ethics specialists and biomedical research scientists from Zimbabwe and South Africa.

The aim of the course was to combine education and training, knowledge-sharing with engagement, group work, and open debate on how best to establish and run biobanks for research, which would support healthcare and biomedical research in Zimbabwe. The course involved lecture presentations, interactive sessions, practical exercises, and assignments. The objectives of the course were as follows:

1. To provide an overview about biobanking methods and practices for health research and application.

2. To understand the current ethics and regulatory framework for governing biobanks and to identify the need for development of guidelines.

3. To understand the challenges and opportunities for biobanking in Zimbabwe.

4. To explore possible strategies for development of a biobank framework for health research in Zimbabwe.

A total of 12 hours were dedicated to lectures (Table 1) and consisted of the following topic areas: biobanking practices, ethics and regulation, and applications for biobanking.

Table 1.

Biobank Course Lectures

Lecture No.	Title
1.	What constitutes a valuable biobank?
2.	Swedish statutory instruments (Acts) for the formation and operation of private and public biobanks—a possible model for consideration for countries wishing to legitimize biobanking.
3.	Sample collection and sample handling processes.
4.	Statutory instrument under which biobanking could be done in Zimbabwe.
5.	Biobanking in international research collaborations, considering the perspectives of limited resource countries.
6.	Ethical and statutory framework for biomedical research and regulations for biobanking in Zimbabwe.
7.	Provisions and regulation of biobanking for samples from Clinical Trial studies—MCAZ position versus international standards/practices.
8.	Biobanking efforts in Zimbabwe and Africa, challenges and opportunities.
9.	Good Biobanking Practice: Implementation of a quality management system and standard operation procedures.
10.	IT infrastructure for data collection sample processing and storage (LIMS).
11.	Public trust: Legal and ethical aspects on biobanks (consent processes, confidentiality, professional conduct of researchers).
12.	Biobanking in Genomics and Pharmacogenetics research Zimbabwe's stakeholders proposition on the way forward with respect to biobanking.

Biobanking

Lectures provided an overview of the overall infrastructural needs, fundamental concepts in “Good Biobanking Practice,” and how to establish and run a biobank. Key elements discussed included the governance and management requirements, the need for qualified staff, and the importance of creating a trustful collaboration between healthcare providers and research institutions. Issues of sample quality, importance of standardization ensuring traceable information and control of specimen collection, transport conditions, processing, storage, and distribution to analytical platforms were also presented. Standard Operating Procedures (SOPs) and implementation of a Quality Management system and Standards and Quality Assurance (ISO) were discussed, including best practices guidelines.

The international perspective was highlighted with information about major initiatives such as the International Society for Biological and Environmental Repositories (ISBER) and the European, Middle Eastern, and African Society for Biobanking and Biopreservation (ESBB), the two organizations with the major aim to foster collaboration and create education and courses in biobanking.^14,15 An important organization since 2013 is the European Biobanking and Biomolecular Research Infrastructure Consortium (BBMRI-ERIC) aimed at establishing, operating, and developing a distributed research infrastructure of biobanks and biomolecular resources.¹⁶ BBMRI-ERIC also acts as a framework for biobank integration between Africa and Europe in cooperation with African countries through the B3Africa program.

As a model example of biobanking, the experience from the biobank at Karolinska Institute in Sweden and the progressive development, from 2004, were presented, as well as the Swedish statutory acts and regulations for the formation and operation of public tax-funded biobanks.

Biobank informatics, for sample management and data collection, was presented, highlighting the reasons information technology is important in biobanking, as well as the legal and ethical compliance approach for data security traceability of samples connected to the donor, consent, sample processing, storage, and tracking informed consent. The use of a Laboratory Information Management system (LIMS) was demonstrated for its application in sample and data management, facilitating sample and data access, monitoring workflow, information validation, and reporting sample quality. The BBMRI-developed Minimum Information about Biobank Sharing (MIABIS) was described, and enables sharing of data and samples between biobanks more efficiently and data describing biobanks, studies, contact information and experiment types, and aggregated data and summary statistics.¹⁷

Ethics and regulation

The regulatory framework for human biological and health research is governed by the Research Act 1986: Chapter 10:22 and the Ministry of Health and Child Care (Statutory Instrument Government notice 225) through the MRCZ and the MCAZ.^18–20 The Anatomical Donations and Post-Mortem Examinations Act has provisions for the storage and use of donated tissue for medical research purposes.²¹ The MRCZ developed Ethics Guidelines for Health Research Involving Human Participants in Zimbabwe (Version 1.4 2011) for use by investigators, ethics review committees, administrators, healthcare practitioners, policy-makers, and community representatives.¹⁹ Guidelines for Good Clinical Practice in Zimbabwe for application in clinical trials (2012) have also been developed by the MCAZ.²²

MRCZ subscribes to the international ethics guidelines on the conduct of human research, which include the Declaration of Helsinki, Council for International Organizations of Medical Sciences (CIOMS), International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use based Good Clinical Practice (ICH-GCP), the World Health Organization (WHO) ethics guidelines, as well as adaptation of the UK Human Tissue Act (2004).^23–27 There are guidelines for consent to use biological materials, use of biological materials and medical records collected during clinical care, and secondary use of records and biological materials. Although these guidelines are not specific to biobanking, a specimen storage consent form, which has provisions for long-term storage and use of samples for future research and sharing, is also available. Guidelines and forms for specimen shipment and material transfer are also available.

Although the current guidelines provide for some aspects of biobanking, they are inadequate to address emerging issues of biobanking such as ownership, benefit sharing, intellectual property, and return of results with unclear policies and guidelines for local and international collaborations and networks in foreign funded and foreign-driven research projects, which collect samples as part of multicenter studies. In addition, the guidelines provide for specific consent and allow for long-term storage and future use, and yet they are silent about broad consent, which would be a better approach for biobanking.

Biobank applications

Biobanking activities in Africa were highlighted in the context of research and capacity building networks such as H3Africa and BCNet. The immediate and practical utility of biobanking in Zimbabwe was discussed, in particular, genomics and pharmacogenomics as potential areas for clinical applications.

Interactive Sessions

Participants were divided into groups and assigned topics to develop a theoretical framework for biobanking, including (1) prioritizing biobank needs, (2) infrastructure, (3) funding, and (4) designing a clinical study with standardized protocols for sample collection, processing, and storage. The tutors facilitated an analysis for strengths, weaknesses, opportunities, and threats (SWOT) and the results are shown in Table 2.

Table 2.

Strengths, Weaknesses, Opportunities, and Threats Analysis

Strengths	Weaknesses
• Strong functional and organized healthcare system • Education and exposure of health professionals to unique diseases • Bioresources, materials, biospecimens • Infrastructure—buildings • Population literacy—willingness to participate from population/potential donors • Scientific personnel, expertise, and specialists with potential to be trained in biobanking • Diversity of pathology • Laws and Regulations in place for medical research	• Finance and support • Infrastructure maintenance • Suboptimal utilization • Coordination of existing infrastructure • Doctor to patient ratio is limiting—heavy clinical load depriving research • Lack of in-country collaboration and networking • Lack of core facilities and coordination • Limited/poor resources for research education • Limited possibilities for qualified training of scientists and health professionals
Opportunities	Threats
• Health improvement • Epidemiology and mechanisms of diseases • Funding from corporate organizations and philanthropists • Collaboration opportunities and building capacity • Development of biobank guidelines and framework to ensure interoperability related to laws and policies for medical research that are already in place • Streamline the regulations for ethical decision and approval of MTA for international collaboration • Access to samples • Technology development	• Cultural acceptance • ELSI and trust issues • Sustainability • Ownership of research agenda • Socioeconomic and political instability • Long-term control, security, trust, transparency, governance • Infrastructure—equipment service and maintenance, loss of samples due to power problems, costs, security, transportation logistics • Biobank supplies and consumables, inconsistencies • Adaption of laws and regulations

ELSI, Ethical Legal and Social Issues; MTA, Materials Transfer Agreement.

Practical Exercises

Four basic practical sessions were conducted over a total duration of 8 hours. The exercises focused on biobanking of blood samples for DNA extraction. These included sample handling processes and preparation for storage; LIMS for biobanks; DNA preparation and purity determination; sample retrieval using LabCollector^® LIMS software, and DNA quality check of stored samples by gel electrophoresis.

Outcomes from the Interactive Sessions

During the interactive sessions, participants agreed on the following points:

1. Biobanks are invaluable resources for biomedical research and clinical applications. A national biobank network would ensure that healthcare providers and research institutions work toward harmonization of biobanking activities such as sample management, data collection formats, and sharing, as well as to explore the possibility for expanding existing biorepositories to meet some basic minimum requirements and standards of biobanking.

2. In addition to funding, a sustainable biobank framework must be based on a professional organization and include health and research professionals with a clear public transparency.

3. The SWOT analysis revealed that Zimbabwe benefits from unique opportunities with a strong and functional healthcare system and the potential for well-educated people to be trained in biobanking.

4. Zimbabwe has a regulatory framework, which needs to be updated to support biobanking, as well as regulate the emerging and persisting issues with regards to codes of practice for collaboration, ethical standards, consent, and sharing policies. A clear regulatory and policy framework is needed, which supports biobanking for transnational networks and multicenter projects.

5. Working groups were established to drive the agenda toward additional consultations on specific topics to address some fundamental issues of biobanking and to provide guidelines for the establishment and operation of biobanks in Zimbabwe, including (1) definitions and scope of biobanking, (2) biobank governance, (3) bioethical guidelines, (4) infrastructural and technical requirements, (5) financial requirements, and (6) intellectual property issues, for updating or the amendment of current statutes to embrace biobanking.

Discussion

There is a growing need for biobanking to support health research and clinical development. While there are increasing activities in biobanking for research and health development in some sub-Saharan countries such as South Africa, Nigeria, and Uganda through the H3Africa and B3Africa initiatives, other countries such as Zimbabwe lag behind capacity for biobanking. As a first step toward uncovering the value of such resources and to develop a sustainable and coordinated biobank framework, we provided an educational and interactive course targeting healthcare professionals and biomedical research scientists who had a limited understanding of biobanking. This provided awareness and basic knowledge about the importance of biobanks, processes, and governance frameworks. Other professionals, who should have been called in to participate, include social scientists, technology, legal, and health advocacy experts. Despite the upsurge of proposals for building capacity and educational strategies, no reports exist of biobank educational initiatives in sub-Saharan Africa, marking this a first of such a course in the region.

Although parts of the course related to more advanced biobanking (as at KI), it was important to demonstrate a system with all the functionalities in place. The costs for development, technical expertise, and functional information technology were highlighted for the efficient operation of a biobank. However, it is acknowledged that such infrastructure and facilities may not be easily achievable in Zimbabwe. Zimbabwe, as with most African countries, faces other challenges for biobanking such as a high ambient temperature, poor transport logistics, in particular in rural areas, and an unreliable power supply. Since these factors will have a high impact on sample collections, they need to be recognized and taken into account when planning for a biobank infrastructure. Understanding these limitations empowers the professionals to deal with these challenges and possibly implement sustainable solutions in the future. The development of LIMS software, which is affordable and accessible to low resource settings, is underway through programs such as B3Africa. In addition to the catalogues such as MIABIS, this may provide a first step in integrating biobanking systems and allowing improved interaction among researchers.

Issues pertinent to biobanking in sub-Saharan Africa and internationally include sample and data sharing, stakeholder and community engagement, broad consent, governance, sociocultural issues, regulatory capacity, ownership and trust, sample and data sharing, return of results, intellectual property, and the business of biobanking.^28–31 The ethical issues of sample export and international collaborations should be considered due to concerns, which relate to obtaining culturally appropriate consent for sample export and reuse, understanding cultural sensitivities around the use of biospecimens, and facilitating a degree of local control of samples and sustainable scientific capacity building.³² Although these topics were inadequately discussed during this foundational biobank course, we acknowledge their importance, and collaboration with the education and training programs of the above-mentioned regional networks will be planned.

In addition, incorporation of biobanking topics in the existing medical and science curricula in undergraduate studies, as well as continuing professional education, should be considered and could be incorporated into the medical education curriculum development projects at academic institutions in Zimbabwe such as the Medical Education Partnership Initiative (MEPI).³³ Online courses such as those offered by the Biobank Resource Centre (BRC),³⁴ which include comprehensive modules from the basics of biobanking to data management, could also be made available for health professionals. Another resource, which can be applied in the future, includes the Public Population Project in Genomics and Society (P3G), which provides step by step approaches for development of policies, guidelines, SOPs, and other databases to support ethics and governance of biobanks.³⁵

Biobank donors such as the citizens of Zimbabwe are the primary stakeholders in biobanking. Therefore, in the future, participation from members of the wider community is critical. Collaboration with social scientists will also ensure that community engagement is applied at all steps of biobanking and biomedical research. In addition, educational materials and vignettes should be developed and translated for the local communities to facilitate their understanding of the biobanks, the processes, values, and benefits and how they can contribute to health improvement for the population.

The lack of a biobank-specific legislation suggests the need for developing a biobank governance framework. Although the National Health Act in South Africa focuses more on the storage and use of biological material for therapeutic measures rather than biobanking, the recent South African Department of Health Ethics Guidelines (2015) now takes biobanking into account with Section 3.5.2 being specific to biorepositories, supporting the growing activities in biobanking in the country.³⁶ Programs such as the Zimbabwe Forum of Research Institutions (ZIMFRI) aim to strengthen and harmonize Health Research Ethics in Zimbabwe and could provide a platform for the development of local guidelines and policies and their implementation.

Regulations for biobanking and biomedical research should be enabling research, with particular efforts to promote technical and research capacity.³⁷ Maintaining respect and fairness in the usage of stored shared specimens in low resource countries has been discussed with a call for education in all sectors of biomedical research.³⁸ In particular, education is needed to strengthen IRB-member capacity to review and monitor protocols calling for the collection and use of biospecimens, guided by clear national policy on priority setting, partnerships, review, and oversight.³⁹ Our program has taken a leading role in providing education and driving awareness on the importance of strengthening biobank regulatory frameworks and the development of policies.

A recently launched H3Africa consortium-based project entitled “Genomics Inheritance Laws Ethics and Societies” aims to understand ethical, legal, and social issues of biobanking and genomics in Zimbabwe through community engagement, education, and focused group discussions among professionals and religious and community leaders. This will also contribute to the development of local policies and guidelines for biobanking in collaboration with the H3Africa Ethics Working Group, which has provided some guidelines on ethics and governance of biobanks for genomic research in Africa.

The contributions by participants during the interactive sessions demonstrated understanding of biobanking and identified challenges and opportunities for biobanking in Zimbabwe using the SWOT analysis (Table 2). The discussions, group presentations, and practical exercises indicated that members had grasped the necessary knowledge to be involved in debate and dialogue about biobanking and how a framework could be developed in Zimbabwe despite the limited resources and access to infrastructure. Although participants pledged to collaborate toward building capacity for biobanking, leadership and champions will be required to drive the biobanking agenda in Zimbabwe. Therefore, a biobank leadership program encompassing training and mentorship of biomedical and clinical scientists, technology and engineering experts, and regulators and policy-makers may be necessary to support innovation for local sustainable solutions in biobanking.

Taking into consideration the challenges highlighting the approach to biobanking will require further research to understand the status and local needs for biobanking to build or upgrade existing infrastructure and establishment of an organized, standardized harmonized system. Education and training of ethics and regulatory committees, policy-makers, health professionals, and scientists and building awareness among patient donors and the public is key for sustainable implementation of a national biobank network and requires commitment at the government and institutional levels, as well as funding.

Conclusions

The major outcome was a successful biobank course, which provided a basic, practical, and learning experience for participants. This facilitated a broader insight and enabled participants to conduct a SWOT analysis for an approach to biobanking in Zimbabwe. The authors acknowledge that it will take time to build functional biobanks comparable to larger established ones in developed countries. However, this article presents a first step toward building capacity for biobanking through awareness and education of stakeholders using an inclusive and interactive approach and could act as a model for other sub-Saharan African countries. The authors also acknowledge opportunities for collaboration with existing African focused network initiatives, including the H3Africa, BCNET, and B3Africa.

Footnotes

Acknowledgments

The course and Biobank initiative were supported by funds from the African Institute of Biomedical Science and Technology (AiBST), Karolinska Institute (KI), and BBMRI.se. The input from participants is greatly appreciated and acknowledged. The Medical Laboratory and Clinical Scientists and Medical Research Council of Zimbabwe (MLCSCZ) are acknowledged for approving this course and awarding the participants continuing professional development (CPD) credit points. Mrs. A. Muzite, the executive director of the RCZ, is acknowledged for being the guest of honor at the course and Dr. Paul Ndebele, MRCZ director, for his comments and input in the article.

Author Disclosure Statement

No conflicting financial interests exist.

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