The Malian-German Network: Opportunities and Challenges in the Development of Academic Biobanks and Comparative Biomedical Research

Population Diversity—Challenges and opportunities

Mali and Germany, two strikingly different nations, each present unique challenges, and opportunities regarding research. Mali, a West-African LIC faces underrepresentation in research due to insufficient funding. A fascinating situation with 13 national languages creates enormous diversity, but poses challenges in documentation, translation, and standardization of questionnaires as well as medical reports. However, only English and French are used for written and signed research documents, namely consent and assent documents. Given the plethora of languages, the German biobank quality handbook was translated into French and English during the planning phase to guarantee consistent terminologies throughout the project. Furthermore, research participants are expected to be clearly informed and consent documents explained in their language of choice by the investigators as required by ethics committees. Moreover, in a society with a relevant illiteracy rate such as Mali, oral communication assumes different significance compared with HICs. ⁴ For instance, Grosse-Frie et al. made the experience that written consent procedures caused confusion and discomfort among illiterate patients, that were unfamiliar to the practice of signing documents, leading them to obtain oral consent instead. ⁵ This aligns with a cultural background, where the spoken word and oral tradition represent a crucial element for social and historical reception. ⁶ Illiterate patients represent a vulnerable population, which we aim to protect during our research activities by applying the recommendations of the Human Research Protection Program of the University of California. ⁷ In Mali, all consent and assent documents are either in English or in French. If the participant is illiterate, the document is translated (i.e., explained orally) into the language of choice by the investigator to ensure that the patient fully understands the study and its implications before he or she signs or stamps the document. The informed consent status will be documented in the biobank data management system.

Alternately, Germany, a HIC with a robust biobanking infrastructure, is coordinated under the German Biobank Node, leading to high levels of formalization through written contract and historiographical tradition. ⁸

Furthermore, differences in socio-demographics and economic development degrees may influence epidemiologic and histologic disease patterns. ⁹ Recognizing these specific differences in a pathology is critical when examining two populations.

Contrary to European populations, African populations display increased genetic diversity and vast population substructures with multiple ethnic groups. Genetic variation can result from a combination of factors, including historical migrations, intermixing, and adaptations to different environments. ¹⁰ This genetic heterogeneity was demonstrated to impact susceptibility to diseases such as tuberculosis and malaria resistance in African populations. Although the prevalence of hypertension, diabetes, and obesity is relatively low in Africa, African Americans in the United States face an elevated risk for these conditions. Multiple candidate loci were identified as potential contributors to this susceptibility. ¹⁰

Unlike HICs, biomedical research in Mali focuses on rural populations in endemic areas with tropical diseases. In this context, global initiatives have made a valuable contribution in fighting infectious diseases, such as malaria. For example, the Mali International Center for Excellence in Research (ICER) program is one of these concepts from which the Malian-German network can learn. ¹¹ However, the under-representation of Southern populations in cancer research necessitates significant efforts to establish partnerships within the biobank system. The handling of tissue samples and the standardization of data introduce a new dimension to the scope of global collaborations. However, establishing collaborative research and a sustainable biobank system in Mali, does not mean to copy the European biobanking strategy, but to provide infrastructure tailored to Mali’s specific needs. German biobanks could seize this opportunity to learn from Mali about population heterogeneity, a topic gaining importance due to immigration movements.

Creating a shared research data Base—The Malian-German network

The collaboration includes the University of Science, Techniques, and Technologies of Bamako in Mali and the Institute of Pathology Mannheim with its integrated biobank in Germany, emphasizing a mutual approach to knowledge exchange and cooperation. Despite political instability, the Malian team is well-prepared with various stakeholders involved and a growing pool of skilled researchers, making it a cost-effective research location.

Through a harmonized protocol, our collaboration will collectively define a shared framework for collecting, processing, and storing samples and data. First, we intend to establish collaborative initiatives focusing on cancer-related research. Second, we aim at expanding the platform for enhanced cancer prevention, diagnosis, and treatment. Finally, we seek to provide researchers with high-quality resources and advancing precision medicine through comprehensive training programs. Furthermore, the platform will provide its resources to various stakeholders (Fig. 1).

OPEN IN VIEWER

FIG. 1.

The German-Malian collaboration, through the implementation of a harmonized protocol, aims to collectively define a standardized framework for the collection, processing, and storage of samples and data. The platform offers its resources to a diverse range of stakeholders, including scientists engaged in biomedical research, academic researchers, government institutions, and non-profit organizations.

The project is planned as a long-term cooperation with intense exchange during the biobank setup phase. Subsequently, the focus will shift to shared research projects. Semi-annual structural evaluations and monthly team meetings should take place to monitor progress and identify potential challenges. Furthermore, a first scientific exchange including a training program took place in Germany to strengthen the relationship between the German and Malian partners and synchronize workflows. In this context, we shared our management handbook to compare and modify workflows in our biobanks. For this purpose, we translated our handbook into French and English. Additionally, we compared the minimal datasets in each biobank to harmonize them, aiming to optimize data exchange. Monthly video conferences with the biobank directors were focused on discussing relevant issues from the handbook, identifying subjects that needed modification according to local requirements. Furthermore, both biobank directors and scientific staff heads participated in biobanking training events to establish a common ground regarding technical and quality aspects. Finally, the technical staff of both biobanks participated in an online education program focusing on quality management, sample handling, and ethical considerations. After this initial orientation phase, we will transition into a practical phase, during which we will develop a comprehensive roadmap for collaborative work. Establishing robust funding strategies is also crucial for enhancing the longevity and sustainability of our collaboration in the future.

Collaborating on comparative cancer research projects

Cancer research is supposed to take a crucial role within our approach, since mortality rates are disproportionately high in Sub-Saharan Africa compared with HICs. ¹² However, effective prevention, early detection, and management could reduce the cancer burden by 30% to 50%. ³

In this context, translational research and precision medicine play a crucial role. Therefore, the analysis of biobank samples and comprehensive data collections, including medical data and respecting potential population heterogeneity, biomarkers, and lifestyle characteristics, is central to enhance our understanding of pathomechanisms. For instance, triple-negative breast cancer (TNBC) accounts for approximately 33% of breast cancer cases in African countries, compared with less than 20% in other nations making it a relevant research topic for our collaboration. ¹³ Martini et al. identified biological links between African ancestry and pathological processes that impact TNBC, by comparing samples from African Americans, European Americans, West Africans, and East Africans. ¹³ Based on the scientific literature and for practical reasons, our network identified breast cancer as a potential first research project. This choice is guided by the high social relevance of the disease, alongside the feasibility of sample acquisition and the availability of sample material in both countries.

Consequently, access to high-quality data is mandatory for comparative trials among diverse populations. Initiating a pilot research collaboration aims to characterize and compare the minimum dataset used in tumor registration and cancer research in both countries. Furthermore, this allows to analyze key factors involved in decision-making for including parameters in cancer registries and biobank data management systems.

A significant challenge that requires special attention is the data transfer between the two countries. In this context, it must be recognized that there are distinct requirements regarding data protection in each country. Germany has very strict data protection laws especially regarding sharing of health-related data. They are embedded in national law and in the European General Data Protection Regulation (GDPR). For Mali, decree n°2017-0245 of Law n° 09-059 (December 28, 2009) in Article 2 stipulates that biomedical research is conducted on the basis of the fundamental ethical principles recognized, nationally and internationally, respecting the human person, the principles of beneficence and non-maleficence, justice, and equity. This is also based on the need to protect the fundamental privacy and personal rights of participants in research projects. In addition, law n°. 2013-015 (May 21, 2013) on the protection of personal data in the Republic of Mali specifies the framework for the use of personal data. ¹⁴ Indeed, these laws on research involving humans and data protection enable collaborative research and sharing data and samples. It should be noted that any data must be anonymized and codified before being shared.

Therefore, a main aspect of our network represents the adjustment of ethical and legal requirements with view to the European GDPR, as it was recently performed for many other countries and regional regulation. ⁸ Furthermore, we are currently comparing and standardizing the minimal data sets of both biobank, the biobank of Bamako and the Biobank of the Medical Faculty Mannheim of Heidelberg University, which mainly consist of the harmonized minimal data set of the German Biobank Alliance. In this context, our ongoing analysis revealed that it should be of high interest to implement population specific parameters such as the high prevalence of TNBC in African countries. In a next step, we will harmonize the data sets so that an exchange for research projects will be more convenient. The ultimate objective within our network is to establish a framework that includes interactive standard operating procedure (SOP) development related to tissue sampling, pre-analytic processes, and tissue storage techniques between German and Malian institutions while identifying and respecting relevant cultural differences. One example for these cultural differences is given by the significance of traditional medicine in Mali. ¹⁵ The impact of this, along with other cultural differences, on biobanking cooperation will be analyzed more in detail in a future study.

Ultimately, this network will promote other collaborative projects involving various noncommunicable diseases, supported by harmonized SOPs and precision medicine training activities.