Abstract
Human tissue samples and data are essential for clinical research, enhancing our understanding of disease biology and clinical manifestations. The scientific advancements propelled by their use offer remarkable insights for better health. However, the global relevance of these advancements is not always robustly evaluated, and international access to innovative treatments can be limited. Yet, the interconnectedness of our world is evident as individuals travel extensively for leisure, work, or business, often to regions with high infectious disease risks. In our one world, health should be approached as a global endeavor.
To ensure robust and inclusive advancements, the data and samples used in clinical research must be well-curated and globally representative. Biobanks and institutions play a crucial role in ethically handling and utilizing these samples and data. Over the past 30 years, the number of biobanks and data centers has significantly increased, accompanied by a proliferation of laws and regulations within countries and regions. The specificity and maturity of these frameworks vary significantly across jurisdictions, and authoritative information on existing international laws and regulations is often hard to find.
This issue features two articles that highlight the challenges of biobanking and research due to international regulatory fragmentation: “A Review of Regulatory Frameworks for Biobanking in Southeast Asia” by Medina et al., 1 and “Biobanking in Sub-Saharan Africa: A Review of Data Protection Frameworks” by Mohammadzadeh et al. 2
Southeast Asia: A Region Striving for Collaboration
Medina et al. review the various national frameworks for detecting emerging infectious diseases, biosecurity, and biosafety, highlighting the diverse biobanking regulations across countries of the Association of Southeast Asian Nations (ASEAN). They note significant differences in the legal umbrellas under which these regulations are housed and that the sophistication and maturity levels of these legal frameworks vary. The authors argue that while nationally tailored approaches suffice for internal needs, they hinder regional sharing and restrict research benefits across borders. Overlapping frameworks create interpretative challenges, indicating a need for consolidation. Medina et al. found that this fragmentation is particularly problematic during infectious disease outbreaks, as highlighted during the COVID-19 pandemic, where sample and information sharing was inadequate.
The authors voice concerns that without harmonization among stakeholders, coordination during health crises may not meet global needs, potentially exacerbating health inequities. Regional initiatives like the European Virus Archive (https://www.european-virus-archive.com/) and WHO Bio-Hub (https://www.who.int/initiatives/who-biohub) could serve as potential models for international harmonization.
Sub-Saharan Africa: An Emerging Regulatory Landscape Facing Hurdles
Human samples used in research are typically associated with clinical and demographic information, and the research with these samples generates further data. While the current amount of biospecimen research on the African continent may be relatively limited, its populations are genetically the most diverse. This diversity presents an opportunity to better understand human biology but also mandates considering this variability in clinical research and health for all. In this context, Mohammadzadeh et al. explore the extent to which biobanking data from sub-Saharan Africa is protected, can be shared internationally, and is positioned to contribute to global research. Their review shows a highly fragmented field of regulatory frameworks across the African continent, with data protection frameworks still emerging at different speeds. They point out that data sharing agreements (DSAs) in Sub-Saharan Africa exhibit deficiencies that may limit biobanking’s potential to contribute to global research, citing a lack of clear provisions on data ownership, access rights, and accountability measures. Few legislations provide a full description of these provisions. With gaps in most DSAs regarding cross-border data sharing, navigating legal concerns related to data protection in multi-country research is challenging. Importantly, the authors note a lack of enforcement mechanisms and oversight bodies to ensure compliance with DSAs, making it difficult to monitor and control data flows effectively. The authors recommend capacity building to enhance biobanking effectiveness in sub-Saharan Africa, including training in data management, cybersecurity, and bioethics, and increased government investment in digital infrastructure for secure data storage and sharing. Like Medina et al., they see the harmonization of frameworks as crucial for supporting data sharing and ensuring protective regulations across stakeholders.
The Need for Global Action
A common thread in both review articles is the observation that regulatory fragmentation is hindering international biobanking collaboration in both regions. To address transboundary health issues and advance global health, we must empower international research.
Laws and regulations are the enforceable manifestations of societal social contracts, greatly influenced by history and culture. The variability in national and regional approaches to research with human samples and data, as described in the two review articles, is partly a byproduct of local cultural and historical differences. An example of this is the African philosophy of Ubuntu, discussed by Mohammadzadeh et al., which emphasizes community, interconnectedness, and mutual respect. Unlike the prevailing Western perspective, Ubuntu views privacy not primarily as an individual right but as a communal value. Within this framework, personal information is respected and protected to maintain harmony and trust within the community, balancing individual dignity with collective well-being.
Both reviews and previous articles published in Biopreservation and Biobanking 3 call for the harmonization of international regulations. Achieving this harmonization is never trivial. Mohammadzadeh et al. suggest an approach that relies on distilling ethical principles to guide and influence emerging laws and regulations towards closer alignment, a perspective we share. They mention influential initiatives like the Human Heredity and Health in Africa (H3Africa; https://h3africa.org/) and the low- and middle-income countries Biobank and Cohort Building Network (BCNet; https://bcnet.iarc.fr/about-bcnet/bcnet/). Additionally, we might note the emerging Seattle Principles, a set of ethical guidelines for the banking and secondary research use of human biospecimens and associated data. These principles, first presented at the May 2023 ISBER Annual Meeting in Seattle, Washington, are aimed at establishing common ground among scientists, biobankers, ethics review committees, regulators, policymakers, and the public.
We commend the authors for their scholarly and insightful systematic reviews of international regulations and legislations pertaining to biobanking and the use of biospecimens in research. Despite the barriers posed by the multiplicity of languages and highly fragmented legal and regulatory records, these reviews provide solid landscape analyses that are timely and critical. They represent essential steps towards the greater international harmonization needed to fully realize the potential of biobanking that benefits the health of all populations. One world for human health.