Challenges of Biobanking in South Africa to Facilitate Indigenous Research in an Environment Burdened with Human Immunodeficiency Virus, Tuberculosis, and Emerging Noncommunicable Diseases

Abstract

The high burden of infectious diseases and the growing problem of noncommunicable and metabolic disease syndromes in South Africa (SA) forces a more focused research approach to facilitate cutting-edge scientific growth and public health development. Increased SA research on these diseases and syndromes and the collection of associated biospecimens has ensured a plethora of biobanks created by individuals, albeit without the foresight of prospective and collective use by other local and international researchers. As the need for access to high-quality specimens in statistically relevant numbers has increased, so has the necessity for the development of national human biobanks in SA and across the Continent. The prospects of achieving sustainable centralized biobanks are still an emerging and evolving concept, primarily and recently driven by the launch of the H3Africa consortium, which includes the development of harmonized and standardized biobanking operating procedures. This process is hindered by a myriad of complex societal considerations and ethico-legal challenges. Efforts to consolidate and standardize biological sample collections are further compromised by the lack of full appreciation by national stakeholders of the biological value inherent in these collections, and the availability of high quality human samples with well-annotated data for future scientific research and development. Inadequate or nonexistent legislative structures that specifically regulate the storage, use, dispersal, and disposal of human biological samples are common phenomena and pose further challenges. Furthermore, concerns relating to consent for unspecified future uses, as well as access to information and data protection, are all new paradigms that require further consideration and public engagement. This article reviews important fundamental issues such as governance, ethics, infrastructure, and bioinformatics that are important foundational prerequisites for the establishment and evolution of successful human biobanking in South Africa.

Supporting the development of biobanks in low and medium income countries

“…The challenge of ethical, legal and social issues (ELSI) related to biobanking was also highlighted in this survey, as well as in previous reports [6], [7]. Although the different ethics and scientific committees have established various mechanisms to deal with ELSIs in scientific research, in most cases, the committees lack the experience and the regulatory framework to adequately review applications specific to biobanking or biobank projects.…”

Biobanks and human health research: Balancing progress and protections

“…[4,5] However, in SA, biobanks are typically concerned with the storage of specimens and the crucial bioinformatics capacity of these repositories seem to be very much in their nascent stages. [6] The two broad categories of biobanks are:…”

“…A review documented just over a dozen biobanks in the country and these operate on a smaller scale. [6] Not all of them are specific to research. Those that are involved in human health research are usually smaller collections from research projects within academic institutions.…”

“…Those that are involved in human health research are usually smaller collections from research projects within academic institutions. [6] While the National Health Laboratory Services in SA has attempted to establish a population level biobank, [8] this has unfortunately not materialised. The reasons for this are probably multifactorial but in our opinion include bureaucratic hurdles and the lack of a comprehensive ethico-legal framework for biobanks in the country.…”

“…[4,5] However, in SA, biobanks are typically concerned with the storage of specimens and the crucial bioinformatics capacity of these repositories seem to be very much in their nascent stages. [6] The two broad categories of biobanks are:• those that are involved in large cohort studies where a minimum of tens of thousands of participants is required • those that are disease specific. [4] Biobanks are repositories that store human biological materials and their associated data.…”