Role of a regulatory and governance framework in human biological materials and data sharing in National Biobanks: Case studies from Biobank Integrating Platform, Taiwan and the National Biorepository, Uganda

Abstract

Background: In the last decade, Low- and Middle-Income Countries (LMICs) have set up Biobanks to collect human biological materials and associated data for genomic research and public health purposes. Biobanking gives rise to ethical challenges, such as informed consent, benefit sharing, confidentiality, ownership, commercialization and public participation which are harder to navigate in LMIC settings due to disparities in research infrastructure and capacity. This paper summarizes presentations on Biobank related case studies from two countries, with a focus on challenges in the regulatory and governance framework and suggestions on how to mitigate them. Methods: Two case studies of Biobanks from LMICs have been used. The case studies were presented at the 2018 Global Forum on Bioethics in Research (GFBR) meeting on the “Ethics of data sharing and Biobanking in health research”. Results: The case studies show that an integrated, well-regulated platform for human biological materials and data ensures good quality of human biological materials, saves resources and promotes mutual collaboration of work among researchers. National regulatory bodies are required to generate Biobanking guidelines and policies to facilitate guidance to the rapidly changing landscape of science. Discussion: In general, LMICs have weaker research regulatory infrastructure and governance mechanisms for Biobanks than high-income countries. This has increased the fear of exploitation i.e. unfair distribution of risks and benefits. Establishment of Biobanks and producing effective scientific outcomes based on the Biobanking resources is difficult without a proper legislative, regulatory and governance framework. Conclusion: These two case studies from different LMICs settings show that although in both settings there is strong awareness of the scientific and population health value of Biobanks and strong commitment to their establishment, regulatory and ethical guidance show gaps that need to be addressed.

Considerations for an integrated population health databank in Africa: lessons from global best practices

“…For data to be shared for further future use, RECs need to issue waivers permitting the use of de-identified data or broad consent from research participants 110 , as well as contending with emerging considerations of data stewardship such as the longer than usual data storage, sharing, re-identification and indeterminate future use of collected data 26 – 30 . These approaches have their limitations.…”

“…The rapid growth in human subject or tissue databanks and sharing facilities gives urgency for national regulatory bodies to create guidelines and policies on data management and sharing 110 . Inadequate, or the absence of, such policy guidelines is a major setback in most LMICs, and Africa.…”

Health care users’ acceptance of broad consent for storage of biological materials and associated data for research purposes in Uganda

“…Several bottlenecks in governance and regulation of Biobanks in LMICs were highlighted in our previous work 3 . National Research Biobanking Guidelines have since been developed.…”

Perceptions, attitudes, and willingness of the public in low- and middle-income countries of the Arab region to participate in biobank research

“…However, biobanks have been limited to HICs and have infrequently been established in LMICs, primarily due to differences in infrastructure, training, and financial sustainability between HICs and LMICs [ 5 ] [ 6 ]. Additionally, a meaningful contribution of LMICs to the global database depends on the public awareness and acceptance of the importance of biobanks and consequently, their willingness to donate their biospecimens and associated health information to research.…”