Challenges in Regulatory and Governance Framework in LMICs Biobanks

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. The case studies show that there is a gap in regulatory and ethical guidance in LMICs biobanks and it needs to be addressed by National regulatory bodies.

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