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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.

wellcome open research

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