Appendix F
Data Governance Resources

The following resources on data governance were shared by committee members, panelists, or other participants during the workshop series.

International Resources

• The Recommendation on Science and Scientific Researchers (2017)¹ and Recommendation on Open Science (2021)² of the United Nations Educational, Scientific and Cultural Organization (UNESCO), a human rights-based organization that promotes open science and benefits sharing.
• The Sharing and Reuse of Health-related Data for Research Purposes: WHO Policy and Implementation Guidance (2022)³ of the World Health Organization (WHO), an agency of the United Nations that connects nations, partners, and people to promote health, keep the world safe, and serve the vulnerable. WHO published guidance for sharing and reuse of health data for research purposes based on lessons learned from the pandemics and is currently working on an international pandemic treaty to facilitate data and sample sharing during times of pandemic.
• The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization,⁴ a supplementary agreement to the Convention on Biological Diversity. The convention and protocol only apply to nonhuman biological samples and genetic resources and establish a specific, procedural system of benefits sharing when sharing genetic resources.
• The FAIR Guiding Principles for Scientific Data Management and Stewardship (2016)⁵, a set of technical principles to improve the Findability, Accessibility, Interoperability, and Reusability of digital assets. These principles describe aspirational technical requirements needed to share data at the international level.
• The Beacon API,⁶ Framework for Responsible Sharing of Genomic and Health-Related Data,⁷ and Data Use Ontology⁸ of the Global Alliance for Genomics & Health (GA4GH), an organization that promotes and facilitates international sharing of genomic and health data.

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¹ See https://en.unesco.org/themes/ethics-science-and-technology/recommendation_science.

² See https://en.unesco.org/science-sustainable-future/open-science/recommendation.

³ See https://www.who.int/publications/i/item/9789240044968.

⁴ See https://www.cbd.int/abs/about/.

⁵ See https://www.go-fair.org/fair-principles/.

⁶ See https://beacon-project.io/.

⁷ See https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4685158/.

⁸ See https://www.ga4gh.org/our-products/.

• The framework for the promotion of ethical benefit sharing in health research⁹ (2022), PHA4GE hAMRonization Tool,¹⁰ and COVID-19 Metadata Template¹¹ of the Public Health Alliance for Genomic Epidemiology (PHA4GE), the nonhuman equivalent organization to GA4GH, for pathogens and microbes.

National and Regional Resources

• In the European Union, the General Data Protection Regulation¹² establishes rules for the processing and transfer of personal data.
• In Kazakhstan, the Law on Informatization,¹³ the Law on Personal Data and Their Protection,¹⁴ and the Code on the Health of the People and the Healthcare System¹⁵ provide regulatory frameworks for the information, communication technology, and medical industry. Also, the Law on Biological Safety of the Republic of Kazakhstan¹⁶ requires compliance with legal requirements when working with restricted pathogen information.
• In Kyrgyzstan, the National Statistical Committee communication strategy helps ensure data access and security; a database being launched by the Ministry of Digital Development aims to improve data management and information protection. The Law on Electronic Governance defines the rights and obligations of data owners, and the Law on the Conflict of Interest addresses national security, transparency, and control, as well as personal responsibility and liability.
• In India, the Digital Personal Data Protection Bill¹⁷ is a proposed law to address the management of digitized personal data.
• In Taiwan, the National Health Insurance Research Database¹⁸ links more than 400 sources of data and establishes data protections and access protocols to protect security and confidentiality.
• In Tajikistan, the Law on Protection of Personal Data; Law on Ensuring Biological Safety, Biological Security, and Biological Protection; Law on Genetic Resources; and Healthcare Code establish frameworks for data collection, management, and use of various types of biological data.
• In Uganda, the National Biorepository¹⁹ establishes a workflow and requirements for storing and accessing biological samples and data.

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⁹ See https://gh.bmj.com/content/7/2/e008096.

¹⁰ See https://github.com/pha4ge/hAMRonization.

¹¹ See https://docs.google.com/spreadsheets/d/17PuBcA0cCT-j9hV5tbwMFKtwWwKE-a_MYRqOOsIxj7c/edit#gid=136997361.

¹² See https://gdpr.eu/.

¹³ See https://adilet.zan.kz/rus/docs/Z030000412_.

¹⁴ See https://adilet.zan.kz/eng/docs/Z1300000094#:~:text=The%20Law%20of%20the%20Republic,94%2DV.&text=This%20Law%20regulates%20the%20public,and%20protection%20of%20personal%20data.

¹⁵ See .https://adilet.zan.kz/rus/docs/K2000000360.

¹⁶ See https://adilet.zan.kz/eng/docs/Z2200000122/links.

¹⁷ See https://prsindia.org/billtrack/draft-the-digital-personal-data-protection-bill-2022.

¹⁸ See https://nhird.nhri.edu.tw/en/.

¹⁹ See https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7479498/.

• In the United States, the National Institutes of Health scientific data sharing resources,²⁰ Genomic Data Sharing Policy,²¹ and Data Management and Sharing Policy²² provide mechanisms for management and sharing of data from federally funded research.
• In Uzbekistan, the National Council on Biological Safety is charged with protecting life science data throughout its life cycle.

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²⁰ See https://sharing.nih.gov/.

²¹ See https://sharing.nih.gov/genomic-data-sharing-policy.

²² See https://sharing.nih.gov/data-management-and-sharing-policy.

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