Poster ID
P-23
Poster Title
Genomic Data as a Public Trust: A Ministerial Decree–Backed Code of Conduct and Trusted Research Environment Model for Responsible Genomic Data Sharing in Indonesia
Authors
Irene L. Indalao and the BGSI ecosystem*
Balai Besar Biomedis dan Genomika Kesehatan (Center for Biomedical and Health Genomics), Kementerian Kesehatan Republik Indonesia (Ministry of Health, Republic of Indonesia)
Balai Besar Biomedis dan Genomika Kesehatan (Center for Biomedical and Health Genomics), Kementerian Kesehatan Republik Indonesia (Ministry of Health, Republic of Indonesia)
Abstract
As national genomic initiatives expand across low and middle income countries (LMICs), implementing trusted governance for responsible genomic data sharing remains a critical hurdle. Biomedical and Genome Science Initiative (BGSI), an Indonesia’s genomic initiative, has adopted a governance model that handles genomic data as a public trust rather, taking GA4GH Strategic Roadmap as a consideration to advance interoperable, trusted, and equitable genomic data sharing,
BGSI's governance framework is anchored in Law No. 27/2022 on Personal Data Protection, which classifies genetic data as sensitive personal data; Law No. 17/2023 on Health, which establishes the legal basis for health data governance and genomic innovation; as well as Ministerial Decree No. 512/2025, which governs BGSI and establishes a legally binding Code of Conduct. Together, these regulatory instruments provide legally binding governance for all users of genomic and associated health data. The framework is built on five principles: binding governance, controlled access, purpose limitation, auditability, and accountability, supported by enforceable sanctions for misuse and protections against unauthorized data redistribution and genetic discrimination.
The implementation of the framework can be seen in the Trusted Research Environment (TRE) developed in the BGSI program using a data visitation model. The model allows approved researchers to analyze data within a secure computational environment without downloading individual level datasets. This approach enables transparent oversight, reproducible research, and compliance with national privacy requirements. BGSI is implementing a phased access strategy, starting from data utilisation by contributing hospital Hubs collaborating institutions, progressing to aggregated analysis by the Ministry of Health and expanding to access by approved national and international researchers from 2028. The governance framework also includes explicit protections against genetic discrimination in employment, insurance, education, and public services.
Indonesia's experience demonstrates how legally enforceable governance, secure research infrastructure, and phased access can enable trusted genomic data sharing while balancing participant protection, national stewardship, and international scientific collaboration in a resource constrained environment.
Keywords: BGSI, genomic data, public trust, trusted research environment model, data visitation model
BGSI's governance framework is anchored in Law No. 27/2022 on Personal Data Protection, which classifies genetic data as sensitive personal data; Law No. 17/2023 on Health, which establishes the legal basis for health data governance and genomic innovation; as well as Ministerial Decree No. 512/2025, which governs BGSI and establishes a legally binding Code of Conduct. Together, these regulatory instruments provide legally binding governance for all users of genomic and associated health data. The framework is built on five principles: binding governance, controlled access, purpose limitation, auditability, and accountability, supported by enforceable sanctions for misuse and protections against unauthorized data redistribution and genetic discrimination.
The implementation of the framework can be seen in the Trusted Research Environment (TRE) developed in the BGSI program using a data visitation model. The model allows approved researchers to analyze data within a secure computational environment without downloading individual level datasets. This approach enables transparent oversight, reproducible research, and compliance with national privacy requirements. BGSI is implementing a phased access strategy, starting from data utilisation by contributing hospital Hubs collaborating institutions, progressing to aggregated analysis by the Ministry of Health and expanding to access by approved national and international researchers from 2028. The governance framework also includes explicit protections against genetic discrimination in employment, insurance, education, and public services.
Indonesia's experience demonstrates how legally enforceable governance, secure research infrastructure, and phased access can enable trusted genomic data sharing while balancing participant protection, national stewardship, and international scientific collaboration in a resource constrained environment.
Keywords: BGSI, genomic data, public trust, trusted research environment model, data visitation model
Digital Poster