Poster Number
42
Poster Title
An Evaluation of the Ethical- Regulatory Framework for Genomic Data Sharing at Three Research-Intense Institutions in Uganda
Authors
Deborah Ekusai Sebatta1, David Kyaddondo2, David Kaawa -Mafigiri3, William Buwembo1, Shenuka Singh4, Erisa Mwaka1
1.Makerere University, College of Health Sciences, Department of Anatomy, Kampala, Uganda
2.Makerere University, College of Health Sciences, Department of Child Health and Development Centre, Kampala, Uganda
3.Makerere University, College of Humanities and Social Sciences, Department of Social work and Social administration, Kampala, Uganda
4.University of KwaZulu Natal, Discipline of Dentistry, Durban, South Africa
1.Makerere University, College of Health Sciences, Department of Anatomy, Kampala, Uganda
2.Makerere University, College of Health Sciences, Department of Child Health and Development Centre, Kampala, Uganda
3.Makerere University, College of Humanities and Social Sciences, Department of Social work and Social administration, Kampala, Uganda
4.University of KwaZulu Natal, Discipline of Dentistry, Durban, South Africa
Abstract
Despite the adoption of data protection regulations in several African countries, limited attention has been given to the governance of genomic data. This study used an evaluative research design to assess the ethical and regulatory frameworks for genomic data sharing in three research-intensive institutions in Uganda.
Three institutions were purposively selected and anonymized as A, B, and C. A document review of eight genomic data sharing agreements (DSAs) was conducted, and findings were validated through key informant interviews with researchers, regulators, and lawyers. DSAs were requested because they are mandatory in collaborative research. A checklist was developed based on the Malabo Convention and the Uganda Data Protection and Privacy Act. Data were analyzed using both deductive and inductive approaches. Five predefined domains guided the assessment: data ownership, protection and security, access, intellectual property, and benefit sharing. Emerging themes included informed consent, legal enforceability, and potential community harms.
Results
All three institutions had DSAs; however, legal enforceability remains challenging. With the exception of one template, all agreements were signed and specific to genomic studies. Most stated that data ownership remained with the provider. Only four mentioned data protection, and just one addressed intellectual property rights. None of the agreements included benefit-sharing statements, and the key informants confirmed the absence of a benefit-sharing framework. Only one institution had a legal office directly involved in research contracts, and two had functioning research ethics committees. Consent processes were considered largely procedural rather than meaningful, and there were concerns about social harm.
Conclusion
While all institutions had some basic guidance for data sharing, gaps remained, particularly around benefit sharing, data protection, and legal oversight. Institutions should strengthen consent processes and adopt participatory policy development approaches informed by frameworks like H3Africa. Legal and ethical support structures are also essential to safeguard the interests of emerging researchers.
Three institutions were purposively selected and anonymized as A, B, and C. A document review of eight genomic data sharing agreements (DSAs) was conducted, and findings were validated through key informant interviews with researchers, regulators, and lawyers. DSAs were requested because they are mandatory in collaborative research. A checklist was developed based on the Malabo Convention and the Uganda Data Protection and Privacy Act. Data were analyzed using both deductive and inductive approaches. Five predefined domains guided the assessment: data ownership, protection and security, access, intellectual property, and benefit sharing. Emerging themes included informed consent, legal enforceability, and potential community harms.
Results
All three institutions had DSAs; however, legal enforceability remains challenging. With the exception of one template, all agreements were signed and specific to genomic studies. Most stated that data ownership remained with the provider. Only four mentioned data protection, and just one addressed intellectual property rights. None of the agreements included benefit-sharing statements, and the key informants confirmed the absence of a benefit-sharing framework. Only one institution had a legal office directly involved in research contracts, and two had functioning research ethics committees. Consent processes were considered largely procedural rather than meaningful, and there were concerns about social harm.
Conclusion
While all institutions had some basic guidance for data sharing, gaps remained, particularly around benefit sharing, data protection, and legal oversight. Institutions should strengthen consent processes and adopt participatory policy development approaches informed by frameworks like H3Africa. Legal and ethical support structures are also essential to safeguard the interests of emerging researchers.
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