Ethical Aspects of Genomics Data Sharing with Commercial Entities: A Case Study of the Awigen Collaborative Satellite Project in Kenya

Abstract

Background: In the past decade, there has been an exponential growth in genomic research in Africa. While these studies have contributed to building scientific capacity on the continent, they have also raised pertinent ethical issues. One of the key genomic initiatives is the Human Heredity and Health in Africa Initiative which has conducted genomics studies across several countries in Africa. During the implementation of the H3Africa AWI-Gen project, one of the key ethical concerns identified was data sharing, particularly with commercial companies. While there is growing interest on this topic, no study has been conducted to explore the perspectives of key stakeholders on the ethical aspects of data sharing with commercial entities on the African continent. Therefore, this study aimed to address this gap using one of the H3Africa collaborative projects – the AWIGen Collaborative project - as a case study. Methods: The research employed an exploratory qualitative case study methodology, which involved observations, in-depth interviews and focus group discussions with key research stakeholders. The primary focus of this study was on individuals residing in Kenya, namely in the informal urban settlements of Korogocho and Viwandani in Nairobi. The study aimed to include a specific sample population consisting of adults aged 45-60 who had prior involvement with a genomic study (the H3Africa AWI-Gen Project), as well as the project staff. The interviews explored participants’ views on policies, laws, and regulations pertaining to the sharing of data with commercial entities, as well as ethical concerns that need to be addressed to promote good ethical practices in data sharing. Results: The study highlighted a general support in genomic data sharing with commercial entities with a specific inclination to benefit sharing or transfer of health benefits to the populace. However, participants also raised concerns around the safety of the blood drawn for tests and its implications. Further, the sample population exhibited hesitance to provide biodata for the wrong usage by data collectors in the future. However, the researchers involved with AWI-Gen were skeptical about sharing genomic data with commercial entities, pointing out the need for diverse protection of participant data. Researchers also reported that the policies that were locally enforced in sharing general biodata and genomic data, such as the Kenyan Data Protection Act 2019, have demonstrated the need for policy and the advancement of ethical understanding surrounding Public Health Data. They recommended that data managers, collectors, and handlers should integrate these policies using identifiers or anonymous data processing and analysis. Conclusion: Local communities participating in genomics research are generally in support of data sharing with commercial entities. However, they expect medical benefits from the data-sharing practices with commercial entities, especially in disease management and prevention. There is the need for research institutions and commercial entities to collaborate to extend research benefits and other socio-economic advantages to communities where the data were collected.