Ethics considerations for precision medicine research and genetic testing in low- and middle-income countries

Abstract

Background: Genetic data transfer within multicentre clinical trials conducted in low- and middle-income countries is common and must be communicated to study participants as part of ethical requirements.

Aims: To analyse ethics practices in precision medicine research in low- and middle-income countries and make useful recommendations.

Methods: We conducted a narrative review of published literature and existing ethics frameworks regarding underrepresentation of low- and middle-income countries in genomic databases, informed consent and data security discussions, as well as the potential for exploitation and limited access to benefits.

Results: The findings highlight the need for increased diversity in research participation, robust ethical frameworks, and knowledge sharing between developed and developing countries. The findings show that strengthening national research ethics committees and fostering collaboration can help low- and middle-income countries in addressing unique challenges and harnessing the potential of precision medicine while ensuring ethical conduct and equitable access for all. Our review emphasizes the importance of ethical considerations in precision medicine research to ensure that its benefits reach all affected populations, promoting a more just and more equitable healthcare future.

Conclusion: There is a need to ensure that research participants are accorded the rights, whether in the ownership of their samples or the right to know what type of genetic studies have been conducted on their samples. It is important to have binding agreements that will allow clinical trial participants to access drugs that proof effective based on the trials they participated in.

Keywords: clinical trials; ethical considerations; ethics committees; ethics principles; low- and middle-income countries; precision medicine research; research equity.