Genomic research in Zambia: confronting the ethics, policy and regulatory frontiers in the 21st Century.

Pascalina Chanda-Kapata,Nathan Kapata,Albertina Ngomah Moraes,Gershom Chongwe,James Munthali

doi:10.1186/s12961-015-0053-4

Abstract

Genomic research has the potential to increase knowledge in health sciences, but the process has to ensure the safety, integrity and well-being of research participants. A legal framework for the conduct of health research in Zambia is available. However, the ethical, policy and regulatory framework to operationalise genomic research requires a paradigm shift. This paper outlines the current legal and policy framework as well as the ethics environment, and suggests recommendations for Zambia to fully benefit from the opportunity that genomic research presents. This will entail creating national research interest, improving knowledge levels, and building community trust among researchers, policymakers, donors, regulators and, most importantly, patients and research participants. A real balancing act of the risk and benefits will need to be objectively undertaken.

Highlights

Genomics is defined as the study of genes and their functions, and related techniques [1, 2]
In order for genomic research in Zambia to be successful, issues such as community engagement, broad consent, and the implications of sharing genetic information need to be debated and the potential risks of stigmatisation and harm need to be considered carefully [32]. These ethical challenges need to be weighed against strategies and approaches for making use of genomic research to address the high burden of disease in Zambia
To what extent will it be necessary, for example, to modify current guidelines on informed consent to provide for research in future, unknown studies – which is a hallmark of bio-banking and genomic research? What about the right of the participants to withdraw from a study? The level of anonymity of genetic information in a database, the rights of participants and relatives to be informed of potential diseases, as well as many other important ethical issues related to genomic research will need to be addressed by regulations that are currently not in place or in use for ordinary research

Summary

Introduction

Genomics is defined as the study of genes and their functions, and related techniques [1, 2]. These ethical challenges need to be weighed against strategies and approaches for making use of genomic research to address the high burden of disease in Zambia.

Results

Conclusion