The role of pharmacogenomics in clinical research in South Africa: ethical, legal and social challenges

Haskins, Marzelle
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Pharmacogenomics (PGx) is a research field where a person's genes are connected to their response to medicine. PGx research can positively influence the way people respond to treatment and treat disease more effectively. PGx research shows promise in clinical trials as better knowledge of the cause for a specific medication response can improve the medicine's safety and therapeutic index. With South Africa's high incidence of communicable and non-communicable diseases, interventions are contingent on prevention and treatment, including drug therapy, leading to toxicity. The South African population exhibits distinctive genetic profiles, and consequently, pharmacogenomics may positively influence the disease burden. With advances in pharmacogenomic research comes social, ethical, and legal challenges and the potential for exploitation. This research report aims to explore these challenges and suggest ethically justified guidelines or criteria that can be incorporated into current health research ethics guidelines when conducting PGx research in clinical trials in South Africa. There are three challenges investigated in this report. The first is the ethical challenges of PGx research. Following this is the legal challenges and, lastly, social challenges. The final chapter consists of suggested ethical guidelines and recommendations when conducting PGx research on human participants in South Africa
A research report submitted to the Faculty of Health Sciences, University of Witwatersrand, Johannesburg, in partial fulfilment of the requirements of the degree of Masters of Science in Medicine in the file of Bioethics and Health Law