Protection of human participants from risks in biomedical research: An analysis of the law of South Africa and international ethical guidelines

Abstract

In order to enhance the quality of lives of South Africans who are afflicted by many diseases, medical researchers have been engaged in biomedical research with the aim of testing, evaluating newly developed prophylactic and therapeutic methods. However, during the testing of newly developed therapeutic methods, participants are sometimes exposed to harm which may ruin the remainder of their lives or even lead to their deaths. Despite the seriousness of harm which may result from research, South Africa does not regard social and economic harms as a threat to the welfare and health of participants. Though they utilize the risk-benefit analysis as outlined by international ethical guidelines to minimize harm, this developed criterion has been shown to be an inadequate safeguard for the welfare and health of participants as it fails to cover the occurrence of scientifically unforeseen risk. To ensure protection of participants, this paper suggests the introduction of a precautionary approach in research and also, specific reference to South Africa, the recognition of all categories of harm.