Clinical trials in South Africa, key ethical issues in the process of realising a valid informed consent

Abstract

A valid Informed consent (IC) is the cornerstone of good research ethics practice from clinical trials to social science research. My research report will explore the idea of IC from its first known beginnings to its many facets as now recognised in the literature. One of my focuses is on the Nuremberg Code which I consider to still carry the fundamental ethical ideals concerning research involving human participants. As I identify the many obstacles to achieving a valid informed consent, it will be clear that in the context of a developing or ‘low income’ country, that a valid informed consent should be taken very seriously as it involves much more than just a research participant putting his or her signature on a piece of paper. In research, particularly in clinical trials where the scientific or clinical impact is potentially very great and in which much money has been invested, researchers should be aware that often their participants hold different views of what participation involves. For example, some may view participation in a clinical trial as a means of obtaining medical treatment they would otherwise not receive. One of the many barriers to realizing a valid informed consent that I consider is the problem of the increasing length of informed consent forms. This, I will suggest represents a shift from the ethical ideal of protecting human participants in research. Rather, it seems to represent as a protection from possible liability on the part of the industry-sponsor. In my research report, I also identify particular South African legislation and research ethics guidelines which should guide good research practice in South Africa. I point out that there are many laws, research ethics guidelines and regulations that have been implemented due to the atrocities of the past (and present) regarding using people in experimentation and the gross human right violations that accompanied these. Yet, in spite of these, I identify the many barriers that are present in obtaining a valid informed consent as well as the recognition that it is a process. A valid informed consent has at its ethical grounding respect for the dignity and worth of every human being. This research report hopes to add to the discussion concerning the importance of a valid informed consent in research involving human participants.