Scientific Response to Deadly Novel Epidemics: The Role of Good Clinical Practice

Abstract

Good Clinical Practice (GCP), has grown to be a widely accepted international quality standard that guides the regulation and conduct of clinical trials involving human subjects. The overall aim of GCP is to protect the welfare and well-being of human research projects by providing a stepwise approach to planning, conducting and monitoring of clinical trials. The International Conference on Harmonization of GCP guidelines provides a strict checklist, which researchers and their nominees must follow when conducting clinical research. Unfortunately, these stringent checklists often fall short of appreciating the complex ground realities usually experienced in their application. This chapter uses an African case study to outline the shortcoming of using the GCP guidelines during a deadly novel epidemic. Using the case study as an example of how GCP can fail to protect research participants at a time when they are highly vulnerable, we highlight important considerations for enhancing research subjects’ protection during a deadly epidemic, especially in an African context.