Ensuring quality in the informed consent process

Abstract

The development of the clinical trial process dates back to the 18th century. More recently, this process has taken on a more disciplined footing, precipitated by the atrocities of World War II and more recently by the thalidomide crises. This article discusses how the informed consent process has evolved alongside the clinical trial process and looks at the new GCP/ICH guidelines, which are now the accepted standard in obtaining consent from participants globally. It also looks at areas of research where obtaining consent and ensuring quality in the process is poorly defined, such as in emergency situations, obtaining consent from children or adolescents, clinical trials in developing countries, and the more recent controversial area of obtaining consent for genetic sampling. © 1997 John Wiley & Sons, Ltd.