Protecting Human Subjects from Risk in the Performance of Clinical Research and the Informed Consent Process

Abstract

Scientific research has produced substantial social benefits. It has also posed a number of ethical questions. Voluntary participation in clinical research and its potential for abuse of human subjects in biomedical experiments needs to be constantly reviewed. The modem history of protection of human subjects began with the Nuremberg code [1], which was developed as a universal standard by which to judge the ethical conduct of human experimentation. The code was a reaction to the abuses in human experimentation occurred in Nazi Germany and contained a number of principles for ethical conduct of clinical research. The first provision of the code stated that “the voluntary consent of human subjects is absolutely essential”. This remains the cornerstone of all ethical experimentation involving human subjects. Other provisions required minimization of risk and harm, a favorable risk-benefit ratio, qualified investigators using appropriate research design, and freedom for the subjects to withdraw their consent from research at any time. Similar recommendations were made by the World Medical Association in its “Declaration of Helsinki Guidelines Involving Human Subjects”.