Protection of Human Subjects in Research Trials

.Horrors of medical experiments done on prisoners in concentration camps during World War II led to the Nuremberg Code, the basis of the present day informed consent process. Informed consent requires that subjects in research projects be fully informed of the risks and benefits of the trial, that they participate freely, and that their well-being be safeguarded throughout the course of the experiment. Experimental treatment must be clearly defined as research. All research in the U.S. must be approved by an Institutional Review Board (IRB) before it starts, and all investigators receiving federal support must receive training in the regulations and ethics of human experimentation. The regulations and opportunities for training are available on the World Wide Web.