There are always risks involved in participating in clinical studies. The side effects of new drugs or devices are not fully understood, which is part of the reason the research is being done. However, clinical study protocols are carefully controlled and designed to monitor the safety of all the participants. In addition, investigational drugs and devices go through extensive pre-clinical testing before they even make it into a clinical study. All clinical study protocols must be reviewed by an Institutional Review Board, or IRB, which may be comprised of doctors, nurses, and/or medical ethics experts, whose job it is to review the study and ensure the potential benefits outweigh the risks.