The IRB is charged with protecting the rights and welfare of people who participate in research as subjects. Any project that involves randomization of patients to different interventions must be reviewed by the IRB. This review is required even if the project is a quality improvement project because random assignment is, by definition, an experiment and thus research. Researchers are often surprised when they discover that studies involving chart review and use of computer-stored data involve risk...the risk of loss of privacy and confidentiality.
to article >> | to pdf >>