Research and quality management studies: ethical considerations

Federal legislation requires that an IRB must review all research studies receiving federal funding and involving human subjects for the protection of human rights. In addition there must be a provision for informed consent so that subjects can freely choose whether or not to participate. Most health care agencies have adopted this as the standard for conducting research. The ethical principles of respect for persons, beneficence, and justice, guide review boards in making decisions for protecting human subjects. The standards for conducting QM studies have not been as explicit, but it seems that similar ethical principles could provide a guiding framework. To protect human subjects in QM studies, it has been suggested that studies be submitted to an IRB when they: (a) are prospective, (b) have potential scientific merit, and/or (c) may have application beyond the study setting. In addition even when data are coming from existing sources or patient records and used only for evaluation purposes within the study setting, mechanisms for ensuring privacy, confidentiality, and consent need consideration.