Читать книгу Leksell Radiosurgery - Группа авторов - Страница 71

The creative team decided that the primary purpose of our registry was to improve health care by analyzing provider outcomes, and therefore this registry would be considered a QA registry for which institutional review board (IRB) oversight or informed consent would not be required. However, if protected health information (PHI) was used for outcome analysis and secondary research, IRB oversight with waiver of informed consent would be required for any such expanded role. If patient data (with PHI) needed to be shared with other organizations such as the International Gamma Knife Research Foundation (IGKRF) or industry or professional national registries, a business associate agreement with these entities would be required.