The Cleveland Clinic regional hospitals (Euclid, Fairview, Hillcrest, Huron, Lakewood, Lutheran, Marymount and South Pointe hospitals) are components of the Cleveland Clinic Federal Wide Assurance, FWA #5367. Therefore, the Cleveland Clinic Foundation IRB and the Cleveland Clinic Regional IRB operate under one set of Policies & Procedures, found at http://intranet.ccf.org/irb/
The Cleveland Clinic Regional IRB has additional Standard Operating Procedures, delinated below:
Humanitarian Use Devices
Humanitarian Use Devices (HUD) are used to treat a disease or condition that affects fewer than 4,000 individuals in the USA. The FDA grants Humanitarian Device Exemptions (HDE) for HUD and the FDA regulates HUD differently that Investigational Device Exemption (IDE) regulated devices or FDA approved medical devices.
Birth Control at Marymount Hospital
Marymount Hospital is a Catholic Hospital sponsored by the Sisters of St. Joseph of the Third Order of St. Francis. Thus, Marymount Hospital neither endorses nor condones the use of birth control. The IRB recognizes the need to address birth control in the informed consent document. Please refer to the Informed Consent template for details.