Documents

Updated FCOI language. This change does not require modification of any existing approved consent forms.

• COST section includes new proposed language for subjects with Medicare Advantage Plan. This section has been reviewed and approved by the UW Attorney General’s Office. • CONFIDENTIALITY AND PRIVACY section includes new language required by the Food and Drug Administration (FDA) about registering clinical trials with ClinicalTrials.gov. This language is mandated by law and may not be changed. • COMPENSATION FOR INJURY section has updated language about the sponsor’s obligation to report to Medicare if the sponsor pays for research related injuries. This language is preferred by major sponsors. • SOURCE OF FUNDING section includes new language for device studies. MedicareNoridian will not pay for the device without this language.

Updates to section on Significant Financial Interest.