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Human Subjects Division (HSD)


New UW Medicine Policy Requiring Research Information in Subjects' Medical Records

May 7, 2008 at 1:15pm
Studies that use UW Medicine clinical facilities (including Harborview & SCCA) will soon be required to add a Research Care Plan to subjects' medical records, using a predefined template. The purpose is to improve patient safety and to help researchers fulfill Medicare requirements for documenting and billing for services related to research. The Research Care Plan lists appropriate contact information for the study. In addition, it will include the study name (in an abbreviated manner), the sponsor name, and the protocol number - as this is information required by Medicare. Most ongoing studies covered by this policy will need to revise their consent forms, and some may also need to re-consent subjects. A special page has been established with more details, forms, and instructions.