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Part 2 delivers more detail on advancing the background and organizational aspects of the project, such as focusing the question, scanning the literature, soliciting project approval from the institutional review board (IRB), and securing institutional commitment. Ethical conduct of clinical research does not end with Institutional Review Board approval and entry of patients; investigators have an obligation to their subjects and the medical community to disseminate study findings. The protocol was approved by our institutional review board, which is registered (IRB00001493) with the Office for Human Research Protections. |
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