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. Author manuscript; available in PMC: 2010 Jan 1.
Published in final edited form as: Conf Proc IEEE Eng Med Biol Soc. 2009;1:2001–2004. doi: 10.1109/IEMBS.2009.5333429

Fig. 1.

Fig. 1

Flow chart for first-in-human testing of a new device for medical imaging, starting with clinical need and ending with a pilot clinical trial. SR vs. NSR status is a key decision point early in the process, but a binding determination by the IRB can only occur after a full application is filed (the “risk conundrum”).