Science & Education
This question is centered on the working arrangements in which a radiologist can participate in a research study in a professional fashion. Since this device is not yet approved for clinical use, written informed consent must be obtained from each subject. Therefore, answer A is incorrect. Please note that it is insufficient for just you or your partners to approve participation in this study. Therefore, answers B and C, respectively, are both incorrect. In this vignette, the university medical center is not the owner of your practice and thus is not legally responsible for your private radiology practice. Therefore, answer E is also incorrect.
Since this is a research study involving an investigational device, this study needs to be reviewed by a group of individuals with expertise in research protocols and without conflict of interest. Institutional review boards and other oversight committees are normally constituted to provide guidance and review for these activities. Therefore, answer D is correct.