A large radiology device manufacturer comes to you—a partner of a large, independent private radiology practice in your region—to request your participation in a research study involving a new piece of equipment that improves both the signal and resolution of MR images obtained using standard pulse sequences on clinical MR imagers. This equipment has received an investigational device exemption (IDE) but is not yet approved for sale and distribution by the FDA. The company will give this equipment to you free of charge, in order to prove that the equipment is safe to use in the clinical practice environment and to demonstrate the superiority of MR images obtained with this device, compared to standard MR images. You have a number of discussions with the representatives of this company about the requirements for participation in this study and the benefits that are being offered for participation.
The company plans to perform this study over the course of a year and will provide you with funds for the salary for a research coordinator. Since the company has not found any problems with the device during its initial testing phases in connection with a few academic centers, the representatives suggest incorporating this device into your routine clinical MR imaging practice. Furthermore, certain MR pulse sequences would be performed both without and with the device so that differences in the technical and imaging quality can be determined. You have decided that this study would be best performed in the large local hospital with which your group is affiliated.
Question 1 of 3: Participation in this study would be considered appropriate professional behavior if ______.
You approve participation in this study; patients enrolled in this study do not need to sign an informed consent.
You approve participation in this study; patients enrolled in this study need to sign an informed consent.
The partners of your practice approve participation in this study and decide that enrolled patients need to sign an informed consent.
An oversight committee of the hospital where you have privileges approves participation in this study and decides that enrolled patients need to sign an informed consent.
The regional university medical center has already approved participation by its own radiologists in this research study.