The documents provided here are the result of many hours of careful work by the MRI Committee, especially Andy Rouse and Ted Trouard. ------------------------------------ **[TBIR_MRI_Code_of_Conduct.docx][1]** Researchers using the MRI for human studies are expected to abide by a set of standards for treating both participants and other researchers appropriately. ----------------------------------- **[TBIR_Umbrella_IRB_Application.pdf][2]** **Devices** *Background*: Members of the MRI Operations Committee have been working closely with the IRB to address their concerns in regard to the use of non-FDA-approved "devices" on the research 3T scanner in the basement of BSRL. "Device" = software, sequences, coils, peripherals, etc that are not FDA approved and that the IRB would like to keep track of. Currently, this only includes non-FDA-approved sequences & coils but other items may be added once the internal audit is completed. *The TBIR Umbrella*: Normally, if you want to use a device you need to fill out a device appendix. To make everyone's life easier, Andy Rouse has created a TBIR Umbrella IRB that lists all devices that are approved for use on the research scanner. As new ones come in, they will be added to this Umbrella IRB. *What you need to do*: If you want to use one of these devices (currently all WIP and C2P sequences, and non-siemens coils) you must first reference the TBIR Umbrella protocol on your protocol. This reference belongs in the Project Abstract - Resources section of your IRB application. For existing protocols, you will need to submit this change to the IRB along with an Amendment form. In either case, the sentence to add is: > This project may use non-FDA devices that are approved for use on the > TBIR scanner through IRB protocol 1911166043 "Translational Bioimaging Resource Umbrella MRI Protocol". Once that is done, you will have access to every device listed in the umbrella protocol. As an example, if we get a new WIP, It will be added to the Umbrella protocol and the MR Tech will be informed that it is ready to use. Then anyone referencing the umbrella protocol will gain instant access to the new WIP without having to go through an IRB update. We highly recommend keeping the specifics of your MRI protocol as general as possible in your IRB applications. Ideally, every protocol would have the right to use any FDA approved device as well as any non-FDA-approved device listed on the TBIR Umbrella protocol. Or if you are specific, try adding language that lets you use other devices as well. ----------------------------------------- **[TBIR_Umbrella_IRB_ICF.pdf][3]** *Incidental Findings*: The TBIR now has an official policy for incidental findings. All scans on the research scanner are non-diagnostic but if an incidental finding is noticed you are obligated to follow up. Please read the "Will I hear back on any results that directly impact me?" section of the TBIR_Umbrella_IRB_ICF document. If your protocol or consent contradicts this wording you would update your documents or talk to Andy Rouse about your situation. If your consent doesn't say anything about incidental findings, we highly recommend you add that section. Either way, the attached ICF describes what we should be doing. What is considered an incidental finding is subjective and that is fine. If you, Scott, Heidi, or another investigator think it's something to look into, then it's something to look into. If you have an incidental finding please bring it to Scott's attention. He will help you obtain the radiologist review. *Suggested IRB wording*: See the TBIR_Umbrella_IRB_ICF.pdf protocol application and consent form. Highlighted sections may be cut/pasted into protocols if you like. *Consenting non-research volunteers*: The TBIR now has a consent form that can be used to scan healthy volunteers that are not associated with a research project. This might be done to test something out or run a tour or class demo on a volunteer. Scott and Heidi can consent using this form. Please talk to them if you have a need for this. [1]: https://osf.io/c83am/ [2]: https://osf.io/v8ym3/ [3]: https://osf.io/4a92t/