...
1. General guidelines for human research. Some general guidelines for human research studies in experimental protocols conducted at the IRC BIC are:
● All subjects will be evaluated by an attending physician, principal investigator, or a level 2 user, with regard to their physical and mental status before entering the control or magnet room. Subjects deemed to have an unsatisfactory status will not be permitted to participate at that time.
...
● All subjects are required to change into a surgical scrub shirt (provided by the IRCBIC) for brain studies, and full surgical scrub garb (again, provided by the IRCBIC) for all other studies.
● Studies involving human subjects require prior approval of the UT IRB. This includes pilot studies. It is the responsibility of the Principal Investigator to ensure that IRB approval for all studies is current. The Operations Administrator will ask investigators for copies of current IRB approvals, and maintain them for the duration of the study.
...
● Whenever minors are to be enrolled in imaging studies conducted using IRC BIC facilities, the investigators must follow the procedures and policies provided in Appendix E.
...
2. Responsibilities of level 2 user. At least two people, including one level 2 certified user, must be present whenever an MR system is being used to scan a human. Before any scanning procedure, the level 2 user will:
...
● Complete a report of any incidents involving severe discomfort or pain, including a description of the associated circumstances (imaging parameters, dB/dt value, level of pain, etc.), and submit this report immediately to the MRI Operations Administrator. The individual investigator is responsible for reporting any incidents to the IRB as well as to the Operations Administrator. All consent forms for studies that might induce peripheral nerve stimulation should include language informing the human subject of the potential for peripheral nerve stimulation.
...
3. Administration of exogenous agents. All MR examinations that include the administration of contrast agent or other pharmaceuticals require the presence of a physician licensed to provide health care in the state of Texas. All examinations that include the administration of contrast agent must follow the relevant IRC BIC policies and procedures, and the risk of NSF (kidney problems, past and present) must be included on screening and consent forms for all subjects. Investigators using contrast agent are responsible for maintaining a stock of pharmaceuticals and delivery equipment suggested by the agent’s manufacturer to manage potential life-threatening hypersensitivity, as well as a properly maintained and fully-stocked crash cart. Before administering a contrast agent to a subject with any renal insufficiency, the subject’s Glomerular Filtration Rate (GFR) must be measured and fall within accepted limits. . MRI contrast agents are NOT allowed to be administered in the NHB facility. Contrast agents may only be administered in the HDB facility if one of the trained technicians or the paramedic is on hand and booked on their schedule to do the injection.