Use of Gadolinium in Research
The Human Subjects Office has released two memos to researchers regarding safety risks associated with the use of gadolinium-based contrast scans as a result of FDA safety warnings issued in 2010 and 2015. When research proposals involving the use of gadolinium-based contrast are submitted in HawkIRB it is expected that the study procedures will comply with the requirements outlined in the documents below.
The 2010 notice is intended to target researchers who may be using or plan to use a gadolinium-based contrast agent with MRI imaging done for research purposes. In particular note the warnings and the screening requirements for possible reduced kidney function.
9-14-10Use_of_Gadolinium_in_research.pdf
The 2015 notice is intended to target researchers who may be using or plan to use a gadolinium-based contrast agent with MRI imaging done for research purposes. In particular, note the warnings and the screening requirements for possible brain deposits of gadolinium following repeated use of gadolinium-based contrast agents for MRIs.