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University of Virginia Institutional Review Board - Health Sciences Research Guidelines for Researchers Using Gadolinium-Enhanced MRI in Research  Table of Contents New Information: 3 IRB-HSR Recommendations for use of Gadolinium-enhanced MRI in Research: 4 New exclusion criteria for protocol using gadolinium-enhanced MRI in research 5 New risk language for the protocol using gadolinium-enhanced MRI in research 6 Required Risk Language for the consent for New Studies or for studies that are Open to Enrollment but have not yet enrolled subjects: 6 Appendix A: FDA Public Health Advisory 9 Appendix B: FDA Recommendations to manufacturers of gadolinium to use boxed warning 11 Appendix C: Department of Radiology policy # PH-006 regarding the use of gadolinium based contrast May 25, 2007 ( R) 12  New Information: In 2006 the FDA released a warning about a new and rare disease called Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) that is linked with the use of Gadolinium. The warning was eventually determined to be most relevant for those people with: severe chronic kidney disease (glomerular filtration rate (GFR) less than 30 mL/min) end-stage kidney disease (GFR less than 15 mL/min) including those requiring dialysis Also included were patients with acute kidney injury ( current or recent ) as well as those who were diagnosed with hepato-renal syndrome, were in the perioperative liver transplant period or have a history of paraproteinemia syndromes such as multiple myeloma. In 2007 the FDA asked manufacturers of gadolinium to include a black box warning in their product labeling to address the concerns associated with the above types of patients. Appendix B NSF causes fibrosis of the skin, connective tissues like muscles, tendons, ligaments, and blood vessels throughout the body. In addition, those who develop NSF may have scarring of their vital organs. The signs of NSF include: