Workshop: Basic Research fMRI Neuroimaging, Pittsburgh, PA, FALL 2001

University Of Pittsburgh, Pittsburgh PA

Investigators

Abstract

Brain imaging using functional Magnetic Resonance Imaging (fMRI) is a rapidly growing research discipline which utilizes technology for basic research investigation that was originally developed for clinical medicine. There are serious safety challenges related to expanding basic research fMRI. These are related to the rapid training of many non-medically trained investigators joining the field; codifying the knowledge of best practices that is not easily available; providing targeted safety training for non-medical MR researchers; dealing with special safety issues in research fMRI; addressing differences between FDA regulations and current practices; assisting Institutional Review Boards in handling detailed technical oversight; and evaluating liability exposure of research procedures. A working group of investigators, regulators, and vendors will identify the problems, and plan methods for effectively addressing these problems. Specific objectives of the workshop are: 1) to bring together members of the basic research, clinical, regulatory (FDA), and vendor communities to identify the risks, precautions, and good practices that should be applied to basic research fMRI imaging procedures; 2) evaluate potential programs that might be initiated to improve the level of safety and quality of imaging done by basic researchers; 3) devise model practices or guidelines for the training of non-medical basic researchers in the areas of patient screening, operating in a magnet, equipment evaluation, scanner operation, use of equipment, and pulse sequence selection; 4) create guidelines for stand-alone MR centers regarding participant safety and responsibility procedures; 5) review existing regulations and practices to determine how they relate to basic research MRI neuroimaging and evaluate the advisability of changes in those regulations; 6) create a plan for production of materials that could be distributed to improve MR training of new basic researchers for fMRI-based research and a plan to encourage adoption of safety guidelines for fMRI- based research; 7) review materials developed following the workshop for distribution via the worldwide web; and 8) present materials regarding the recommendations at major society and researcher meetings. The two-day workshop will be held in Pittsburgh, PA.