As delineated in the “BRAIN 2025: A Scientific Vision” report, crucial scientific knowledge of brain function comes from patients who voluntarily consent to the collection of research data as they undergo diagnostic or therapeutic brain monitoring with recording or stimulating electrodes. Researchers need to access the latest generation of devices to optimize the scientific value of this unique opportunity. Cooperation of clinical and academic research teams with private companies could quickly break down technological barriers and forge a new streamlined path for developing, implementing and integrating new devices for advancing human neuroscience research. Toward this end, NIH is interested in creating public/private partnerships with manufacturers to facilitate broad access to novel intracranial stimulating and/or recording devices for conducting clinical research.
NIH is especially interested in working with manufacturers willing to share their pre-clinical safety and technical data on instruments that fall into the FDA category of “significant risk,” meaning they may be implantable and could pose serious risk to the health, safety, or welfare of subjects. These data can be costly and time-consuming to obtain, but are required for new clinical research protocols using the latest generation of devices. Successful partnerships will facilitate research on human brain function, deepen our understanding of mechanisms and underlying human brain disorders, increase effectiveness of therapies, and enhance the value of diagnostics.
On behalf of the NIH Institutes involved in the BRAIN Initiative, NINDS has issued a Request for Information (RFI) to seek input from interested academic/clinical researchers, regulatory and other government agencies, healthcare professionals, members of the public and potential industry partners, to identify key barriers and potential opportunities for granting NIH investigators earlier access to these significant risk stimulating/recording devices in order to conduct important, ethical human studies research. Small businesses with appropriate technologies are especially encouraged to provide input. This RFI is intended to gather relevant information and identify interested parties to inform a follow-on workshop. The deadline for submitting input is November 21, 2014.
Follow this link to submit your input.