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Please send completed applications to:
Investigator initiated research, also known as Extramural Research Proposals is novel research conducted after a product has been approved for marketing by the FDA for use in treating a specific disease; it is an important part of Post Marketing or Phase IV research. The Clinical Review Committee is a standing committee at Cyberonics made up of representatives from Medical, Marketing, Regulatory, Legal and other scientific disciplines that meet every month to review Extramural Research Proposals. Generally, the intent of the Clinical Review Committee is to foster the development, understanding and clinical utilization of VNS Therapy™ through review and support of basic and/or clinically oriented Investigator initiated scientific research. In accordance with the Cyberonics Business Practice Standards (Chapter 9, Research), found at http://www.cyberonics.com/1corporate_fs.html, Cyberonics supports bona fide research activities that (a) have genuine scientific and/or clinical value, (b) involve researchers and/or investigators selected on the basis of criteria relevant to the research effort, and (c) are designed to comply with both legal and ethical requirements. It is the expectation of Clinical Research Committee that extramural research supported by Cyberonics will be of sufficient quality and interest to be scientifically valid and likely to generate data that will be relevant to a defined use for VNS Therapy™ or other clinical and/or business need, as well as warrant publication in peer reviewed journals and presentation at scientific/medical meetings. The Clinical Research Committee meets approximately once a month to evaluate and monitor Extramural Research Proposals. This is a competitive process to obtain support in the form of devices and/or funding from Cyberonics. A well conceived thorough submission would have a higher likelihood of approval, while an incomplete submission will either delay the process or be rejected outright. Investigators can better utilize the resources of the Clinical Research Committee if they work to develop a comprehensive, detailed submission and consider the guidelines detailed on this website for content. Clinical ReviewProcess: (click on a box to see more information)
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