a. Clinical Trial Research Focus Areas: A clinical trial is defined as a prospective accrual of human subjects where an intervention is tested on a human subject for a measurable outcome with respect to exploratory information, safety, effectiveness, and/or efficacy:
i. Pain Management:
* Alternatives to current opioid analgesics for severe pain management by the medic/corpsman on the battlefield and remote locations: Studies on alternative non-opioid analgesic drugs and routes of administration.
ii. Hearing Loss/Dysfunction, Balance Disorders, and/or Tinnitus:
– Studies to develop standardized metrics for vestibular assessment and monitoring for return to duty (e.g. CPGs, provider and patient mobile applications).
– Studies to develop and/or standardize behavioral testing in the evaluation of hearing loss.
* Restoration and/or rehabilitation:
– Studies to develop effective rehabilitation strategies for TBI/mild TBI patients with auditory/vestibular dysfunction.
– Studies to improve and compare the outcomes of surgical and non-surgical rehabilitative strategies.
– Studies to determine whether training improves auditory function.
– Studies to develop techniques that combine multisensory rehabilitation strategies (e.g hearing and balance).
– Studies to evaluate the most effective rehabilitation for single-sided deafness.
– Studies to evaluate and standardize balance rehabilitation techniques.
– Studies to evaluate and standardize tinnitus rehabilitation techniques (including but not limited to training that reduces the tinnitus neural signal and strategies focused on tinnitus that changes over time).
– Studies to develop acute retraining paradigms for early rehabilitation and return to duty.
– Studies to asses, improve, and/or develop training/therapy/devices to augment or enhance vestibular function.
– Studies to assess, improve, and/or develop training/therapy/devices to augment treatment for tinnitus (e.g. sound therapy procedure that targets areas of the brain that will inhibit the tinnitus neural signal).
b. Applied Research Focus Areas: applied research is defined as work that refines concepts and ideas into potential solutions with a view towards evaluating technical feasibility of diagnostic and therapeutic techniques, clinical guidance, emerging approaches and technologies, promising new products, and/or pharmacologic agents. All applied research applications must specifically address one or more of the Focus Areas in pain management, hearing loss/dysfunction, balance disorders, and/or tinnitus.
c. Award period:
– For applied research applications: The maximum period of performance is 3 years
– For Clinical trial applications: The maximum period of performance is 4 years.
d. Award budget:
– For applied research applications: the maximum allowable total (direct and indirect) cost for the entire period of performance are $1,5 million (M). All direct and indirect costs of any subaward (subgrant or subcontract) must be included in the total direct costs of the primary award.
– For clinical trial applications: The maximum allowable total (direct and indirect) costs for the entire period of performance are $3M.
e. Multi-Institutional Research: Multi-institutional research projects are encouraged when combining the resources of two or more organizations will strengthen the research application.
Cal comunicar abans del 5 de novembre de 2013 que es vol participar a la convocatòria, enviant un e-mail a email@example.com . Termini: 18 de novembre de 2013. L’IISPV gestiona les ajudes dels seus investigadors, no és l’entitat convocant.
i. Pre-application submission: November 25th, 2013.
ii. Invitation to Submit an application: December 23, 2013.
iii. Full-application submission: Official deadline: February 11, 2014.
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