The New Investigator Award (NIA) mechanism is being offered by the GWIRP for the first time in FY14. The intent of the GWIRP NIA is to support investigators new to the field of GWI research at different stages of career development. This award enables such investigators to compete for funding separately from investigators with established programs of GWI research. Previous experience in GWI research is allowed, but not required. However, Principal Investigators (PIs) with a limited background in GWI research are strongly encouraged to strengthen their applications through collaboration with investigators who are experienced in GWI research and/or possess other relevant expertise. It is the PI’s responsibility to describe how the collaboration(s) will augment his or her ability to address the research question. DoD FY14 GWIRP New Investigator Award 4 All applicants for the NIA must meet specific eligibility criteria under one of the following categories, as described in Section I.C., Eligibility Information. • Transitioning Postdoctoral Fellow • Early-Career Investigator • New GWI Researcher The NIA is designed to promote new ideas in GWI research and establish proof-of-principle for further development in future studies. Applications are not required to include preliminary data; however, preliminary data may be used to support the objectives of an application. These data are not required to have come from the GWI research field. Applications not supported by preliminary data should be based on sound scientific rationale and may reflect clinical observations or seek to evaluate discoveries made in relation to other chronic multi-symptom illnesses for their application in GWI. Regardless of the approach, the focus should be clearly on veterans with GWI. It is the responsibility of the PI to clearly and explicitly articulate the project’s potential impact on GWI. The NIA supports research focusing on the complex of symptoms known as GWI, improving the case definition and diagnosis of GWI, characterizing disease symptoms, and better understanding the pathobiology. The NIA encourages basic through clinical research aimed at identification of objective measures (e.g., biomarkers) to distinguish healthy veterans from those with GWI, or improve understanding of the pathobiology underlying symptoms associated with GWI. Particular topic areas of interest include biological processes or abnormalities in GWI associated with: • Central nervous system structure and function, in particular, the role of glial cells, astrocytes, and microglia in GWI symptomatology • Central neuroinflammatory processes • Autonomic nervous system function • Neuroendocrine measures • Immune parameters/Indicators of chronic infection • Gastrointestinal complaints/symptoms • Genetic, genomic, proteomic, or metabolic characteristics • Respiratory symptoms • Sexual dysfunction • Sleep problems Applications may also address other topic areas that are directly relevant to GWI. Studies that characterize chronic effects of neurotoxic exposures at dosages comparable to that encountered in-theatre during the Gulf War are of interest. Studies using animal models should focus on long-term and latent effects of toxic exposures to closely represent the current status of GWI patients. All studies using animal models should use an established model unless there is a compelling scientific justification for the development or use of a new model. Development of new animal models is discouraged. The NIA can also be used for testing of GWI-targeted pharmacologic agents in Adsorption, Distribution, Metabolism, Excretion (ADME) studies, and toxicology testing, including Investigational New Drug (IND)-enabling pharmacology/toxicology testing. Preclinical development of non-pharmacological interventions is also acceptable. All projects should adhere to a core set of standards for rigorous study design and reporting to maximize the reproducibility and translational potential of preclinical research. The standards are described in Landis, S.C. et al. A call for transparent reporting to optimize the predictive value of preclinical research. Nature 2012, 490:187-191 (www.nature.com/nature/journal/v490/n7419/full/nature11556.html). While these standards are written for preclinical studies, the basic principles of randomization, blinding, sample-size estimation, and data handling derive from well-established best practices in clinical studies. Applicants should consult the ARRIVE (Animal Research: Reporting In Vivo Experiments) guidelines to ensure relevant aspects of rigorous animal research are adequately planned for and, ultimately, reported. The ARRIVE guidelines can be found at http://www.nc3rs.org.uk/page.asp?id=1357.