- Are lower model organism systems allowed for this RFA? Only if the model organism system can justify appropriately addressing population variability relevant to human population studies. Some Drosophila population-driven resources will be acceptable. In general, priority will likely be given to rodent population-based systems that can best exemplify, through unique study designs and approaches, the most effective use of population-based model organism resources for an environmental or toxicology-based question. Lower model organisms can always be used in combination with a rodent population-based model as a comparison or validation to assess a specific hypothesis. Applicants are encouraged to speak to the program administrator if considering a unique or unusual population-based model organism resource.
- What diseases and exposures are of particular interest to NIEHS? Environmental agents which are considered of primary interest for NIEHS include: industrial chemicals or manufacturing byproducts, metals, pesticides, herbicides, air pollutants and other inhaled toxicants, particulates or fibers, fungal, and bacterial or biologically derived toxins. Agents that are considered within the primary mission responsibility of other NIH Institutes and Centers include, but are not limited to: alcohol, chemotherapeutic agents, radiation that is not a result of an ambient environmental exposure, smoking, except when considered as a secondary smoke exposure as a component in the indoor environment, drugs of abuse, pharmaceuticals, dietary nutrients, and infectious or parasitic agents. Applications which focus entirely or primarily on exposure factors outside the NIEHS mission responsibility will be considered nonresponsive to this announcement. However, it is appropriate to include these factors as part of the research if the primary goal of the study is on an exposure within the NIEHS mission interest. All diseases or disorders that are relevant to humans and environmentally-related can be considered.
- Can fine genetic or epigenetic mapping experiments be part of these studies? Functional validation of results for identifying genetic/epigenetic susceptibility to environmental exposures can be part of these applications. However, priority will be placed on studies that are broad discovery or systems genetics applications of the population-based model organism resources.
- What preliminary data will be necessary to support these studies? Preliminary data normally considered appropriate for an R01 mechanism will be considered for these applications. In some cases, smaller dose-range finding experiments in a smaller subset of animals may be necessary before embarking on a larger population-based study or preliminary studies may be necessary to support the numbers of animals needed and sex(es) to be appropriately considered for the biological question being addressed.
- Can cells or cell lines alone be used? In vitro approaches can be used but only in combination with in vivo model studies.
- Can the application be about resources necessary to further develop or support a population-based model organism system? Some allocation for resources can be included in the applications but the studies need to be hypothesis-driven while also providing proof-of-principle approaches related to the use of population-based models for better addressing environmental health science questions.
- Can only one sex be used for addressing a particular scientific premise? Adequate and appropriate justification (e.g. literature publication) would need to be included if only one sex is considered in the study design, including details regarding given exposures (dose range) for the single sex that is being interrogated. Cost constraints alone is not adequate justification for excluding one of the sexes from the study design.