Program Overview and Guidelines

The following outlines overall program considerations, application requirements, and budget guidelines for the WU-CDTR pilot and feasibility program.

Additional requirements may apply, please consult the current RFA for more information.

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Budget Guidelines

Allowable Direct Cost Items

Funding will be provided for items essential to the conduct of the project.

Personnel

• Allowable personnel expenses include salary and applicable fringe benefits for: the principal investigator, co-investigator(s), postdocs and graduate students if employees receiving a salary, and other professional and technical staff.
• The current NIH salary cap must be used if applicable. Cost sharing of salary is necessary when using the salary cap or in other situations where the effort exceeds the amount of salary being requested.
• Current KL2/K12 scholars may not request support for effort already supported by their K award. This effort should be shown as cost shared on the budget form pages (show effort, no dollars) and described in the budget justification.

Consultant costs

• Provide the names and organizational affiliations of all consultants other than those involved in consortium/contractual costs and provide any expected compensation, travel and other related expenses. When applicable, signed agreements which meet all compliance requirements of the individual grantee organization must be in place prior to any project-related consultant work being performed.

Equipment

• Only equipment essential to the conduct of this project is allowed. A detailed description must be provided with an explanation as to how it directly relates to this project and is not otherwise available.
• For budget submission purposes, equipment should be defined as items > $5,000 and having a useful life of more than 2 years. Upon award, a grantee institution may re-categorize items to meet internal definitions. Items costing less than $5,000 should be included in the Supply category.

Travel

Travel must adhere to the grantee’s established travel policy and is only allowable if needed to conduct the project. Travel to general scientific meetings is not allowable.

Other Expenses

• Publication costs are limited to $1,000

Consortium/Contractual Costs

Sub-agreements proposed to organizations other than WU-CDTR partners (includes associated community organizations) must be approved by the WU-CDTR Administration prior to submission of the application. The participating consortium organization must submit a separate face page, detailed budget page(s), and budget justification to the PI who will include it as part of the overall application submission.

Other allowable budget categories include: Supplies and Patient Care Costs.

Unallowable Direct Cost Items

Funding will not be provided for the following:

• Administrative personnel
• Stipends for students/trainees
• Dependent Tuition Fringe Benefit
• Administrative supplies/services normally considered indirect costs (i.e. office supplies, phone, fax and modem line charges, etc.)
• Office equipment and furniture
• Tuition
• Purchasing and binding of periodicals and books
• Dues and membership fees
• Honoraria or travel expense for lectures
• Maintenance/Service Contracts
• Construction, alteration, maintenance or rental of buildings or building space
• Faculty/Staff recruiting /relocation expenses
• Entertainment/Social Expenses
• Pre-award costs
• Any expense contrary to applicant’s institutional reimbursement policies

Facilities & Administrative Costs (F&A)

Do not include F&A Costs in the applicant or consortium organization budgets. F&A costs are expected to be a contribution to the program by institutions outside of WU. Any exceptions will be identified in the Notice of Award.

Scored Review Criteria

Reviewers will use the NIH Simplified Framework for NIH Peer Review Criteria to assess applications. The Simplified Framework reorganizes the five regulatory criteria (Significance, Investigators, Innovation, Approach, Environment) into three factors — two receive numerical criterion scores and one is evaluated for sufficiency. All three factors are considered in arriving at the Overall Impact score. 

Factor 1: Importance of the Research [Scored 1-9]

Significance

• Evaluate the importance of the proposed research in the context of current scientific challenges and opportunities, either for advancing knowledge within the field, or more broadly. Assess whether the application addresses an important gap in knowledge in the field, would solve a critical problem, or create a valuable conceptual or technical advance.
• Evaluate the rationale for undertaking the study, the rigor of the scientific background for the work (e.g., prior literature and/or preliminary data) and whether the scientific background justifies the proposed study.

Innovation

• Evaluate the extent to which innovation influences the importance of undertaking the proposed research. Note that while technical or conceptual innovation can influence the importance of the proposed research, a project that is not applying novel concepts or approaches may be of critical importance for the field.
• Evaluate whether the proposed work applies novel concepts, methods or technologies or uses existing concepts, methods, technologies in novel ways, to enhance the overall impact of the project.

Factor 2: Rigor and Feasibility [Scored 1-9]

Approach

• Evaluate the scientific quality of the proposed work. Evaluate the likelihood that compelling, reproducible findings will result (rigor) and assess whether the proposed studies can be done well and within the timeframes proposed (feasibility).

Rigor:

• Evaluate the potential to produce unbiased, reproducible, robust data.
• Evaluate the rigor of experimental design and whether appropriate controls are in place.
• Evaluate whether the sample size is sufficient and well-justified.
• Assess the quality of the plans for analysis, interpretation, and reporting of results.
• Evaluate whether the investigators presented adequate plans to address relevant biological variables, such as sex or age, in the design, analysis, and reporting.
• For applications involving human subjects or vertebrate animals, also evaluate:
  • the rigor of the intervention or study manipulation (if applicable to the study design).
  • whether outcome variables are justified.
  • whether the results will be generalizable or, in the case of a rare disease/special group, relevant to the particular subgroup.
  • >whether the sample is appropriate and sufficiently diverse to address the proposed question(s).
• For applications involving human subjects, including clinical trials, assess the adequacy of inclusion plans as appropriate for the scientific goals of the research. Considerations of appropriateness may include disease/condition/behavior incidence, prevalence, or population burden, population representation, and/or current state of the science.

Feasibility:

• Evaluate whether the proposed approach is sound and achievable, including plans to address problems or new challenges that emerge in the work. For proposed studies in which feasibility may be less certain, evaluate whether the uncertainty is balanced by the potential for major advances.
• For applications involving human subjects, including clinical trials, evaluate the adequacy and feasibility of the plan to recruit and retain an appropriately diverse population of participants. Additionally, evaluate the likelihood of successfully achieving the proposed enrollment based on age, racial, ethnic, and sex categories.
• For clinical trial applications, evaluate whether the study timeline and milestones are feasible.

Factor 3: Expertise and Resources: [Considered in overall impact; no individual score]

Investigator(s) 

• Evaluate whether the investigator(s) have demonstrated background, training, and expertise, as appropriate for their career stage, to conduct the proposed work. For Multiple Principal Investigator (MPI) applications, assess the quality of the leadership plan to facilitate coordination and collaboration.

Environment

Evaluate whether the institutional resources are appropriate to ensure the successful execution of the proposed work.