REAL Pilot Awards: Research Across the Lifespan


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Overview

The Special Populations Core of the Clinical and Translational Science Institute (CTSI) is currently seeking applications for the 2018/2019 cycle of the REAL (REsearch Across the Lifespan) pilot awards. This funding opportunity is designed to encourage new research addressing how biological processes, clinical problems, response to therapy, or other health-relevant phenomena change or evolve during the human lifespan. Research studies are often developed with one particular age group in mind. Data for other age groups may exist but may not be considered by a research team used to focusing on one part of the lifespan. In addition, some life stages are commonly excluded from most research: examples include pregnancy, infancy, and aging.

The aim of this funding opportunity is to stimulate new research into biological and psychosocial mechanisms that change over the course of the human lifespan. Applications should address a focused scientific question with biologically plausible change across the lifespan. To be responsive to this opportunity, projects must include or compare two or more of the following groups: fetuses, infants, children, adolescents, young adults, middle-age adults, and older adults. Simply including multiple age groups or replicating findings in a different age group is not sufficient: Studies must specifically analyze the effects of development and aging in order to determine how underlying biological mechanisms change across life stages.

Because this funding opportunity is for pilot studies, applications should include an explicit discussion of how the intended aims can lead to larger studies in the future.

Examples of projects that would fit this opportunity include:

  • Examination of how pathophysiological factors for a disease change across age or developmental stages
  • Different effects of therapeutic agents across the lifespan
  • Secondary analyses of large data sets across multiple age ranges to examine common biological or psychosocial risk factors for adverse health outcome
  • Drug pharmacokinetics in pregnant and non-pregnant young women
  • Examination of task-based or resting state functional neuroimaging measures to chart developmental trajectories
  • The role of estrogens in modulating serum vitamin D binding proteins in young and aged women

Funds are available at the level of $25,000 over one year.

  • No indirect support will be provided.
  • Funding cannot start until all necessary regulatory approvals have been received (IRB, hSCRO, IBC, CORID, IACUC).
  • The funding cycle will last for 12 months; no extensions of this award period will be made.
  • Proposals that incorporate an epigenetic/epigenomic theme will be eligible to receive an additional $5,000 bonus award (total of $30,000) over one year. This additional epigenomic component may reflect a pre-existing aspect of the research or a new additional component.

Timeline:

Round 1  
Submission Deadline Notification to Advancing Investigators
Wednesday, December 19, 2018 at 11:59 p.m. Monday, January 14, 2019
Round 2  
Submission Deadline Notification to Awardees
Friday, February 15, 2019, at 11:59 p.m.  Wednesday, March 27, 2019
Anticipated Start of Funding  
Monday, May 1, 2019  

 

Funding Information:

Funds are available at the level of $25,000 over one year.

  • No indirect support will be provided.
  • The funding cycle will run from April 1, 2019 through March 31, 2020; no extensions of this award period will be made.
  • Funding cannot start until all necessary regulatory approvals have been received (IRB, hSCRO, IBC, CORID, IACUC).

Eligibility:

The Principal Investigator (PI) must be a faculty member at the University of Pittsburgh. Postdoctoral trainees and trainees in clinical training programs are not eligible to serve as PI; however, faculty members on early-career training awards or clinical research scholars (i.e. recipients of K-series or similar career development grants) are eligible. New PIs are strongly encouraged, but submissions from established investigators will be accepted if there is clear evidence that the pilot project represents a distinctly new direction from their previously funded work.

Study teams that involve cross-disciplinary collaborations are strongly encouraged. Co-Investigators may be from other universities; however, CTSI’s mission is primarily to promote research at the University of Pittsburgh, so applicants should justify extensive off-campus collaboration. Partnerships with non-academic community partners are also acceptable and encouraged.

The submissions for both rounds will be collected via Powered by Pinch, CTSI’s online grant submission platform.

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Round 1

 

Round 1: Letter of Intent
The first round submission for the 2018/2019 cycle of REAL will be a Letter of Intent (PDF format; Arial font, size 11; 0.5 inch page margins) that includes the following categories:

  1. Study Title: Include the title of the proposal at the top of the page, along with the PI name and a contact email.
  2. Abstract and Scope of Work (500 word limit): Please provide a high-level overview of the study and the proposed work. Be sure to indicate
    • Which life stages will be included (fetuses, infants, children, adolescents, young adults, middle-age adults, and older adults)
    • How the proposed work indicates a new direction for the investigators
    • If the proposed work will include an epigenomic theme and be eligible for the bonus funding, be sure to clearly describe the epigenomic component
  3. Study Team: Please provide the names and affiliations of all members of the study team, and a brief description of their role (25-50 words per person).
  4. Suggested Reviewers: To facilitate the final round of review, please suggest 1-3 Pitt faculty members, not from your department, who may be qualified to serve as scientific reviewers.

Round 1: Review Criteria

The Letters of Intent will be reviewed for how responsive the proposed work is to the RFA (i.e. would the research involve the meaningful comparison of multiple life stages, or is it a repurposing of existing research aims to capture funding?), and on the overall scientific impact of the work. The results of this initial review will be used to determine which investigators will be invited to submit a full proposal for the second round of REAL.

Proposals that include an epigenomic component may be eligible for an additional $5,000 in funding. However, the presence of an epigenetic/epigenomic focus will not impact whether or not an investigator is asked to submit to the second round.

 


 

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Round 2

Round 2: Submission Materials

Applications should be combined into a single PDF file. The complete application should be loaded into the Powered by Pinch site before the application deadline. Additional materials or supplemental materials cannot be accepted after the deadline, and will not be reviewed. Use a font no smaller than Arial 11 and 0.5-inch page margins.

Final applications should have the following sections, and each section should begin on a new page.

Applications should be combined into a single PDF file. The complete application should be loaded into the Powered by Pinch site before the application deadline. Additional materials or supplemental materials cannot be accepted after the deadline, and will not be reviewed. Use a font no smaller than Arial 11 and 0.5-inch page margins.

Final applications should have the following sections, and each section should begin on a new page.
A. Scientific Abstract (1 page): The first page should include the following:

  1. Scientific Abstract (250-word limit): Briefly summarize the proposed work.
  2. Inclusion of Life Stages (100-word limit): Indicate which life stages will be impacted by the proposed work, and how the proposed work represents a new direction for the investigators.

B. Research Plan (5-page limit, including tables and figures): This section should include elements from a traditional NIH proposal to best allow reviewers to address the review criteria (below).

  1. Specific Aims
  2. Significance
  3. Innovation
  4. Approach

C. References (no page limit). Literature cited does not count toward the 5-page limit.

D. Budget with Budget Justification (no page limit): Use PHS 398 Forms Pages 4 and 5. The Budget Justification should include sufficient detail for reviewers to assess whether appropriate resources have been requested.

Grant funds may not be budgeted for:

  • Salary support for the PI or faculty collaborators*
  • Effort for post-doctoral trainees or fellows
  • Routine office supplies or communication costs, including printing
  • Meals or travel, including to conferences, except as required to collect data
  • Professional education or training
  • Computers or audiovisual equipment (exceptions require clear justification)
  • Manuscript preparation and submission
  • Indirect costs​

Epigenetic/Epigenomic Bonus Award: Proposals that are eligible for the $5,000 epigenomic bonus award will be instructed to submit a budget for $30,000. The determination of eligibility will be made during the review of the first round, and eligible teams will be informed when they are notified of their acceptance into the second round.

*
Effort is required of the principal investigator and must be reflected on the budget page. This effort should be cost shared by the department or other entity that will support such effort. Reviewers understand that this may be a very small proportion of effort given the size of this award, but will be cautious if investigators do not appear to have sufficient time to complete a project.

Any salary support requested in a submitted budget should reflect federal fringe benefit rates. If an award is made, a budget meeting will be held between principal investigators, their respective research administrators, and financial administrators from the CTSI. If necessary, adjustments to the requested budget will be made at that meeting.

E. Proposal Timeline (up to one page): Describe milestones and timeline for completion of the project. These milestones are critical for the pilot program, because all awards must be expended during the one-year award. The CTSI Pilot program does not have mechanisms to allow no-cost extensions. In the event an award is made, investigators should immediately confer with CTSI staff if any delay in initiation or completion of the project is anticipated.

F. Human and/or Animal Subjects (no page limit): NIH supported pilot awards must address Protection of Human Subjects, Adequacy of Protection Against Risks, Data and Safety Monitoring Plans, Inclusion of Women and Minorities, and Inclusion of Children.

Human Research Protection Office (HRPO) approval is not required prior to submission. However, HRPO approval is required for all projects involving human subjects before NCATS will approve project funding. Likewise, the Institutional Animal Care and Use Committee (IACUC) must approve any projects involving animal subjects prior to final funding approval.

In this section, applicants must describe any human and/or animal subject issues, as well as the sources of materials that will be obtained from human subjects. If human subjects are involved, provide a description of their involvement and characteristics, specific risks to subjects who participate, and protection against those risks. Reviewers may consider whether significant delays in approval are an anticipated barrier for project completion when selecting projects. Evidence of prior or ongoing HRPO / IACUC review is encouraged. Similarly, this section should discuss if other special regulatory approval is required prior to funding: Human Stem Cell Research (hSCRO), Institutional Biosafety Committee (IBC), Research Involving the Dead (CORID), Radiation Safety Office (RSO), etc.

G. NIH Biosketches (no page limit): Include biosketches for the Principal Investigator and Key members of the research team. Use new NIH biosketch format as of May 2015.

It is a requirement that review of CTSI Pilot proposals should address the NIH review criteria. Reviewers will score final applications on an NIH scale (1-9) in the domains of Significance, Investigators, Innovation, Approach and Environment. Special emphasis will be given to a rating of the Overall Impact of the proposed project.

Round 2: Review Criteria

NIH Review Criteria: Note that the review (based on the criteria below) will be adjusted to the pilot nature of the award.

1. Overall Impact of the proposed project (The likelihood for the project to exert a sustained, powerful influence on the research field).
2. Significance (Does the project address an important problem or a critical barrier to progress in the field?)
3. Investigators (Are the PD/PIs, collaborators, and other researchers well suited, sufficient, and able to conduct the project?)
4. Innovation (Does the project shift current research or clinical practice paradigms use novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?)
5. Approach (Are the strategies, methods, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?)
6. Environment (Are the personnel, equipment and other physical resources available to the investigators to perform the proposed research within the timeframe allotted?)

Program-Specific Criteria:
7. Inclusion of populations from multiple points along the lifespan (Does the project appropriately address the scope of the RFA, including meaningful comparison of multiple life stages, as opposed to repurposing existing research aims to capture funding?)
8. Biological Significance (Does the project indicate a clear path to discovering underlying biological differences across the lifespan?)