Geographical Determinants of Health Pilot Program

Overview

The Clinical and Translational Science Institute (CTSI) at the University of Pittsburgh is soliciting applications for pilot translational research projects focused on geographical determinants of health and geographical barriers to health care delivery.   Individuals live at varying distances from medical facilities, and these distances may alter the manner by which patients access resources.  Likewise, providers face challenges delivering services to patients in remote locations.  Understanding the impact of location on health and developing new ways to improve delivery of services to patients who are remote from medical facilities may impact the health of diverse populations.

Scope of Proposals
Pilot projects must explicitly explore how patient location relative to providers of healthcare interacts with health and health care delivery.  Examples of the interaction of location with health include the higher incidence of cerebrovascular disease and the higher incidence of motor vehicle crashes in less urban counties.  Examples of the interaction of the interaction of location with health care delivery include the systems required for rural patients to access comprehensive stroke centers that are built primarily in urban areas. 

While there may be many different types of geographical influences on health, distinctions between urban and rural populations are most obvious.  There are multiple definitions for rural versus urban populations.  Examples include the six-level designations of the CDC National Center for Health Statistics (access their website or view the PDF to learn more), wherein rural populations might be those who live in “non-core” counties.  We recommend using this or a similar established nomenclature in proposals.

Proposals may use data from international settings.  However, the emphasis of the proposal is to enhance health in U.S. populations, and the impact on U.S. health will be a priority in review.

In order to be responsive to the translational mission of CTSI, projects should involve human subjects or data from human subjects. In order to be responsive to the pilot and innovation focus of the pilot program, projects must be distinctly new directions for the investigator rather than extensions of existing funded work.   Cross-disciplinary efforts and new collaborations are desirable, but projects from single investigative groups are also eligible.

Examples of projects that might fit this opportunity include:

• Comparing specific disease incidence and outcomes in rural versus urban populations.
• Testing feasibility of telemedicine approaches to deliver specialized services at a distance.
• Describing engagement with healthcare or motivation for health behaviors in relation to locale
• Exploring the biological or social factors that lead to differential incidence, prevalence, or outcome of a specific disease among populations in different geographical settings.

Funding Information

Award funding of up to $25,000 is available to cover direct costs; no indirect support will be provided. The award period will last for 12 months, beginning when all regulatory and administrative approvals have been received. Pilot programs from CTSI do not have any mechanism for no-cost extensions; any funds that are not spent during the award period will be forfeited.

Before any funding can begin, awardees must provide documentation of all necessary regulatory approvals (IRB, IACUC, hSCRO, IBC, CORID, etc.). Once regulatory documentation is provided, awarded projects will undergo an administrative review from NCATS, which may take up to 30 days. Funding cannot begin until projects have been approved by NCATS. Because of this, all applicants are strongly encouraged to have the necessary regulatory documents ready for submission.

All funds for this pilot mechanism must be spent before June 1, 2021. Projects that are unable to start before June 1, 2020, will not have a full 12 months to spend their award and will forfeit any funds unspent on May 31, 2021.

Eligibility and Requirements

Eligibility:
The Principal Investigator (PI) must be a University of Pittsburgh faculty member.  Postdoctoral trainees and trainees in clinical training programs are not eligible. Early career faculty members on training awards or clinical research scholars (for example, K-series grants or similar career development grants) would be eligible. 

New investigators are encouraged. Established investigators must demonstrate how the pilot project is a distinctly new effort relative to their prior funded work. 

Study teams that involve cross-disciplinary collaborations are strongly encouraged. Co-Investigators may include collaborators from any institution.  We encourage cross-disciplinary teams, teams connecting community partners, or teams including other universities.  Because the mission of CTSI includes promotion of research at the University of Pittsburgh, applicants should justify extensive off-campus collaborations.

Special Requirements:  
The National Center for Advancing Translational Sciences (NCATS) funds the CTSI Pilot Translational Core in order to promote research solutions that explore novel and new opportunities to move discoveries into humans. In contrast to the disease or organ-specific branches of NIH, the NCATS mission is to catalyze translation of discoveries rather than on basic discovery research. Therefore, these programs particularly encourage research that goes beyond a select disease category or specialty.

Questions? Contact the CTSI Pilot Core at ctsipilots@pitt.edu

Submission Format and Requirements

CTSI Uses the Powered by PInCh®  grant submission platform to collect and review all submissions to pilot competitions. For instructions on how to use the system, please see the section below titled Using the Powered by PInCh® Submission Platform (jump to section).

Round 1: Letter of Intent
Submit a letter of intent that summarizes the proposed research. Each submission must include the following sections:

1. Study Title: Include the title of the proposal at the top of the page, along with the PI name and contact email.
2. Abstract and Scope of Work (500 word limit): Provide a high-level overview of the study and the proposed work. Be sure to indicate how the proposed research is responsive to the geographical requirements of this funding program.
3. Study Team:  Provide the names and affiliations of all members of the study team and a brief description of their roles (25-50 words per person).
4. Suggested Reviewers: To facilitate the final round of review, please suggest two to three Pitt/UPMC faculty members to potentially serve as non-conflicted scientific reviewers. For each suggested reviewer, list their name, title, department, and contact email.

Applications should be in the form of a single PDF document that uses Arial size 11 font with margins of 0.5 inches. All materials must be submitted before 11:59:59 p.m. on Wednesday, December 18, 2019. Additional or supplemental materials cannot be accepted after the deadline and will not be reviewed.

See below for review criteria (jump to review criteria).

SUBMISSION PORTAL

  
  

Round 2: Full Packet Submission
Applications should be in the form of a single PDF document; please use Arial size 11 font, with margins of 0.5 inches. All materials must be submitted before 11:59:59 p.m. on Friday, February 21, 2020. Additional or supplemental materials cannot be accepted after the deadline and will not be reviewed.

Include the following sections, beginning each section on a new page:

A. Scientific Abstract (250-word limit): Briefly summarize the proposed work.

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

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

C. References (no page limit): Literature cited does not count toward the Research Plan's three-page limit.

D. Budget with Budget Justification (no page limit): Use PHS 398 Form Page 4 and Page 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​

^*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 half a 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.

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 Oversight (hSCRO), Institutional Biosafety Committee (IBC), Committee for Oversight of Research Involving the Dead (CORID), Radiation Safety Office (RSO), etc.

Review Criteria

Round 1 Review Criteria
The review of letters of intent will be conducted by the leadership and faculty at CTSI. Proposals will primarily be evaluated based on the responsiveness to the geographical requirements of this RFA, as well as the overall scientific impact of the proposed work. The results of this evaluation will determine which investigators will be invited to submit a full proposal for the second round. (back to Submission Requirements)

Round 2 Review Criteria
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. (back to Submission Requirements)

NIH Review Criteria:

1. Overall Impact: 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 does the 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 time frame allotted?

Program-Specific Criteria:

1. Responsiveness to the RFA: Does the proposed project have relevance to understanding spatial determinants of health and healthcare?
2. Growth Potential: Will the project provide a basis for future successful funding or for successful innovations within the CTSA framework?
3. New Direction: Does the project represent a new multidisciplinary team or significant change of research direction for an existing team?
4. Partnership: Does the proposal develop inter-institutional, inter-departmental, or inter-disciplinary partnerships? Does the project promote community engagement in the research enterprise?