Exploring Existing Data Resources Pilot Award

CTSI includes in its mission a goal to increase the development and dissemination of skills throughout the University’s research workforce. To address this goal, we are offering Pilot Awards for investigators to incorporate into their research the use of existing data resources of a type that they have never used before. Examples of existing data resources include “-omics” data, large national databases, physical science databases, biorepositories, public records, marketing databases, and social media. 

This Pilot Award should stimulate exploration, novel analyses, or novel applications of the many biorepositories and data collections that are already available or develop new skills for the principal investigator and team. This funding opportunity is analogous to NIH requests for analysis of existing data sets (e.g. https://grants.nih.gov/grants/guide/pa-files/PAR-20-078.html). This award might include exploration of a new data acquisition technique if the type of data is truly novel for the investigator team, but large-scale new data acquisition is likely to be beyond the scope of these awards. 

To be responsive to this opportunity, the project must be both a new direction and a new type of data for the primary investigator. We will not consider it responsive, for example, if an experienced health services researcher proposes using a different large clinical data set because the new data has a similar type and structure as prior work. It would be responsive if that same researcher proposed a study using proteomics data from a tissue bank or social media data scraped from Facebook in a way that they have never before tried. It would also be responsive if a researcher wants to combine datasets with which they are already familiar (e.g. administrative billing data) with a new dataset that is qualitatively different (e.g. crime report data or weather data). The emphasis in the review will be that the investigative team is branching into research with a new type of data and learning methods that are new to the investigator team in order to use the data.

Successful projects are likely to include new collaboration with other investigators who are experienced with or even curate the new data resource or similar types of data. To be responsive, this must be a new collaboration. For example, a clinical trialist who has never used genomics data might collaborate with an expert in bioinformatics. A basic scientist who wants to use Medicare data might collaborate with a health services researcher. Development of research skills and transfer of skills to new investigator teams is a priority. 

Examples of projects might include:

• Exploring interactions between social determinants of health and genomics data using a biorepository
• Estimating quality of life in persons living with a certain medical condition using Twitter and other social media
• Measuring effects of climate on burdens of disease using atmospheric or climate data (e.g. NOAA records)
• Identification and tracking of cohorts using commercial marketing data
• Describing associations between particular behaviors and drug response using a large administrative data set (e.g. Medicare).
• Exploring the relationship between exacerbations of chronic illness and social stressors using combinations of medical, police and court records

Examples of existing data resources include but are not limited to local, regional and national collections. Some examples are:

• Local databases (see for example the Pitt Data Catalog - https://datacatalog.hsls.pitt.edu/)
• National research  databases (see for example All-of-Us  - https://allofus.nih.gov/get-involved/opportunities-researchers)
• Large administrative or quality databases (see for example: NCDR - https://cvquality.acc.org/NCDR-Home/research)
• Biorepositories (see for example: https://www.pbd.pitt.edu/, http://www.pittbiospecimencore.pitt.edu/)
• Public research data (see for example:  https://biodatacatalyst.nhlbi.nih.gov/)
• Large health system electronic health records (see for example UPMC EPIC/Cerner data: https://www.rio.pitt.edu/services)
• Public records (e.g. court records - https://ujsportal.pacourts.us/CaseSearch)

CTSI will offer active project management for this Pilot Grant program. Staff from CTSI will meet regularly with funded teams to assist with project progress.

Research facilitators at CTSI are available to assist investigator at any stage of a project (https://ctsi.pitt.edu/research-services/research-facilitator-services/). Facilitators can advise on finding collaborators, regulatory issues, human research protection, other required approvals, and research design or conduct. 

Limited statistical consulting on projects is available from CTSI (https://ctsi.pitt.edu/research-services/core-services/biostatistics-epidemiology-research-design/).

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.

Before any funding can begin, awardees must provide documentation of all necessary regulatory approvals (IRB, IACUC, hSCRO, IBC, CORID, etc.). Projects must start within three months of Notification of Award.  Projects that do not start within three months will be forfeited.

CTSI pilots do not have any mechanism for no-cost extensions; any funds that are not used during the award period will be forfeited.

The Principal Investigator must be a University of Pittsburgh faculty member; postdoctoral trainees and trainees in clinical training programs are not eligible to serve as PI but are encouraged to be members of the study team. 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 and early career investigators are strongly encouraged and favored, 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 primary mission is 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.

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

Please 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): Please provide a high-level overview of the study and the proposed work. Be sure to indicate how the study will include a new data resource and how that type of data is new for the investigator team.
3. Specific Data Resources: name the databases or resources that you will use
4. Study Team: Please provide the names and affiliations of all members of the study team and a brief description of their roles (25-50 words per person).
5. Suggested Reviewers: To facilitate the final round of review, please suggest two to three faculty members, not from your department, who may be qualified to serve as scientific reviewers. Include email addresses for each suggested reviewer.

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 p.m. on Friday, November 4, 2022. Additional or supplemental materials cannot be accepted after the deadline and will not be reviewed.

The review of letters of intent will be conducted by the faculty and staff of CTSI. Proposals will primarily be evaluated based on responsiveness to the funding opportunity announcement, 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.

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 p.m. on Monday, December 5, 2022. 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:

1. Project Overview (one page): The first page should include the following:
   
   • Scientific Abstract (250-word limit): Briefly summarize the proposed work.
2. Research Plan (five-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:
   
   • Specific Aims
   • Significance
   • Innovation
   • Approach
3. References (no page limit): Literature cited does not count toward the Research Plan's three-page limit.
4. 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 non-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.
5. 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.
6. 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.
7. NIH Biosketches (no page limit): Include biosketches for the Principal Investigator and key members of the research team. Use new biosketch format as of September 2020.
8. Letters of Support (optional): Letters of support are not required, but are encouraged (e.g., advisory committee members and health system partners/organization collaborators).

Review of CTSI pilot proposals uses the NIH review criteria and Program-specific 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. Note that the review (based on the criteria below) will be adjusted to the pilot nature of the award.

NIH Review Criteria:

• Overall Impact: The likelihood for the project to exert a sustained, powerful influence on the research field
• Significance: Does the project address an important problem or a critical barrier to progress in the field?
• Investigators: Are the PD/PIs, collaborators, and other researchers well suited, sufficient, and able to conduct the project?
• Innovation: Does the project shift current research or clinical practice paradigms use novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?
• Approach: Are the strategies, methods, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?
• 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:

• Use of a New Data Resource: Does the project use a data resource that is of a novel type for the investigator and that will give new analytical skill to the investigator team, as opposed to just accessing new data that are similar to past projects?   
• New Collaborations: Does the project build a new collaboration that brings new skill sets to the core team? 
• Early Career Investigators: Does the investigative team include early career investigators who will benefit by learning new research tools?