The Coronavirus Disease (COVID-19) pandemic is a public health emergency that has been particularly severe in its effects on racial and ethnic minority populations in the United States. There is tremendous hope that vaccinations for SARS-CoV2 that are now being deployed in the United States under Emergency Use Authorizations will slow the spread of this virus and protect the general population. While there are recommendations about the highest priority groups to receive initial vaccinations (e.g. https://www.cdc.gov/mmwr/volumes/69/wr/mm6949e1.htm), there are concerns that minority groups also will be disadvantaged in receiving vaccinations, may have differential acceptance of vaccines, and there might be disparities in deployment of other treatments (e.g. monoclonal antibodies).
The Clinical and Translational Science Institute (CTSI) wishes for University of Pittsburgh investigators to identify potential disparities and to develop solutions to reduce any disparities in delivery of COVID-19 vaccines and/or therapeutics. To help this effort, CTSI will award a small number of grants for up to $25,000 in funding to reduce disparities in COVID-19 vaccination and/or therapeutics.
To be eligible for funding, proposals must investigate a problem directly related to equitable distribution of COVID-19 vaccines and/or therapeutics. There are no restrictions on whether this work is basic science, clinical science, epidemiology, health services or psychosocial research. This program is designed to support research which will help understand the causes and magnitude of disparities in delivery of COVID-19 vaccines and/or therapeutics and that will help develop countermeasures to these disparities. These grants are designated for research that creates generalizable knowledge and are not to support rescue or operational efforts.
This program will favor projects with a well-described and direct implementation path to reducing the harmful effects of COVID-19 in populations. This program will have preference for projects that are novel as opposed to incremental efforts from already established and funded research.
Given the size of pilot awards, some investigators may propose to begin projects that lead into larger scale trials or studies. In those instances, applications should include a clear plan for how the work will obtain subsequent funding. Preference will be given for pilot projects that achieve a deliverable increment of knowledge within the funding period.
Examples of responsive proposals might include:
Round 1 Submission Deadline:
Friday, March 12 at 11:59 p.m.
Round 2 Submission Deadline:
Friday, April 9 at 11:59 p.m.
Implementation Meetings (Remote):
Wednesday, April 28 - Friday, May 7
Notification to Advancing Investigators:
Tuesday, March 23
Notification to Awardees:
Monday, April 26
Anticipated Start of Funding:
Tuesday, June 1
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 awards 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.).
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.
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 firstname.lastname@example.org
Using the Powered by PInCh® Submission Platform
CTSI uses the Powered by PInCh® grant submission platform to collect and review all pilot project submissions. If applicants have not previously used this system, they should be aware that they will be required to create a new project before they are able to upload their PDF submission. Project creation should only take a few minutes and asks applicants to register their project in the system by providing the following information:
These fields are used primarily for internal reference and can be edited after the project has been registered.
If you have any questions while using the system or encounter any errors while submitting, please contact Will Hierholzer, CTSI Pilot Funding Core Administrator, at email@example.com or 412-282-3845.
Submit a letter of intent that summarizes the proposed research. Each submission must include the following sections:
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 Friday, March 12. Additional or supplemental materials cannot be accepted after the deadline and will not be reviewed.
See below for review criteria.SUBMISSION PORTAL
The review of letters of intent will be conducted by the faculty and staff of CTSI. The results of this evaluation will determine which investigators will be invited to submit a full proposal for the second round. Advancing projects will be notified by 5 p.m. on Tuesday, March 23.
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, April 9. 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:
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:
*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.
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.
NIH Review Criteria: