Goals & Background
The Pilots Projects Program solicits clinical and translational research applications. Pilot Grants provide funds for a one-year period that will allow a research team to develop a more substantial basis for independent external support from the NIH. Meritorious projects may be renewed for a second year.
The technical scope of the research plan should be related to clinical and translational research (see Rubio et al., 2010). Areas of high importance to the DE-CTR ACCEL Program include
- Cardiovascular Diseases
- Big Data
- Women’s Health and Infant Mortality
- Community Engaged Research
Other areas of clinical and translational research will be considered. Use of one or more of the research cores at the ACCEL institutions is encouraged, but not mandatory. Information about these cores can be found on the ACCEL website
The proposal format (11 point, Arial) is similar to that for an NIH R03 proposal, except in terms of the length of the research description section. Proposals should be submitted using PHS 398 forms. Instructions can be found here. Each proposal should include the following sections:
- NIH face page (download here)
- NIH Page 2&3: Summary, Relevance, Project/Performance Sites, Senior/Key Personnel (download here)
- Budget using NIH forms Page 4, including budget justification on Page 5 (download hereand here)
- Biographical Sketch(es) of PI and Key Personnel including the primary mentor (if needed), other members of the mentoring team (if needed), and collaborators who would play a significant role in accomplishing the goals of the proposal (Biosketch Format Pages, Instructions and Samples)
- Research Strategy (See below—using NIH continuation forms—download here)
- F. Success from Prior Awards: PIs who have led a project supported by CTR, INBRE, COBRE or DHSA grants should include a short section (1 page maximum) outlining the progress on that prior work, including their success in leveraging that research into independent external support and explaining why further support is necessary. If this is a renewal request for a second year of funding, a one-page progress report is required. Use NIH continuation forms.
- NIH Human subjects (download here) and planned enrollment forms (here), if applicable
- Vertebrate animals justification and protection (download here), if applicable
- A letter of Support from the PI’s Department Head/Chair
- If the project is led by a new investigator (see NIH definition), the application must include a letter of support from the primary mentor detailing previous experience, the candidate’s potential, the existing mentoring or working relationship (if any), and specifics as to how the mentor will interact with the candidate during the funding period (see mentoring agreement)
The proposal need not be routed through the institutional research offices for institutional signatures, but upon submission may be forwarded to the PI’s appropriate institutional office for budget and effort verification.
Pre-Submission Assistance and Feedback
Applicants are encouraged to have the ACCEL Biostatistics, Epidemiology & Research Design (BERD) Core provide assistance with and/or review their statistical and methodological approach prior to submission:
The BERD team will review and provide comments on the information submitted through the Request for Assistance form. Be sure to indicate that the request is linked to a Clinical and Translational Pilot Grant submission. Note that the average turn-around time is 18 days.
Proposals led by new investigators (see NIH definition) will be required to work with our Professional Development Core (PD-Core) to submit detailed mentoring plans (from the mentors) and Individual Development Plans (from the PIs) prior to receiving funds. The Mentoring Plan and IDP are not required as part of the original submission process but applicants are encouraged to use the tools to help in planning the submission (see PD-Core Tools).
Applicants are also encouraged to engage with our Community Engagement and Outreach (CEO) Core as part of the pre-submission process.
Community Engagement and Outreach (CEO) Core
Experts from the CEO Core will review and provide feedback on Section B, which includes a statement of the relevance of the proposed research to public health. This statement is a critical component of NIH and DE-CTR ACCEL sponsored research and will be a part of the evaluation process. The statement of relevance should use plain language that can be understood by a general, lay audience. Contact the CEO core for assistance with framing the relevance and potential impact of projects and for connection to community partners where appropriate.
The Research Strategy part of the proposal (section E above) should describe the (1) Specific Aims of the work, (2) Significance, (3) Innovation, and (4) Approach. Together, these should be four pages in length. Within the Approach section, a statistical analysis subsection is required. If applicable, within the Approach section applicants should also discuss the potential for community engagement. Information about the ACCEL Cores can be found on the ACCEL website.
Human subjects Institutional Review Board (IRB) or Vertebrate animal IACUC approval is not required at the time of pilot project submission. However, if applicable, such approval is required before the selected pilot projects are sent to the NIH for federal approval on May 15. If a project is selected for funding by the ACCEL External Advisory Committee but does not have IRB/IACUC approval by May 15, funding of the proposal may be deferred.
Investigators who will be doing work at hospitals may need to obtain credentials. Such investigators are encouraged to begin that process well in advance of the start date of the grant as the process can take several months.
Each proposal must be submitted by one investigator from one of the ACCEL partner institutions (i.e., University of Delaware, Nemours, Christiana Care Health System, Delaware State University and the Medical University of South Carolina). Proposals that include investigators from multiple partner institutions are especially encouraged and are given priority. Note: multiple PI applications are not allowed and only a single PI will be recognized.
Leaders of pilot projects must hold a faculty appointment or equivalent at the time the pilot award commences. These are individuals who can independently apply for Federal or non-Federal investigator-initiated peer-reviewed Research Project Grants (RPG). Individuals holding postdoctoral fellowships or other positions that lack independent status are not eligible to lead pilot projects.
The Project lead for Pilot projects may not concurrently have research funding from other IDeA Program award mechanisms (e.g. INBRE, COBRE).
Pilot projects may not overlap with ongoing funded projects.
Mentors: Proposals led by junior or “new” investigators (see NIH definition) must identify a suitable mentor, and include the proposed mentor’s Letter of Support demonstrating his willingness to participate and support the applicant and project. Mentors with prior experience as PI on an NIH funded grant are preferred.
Proposals should be submitted electronically using the ACCEL website grant proposal form by noon on March 1, 2019. Note that all investigators on the proposal must have user accounts on the ACCEL website prior to submission. Contacting the other cores for support (i.e., Epidemiology/Biostatistics and Community Engagement—see Pre-Submission section above) must be done at least two weeks before the submission date.
Up to $80,000 (direct costs) may be requested. Two types of awards will be made: Community Engagement (CoE) Pilots and regular Pilots. The CoE Pilots will be for up to $40,000/year for two years and the regular Pilots will be up to $80,000 for one year. CoE Pilots are those that focus on a problem related to Community Engagement. We have learned that these projects generally take longer to complete, hence the extra time. A typical pilot grant will support clinical research coordinators, postdoctoral fellows, or graduate students, as well as appropriate amounts for supplies, travel, etc. PI salary is discouraged as faculty release time for this work is expected to be provided as an institutional commitment; the anticipated effort should be indicated in the budget. A budget period of up to one year may be requested. Investigators should plan for funding to begin on July 1, 2019.
Each ACCEL Pilot Project will be evaluated via a three-step process. In the first step, proposals will be evaluated based on scientific merit as is done in NIH study sections. Proposals will be given five scores based on significance, investigators, innovation, approach, and environment (especially as it pertains to the type of research being proposed in relation to established Cores). They will then be given an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, as well is its chance of being developed into a full NIH proposal with a high likelihood of success. Scores are on a 1 (exceptional) through 9 (poor) scale, following the standard NIH guidelines for reviews of individual (R-type) research grants. Proposals will be given another score based on how the scope of work and investigator’s status correspond to the priorities of the ACCEL Program. Questions to be addressed include: Has the investigator received previous funding? If so, has it been well used? Is the research translational?
In the second step, the ACCEL Executive Committee will then determine which grants to recommend for funding based on the priority scores and the ACCEL mission. An addition score based on Community Engagement will be provided by our CEO Core to determine if projects are addressing the health outcomes of Delawareans. In the third step, final approval for funding will be made by the External Advisory Committee, albeit with NIH approval.
Preference will be given as follows:
- Proposals from multiple partner institutions are given priority over those from single institutions.
- While all projects must be translational, at least half of the projects that will be funded must be clinical in nature (i.e., although not a requirement, clinical projects are especially welcome).
- Projects generated from ACCEL sponsored research planning retreats will be given priority.
Awardees are required to attend the annual ACCEL Research Conference and to present their work at the annual (national or regional) NIH IDeA Conference. They are required to cite the ACCEL grant (NIH U54 GM104941) on all publications and to submit quarterly progress reports. Also, for “new” investigators, active participation in the mentoring process is required for both mentors and mentees, which includes completion of mentor reports.
- Thursday, February 7, 2019 Pre-Submission Assistance and Feedback from BERD Core Deadline
- Friday, March 1, 2019 Proposals due
- Monday, April 1, 2019 Reviews completed, send to ACCEL Executive Committee
- Wednesday, May 15, 2019 ACCEL Executive Committee recommendation forwarded to EAC (JIT info requested at this time). Meet with the PD Core and complete the Mentoring Plan and Individual Development Plan.
- Monday, May 20, 2019 EAC decision made. Institutional IRB/IACUC approval due. Projects sent to NIH for approval. Approved projects should work to ensure they have their mentoring plans and community engagement approval prior to project commencement
- Monday, July 1, 2019 Pilot projects commence