Delaware INBRE Pilot Project Award RFA Information

The Delaware IDeA Network of Biomedical Research Excellence (DE-INBRE) is a National Institutes of Health (NIH) and State of Delaware co-funded program to build Delaware’s capacity to conduct biomedical research by supporting investigator driven research projects, undergraduate research training, student/faculty professional development, and research infrastructure (e.g. core facilities and data access). Since this mission includes engagement with undergraduate researchers, funded investigators are required to engage undergraduates in their project and will be asked to describe this inclusion as part of the application. Eligible investigators across our network are welcome to apply to these funding mechanisms. The DE-INBRE network includes five institutions:

• The University of Delaware (UD)
• Delaware State University (DSU)
• Christiana Care Health System (CCHS)
• Nemours Children’s Hospital (Nemours)
• Delaware Technical Community College (DTCC)

DE-INBRE also works with several affiliated institutions including the Wilmington VA Medical Center (Wilmington VA), Delaware Public Health Laboratory (DPHL), Delaware Health Information Network (DHIN), and the Delaware Biosciences Association. Research faculty with PI eligibility employed by these institutions are also eligible to receive support from DE-INBRE.

Pilot Project awards are mentored, one-year grants (up to $40K) that provide seed funding to support new research directions. Pilot Project award applications must address an important research question relevant to NIH’s goals. Applicants are not limited to topical focus areas; any proposals addressing the NIH’s mission are welcome.  

DE-INBRE Pilot Project applicants must be employed by a DE-INBRE partner institution; (UD, Nemours, ChristianaCare, DSU or DTCC) or a DE-INBRE affiliate institution and hold independent investigator status as defined by their institution. Note: graduate students, clinical fellows and post-doctoral scholars are not eligible to serve as PIs.

NIH-defined “established investigators” can apply for Booster, High-end core facility, or DE data science awards only while NIH-defined “Early-Stage Investigators (ESIs)” and NIH-defined “new investigators” are eligible for all award types. 

Investigators who have active research support from other IDeA mechanisms (e.g., Centers of Biomedical Research Excellence [COBRE], Center for Translational Research [CTR]), IDeA States Pediatric Clinical Trials Network [ISPCTN] are not eligible for simultaneous DE-INBRE Pilot Project funding.

NIH NIGMS requires that Pilot Project Investigators funded through DE-INBRE devote at least 25% of their overall professional effort (equivalent to 3.0 person months) to career development and research activities. Applicants must provide a letter from the appropriate chair, dean, or supervisor certifying that the applicant will have this level of protected time. This 3.0 person months may be fulfilled for individuals on 9 month academic year contracts by research activities performed in the summer.

Take-off awards will prioritize funding of early stage and new investigators who need to collect feasibility data in order to be competitive for larger grants. All investigators will be considered for Booster, High-end core facility, and Delaware Data Science awards, with early stage and new investigators getting priority. For all mechanisms, investigators who have limited access to research resources will be prioritized over those with substantial start-up packages from their home institutions or other research funding. 

The type of awards included under the pilot project mechanism are:

1. Take-off awards that prioritize funding of new research directions with no requirement for pilot data.
2. Booster awards that support ongoing studies needing additional support to establish feasibility and/or collect pilot data to increase competitiveness for either DE-INBRE Research Project awards or other funding mechanisms.
3. High-end core facility awards that support projects focused on the use of a DE-INBRE core facility to perform a coherent study with anticipated costs far exceeding that of a DE-INBRE core access voucher ($4,000), but under $40,000. Currently, this is anticipated to support studies seeking to utilize single-cell RNA sequencing and spatial genomics performed in a DE-INBRE-affiliated core facility, but other high-end technologies will be considered.  Allowable costs include sample preparation, consumables, equipment time, core facility user fees/staff time, and analysis costs (Data Science Core etc.). The relevant core facility director(s) MUST be engaged in proposal development prior to application and must provide documentation supporting the project as part of the applicant’s mentoring plan.
4. Delaware data science awards that fund projects seeking to use data derived from Delaware’s biomedically relevant databases such as UD-supported Medicaid claims data, Delaware Health Information Network (DHIN) “All Payers-based claims” data, or Electronic Health Records (EHR) from Christiana Care, or Nemours Children’s Hospital’s PEDSnet data. This mechanism is intended to improve the health of Delawareans while providing our investigators with more data science research opportunities. Note: Data science projects involving national datasets (e.g. N3C, ECHO, or Omics data, etc.) are eligible for Take-off or Booster funding mechanisms depending on whether they are new ideas by early stage/new investigators or somewhat established ideas by senior investigators.
   • UD’s Medicaid Claims Data Access: UD’s Center for Community Research and Service (CCRS) at the Biden School of Public Policy & Administration manages Delaware Medicaid data for research in close collaboration with the Delaware Division of Medicaid and Medicare Services (DMMA). For budgeted effort on this award, CCRS assists PIs by supporting statistical analyses and obtaining IRB approval for the project. They will collaborate with the PI’s team to develop their protocol, identify the appropriate and available variables that can be built from the Medicaid claims and conduct statistical analyses. For more information, please contact Dr. Katie Gifford (katig@udel.edu). Note that all projects involving use of Medicaid data must be approved by DMMA and any publication from these projects require submission to DMMA for review.
   • Delaware Health Care Claims Database (HCCD): The state of Delaware’s All Payer Claims Database, powered by Delaware Health Information Network (DHIN), collects healthcare claims, enrollment and provider data from Medicare, Medicaid and the seven largest commercial health insurers. The fee schedule varies based on the complexity of the dataset, but de-identified datasets are available at a reduced cost. These costs will need to be budgeted on this award application. To explore what’s available, PIs should first complete an HCCD application form with details regarding the goals of the project, the variables of interest and data security information. Once reviewed, the next step is for the PI to present the proposal at a monthly meeting of the HCCD Committee, which is tasked with oversight of data access requests and is comprised of representatives from the data senders, including hospitals and payers. To note: IRB approval should ideally be in place prior to the HCCD committee meeting. A data use agreement (DUA) between DHIN and the PI’s institution will be required once the project is approved for funding, and any publications or presentations featuring the HCCD data must be approved by the Committee prior to publication or presentation. PIs are encouraged to begin the process for obtaining IRB and HCCD Committee approvals and for executing the DUA early so that they are in place by March 3, 2025. To get started, please complete the HCCD application form and a member of the DHIN team will follow up with you on your request within a week’s time. It is recommended that PIs work with the DHIN team prior to submitting the application, to determine the feasibility of the project and to receive assistance with the application itself. For more information, please contact DHIN Strategic Relationship Manager Juan Arjona (juan.arjona@dhin.org).
   • ChristianaCare EHR Data Access: For budgeted effort on this award, the ChristianaCare data analyst team will extract electronic health record (EHR) data to develop a de-identified, research-ready database based on PI’s research questions following close collaborations between the PI’s team, ChristianaCare data analyst team, as well as a ChristianaCare clinical content expert, who serves as a co-investigator. The data variables and data dictionary will be developed in collaboration with the PI’s team. Statistical analysis support will be available through the ACCEL-CTR Biostatistical Epidemiology and Research Design (BERD) core. IRB approval will need to be sought at both the PI’s institution and at ChristianaCare. A DUA between ChristianaCare and the PI’s institution will need to be in place before the work begins. PIs are encouraged to begin the institutional IRB approvals and DUA processes early so that they are in place by March 3, 2025. For more details, contact Dr. Claudine Jurkovitz (cjurkovitz@christianacare.org), Director of the BERD Core.
   • Nemours PEDSnet Data Access: For budgeted effort on this award, Nemours Children’s Hospital’s Biomedical Research Informatics Center (BRIC) data science team can extract pediatric EHR data from within their health system as well as the larger PEDSnet database. Access to the PEDSnet national data requires submission of a PEDSnet Collaboration Request for review. That would not be necessary for access to Nemours data alone, but in all cases, potential investigators must first discuss their project with Nemours’ PEDSnet site Co-PI, Dr. Tim Bunnell to be sure their project is feasible for PEDSnet. All analysis of the national PEDSnet data must be completed within the PEDSnet Data Coordinating Center (DCC) and at present requires collaboration with a Nemours data scientist who is trained to conduct studies within the DCC. Statistical analysis support will be available through the CTR-ACCEL BERD team. IRB approval will need to be sought at both the PI’s institution and Nemours, which would serve as the IRB of record for PEDSnet studies. DUAs may need to be in place before the work begins. The Nemours data science team is willing to collaborate with the PI’s team to develop the research question and extract appropriate data (for local Nemours data) or run analyses within the DCC. PIs are encouraged to begin the institutional IRB approvals and DUA processes early so that they are in place by March 3, 2025. For more details, contact the Nemours site Co-director, Dr. Tim Bunnell (tim.bunnell@nemours.org).

Investigators whose projects focus on Clinical Translational / Community Engaged Research involving Human Subjects are encouraged to direct their applications to the DE-CTR-ACCEL program.

Mentors are required for all early stage and new investigators

Delaware INBRE Pilot Projects have a strong mentoring component for early stage and new investigators. Thus, applications from NIH early stage and new investigators require a mentor and a mentoring plan described through a letter of support written by the mentor. The Primary Mentor (or Mentoring Team) is expected to have an established track record of NIH funding and investigator training. The primary mentor must:

• Be a full-time, established investigator with a history of independent funding.
• Be experienced in the area of the applicant’s proposal
• Demonstrate commitment to the applicant’s career development
• Have an established track record of training new / ESI faculty or fellows at the applicant’s career stage.

Applicants are encouraged to identify more than one mentor as this is often advantageous while developing sustainable programs. The applicant should seek out their mentor(s) in preparing their application. Potential applicants having difficulty identifying an appropriate mentor are encouraged to reach out to the DRPP Director, Anjana Bhat at abhat@udel.edu for assistance. Established investigators applying for DE data science, or High-end core facility or Booster awards do not need to provide a mentoring plan. Note that the high-end core facility award requires a support letter from the core facility director.

Letter of Intent Due: September 23, 2024 (11:59ET)
Full Proposal Due: October 21, 2024 (11:59ET)
Potential Awardees Notified: Mid January 2025
Just In Time (JIT) Deadline: March 3, 2025 (IRB/IACUC Approval/DUAs Due, failure to have these in place by this deadline may result in forfeiture of the award)
Grant Year begins: May 1, 2025 (contingent upon the availability of NIH funding)

Submission Requirements:

• All LOI and Application materials will be submitted using the DE-INBRE Piestar RFx system. UD applicants should log into the Piestar system using their UD credentials (via CAS SSO). Non-UD applicants must create their own username and password for the DE-INBRE Piestar RFx system. Once an account is created, an applicant can apply for any DE-INBRE funding opportunities in the future using the same log in information. The Piestar system is compatible with firewalls and security protocols at all DE-INBRE partner and affiliate organizations. If you have problems setting up your Piestar account, please contact INBRE-evaluation@udel.edu for assistance.

A Piestar Fillable Form must be submitted by September 23, 2024 (11:59 pm ET) and should include:

• A descriptive title of proposed research
• Principal investigator’s name, email address, phone number
• Mentor’s name and email address
• Names of other key personnel and participating institution(s)
• The application type: Pilot Project. Please specify the mechanism you are applying to: Take-off, Booster, High-end Core Facility, or DE Data Science Awards
• State if your project will require IRB/IACUC approvals or DUA approvals.
• A concise description of your proposed project with sufficient detail to identify expert reviewers for your proposal
• A list of 3-4 potential scientific reviewers familiar with the proposed research. These potential reviewers need not be from Delaware. Professional familiarity with the applicant is allowed, however, a potential reviewer should not have a significant conflict of interest. 
• All PIs submitting an LOI are invited to submit a full proposal.

Full proposals are due by October 21, 2024 (11:59 pm ET)

Document Formatting & Naming Requirements:

• Please upload the requested information in PDF Format specified below using currently approved NIH forms/formats. All pages must be prepared using 11 point or larger Arial, Helvetica, Georgia, or Palatino Linotype fonts (non-condensed), single (or higher) paragraph spacing, and ½ inch margins. Forms and formatting are similar to those of NIH R type, small grant proposals.
• Templates and samples for most forms are provided under Templates and Downloads
• To help keep all applications well organized, please name each document file beginning with the PI’s last name, then name of the item (e.g. duncan_sf424)
• Using the appropriate template files and file naming conventions will ensure your records stay together and will reduce the administrative burden for reviewers and research staff.

• SF424 (R&R) form provided here 

• Biosketches: (<5 pages each): in the current NIH format for PI and Key Personnel including the primary mentor, other members of the mentoring team, and collaborators who would play a significant role in accomplishing the goals of the proposal. Please review NIH Biosketch policy and consider using the Sciencv system to create the biosketches.
• Specific Aims Page (1 page): Follow guidance on Specific Aims here and here. It is recommended that ESI/new applicants work closely with their mentors on this section. This document should end with an explicit impact statement specifying why this work if successful will make a sustained impact on the field of study.
• Research Strategy (6 pages)& Bibliography (no page limit): Follow guidance on Research Strategy here and  here. It is recommended that applicants work closely with their mentors on this section which includes Significance, Innovation, and Approach (including Preliminary Data, if available). Please include the Bibliography & References Cited (no page limits) uploads with this form. Follow guidance here and here.
• Budget & Justification: Provide an itemized, detailed budget form (R&R budget form – 5 yr.) for the period of May 01, 2025 – April 30, 2026 for pilot projects.
  • Provide a written budget justification to match the items listed in the budget per these budgetary guidelines. Please work with your institution’s research contact (see contact list below) to develop your budget. 
• Undergraduate Inclusion Plan (1 page): Briefly describe your plans for engaging undergraduate students in your research including high-quality opportunities to participate in bona fide research projects in the summer or academic year during your award period. 
• A letter of Support from the PI’s Department Head/Chair: Letter should indicate the level of institutional support. The letter must include assurance that the applicant will have sufficient time available over the course of the award to participate in the proposed research program. 

• Individual Development Plan (1-2 pages): The IDP should include mentor names, applicant’s overarching career goals (broad, general, long-range statements), specific objectives in the next few years in four different career development domains: clinical, teaching, research, and leadership. Include SMART objectives that are specific, measurable, short-term actions and are designed to achieve applicant’s goals. 
• Mentoring plan letter from primary mentor (2 pages) must confirm their willingness to be a mentor and should include proposal PI (mentee) and mentor names and titles, the mentor’s past research and training record (their own research expertise and funding record, as well as the number of past mentees they trained and the mentees’ career trajectory including positions held and grant/research productivity). Explain the mentor’s understanding of the PI (mentee)’s potential for future research success and their goals for developing further expertise. In addition, describe the details of existing mentoring or working relationship (if any) and any additional specifics of the planned mentoring interactions during the funding period. Explain how the mentor will support the PI (mentee) in achieving the specific goals stated including future proposal development for NIH and other extramural funding (e.g., meeting frequency, topics covered, and grant writing guidance). Names and roles of any other mentors and their roles can also be explained. In cases where there are multiple mentors or a mentoring team, this letter should indicate each mentor’s full understanding of their role and commitment to the PI’s research progress.

• Letter(s) of Support from Core Directors or Collaborators, if applicable. For high-end core facility award applicants, the relevant core facility director must provide a letter of support explaining how the proposed technology will be incorporated within the applicant’s research agenda.
• Plans for Vertebrate Animal Use, if applicable (no page limits): Follow guidance provided here, for this section. See specific bullets under Additional Specific Details.
• Human Subjects Clinical Trials Forms, if applicable: Follow guidance provided for Form G, for this section. Use the PHS Human Subjects and Clinical Trials form provided here.
• Plans for Human Subjects Research, if applicable (no page limits): Follow guidance provided here and here. See specific bullets under Additional Specific Details. Upload this file in the Human Subjects Clinical Trials Form pdf.
• Statement of success from prior awards (1 page), if applicable: PIs who have led a project supported by CTR, DE-INBRE, COBRE grants should include a progress report on the prior work, including their success in leveraging that research into independent external support and explaining why further support is necessary.

Applicants will be expected to submit itemized budgets at levels that reflect justified projected needs up to and not exceeding: 

      Pilot Projects ($40,000 for 1 year): $40k in direct costs for the funding period of one year. 

• A typical DE-INBRE Project will provide support for undergraduate or graduate students or a postdoctoral fellow, and appropriate amounts for:
  • PI summer salary (i.e., buyout of PI salary is permitted). However, institutional policies and employee expectations vary across DE-INBRE institutions. Therefore, petitions for PI salary buyout will be reviewed on a case-by-case basis by the RDC. RDC recommendations will be forwarded to the DE-INBRE PI, Dr. Melinda Duncan (duncanm@udel.edu) for final decision with oversight and review by the DE-INBRE External Advisory Committee (EAC) and, as appropriate, NIH Program Officials.
  • Supplies
  • Travel
  • Use of DE-INBRE affiliated centralized core facilities and/or data science resources.
  • Contractual or consultative work (if applicable)

DE-INBRE Pilot Project awards are designed to provide funding for 12 months. After that, early stage/new investigators could apply for Research Project awards that provide funding for 2 years. 

Reporting Requirements

DE-INBRE investigators are required to sign agreements that set out the conditions of their award. Investigators must submit research reports and financial updates at intervals outlined in their agreements and provide periodic updates on career progress after the completion of DE-INBRE support. In addition, they will be required to participate in DE-INBRE professional development events and program evaluation activities. They will be required to present posters and/or talks at External Advisory Committee Meeting(s), and the DE-INBRE research conference to be held in Spring 2026.

Protections for Human Subjects:

• For research that involves non-exempt, human subjects research (see 45 CFR Part 46), the investigator should discuss the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five criteria: risk to subjects, adequacy of protection against risks, potential benefits to the subjects and others, importance of the knowledge to be gained, data and safety monitoring for clinical trials
• For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the applicant should discuss: the justification for the exemption, human subjects involvement and characteristics, sources of materials.
• More guidance is provided here and here.

Inclusion of Women and Minorities: Applicants must detail how they will assure that women and minority groups are included in any clinical research in a manner that is appropriate to the scientific question under study.

• Follow guidance here.

Inclusion Across the Lifespan: To comply with the NIH’s Inclusion Across the Lifespan Policy, applicants must explain how they will ensure that individuals are included in clinical research in a manner appropriate to the scientific question under study so that the knowledge gained is applicable to all those affected by the condition.

• Follow guidance here.

Planned Enrollment: Use the planned enrollment table format provided in the Human Subjects and Clinical Trial Form.

Plans for Vertebrate Animal Use, if applicable:

• The vertebrate animal use justification and protection section should cover:
  • Description of Procedures: Provide a concise description of the proposed procedures to be used that involve vertebrate animals. Identify the species, strains, ages, sex and total number of animals by species to be used. If dogs or cats are proposed, provide the source of the animals.
  • Justifications: Provide justification that the species are appropriate for the proposed research. Explain why the research goals cannot be accomplished using an alternative model (e.g., computational, human, invertebrate, in vitro).
  • Minimization of Pain and Distress: Describe the interventions to minimize discomfort, distress, pain and injury. These include analgesia, anesthesia, sedation, palliative care and humane endpoints.
  • Euthanasia: State whether the method of euthanasia is consistent with the recommendations of the American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals. If not, describe the method and provide a scientific justification. Follow guidance provided here, for this section.

For general application questions please email DRPP Director, Dr. Anjana Bhat (abhat@udel.edu)

See a list of support contacts here:

Institution-Specific Program Contacts

Type of Support	Contact Name	Email
Piestar RFX System Support	Linda Polasko	lpolasko@udel.edu
Christiana Care Health System
Research Contact, Application Assistance (Forms, Rules)	Ross Budziszewski	ross.budziszewski@christianacare.org
Budget, Allowable expenses	Mary Thomas	mary.thomas@christianacare.org
EHR/Data Science/Core Facilities	Claudine Jurkovitz	cjurkovitz@christianacare.org
IRB Approval	Institutional Review Board	IRBOffice@christianacare.org
Delaware State University
Grant writing mentoring	Hacene Boukari	hboukari@desu.edu
Grant writing mentoring	Hakeem Lawal	hlawal@desu.edu
Grant writing mentoring	Melissa Harrington	mharringon@desu.edu
Research Contact, Application Assistance (Budget, Forms)	Rohina Niamat	rniamat@desu.edu
IRB/IACUC approval	Chanel Haman	chaman@desu.edu
Core Facilities	Michael Moore	mmoore@desu.edu
Nemours Children’s Hospital
Grant writing mentoring	PI Mentoring Program	mentoring@nemours.org
Director, Mentoring Program & DE-INBRE Proposal Approver	Robert Akins	robert.akins@nemours.org
Research Contact	Ranita Chakrabarti	ranita.chakrabarti@nemours.org
Core Facilities	Heather Hardy	heather.hardy@nemours.org
University of Delaware
Grant writing mentoring / Application assistance	Anjana Bhat	abhat@udel.edu
Research Contact, Budget and Forms	Dawn Everhart	dawnm@udel.edu
IRB Approvals	Humans Subjects Review Board	hsrb-research@udel.edu
IACUC Approvals	Eric Hutchinson and Julie Hoffman Forms available on Research office web site https://research.udel.edu/	UD-IACUC@udel.edu
Core Facilities	Jeffrey Caplan	jcaplan@udel.edu
Wilmington VA
Application assistance & VA procedures	Suzanne Milbourne	suzanne.milbourne@va.gov

Please see a list of resources here.

For examples of applications and components, please email DRPP Director, Anjana Bhat, abhat@udel.edu directly.

If you still have a question don’t hesitate to email us at info@de-inbre.org and we will direct your question to the direct source!

• Written Resources
  • Sample Proposals can be found here
  • NINDS Grant Writing Pages & NIAID Grant Writing Pages
• Video-based Training
  • NIH Grants Fundamentals
  • NIH Grant Application Tips
  • SuRE Grant Writing Resources A & SuRE Grant Writing Resources B
  • JIN Youtube Podcasts – Grant Writing Tips & Tricks & DE-CTR-ACCEL Career Development Zone

• Other Blogs & Websites
  • Edge for Scholars

• To join the Junior Investigators’ Network (JIN), please email Erin Riegel (erin.riegel@nemours.org)

To download a template or sample form please click below:

• Proposal Checklist
• SF424 Template
• Biosketch Template
• Biosketch Sample 1 & Biosketch Sample 2
• R&R Budget Form Template
• Budget Justification Template
• Undergraduate Inclusion Plan Sample
• Chair Letter of Support Template
• Individual Development Plan (IDP) Template & Individual Development Plan (IDP) Sample
• Mentor Plan Letter Template & Mentor Plan Letter Sample
• PHS Human Subjects and Clinical Trials Form Template
• Statement of Success from Prior Awards Sample

Clinical Trials Forms & Templates:

• Study Record Form
• Study Record Form Example
• Study Record Form Uploads
  • Human Subjects Section
  • Single IRB Plan
  • Data Safety Monitoring Plan
  • Inclusion of Individuals Across the Lifespan
  • Inclusion of Women and Minorities
  • Recruitment and Retention Plan
  • Study Timeline
  • Resource/Data Sharing Plan
  • Structure of the Study Team
  • Statistical Design and Power
  • Dissemination Plan

View our zoom info sessions here:

RFA Overview Recording & Presentation PDF

Template Overview Help Session Recording & Presentation PDF

Clinical Trials Forms Help Session Recording & Presentation PDF