2021 Call for Pilot Projects

Purpose

The goal of the ALLIANCE Pilot Projects Program (PPP) is to increase the number of underrepresented scientists in clinical and translational research dedicated to the study of health conditions affecting a Hispanic population. The objective of the PPP is to increase the cadre of underrepresented minorities (URM), independent investigators, by advancing their development in clinical and translational research with an emphasis on community. The PPP will address the objectives of the IDeA-CTR in sustaining the collaboration and coordination of clinical and translational research and addressing health conditions prevalently affecting the medically underserved Hispanic population in Puerto Rico (PR). The PPP will also help implement the Alliance objective to integrate basic, clinical, and translational research among the Alliance partners, collaborating partners, and IDeA state organizations. The PPP will facilitate access to resources, mentorship, and technology for the success of the URM investigators in transitioning into independent researchers. This call provides the guidelines and evaluation criteria for research proposal submissions.

 

Research Scope

 

However, other conditions relevant to our Hispanic population can be submitted. This year we are prioritizing research studies on the topic of Emerging Infection COVID-19.  Studies using short interventions to obtain preliminary data aimed at future larger interventions to decrease an established health disparity need to comply with NIH Clinical Trials new definitions and registration at the clinical trials site.

 

Available Support

Seven (7) pilots will receive up to $50,000 for a one-year study. Two (2) pilots may be extended to a second year with adequate justification. At least one award will involve community engagement.

 

 

Eligibility

• PIs may be junior faculty (early stage and new investigators) or an established investigator embarking into a new area of clinical and translational research that is different from their previous research. Individuals holding postdoctoral fellowships or other positions that lack independent status are not eligible to lead pilot projects. The PI of the pilot project should not have concurrent research funding from other IDeA Program award mechanisms (e.g., INBRE, COBRE). For more information, please contact antonia.ortiz@upr.edu)
• A committed and experienced mentor for the PI’s career development must be identified. All projects must have a research approach and a career development plan and may not overlap with ongoing funded projects. The career development plan should represent the work between mentor-mentee. Distant mentoring for special areas of interest is encouraged; however, the PI must have a local mentor and a detailed career development plan.
• All mentors/co-mentors must submit a letter of support specifying detailed mentoring activities, and their biosketch.
• Projects should be about health issues that the Alliance has targeted as affecting the PR population.
• Clinical research is strongly encouraged and will be prioritized. Projects must include collaborations among basic, clinical (including behavioral), and/or translational scientists. Community projects must be community-based, and must include community and academic partners, and Community Engagement.
• Collaboration among other institutions of the Alliance is highly recommended and will be prioritized. Other collaborations with the Alliance partners are encouraged.

Important Dates

• PPP Call for 2021-2022: March 1, 2021
• Deadline for Concept paper submission (including submission to regulatory committees): March 21, 2021
• Invitation to submit a 6-page pilot project: March 26, 2021
• Invited pilot project submission deadline: April 18, 2021
• Evaluation Process: April 19- May 10, 2021
• Earliest date to start: July 2021

If you are invited to submit a Pilot Project be ready to submit the following documents

Page Order

All Pilot Project applications must adhere to the following page order and specifications. Those applications that do not follow these specifications will be returned without review.

Use the most recent NIH format

1. Face page (Form Page 1)
2. Index Page
3. Cover page with abstract (Form Page 2)
4. Budget (Form Page 4) and detailed budget justification (2-3 pages). Only direct funds can be requested. Funds may cover up to 20% of the PIs time, up to $20,000 for a technician or study coordinator’s salary, expenses associated with research procedures, and/or for on-site and off-site visits. Travel to scientific meetings to present an abstract is limited to domestic travel and should not exceed $2,500.  Medical and/or lab supplies directly related to the proposed study are allowed.  Request for equipment requires a quote, proper justification, and plans for future use once the project is completed. (For advice please contact antonia.ortiz@upr.edu).
5. Biographical Sketch, (BS) latest version, not exceed 5 pages for each person. All BS for key personnel and collaborators should follow the NIH format
6. Research Plan (6pages) Specific Aims (1 page)- Should include a brief description of the knowledge gap to be filled with the proposed project, list the goals and the specific research outcomes it intends to accomplish, state the hypothesis to be tested. State the relevance the proposed project has it related to the health conditions in Hispanics. Significance, preliminary studies (scientific premises), and Innovation(1-2 page)- This page should include one paragraph regarding the significance of the proposed study and its relevance to health conditions in Hispanics; and a paragraph explaining how the proposed project is innovative. Approach, Research Design and Research Timetable (1½-2½pages)–Describe the experimental approach for each aim proposed including the methods (data collection) and statistical analysis (including interpretation). Include a section of pitfalls and alternative strategies. A timetable for the proposed project is required and should include plans for abstract presentations and/ or peer-reviewed manuscript submission, and submission of NIH or equivalent funding grant.
7. Structured Career Development Plan (1½pages)–  Describe the career development activities to be performed, including methods and evaluation of outcomes. Also, include a justification regarding the plan and the objectives of the proposed pilot project and future directions.
   -All PIs must work with a mentor.-All PIs need to submit a Career Development Plan previously discussed and approved by the mentor. This plan is equivalent to an NIH K award career development plan.-A timetable and outcome measures should be clearly delineated in the plan. This timetable can be joined with the research timetable.-A  paragraph describing how this project will lead the investigator to independent funding must be included.
8. Bibliography and References Cited
9. Human Subjects Section, if applicable.
10. Vertebrate animals
11. Targeted/Planned Enrollment Table, if applicable.
12. IRB or IACUC, Institutional Biosafety Committee, and Good Clinical Practice (as applicable) Submit approval letter or evidence of submission. If the proposal consists of multiple institutions, it should have the reciprocal IRB or dual approval from the primary institution and UPR-MSC. (For advice please contact adelma.rivera@upr.edu).
13. Training Certifications All investigators must submit certifications for training in Human Subject Protection, HIPAA & GCP.  If the project involves infectious material (i.e. clinical samples, bacterial strains, etc) or animals the investigators must also submit training certificates for Biosafety and/or & IACUC training as applicable.
14. Multiple PD/PI Leadership Plan (if applicable)
15. Resource Sharing Plans (including data sharing, model organism sharing, and genome-wide association study [GWAS], if applicable).
16. Letters of Support of Mentors, Key Personnel, and Consultants.

Review Process

All research proposals will be reviewed by two to three independent reviewers using the NIH scoring protocol to evaluate:

• Significance of the study
• Innovation
• Approach
• Environment
• Investigators
• Collaborations
• Career development plan
• Impact on human health and health conditions in  Hispanics
• Potential to lead to independent funding

All proposals will have at least two peer-review and will be discussed by the Alliance PPP evaluation committee. The proposals with the higher scores will be sent to NIH-NIGMS for final approval. Incomplete applications will not be reviewed.

 

Commitments between the PI,  Mentors, and the Alliance PPP

1. Participation in the Professional Development Core Grantsmanship courses designed for the PPP awardees.
2. Participation in Alliance Scientific Day.
3. Participation in progress meetings: A face-to-face or tele-video conference will be scheduled with the PI, mentor, PPP leadership, and representatives of the PDC and CoE (in case of CE project) to discuss the progress and potential problems. These meetings will be scheduled before the implementation of the study and biannually.
4. Submit progress reports: All PIs will be required to submit a written progress report in the NIH format, including career development activities, at least 2 months before the end of first-year funding period and at the end of the 2nd Year funding period (if applicable). The PPP and PDC leadership (including PPP Advisory Committee) will meet annually to discuss the progress reports and make recommendations.
5. All PIs will comply with ethical guidelines and oversee the regulatory aspects of their projects (monitoring data collection and storage, updated CITI program training/certificates, active IRB and IBC committee approvals, and safety in clinical research projects). In the event of identifying problems in a project, the PPP leadership and Research Subject Advocate will develop a plan to overcome these and follow accordingly.
6. PIs will provide information regarding productivity to the TEC.
7. The PI’s mentor will participate in the Mentor’s Meetings/ Retreats and other activities. Mentors will agree to participate in a brainstorming meeting with PDC and PPP cores twice a year to discuss their experiences, potential issues, and the need of further training.
8. PIs will participate in the frequent periodic informal telephone meetings with the PPP leaders to discuss progress and challenges.
9. Participate in a Mock Study Section Process.
10. Present the study at a local/ regional/ national scientific meeting.
11. Submit at least one peer-reviewed manuscript with the collected data.
12. Submit at least one research grant for external funding using the generated data.
13. Complete Reporting Activities:
    a) Comply with the mid-year and final research progress report.
    b) Comply with the annual research progress performance report for NIH.
14. Administrative & Monitoring Activities:
    a)   Participate in the Awardees Initiation and Exit Meeting.
    b)   Participate in the Alliance Evaluation Core metrics across the supported years
    c)  Attend other PPP activities for PIs and Mentors.

Inquiries

While preparing your research proposal, we highly recommend you seek advice with the Alliance Core Staff, as needed

We thank you for your interest in the Pilot Project Program. If you need further information and assistant, please contact:

Valerie Wojna, MD	Core Leader	valerie.wojna1@upr.edu
Evangelia Morou, DDS	Core Co-Leader	evangelia.morou@upr.edu
Michelle Martinez, PhD	UCC Co-Leader	michelle.martinez@uccaribe.edu
Martin Hill, PhD	PHSU Co-Leader	Mhill@psm.edu
Julio Benabe, MD	Research Associate	julio.benabe@upr.edu
Antonia Ortiz, BS, MT, CHS	Core Coordinador	Antonia.ortiz@upr.edu, 787-759-0306 Ext. 227
Adelma Rivera	Research Subject Advocate	adelma.rivera@upr.edu