Notice of Funding Opportunity Developmental Pilot Project

Alaska IDeA Network of Biomedical Research Excellence (Alaska INBRE)

Announcement Date: October 28, 2024 Recommended Letter of Intent Due: December 2, 2024 Submission Date & Time: February 6, 2025 at 5 pm AKT

Award period: 1 year

Budget total = up to $50,000 Awards Announced pending NIH Approval: July 2025

Funding Period: August 2025 - July 31, 2026*

*Award dates and funding period are contingent on funding of the pending Alaska INBRE renewal

application.

Section I. Funding Opportunity Purpose/Description

The Alaska IDeA Network of Biomedical Research Excellence (AK INBRE 5), supported by a grant from the National Institutes of Health, provides awards to build biomedical research and training capacity within the AK INBRE network. The Developmental Research Pilot Program (DRPP) accepts applications from partner institutions for Developmental Pilot Project (PP) awards with goals to support biomedical research and training in the AK INBRE network and to train undergraduate students through active participation in meaningful research. AK INBRE 5 maintains a One Health theme to promote interdisciplinary and clinical and translational research collaborations to address Alaska’s needs for enhancing the health of individuals, families, and communities. PP awards may support any compelling topic in basic, applied, translational, or clinical biomedical or behavioral health research. Projects that are collaborative are strongly encouraged. PP awards may also support projects that will lead to applications for more expansive work, such as development of IRB protocols, Tribal review, and community engagement necessary for broader community-based participatory research (CBPR) projects.

Investigators are encouraged to work with Alaska INBRE Core Resources in the development of their research application and take advantage of the resources available in the Alaska INBRE network. Letters of Intent are recommended, particularly for any projects that seek mentorship from the CBPR Core, such as on identifying appropriate communities, hearing from communities about their research priorities, sharing research ideas or findings with community members, or including community members in the research process. Additional core resources are available through the Regional Alliance of INBRE Networks (RAIN). Use of RAIN resources is encouraged when services are not available in Alaska at this link.

PPs include a research mentoring component and support for a research mentor with a record of NIH or other federal biomedical funding and domain-specific research experience.

Section II. Award Information

Award Budget. AK INBRE 5 PPs will provide up to $42,000 for a one-year biomedical or behavioral project, with an additional $8,000/year available to PPs that include support for one or more undergraduate student researchers.

Renewal awards: Pilot project leader (PPL) awardees may apply for successive awards.

Section III. Eligibility Information

Eligible Organizations - Must be part of the 6 Alaska INBRE partner institutions.

Eligible Individuals - The PP leader, preferably early-stage investigators (ESIs), must have a full-time faculty appointment (tenure-track & research faculty) at a partner college or university or serve as a full-time investigator at SCF or ANTHC at the time of award. Collaborating investigators with activity/supplies included in the budget may be from any institution within an NIH IDeA state. Established investigators pursuing new areas of inquiry, such as recipients of R-series awards, are eligible for AK INBRE 5 DRPP awards. Potential applicants are encouraged to contact the AK INBRE 5 PC or PD/PI to confirm their eligibility and to discuss project plans prior to submission. Per NIH rules, PP leaders (PPL) are required to have 3-months of effort towards research during the 12-month grant year.

PPLs will be eligible to compete for successive DRPP awards using the following guidelines as applied during EAC review: PPLs are expected to include undergraduate students in their research, show they have disseminated the conceptual basis of the research and/or preliminary results in a poster or oral presentation at a professional meeting or students have presented work at either a local or external meeting.

Applications for multi-disciplinary studies with a collaborator at an AK INBRE network institution or an IDeA eligible state are encouraged; however, each PP must be led by a single project leader at the awardee or network institution.

COBRE, INBRE and IDeA-CTR Research and Pilot Project leaders are not eligible for simultaneous research funding from two IDeA programs

.

Section IV. Application and Submission Information

LETTER OF INTENT (recommended)

Alaska INBRE will accept letters of intent (LOI) for this funding opportunity for investigators wishing initial feedback on their research ideas and target mechanisms. The LOI is not required or binding and does not enter into the review of a subsequent application. AK INBRE 5 leadership and/or the INBRE External Advisory Committee (EAC) members will reply with feedback on the appropriateness of the research area for support through this mechanism. A two-page LOI should include the following:

• Descriptive title of proposed research
• Anticipated aims and approaches
• If applicable: any aspects of the proposed project that address community priorities or engage community members, including sharing study ideas or findings with community members, asking for input from community members, or having community members guide the project
• How the work if funded will lead to applications for independent research support
• How the work will meaningfully include undergraduate students in research
• Participating institutions
• Name, address, and telephone number of the principal investigator(s)
• Names of other key personnel

The LOI can be uploaded no later than December 2nd at this link. Navigate to the Mod 24 Pilot Project Letter of Intent. Click Learn More and Apply, Apply Now, and the system will prompt you to create an account unless you have a Piestar account from previous INBRE reporting. Create your account, answer the questions, and upload the document with the following naming scheme: “LOI Mod 24 PP PI Last Name”. For more information, contact Julie Benson at jcbenson@alaska.edu.

APPLICATION

1. Applicants will use the NIH ASSIST system to assemble PP applications responsive to NIH review criteria of Significance, Innovation, Approach, Investigator, and Environment. The PP application should be formatted and assembled in ASSIST as an R03 application (see PA-20-200 (Clinical not allowed)). A complete application will include all sections noted in the solicitation, including a Data Management and Sharing Plan (DMSP), and be exported to a single PDF file through the ASSIST “preview application” function.

The application forms package specific to this opportunity must be accessed through ASSIST.

1. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations

All page limitations described in the SF424 Application Guide and the NIH Table of Page Limits must be followed.

1. Submission dates & times - see the information provided at the top of this document.

2. APPLICATION INSTRUCTIONS:

Applicants must follow the instructions for current SF424 forms and upload the following sections in ASSIST:

Research Strategy

Include year 1 project milestones. Preliminary data are not required for PP applications.

Other Attachment: AK INBRE 5 specific section

1. Explain how your research project expands biomedical or health research and undergraduate student training opportunities within the AK INBRE network and builds research and undergraduate student training capacity: a) How will your research project include students engaged with the AK INBRE 5 Student Research Program (SRP)? b) Will your project use resources or training available within the AK INBRE 5 Data Science Core, Research Analytics Core and/or Community-Based Participatory Research (CBPR) Core?
2. Explain how your project is relevant to NIH and develops further expertise in alignment with the One Health aims and initiatives of AK INBRE 5;
3. Explain how the research accomplishments will lead to peer-reviewed publications and potential submissions of proposals for independent, extramural grants;
4. Explain how the project is, or can lead to, research that is translational in nature, CBPR in nature, and/or how the project will impact people in Alaska;
5. Summarize your outcomes and products of any prior AK INBRE research support. Include all support: project, travel, bioinformatics, exceptional request, GRA for your students, etc.

Other Forms: R & R Budget & Budget Justification

AK INBRE 5 PPs will provide up to $42,000 in direct costs per year for a one-year biomedical or behavioral health research project. An additional $8,000/year is available to PPs that include budget support for one or more undergraduate student researchers at a minimum of 10 hours/week/student. Students may be recruited independently or in collaboration with the AK INBRE Student Research Program, where students may participate as URA Scholars (see Student Research Project, Specific Aim 2). Student participation in projects must be included in annual project reporting.

Submit a detailed budget justification AND your institutional budget spreadsheet. Please note: Do not include indirect costs on these awards in your budget forms.

University of Alaska System (UAF, UAA, UAS) applicants - your home department will be distributed 2.5% of your institution’s F&A rate towards the overhead of administering your research project. At the time of award, the INBRE Fiscal Officer will set up this distribution and notify your department head of the incoming revenue to cover overhead.

Iḷisaġvik College, ANTHC, and SCF applicants – Indirect costs are based on your institution’s negotiated

indirect cost rate agreement.

Helpful Budget Hints:

1. Describe how you will meet the 3-month (as applicable) commitment to research, trainee mentoring, and professional development.
   1. Use only calendar months OR academic year and summer months but not both. NIH identifies one month as 160 hours.
      1. Include costs for your mentor (see Section IV)
         1. Covering tuition for a graduate student is “tuition remission” in NIH terminology; please use this terminology.
         2. Include costs for travel and publication fees to disseminate results including travel for student/trainees.
            1. Honorariums, stipends, scholarships, participant support costs, and foreign components are unallowable costs.
               1. Data management plan form.

Budget questions? Contact INBRE Fiscal Officer Sarah Garcia via email ssgarcia@alaska.edu.

Letter of support from your supervisor

Applicants must include a letter from their supervisor (typically an administrator with authority to approve workload) to ensure that their workload distribution for research will be compatible with expectations if an INBRE award is made. PP leaders may only be supported by a single NIGMS project at a given time.

Letter of support from a research mentor

Each PPL must have a mentor with expertise relevant to the proposed research, a willingness to mentor the project leader, and who may be a collaborator on the project, unless the awardee is already senior faculty/researcher experienced in leading NIH research projects. A letter from your research mentor must be provided at time of submission (Section VI) and will be confirmed by the EAC chair as having the appropriate research expertise and experience with NIH (or other federal) funding.

Human Subject Section

Attach the required documentation as needed and per instructions.

Submit the ASSIST preview that includes sections as a single PDF via this link. Navigate to the Mod 24 Pilot Project, click Learn More and Apply, and apply now. The system will prompt you to create an account unless you have a Piestar account from previous INBRE reporting. Create your account, answer the questions, and upload the single .pdf document. If you have any questions regarding submission, please contact Associate Director Julie Benson. PDF FORMAT IS REQUIRED. Save the ASSIST preview file as follows: “researcher(s) last name MAU/Partner Institution Mod-24 PP app.” Examples: Smith UAS Mod-24 PP App; Turner ANTHC Mod-24 PP App. If you have any questions regarding the file name or format, please contact Alaska INBRE Associate Director Julie Benson at jcbenson@alaska.edu.

This is an internal application. Institutional signatures are not required at this time. If your application is selected to move forward to NIH, institutional signatures will be obtained as a JIT (just in time).

Section V. Application Review Information

REVIEW PROCEDURES & CRITERIA

Applications that are complete will be evaluated for scientific and technical merit by independent scientific expert reviewers in accordance with and by the EAC using NIH peer review criteria.

Step 0: Early submission is encouraged. If submitted before January 30, 2025, at 5 pm AKT, an administrative review will be conducted and feedback on completeness and compliance to directions will be provided no later than 5pm February 3rd so that corrections can be made in advance of the 5pm February 6th deadline.

Step 1: Submission deadline is February 6, 2025 at 5pm AKT. All submissions will receive an email

confirmation of receipt within 24 hours of submission.

Step 2: The proposal will be externally reviewed by two reviewers. These reviews are returned to the INBRE PI prior to distribution to the INBRE External Advisory Committee (EAC).

Step 3: The INBRE EAC will review and rank the proposals and make recommendations to the AK INBRE 5 leadership.

Step 4: The AK INBRE 5 leadership will select proposals that will be forwarded to NIH for final review from those determined to be meritorious by the EAC.

Step 5: NIH will review and approve the proposals for funding.

Step 6: Upon confirmation from NIH, Alaska INBRE will fund the selected pilot projects.

SELECTION PROCESS

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended DRPP project applications. Priority will be to fund highly-ranked proposals that will promote the professional development of the Project Leader, are in alignment with INBRE’s aims, demonstrate collaboration, are not funded by other sources, and most likely will lead to extramural funding. Preference will be given to those engaged in One Health research, those who present findings at national meetings, and those who plan publications in peer reviewed journals. All proposals will be reviewed externally by subject experts and their comments will be made available to applicants.

Only highly-ranked applications that are complete (Section IV) and contain all required information including, if applicable, IACUC approval letter and Vertebrate Animal Section, or IRB approval letter, PHS Human Subject and Clinical Trials Information, and CITI certificates can be submitted to NIH for approval. Applications that include animal or human subjects research per the face page (section 4 or 5) must provide IACUC and/or IRB approval letters by April 15, 2025, unless the projects are developmental with specific aims to secure IRB and/or Tribal approval.

Section VI. Award Administration Information

AWARD CONDITIONS

Pilot project recipients will provide a substantive report of research progress in August 2026, which will be reviewed by the INBRE EAC. Pilot Progress Reports are due in April each year for submission in the AK INBRE annual progress report. Additional reporting details will be provided in the award notification.

By submitting an application for an Alaska INBRE 5 PP, you agree to the following expectations: AK INBRE 5 DRPP-supported projects will be an investment that should result in meaningful research and training opportunities in the network. PP awards are investments in Alaska’s biomedical research capacity.

Though it is not expected that PP support will necessarily lead to extramural research funding, we will encourage PPLs to develop action plans to apply for external funding, as growing the number of independent investigators will build additional network research and training capacity. PPLs will be encouraged to apply for awards such as SuRE (R16), AREA/REAP (R15), R03, R01, and other awards as appropriate.

All PPLs will be required to complete the Mentoring Undergraduate Students self-paced course offered by the NIH-supported National Research Mentoring Network (NRMN) prior to the award start date.

All training including the responsible conduct of training required at your institution must be completed in the first month of work performed.

Presentations (oral or poster) and publications must include the following acknowledgment and disclaimer:

“Research reported (on this poster/in this publication) was supported by an Institutional Development Award (IDeA) from the National Institute of General Medical Sciences of the National Institutes of Health under Award Number P20GM103395. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.”

The PPL must implement the planned activities outlined in the budget section of the application. The expenditures and activities must adhere to applicable NIH rules and regulations that will be listed in the award letter and adhere to institutional policies. Failure to progress reasonably throughout the year of funding could result in dollar reallocation or reduction. All funds must be appropriately expended within the requested time frame. Per NIH rules, carryover is not allowed.

Failure to comply with prior or current award conditions will render the researcher ineligible for one year to apply for future INBRE funding.

MENTORS

Each PPL must have a mentor with expertise and a record of NIH or other federal biomedical funding relevant to the proposed research, a willingness to mentor the project leader, and who may be a collaborator on the project. The mentor letter of support must be provided at time of submission (Section IV) and if recommended for funding will be confirmed by the EAC chair as having the appropriate research expertise and experience. Mentors may be from the AK INBRE 5 network or from outside institutions and serve to help oversee the proposed research and professional development. Mentors can aid in the development of hypotheses, research design, and methodology relevant to the investigator’s research, and provide technical training in their laboratory, if appropriate. Mentors will be expected to mentor pilot project leaders and review manuscripts and proposals.

Prior to award, the PPL and mentor will develop a mentoring plan describing their scientific and developmental goals, meeting frequency and the types of collaborative input will be generated. Mentor costs of $2000 each budget period (plus additional costs if needed) must be included in the submitted project budget. Mentor costs may include travel between the project leader and mentor’s institutions, salary support for the mentors (if in an IDeA state), and other mentoring plan support. AK INBRE will request a report from the mentor and addressed to the AK INBRE PI that describes the scientific progress and professional development of the project leader and any associated challenges.

Section VII. Program Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

PI/Director Brian Barnes

Co-Investigator & INBRE 5 Program Coordinator Jason Burkhead Associate Director Julie Benson

Fiscal Officer Sarah Garcia

Student Research Program co-Directors Kristin O'Brien Jonathan Stecyk Holly Martinson CBPR Core Co-Directors Stacy Rasmus Katie Cueva

Research Analytic Core co-Director Patrick Tomco Matthew Wooller Devin Drown Data Science Core Director Devin Drown

Section VIII. Other Information

CONFLICT OF INTEREST

Alaska INBRE follows the NIH Guidelines for Conflict of Interests.

UA is an affirmative action/equal opportunity employer, educational institution and provider and prohibits illegal discrimination against any individual: www.alaska.edu/nondiscrimination.