National Institutes of Health (NIH)

(CLOSED) RFA-AI-22-076: Consortium for Food Allergy Research: Clinical Research Center (U01 Clinical Trial Required)

Slots: 1

Deadlines

Internal Deadline: Contact RII.

LOI: 30 days prior.

External Deadline: June 9, 2023

Award Information

Award Type: Cooperative Agreement

Estimated Number of Awards: NIAID intends to commit a total of $12.1 million in FY 2024 to support all the activities of the Consortium for Food Allergy Research Program. This $12.1 million includes funding for: 1) 12 awards for CoFAR CRCs at an estimated $400,000 per award, and 2) through the companion FOA, the support for one award for the CoFAR Leadership Center.

Anticipated Award Amount: Costs should be appropriate to the needs of the proposed project(s). This includes funding for: 1) personnel time to partially support CoFAR network-wide clinical research projects, 2) personnel time and other costs for the proposed CRC-specific research project(s).

Who May Serve as PI: Standard NIH requirements.

Link to Award: https://grants.nih.gov/grants/guide/rfa-files/RFA-AI-22-076.html

Process for Limited Submissions

PIs must submit their application as a Limited Submission through the Research Initiatives and Infrastructure (RII) Application Portal: https://rii.usc.edu/oor-portal/. Use the template provided here:

RII-Limited-Submission-Application-Template.

Materials to submit include:

(1) Two-Page Proposal Summary (0.5” margins; single-spaced; font type: Arial, Helvetica, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 2-page limit will be excluded from review. You must use the template linked above.
(2) CV – (5 pages maximum)

Note: The portal requires information about the PIs in addition to department and contact information, including the 10-digit USC ID#, Gender, and Ethnicity. Please have this material prepared before beginning this application.

Purpose

CoFAR is a clinical network consisting of two distinct entities, the CoFAR Leadership Center (LC) and the CoFAR Clinical Research Centers (CRCs). The two entities will work collaboratively to conduct network-wide, ground-breaking clinical research projects in the areas of prevention, therapy, and understanding of the mechanisms of food allergy. The CoFAR-LC will provide leadership, overall strategy, and support for the network-wide clinical research projects. The CoFAR-CRCs will execute all network-wide clinical research projects.

It is expected that CoFAR will conduct at least two network-wide clinical research projects. At least one of these projects will be a therapeutic or preventive clinical trial. Both the CoFAR-LC and the CoFAR-CRCs will propose network-wide clinical research projects. Once CoFAR is formed, these proposals will be considered by the CoFAR Steering Committee and those to be executed will be chosen by the CoFAR-LC PD(s)/PI(s). The network-wide clinical research projects that the CoFAR will conduct will require approval by NIAID, which will consider programmatic priorities in its decision.

Each CoFAR-CRC will propose one network-wide clinical trial or observational study. In addition, each CoFAR-CRC will conduct one or two center-specific research projects.

The scope of the network-wide, multi-center clinical trial or observational study the CoFAR-CRC will propose includes but is not limited to:

Therapeutic or preventive trials of
- Early allergenic food introduction for the prevention of IgE-mediated food allergy
- Direct or indirect manipulation of the microbiome
- Food allergen immunotherapy
- Drugs, biologics, adjuvants, or devices for the management of food allergy conditions
- Combinations of the above
Studies to improve the diagnosis of food allergy aiming at replacing oral food challenges
Studies to accurately assess the incidence and prevalence of food allergy conditions in diverse populations, in the US
Studies examining the interactions between immunologic, microbial, environmental, and genetic or epigenetic factors underlying the development of food allergy conditions
Studies of molecular mechanisms associated with the development and clinical presentation of food allergy conditions or response to therapy (targeted and/or unbiased approaches)
Studies on the mechanisms underlying severe allergic reactions

The center-specific research projects the CoFAR-CRCs will conduct can be a non-therapeutic observational study, a clinical mechanistic study, or a laboratory study utilizing new or existing human biosamples. The center-specific project should involve junior faculty investigators in key roles whenever possible. Clinical trials per the NIH definition (https://grants.nih.gov/policy/clinical-trials/definition.htm) are not allowed to be proposed for center-specific research projects. One of the goals of the center-specific research projects is to provide pilot data to inform potential larger, future CoFAR network-wide projects and to assess various aspects of the presentation of food allergy in diverse populations.

The scope of center-specific research projects includes, but is not limited to:

Small scale investigations of mechanisms related to response to oral food challenges
Development of biomarkers for the diagnosis of a particular food allergy condition or for predicting severity of food reactions
Analysis of samples obtained prospectively from protocols funded by other sources or clinical samples obtained under IRB approval
Analysis of existing data sets or samples available to the site
Electronic Health Record research on food allergy conditions
Development of a new laboratory methodology with direct clinical implications
Qualitative assessments to investigate practices/ perceptions/ behaviors as they pertain to various food allergy conditions

Applicants may submit to both the CoFAR Leadership Center (RFA-AI-22-077) and the CoFAR Clinical Research Centers. However, an applicant must propose different network-wide clinical trials in each of the two applications.

Applications that propose the following topics will be considered non-responsive and will not be reviewed

Research conducted in animals or animal cells (including humanized mice)
Center-specific projects involving more than one clinical site
Center-specific clinical trials
Research on immunologic or non-immunologic food-related diseases other than IgE-mediated food allergy, FPIES, AGS, or EoE, such as celiac disease, irritable bowel syndrome, or food intolerances
Research on HIV/AIDS

Note: Foreign Components may only provide services in support of clinical study or clinical trial activities (e.g., conduct of laboratory assays). Foreign Components must not conduct clinical trials or clinical studies.

Visit our Institutionally Limited Submission webpage for more updates and other announcements.

RFA-AI-22-077: Consortium for Food Allergy Research: Leadership Center (UM1 Clinical Trial Required)

Slots: 1

Deadlines

Internal Deadline: Contact RII.

LOI: 30 days prior.

External Deadline: June 9, 2023

Award Information

Award Type: Cooperative Agreement

Estimated Number of Awards: NIAID intends to commit a total of $12.1 million in FY 2024 to support all the activities of the Consortium for Food Allergy Research. This $12.1 million includes funding for: 1) one award for the CoFAR Leadership Center for an estimated $7.3 million, and 2) through the companion FOA, the support for 12 awards for CoFAR CRCs.

Anticipated Award Amount: Application budgets should reflect the actual needs of the project. These include funding for 1) the CoFAR-LC functions, 2) The CoFAR network-wide clinical research projects including protocol-specific funds for CoFAR-CRCs and for the mechanistic studies incorporated in these projects, 3) 2 years of support to complete CoFAR-11.

Who May Serve as PI: Standard NIH requirements.

Link to Award: https://grants.nih.gov/grants/guide/rfa-files/RFA-AI-22-077.html

Process for Limited Submissions

RII-Limited-Submission-Application-Template.

Materials to submit include:

(1) Two-Page Proposal Summary (0.5” margins; single-spaced; font type: Arial, Helvetica, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 2-page limit will be excluded from review. You must use the template linked above.
(2) CV – (5 pages maximum)

Purpose

In addition to providing leadership, scientific strategy and organizational structure for the network, the CoFAR-LC will be responsible for distributing protocol funds to the CoFAR-CRCs to execute the network-wide CoFAR clinical research projects. Furthermore, the CoFAR-LC is expected to propose mechanistic research using clinical samples provided by the CRCs as part of the CoFAR clinical research projects to accelerate the translation of basic research advances into clinical applications. All research developed by the CoFAR-LC will involve human subjects.

The CoFAR-LC will propose two clinical research projects. The scope of these projects includes but is not limited to therapeutic or preventive clinical trials focusing on innovative approaches, observational human studies to improve the epidemiology and better understand the pathophysiology of food allergy conditions, and studies to improve food allergy diagnosis. Phase 3 trials are acceptable but will require strong justification and demonstration of feasibility. Focus areas might include:

Therapeutic or preventive trials of
- Early allergenic food introduction for the prevention of IgE-mediated food allergy
- Direct or indirect manipulation of the microbiome
- Food allergen immunotherapy
- Drugs, biologics, adjuvants, or devices for the management of food allergy conditions
- Combinations of the above
Studies to improve the diagnosis of food allergy aiming at replacing oral food challenges
Studies to accurately assess the incidence and prevalence of food allergy conditions in diverse populations, in the US
Studies examining the interactions between immunologic, microbial, environmental, and genetic or epigenetic factors underlying the development of food allergy conditions
Studies of molecular mechanisms associated with the development and clinical presentation of food allergy conditions or response to therapy (targeted and/or unbiased approaches)
Studies on the mechanisms underlying severe allergic reactions

Applicants may submit to both the CoFAR Leadership Center and the CoFAR Clinical Research Centers (RFA-AI-22-076). However, the two network-wide clinical research projects proposed in the CoFAR-LC application must be different than the network-wide clinical trials or studies proposed in the CoFAR-CRC application.

The CoFAR-LC will be responsible for ensuring completion of two ongoing CoFAR studies:

CoFAR-11: Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Children and Adults (https://clinicaltrials.gov/ct2/show/NCT03881696). It is anticipated that the trial will be completely enrolled by the end of the current grant and that the last patient last visit will occur by March of 2026.

CoFAR-12: Systems Biology of Early Atopy (https://clinicaltrials.gov/ct2/show/NCT04798079). This observational study is anticipated to complete recruitment in July 2023 and will continue through at least July 2026.

Visit our Institutionally Limited Submission webpage for more updates and other announcements.

PAR-21-075: Research Experience in Genomic Research for Data Scientists

Slots: 1

Deadlines

Internal Deadline: Contact RII.

LOI: 30 days prior.

External Deadline: May 25, 2023

Award Information

Award Type: Grant

Estimated Number of Awards: The number of awards is contingent upon NHGRI appropriations and the receipt of a sufficient number of meritorious applications.

Anticipated Award Amount: Application budgets are limited to $250,000 direct cost per year. The project period is limited to five years.

Who May Serve as PI: The PD/PI must be an established investigator with significant research funding from NIH (e.g. multiple research grants, a large center grant, or cooperative agreement, etc.) in genomics data science and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.

Link to Award: https://grants.nih.gov/grants/guide/pa-files/PAR-21-075.html

Process for Limited Submissions

RII-Limited-Submission-Application-Template.

Materials to submit include:

(1) Two-Page Proposal Summary (0.5” margins; single-spaced; font type: Arial, Helvetica, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 2-page limit will be excluded from review. You must use the template linked above.
(2) CV – (5 pages maximum)

Purpose

The NIH Research Education Program (R25) supports research educational activities that complement other formal training programs in the mission areas of the NIH Institutes and Centers. The overarching goals of the NIH R25 program are to: (1) complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical research needs; (2) encourage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, to pursue further studies or careers in research; (3) help recruit individuals with specific specialty or disciplinary backgrounds to research careers in biomedical, behavioral and clinical sciences; and (4) foster a better understanding of biomedical, behavioral and clinical research and its implications.

The over-arching goal of this NHGRI R25 program is to support educational activities that encourage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, to pursue further studies or careers in research. To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on:

Research Experiences: For students currently enrolled in master’s degree programs in data science (including programs in statistics/biostatistics, mathematics, computer science or equivalent fields) to provide hands-on exposure to genomics data sets as a substrate for their analytical skills. Through this announcement, NHGRI hopes to attract such students to the genomics workforce. NHGRI also seeks to both encourage data scientists who plan to opt for a terminal master’s degree to join genomics research, as well as reinforce the intent of current master’s degree students who are considering entering a doctoral program with an eventual dissertation focused on genomic data science.

This FOA is explicitly intended to support the entry of master’s degree students in data science into the genomics workforce. Undergraduate or doctoral students will not be supported under this FOA. The following groups explicitly cannot be supported under this announcement:

Data scientists who have completed an undergraduate degree but are not enrolled in a data science master’s degree.
Data scientists currently with extensive genomics research experience.
Master’s degree students currently enrolled in genomics programs who are interested in gaining exposure to data science.

For this FOA, “genomics research” is defined as biological investigation at the scale of the complete genome without having a focus on a single gene, a group of genes, a particular genomic locus, or a specific disease or organ system. “Genomics programs” are defined as research or educational programs that have a complete or substantial focus on genomics research, including both experimental and computational approaches towards genomics. Programs that focus on biological research or education with genetics topics included without a specific focus on genome-scale topics will ordinarily be considered outside the scope of “genomics programs”.

“Data science programs” are defined as those training students to obtain master’s degrees in statistics, mathematics, computer science or equivalent quantitative or analytical fields, but without an existing genomics component. Existing master’s degree programs which focus on bioinformatics (or more specifically, genome informatics) are outside the scope of this funding opportunity announcement, which is intended to bring more data scientists into the genomics community who have very little or no previous experience working with genomics data sets.

Research education programs may complement ongoing research training and education occurring at the applicant institution, but the proposed educational experiences must be distinct from those training and education programs currently receiving Federal support. R25 programs may augment institutional research training programs (e.g., T32, T90) but cannot be used to replace or circumvent Ruth L. Kirschstein National Research Service Award (NRSA) programs.

Visit our Institutionally Limited Submission webpage for more updates and other announcements.

PAR-22-000: Team-Based Design in Biomedical Engineering Education (R25 Clinical Trial Not Allowed)

Slots: 1

Deadlines

Internal Deadline: Contact RII.

LOI: April 30, 2023

External Deadline: May 30, 2023

Award Information

Award Type: Grant

Estimated Number of Awards: The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Anticipated Award Amount: Direct costs of up to $20,000 per year may be requested. Programs that include a clinical immersion program outside the academic year and lasting 6 to 10 weeks (at least 30 hours per week) may request an additional $20,000 to cover participant costs (see Participant Costs section below), yielding a total of $40,000 in direct costs.

Who May Serve as PI: The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.

Link to Award: https://grants.nih.gov/grants/guide/pa-files/PAR-22-000.html

Process for Limited Submissions

RII-Limited-Submission-Application-Template.

Materials to submit include:

(1) Two-Page Proposal Summary (0.5” margins; single-spaced; font type: Arial, Helvetica, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 2-page limit will be excluded from review. You must use the template linked above.
(2) CV – (5 pages maximum)

Purpose

The NIH Research Education Program (R25) supports research educational activities that complement other formal training programs in the mission areas of the NIH Institutes and Centers.

The overarching goal of this R25 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical research needs.

To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on:

Courses for Skills Development: For example, courses and programs that use a team-based design approach which incorporates health equity, universal design (the purposeful design of products and environments to be useable by people of varying abilities and characteristics), design concepts early in educational activities, interaction between design students at different career/education levels, and state-of-the-art best practices (such as multidisciplinary/interdisciplinary education, the regulatory pathway and other issues related to the commercialization of medical devices), and further enhances these with novel creative and/or ground-breaking approaches and activities which will be implemented and evaluated with the goal of disseminating the outcomes for the benefit of the larger biomedical engineering education community. Programs may also include a clinical immersion experience that enhances skills and experiences in needs finding, communication across disciplines (including with healthcare providers, patients, caregivers, and/or communities), ideation coupled with frequent clinical/user feedback, and/or small projects to address minor, immediately solvable needs.
NIBIB Statement of Interest: NIBIB interests include the development and integration of advanced bioengineering, sensing, imaging, and computational technologies for the improvement of human health and medical care. With this FOA, in addition to the goals described above NIBIB especially encourages courses and programs that incorporate the following topics: 1) Expanding the design perspective by designing for low resource settings; 2) Expanding the clinical immersion perspective by incorporating community-based engagement or emphasizing problem driven solutions; and, 3) Expanding the team perspective by including students from disciplines such as nursing, computer engineering, data science, and/or public health, as well as different education levels.

Visit our Institutionally Limited Submission webpage for more updates and other announcements.

PAR-21-147: Maximizing Access to Research Centers (T34) (NIH)

Slots: 1

Deadlines

Internal Deadline: Contact RII.

LOI: N/A

External Deadline: May 26, 2023

Award Information

Award Type: Grant

Estimated Number of Awards: The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Anticipated Award Amount: Application budgets should reflect the actual needs of the proposed project.

Who May Serve as PI: As described in the instructions for the Training Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) in Section IV.2 below, NIGMS encourages multiple PDs/PIs, particularly when each brings a unique perspective and skill set that will enhance training. At least one of the training PD(s)/PI(s) should be an established investigator in the biomedical sciences and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. Additional PDs/PIs, including individuals with experience in the science of education, relevant social science disciplines, program evaluation, mentoring, and university administration may be included to achieve the training goals. Any of the PDs/PIs may serve as the contact PD/PI. The contact PD/PI is expected to have a full-time appointment at the applicant institution unless extremely well-justified. If the full-time status of the contact PD/PI changes after the award, the institution must obtain prior program approval to appoint a new PD/PI or request a deviation from the full-time rule. The PD(s)/PI(s) will be responsible for the selection and appointment of trainees to the approved research training program, and for the overall direction, management, administration, and evaluation of the program. The PD(s)/PI(s) will be expected to monitor and assess the program and submit all documents and reports as required. The PD(s)/PI(s) have responsibility for the day-to-day administration of the program and are responsible for appointing members of the Advisory Committee (when applicable) and using their recommendations to determine the appropriate allotment of funds.

Link to Award: https://grants.nih.gov/grants/guide/pa-files/PAR-21-147.html

Process for Limited Submissions

RII-Limited-Submission-Application-Template.

Materials to submit include:

(1) Two-Page Proposal Summary (0.5” margins; single-spaced; font type: Arial, Helvetica, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 2-page limit will be excluded from review. You must use the template linked above.
(2) CV – (5 pages maximum)

Purpose

The Overarching Objective of the Maximizing Access to Research Careers program is to develop a diverse pool of undergraduates who complete their baccalaureate degree and transition into and complete biomedical, research-focused higher degree programs (e.g., Ph.D. or M.D./Ph.D.). The long-term goal is to develop a diverse pool of well-trained biomedical scientists, who have the following technical, operational, and professional skills:

A broad understanding across biomedical disciplines and the skills to independently acquire the knowledge needed to advance their chosen fields;
Expertise in a biomedical scientific discipline and the skills to think critically and independently, and to identify important biomedical research questions and approaches that push forward the boundaries of their areas of study;
A strong foundation in scientific reasoning, rigorous research design, experimental methods, quantitative and computational approaches, and data analysis and interpretation;
The skills to conduct research in the safest manner possible, and a commitment to approaching and conducting biomedical research responsibly, ethically, and with integrity;
Experience initiating, conducting, interpreting, and presenting rigorous and reproducible biomedical research with increasing self-direction;
The ability to work effectively in teams with colleagues from a variety of cultural and scientific backgrounds, and to promote inclusive and supportive scientific research environments;
The skills to teach and communicate scientific research methodologies and findings to a wide variety of audiences (e.g., discipline-specific, across disciplines, and the public); and
The knowledge, professional skills and experiences required to identify and transition into careers in the biomedical research workforce (i.e., the breadth of careers that sustain biomedical research in areas that are relevant to the NIH mission).

Diversity at all levels—from the kinds of science to the regions in which it is conducted to the backgrounds of the people conducting it— contributes to excellence in research training environments and strengthens the research enterprise. This FOA is intended to support outstanding research training programs that will enhance diversity at all levels. As part of a larger initiative to enhance diversity, the MARC program will support trainees who are earning a baccalaureate degree at research-intensive institutions and who intend to complete a biomedical research higher degree program (e.g., Ph.D., or M.D./Ph.D.).

Visit our Institutionally Limited Submission webpage for more updates and other announcements.

PAR-23-077: Collaborative Program Grant for Multidisciplinary Teams (RM1 – Clinical Trial Optional)

Slots: 2

Deadlines

Internal Deadline: Contact RII.

LOI: 30 days prior.

External Deadline: May 26, 2023

Recurring Deadlines: January 26, 2024; May 29, 2024; January 28, 2025; May 28, 2025; January 27, 2026

Award Information

Award Type: Grant

Estimated Number of Awards: 4-6

Anticipated Award Amount: While applications may request research program budgets of up to $1.5 million direct costs per year, it is anticipated that most awards will be between $700,000-$900,000 direct costs. Annual inflationary increases are not allowed. The requested budget should be consistent with the number of PDs/PIs and the complexity and needs of the proposed program. An additional $250,000 direct costs per year may be requested for optional developmental funds to support the addition of ESIs to the program in years 2-5.

Who May Serve as PI:

The application is required to be submitted as a multiple PD/PI application, with three to six PDs/PIs. All PDs/PIs must have an appointment at a domestic institution. Scientists employed solely by foreign institutions may not serve as one of the PDs/PIs of the multiple PD/PI team, although they may be included in the application as collaborators/co-investigators, consultants, or other significant contributors. See the multiple PD/PI Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide, and the Grant Policy Statement on Multiple Principal Investigators. Minimum allowed efforts by the PDs/PIs are described in the R&R Budget instructions in Part 2. Section IV.2.

Any eligible scientists with the interest and ability to develop a team science program to address an important research question are welcome to apply.

NIGMS encourages the participation of early career investigators as part of the multiple PD/PI team as appropriate.
- Note that ESIs and new investigators who participate as a PD/PI will lose their ESI or new investigator status for future NIH applications.
- ESIs supported by developmental funds in future years are not designated as PDs/PIs and will not lose ESI status.
PDs/PIs who have an active NIGMS R35 award can participate as a RM1 PD/PI. Their RM1 effort will be part of the 51% research effort on their current R35 award but may not receive additional funds .
Applicants with substantial unrestricted research support may receive funding from this award as their one NIGMS grant award, or may participate in an unfunded advisory or consulting role without loss of their ability to receive one funded NIGMS grant, consistent with NIGMS funding policies.

Link to Award: https://grants.nih.gov/grants/guide/pa-files/PAR-23-077.html

Process for Limited Submissions

RII-Limited-Submission-Application-Template.

Materials to submit include:

(1) Two-Page Proposal Summary (0.5” margins; single-spaced; font type: Arial, Helvetica, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 2-page limit will be excluded from review. You must use the template linked above.
(2) CV – (5 pages maximum)

Purpose

Complex and challenging research questions benefit from the integrated efforts of teams/labs employing complementary approaches with multiple areas of expertise. Team-based efforts can converge on high-impact discoveries, such as creating new disciplines, resolving longstanding or intractable problems, or defining new areas that challenge existing paradigms.

This funding opportunity announcement (FOA) encourages Collaborative Program Grant applications from institutions/organizations that propose projects addressing complex and challenging biomedical problems within the mission of NIGMS. Multidisciplinary research teams must have a highly integrated approach for each of their project goals. The Collaborative Program Grant is designed to support research in which funding a team of interdependent investigators to achieve a unified scientific goal offers significant advantages over supporting individual research project grants.

Features of successful applications include:

Each PD/PI is committed to team science and willing to devote a major part of their research effort to the team project.
Achieving the goal(s) requires a team approach.
Each biological question posed requires a cohesive team with an integrated approach.
A team management structure is developed for achieving program goals.

NIGMS recognizes that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. There are many benefits that flow from a diverse scientific workforce, including fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from, research and enhancing public trust. To support the best science, NIGMS encourages inclusivity in research. Examples of structures that promote diverse perspectives include but are not limited to:

Engagement from different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
Individual applications and partnerships that enhance geographic and regional engagement.
Investigators and teams composed of researchers at different career stages.
Participation of individuals from diverse backgrounds, including groups traditionally underrepresented in the biomedical, behavioral, and clinical research workforce (see NOT-OD-20-031), such as underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women.
Project-based opportunities to benefit early- and mid-career investigators.

This FOA requires a Plan for Enhancing Diverse Perspectives (PEDP) as part of the application (see Section IV.2 SF424(R&R) Other Project Information. Other Attachments). For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see https://braininitiative.nih.gov/about/pedp-key-elements-and-examples.

Applications may address any area of science within the NIGMS mission. NIGMS supports generalizable, foundational basic research that increases understanding of biological processes at a range of levels, from molecules and cells, to tissues, whole organisms, and populations. NIGMS also supports research in a limited number of clinical areas that affect multiple organ systems. Truly new interdisciplinary ideas for approaching significant biological problems are encouraged. Applications that bridge the research interests of more than one area of science supported by NIGMS are also encouraged but must remain within the NIGMS mission.

Research with the overall goal of gaining knowledge about a specific organ or organ system, or the pathophysiology, treatment, or cure of a specific disease or condition will, in most cases, be more appropriate for another Institute or Center. Consultation with NIGMS staff (see below) prior to preparing an application is strongly encouraged.

Projects outside the NIGMS mission will be rejected without review.

Applicants for smaller projects with one or two PD/PIs should consider submitting a multi-PD/PI application to the “NIH Research Project Grant (Parent R01)” FOA (see the Parent Announcement website for the current issuance of that FOA), or if they are current NIGMS R35 MIRA awardees, they could consider collaborating as part of the 51% research effort on their current R35 award (note they will not receive additional funds from the RM1).

Applications that are mainly focused on the creation, expansion, and/or maintenance of community resources, or on infrastructure development, are not appropriate for this FOA. Although Collaborative Program Grants may include some technology development, applications with a central focus on the creation of new technologies would not be considered for funding as a Collaborative Program Grant and are more appropriate for the other NIGMS mechanism for funding technology research and resources.

Applications that employ specific cells or tissues to address a fundamental biomedical question are appropriate. However, applications that focus solely on a specific organ or disease state and that are within the mission areas of other NIH Institutes and Centers would not be appropriate for this FOA.

Research involving human subjects is permitted in the Collaborative Program Grant. Clinical research must be completely within the context of the NIGMS clinical areas (anesthesiology, clinical pharmacology, sepsis, injury, and critical illness). Mechanistic clinical trials are permitted when the mechanistic study is an essential part of the research program. Clinical trials that are designed to test safety and efficacy of interventions (Phase I, Phase II, Phase III) for the purpose of future clinical treatment and/or regulatory approval are not permitted. Potential applicants are encouraged to confer with the NIGMS Scientific/Research staff (in Section VII. Agency Contacts of this FOA) before submitting an application that includes clinical research. NIGMS does not intend to fund applications that contain clinical research within the missions of other Institutes and Centers at NIH or other federal agencies.

Program Organization

Applications submitted to this FOA are expected to propose a single, well-integrated research plan of sufficient scope, complexity, and impact to justify the investment of significant resources. Applicants are expected to describe a cohesive program with a single set of specific aims sufficient to accomplish program objectives that can be achieved within a maximum of ten years (one five-year program with one five-year competitive renewal). Program objectives that are not likely to be achieved within ten years are not appropriate for this FOA.

Applications that propose extrapolations of a single line of research or propose parallel but independent advancement of different areas are not appropriate for this FOA.

Applicant teams should be nimble to incorporate new knowledge and techniques to achieve program objectives and tackle unanticipated challenges. The application may include early-stage investigtor (ESI)-led development projects in future years to investigate new, but related, lines of research.

Team Management and Optional Activities

An RM1 must be a multiple PI application. Therefore, applicants must include a MPI leadership plan as required by the NIH. In addition, applications are expected to develop a comprehensive team management plan that addresses the following:

Appropriate organizational structure and team composition
Shared leadership, contributions, and distributed responsibility for decision making
Resource allocation
Plans for professional development
Conflict resolution

Applicants may wish to address how they will develop trust and a shared vision, as well as how shared responsibilities, interpersonal interactions, and professional credit will be managed. Additionally, applicants may consider a scientific project manager or program coordinator as part of the management plan.

Collaborative Program Grant applications may propose the use of optional future year developmental funds to support ESIs at domestic institutions whose availability was unknown and/or who can bring new ideas and expertise to the program that was not initially conceived to be relevant at the time of application. Developmental funds are in addition to the base grant budget and will be made available after the first year of the award, subject to NIGMS staff approval and availability of funds. See Section VI. Award Administration Information. Prior Approval for Use of Developmental Funds.

The proposed new work that ESIs will pursue must be well aligned with the aims of the original grant.

If the application requests developmental funds for studies directed by ESIs, plans must be included for selecting the ESIs and for leveraging existing resources for appropriate mentoring, including the effective conduct of multidisciplinary team science, as described in Part 2. Section IV.2 of this FOA.

ESIs supported by developmental funds will be able to seek and receive independent funding. A review criterion and funding consideration for any subsequent Renewal application will be evaluation of the outcomes of the ESI mentoring and support, including whether ESIs successfully obtained independent funding. Note that a plan for the use of developmental funds to support ESIs is an optional activity.

Prior Consultation with IC staff

NIGMS intends to fund a limited number of applications. Therefore, consultation with relevant staff at least 10 weeks prior to the application due date is strongly encouraged. Once applicants have identified overall program objectives and PD/PI participants, NIGMS staff may be able to advise applicants whether the proposed research strategy meets the goals and mission of the Institute, whether it addresses one or more high priority research areas, and whether it is appropriate for a Collaborative team program. A collaborative program that is closely related to the goal of a PD/PI’s existing NIGMS-funded research might require that funding be relinquished to avoid scientific overlap. Institute staff will not evaluate the technical and scientific merit of the proposed program in advance; technical and scientific merit will be determined during peer review using the review criteria indicated in this FOA. During the consultation phase, if the proposed research strategy does not meet NIGMS’ programmatic needs, is not appropriate as a Collaborative Program Grant, or is outside the NIGMS mission, applicants will be encouraged to consider other funding opportunities.

Visit our Institutionally Limited Submission webpage for more updates and other announcements.

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