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National Institutes of Health (NIH)

RFA-HL-24-004: Programs for Inclusion and Diversity Among Individuals Engaged in Health-Related Research (PRIDE) (R25 Clinical Trial Not Allowed)

Slots: 1

Deadlines

Internal Deadline: Contact RII.

LOI: February 10, 2023

External Deadline: March 10, 2023

Award Information

Award Type: Grant

Estimated Number of Awards: 11

Anticipated Award Amount: $3,765,960

Who May Serve as PI: Institutions may apply for both the Summer Institute (RFA-HL-24-004) and CC components of this program. However, the PD(s)/PI(s) for the CC must not be the same PD(s)/PI(s) for the Summer Institute application.  

Link to Award: https://grants.nih.gov/grants/guide/rfa-files/RFA-HL-24-004.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/.

Materials to submit include:

  • (1) Single 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 1-page limit will be excluded from review.
  • (2) CV – (5 pages maximum)

Note: The portal requires information about the PIs and Co-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

The primary goal of the Summer Institutes (SIs) of the PRIDE program is to establish long-term mentoring that will enable junior faculty and transitioning postdoctoral students from diverse backgrounds, including those from groups that are underrepresented in the biomedical sciences, to develop a research program and work with their home institutions to obtain NIH funding. Through active involvement in research education and mentorship activities, program participants will further develop their skills and gain experience in advanced methods and experimental approaches in the basic and applied sciences relevant to the NHLBI. Ultimately, the enhanced skills gained from participation in the PRIDE program will contribute to mentees’ career development as faculty members and scientists. SI programs have demonstrated efficacy for furtherance of participants’ research careers.

This FOA specifically invites applications that would support senior faculty, established researchers, and experienced mentors to develop and direct SIs that will provide opportunities for skills development, research experiences, and mentoring to promising junior faculty and transitioning postdoctoral scientists from diverse backgrounds, including those from groups that are underrepresented in the biomedical sciences, who have received a formal, full-time, faculty appointment letter in hand by the time the SI program to which they are recruited is convened. In this FOA, ‘applicant’ refers to the Principal Investigator(s) of the SI program, and ‘mentees’ refers to the junior faculty/transitioning post-doctoral scientists.

To facilitate coordination of the research education and evaluation activities among and between SI awardees and the NHLBI, this FOA runs in parallel with a separate FOA soliciting applications for a Coordination Center (CC) for the PRIDE program (described in detail in RFA-HL-24-003). SI applicants may apply to the CC FOA (RFA-HL-24-003) and vice versa; however, the PD/PI for the SI application must be different than the PD/PI for the CC application.

Research Education Objectives

This FOA will support the development, organization, and implementation of NHLBI mission-focused SI programs. The SI programs must be open nationwide to individuals from diverse backgrounds, including those from groups that are identified by the National Institutes of Health as nationally underrepresented in the biomedical research workforce. SI applications must describe plans to support enhancement of mentees’ skills through focused research education and mentoring activities in NHLBI mission-relevant areas. NHLBI’s mission-oriented goals are at the center of the NHLBI Strategic Vision and are discussed on the Strategic Goals and Objectives web page. It is intended that the SIs will be structured to provide research education activities related to research design, methodologies, skills and strategies important to preparing NIH research grants, as well as to provide mentorship on strategies for success and tips for obtaining external research funding related to HLBS disorders.

Applications submitted in response to this FOA must propose to develop an NHLBI mission-focused research education and mentoring SI program during the last quarter of 2023 and early part of 2024, and to implement the proposed SI program during the summers of 2024, 2025, 2026, 2027 and 2028 with appropriate modifications or refinements following each of the prior years. The CC will support the SI program as detailed in RFA-HL-24-003 and will facilitate cross-site collaborative activities.

This FOA therefore intends to support applicants who offer mentoring and research education experiences in one of the NHLBI mission-relevant disease areas (i.e., heart, lung, blood, or sleep conditions), or cross-cutting HLBS areas such as health disparities or implementation science. Applications characterized by innovation, scholarship, and responsiveness to the priorities and/or changing needs of the NHLBI in meeting its objectives as described in its Strategic Vision are of high programmatic interest.

Examples of relevant topic areas and research approaches include but are not limited to:

  • Basic and clinical aspects of the mechanisms of and treatment for HLBS conditions
  • Research to mitigate health or health care disparities in HLBS conditions in the United States and abroad
  • Health services research focused on treatment optimizing the care for HLBS conditions
  • Implementation science research to facilitate adoption of proven-effective interventions to treat and prevent HLBS related diseases
  • Intervention research methods, such as adaptive and pragmatic trials, to enhance the efficiency and applicability to populations with HLBS conditions
  • Behavioral and social science research targeted at the prevention and treatment of HLBS conditions in areas such as health communication, adherence, behavioral economics, and social and structural determinants of health
  • Emerging technology and informatics, such as artificial intelligence/machine learning and integration of wearable technology in research and clinical care of HLBS conditions
  • Genomics, “populomics”, and precision health to advance the science of tailored treatment approaches for HLBS conditions

Applications must contain the following to be considered responsive to this FOA. Non-responsive applications will not proceed to review.

  • Evidence of a planned program that occurs during the summer for no less than the minimum required time specified (i.e., 10 days) and for two consecutive summers for each cohort
  • The number and positions of the intended participants (specifically HLBS-oriented junior faculty or transitioning post-docs, including those from underrepresented groups) with intent to recruit nationally
  • A research education program focusing on NHLBI mission-relevant areas
  • An evaluation protocol to assess mentees’ progress and program goals
  • A detailed account of experiences of the previously awarded program (applicable to renewal applications only)
  • Evidence of ability to subcontract small research project (SRP) awards to mentees’ institutions, including appropriate letter(s) of support demonstrating the ability to subcontract or the intent to develop appropriate subcontracting relationships with institutions of higher education from which mentees may come
  • A proposed budget within the limit specified in the FOA

Program Structure

Summer Institutes (SIs)

While the specifics of the SI program will be left to the applicant, this FOA will support a four-component program consisting of two consecutive summers of research enhancement and skills development activities, supplemented by mentoring and relevant research experiences occurring throughout the intervening and follow-up academic year.

First Component: First Summer Institute (SI-1)

The first component must be an initial summer session lasting from 10-28 days, which may be divided into more than one segment with mentees participating in multiple segments. The segments may involve classroom, laboratory, and/or field research activities. Topics for consideration may include instructional segments about the unique challenges related to conducting research and obtaining funding faced by researchers, including those from underrepresented groups, reviewing manuscripts, participating on grant review committees, research project management, and budgeting for research proposals. It is preferred that these are an in-person format, but allow flexibility for hybrid or fully virtual formats as needed.

Second Component: Longitudinal Mentoring and Networking

The second component must consist of mentoring and networking activities that occur throughout the academic year following the first summer session. It is recommended that mentees plan to commit at least 5% effort between the first and second year to mentoring and networking activities and research experiences. It is anticipated that, with the assistance of the CC, a mentorship committee tailored to the research pursuits of mentees will be developed for each individual mentee. The mentorship committee would ideally consist of experienced or senior faculty from the mentee’s institution, from the SI, and/or other thought leaders, nationally. Applicants may want to consider how to leverage existing mentoring resources such as the NIH-funded National Research Mentoring Network, professional society supported mentoring and/or career development programs, or other similar resources to enhance the required mentoring committee. Mentoring plans can be designed for virtual, telephone, and/or in-person interactions. Mentoring activities may include assistance with career goal-setting, research design and statistical analysis, external funding, proposal development for submission, and mentored visits to the laboratory or research site of a mentor during the academic year.

It is anticipated that applications will propose at least one in-person mid-year mentoring meeting that can be held either during intervals between semesters, in conjunction with a conference, a three-day weekend during the winter, or at another appropriate time and location. Additional mentoring activities that could occur during the mid-year meeting include identifying appropriate grant mechanisms and funding agencies, review and feedback on draft research concepts or unfunded applications, and progress on funded and ongoing research projects.

Third Component: Second Summer Institute (SI-2)

The third component is a follow-up session that will be held the following summer (Summer Session 2) as a continuation of the first component of the program. It may be of a different duration than the first summer session. This second summer session could be held either at one location for all mentors and mentees, or each mentee could attend a summer session at the laboratory of their mentor(s). Activities could include developing and writing a grant application, holding a mock study section meeting, additional coursework on relevant topic areas, focused mentoring, or research projects progress updates. It is preferred that these are an in-person format, but allow flexibility for hybrid or fully virtual formats as needed.

Fourth Component: Small Research Program (SRP)

A fourth component will be supported through a separate administrative supplement specifically for PRIDE mentees to support mentee-proposed small research projects (SRPs) to facilitate transition to research independence and possibly lead to support from subsequent NIH research grant applications.   Briefly, in collaboration with their host PRIDE Summer Institute, mentees in an active cohort will be eligible to apply for an SRP administrative supplement during or following their first summer institute. Oversight of this component would occur throughout the intervening year between Summer 1 and Summer 2, and updates on projects could be provided at the mid-year meetings or at Summer Session 2. Mentees could also present their research progress and findings at the consortium-wide PRIDE Annual Meetings. Details about the eligibility, application, and administration of the SRP are available in NOT-HL-22-039.

NOTE: Pending scheduling, an optional informational webinar session will be held for applicants prior to application submission and a Notice will be published in the NIH Guide to Grants and Contracts.

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.

RFA-HL-24-003: Programs for Inclusion and Diversity Among Individuals Engaged in Health-Related Research (PRIDE) Coordination Center (U24 Clinical Trial Not Allowed)

Slots: 1

Deadlines

Internal Deadline: Contact RII.

LOI: February 10, 2023

External Deadline: March 10, 2023

Award Information

Award Type: Cooperative Agreement

Estimated Number of Awards: 1

Anticipated Award Amount: $546,000 per year.

Who May Serve as PI: Institutions may apply for both the Summer Institute (RFA-HL-24-004) and CC components of this program. However, the PD(s)/PI(s) for the CC must not be the same PD(s)/PI(s) for the Summer Institute application.  

Link to Award: https://grants.nih.gov/grants/guide/rfa-files/RFA-HL-24-003.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/.

Materials to submit include:

  • (1) Single 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 1-page limit will be excluded from review.
  • (2) CV – (5 pages maximum)

Note: The portal requires information about the PIs and Co-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

The overarching goal of the NHLBI PRIDE program is to support educational activities that enhance the diversity of the biomedical, behavioral and clinical research workforce through Summer Institute (SI) programs.

The major goal of the PRIDE program is to establish long-term mentoring that will enable junior faculty and transitioning postdoctoral scientists from diverse backgrounds, including those from groups that are underrepresented in the biomedical sciences (see, e.g., NOT-OD-20-031), to develop a research program and obtain NIH funding. The goal is that through these experiences participants will further develop their research skills and gain experiences in advanced methods and experimental approaches in basic and applied sciences that are relevant to NHLBI mission areas. These include the prevention and treatment of heart, lung, blood, and sleep (HLBS) disorders. Ultimately, participants in the PRIDE programs will use these enhanced skills to apply for NIH grants in the areas relevant to the of NHLBI mission. It should be noted that the terms “participants” and “mentees” are used interchangeably in this FOA.

The goal of this Funding Opportunity Announcement (FOA) is to support the creation of a Coordination Center (CC) for the Programs for Inclusion and Diversity among Individuals Engaged in Health-Related Research (PRIDE) Summer Institutes (SI). The PRIDE CC will support and complement the activities of the SIs as they foster the development of a diverse workforce to meet the nation’s biomedical, behavioral, and clinical research needs. The SI grantees will develop their PRIDE SI programs (as detailed in the companion FOA RFA-HL-24-004) during the last quarter of 2023 and early part of 2024, and implement them during the summers of 2024, 2025, 2026, 2027, and 2028 with appropriate modifications or refinements following each of the preceding years. The primary tasks of the CC will be to facilitate, coordinate and support execution of research education activities between the SI awardees and mentees, and to conduct ongoing evaluation of the program as per NIH requirements. As such, the PD(s)/PI(s) applicants of the CC team should exhibit strong expertise in both program evaluation and program coordination. 

The CC’s role is also to facilitate candidate recruitment and selection, program-wide organization, and mentor identification and orientation. Additionally, the CC will also plan, arrange, and facilitate the PRIDE annual meetings, monthly steering committee meetings, and other PD/PI meetings for the PRIDE program overall.  

Specific activities and roles of the PRIDE CC will include, but are not limited to:

Outreach and Recruitment

  • Develop, coordinate, and support SI program outreach efforts to recruit and select participants.
  • Facilitate mentorship and networking activities.
  • Coordinate the identification, formation and evaluation of mentees’ mentorship committees.
  • Develop, conduct and/or facilitate skills development and training programs for mentors.
  • Identify, coordinate, administrate and disseminate information on additional research training and networking opportunities for mentees throughout the academic year. For example, applicants may suggest ways that linkages can be made with existing NHLBI programs of research, such as the Jackson Heart Study, Strong Heart Study, and TOPMED program or data resources such as BioLINCC, or may propose the use of elements from existing mentoring/networking programs (e.g., the Sarnoff fellowship program, or the National Research Mentoring Network) in order to increase applicants’ long-term opportunities for learning, networking and funding success.  
  • Propose a plan to work with the NHLBI program office to appoint an Advisory Committee consisting of 4-5 individuals from outside of the applicant’s institution to periodically advise the PRIDE program on issues such as outreach, recruitment and selection of mentees and faculty; curricular design and implementation; training and support of mentors; institutional engagement; and program evaluation.

Program-wide Communications

  • Coordinate and facilitate all conference calls, including monthly calls between SI directors/staff and NHLBI.
  • Co-plan and distribute the agenda for the monthly calls between SI directors, staff, and the NHLBI program office.
  • Develop, share, and post minutes of the conference calls and in-person meetings on the program website.
  • Create web-based resources for SI faculty, mentees, and mentors, including a program-wide website addressing such areas as: NIH policies, procedures and application information and materials (e.g., application timelines and templates), web-based courses, and email and other web-based systems for group communication.
  • Facilitate information exchange across the PRIDE Summer Institute sites and the NHLBI program office.
  • Oversee the equitable use and distribution of research education resources across PRIDE Summer Institute sites.

Facilitate Recruitment of Mentors

  • Facilitate and support SIs in the recruitment of research-focused mentors, including individuals from underrepresented groups. Each mentor should have research expertise and experience relevant to the proposed program and be committed to continue their involvement throughout the total period of their assigned mentees’ participation in their respective SI program.

Research Education Development Activities

  • Support SIs and their mentees in implementing the small research projects (SRPs) component of the PRIDE program. Full details of the SRP are described in NOT-HL-22-039. The CC will not be eligible for the SRP administrative supplement; however, they may provide technical assistance to the SIs and mentees to support the preparation and submission of applications. Distribution of the SRP funds, and scientific oversight of the SRP program will reside solely with the SI programs. The CC will lead the evaluation of the overall SRP component of the program.

Evaluation

  • Propose a plan to coordinate a unified and robust evaluation protocol across the entire PRIDE program including both accessing and assessing data from previous cohorts that are currently under evaluation. Each SI will propose an evaluation protocol and the CC will work to coordinate these protocols across the SIs to ensure common measures and reporting.

Applications must contain the following to be considered responsive to this FOA. Non-responsive applications will not proceed to review.

  • Description of the appropriate type and number of the targeted beneficiaries defined in this FOA (specifically HLBS-oriented junior faculty and/or transitioning postdoctoral scientists) with intent to recruit nationally. (Transitioning postdoctoral scientists are those who would have completed their post-doctoral appointment and have received a formal full-time faculty appointment by the time the Summer Institute program to which they are recruited is convened.)
  • Description of program-wide coordination of mentee and mentor recruitment, communications, and evaluation

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

RFA-AR-24-002: NIAMS Resource-based Centers for Bone, Muscle and Orthopaedic Research (P30 – Clinical Trial Not Allowed)

Slots: 1

Deadlines

Internal Deadline: Friday, March 10th, 2023, 5pm PT

LOI: 30 days prior.

External Deadline: May 18, 2023

Award Information

Award Type: Grant

Estimated Number of Awards: 4

Anticipated Award Amount: $2 million. Application budgets are limited to $500,000 direct costs per year.

Who May Serve as PI: Standard NIH requirements.

Link to Award: https://grants.nih.gov/grants/guide/rfa-files/RFA-AR-24-002.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/.

Materials to submit include:

  • (1) Single 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 1-page limit will be excluded from review.
  • (2) CV – (5 pages maximum)

Note: The portal requires information about the PIs and Co-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

The emphasis of the NIAMS Resource-based Centers Program is to improve access to critical research infrastructure, shared facilities, services, and resources. Each Center will contain one or more Resource Cores that serve a strong research community. For the purposes of this particular announcement, the research community is defined as those investigators (and their funded projects) who will use Center resources for research within the focus of the Center, which should be within the NIAMS mission. Successful Resource-based Centers are expected to expand the chosen field(s), provide new research opportunities, and increase the efficiency and impact of research due to resource access.

The focus of the Center is determined by the Program Director/Principal Investigator (PD/PI) and may encompass basic, translational, and/or clinical research. For this particular announcement, the Center focus is restricted to bone, muscle, and orthopaedic research areas within the NIAMS mission. The focus of the Center may be very broad (e.g., bone, muscle, and orthopaedic research in general) and serve a diverse group of investigators including individuals from groups that are underrepresented in the biomedical, clinical, behavioral and social sciences (NOT-OD-20-031) that share the need for critical common core services. Alternatively, a Center may have a narrow disease or biology focus or theme. In some cases, the relevant research community may share a highly specialized resource such as a well-defined patient cohort with associated patient data and biospecimens or may share a need for highly specialized technologies and services (e.g., advanced imaging, single cell analysis, or computational biology and machine learning). Potential PDs/PIs are strongly encouraged to contact the Scientific/Research Contact listed in Section VII. Agency Contacts early in the application planning process to discuss the NIAMS mission relevance and FOA responsiveness.

It has become increasingly common and feasible for investigators at different institutions to collaborate to achieve common goals. Therefore, to facilitate collaborative and interdisciplinary research, resources and investigators may be distributed at different institutions and different geographic regions, particularly for resources that do not need to be duplicated at every research site. Similarly, the research community may be defined at the national or regional level and may include foreign collaborators. Centers designed to serve a research community primarily at a single institution should include outreach plans to expand access to researchers from other institutions to maximize the value of the Center resources.

The NIAMS Resource-based Centers will provide support for

  • One or more Resource Cores
  • An Administrative Core that includes a Center Enrichment Program

Resource Cores

Each Center must include one or more Resource Cores. A Resource Core is a facility or resource shared by or providing services to multiple research community investigators, enabling them to conduct their independently funded individual or collaborative research projects more efficiently and effectively. The selection of Resource Cores is left up to the PD/PI, but should be justified by the needs of the research community and should be appropriate for the focus of the Center, which should be within the NIAMS mission. Resource Cores may be located at multiple institutions separated geographically as long as the PI can justify the feasibility of such arrangement.

For the purpose of this FOA, examples of Resource Cores include, but are not limited to, Cores providing the following:

  • A technology that lends itself to standardized procedures, automation, or preparation in large batches (e.g., histology, tissue culture, biobanking, high throughput sequencing, genotyping, and other genomic, epigenomic, proteomic, and microbiomic assays) or that requires complex instrumentation (e.g., electron microscopy, flow cytometry, confocal microscopy, intravital microscopy, whole animal imaging, and mass spectrometry).
  • Animal preparation (including transgenic, knockout, and other forms of genetic engineering/gene editing) and care.
  • Highly specialized technologies, tools, and expertise such as genetics, medical informatics, bioinformatics, biostatistics, systems biology, computational biology and machine learning, and pharmacogenomics.
  • Critical infrastructure to support broad sharing of accessible pre-existing patient cohorts and registries, including appropriately consented patient samples and associated clinical data.

A single Center may propose multiple Resource Cores offering different types of technologies, services, and critical resources. However, applications solely focusing on a clinical methodology core(s) supporting outcomes, epidemiology, clinical trials, and/or health services research exclusively are not responsive to this FOA and will not be reviewed. Prior consultation with the NIAMS Scientific/Research contact is strongly recommended.

Although the Cores themselves are not required to be innovative, they should be “state-of-the-art” and drive innovation within the research community. In addition, Cores are encouraged to support limited research focused on technology development or adaptation of technologies to meet the needs of the research community through new or unique state-of-the-art core services. Resource Core support may include personnel, equipment, supplies, services, and facilities. It is expected that the Resource Cores will be sustainable in their operation and receive some reimbursement for the cost of providing services or other resources through user fees, making the prospect of sustainability at the conclusion of NIAMS support feasible.

Cores are encouraged to leverage existing resources, such as registries, tissue banks, and cohorts, and to coordinate with other Cores at the same or nearby institutions, particularly if they provide similar or overlapping technologies and services.  Cores may support existing service cores, but should add value beyond the normal use of a resource by fee-for-service or simple access. Whenever possible, generic services (e.g., histology, flow cytometry, genetically engineered animals), whether offered by new or existing Cores, should be customized to meet the needs of the research community. Examples of such customization include the provision of relevant reliable monoclonal antibodies (e.g., for immunostaining of cells and tissues, for flow cytometry, or for ChIP-seq) and tissue or cell type-specific promoters and cre-drivers for genetically engineered animal studies. All Cores are strongly encouraged to enhance the value of the resources they offer through education and training on technologies and other resources offered by the Core, as well as consultation on experimental design and data analysis and interpretation. Applicants from institutions that have a Clinical Translational Science Award (CTSA) funded by the NIH may wish to identify the CTSA as a resource for supporting the research community.

Administrative Core

The Administrative Core has oversight responsibility for the entire Resource-based Center (P30) and also plans and carries out activities that promote the goals of the Center. These goals and activities are selected by the PD/PI of the application, but at the very least need to include outreach activities that promote use of the resources offered by the Center as well as enrichment activities that expand the research community or promote innovative research on the topic of focus of the Center and within the NIAMS mission. Outreach for Centers that have a research community at a single institution should extend beyond the borders of that institution in order to make Center resources more available wherever possible. The Administrative Core should have a Director, an Associate Director, and an Advisory Committee to coordinate the Center activities and to evaluate and improve the Center. The Director of the Administrative Core is also the Director of the overall Center. The Advisory Committee should include users of the scientific cores and experts outside the Center with expertise in the management of scientific core facilities. This Committee should help the Director and Associate Director to regularly evaluate and optimize strategies to meet the scientific needs of the research community over the course of the grant award.

The following are examples of additional goals that would be appropriate for a Resource-based Center. This list is neither mandatory nor inclusive. PDs/PIs are encouraged to propose other innovative goals.

  • Provides leadership for research on the topic of focus by the Center
  • Expands the research community by attracting new investigators and established investigators from other fields
  • Enhances the research environment and promotes synergistic collaborations or interdisciplinary research

The Administrative Core must include an Enrichment Program that is designed to expand the research community and/or promote innovative research on the topic of focus of the Center. The Enrichment Program should include outreach activities for the Resource Core(s). Each Center may choose the activities that best suit the needs of the research community, but all activities should occur within the context of or with the involvement of the Resource Core(s). Through this Enrichment Program, the Administrative Core can utilize the Resource Cores to nurture the career development of new investigators, attract investigators from other research fields, enhance the biomedical research workforce by including investigators from diverse backgrounds, including those from underrepresented backgrounds (see, e.g., Notice of NIH’s Interest in Diversity, NOT-OD-20-031), develop new technologies, or foster new collaborations with investigators who have not previously engaged in research within the focus of the Center. The Enrichment Program may include a Pilot and Feasibility (P&F) grant program, but this is optional. Innovative approaches to the Enrichment Program are encouraged.

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

RFA-AI-22-071: Autoimmunity Centers of Excellence, Clinical Research Program (UM1 Clinical Trial Required)

Slots: 1

Deadlines

Internal Deadline: Friday, February 17, 2023, 5pm PT

LOI: 30 days prior.

External Deadline: May 19, 2023

Award Information

Award Type: Cooperative Agreement

Estimated Number of Awards: 2 – 4

Anticipated Award Amount: NIAID plans to commit $7.2 million to the ACE Program (Clinical and Basic) in fiscal year 2024, which includes approximately $3 million direct costs annually to support an ACE Clinical Project Fund and an ACE Collaborative Project Fund. 

Who May Serve as PI: An individual may serve as PD/PI on an application to either this Clinical ACE program FOA or the companion Basic ACE program FOA (RFA-AI-22-070), but not both. An individual may serve as Project Leader or in another role (non-PD/PI) on applications to both FOAs. Note that the multiple PDs/PIs option may only be used for the overall Program Leader.

Link to Award: https://grants.nih.gov/grants/guide/rfa-files/RFA-AI-22-071.html

Process for Limited Submissions

PIs must submit their application as a Limited Submission through the Research Initiatives and Infrastructure Application Portal: https://rii.usc.edu/oor-portal/.

Materials to submit include:

  • (1) Single 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 1-page limit will be excluded from review.
  • (2) CV – (5 pages maximum)

Note: The portal requires information about the PIs and Co-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

This FOA solicits applications for the Clinical research program of the Autoimmunity Centers of Excellence (ACE). The companion FOA (RFA-AI-22-070) solicits applications to the Basic research program of the ACE. The goal of the ACE is to conduct insightful analyses of human immunology as it applies to autoimmune disease(s), within and among collaborative Centers and especially in the context of Clinical Projects, i.e., clinical trials with integrated mechanistic studies. The members of the Clinical and Basic ACE will work together after award to design, develop, and conduct studies of autoimmunity and autoimmune diseases in humans.This approach is expected to advance our fundamental understanding of human autoimmunity, identify common and distinct mechanisms in the pathogenesis of autoimmune diseases, and clarify mechanisms of action of immune-modulating interventions used in therapy or tested in clinical trials.

Research Objectives and Scope

The objectives of the ACE are to accelerate the discovery and translation from lab to clinic of therapies for autoimmune diseases. The ACE program approaches these objectives by conducting cooperative basic, clinical, and mechanistic studies; fostering intellectual and material collaborations among basic and clinical scientists; and facilitating the study of clinical samples by basic research scientists. Projects designed to test explicit hypotheses are preferred though ‘data-driven’ projects are permitted. The program is expected to advance our fundamental understanding of human autoimmunity, identify common and distinct mechanisms in the pathogenesis of autoimmune diseases, and clarify mechanisms of action of immune-modulating agents used in therapy or tested in clinical trials.

Research Scope: All projects must investigate autoimmune disease in humans.

Approach: The ACE program coordinates individual Centers, each awarded through either this clinical program or through the companion basic research program. The 6 elements of each Clinical Center are described below in this section (Administration Coordination, ACE Funds Management Coordination (AFMC), ACE Biorepository Coordination (ABC), Primary and Alternate Clinical Projects, and the Collaborative Project). The elements of the ACE program, and how the Centers work together, are described in the following section (ACE Program).

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

PAR-23-045: Biomedical Research Facilities (C06 Clinical Trial Not Allowed)

Slots: Only one application per institution (identified by NIH IPF number) is allowed. Moreover, institutions with C06 awards funded under the Biomedical Research Facility Program (FOAs PAR-20-086, PAR-21-139, or PAR-22-088) are not eligible to apply to this FOA, provided the awards are active on the receipt date for this FOA. Thus, only one C06 Biomedical Research Facility active award per institution would be allowed at any given time.

Deadlines

Internal Deadline: Contact RII.

LOI: January 20, 2023

External Deadline: February 24, 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: The maximum award budget from Federal funds is $8,000,000. Applications with a budget less than $3,000,000 will not be considered. 

Who May Serve as PI: Multiple PDs/PIs are not allowed. Otherwise, standard NIH eligibility information.

Link to Award: https://grants.nih.gov/grants/guide/pa-files/PAR-23-045.html

Process for Limited Submissions

PIs must submit their application as a Limited Submission through the Research Initiatives and Infrastructure Application Portal: https://rii.usc.edu/oor-portal/.

Materials to submit include:

  • (1) Single 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 1-page limit will be excluded from review.
  • (2) CV – (5 pages maximum)

Note: The portal requires information about the PIs and Co-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

This Funding Opportunity Announcement (FOA) invites eligible institutions of higher education and research organizations to seek funding to modernize and improve existing shared-use research facilities (e.g., core laboratories, animal research facilities, or other collaborative research spaces), or to construct new biomedical research space that will be furnished with necessary casework or other essential infrastructure and eligible integrated equipment (subject to the requirements described below under Funding Restrictions). The objective of this FOA is to support the development of modern facilities that will enable and enhance the conduct of high impact, cutting-edge biomedical research with national or regional significance. Thus, any facility supported by this FOA must serve a broad research community at local (within the applicant’s own institution), regional (beyond the applicant’s own institution), or national level.

NIH recognizes that modern physical infrastructure is necessary for the conduct of advanced, innovative research. As science progresses and new technologies become available, dedicated space is required to house specialized equipment and to carry out novel experimental protocols. Both Institutions of Emerging Excellence (IEE, as defined in 42 USC 283k(c)(2)) and non-IEE institutions as well as highly resourced and low resourced institutions are encouraged to apply. Projects will vary and depend on the current institutional infrastructure and long-term institutional strategic plans. Focusing on the advancement of science through the modernization of physical space will be an essential and integral feature of all proposed projects. When completed, construction/modernization projects will have a significant impact by enabling innovative and new research opportunities and/or by raising the research capacities and capabilities to a new and higher level. An institution may request funds to modernize a core facility to create an environment required for research-driven specialized technological services. Likewise, funds may be requested to consolidate space for an institution-wide core which would provide streamlined workflows for contemporary multi-disciplinary investigations. Modernizing laboratory space used on a shared basis to meet the growing needs consistent with an institutional strategic vision for biomedical research is another example of a suitable request. A successful construction/modernization project will serve research teams and a broad range of research efforts. Laboratory space exclusively dedicated to individual Program Directors/Principal Investigators (PDs/PIs) or single research groups is not supported under this FOA.

Various factors are typically considered when developing or modernizing research infrastructure. For applications submitted to this FOA, defined research needs will drive the requests for modern engineering solutions. As science progresses and new technologies become available, required dedicated space must comply with relevant technical specifications to provide a proper and well-controlled environment, to enable novel experimental approaches, and to house specialized equipment. It is encouraged that these new spaces adhere to the highest possible standards of green engineering designs and operations.

Modern physical infrastructure requires the implementation of advanced engineering designs. Some protocols may only be conducted in designated clean rooms, such as barrier facilities for pathogen-free research or space for synthesis of compounds meeting standards for human subject experiments. Certain equipment and/or research protocols require specially shielded rooms or rigorous control of environmental variables such as temperature or humidity. The shared space also needs to be adequately maintained to serve its desired function over many years. The formal structure of an institutional core typically offers effective oversight to ensure that the required engineering standards of a space it occupies are met and maintained over time. Also, such centralized facilities are organized to provide rigorous scientific support for the conduct of research.

NIH recognizes the importance of all institutions of higher learning and research organizations in contributing to the nation’s research capacity. NIH intends to award 25% of the available funds to support projects from IEEs. These institutions play a special role in advancing biomedical research as they leverage their research abilities to address a problem, concern, or unmet health need. Often these institutions are located in a geographic area whose population includes a significant number of individuals with health status deficit, and the applicant provides health services to such individuals; or is located in a geographic area in which a deficit in health care technology, services, or research resources may adversely affect the health status of the population of the area in the future, and the applicant is carrying out activities with respect to protecting the health status of such population.­­­ As a part of their mission, IEEs must have plans and the ability to carry out the plans to conduct biomedical research or provide training to enhance the health of individuals from such population. These institutions often serve as centers for dissemination of health information, training development, and advancement of research. At times, low levels of research funding from NIH, other federal agencies, private foundations, and other sources, as well as a deficit in health care technology, services, or research resources such as a physical research infrastructure, may curtail the full potential of these efforts.

Many IEEs are located in designated geographic locations; however, geographical location, alone, is not sufficient to define an IEE. An institution in an Institutional Development Award (IDeA)-eligible state may qualify as an IEE if the institution has deficient or inadequate physical infrastructure that deters it from achieving well-defined and well-focused research-related goals. These goals build on local capacity for research that encompasses various factors such as in-house scientific expertise, unique local resources, or special local populations and their health-related needs. Many institutions in non-IDeA-eligible states also meet these criteria and are equally qualified to apply as IEEs.

As IEEs often have low levels of federal and private funding for biomedical research, faculty at these institutions usually contribute a significant amount of their time to teaching either undergraduate or graduate curriculum courses, or both. Note, however, projects that would serve purely didactic activities are not permitted under this FOA.

IEE applicants should be striving to establish a particular research or research training capacity or research or research training focus that serves the needs described above. Improvements in physical infrastructure are one element that can help meet these needs. An applicant should explain in what domain of biomedical research the institution is seeking to achieve excellence and how this proposed project will advance the effort. Ultimately, to be considered as an IEE for the purpose of this FOA, an applicant institution must identify itself as an IEE and justify its status – see the Project Narrative section for more information.

It is expected that all projects – both from research-intensive institutions and IEEs – will have long-term effects and will benefit the broad biomedical research community at the applicant institution by providing a modern research environment, accessible on a shared basis. It is also expected that projects awarded under this FOA will have a transformative impact on research at the recipient institution.

Applications based entirely on regular maintenance, replacement of aging or failing equipment, and other routine work are not appropriate for this FOA, and such applications will not be supported. Applications for upgrades of a space serving a single investigator are also inappropriate as are applications to support facilities for billable medical care, office space, or classrooms.

To appropriately conceive, develop, construct, and successfully complete the construction/modernization project, a PD/PI should possess knowledge of the relevant scientific field(s) to be served by the proposed facility, demonstrate leadership skills, and assemble a team with technical expertise related to all aspects of the project. The PD/PI does not need to be an NIH-funded investigator, but should have the appropriate standing in the institutional administration and the research community to lead and oversee the project.

The project should be consistent with the following criteria and documentation requirements:

  • The project is essential for biomedical research activities supported and the space involved will be used for these activities.
  • The facility must be utilized for biomedical research purposes for which it was constructed or improved for at least 20 years beginning on the date of beneficial occupancy of the space.
  • If the project is located in an existing building, the building must have a useful life consistent with program purposes, including the time to construct and complete the project plus 20 years of use following the occupancy of the research space; the building must be architecturally and structurally suitable for conversion to the type of research space required.
  • If the space is rented, evidence must be provided that the terms of the lease and expected subsequent 20-year use of the facility are consistent with the proposed project. Specifically, a signed document from the building owner must be provided showing that the terms of the lease agreement and subsequent use of the facility will comply with the 20-year term of the Notice of Federal Interest (NFI) requirement following the occupancy of the facility. A statement of agreement by the owner of the space must be included. These documents will be verified if/when the application is considered for funding.
  • If the project will affect a site listed (or eligible for inclusion) in the National Register of Historic Places, the requirements specified in “Preservation of Cultural and Historic Resources” must be followed.

PDs/PIs are strongly encouraged to contact the Scientific/Research Contact listed in Section VII. Agency Contacts to discuss their planned projects before submitting applications. Potential applicants are also encouraged to visit the C06 Frequently Asked Questions web page for additional guidance.

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

(CLOSED) RFA-OD-23-005: NIH Research Evaluation and Commercialization Hubs (REACH) Awards (U01 Clinical Trial Optional)

Slots: 1

Deadlines

Internal Deadline: Closed.

LOI: N/A

External Deadline: February 9, 2023

Award Information

Award Type: Cooperative Agreement

Estimated Number of Awards:  5

Anticipated Award Amount: $20,000,000

Who May Serve as PI: Standard NIH requirements.

Link to Award: https://grants.nih.gov/grants/guide/rfa-files/RFA-OD-23-005.html

Process for Limited Submissions

PIs must submit their application as a Limited Submission through the Office of Research Application Portal: https://rii.usc.edu/oor-portal/.

Materials to submit include:

  • (1) Single 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 1-page limit will be excluded from review.
  • (2) CV – (5 pages maximum)

Note: The portal requires information about the PIs and Co-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

The NIH Research Evaluation and Commercialization Hub (REACH) program is a partnership program between NIH and the qualifying research institutions to accelerate the creation of small businesses and the transition of discoveries originating from academic research into products that improve patient care and enhance health. REACH Hubs foster the advancement of therapeutics, preventatives, diagnostics, devices, and research tools that address unmet patient and public health needs across the entire NIH mission. Applicants are encouraged to focus on building robust entrepreneurial ecosystems in the areas of highest U.S. burden of disease and disability and areas that historically attract lower levels of private biomedical capital investment.

The new REACH Hubs will build upon lessons learned from previous awardees to transition promising technologies to the next stage of commercialization. Proposed technology development projects should have already advanced from scientific discovery into the early stages of product development. As a guiding principle, proposed technology development projects should be within one or two steps of a commercial transaction (selling, partnering, licensing, startup, or entry into another suitable program to continue development), but require additional validation in order to be considered competitive for a Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) award. Although every technology development project is unique, broad guidelines for different types of projects are as follows:

  • Small Molecule Therapeutics: The compound is at the lead optimization or preclinical stage. The target is known, and/or there is some method or assay to determine its effect.
  • Biologics or Cell Based Therapies: The biologic or cell population has been identified and some reasonable method of development, sourcing, manufacture, or proliferation is proposed. Mechanism of action has been determined to a sufficient level that there is a reasonable understanding of the product to be developed or tested in the project.
  • Interventional Medical Device: The proposal includes prototype development and testing, either on the bench or in animals. Physiologic experiments have been conducted or reported in the literature, providing rationale for prototype development.
  • Diagnostic Medical Device/IVD/MDx: The proposal includes prototype development and some method of testing.
  • Health IT, Software, Apps, and Algorithms: The proposal should be beyond the concept stage and already have an existing code base. The idea should be grounded in previous experiments or solid peer reviewed evidence. The proposal should include steps to validate the technology by demonstrating its efficacy versus the standard of care or utility in pilot studies or user testing, or, if already validated, to refine the technology to make it appropriate for commercialization.

The program aims to strengthen and de-risk technologies toward this goal through a team-based developmental approach that addresses downstream requirements, including but not limited to intellectual property, regulatory, and reimbursement issues, and business case development. It is expected that spinout companies will be in a position to submit strong SBIR and STTR program applications. The Hubs will establish novel partnerships, strengthen existing alliances between stakeholders (including academic, non-profit, and industry sectors), provide entrepreneurial educational opportunities for innovators from diverse backgrounds, and create cultural and systemic changes to more rapidly transform breakthrough innovations into products that will have health, economic, and societal impact.

Objectives and Requirements for this FOA

Each Hub will assemble a diverse group of experts in biomedical product development and will have the expertise to identify and source technology development projects that have progressed to a point where a potential commercial product can be envisioned, but additional research and development efforts are required to define the product (demonstrate feasibility and proof-of-concept). Through a combination of in-house efforts and collaboration, each Hub funded under this FOA will perform functions to address the critical knowledge and funding gaps that hinder the early steps needed to turn novel discoveries into products with health, economic, and societal impact. The work supported by the REACH Hubs should include technical validation, facilitating business development opportunities, clarifying intellectual property and identifying barriers to entry, performing market research (including market needs and competitive advantages), and clarifying regulatory, manufacturing, clinical, or payer requirements.

Hubs must meet all the following requirements:

1) Hub Leadership: Be governed by leadership with a documented track record of success in biomedical product development.

2) Collaborations and Partnerships: Develop the necessary collaborations and partnerships with stakeholders (including academic, non-profit, and industry sectors) to meet the goals of this FOA. Each Hub is expected to partner with existing federal government resources, including those within the Hub’s ecosystem, as appropriate, such as: EDA’s Build to Scale (B2S), NSF’s Regional Innovation Engines, Innovation Corps (I-Corps™) and the National Innovation Network; SBA Growth Accelerators, SBA Federal and State Technology (FAST) Awardees, NCATS Clinical and Translational Science Awards (CTSA), NIBIB’s Concept to Clinic: Commercializing Innovation Program (C3i) and Point-of-Care Technologies Research Network (POCTRN); NIGMS’ Regional Technology Transfer Accelerator Hubs for IDeA States and IDeA Regional Entrepreneurship Development Program (I-RED), IDeA Networks of Biomedical Research Excellence (INBRE), IDeA Networks for Clinical and Translational Research (IDeA-CTR), and Centers of Biomedical Research Excellence (COBRE); NIH Centers for Accelerated Innovations (NCAI) and REACH, and the Coulter Translational Partnership Award in Biomedical Engineering (TP) or other appropriate programs identified by the Hub.

Hubs are strongly encouraged to partner with several educational institutions, particularly those that are Minority Serving Institutions [including but not limited to Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and/or Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)], those institutions that have not been major recipients of past NIH support, and/or institutions in IDeA states.

This FOA encourages cost matching. Each Hub is encouraged to have identified at the time of application and committed at the time of award a minimum of $250,000/year of matching funds to augment the federal investment for product definition studies. Matching funds can originate from any non-federal source (e.g., awardee institution, foundations, for-profit investors, state or local economic development resources).

3) Regional and Local Impact: Make a unique impact on small business development, entrepreneurial culture, workforce diversity, and health disparities. Hubs should serve innovators from diverse backgrounds (see Notice of NIH’s Interest in Diversity) or meet pressing local or regional needs in areas such as economic development, entrepreneurial education, research funding, disease burden, and health disparities.

4) Technology Development: Demonstrate the ability to support technology development ranging from early-stage laboratory-based technology feasibility through pre-clinical testing for technologies across the breadth of the NIH mission. Hubs must provide infrastructure to solicit, evaluate, and select the most promising technology opportunities with health, economic, and societal impact that otherwise would not receive support for early-stage proof-of-concept work. In addition to supporting technology development projects from innovators within the Hub’s partner institutions, each Hub should develop and implement efficient strategies to support technology development projects from innovators at other institutions within their research and development ecosystem. The budget of any technology development project can utilize a maximum of $100,000 from the REACH award, with the balance coming from the Hub’s matching funds. It is expected that Hubs will be continuously developing 4 – 6 technologies each year.

5) Project Management: Develop and implement milestone-driven, market-focused project management oversight and decision-making processes. Each Hub should use project management processes that enable continuous assessment of progress relative to established milestones in order to make strategic decisions regarding the support of each technology development project (e.g., discontinue a failing project early, pivot to a new application, or provide additional resources). Hubs are expected to provide agile management to assemble a package of resources and services tailored to each technology development project. Hubs are strongly encouraged to utilize project managers with formal project management training and/or biomedical industry experience. Salary support for the project manager is considered to be part of the direct cost of each technology development project. The Hubs should leverage best practices from current pilot programs and any other relevant program to promote and facilitate the open exchange of information regarding the scope, methods, analysis, results, and lessons learned from each technology development project.

6) Educational Activities: Provide innovators from diverse backgrounds, including innovators from underrepresented groups  access to skills development, hands-on entrepreneurial experience, and educational and networking activities. Each Hub must provide entrepreneurial educational opportunities to academic investigators at all career levels about the design and conduct of technology development projects and the commercialization processes required for transition promising technologies to the next stage of commercialization (e.g., additional financing, spinout company development, or university licensing). The Hub should catalyze professional development by:

  • Training innovators to assess the commercial potential of their research discoveries and to develop comprehensive product development plans
  • Bringing together experienced entrepreneurs and scientists to provide guidance and mentoring
  • Providing the broader investigator community with access to forums, seminars, workshops, and related activities
  • Providing connections between research performing institutions and life science businesses, industries, and sources of private capital
  • Providing focused entrepreneur support and “hands-on learning” targeted at the needs of the innovator, so that scientists have the opportunity to engage in entrepreneurial activities. Cross-disciplinary (science, business, regulatory, reimbursement, etc.) career development is highly encouraged to achieve the goal of exposing innovators to the myriad processes required to translate discoveries into marketable products.

Applicants are encouraged to review examples of Healthcare Commercialization Programs, which are designed to teach innovators to identify valuable product opportunities resulting from academic research, and gain entrepreneurial skills through stakeholder discovery and guidance from development experts.

7) Sustainability Plan: Develop and implement a plan for ensuring that the capacity developed under their REACH award will be sustained at their institutions, including assimilation into existing or new innovation management strategies, academic entrepreneurship support functions, technology transfer or commercialization offices, and other supportive programs and policies at their institutions.

Each Hub should demonstrate the core competencies necessary to fulfill all the objectives of this FOA.

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

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