National Institutes of Health (NIH)

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

Slots: 2

Deadlines

Internal Deadline: Friday, October 27th, 2023, 5pm PT

LOI: 30 days prior.

External Deadline: January 26, 2024

Recurring Deadlines: 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

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

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.

RFA-CA-23-042: The NCI Predoctoral to Postdoctoral Fellow Transition Award (F99/K00 Clinical Trial Not Allowed)

Slots: 1

Deadlines

Internal Deadline: Contact RII.

LOI: October 17, 2023

External Deadline: November 17, 2023

Recurring Deadlines: November 19, 2024

Award Information

Award Type: Grant

Estimated Number of Awards: 24

Anticipated Award Amount: NCI intends to commit $1.1 M to fund up to 24 awards in FY2024, and $1.1 M to fund up to 24 awards in FY 2025.

Who May Serve as PI: An applicant must be a citizen or a noncitizen national of the United States, or has been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status), or be a non-U.S. citizen with a valid U.S. visa. For applications submitted on behalf of non-U.S. citizens with valid U.S. visas, the visa status during each phase of the F99/K00 award must allow the PD/PI to conduct the proposed research at the applicant institution. For the F99 phase of the award, the applicant F99 institution is responsible for determining and documenting, in the nomination letter, that the applicant’s visa will allow the applicant to remain in the U.S. to complete the F99 phase of the award, and that there are no known obstacles that would prevent the applicant from obtaining a visa for the K00 phase. For the K00 phase of the award, the U.S institution at which the K00 phase of the award will be conducted is responsible for determining and documenting, in the transition application, that the PD/PI’s visa will allow the PD/PI to remain in the U.S. for the duration of the K00 award. NCI may request verifying information as part of the pre-award process.

The applicant must have a baccalaureate degree and be currently enrolled as a graduate student in the third or fourth year of a mentored PhD or equivalent research degree program (e.g., DrPH, ScD) in the biomedical, behavioral, or clinical sciences at a domestic institution. F99 eligibility is determined from the date of enrollment as a graduate student at the PhD institution and includes the time spent to earn a MS degree unless there was a major change in research area and a change in research mentor. The applicant must be at the dissertation research stage of training at the time of award, and must show evidence of high academic performance in the sciences and commitment to a career as an independent cancer research scientist.

This program is expected to enhance the research career trajectories of cancer researchers and foster progression to research independence. K00 awardees remain eligible to apply to subsequent mentored Career Development (K) and Pathway to Independence (K99/R00) award programs.

Exceptions:

If a 2nd-year student is expected to graduate within 2 years, an exception may be requested. Applicants may check with the Program Official prior to the selection of the nominee. If granted, the exception should be explained in the Nomination Letter.
If a 5th-year student took a documented and extended Leave of Absence, an exception may be requested. Applicants must check with the Program Official prior to the selection of the nominee. If granted, the exception should be explained in the Nomination Letter.

Potential candidates are encouraged to discuss their individual situation with the NCI Scientific Program Contact prior to seeking institutional nomination.

The F99/K00 award may not be used to support studies leading to the MD, DDS, or other clinical, health-professional degree (e.g., DC, DMD, DNP, DO, DPM, DVM, ND, OD, AuD). Students matriculated in a dual-degree program (e.g. MD/PhD, DO/PhD, DDS/PhD, or DVM/PhD) are not eligible for the F99/K00 program.

If an applicant completes all doctoral dissertation requirements or begins a postdoctoral position before an F99 award is issued, neither the F99 nor the K00 will be awarded.

Link to Award: https://grants.nih.gov/grants/guide/rfa-files/RFA-CA-23-042.html

Process for Limited Submissions

Materials to submit include:

(1) Two-Page Proposal Summary (1” margins; single-spaced; standard font type, e.g. Arial, Helvetica, Times New Roman, 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

Note: This Notice of Funding Opportunity (NOFO) does not allow applicants to propose to lead an independent clinical trial, but does allow applicants to propose research experience in a clinical trial led by a sponsor or co-sponsor.

The objective of the NCI Predoctoral to Postdoctoral Fellow Transition Award (F99/K00) is to identify and encourage outstanding graduate students who are recognized by their institutions as having high potential and strong interest in pursuing careers as independent cancer researchers, and then to facilitate their successful transition to postdoctoral positions.

The F99/K00 award is intended for individuals who require 1-2 years to complete their Ph.D. dissertation research training (F99 phase) before transitioning to mentored postdoctoral research training (K00 phase). Consequently, applicants are expected to propose an individualized research training plan for the next 1-2 years of dissertation research training and a plan for 3-4 years of mentored postdoctoral research and career development activities that will prepare them for independent cancer-focused research careers.

The F99/K00 award is meant to provide up to 6 years of support in two phases. The initial (F99) phase will provide support for 1-2 years of dissertation research (final experiments, dissertation preparation, and selection of a postdoctoral mentor). The second (K00) phase will provide up to 4 years of mentored postdoctoral research and career development support, contingent upon successful completion of the doctoral degree requirements and securing a cancer-focused postdoctoral position at a new institution. The two award phases are intended to be continuous in time but a gap of up to 3 months between the two phases will be allowed. However, the F99 phase of the award may not continue beyond the completion of all doctoral degree requirements (i.e., the date of acceptance and approval of the PhD thesis by the institution and not when the degree is conferred). A K00 award will only be made to a PD/PI who has successfully completed the F99-supported training, provided NCI with a strong research and career development plan, and started a cancer-focused postdoctoral appointment.

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

PAR-23-289: Diagnostic Centers of Excellence for the Undiagnosed Diseases Network (U01 – Clinical Trial Not Allowed)

Slots: 1

Deadlines

Internal Deadline: Contact RII.

LOI: October 3, 2023

External Deadline: November 3, 2023

Award Information

Award Type: Cooperative Agreement

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 may not exceed $500,000 Direct Costs per year and must reflect the actual needs of the proposed project. Budgets may be administratively reduced before award based on program priorities and the amount of NIH appropriations.

Who May Serve as PI: Applications for this DCoE U01 NOFO (RFA-NS-24-008) may be submitted by individuals located at the same institution(s) as the DMCC award (see RFA-NS-22-051), but an individual may not be the PD/PI of both the DMCC award and a DCoE application. Institutions/organizations and PD/PIs are allowed only one DCoE award that is active at the same time [e.g., under this NOFO (i.e., RFA-NS-24-008), PAR-NS-23-171 or RFA-NS-23-004]. Therefore, recipients and PD/PIs of an approved X01 access award under PAR-23-171 may submit an application under this NOFO but will be required to relinquish the X01 access award if this U01 is awarded. Likewise, if recipients of a U01 award under RFA-NS-23-004 submit a New application under this NOFO, versus a Renewal application, they will be required to relinquish the original grant if a new U01 is awarded.

Link to Award: https://grants.nih.gov/grants/guide/pa-files/PAR-23-289.html

Process for Limited Submissions

Materials to submit include:

(1) Two-Page Proposal Summary (1” margins; single-spaced; standard font type, e.g. Arial, Helvetica, Times New Roman, 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

Purpose and Research Objectives

The purpose of this NOFO is to solicit proposals from highly qualified clinical sites in the US to join the Phase III Network as DCoEs through a U01 Cooperative Agreement award. Awarded DCoEs will have access to DMCC resources and infrastructure including high-quality phenotypic and genotypic data and collaboration with highly skilled physicians, researchers, and bioinformaticians. Successful applicants will demonstrate that they have the appropriate expertise, resources and infrastructure needed to conduct advanced diagnostic evaluations at their site and propose a research plan that meets the following Phase III priorities:

Scale clinical capacity to engage more participants across the US by increasing diagnostic efficiencies and incorporating community and third-party payer support for patient services. To achieve this goal, DCoEs are expected to:
- Provide a plan to enroll an achievable number of participants based on the site’s experience, outreach capabilities, community needs, and budget. Awarded DCoEs are expected to work with the DMCC to develop an enrollment plan that utilizes a tiered evaluation approach and is based on the specific diagnostic needs of each participant (e.g., Tier 1: initial screening/record review; Tier 2: telemedicine visits; Tier 3: comprehensive on-site clinical evaluations for a subset of participants; Tier 4: research activities) with plans to scale up enrollment as diagnostic efficiencies are established.
- Work closely with the DMCC and other DCoEs to improve the efficiency and cost-effectiveness of the clinical evaluation (e.g., Artificial Intelligence (AI)/machine learning and other innovative tools for record review and data analysis, tiered evaluation strategies and remote visits as described above, etc.), while still providing a comprehensive and expeditious clinical evaluation of participants.
- Although DCoEs are encouraged to enroll and evaluate participants with disorders in any clinical specialty, applicants have the option to specialize in one or more areas of clinical practice including but not limited to pediatrics, neurology, ophthalmology, cardiology, gastroenterology, immunology, metabolism, environmentally-linked or infectious diseases, etc.
- Seek reimbursement when possible from non-NIH sources for patient services, for example, by billing insurance, utilizing support from their institutions, outside partnerships, foundations, or private donors.
- Collaborate with the DMCC and other DCoEs to incorporate health economics approaches into network operations and establish additional outside funding partnerships including institutional and philanthropic support, and private donations to support the expansion and sustainability of the UDN in Phase III.
Expand access to the UDN for individuals and groups who historically have not benefited from modern diagnostic investigations due to race, ethnicity, socioeconomic status, geographic location, sex/gender, linguistic or other systemic barriers. To achieve this goal, DCoEs are expected to:
- Collaborate with the DMCC to recruit and enroll individuals from populations defined by the NIH to experience health disparities in the US.
- Partner with community collaborators that serve populations defined by the NIH to experience health disparities, including but not limited to academic institutions, local healthcare systems and hospitals, state and local public health agencies, community-based organizations, faith-based organizations, and rural or urban community health centers including those that serve economically disadvantaged individuals. At least one of the partnerships must be a community healthcare organization that provides services for economically disadvantaged individuals who are under/uninsured. Applicants are expected to establish cooperative and mutually beneficial partnerships with the community collaborators beyond simply providing patient referrals to the DCoE (e.g., opportunities for the community collaborators to partner with the DCoE in the clinical evaluation, gain clinical and research expertise in undiagnosed diseases, engage fully in UDN activities, and participate in DCoE decisions that impact the partnership) and provide appropriate reimbursement for research performed by the community collaborator. Note: the partnerships with community collaborators may also comprise a component of the applicant’s Plan for Enhancing Diverse Perspectives (PEDP), as described below.
- Prioritize NIH funds to cover the patient costs of under/uninsured participants along with research studies that facilitate a diagnosis.
In addition to continuing the fruitful genomic approaches established in Phase I/II of the UDN, Phase III DCoEs are expected to propose and develop innovative strategies to investigate other potential causal factors in undiagnosed diseases such as environmental insults, infectious, oncologic, immunologic, or complex genetic disorders.
Ensure that participants consistently receive a high-quality experience, for example, by collaborating with the DMCC to survey and incorporate input from patients, caregivers and family members into the practice of the UDN.

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

RFA-OH-24-001: National Center for Construction Safety and Health Research and Translation (U54)

Slots: 1

Deadlines

Internal Deadline: Friday, September 29, 2023

LOI: November 1, 2023

External Deadline: December 1, 2023

Recurring Deadlines: October 31, 2024; October 31, 2025; October 30, 2026; LOI 30 days prior to application due date.

Award Information

Award Type: Cooperative Agreement

Estimated Number of Awards: 1

Anticipated Award Amount: NIOSH intends to commit approximately $28.75 million in total costs (direct and indirect) over the entire project period (up to 5 years).

Who May Serve as PI: Standard NIH requirements.

Link to Award: https://grants.nih.gov/grants/guide/rfa-files/RFA-OH-24-001.html

Process for Limited Submissions

Materials to submit include:

(1) Two-Page Proposal Summary (1” margins; single-spaced; standard font type, e.g. Arial, Helvetica, Times New Roman, 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

This funding opportunity provides support for a National Center for Construction Safety and Health Research and Translation (National Construction Center) to address the significant and varied burden of work-related injuries and illnesses in the U.S. construction industry. The NIOSH National Construction Center serves as a national leader in construction research, implementation, and dissemination of scientific discoveries to benefit construction workers by working to prevent or reduce work-related injuries and illnesses. The NIOSH National Construction Center recipient will address both regional and national construction worker safety and health issues and prioritize the creation, dissemination, and widespread use of evidence-based solutions to address the most critical safety and health problems in the construction industry. Furthermore, the NIOSH National Construction Center will establish a publicly accessible online repository for research data, indicators, and research-to-practice materials and products. The overarching goal of the National Construction Center is to reduce adverse construction worker health and safety outcomes by studying, developing, and implementing evidence-based practices and solutions.

Approach

Applications for this funding opportunity should have a national scope for research, implementation, dissemination, and related activities described in this announcement. The proposed projects should aim to achieve the following objectives: 1) reducing and preventing construction worker exposures to safety and health hazards, 2) improving the safety culture and safety climate within the construction industry, 3) applying prevention through design, the hierarchy of controls, and emerging technologies where appropriate to address industry hazards, and 4) widely disseminating best practices and other information for use by workers, employers, contractors, and site owners. The National Construction Center is expected to work closely with NIOSH construction program leadership, academic and research partners, and other organizations to advance research integration and inform best practices and effective worksite solutions in the U.S. construction industry. Applicants should clearly describe how the intended outcomes of the proposed work will contribute to the specified goals in NIOSH’s Strategic Plan and, in the NIOSH Priority Goals for Extramural Research.

National Construction Center Structure

The NIOSH National Construction Center provides interdisciplinary research and outreach efforts to address occupational health and safety hazards in construction. Applicants should consider the required and optional components essential to the National Construction Center function, detailed below, in providing an overall description of the proposed Center, addressing 1) the burden of occupational injuries and illnesses for the construction sector, 2) the national need for the Center’s proposed programs and projects, and 3) the Center’s impact, or potential for impact, on construction worker health and safety.

To effectively address the purpose and scope of this NOFO, the following required components will enable the Center to cohesively address established goals and objectives for providing impact:

Planning, Administration, and Evaluation Core
Construction Industry Data and Statistical Core
Communication, Outreach, and Education Core
Research-to-Practice Core
Applied Research Projects (collectively, the Applied Research Core)

Please visit the RFA link above for more information.

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

RFA-NS-23-030: NINDS Clinical Trial Methods in Clinical Neurological Disorders Course (R25 Clinical Trial Not Allowed)

Slots: 1

Deadlines

Internal Deadline: Contact RII.

LOI: 30 days prior to the application due date

External Deadline: October 23, 2023

Award Information

Award Type: Grant

Estimated Number of Awards: 1

Anticipated Award Amount: $250,000/year

Who May Serve as PI: Standard NIH requirements.

Link to Award: https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-23-030.html

Process for Limited Submissions

Materials to submit include:

(1) Two-Page Proposal Summary (1” margins; single-spaced; standard font type, e.g. Arial, Helvetica, Times New Roman, 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 help recruit individuals with specific specialty or disciplinary backgrounds to research careers in biomedical, behavioral and clinical sciences.

Despite recent breakthroughs in neuroscience there are thousands of neurological disorders that still cause significant mortality and disability. There is an urgent need to continue to improve the efficiency of rigorous clinical trials in order to explore new therapeutic avenues. Effective training of researchers new to clinical trials is essential to promote successful and rigorous clinical trials to ultimately decrease burden of global neurological diseases.

The purpose of the “Clinical Trial Methods in Neurological Disorders Course” Notice of Funding Opportunity (NOFO) is to support educational activities in the mission areas of NINDS. The overarching goal of this R25 is to attract investigators who are new to or with limited exposure to clinical research, promote training of this workforce with the long-term goal of increasing the reliability and effectiveness of clinical trials by 1) introducing the principles of good clinical practice to investigators in any clinical neuroscience subspecialty, thereby providing a foundation for scientifically rigorous and ethical performance of patient oriented clinical research 2) exposing early career clinical scientists to the challenges and potential solutions to overcome these challenges in clinical research and, 3) increasing the number and expertise of knowledgeable clinical research investigators in the workforce to enhance the pipeline of scientifically sound, well-designed clinical trials. Long term, the development of well-trained, experienced clinical researchers with expertise will foster better clinical trials design and thereby hasten the introduction of improved regimens for therapy and prevention of neurological disorders into everyday medical practice and patient care.

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

Courses for Skills Development: The goal of this activity is to support a clinical trial methodology course to train a group of talented, dedicated clinical neuroscience researchers to enable them to obtain external funding in the future. Key components of the course include a program of didactic lectures, individual or group projects, discussion sessions, and mentoring sessions. The award will provide support for expenses for the implementation of the course in each year, including travel for all non-government course participants (faculty, advisors, and scholars) and all necessary materials and facilities, including meeting space, computer access, virtual meeting platform and course materials.

Research Experiences: An emphasis on early phase (i.e., phase I /II or pilot) trials within the mission areas of NINDS is essential, including pediatrics and rare diseases to address the full spectrum of neurological disorders. Developing trial designs for early phase trials are especially challenging yet critical to inform future scientific steps. A major component of the educational course is expected to be small group protocol development sessions and individual one-on-one mentoring sessions with faculty, as well as outreach/engagement in the community to learn crucial aspects of trial development and potential recruitment. At the conclusion of the course, participant scholars should have developed a sound clinically relevant and feasible clinical trial protocol.

This NOFO aims to provide support for research education projects focused on clinical trial methodology in neurological disorders that are novel, innovative and designed to accomplish a specific goal based on a well-conceived evaluation plan. Applications will be expected to include a detailed plan to evaluate the effectiveness of the activities proposed and to include a plan for disseminating results of this program.

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-DK-23-001: A Consortium for Gut-Brain Communication in Parkinson’s Disease (U24 Clinical Trial not allowed)

Slots: 1

Deadlines

Internal Deadline: Contact RII.

LOI: October 16, 2023

External Deadline: November 15, 2023

Award Information

Award Type: Cooperative Agreement

Estimated Number of Awards: 1

Anticipated Award Amount: Application budgets are limited to $400,000 in direct costs in 2024 and $925,000 in direct costs in 2025-2029. Budgets need to reflect the actual needs of the proposed project.

Who May Serve as PI: Standard NIH requirements.

Link to Award: https://grants.nih.gov/grants/guide/rfa-files/RFA-DK-23-001.html

Process for Limited Submissions

Materials to submit include:

(1) Two-Page Proposal Summary (1” margins; single-spaced; standard font type, e.g. Arial, Helvetica, Times New Roman, 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

CDMC Purpose and Research Objectives

Parkinson’s disease (PD) is the second most common and fastest growing neurodegenerative disorder, with approximately 60,000 Americans diagnosed annually. PD symptoms are not limited to motor dysfunction and more than 50% of patients who develop PD often have a history of complaints affecting nearly all parts of the gastrointestinal (GI) system. These GI symptoms often precede the onset of motor symptoms, indicating that GI dysfunction may be an early manifestation of the disease and the gut may be an unexplored diagnostic and/or therapeutic target. Few, if any, centers have sufficient information on GI dysfunction in patients with PD. Critical to moving the field forward is the collection of data and samples under a large-scale data sharing effort starting from the prodromal non-motor GI phase to the overt motor phase. Coordination of a multidisciplinary collaborative effort will provide the infrastructure needed to establish an annotated repository of biospecimens (e.g., CSF, blood, stool, and GI tissues) to allow for the identification and validation of developing innovative early-phase GI-based diagnostic tools and biomarkers for PD.

There is an acknowledged gap in our understanding of the temporal onset of GI symptoms and changes in gut-brain communication in PD that may contribute to disease pathogenesis or severity. This initiative seeks to leverage the potential role of the GI tract in the pathogenesis and progress of PD in order to improve patient diagnosis, care, and outcomes. To achieve this objective, two different types of centers will form a consortium investigating the role of the GI track in PD. This Notice of Funding Opportunity (NOFO) is to solicit new cooperative agreement applications for a single Coordinating and Data Management Center (CDMC) that will manage the Gastroenterology Neurology Research Centers (GNRCs) described in the companion NOFO, RFA-DK-22-036. The CDMC and GNRCs together will form the Gut Brain Parkinson’s Disease Consortium (GBPDC). While a major goal of the GBPDC is enrollment of PD patients and collection of biological samples relevant to gastroenterology- and neurology-based analyses, GNRC applicants are asked also to plan mechanistic studies that leverage the use of these biosamples. For example, the role of the intestinal microbiota in the pathogenesis of PD remains unclear and the GBPDC may undertake studies of the composition and activity of the intestinal microbiome, and integrate these results with clinical data and other analyses.

CDMC Organization and Management of the GNRCs of the GBPDC (additional information available at https://www.niddk.nih.gov/research-funding/human-subjects-research/policies-clinical-researchers)

It is essential that CDMC applicants familiarize themselves with the companion NOFO for the U01 Centers that will form the GBPDC (described fully in accompanying RFA DK-22-036). The CDMC will be the scientific and organizational nucleus and serve as the central resource for the activities of the GBPDC. As such, the administrative structure should bring strong leadership and program management skills to the GBPDC. The CDMC requires a team with a track record of academic excellence in the field of gastroenterology, neurology, or related areas, with expertise and experience in implementation of protocol harmonization and quality control and assurance. The GNRCs will be expected to conduct independent analyses (enlisting support from the CDMC, as appropriate), and also to participate in collaborative projects with other GNRCs in the GBPDC and to allocate resources and personnel for the performance of both independent and collaborative studies.

The CDMC will be responsible for the collation, management, and support of analysis of the clinical, molecular, and other data, and coordinating communication and research among the GNRCs. It will manage the processing of biospecimens, submission of clinical, cellular and molecular data to central databases, and data analysis. It will also coordinate large scale analyses (e.g., histopathology and molecular), contracting them to third-party providers of the appropriate laboratory services when this expedient is cost-effective. Inventory management, sample tracking, and publication monitoring will be essential required activities of this project.

GNRCs will be expected to share data and participant specimens with other GBPDC centers, as appropriate and consistent with program goals. The CDMC will coordinate shipment of blood and other biological samples from the GNRCs to create a repository for the GBPDC. The GBPDC will send a biological sample (when applicable) produced from each enrolled subject to the NIDDK Central Repository, an NIDDK supported resource, for eventual sharing with the broader research community, as appropriate and consistent with achieving the goals of the program. Collection of biological specimens should conform to the specimen collection protocols of the NIDDK-CR (https://repository.niddk.nih.gov/pages/for_submitters/) and NINDS BioSEND Repository (https://biosend.org/expertise.html ). To further promote data sharing, the CDMC will use Global Unique Identifiers (GUIDs) to provide a secure mechanism to link research participants across disciplines. GUIDs are required for each GNRC participant and the NIDDK has joined the NIH-centralized GUID server for participant sharing across institutes and studies. GUIDs allow data to be associated with a research participant without exposing or transferring personally identifiable information (PII) and/or protected health information (PHI). To support these activities, a web-based portal for this project will need to be developed and launched within the first 2 months after award, and updated in a timely fashion to reflect growth of the project. Raw and analyzed data should be made widely available via the project website if the associated projects do not themselves host a website for this activity.

In addition, the CDMC will be expected to oversee the following activities of the GNRCs, as well as others not mentioned in this list:

Develop study protocols, the manual of operations, data collection forms, questionnaires and monitoring of adherence to research plans and protocols, and other data formats to support secure data deposition from grantees of RFA-DK-22-036.
Support GNRC training, implementation, and study monitoring. Work with GNRC investigators on study design, including developing statistical analysis plans, power analyses, and study budgets.
Develop and maintain the study website, data repositories? and the data commons, including analytical tools and user-friendly web portals with the goal of enhancing dissemination, accessibility and utilization of GBPDC-generated resources across relevant research communities. Data management and web-based activities will include creating and curating a searchable database with detailed pre-analytic quality control (QC) and protocol information. All aspects of the databases and portal should conform to current NIH policies regarding encouraging compliance with FAIR principles: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4792175/.
Provide logistical support necessary to run an efficient and productive network, including videoconference support, meeting facilitation, and taking meeting minutes.
Coordinate closely with and/or manage the GNRC single Investigational Review Board (sIRB) to obtain and maintain IRB approvals and continuing renewals for all studies and ensure all recruiting sites have appropriate reliance agreements in place.
Conduct statistical analyses of study data for interim monitoring, final results, and secondary data analyses, and collaborating with study investigators to publish results of GBPDC studies and studies in a timely and accurate manner
Manage GBPDC-wide reporting and data and specimen sharing requirements, to include coordination of distribution of blood, biopsies, and other biological samples to the GNRCs, the CDMC, and to third-party providers of analytic services (which may be supported by subcontracts). Oversee all aspects of the data deposition, including timeliness and completeness of data, and provide any curation needed to ensure quality of data submission.

The Principal Investigator (PI) of the CDMC is expected to have broad experience in working collaboratively with a variety of health care systems in extracting health care data for research and in managing the related regulatory, ethical, and policy issues, including the NIH single IRB policy (NOT-OD-16-094). The PI should also have experience in coordinating transdisciplinary research teams. The CDMC must demonstrate expertise and capabilities in biostatistics, computational analysis and modeling, information technology and bioinformatics, data management, protocol development, and in coordinating and providing logistical support for meetings and conferences.

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