National Institutes of Health (NIH)

RFA-AG-26-003: National Alzheimer’s Coordinating Center (U24 Clinical Trial Not Allowed)

Slots: 1

Deadlines

Internal Deadline: Friday, July 18th, 2025, 5pm PT

LOI: September 16, 2025

External Deadline: October 17, 2025

Award Information

Award Type: Cooperative Agreement

Estimated Number of Awards: 1

Anticipated Award Amount: $16.56 million

Who May Serve as PI: Standard NIH requirements

Link to Award: https://grants.nih.gov/grants/guide/rfa-files/RFA-AG-26-003.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/. Use the template provided here: RII Limited Submission Applicant Template

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)

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

Purpose

A National Alzheimer’s Coordinating Center (NACC) is to serve NIA as:

1) a national data resource, collecting data from the ADRCs and their affiliated data and sample repositories;
2) a facilitator of current and future research on AD/ADRD; and
3) the central hub for organizing and enabling communication within and outside the ADRC program, including annual meetings and steering committees.

The goal of the overall ADRC program is to serve as major sources of discovery regarding the nature of AD/ADRD and the development of more effective approaches to prevention, diagnosis, care, and therapy. The ADRCs contribute significantly to the development of shared resources that support dementia-relevant research, and they collaborate to coordinate their research efforts with other NIH-funded programs and investigators. They also provide substantial support to increase the number of researchers engaged in these fields through a variety of research and infrastructure activities.

Structure

NACC will include the following three teams: Administrative, Database and Computing, and Research and Consulting.

Administrative Team

NACC will financially and logistically support semiannual in-person meetings, including support for outside speakers.

NACC will support a wide variety of communication functions for the overall ADRC program, including the following:

Serve as the point of contact for NIA, other NIA funded Centers and programs, and the broader scientific community, including the Research Coordinating Center Network (RCCN).
Provide a user-friendly web interface to serve the lay public as well as ADRCs and other investigators wishing to access ADRC clinical, neuropathological, neuroimaging, and biomarker data. The website should provide documentation such as coding guidebooks and data dictionaries as well as forms and instructions.
Conduct outreach activities to raise awareness of the availability of the data, including providing database training and support instructional webinars that bring new users to the data.
Track usage of the website and data resources, maintain a library of ADRC program activities, and follow up to early career investigator awards.
Maintain and update, as needed, interest group and Core Leader communications, support core steering committee elections, and organize and coordinate steering committee activities.
Maintain and regularly update the ADRC personnel directory.

Support the following additional administrative activities:

Solicit and support the review process and funding for peer-reviewed Early Career Investigator projects utilizing NACC data and affiliated resources.
Support subcontracts with each of the ADRCs to enable availability of rapid multi-center/national efforts and ensure timely and efficient data submission.
Ensure that copyrights for any assessment tools allow for broad sharing of the tools as well as the resulting data.
Ensure that data use agreements and safeguards are in place to prevent inadvertent release of personally identifiable information (PII).
Provide timely responses to inquiries from interested researchers.
Provide administrative support for the NACC Steering Committee, External Advisory Committee, Clinical Task Force, and collaborative activities as described below.
Prepare, conduct and analyze survey data as requested by Steering committees.
Plan for and advance future research needs for the ADRC program through the collaborative activities as described below.

Database and Computing Team

The Database and Computing Team will be responsible for ensuring the quality and accessibility of data, both for ADRC submission and for outside researcher access, as follows:

Maintain high standards of data quality for all new and existing NACC data.
Use modern database structures and functions, including streamlining of data submission and access processes, expanding version control, and developing automated processes for users.
Provide high-security-compliant, high-capacity informatics infrastructure suitable for data integration, storage, management, and sharing and ensure that the data meet findable, accessible, interoperable, and reusable (FAIR) principles.
Support collection and facilitate availability of digital biomarker data, as available and connected to other data on each participant.
Support collection of a standard set of imaging data as described by the ADRC Imaging Steering Committee, and coordinate with SCAN to analyze and provide data from images collected across the ADRCs (e.g., obtain segmented volumes for existing MRIs).
Implement and utilize global unique identifiers (GUID) collection throughout the ADRC program, facilitate deidentified submission to NACC and integration into the NACC database, and coordinate with other related data and sample resources such as NIAGADS and NCRAD.
Manage continuous improvements and expedite data distribution, e.g., quick access full data download for users.
Provide advanced online query and data visualization capabilities, investigator training, and instructions for data access.
Provide a plan for receiving and storing other imaging and biomarker assay data (in anticipation of future NIA, Clinical Task Force (CTF), or NACC Steering Committee directives).
Augment the ability to include legacy and other non-UDS data (currently held at individual sites) from participants already included in the national database, particularly access to item-level data.
Enhance and support data harmonization and integration with other NIA-funded programs (e.g., SCAN, NCRAD), as well as linkages with administrative data sources.

As a national data resource, NACC must foster communication and collaborative activities within and across ADRCs and interact with other connected national resources, including:

The National Centralized Repository for Alzheimer’s Disease and Related Dementias (NCRAD) to allow samples from the ADRCs to be connected with the data at NACC.
The National Institute on Aging Genetics of Alzheimer’s Disease Data Storage Site (NIAGADS) and the Alzheimer’s Disease Genetics Consortium (ADGC) to connect genetic information with other participant data.
Standardized Centralized Alzheimer’s Neuroimaging (SCAN) to develop standardized magnetic resonance imaging (MRI) and positron emission tomography (PET) neuroimaging protocols at participating ADRCs, then harmonizing this neuroimaging data so that it can be shared and used by the scientific community. NACC will be responsible for the collection and management of new neuroimaging data by creating a repository, ensuring its integrity, and providing qualified investigators access to the neuroimaging data and any associated non-neuroimaging data.

Research and Consulting Team

Promote and conduct research using NACC data.
Develop statistical/research methodology important to the research field.
Facilitate standardization of data collection and sharing processes throughout the ADRC program, where deemed appropriate by NIA and the NACC Steering Committee.
Provide monthly and annual data summaries to individual ADRCs and to NIA; seek novel ways to communicate and display summary information.
Plan to support data evaluations for future recommended changes to UDS or added data and data types to be collected.
Provide in-depth consultation to researchers interested in utilizing the NACC data for research questions.
Support planning and consultation for potential future ADRC applicants.

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

PAR-25-194: Limited Competition: Ruth L. Kirschstein National Research Service Award (NRSA) Predoctoral Research Training Grant for the Clinical and Translational Science Awards (CTSA) Program (T32 Clinical Trial Not Allowed)

Slots: 1

Deadlines

Internal Deadline: ~~Friday, June 27th, 2025, 5pm PT~~ Contact RII.

LOI: N/A

External Deadline: September 29, 2025;

Recurring Deadlines January 28, 2026; May 28, 2026; September 28, 2026; January 28, 2027; May 28, 2027; September 28, 2027

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.

Who May Serve as PI: The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be responsible for the selection and appointment of trainees to the approved research training program, and for the overall direction, management, administration, and evaluation of the program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required. The PD/PI has responsibility for the day to day administration of the program and is responsible for appointing members of the Advisory Committee (when applicable), using their recommendations to determine the appropriate allotment of funds.

The UM1 PD(s)/PI(s) may not be a PD(s)/PI(s) on the T32 application or award in order to ensure the PD(s)/PI(s) have adequate time to devote to the respective programs.

Link to Award: https://grants.nih.gov/grants/guide/pa-files/PAR-25-194.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 Background Information

The NRSA program has been the primary means of supporting predoctoral and postdoctoral research training programs since enactment of the NRSA legislation in 1974. Research training activities can be in basic biomedical or clinical sciences, in behavioral or social sciences, in health services research, or in any other discipline relevant to the NIH mission.

Institutional NRSA programs allow the Training Program Director/Principal Investigator (Training PD/PI) to select the trainees and develop a program of coursework, research experiences, and technical and/or professional skills development appropriate for the selected trainees. Each program should provide high-quality research training and offer opportunities in addition to conducting mentored research. Trainees should develop the ability to work effectively in teams with colleagues from a variety of cultural and scientific backgrounds, and to promote inclusive and supportive scientific research environments. The grant offsets the cost of stipends, tuition and fees, and training related expenses, including health insurance, for the appointed trainees in accordance with agency-approved support levels.

This Notice of Funding Opportunity (NOFO) provides an opportunity for the Hub to create, provide, and disseminate clinical and translational science training and career support programs for translational scientists and to support meaningful translational science research projects that address demonstrable needs among stakeholder communities.

Program Objective

The goal of the Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Predoctoral Research Training Grant for the Clinical and Translational Science Awards (CTSA) Program is to equip trainees with the knowledge, skills and abilities (KSAs) to advance diagnostics, therapeutics, clinical interventions, and behavioral modifications that improve health.

The National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH), is transforming the translational science process so that new treatments and cures for disease can be delivered to patients faster. NCATS strives to develop innovations to reduce, remove or bypass costly and time-consuming bottlenecks in the translational research pipeline in an effort to speed the delivery of new drugs, diagnostics and medical devices to patients.

Translation, translational research, and translational science are related but different. Translation turns observations in the laboratory, clinic, and community into diagnostics, therapeutics, medical procedures, and behavioral changes that improve people’s health. Translational research moves a project to the next step in the translational process. Translational science enables these projects to reach their goals faster and more efficiently. At NCATS, we define translational science as the field that generates scientific and operational innovations that overcome the long-standing barriers along the translational research pipeline. With its focus on improving the process, translational science ultimately leads to more treatments for all people more quickly.

The NCATS Translational Science Principles characterize effective approaches for advancing translational progress. These principles are described on the NCATS website (https://ncats.nih.gov/about/about-translational-science/principles). These principles are intentionally broad and apply to research anywhere along the translational continuum. While they exemplify translational science approaches, they are not intended to be comprehensive.

The NCATS Clinical and Translational Science Awards (CTSA) Program is designed to develop innovative solutions that will improve the efficiency, quality and impact of the process for turning observations in the laboratory, clinic and community into interventions that improve the health of individuals and the public. Sustaining a vibrant clinical and translational research enterprise requires a 21st century workforce that can advance clinical and translational science (CTS) that will, in turn, increase the efficiency and efficacy of translation, with the ultimate goal of getting more treatments to more patients more quickly.

Clinical and translational scientists will possess both deep scientific domain expertise and systems understanding, and their research is expected to be designed to produce discoveries that are simultaneously important for their discipline(s) and contribute to other disciplines, thus intentionally advancing the translational process as a whole. These characteristics will be required to successfully prepare trainees to transition into the many and varied productive career paths available to clinical and translational scientists within the translational science spectrum. Proposed training programs are expected to help trainees develop the following characteristics independent of their particular area(s) of expertise:

Domain Expert: Possesses deep disciplinary knowledge and expertise within one or more of the domains of the translational science spectrum ranging from basic to clinical to public health research and domains in between.
Boundary Crosser: Breaks down disciplinary silos and collaborates with others across research areas and professions to collectively advance the development of a medical intervention.
Team Player: Practices a team science approach by leveraging the strengths and expertise and valuing the contributions of all players on the translational science team. Has the ability to work effectively with colleagues from a variety of cultural and scientific backgrounds, and to promote inclusive, safe and supportive scientific research and training environments.
Process Innovator: Seeks to better understand the scientific and operational principles underlying the translational process and innovates to overcome bottlenecks and accelerate that process.
Skilled Communicator: Communicates clearly with all stakeholders in the translational process across social, cultural, economic, and scientific backgrounds, including patients and community members.
Systems Thinker: Evaluates the complex external forces, interactions, and relationships impacting the development of medical interventions, including patient needs and preferences, regulatory requirements, current standards of care, and market and business demands.
Rigorous Researcher: Conducts research at the highest levels of rigor and transparency within their field of expertise, possesses strong statistical analysis skills, and designs research projects to maximize reproducibility.

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

PAR-25-195: Limited Competition: Ruth L. Kirschstein National Research Service Award (NRSA) Postdoctoral Research Training Grant for the Clinical and Translational Science Awards (CTSA) Program (T32 Clinical Trial Not Allowed)

Slots: 1

Deadlines

Internal Deadline: ~~Friday, June 27th, 2025, 5pm PT~~ Contact RII.

LOI: N/A

External Deadline: September 29, 2025

Recurring Deadlines: January 28, 2026; May 28, 2026; September 28, 2026; January 28, 2027; May 28, 2027; September 28, 2027

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.

Who May Serve as PI: The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be responsible for the selection and appointment of trainees to the approved research training program, and for the overall direction, management, administration, and evaluation of the program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required. The PD/PI has responsibility for the day-to-day administration of the program and is responsible for appointing members of the Advisory Committee (when applicable), using their recommendations to determine the appropriate allotment of funds.

The UM1 PD(s)/PI(s) may not be a PD(s)/PI(s) on the T32 application or award in order to ensure the PD(s)/PI(s) have adequate time to devote to the respective programs.

Link to Award: https://grants.nih.gov/grants/guide/pa-files/PAR-25-195.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 is a limited competition. The National Center for Advancing Translational Sciences (NCATS) will award Ruth L. Kirschstein National Research Service Award (NRSA) Postdoctoral Institutional Research Training Grants for the Clinical and Translational Science Awards (CTSA) Program (T32) to eligible institutions to create, provide, and disseminate clinical and translational science training and career support programs that enhance postdoctoral research training of individuals with doctoral degrees (these include, but are not limited to, the following: D.M.D., DC, DO, DVM, OD, DPM, ScD, EngD, DrPH, DNSc, DPT, PharmD, ND [Doctor of Naturopathy], DSW, PsyD, as well as a doctoral degree in nursing research) and help ensure a heterogenous pool of clinical and translational scientists trainees are equipped with the knowledge, skills and abilities to advance diagnostics, therapeutics, clinical interventions, and behavioral modifications that improve health and support meaningful translational science research projects that address demonstrable needs among stakeholder communities.

NCATS will not accept applications proposing combined predoctoral and postdoctoral training under this Notice of Funding Opportunity (NOFO). Applications proposing predoctoral research training should apply to the Ruth L. Kirschstein National Research Service Award (NRSA) Predoctoral Institutional Research Training Grant for the Clinical and Translational Science Awards (CTSA) Program (PAR-25-194).

Applicants interested in providing short-term research experiences should apply to the companion NCATS Clinical and Translational Science Award (CTSA) Program Research Education Grants Programs (R25) (PAR-25-197). A short-term research experience is one where the participant is full-time (40 hours per week) for a period of 10 to 15 weeks, or as specified by the sponsoring institution in accordance with its own policies.

The proposed institutional research training program may complement other ongoing research training and career development programs at the applicant institution, but must be clearly distinct from related programs currently receiving Federal support.

This NOFO does not allow appointed Trainees to lead an independent clinical trial but does allow them to obtain research experience in a clinical trial on which the principal investigator is a mentor or co-mentor.

This NOFO is part of a required set of companion applications: the Clinical and Translational Science Award (UM1) and companion Institutional Career Development Award (K12). The remaining NOFOs in the suite are optional and include the Ruth L. Kirschstein National Research Service Award (NRSA) institutional training programs (T32 predoctoral and T32 postdoctoral), the Research Education Grant (R25), and the Specialized Innovation Program (RC2). These optional NOFOs are only available to CTSA Program UM1 applicants and award recipients. Applications to the companion NOFOs cannot be awarded until an award has been issued for the UM1 (see Section III. Eligibility Information of this NOFO and the respective NOFOs for more information).

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

PAR-24-128: Medical Scientist Training Program (MSTP) (T32)

Slots: 1

Deadlines

Internal Deadline: ~~Friday, June 27th, 2025, 5pm PT~~ Contact RII.

LOI: N/A

External Deadline: September 25, 2025

Recurring Deadlines: January 25, 2026; May 25, 2026; September 25, 2026; January 25, 2027

Award Information

Award Type: Grant

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

Anticipated Award Amount: Application budgets are not limited but must reflect the actual needs of the proposed project.

Who May Serve as PI:

To provide research training leadership for the program, at least one of the training PDs/PIs should have a record of using rigorous and transparent methods in experimental design, data collection, analysis, and reporting in a biomedical research field applicable to the program.
Additional PDs/PIs may be included to strengthen the expertise of the PD/PI team. Examples include individuals such as program directors who regularly interact with students, or individuals with expertise in education, relevant social sciences, program evaluation, mentoring, or university administration.

Any of the PDs/PIs may serve as the contact PD/PI. The contact PD/PI is expected to have a full-time appointment at the applicant organization unless extremely well-justified. If the full-time status of the contact PD/PI changes after the award, the organization must obtain prior program approval to appoint a new PD/PI or request a deviation from the full-time rule. The PD(s)/PI(s) will be responsible for:

The overall direction, management, administration, and evaluation of the program.
The day-to-day administration of the program, including direct involvement with trainees.
The selection and appointment of trainees to the research training program.
The selection of faculty mentors for the program, assessment of mentor performance, and ensuring the program deals appropriately with substandard mentor performance.
Monitoring and assessing the program and submitting all documents and reports as required.
Appointing members of the Advisory Committee (when applicable) and implementing their guidance as appropriate.

Link to Award: https://grants.nih.gov/grants/guide/pa-files/PAR-24-128.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)

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

The overall goal of the NIH Ruth L. Kirschstein National Research Service Award (NRSA) program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the nation’s biomedical, behavioral, and clinical research needs. More information about NRSA programs may be found at the Ruth L. Kirschstein National Research Service Award website. The NRSA program has been the primary means of supporting predoctoral and postdoctoral research training programs since enactment of the NRSA legislation in 1974.

Each NIGMS-funded MSTP award is expected to provide a rigorous, well-designed research training program that includes mentored research experiences, courses, seminars, and additional training opportunities that equip clinician scientists with the following skills required for careers in the biomedical research workforce:

Technical (for example, appropriate methods, technologies, and quantitative/computational approaches).
Operational (for example, independent knowledge acquisition, rigorous experimental design, interpretation of data, and conducting research in the safest manner possible).
Professional (for example, management, leadership, communication, and teamwork).

Through this funding announcement, NIGMS encourages changes in integrated clinical and graduate research training to keep pace with the rapid evolution of the biomedical research enterprise, which is increasingly complex, interdisciplinary, quantitative, and collaborative. Other changes in the biomedical research enterprise include greater diversity in the backgrounds of people participating in biomedical research, the approaches utilized to investigate clinically relevant research questions, and the range of careers that dual-degree recipients are pursuing. Additionally, there is an increasing recognition of the need to enhance reproducibility of biomedical research results through scientific rigor and transparency, and to promote a culture where the highest standards of practice are used to ensure the safety of all individuals in the research environment. This funding opportunity is intended to encourage and enable the scientific community to develop and implement evidence-informed approaches to biomedical research training and mentoring that will effectively train future generations of rigorous clinician scientists to become leaders in biomedical research and clinical medicine.

Programs are encouraged not to simply layer additional activities onto existing structures but to instead use creative and transformational approaches to integrate clinical and biomedical graduate training, including curricular reform, that preserve the best elements of current programs, while enhancing the focus on the development of trainee skills.

NIGMS strives to ensure that future generations of researchers will be drawn from the entire pool of potential contributors and seeks to expand opportunities to support individuals from a variety of backgrounds at multiple training and career stages in a variety of organizations and educational settings across the country. The Overarching Objective of the MSTP is to develop a diverse pool of well-trained clinician scientists (that is, a Ph.D. combined with a clinical degree, such as an M.D., D.O., D.V.M., D.D.S., Pharm.D., etc.) who have the following:

A broad understanding across biomedical disciplines.
The skills to independently acquire the knowledge needed to advance their chosen fields and careers.
The ability to think critically and identify important biomedical research questions and approaches that push forward the boundaries of their areas of study.
A strong foundation in scientific reasoning, rigorous research design, experimental methods, quantitative and computational approaches, and data analysis and interpretation.
The skills to conduct research in the safest manner possible, and a commitment to approaching and conducting biomedical research responsibly, ethically, and with integrity.
Experience initiating, conducting, interpreting, and presenting rigorous and reproducible biomedical research with increasing self-direction.
The ability to utilize clinical experience and observations to identify biomedical research questions and to develop impactful research programs that push forward the boundaries of their areas of study.
The skills necessary to integrate research and clinical activities and the capacity to translate scientific research findings into clinical practice.
The ability and skills to lead changes that promote health equity, reduce health disparities and improve the health of those medically underserved across diseases, disorders, and conditions.
The ability to work effectively in teams with colleagues from a variety of cultural and scientific backgrounds, and to promote inclusive and supportive scientific research environments.
The skills to teach and communicate scientific methodologies and findings to a wide variety of audiences (for example, discipline-specific, across disciplines, and for the public).
The knowledge, professional skills and experiences required to identify and transition into careers in the biomedical research workforce that utilize the dual-degrees (for example, the breadth of careers that sustain biomedical research in areas that are relevant to the NIH mission).

Program Considerations

NIGMS will accept predoctoral training grant applications supporting integrated clinician and graduate research training through this MSTP funding announcement and subsequent reissuances (graduate research training in basic biomedical sciences is supported through PAR-23-228 and subsequent reissuances). Applicants are strongly encouraged to read information about NIGMS predoctoral training grant programs, including the MSTP and Leading Equity and Diversity in the Medical Scientist Training Program (LEAD MSTP) (PAR-23-030), found on the NIGMS website and to contact program staff before preparing or submitting an application to verify that the proposed program is eligible and in alignment with NIGMS funding priorities.

General Considerations. NIGMS intends to fund applications that propose feasible, rigorous, well-designed and integrated dual-degree research training programs that will build on the most effective elements of successful programs, while encouraging creative and transformational approaches to clinician scientist research training, ranging from curricular reform to changes in the research training environment. Funded programs should implement plans to optimize the time required to earn the dual degree. Programs are expected to limit appointments to individuals committed to research careers that utilize the dual-degree qualifications.

NIGMS encourages programs to devise and test alternative entry pathways in addition to or instead of the direct application and admission to the first year of the dual-degree training program, thus providing opportunities to recruit students from clinician-only or from Ph.D.-only programs. NIGMS encourages institutions to offer MSTP trainees the opportunity to earn the Ph.D. in a broad range of biomedical, physical, and social and behavioral sciences, and engineering to meet the needs for clinician scientist researchers in all areas of the biomedical workforce. Programs that provide interdisciplinary research training, incorporate training in data science, or take advantage of clinical research opportunities within nationwide networks and infrastructures such as the NIH Clinical and Translational Science Award program are encouraged to apply. NIGMS encourages applicants to offer training across the landscape of medical fields and scientific disciplines related to health, and to promote opportunities for the exploration of clinician scientist career options. Funded programs are expected to:

Be a well integrated dual-degree program that exerts a strong, positive influence at the organizational level on research training and mentoring practices.
Have clearly defined training objectives and show evidence of meeting the objectives in progress reports and in renewal applications.
Implement evidence-informed training and mentoring activities (for example, approaches that are grounded in the literature and evaluations of existing relevant dual-degree research training programs). Programs are expected to be responsive to evaluations, particularly with respect to trainee feedback.
Provide rigorous, well-designed mentored research experiences, and additional opportunities that will build a strong cohort of dual-degree research-oriented individuals. Training grant funds may not be used solely as a vehicle to provide financial aid for trainees to conduct research.
Demonstrate effective oversight of dual-degree trainee development and promote retention for the entire time the dual-degree trainee is in the training program. Retention efforts are activities designed to sustain the scientific interests and participation of trainees from all backgrounds. Retention and oversight activities might include monitoring academic and research progress, building strong trainee cohorts, as well as increasing science identity, self-efficacy, and a sense of belonging within research training environments. Programs are expected to make efforts to identify individuals who may need additional academic and social supports to successfully complete the program, and ensure they receive the needed support.
Promote inclusive, safe, accessible, and supportive research training environments to maximize success for all individuals in the training program. Specifically, funded programs should have organizational and departmental environments where individuals from all backgrounds are welcomed, feel integrated into, and supported by the biomedical research community. Safety in research training should encompass (1) environments free from harassment, discrimination, and intimidation, in which all are treated in a respectful and supportive manner, (2) laboratory and clinical settings where individuals exercise the highest standards of practice for chemical, biological and physical safety, and (3) practices at the organizational leadership and research community levels that demonstrate core values and behaviors to emphasize safety over competing goals.

Trainee Support. The training grant defrays the cost of stipends, tuition and fees, and training related expenses, including health insurance, for the appointed trainees in accordance with the approved NIH NRSA support levels. NIGMS typically provides full-time support for approximately 25% of the trainees in the training program during any given year. Individuals may receive up to six years of aggregate Kirschstein-NRSA support at the predoctoral level for dual-degree training, including any combination of support from institutional training grants (for example, T32) and an individual fellowship award (for example, F30 or F31 awards). Many dual-degree training programs guarantee enrolled students full support for the duration of the dual-degree program (through combinations of federal support, institutional funds, other fellowships, and grants). Training programs may implement institutional policies regarding payback of non-NRSA institutional sources of funds by students who start training but do not complete one or both degrees. NIGMS does not require nor permit institutions to receive payback NRSA funds from trainees who are appointed to NIH training grants, but do not complete training.

Synergies of Federally Funded Training Programs. Funded research training programs are encouraged to complement and synergize with other ongoing federally supported predoctoral research training programs at the applicant organization (for example, in the development of skills needed for careers in the biomedical research workforce that are not discipline-specific); however, the scientific training goals must be distinct from related programs at the same organization currently receiving federal support. In cases where an organization has multiple NIGMS predoctoral training grants, it is expected that these programs will work together to create administrative and training efficiencies to reduce costs and improve trainee services and outcomes.

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

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

Slots: 2

Deadlines

Internal Deadline: TBA

LOI: 30 days prior.

External Deadline: January 27, 2026

Award Information

Award Type: Grant

Estimated Number of Awards: 4-6

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

Who May Serve as PI:

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

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

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

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

Process for Limited Submissions

RII-Limited-Submission-Application-Template.

Materials to submit include:

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

Purpose

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

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

Features of successful applications include:

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

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

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

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

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

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

Projects outside the NIGMS mission will be rejected without review.

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

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

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

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

Program Organization

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

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

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

Team Management and Optional Activities

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

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

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

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

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

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

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

Prior Consultation with IC staff

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

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

PAR-23-286: NCI Pathway to Independence Award for Early-Stage Postdoctoral Researchers (K99/R00 – Independent Clinical Trial Not Allowed)

Slots: Each eligible institution (defined as having a unique UEI number or NIH IPF number) may submit up to a combined total of four applications (one in Cancer Data Science, one in Cancer Control Science, one in Molecular/Precision Cancer Prevention, and one in Other Cancer Research) to any companion NOFO or any combination of companion NOFOs (PAR-23-286, PAR-23-287, and/or PAR-23-288).

Deadlines

Internal Deadline: ~~Friday, March 14th, 2025, 5pm PT~~ Contact RII.

LOI: N/A

External Deadline: June 16, 2025

Recurring Deadlines: October 14, 2025; February 17, 2026; June 15, 2026; October 14, 2026

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: Award budgets are composed of salary and other program-related expenses, as described in “Other Award Budget Information” of the RFA.

Who May Serve as PI:

NOTE: Candidates for this NOFO are strongly encouraged to obtain confirmation of their eligibility from NCI before seeking institutional nomination. It is incumbent upon the candidate to provide evidence that all eligibility criteria have been met.

Any candidate with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to seek institutional nomination and work with his/her mentor and organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. See, Reminder: Notice of NIH’s Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019. Multiple PDs/PIs are not allowed.

K99/R00 candidates must have no more than 2 years of postdoctoral research experience as of the relevant application due date. Individuals must be in mentored, postdoctoral training positions to be eligible for support under to the K99/R00 program. If a candidate achieves independence (i.e., any faculty or non-mentored research position) before a K99 award is made, neither the K99 award, nor the R00 award, will be issued.

Consistent with the NIH Extension Policy for Early Stage Investigator Status (ESI), NIH will approve an extension of one year for childbirth within the 2 year K99 eligibility window. Applicants with candidates who will be PD/PIs on a K99 application must provide the child’s date of birth in the extension request justification submitted to IC program officials and/or scientific/research contacts listed in the NOFO at least 12 weeks before submitting an application.

In addition, parental, medical, military, or other well-justified leave for personal or family situations of generally less than 12 months duration is typically not included in the 2-year eligibility limit, nor is clinical training with no research involvement (e.g., full-time residency training). Only time dedicated to research activities counts toward the 2-year limit. Part-time postdoctoral research training, related to personal or family situations or occurring during a research residency or fellowship, will be pro-rated accordingly.

Additional clarifications are provided under Frequently Asked Questions. Potential candidates are encouraged to discuss their individual situation with an NCI Scientific Program Contact before applying.

There is no citizenship requirement for K99 applicants. An applicant may be a citizen or a non-citizen national of the United States, have 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.

For applications submitted on behalf of non-U.S. citizens with temporary U.S. visas, visa status during each phase of the K99/R00 award must allow the PD/PI to conduct the proposed research at the applicant institution. For the K99 phase of the award, the applicant institution is responsible for determining and documenting, in the K99 application, that the candidate’s visa will allow him or her to remain in the U.S. long enough to complete the K99 phase of the award. For the R00 phase of the award, the U.S. institution at which the R00 phase of the award will be conducted is responsible for determining and documenting, in the R00 application, that the PD/PI’s visa will allow the PD/PI to remain in the U.S. for the duration of the R00 award.

Candidates for the K99/R00 award must have a clinical or research doctorate (including PhD, MD, DO, DC, ND, DDS, DMD, DVM, ScD, DNS, PharmD or equivalent doctoral degrees). Clinicians (including those with MD, DDS, DVM and other licensed health professionals) in a clinical faculty position that denotes independence in clinical responsibilities but not in research may also be eligible for the K99/R00 award.

Individuals are NOT eligible if they:

Have currently or previously held an independent research faculty or tenure-track faculty position, or its equivalent, in academia, industry or elsewhere; or
Have more than 2 years of related postdoctoral research training at the time of initial application or resubmission; or
Have been an independent PD/PI on NIH research grants (e.g. R01, R03, R21), NIH career development awards (e.g., K01, K07, K08, K23, K25), or other peer-reviewed NIH or non-NIH research grants over $100,000 direct costs per year, or Project Leaders on sub-projects of program project (P01) or center (P50) grants or the equivalent.

Ph.D. (or equivalent research doctorate degree) candidates in positions other than postdoctoral fellow positions: It is recognized that some institutions appoint postdoctoral fellows in positions with other titles although they are still in non-independent, mentored training positions. Candidates in such positions are encouraged to obtain confirmation of their eligibility from the relevant IC before they begin to prepare their applications. It is incumbent upon the candidate to provide evidence that their position complies with the intent of this eligibility requirement. If a potential applicant is in a position that is not clearly identifiable as a postdoctoral training position, candidate should provide the relevant NIH Institute or Center an official statement of the institution’s policy (e.g. published position description in an official institutional document) which documents the position as a mentored, postdoctoral training position.

Clinicians (including those with M.D., D.D.S, D.V.M. and other licensed professionals) in positions not designated as postdoctoral positions: Following clinical training or fellowship training periods, clinicians often obtain a clinical faculty position that denotes independence in clinical responsibilities but not in research. A clinical faculty member who does not hold an independent research faculty position may be eligible for the K99/R00 award, and should contact a Program Director at the relevant NIH Institute for guidance. Clinicians in such positions are encouraged to obtain confirmation of their eligibility before they begin to prepare their applications. Such individuals may also wish to consider other career awards (see K Kiosk) available for junior faculty development.

The following is provided as an aid to distinguish independent from non-independent positions: However, it is not sufficient merely to cite one or more of the following items to document eligibility.

Evidence for non-independence may include:

The candidate’s research is entirely funded by another investigator’s grants.
The candidate’s research is conducted entirely in another investigator’s assigned space.
According to institutional policy, the candidate cannot hire postdoctoral fellows or technical staff or be the responsible supervisor of graduate students.
According to institutional policy, the candidate is not allowed to submit an application as the PD/PI of an NIH research grant application (e.g., R01).
The candidate lacks other rights and privileges of faculty, such as attendance at faculty meetings.

Conversely, evidence for independence, and therefore lack of eligibility, includes:

The candidate has a full-time faculty position.
The candidate received a start-up package for support of their independent research.
The candidate has research space dedicated to their own research.
The candidate may attend faculty meetings, be the responsible supervisor for graduate students, and/or hire technical support or postdoctoral fellows.
The candidate is eligible to apply for independent research funding as the PD/PI of an NIH research grant.

Link to Award: https://grants.nih.gov/grants/guide/pa-files/PAR-23-286.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 overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation’s biomedical, behavioral, and clinical research needs. NIH Institutes and Centers (ICs) support a variety of mentored and non-mentored career development award programs designed to foster the transition of new investigators to research independence and to support established investigators in achieving specific objectives. Candidates should review the different career development (K) award programs to determine the best program to support their goals. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

The objective of the NCI Pathway to Independence Award for Early-Stage Postdoctoral Researchers (K99/R00) is to help postdoctoral researchers complete needed, mentored training and transition in a timely manner to independent tenure-track (or equivalent) faculty positions. The K99/R00 award is intended to foster the development of a creative, independent research program that will be competitive for subsequent independent funding and help advance the NCI mission.

This program is designed for postdoctoral fellows with research and/or clinical doctoral degrees who do not require extended periods of mentored research training beyond their original doctoral degrees before transitioning to research independence, which is common for those working in cancer control, cancer prevention and cancer data sciences, as defined in Section III. 3. Additional Information on Eligibility. Therefore, researchers from these disciplines are particularly encouraged to work with their institutions to apply.

This K99/R00 award is intended to support individuals who require no more than 2 additional years of mentored research training and career development (K99 phase) before transitioning to the independent stage (R00 phase) of the program. Consequently, the strongest applicants will require and will propose, a well-conceived plan for 1 2 years of substantive mentored research training and career development that will help their investigators become competitive candidates for tenure-track faculty positions and prepare them to launch robust, independent research programs.

Individuals must be in mentored, postdoctoral training positions to be eligible for support under the K99/R00 program. If an applicant’s candidate achieves independence (any faculty or non-mentored research position) before a K99 award is made, neither the K99 award, nor the R00 award, will be made. The K99/R00 award will provide up to 5 years of support in two phases. The initial (K99) phase will support up to 2 years of mentored postdoctoral research training and career development. The second (R00) phase will provide up to 3 years of independent research support, which is contingent on satisfactory progress during the K99 phase and an approved, independent tenure-track (or equivalent) faculty position. The two award phases are intended to be continuous in time. Therefore, although exceptions may be possible in limited circumstances, R00 awards will generally only be made to those applicants’ K99 PDs/PIs who accept independent, tenure-track (or equivalent) faculty positions by the end of the K99 award period.

Pre-Application Webinar: The NCI anticipates holding a pre-application webinar to which all interested prospective candidates, mentors, administrators, and grant managers are invited. An NCI program director will explain the goals and objectives of the NCI Pathway to Independence Award for Early-Stage Postdoctoral Researchers, discuss the eligibility and nomination requirements, explain the peer-review process, and answer questions. For details on the nomination letter see Sections III and IV. Information about the pre-application webinar will be available after the publication of the NOFO under the “NCI Early K99 Award” tab of the NCI Cancer Training Branch website.

Note: This Notice of Funding Opportunity (NOFO) is designed specifically for candidates proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. Under this NOFO candidates are permitted to propose a research experience in a clinical trial led by a mentor or co-mentor. Those proposing a clinical trial or an ancillary clinical trial as lead investigator, should apply to the companion NOFOs (PAR-23-287 or PAR-23-288).

NIH defines a clinical trial as “A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes” (NOT-OD-15-015).

NIH not only supports trials of safety and efficacy, it also supports mechanistic exploratory studies that meet the definition of a clinical trial and are designed to explore or understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention. These studies may focus on basic and/or translational discovery research in healthy human subjects and in human subjects who are affected by the pathophysiology of diseases and disorders. By addressing basic questions and concepts in biology, behavior, and pathophysiology, these studies may provide insight into understanding human diseases and disorders along with potential treatments or preventive strategies. NIH also supports biomarker studies that meet the definition of a clinical trial and that may provide information about physiological function, target engagement of novel therapeutics, and/or the impact of therapeutics on treatment response. NIH thus supports studies that meet the definition of clinical trials (as noted above) but do not seek to establish safety, clinical efficacy, effectiveness, clinical management, and/or implementation of preventive, therapeutic, and services interventions. All applications proposing basic science experimental studies involving humans, otherwise referred to in NOT-OD-18-212 as prospective basic science studies involving human participants, that fall within the NIH definition of a clinical trial and also meet the definition of basic research should apply to the companion NOFO (PAR-23-288).

Scientific Areas

(A) Cancer Data Science: For the purposes of this K99/R00 award, cancer data science is defined as an interdisciplinary field of inquiry in which quantitative and analytical approaches, processes, and systems are both developed and used to extract knowledge and insights from increasingly large and/or complex sets of data. This includes cancer-focused data integration and visualization, systems biology, artificial intelligence, machine learning, informatics, genomics, precision oncology, and developing analytics for epidemiological or biostatistical studies.
(B) Cancer Control Science: For the purposes of this K99/R00 award, cancer control science is defined as basic and applied research in the behavioral, social, and population sciences to create or enhance interventions that, independently or in combination with biomedical approaches reduce cancer risk, incidence, morbidity, and mortality, and improve quality of life. This includes research in epidemiology, behavioral sciences, health services, surveillance, cancer survivorship, and healthcare policy.
(C) Molecular/Precision Cancer Prevention: For the purpose of this K99/R00 award, early translational research in cancer prevention is defined as basic research to understand mechanisms of cancer formation, development and progression of cancer precursors, and to translate basic biological knowledge into novel human interventions and human-centered adaption of current interventions with the potential to reduce cancer risk, incidence, and mortality, and improve quality of life. This includes but is not limited to research in molecular and systems biology, diagnostics, vaccine and drug development, pharmacology, and biomedical engineering.
(D) Other Cancer Research: For the purposes of this K99/R00 award, “Other Cancer Research” includes all scientific fields supported by the NCI that are not included in (A), (B) or (C). Applicants proposing research in (D) “Other Cancer Research” may apply only if it is reasonable to expect their candidates to transition to independence with an abbreviated period of mentored research training beyond their original doctoral degrees.”

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