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The objective of the NIA Academic Leadership Career Award (K07) is to provide support for senior investigators who have the expertise and leadership skills to enhance aging and geriatric research capacity within their academic institution. This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by another investigator.

The purpose of this Funding Opportunity Announcement (FOA) is to encourage pilot and/or feasibility research in the following areas: 1) the development and pilot testing of new or adapted interventions to prevent or delay the initiation of substance use and/or the progression from use to misuse or disorder and 2) pre-trial feasibility and acceptability testing of services and service system research relevant to the prevention of substance use. In addition to the prevention of substance use, misuse and disorder, other outcomes of interest for the research supported through FOA include a reduction in negative sequalae such as deaths related to impaired driving, suicidal behavior (e.g., nonfatal and fatal attempts), and drug- or alcohol-related acquisition or transmission of HIV infection and viral hepatitis among diverse populations and settings.

The purpose of this funding opportunity announcement is to provide tailored support for early stage investigators (ESIs) to initiate basic or translational research with nonhuman primates (NHPs). These awards will allow ESIs additional funds, time to generate preliminary data, and the opportunity to establish all skills needed to set up and run an NHP laboratory independently. It is expected that these awards will thereby improve an ESIs ability to secure larger research awards (e.g., R01) and will facilitate their transition to independent tenure-track positions.

This Funding Opportunity Announcement (FOA) invites applications to develop and implement Phase Ib to III clinical trials of promising pharmacological and non-pharmacological interventions that may prevent, delay, or treat the symptoms of Alzheimer's disease (AD) and other age-related dementias using the Alzheimer's disease Clinical Trials Consortium (ACTC) trial coordination and management infrastructure.Research Objectives Utilizing the ACTC, the goal of this FOA is to invite research grant applications that provide clinical testing (Phases Ib-III) of promising pharmacological and/or non-pharmacological interventions for cognitive and neuropsychiatric symptoms in individuals with AD or other aging-related dementias across the spectrum from pre-symptomatic to more severe stages of disease. Working with the ACTC is a cooperative venture between the applicant, the NIA, and the ACTC network. NIA and the ACTC leadership will provide guidance to potential applicants. Potential applicants are strongly encouraged to contact NIA Scientific/Research Contacts (see Agency Contacts, Section VII) and the ACTC study team in order to discuss the feasibility of conducting the proposed trial through the ACTC infrastructure before considering an application. The ACTC infrastructure is welcoming of the following: Academic and industry applicants Pharmacological and non-pharmacological interventions Applications are encouraged that propose the following: Testing candidate therapeutic compounds against novel therapeutic targets Testing repurposed drugs derived from data-driven approaches, including candidates coming from NIA's translational bioinformatics FOA (PAR-17-032) Logistical guidance: Potential applicants undergo initial vetting of proposed study by the ACTC protocol evaluation committee and final review by the steering committee. Applicants should contact the ACTC study team at least 5 months prior to their desired NIA submission cycle. Contact details and more information may be found at actcinfo.org. Applications should anticipate using a centralized IRB. Applicants should be aware of the data and resource sharing requirements. The use of common contract language is strongly encouraged. Note, the ACTC infrastructure is not appropriate for: Single site clinical trials Routine Phase Ia first-in-human Clinical trials funded from this FOA will be implemented through the ACTC. The clinical trials approved for funding will develop their final protocols in conjunction with the ACTC. All ACTC sites will have the option to request participation and will be selected based on their capabilities specific to the individual protocols. Investigators are strongly encouraged to collect blood and other biosamples for future genomic and other 'omic' analyses aimed at interrogating treatment responsiveness and examining predictors of decline and progression. See Section VIII. Other Information for award authorities and regulations.

This funding opportunity provides financial support to researchers with active NIH grants to address unexpected costs and enhance their projects without changing the original research scope.

NLM wishes to accelerate the availability of and access to secure, complete data sets and computational models that can serve as the basis of transformative biomedical discoveries by improving the speed and scope of the curation processes.NLM wishes to accelerate the availability of and access to secure, complete data sets and computational models that can serve as the basis of transformative biomedical discoveries by improving the speed and scope of the curation processes. This Funding Opportunity Announcement is focused on automating curation of biomedical digital assets in support of Goal 1. Objective 1.1 of the NLM Strategic Plan 2017-2027: An important research direction will develop strategies for curation at scale." The ability to re-use, integrate or add to existing data sets will open new avenues of opportunity and can speed discoveries that will improve health. But this promise will go unrealized without advances in automated and autonomous curation. Objective 1.2: Automatic, autonomous curation strategies will allow for operational efficiency as well as accelerate the speed of discovery Digital curation involves characterizing, annotating, managing, and preserving digital assets such as research data sets, computational and other types of models, reusable visualization tools, and other digital assets. Proficient curation of digital assets maximizes their reuse potential, mitigates risk of obsolescence, reduces the likelihood that their long-term value will diminish or be lost, and helps assure reproducibility of research. The evolving digital ecosystem supports data-driven biomedical discovery by providing access to large quantities of biomedical and health-related data, to computational models and to open source software and code. The scope, scale and heterogeneity of digital data alone are vast, ranging from genome sequences to biomedical images, from observational health findings to environmental measurements, from family histories to sensor readings from personal trackers. As the amount and complexity of digital assets continue to grow, manual curation will not scale to meet future needs. At the same time, as researchers make research data sets, models and other tools available for new uses or re-analysis, it is important to minimize duplication and simplify the process of finding, managing, visualizing and mining all types of digital assets. To help researchers who want to find, interoperate and use these data sources to make new discoveries, and to share their findings so others can build upon them, the purpose of this funding announcement is to encourage applications for new approaches that (1) increase the speed and assure quality and security of storage techniques, retrieval strategies, annotation methods, data standards, visualization tools and other advanced data management approaches and (2) improve our ability to make biomedical data and other digital research assets findable, accessible, interoperable and reusable (FAIR).

This funding opportunity is designed for researchers and organizations to develop innovative solutions that improve the health and performance of Air Force personnel in challenging operational environments.

The primary purpose of the NIH Mentored Clinical Scientist Research Career Development Awards (K08) program is to prepare qualified individuals for careers that have a significant impact on the health-related research needs of the Nation. This program represents the continuation of a long-standing NIH program that provides support and "protected time" to individuals with a clinical doctoral degree for an intensive, supervised research career development experience in the fields of biomedical and behavioral research, including translational research.

The primary purpose of the NIH Mentored Clinical Scientist Research Career Development Awards (K08) program is to prepare qualified individuals for careers that have a significant impact on the health-related research needs of the Nation. This program represents the continuation of a long-standing NIH program that provides support and "protected time" to individuals with a clinical doctoral degree for an intensive, supervised research career development experience in the fields of biomedical and behavioral research, including translational research.

The primary purpose of the NIH Mentored Clinical Scientist Research Career Development Awards (K08) program is to prepare qualified individuals for careers that have a significant impact on the health-related research needs of the Nation. This program represents the continuation of a long-standing NIH program that provides support and "protected time" to individuals with a clinical doctoral degree for an intensive, supervised research career development experience in the fields of biomedical and behavioral research, including translational research.

The purpose of the Mentored Quantitative Research Career Development Award (K25) is to attract to NIH-relevant research those investigators whose quantitative science and engineering research has thus far not been focused primarily on questions of health and disease. The K25 award will provide support and "protected time" for a period of supervised study and research for productive professionals with quantitative (e.g., mathematics, statistics, economics, computer science, imaging science, informatics, physics, chemistry) and engineering backgrounds to integrate their expertise with NIH-relevant research. This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary clinical trial, as part of their research and career development. Applicants not planning an independent clinical trial, or proposing to gain research experience in a clinical trial led by another investigator, must apply to companion FOA.

The purpose of the Mentored Quantitative Research Career Development Award (K25) is to attract to NIH-relevant research those investigators whose quantitative science and engineering research has thus far not been focused primarily on questions of health and disease. The K25 award will provide support and "protected time" for a period of supervised study and research for productive professionals with quantitative (e.g., mathematics, statistics, economics, computer science, imaging science, informatics, physics, chemistry) and engineering backgrounds to integrate their expertise with NIH-relevant research.

The purpose of the NIH Mentored Research Scientist Development Award (K01) is to provide support and protected time (three to five years) for an intensive, supervised career development experience in the biomedical, behavioral, or clinical sciences leading to research independence. Although all of the participating NIH Institutes and Centers (ICs) use this support mechanism to support career development experiences that lead to research independence, some ICs use the K01 award for individuals who propose to train in a new field or for individuals who have had a hiatus in their research career because of illness or pressing family circumstances. Other ICs offer separate K01 FOAs intended to increase research workforce diversity.

The purpose of the NIH Mentored Research Scientist Development Award (K01) is to provide support and protected time (three to five years) for an intensive, supervised career development experience in the biomedical, behavioral, or clinical sciences leading to research independence. Although all of the participating NIH Institutes and Centers (ICs) use this support mechanism to support career development experiences that lead to research independence, some ICs use the K01 award for individuals who propose to train in a new field or for individuals who have had a hiatus in their research career because of illness or pressing family circumstances. Other ICs offer separate K01 FOAs intended to increase research workforce diversity.

The purpose of the Mentored Quantitative Research Career Development Award (K25) is to attract to NIH-relevant research those investigators whose quantitative science and engineering research has thus far not been focused primarily on questions of health and disease. The K25 award will provide support and "protected time" for a period of supervised study and research for productive professionals with quantitative (e.g., mathematics, statistics, economics, computer science, imaging science, informatics, physics, chemistry) and engineering backgrounds to integrate their expertise with NIH-relevant research. This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor. Applicants proposing a clinical trial or an ancillary clinical trial as lead investigator, should apply to the companion FOA ().

The purpose of the NIH Mentored Research Scientist Development Award (K01) is to provide support and protected time (three to five years) for an intensive, supervised career development experience in the biomedical, behavioral, or clinical sciences leading to research independence. Although all of the participating NIH Institutes and Centers (ICs) use this support mechanism to support career development experiences that lead to research independence, some ICs use the K01 award for individuals who propose to train in a new field or for individuals who have had a hiatus in their research career because of illness or pressing family circumstances. Other ICs offer separate K01 FOAs intended to increase research workforce diversity.

The purpose of the NIH Midcareer Investigator Award in Patient-Oriented Research (K24) is to provide support to mid-career health-professional doctorates for protected time to devote to patient-oriented research (POR) and to act as research mentors primarily for clinical residents, clinical fellows and/or junior clinical faculty. Section I. Funding Opportunity Description 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 NIH Midcareer Investigator Award in Patient-Oriented Research (K24) is designed to enable mid-career clinician-scientists to: Devote more time to augment their capabilities in Patient-Oriented Research (POR); and Provide mentoring to junior clinical investigators in the conduct of POR (see below for definition). The K24 award is intended to provide protected time to mid-career clinical investigators to provide mentoring to junior clinical investigators, particularly K23 grantees, in POR and to stabilize the careers of these investigators. The intent is to allow these investigators to continue to conduct POR and be available as mentors in POR. It is expected that K24 recipients will obtain new or additional independent, peer-reviewed funding for POR as PD/PI and establish and assume leadership roles in collaborative POR programs. In addition, it is expected that there will be an increased effort and commitment to act as a mentor to beginning clinician investigators in POR to enhance the research productivity of both the K24 investigator and increase the pool of well-trained clinical researchers of the future. For the purposes of the K24 award, Patient-Oriented Research is defined as research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. This area of research includes: (1) mechanisms of human disease; (2) therapeutic interventions; (3) clinical trials, and; (4) the development of new technologies. Excluded from this definition are in vitro studies that utilize human tissues but do not deal directly with patients. In other words, patient-oriented research is research in which it is necessary to know the identity of the patients from whom the cells or tissues under study are derived. Studies falling under Exemption 4 for human subjects research are not included in this definition. See also the NIH Director's Panel on Clinical Research Report. 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. Note: This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary clinical trial, as part of their research and career development. Applicants not planning an independent clinical trial, or proposing to gain research experience in a clinical trial led by another investigator, must apply to companion FOA Special Note: Because of the differences in individual Institute and Center (IC) program requirements for this FOA, prospective candidates are strongly encouraged to consult the Table of IC-Specific Information, Requirements and Staff Contacts, to make sure that their application is appropriate for the requirements of one of the participating NIH ICs. See Section VIII. Other Information for award authorities and regulations. Section II. Award Information Funding Instrument Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed New Resubmission Revision Renewal The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA. Clinical Trial? Required: Only accepting applications that propose an independent clinical trial(s) Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Award Budget Award budgets are composed of salary and other program-related expenses, as described below. Award Project Period The total project period may not exceed 5 years.

The purpose of the NIH Midcareer Investigator Award in Patient-Oriented Research (K24) is to provide support to mid-career health-professional doctorates for protected time to devote to patient-oriented research (POR) and to act as research mentors primarily for clinical residents, clinical fellows and/or junior clinical faculty. Level of Effort Candidates must be able to demonstrate the need for protected time, 3-6 person months (25-50% of full-time professional effort) for a period of intensive research focus as a means of augmenting their capabilities in POR and ability to act as a mentor to new clinical investigators in the conduct of POR during this period. Candidates for the K24 award may not concurrently apply for any other PHS career award or have another PHS career award pending review. Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution. Candidates with VA appointments should contact the staff person in the relevant Institute or Center prior to preparing an application to discuss their eligibility. After the receipt of the award, adjustments to the required level of effort may be made in certain circumstances. See NOT-OD-09-036 for more details. Renewals Depending on the policies of the sponsoring NIH Institute/Center, awardees may apply for a one-time renewal for an additional three to five years of support if the recipient continues to have independent peer-reviewed research support at the time of submission of the renewal application. Candidates should clearly demonstrate their continuing need for protected time to expand their research programs. Peer-Reviewed Research Support Depending on the policies of the sponsoring NIH Institute/Center, candidates are expected to continue to hold independent peer-reviewed research support for the period of this award. Candidates losing this support during the award period must document in their annual Progress Reports efforts to replace this support and demonstrate that they continue to meet all other requirements of the career award. Institutional Environment The applicant institution must have a strong, well-established record of research and career development activities and faculty qualified to serve as mentors in biomedical, behavioral, or clinical research.

The purpose of the NIH Midcareer Investigator Award in Patient-Oriented Research (K24) is to provide support to mid-career health-professional doctorates for protected time to devote to patient-oriented research (POR) and to act as research mentors primarily for clinical residents, clinical fellows and/or junior clinical faculty. Section IV. Application and Submission Information 1. Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution. 2. Content and Form of Application Submission It is critical that applicants follow the Career Development (K) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review. Page Limitations All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed. Instructions for Application Submission Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages. The following section supplements the instructions found in the SF 424 (R&R) Application Guide and should be used for preparing an application to this FOA. SF424(R&R) Cover All instructions in the SF424 (R&R) Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide must be followed. Other Project Information All instructions in the SF424 (R&R) Application Guide must be followed SF424(R&R) Senior/Key Person Profile Expanded All instructions in the SF424 (R&R) Application Guide must be followed. IMPORTANT REMINDER: The personal profile associated with the eRA Commons username entered in the Credential field for the PD/PI (candidate) must include an ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help. R&R Budget All instructions in the SF424 (R&R) Application Guide must be followed. PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) Application Guide must be followed. PHS 398 Career Development Award Supplemental Form Other Plan(s): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages. All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The PHS 398 Career Development Award Supplemental Form is comprised of the following sections: Candidate Research Plan Other Candidate Information Mentor, Co-Mentor, Consultant, Collaborators Environment & Institutional Commitment to the Candidate Other Research Plan Sections Appendix All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Candidate Section All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Candidate Information and Goals for Career Development Candidate’s Background Provide details of the candidate’s immediate and long-term career objectives in POR and in mentoring new clinician investigators. Include a summary of the research career of the candidate, documenting the ability of the candidate to conduct high quality POR and commitment to a career in POR. Document the ability of the K24 candidate to provide mentoring to new clinician investigators without duplicating information in the biosketch. Provide the number of years of mentoring experience, mentoring role (i.e., research advisor, clinical mentor, etc.), the number of clinicians mentored, the specialties of the individual mentees and the stages in their professional career. In addition, describe the types of research that were conducted by the individuals mentored, and the proportion of mentored individuals currently in academic medicine and/or directly participating in POR. Provide an explanation as to how relief from patient care or administrative responsibilities through the protected time provided by this award will contribute to the development or expansion of the candidate’s POR program and increased level of commitment to mentoring new and early stage clinician investigators. It is important to convey to the reviewers the reasons for needing protected time to continue a vital research program and continue to engage in the mentoring of new scientists. It should be clear that this award will permit the candidate to spend more time on research and mentoring and less time on administrative and clinical responsibilities for the institution. Career Goals and Objectives Describe the candidate's career goals and objectives under this award, including prior experience, and current research support. Candidates are encouraged to provide a timeline for accomplishing these goals and how this award will enhance mentoring or inclusion of mentoring in their career activities. Candidate’s Plan for Career Development/Training Activities During Award Period Describe the professional responsibilities/activities including other research projects beyond the minimum required effort commitment to the career award. Explain how these responsibilities/activities will help ensure career progression to achieve independence as an investigator. The candidate should describe any new or enhanced research skills and knowledge he/she will acquire during the career award period, and how these skills and experiences will significantly enhance his/her ability to continue his/her research programs as an independent scientist. Research Plan Section All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Research Strategy Currently supported research: There is no need to provide extensive detail with regard to ongoing, funded research. Enough information should, however, be provided in the areas of Hypotheses and Specific Aims; Background, Significance and Rationale; Preliminary Studies and Results; and Research Design and Methods to permit the peer reviewers to evaluate the extent, special features and general quality of the candidate's research activities and opportunities for mentoring. New research to be specifically supported by this award: Describe how this award will be used to help augment the candidate’s research skills and/or develop new directions in POR. This description should include a Statement of Hypothesis and Specific Aims; Background, Preliminary Studies and Aims; Significance and Rationale; and Research Design and Methods. Although it is not expected that this description would be as detailed as an application for an investigator-initiated research grant (e.g., R01), it is expected that sufficient detail be provided to permit an evaluation of the scientific merit of the research, and to clearly show research opportunities for mentoring. Documentation must be provided that appropriate and adequate resources, both in terms of support and facilities are available to the candidate to conduct the research program(s). This is an important part of the application because it will provide the main rationale and justification for needing protected time for research. The candidate must ensure that the inclusion of women, members of minority groups and their subpopulations, and children, has been addressed in the development of the design for all proposed patient-oriented research. The candidate must provide this information for each new research project proposed. Candidates must provide plans for ensuring continuing support of their POR programs preferably with them as the PD/PI. If the applicant is proposing to gain experience in a clinical trial, ancillary clinical trial or a clinical trial feasibility study as part of his or her research career development, describe the relationship of the proposed research project to the clinical trial. Training in the Responsible Conduct of Research All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). See SF424 (R&R) Application Guide for instructions. Other Candidate Information Section Candidate's Plan to Provide Mentoring This required component should include a description of the availability of appropriate junior investigators for mentoring; their previous training and specialization; plans for recruitment, selection and supervision; the types of educational and research experiences that will be provided; and the capacity in which the candidate for the career award will serve as a mentor. If there is an existing (clinical) research curriculum (e.g., through a CTSA), describe how the mentoring plan will be integrated with the curriculum. Candidates must also describe a plan for supporting the research of their mentees during the period of the career award. Candidates must indicate the proposed person months committed to the mentoring plan. Mentor, Co-Mentor, Consultant, Collaborators Section All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Plans and Statements of Mentor and Co-mentor(s) Not Applicable Letters of Support from Collaborators, Contributors and Consultants Signed statements must be provided by all collaborators and/or consultants confirming their participation in the project and describing their specific roles. Collaborators and consultants do not need to provide their biographical sketches unless also listed as senior/key personnel. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration. Environmental and Institutional Commitment to the Candidate All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Description of Institutional Environment The sponsoring institution must document a strong, well-established research and career development program related to the candidate's area of interest, including a high-quality research environment with key faculty members and other investigators capable of productive collaboration with the candidate. Describe how the institutional research environment is particularly suited for the development of the candidate's research career and the pursuit of the proposed research plan. Describe the resources and facilities that will be available to the candidate Institutional Commitment to the Candidate’s Research Career Development The sponsoring institution must provide a statement of commitment to the candidate's development into a productive, independent investigator and to meeting the requirements of this award. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of this career award. The letter of commitment from the institution should provide statements concerning the amount of protected time the candidate will receive (3-6 person-months or 25 to 50% full-time professional effort required); the duties from which he/she will be relieved (if clinical duties, the institution should describe specific steps that will be taken to cover these duties, such as hiring clinical staff); and the institutional commitment to enhancing the candidate's ability to be a productive, independent investigator. Appendix Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions. PHS Human Subjects and Clinical Trials Information When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions: If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions: Do not complete Section 4 – Protocol Synopsis information or Section 5 - Other Clinical Trial-related Attachments. Delayed Onset Study Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed. PHS Assignment Request Form All instructions in the SF424 (R&R) Application Guide must be followed. 3. Unique Entity Identifier and System for Award Management (SAM) See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov. 4. Submission Dates and Times Part I. Overview Information contains information about Key Dates and Times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day. Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission. Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission. Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide. 5. Intergovernmental Review (E.O. 12372) This initiative is not subject to intergovernmental review. 6. Funding Restrictions All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. Pre-award costs are allowable only as described in the NIH Grants Policy Statement. 7. Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted. Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration. For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission contact the Application Submission Contacts in Section VII. Important reminders: All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide. See more tips for avoiding common errors. Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed. Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy. Section V. Application Review Information 1. Criteria Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review. Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system. Overall Impact Reviewers should provide their assessment of the likelihood that the proposed career development and research plan will enhance the candidate’s potential for a productive, independent scientific research career in a health-related field, taking into consideration the criteria below in determining the overall impact score. Scored Review Criteria Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. Candidate Is there evidence of ongoing high quality patient-oriented research, and what is the relationship of that research to this K24 application? Is there evidence of the candidate's capabilities and commitment to serve as a mentor for new clinical investigators in the conduct of patient-oriented research? Does the application demonstrate that the proposed program and protected time will relieve the candidate from non-research patient care and administrative duties and allow him/her to devote additional time and to augment his/her capabilities in patient-oriented research? Does the application demonstrate a record of independent peer-reviewed support for patient-oriented research that is likely to continue during the K24 award? Plan to Provide Mentoring Are the plans to provide mentoring or supervising new clinical investigators in patient oriented research adequate? Are plans to integrate appropriate clinical research curricula, into the mentoring plans adequate? Is an appropriate level of effort proposed for the mentoring component? Research Plan Candidates are expected to have independent, peer reviewed research support at the time the career award is made. In such instances, reviewers should not re-evaluate the research plan. Rather, the reviewers should evaluate how the research and career development plans together further the candidate’s research career. Is the research plan an appropriate vehicle for demonstrating and developing the prospective mentee’s skills and capabilities in patient-oriented research? Are the scientific and technical plans of the proposed research of merit? Is the proposed research relevant to the candidate's career objectives? Are adequate resources available to conduct the research program? This includes adequacy of plans for continued support of the research during the funding period of the grant. If proposed, will the clinical trial experience contribute to the proposed research project? Consultant(s), Collaborator(s) Is adequate information provided that clearly documents expertise in the proposed area(s) of consulting/collaboration? Environment & Institutional Commitment to the Candidate Are the research facilities, resources and training opportunities, including faculty capable of productive collaboration with the candidate adequate and appropriate? Is there assurance that the institution intends the candidate to be an integral part of its research program as an independent investigator? Is the level of the applicant institution’s commitment to the scientific development of the candidate appropriate? Are the size and quality of the pool of clinician investigators to be mentored by the PD/PI adequate? Are the quality and relevance of the environment for continuing the scientific and professional development of the candidate and for others pursuing patient-oriented research appropriate and adequate? Is there adequate commitment from the sponsoring institution to provide protected time for the candidate to conduct the research and mentoring program? Is the level of commitment of the candidate’s institution to the career development in patient-oriented research of new clinical investigators mentored by the candidate adequate? Additional Review Criteria As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items. Protections for Human Subjects For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: (1) risk to subjects, (2) adequacy of protection against risks, (3) potential benefits to the subjects and others, (4) importance of the knowledge to be gained, and (5) data and safety monitoring for clinical trials. For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: (1) the justification for the exemption, (2) human subjects involvement and characteristics, and (3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects. Inclusion of Women, Minorities, and Individuals Across the Lifespan When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals across the lifespan (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research. Vertebrate Animals The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section. Biohazards Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed. Resubmissions For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project. Renewals For Renewals, the committee will consider the progress made in the last funding period. Revisions For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

The purpose of the NIH Pathway to Independence Award (K99/R00) program is to increase and maintain a strong cohort of new and talented, NIH-supported, independent investigators. This program is designed to facilitate a timely transition of outstanding postdoctoral researchers with a research and/or clinical doctorate degree from mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions. The program will provide independent NIH research support during this transition in order to help awardees to launch competitive, independent research careers.