National Institutes of Health (NIH)
National Institute on Minority Health and Health Disparities (NIMHD)
National Institute on Aging (NIA)
National Institute of Nursing Research (NINR)
National Cancer Institute (NCI)
All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.
Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)
All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.
R01 Research Project Grant
See Section III. 3. Additional Information on Eligibility.
The purpose of this initiative is to advance the science and implementation of innovative multi-level health care research for older adults from populations that experience health disparities. The initiative will support research designed to (1) gain a better understanding of appropriate screening, diagnostic, and clinical care guidelines in a primary care setting, (2) explore shared decision-making that is needed to enhance care planning and patient agency between clinicians and care teams with the older adult and their caregiver(s), and (3) identify effective strategies for care coordination.
Not applicable
Application Due Dates | Review and Award Cycles | ||||
---|---|---|---|---|---|
New | Renewal / Resubmission / Revision (as allowed) | AIDS - New/Renewal/Resubmission/Revision, as allowed | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
February 05, 2025 * | March 05, 2025 * | May 07, 2025 * | July 2025 | August 2025 | December 2025 |
June 05, 2025 * | July 05, 2025 * | September 07, 2025 * | November 2025 | January 2026 | April 2026 |
October 05, 2025 * | November 05, 2025 * | January 07, 2026 * | March 2026 | May 2026 | July 2026 |
February 05, 2026 * | March 05, 2026 * | May 07, 2026 * | July 2026 | August 2026 | December 2026 |
June 05, 2026 * | July 05, 2026 * | September 07, 2026 * | November 2026 | January 2027 | April 2027 |
October 05, 2026 * | November 05, 2026 * | January 07, 2027 * | March 2027 | May 2027 | July 2027 |
February 05, 2027 * | March 05, 2027 * | May 07, 2027 * | July 2027 | October 2027 | December 2027 |
June 05, 2027 * | July 05, 2027 * | September 07, 2027 * | November 2027 | January 2028 | April 2028 |
October 05, 2027 * | November 05, 2027 * | January 07, 2028 * | March 2028 | May 2028 | July 2028 |
All applications are due by 5:00 PM local time of applicant organization.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
IMPORTANT: Per NOT-OD-24-086 updated application forms (FORMS-I) will be used for this opportunity. The updated forms are not yet available and will be posted 30 calendar days or more prior to the first application due date. Once posted, you will be able to access the forms using one of the following submission options:
Key Definitions
The term older adult refers to the chronologic definition of an older adult- arbitrarily set as individuals aged 65 and older.
The term populations that experience health/health care disparities refers to NIH-designated populations that experience health disparities in the United States: racial and/or ethnic minority populations, less privileged socioeconomic groups status (SES), underserved rural populations, persons with disabilities, and sexual and gender minority (SGMs) groups (https://www.nimhd.nih.gov/about/overview/).
The term multi-level refers to the multi-dimensional framework of determinants relevant to understand and address minority health and health disparities. This concept is further described under the NIMHD Research Framework (https://www.nimhd.nih.gov/about/overview/research-framework/).
The term care coordination refers to deliberately organizing patient care activities and sharing information among all the participants concerned with a patient's care to achieve safer and more effective care. Examples of broad care coordination include care management, medication management, home safety, and others.
The term care transition refers to the movement of a patient from one setting of care to another. Settings of care are defined as acute care hospitals, ambulatory primary care practices, ambulatory specialty care practices, long-term care facilities, home health, and rehabilitation or skill nursing facilities.
The term shared decision making refers to when a clinician and a patient/ their caregivers work together to make a health care decision that is best for the patient and consistent with the patients preferences. The optimal decision takes into consideration evidence-based information about available treatment and care options, the clinician's knowledge, experience, and ethos to do no harm and minimize risks, and the patient's values and preferences.
The term caregiver refers to a person or persons who provide care in a paid/ formal or unpaid/ informal capacity to people who need help taking care of themselves. This may include health professionals, family members, non-family members, friends, social workers, or members of the clergy. They may provide care at home or in a hospital or other health care setting.
The term diagnostic and clinical guidelines refers to evidence-based and evidence-informed recommendations that summarize current medical knowledge, weigh the benefits and harms of diagnostic procedures, treatments, and follow-up, and give specific recommendations or rely on empirical approaches on how to diagnose and treat a medical condition. In addition, within the context of the healthcare of older adults, some diagnostic and treatment decisions may be informed by expert consensus, up-to-date scientific knowledge, or patient preferences. In clinical scenarios in which there is not sufficient evidence, the diagnostic and/or treatment course of action may be based on the patient, caregiver and clinician shared decision in which do no harm principle and the best patient-centered outcomes and quality of life are considered.
Background:
The U.S. older adult (those aged 65 and over) population is rapidly growing and becoming more diverse. By year 2060, it is projected that nearly half of this population will be comprised of persons from racial and/or ethnic minority populations. Older adults from populations that experience health disparities are more likely to report poorer physical health, mental health, and quality of life. They also tend to have more coexisting health conditions including cognitive impairment and functional limitations, less access to timely diagnosis and optimal quality of care, and experience more hospital admissions, readmissions, and multiple care transitions. Furthermore, disparities in health and healthcare continue to persist among these populations and were magnified during the COVID-19 pandemic. Therefore, the current U.S. health care systems and workforces lack of preparedness to meet the challenges of caring for older adults, especially those from populations that experience health disparities is a serious public health and societal concern.
There is ample research evidence indicating that there are many factors that may lead to omissions and commissions of care for older adults that often result in preventable adverse outcomes including delays in or over-screening, missed or delayed diagnoses, and untimely treatment or over-treatment. Such factors include ageism, mistreatment, delivery of substandard care, errors in clinical judgement, providing care that may do more harm than good, and dismissal of health concerns by healthcare providers and/or caregivers. All of these can negatively affect the physical and mental health of older adults and co-occur with other forms of discrimination (e.g., racism).
In addition, making a correct and timely diagnosis and care plan for older adults is a process influenced by a myriad of factors that can influence screening and diagnostic tests performance and accuracy. Some of these include:
Well synchronized care coordination within and across care teams and care settings can mitigate health disparities in older adults. For example, well-coordinated in-home health care can allow individuals to remain living at home and maintain their independence by receiving care and support from a family caregiver or home health aide. Also, transitional care interventions for older adults are associated with reductions in preventable hospital and emergency room readmissions. On the other hand, many in-home caregivers may not be trained to properly handle the complex demands of providing and coordinating care. In addition, the effectiveness of care coordination may be impaired by the fragmentation of care, and breakdowns in coordination, communication, and collaboration processes between care team members, including the older adults and caregivers. These could result in delayed or missed diagnoses and timely treatment. Furthermore, interventions on care coordination involving in long-term care, palliative and/or end-of-life care settings -where most hospice care takes place-, and for patients from populations that experience health disparities are sparse.
Hence, crucial research gaps remain for improving the prevention, diagnosis, and treatment for many health conditions that burden older adults from populations that experience health disparities. Similarly, novel interventions that explore the role of shared decision-making and care coordination are needed.
Neglect and mistreatment of older adults would be expected to impair the effectiveness of medical care/diagnostic recommendations, care coordination and shared decision making. However, the risk and protective factors associated with mistreatment of older adults from populations that experience health disparities - and interventions to address it- are understudied. Therefore, the design, study and/or evaluation of strategies or interventions that address neglect and/or mistreatment within the context of care coordination across care teams, care settings, and agencies (e.g., protective services, home health, financial, legal services, housing) of older adults from populations that experience health disparities is another crucial research gap to be filled.
Research Objectives:
In addition to the goals stated under the Purpose, the overarching aim of this NOFO is to identify and understand best practices to engage older adults and their caregivers in providing appropriate care that is central to the attainment of optimal physical and mental health and wellbeing of older adults and the reduction of health disparities in this population.
Projects should focus on one or more NIH-designated health disparity populations living in the 50 states, the District of Columbia, Tribal Nations, and the U.S. territories. Projects that focus on racial and ethnic minority populations and/or low socioeconomic status (SES) persons are of particular interest. For all other categories, projects that explore the intersectionality of age, sex, race, and ethnicity and/or low SES with rural populations or SGM groups, and people with disabilities are encouraged. Applications proposing approaches which consider multi-level determinants of health (e.g., patient, clinician, health care system, community) to address health disparities while optimizing the health and well-being of older adults from populations that experience health disparities are encouraged. Please refer to the NIMHD Research Framework for additional detail. Applications that plan to collect primary data from older adults, caregivers, clinicians and other persons are strongly encouraged to use the measures on social determinants of health in the PhenX tool kit.
This initiative will support research in outpatient, inpatient, institutional-based long term care settings, home-based care, and emergency care facilities serving diverse older adults. In addition, research that involves a partnership with relevant agencies (such as area agencies on aging, state units on aging, senior services, advocacy organizations for older adults, faith-based services) that offer home and community-based services for the older adult such as home-delivered meals, case management, companionship programs, are welcome. Outpatient settings include primary care, specialty clinics and specialty care settings such as dialysis or chemotherapy centers. Inpatient and institutional long-term care settings include hospitals, assisted living facilities, skilled nursing facilities, and long-term chronic care institutions. Research within the context of transitional care (e.g., hospital to home, or rehabilitation to home), palliative care, end-of-life care, and long-term care, where patients interact with clinicians on a regular basis, is also of interest. Studies may involve in-person and/or telemedicine encounters. This initiative is not solely focused on clinical health outcomes. Research on intermediary measures of non-clinical outcomes (e.g., trust, self-efficacy, self-autonomy, empowerment, safety, and resilience) are of interest.
Research Methodology
This NOFO seeks to support descriptive studies, interventions (especially multi-component, multi-sectoral, and/or or multi-level interventions), clinical trials (including cluster-randomized trials, and pragmatic trials), quasi-experimental studies, natural experiments (e.g., impact of policy), quality improvement studies, mixed methods research, and simulation modeling. Projects focused on rural populations, SGM groups, and people with disabilities are encouraged to examine intersections with race and/or ethnicity, and SES. Comparison groups/populations may also be included as appropriate for the research questions posed. It is expected that lessons learned from this initiative can help build research evidence regarding approaches to improve health outcomes for older adults from populations that experience health disparities.
Specific Areas of Research Interest
NIMHD areas of research interests include but are not limited to the following:
Optimization of screening, diagnostic and clinical care guidelines for commonly experienced conditions
Shared medical decision-making to enhance care planning and patient agency.
Effective strategies for coordinating care for older adults from populations that experience health disparities.
Specific Areas of Research Interest for Participating Organizations:
National Cancer Institute (NCI)
NCI is interested in studies that will advance the development and implementation of innovative healthcare strategies across the cancer care continuum for older adults from populations that experience health disparities. Research areas of interest to NCI include, but are not limited to:
National Institute of Nursing Research (NINR)
The National Institute of Nursing Research (NINR) supports research aligned with our mission and strategic priorities, conducted by scientists from any discipline. NINR discovers solutions to health challenges through the lenses of health equity, social determinants of health, population and community health, prevention and health promotion, and systems and models of care. Drawing on the strengths of nursings holistic, contextualized perspective, core values, and broad reach, NINR funds multilevel and cross-sectoral research that examines the factors that impact health across the many settings in which nurses practice, including homes, schools, workplaces, clinics, justice settings, and the community.
National Institute on Aging (NIA)
The mission of NIA is to support and conduct genetic, biological, clinical, behavioral, social, and economic research on aging; foster the development of research and clinician scientists in aging; provide research resources; and disseminate information about aging and advances in research to the public, health care professionals, and the scientific community, among a variety of audiences. Work should be guided by the NIA Health Disparities Framework and intervention development aligned with the NIH Stage Model for Behavioral Intervention Development and Science of Behavior Change.
NIA supports research that involves primary data collection as well as secondary data analysis.
NIA areas of research interests related to older adults from minoritized populations include, but are not limited to, the following:
Office of Disease Prevention
Ofice of Disease Prevention (ODP): The ODP is the lead office at the NIH responsible for assessing, facilitating, and stimulating research in disease prevention. In partnership with the 27 NIH Institutes and Centers, the ODP strives to increase the scope, quality, dissemination, and impact of NIH-supported prevention research. The ODP provides co-funding support for research that has strong implications for disease and injury prevention, health equity, and research that includes innovative and appropriate research design, measurements, and analysis methods.
The ODP does not award grants; therefore, applications must be relevant to the objectives of at least one of the participating NIH ICs listed in this announcement. The ODP only accepts co-funding requests from NIH ICs. For questions regarding IC research and/or funding priorities, be sure to contact the relevant IC Scientific/Research Contact(s) named in this NOSI. For additional information about ODP, please refer to the ODP Strategic Plan or visit prevention.nih.gov.
Applications Not Responsive to the NOFO:
See Section VIII. Other Information for award authorities and regulations.
Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.
Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.
Optional: Accepting applications that either propose or do not propose clinical trial(s).
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
The scope of the proposed project should determine the project period. The maximum project period is 5 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women 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 and Notice of NIH's Interest in Diversity, NOT-OD-20-031.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply-Application Guide.
This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.
Number of Applications
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:
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 NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity 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.
Not Applicable.
All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply- Application Guide must be followed.
All instructions in the How to Apply- Application Guide must be followed.
All instructions in the How to Apply- Application Guide must be followed.
All instructions in the How to Apply- Application Guide must be followed.
All instructions in the How to Apply-Application Guide must be followed.
All instructions in the How to Apply- Application Guide must be followed.
All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:
Describe to what extent the project will contribute to advancing approaches to improving health outcomes for older adults from populations that experience health disparities across multiple levels and/or multiple domains of influence.
Describe the conceptual framework for the multi-level analysis.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.
Other Plan(s):
All instructions in the How to Apply-Application Guide must be followed, with the following additional instructions:
Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply- Application Guide.
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 How to Apply- 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 Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the How to Apply- Application Guide must be followed.
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 How to Apply- Application Guide must be followed.
All instructions in the How to Apply- Application Guide must be followed.
See Part 2. 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
Part I. 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). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIHs 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.
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 How to Apply-Application Guide.
This initiative is not subject to intergovernmental review.
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 Section 7.9.1 Selected Items of Cost.
Applications must be submitted electronically following the instructions described in the How to Apply 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 form. 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. See Section III of this NOFO for information on registration requirements.
The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organizations profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply 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 and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Requests of $500,000 or more for direct costs in any year
Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.
Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.
Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.
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.
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.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.
Reviewers will evaluate Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate criterion score.
Significance
Innovation
Approach
Rigor:
Feasibility:
Investigator(s)
Environment
As applicable for the project proposed, reviewers will consider the following additional items while determining scientific and technical merit, but will not give criterion scores for these items, and should consider them in providing an overall impact score.
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, 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, 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.
When the proposed research includes Vertebrate Animals, evaluate the involvement of live vertebrate animals 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. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section.
When the proposed research includes Biohazards, evaluate whether specific materials or procedures that will be used are significantly hazardous to research personnel and/or the environment, and whether adequate protection is proposed.
As applicable, evaluate the full application as now presented.
As applicable, evaluate the progress made in the last funding period.
As applicable, evaluate the appropriateness of the proposed expansion of the scope of the project.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Not Applicable.
Evaluate whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by Center for Scientific Review, in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.
Prior to making an award, NIH reviews an applicants federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicants integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.
A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipients business official.
In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk. For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:
All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.
Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. NIH may terminate awards under certain circumstances. See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support.
Not Applicable
Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.
When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Yewande Oladeinde, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-402-4307
Email: yewande.oladeinde@nih.gov
Michelle Doose, PhD, MPH
National Cancer Institute (NCI)
Telephone: 240-276-7674
Email: michelle.doose@nih.gov
Karen Huss, PhD, RN, ANP-BC, FAAN, FAAAAI, FAHA
National Institute of Nursing Research (NINR)
Telephone: 301-594-5970
Email: hussk@mail.nih.gov
Priscilla Novak, PhD, MPH
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: Priscilla.Novak@nih.gov
Robert McNellis, MPH, PA
Office of Disease Prevention (ODP)
Telephone: (301) 435-0824
E-mail: bob.mcnellis@nih.gov
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: pg38h@nih.gov
Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: crystal.wolfrey@mail.nih.gov
Ron Wertz
National Institute of Nursing Research (NINR)
Telephone: 301-594-2807
Email: wertzr@mail.nih.gov
Jeni Smits
National Institute on Aging (NIA)
E-mail: Jeni.smits@nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.