NIMHD Exploratory/Developmental Research Grant Program (R21 - Clinical Trial Optional)

NIMHD Exploratory/Developmental Research Grant Program (R21 - Clinical Trial Optional) is sponsored by National Institute on Minority Health and Health Disparities (NIMHD), NIH. Encourages exploratory and developmental research projects that address health disparities, including vascular health issues in minority populations.

Expired PAR-23-111: NIMHD Exploratory/Developmental Research Grant Program (R21 - Clinical Trial Optional) This notice has expired. For NIH, in limited situations, applications may be accepted on a case-by-case basis for a short period after expiration to accommodate NIH late or continuous submission policies . Contact the eRA Service Desk for any submission issues.

Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute on Minority Health and Health Disparities ( NIMHD ) Funding Opportunity Title NIMHD Exploratory/Developmental Research Grant Program (R21 - Clinical Trial Optional) R21 Exploratory/Developmental Research Grant Notices of Special Interest associated with this funding opportunity May 9, 2025 - Notice to Applicants That the Simplified Review Framework Will be Applied to All Relevant Applications for August/October 2025 Councils.

See Notice NOT-OD-25-116 . March 31, 2025 - This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission.

April 04, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 February 21, 2024 - Notice of Change in Key Dates for PAR-23-111, "NIMHD Exploratory/Developmental Research Grant Program (R21 - Clinical Trial Optional)".

See Notice NOT-MD-24-006 NOT-OD-22-195 New NIH "FORMS-H" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2023 NOT-OD-22-189 Implementation Details for the NIH Data Management and Sharing Policy NOT-OD-22-198 Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023 NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity See Section III.

3. Additional Information on Eligibility .

Assistance Listing Number(s) Funding Opportunity Purpose NIMHD invites applications to support short-term exploratory or developmental research projects that have the potential to break new ground in the fields of minority health and/or health disparities or extend previous discoveries toward new directions or applications that can directly contribute to improving minority health and/or reducing health disparities in the U. S .

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) The following table includes NIH standard due dates marked with an asterisk. Renewal / Resubmission / Revision (as allowed) 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.

New Date May 24, 2025 per NOT-OD-25-113 (Originally May 08, 2026) Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide , except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the FOA) 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. Part 1. Overview Information Part 2.

Full Text of Announcement Section I. Funding Opportunity Description Section II. Award Information Section III.

Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Part 2.

Full Text of Announcement Section I. Funding Opportunity Description While scientific and technological discoveries have improved the health of the U.S. population overall, many populations, including racial/ethnic minorities and other disadvantaged groups, continue to bear disproportionate burdens of disease and adverse health conditions.

The purpose of this FOA is to encourage new exploratory or developmental research projects that have the potential to break new ground in the fields of minority health and health disparities or extend previous discoveries toward new directions or applications that can directly contribute to improving minority health or reducing health disparities.

Long-term projects or projects designed to incrementally increase knowledge in a well-established area are not appropriate for this FOA. Consistent with the exploratory and/or developmental nature of research projects envisioned under this FOA, applications are not expected to include and are strongly encouraged to not include preliminary data. Projects led by NIH-defined early-stage investigators (ESI) are particularly encouraged.

Such projects should exhibit strong potential to position the ESIs to compete successfully for R01 funding in the near future. Investigators, whether established or early stage, who have supportive preliminary data are strongly encouraged to consider applying through a relevant R01 FOA instead of this FOA.

Projects are expected to focus on human and population-based studies in the biomedical, clinical, population, behavioral or social sciences.

This can include research with human participants, in vitro studies that utilize human tissues to investigate mechanisms underlying resilience or susceptibility to disease, observational studies, epidemiologic studies, patient outcomes research, intervention research, dissemination and implementation research, and health services research. Animal studies will not be supported under this FOA.

Projects must include a focus on one or more NIH-designated health disparity populations in the US, which include Blacks or African Americans, Hispanics or Latinos, American Indians and Alaska Natives, Asians, Native Hawaiians and Other Pacific Islanders, socioeconomically disadvantaged populations, and underserved rural populations. Comparison groups may be included as appropriate for the research question(s) posed.

Populations outside the US may be included if the purpose is to inform understanding of the health of immigrants in the US who belong to designated health disparity populations. NIMHD has organized its extramural scientific programs around three broad research interest areas: 1) Clinical and Health Services Research, 2) Community Health and Population Sciences, and 3) Integrative Biological and Behavioral Sciences.

The Clinical and Health Services Research area supports clinical research focused on improving patient health care outcomes and the quality of healthcare services for health disparity populations.

The Community Health and Population Sciences area supports research on interpersonal, family, neighborhood, community and societal-level mechanisms and pathways that influence disease risk, resilience, morbidity, and mortality in health disparity populations.

The Integrative Biological and Behavioral Sciences area supports research examining how human biological and behavioral mechanisms and pathways acting at the individual and interpersonal levels influence resilience and susceptibility to adverse health conditions that disproportionately affect health disparity populations. For details about these research areas please visit https://www. nimhd.

nih. gov/programs/extramural/research-areas/ .

Projects are expected to use multidisciplinary approaches encompassing multiple domains of influence (e.g., biological, behavioral, socio-cultural, environmental, physical environment, health system) and multiple levels of influence (e.g., individual, interpersonal, community, societal) to understand and address minority health and health disparities (see the NIMHD Research Framework, https://www. nimhd. nih.

gov/about/overview/research-framework. html , for more information). Projects are expected to fall into one of three broad categories: Secondary analysis of existing data.

Projects in this category are expected to use quantitative analytic approaches. Quantitative data analysis may be supplemented or complemented with qualitative data collection as appropriate for the research questions posed.

Secondary data sources may include but are not limited to the following: Completed or ongoing studies funded by NIH, including large cohort studies, e.g., Jackson Heart Study, Hispanic Community Health Study/Study of Latinos, Strong Heart Study, Multiethnic/Minority Cohort Study of Diet and Cancer, Coronary Artery Risk Development in Young Adults, Multi-Ethnic Study of Atherosclerosis, Adolescent Brain and Cognitive Development Study, Environmental influences on Child Health Outcomes Program, All of Us Research program, Collaborating Consortium of Cohorts Producing NIDA Opportunities (C3PNO), Population Assessment of Tobacco and Health Study, and others; Federal- or state-sponsored population-based surveys or surveillance programs, e.g., National Health Interview Survey, National Health and Nutrition Examination Survey, Behavioral Risk Factor Surveillance System, NCI Surveillance, Epidemiology, and End Results (SEER) Program and other NIH data repositories, American Community Survey, and other studies in the public domain.

Private or public administrative or clinical datasets, e.g., Medicaid/Medicare claims data, Hospital Consumer Assessment of Healthcare Providers and Systems data, state all-payer claims databases, patient or disease registries, electronic health record systems in community health centers or health systems caring for a disproportionate share of health disparity populations, vital statistics records, and others Development and application of novel research measures, methodologies or analytic approaches.

Projects in this category are expected to offer innovative, multidisciplinary research approaches to advance the science of minority health and health disparities. Potential topics include but are not limited to the following Development or adaptation of measures or assessment tools for use with health disparity populations and/or to assess relevant determinants or risk and resilience factors related to health disparities.

Novel strategies to identify mechanistic pathways that cause, sustain, or reduce health disparities or promote resilience. Novel approaches to characterize and analyze interactions and underlying pathways among multiple etiologic risk and protective factors, e.g., socioeconomic, environmental, behavioral, psychosocial, and biological factors. Novel approaches to characterizing or quantifying sociocultural influences on health.

Novel methods to engage health disparity populations in research or to collect relevant data, including multi-level data. Novel strategies for linkage and analysis of multi-level and other complex data, strengthening causal inferences in observational data, and developing or evaluating algorithms used in clinical care or other service delivery. Novel approaches to conducting community-engaged research.

Projects proposing to apply existing measures, methodologies, or analytic approaches to health disparity populations without specifically adapting or adjusting these approaches to address health disparity-related research questions are not a priority for support under this FOA Development and pilot testing of new or adapted interventions.

Projects in this category are expected to focus primarily on testing the feasibility, acceptability and/or preliminary efficacy of new or adapted interventions for improving minority health and reducing health disparities in the US. Testing preliminary efficacy refers to the examination of the impact of the intervention on short-term outcomes related to health attitudes, cognitions, behaviors, or health status.

It is not expected that pilot project results will be used to generate effect sizes for future studies. Projects should be supported by a conceptual model that includes a rationale for why new or adapted interventions are needed for the target population.

Potential intervention approaches include but are not limited to the following: Developing and piloting novel community-derived interventions Developing and testing adaptations of existing evidence-based interventions Piloting the conversion of existing single-level interventions into multi-level interventions (e.g., adding a community-level intervention component to an individual lifestyle intervention) Piloting and analyzing individual intervention components for subsequent optimization studies (e.g., Multiphase Optimization Strategy (MOST) designs, Sequential Multiple Assignment Randomized Trial (SMART) designs).

Developing and piloting novel interventions that utilize social networks. Projects with the sole rationale being that an existing intervention has never been tested with the target population(s) are not a priority for this FOA.

As appropriate for the research questions posed, projects may involve partnerships with relevant stakeholders such as community-based organizations, faith-based organizations, patient advocacy groups, clinicians and healthcare organizations, state and local health departments, schools, housing agencies, and other organizations.

Inclusion of key stakeholders in the conceptualization, planning and implementation of the research is encouraged where appropriate to generate better-informed hypotheses and facilitate future translation of research findings into practice. 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. Section II. Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed 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. Optional: Accepting applications that either propose or do not propose 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. The combined budget for direct costs for the two-year project period may not exceed $275,000.

No more than $200,000 may be requested in any single year. The total project period may not exceed 2 years. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) 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 allowed. Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) 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. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

System for Award Management (SAM)– Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM. gov registration process.

The same UEI must be used for all registrations, as well as on the grant application. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants. gov registrations; all registrations must be in place by time of submission.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants. gov – Applicants must have an active SAM registration in order to complete the Grants.

gov registration. 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.

Eligible Individuals (Program Director/Principal Investigator) 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 his/her organization to develop an application for support.

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 SF424 (R&R) Application Guide. This FOA does not require cost sharing as defined in the NIH Grants Policy Statement. 3.

Additional Information on Eligibility 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 2. 3.

7. 4 Submission of Resubmission Application . This means that the NIH will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.

A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application. An application that has substantial overlap with another application pending appeal of initial peer review (see 2. 3.

9. 4 Similar, Essentially Identical, or Identical Applications ). 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 instructions in the Research (R) 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. All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed. Instructions for Application Submission The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

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 application forms packages. 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.

SF424(R&R) Other Project Information All instructions in the SF424 (R&R) Application Guide must be followed. SF424(R&R) Senior/Key Person Profile All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) Application Guide must be followed.

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.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Research Strategy: Describe how the project is expected to contribute to the improvement of minority health and/or the reduction of health disparities in the U.S. As appropriate for the research questions posed, describe the multi-domain and/or multi-level conceptual model underpinning the project.

Describe any partnerships with collaborators and provide a rationale for their role on the project. Identify the NIH-designated health disparity population(s) on which the research will focus and provide a scientific rationale for the proposed focus.

If there are foreign component(s) or foreign study populations, describe how the proposed activities at foreign sites are expected to improve minority health and/or help to reduce or eliminate health disparities in the United States. Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

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 application forms packages.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: 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. Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

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 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.

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). 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.

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. 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 FOA 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 organization’s profile in the eRA Commons and for the System for Award Management. 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 Section V.

Application Review Information 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. Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.

For this particular announcement, note the following: The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information.

Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

In addition, for applications involving clinical trials: A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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 review criteria and additional review criteria (as applicable for the project proposed).

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. For example, a project that by its nature is not innovative may be essential to advance a field.

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?

How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

In addition, for applications involving clinical trials Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms?

For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Specific to this FOA: To what extent can the project contribute to the improvement of minority health and/or the reduction of health disparities? Is a clear and appropriate multi-domain and/or multi-level conceptual model provided for the project? Is the focus on one or more NIH-designated populations that experience health disparities clearly identified and justified?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?

If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

In addition, for applications involving clinical trials With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics?

For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center? Specific to this FOA: Are any partnerships with collaborators clearly described and appropriate?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense?

Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? In addition, for applications involving clinical trials Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge