National Institutes of Health (NIH)
National Institute on Minority Health and Health Disparities (NIMHD)
U24 Resource-Related Research Projects – Cooperative Agreements
Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.
NIMHD invites applications from eligible institutions to establish a national coordinating center (CC) for NIMHD-funded Research Centers in Minority Institutions (RCMIs). The RCMI CC will work closely with key personnel at all RCMI Specialized Centers and with NIMHD staff to help the centers collectively achieve their primary goals to: (1) enhance institutional research capacity to conduct world-class basic biomedical, behavioral, population, and/or clinical patient-centered or health services research; (2) enable all levels of investigators at recipient institutions to become more successful in obtaining competitive extramural support, especially from NIH, for research on diseases and conditions that disproportionately impact populations that experience health disparities; (3) foster institutional environments conducive to research career development and enhancement for post-doctoral fellows, junior faculty members, and other early-stage investigators; (4) enhance the tools for and conduct of research generally and specifically for improving minority health and reducing health disparities; and (5) establish sustainable partnerships with community-based organizations to promote research efforts and the dissemination of research findings that partner with RCMI centers, and (6) centralize and harmonize study operations, coordinate data management, provide biostatistical support to facilitate rapid development and implementation of minority health and health disparity studies conducted in the RCMI-CRNHE (Clinical Research Network for Health Equity) (see RFA-MD-22-006), and also manage a Network Steering Committee. The RCMI CC will be responsive to requests generated by RCMI site key personnel, NIMHD, NIH, the scientific community, and the general public. Eligible applicant institutions for this NOFO are limited to recipients of RCMI awards through RFA-MD-17-003, RFA-MD-17-006, RFA-MD-18-012, RFA-MD-20-006, PAR-11-132, RFA-MD-22-002, RFA-MD-23-001, or RFA-MD-24-001.
December 25, 2024
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 |
January 25, 2025 * | January 25, 2025 * | Not Applicable | July 2025 | October 2025 | December 2025 |
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.
No late applications will be accepted for this Notice of Funding Opportunity (NOFO).
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 How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
Background
The NIH established the Research Centers in Minority Institutions (RCMI) program in 1985 in response to Congressional interest in expanding the national capacity for research in the health sciences by providing support to eligible institutions that offer doctorate degrees in the health professions or health-related sciences and have a documented historical mission or historical commitment to educating underrepresented students and, for institutions that deliver health care services, have a record of providing clinical services to medically underserved communities. NIMHD recognizes the important role such institutions play in supporting scientific research and providing health care in underserved communities. These institutions are uniquely positioned to engage minority populations and other U.S. populations that experience health disparities in research and in the translation of research advances into culturally competent, measurable and sustained improvements in health outcomes.
NIMHD Interest in the RCMI Program
The NIMHD's mission is to conduct and support research, training, health information dissemination, and other programs with respect to minority health and health disparities. This funding opportunity seeks to support an eligible institution to establish a national coordinating center that will work closely with key personnel at all RCMI Specialized Centers and with NIMHD staff to help facilitate enhancement of research capacity and faculty development in RCMI institutions to pursue basic biomedical, behavioral, and/or clinical research (patient-oriented research and health services research), particularly on diseases and/or conditions that disproportionately impact racial and ethnic minority populations and other populations that experience health disparities.
Programmatic Objectives
The RCMI Coordinating Center (CC) will serve as a national resource to help RCMI U54 centers achieve their primary goals to: : (1) enhance institutional research capacity to conduct world-class basic biomedical, behavioral, population and/or clinical patient-centered or health services research; (2) enable all levels of investigators at recipient institutions to become more successful in obtaining competitive extramural support, especially from NIH, for research on diseases and conditions that disproportionately impact populations that experience health disparities; (3) foster institutional environments conducive to research career development and enhancement for post-doctoral fellows, junior faculty members, and other early-stage investigators; (4) enhance the tools for and conduct of research generally and specifically for improving minority health and reducing health disparities; (5) establish sustainable partnerships with community-based organizations to promote research efforts and the dissemination of research findings; and (6) centralize and harmonize study operations, coordinate data management, provide biostatistical support to facilitate rapid development and implementation of minority health and health disparity studies conducted in the RCMI-CRNHE (Clinical Research Network for Health Equity) (see RFA-MD-22-006), and also manage a Network Steering Committee. The RCMI CC will collectively advance the science of minority health and health disparities through intellectual exchange and collaborative interactions that enhance research capacity and competitiveness at participating institutions.
As mentioned in the Notice of Funding Opportunity focused on Research Centers in Minority Institutions (RCMI) (see RFA-MD-24-012), the three types of proposed research focus areas under the RCMI program are defined as follows:
Note: Studies falling under 45 CFR 46.101(b) (4) (Exemption 4) are not considered clinical research under this definition. Therefore, studies involving deidentified human health data are not considered clinical research.
Evaluation of the RCMI Consortium
Investigator Development
The RCMI CC is expected to help RCMI investigators take advantage of research and career development opportunities and address research needs as they arise in priority areas of basic biomedical, behavioral and clinical sciences. This can include professional development and mentoring promoting submission of applications by organizations supporting RCMI investigators to relevant NIH funding opportunity announcements, as well as to ongoing NIH programs to support the development of early-career scientists, such as Research Supplements to Promote Diversity in Health-Related Research and mentored career development awards (K01, K08, K23, and K99) and research educational programs like the NIMHD Health Disparities Research Institute and other NIH-supported opportunities.
Capacity Building
The RCMI CC will also assist efforts to build capacity in RCMI U54 centers to not only engage communities in research as partners and participants but also to effectively communicate and disseminate their research findings that advance scientific knowledge at all levels to their communities. Specific discoveries that are useful to the community and have the potential to benefit health and well-being at the neighborhood, community and population levels can be promoted.
RCMI-CC Core Activities
RCMI CC activities are expected to align with and support the objectives of the RCMI U54 centers in four key domains: (1) project administration and coordination among sites, (2) research resources to support scientific projects, (3) early-stage investigator development and mentoring, and (4) community engagement. Toward that end, the RCMI CC must have the following essential functions:
Additional activities may be proposed to promote collaboration among RCMI U54 sites, contribute to the professional development of RCMI investigators, encourage interactions between the RCMI program and other NIMHD- and NIH-supported resources, and enhance the value, visibility and scientific impact of the RCMI program. Examples include but are not limited to:
In terms of coordination of the RCMI-CRNHE, the RCMI CC is expected to perform the following activities:
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.
Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this NOFO.
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).
NIMHD intends to commit $5 million in FY 2025 to fund one award.
Application budgets cannot exceed $3,500,000 annually in direct costs.
The proposed project period cannot exceed five 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
To be eligible for this FOA, the applicant institution must be a domestic institution located in the United States and its territories which:
Eligible applicant institutions for this FOA are limited to recipients of RCMI awards through RFA-MD-17-003, RFA-MD-17-006, RFA-MD-18-012, PAR-11-132, RFA-MD-20-006, RFA-MD-22-002, RFA-MD-23-001, or RFA-MD-24-001.
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 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 individuals from 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 NIH Grants Policy Statement Section 1.2 Definition of Terms.
Number of Applications
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:
Only one application per institution (normally identified by having a unique UEI number or NIH IPF number) is allowed.
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 How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
Letter of Intent
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Yujing Liu, MD, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-827-7815
Email: [email protected]
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.
The PD/PI of the RCMI CC must be the lead Director of the CC and is the person responsible for the overall management of the CC; if there are multiple PDs/PIs of the CC, the MPIs will serve as co-Directors. The relationship between the RCMI CC and the RCMI U54 centers should be one of equal and substantial partners in all joint activities.
The RCMI CC team is expected to have significant experience and knowledge in (1) priority areas of basic biomedical research, behavioral and social sciences, and clinical research, including research on minority health and health disparities; (2) in program management, evaluation and coordination; and (3) in support of activities to promote diversity, equity, inclusion, and accessibility in the scientific research workforce.
All instructions in the How to Apply - Application Guide must be followed.
The RCMI CC will be responsible for organizing and attending annual face-to-face meetings meant to facilitate coordination among RCMI U54 centers and any subcommittees in which they participate. The RCMI CC application budget should include funds for organizing the annual meeting and for travel of the RCMI CC PD(s)/PI(s) and other key personnel to the meeting. The RCMI CC is not responsible for the travel of participants from individual RCMI U54 sites.
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:
Research Strategy
Describe how the RCMI CC will work in close collaboration with approximately 22 RCMI U54 centers to facilitate and coordinate RCMI program activities nationally. Include plans for fostering communication and collaborative research arrangements between the U54 centers, such as through arranging and hosting monthly PD/PI conference calls as well as similar calls and support for the various U54 Cores as needed, as well as providing logistical support to the U54 centers and NIMHD staff to arrange a yearly RCMI grantee meeting. Include plans and mechanisms for maintaining active involvement of all U54 sites in all aspects of the program.
Describe plans and mechanisms for providing methodological consultation to RCMI investigators on study design, regulatory compliance, biostatistics and other technical areas to augment expertise and research resources at individual U54 sites.
Describe plans for developing and maintaining a secure database to collect information from RCMI U54 centers on scientific advances from full research projects and pilot projects, as well as career development of pilot award recipients. Include plans for working with U54 centers to develop, adapt or use existing common structured data elements and performance metrics to assess progress on achieving programmatic objectives and evaluation of the overall RCMI program. Describe plans for conducting yearly evaluation, analysis and reporting the data to NIMHD.
Describe how the RCMI CC will support RCMI activities aimed at diversifying the scientific workforce in basic biomedical research, behavioral and social sciences, and clinical research. While the RCMI CC and U54 centers may not select, hire, or determine eligibility for training or mentoring programs based on an investigators race, ethnicity or sex (including gender identity, sexual orientation, or transgender status), as part of the research strategy description, i.nclude plans and mechanisms to facilitate broad access to research mentors and other resources that can enhance the competitiveness and career development of early stage investigators. Highlight how the relevant expertise of the RCMI CC team will support these activities.
Describe plans to assist community engagement efforts at RCMI U54 sites to (1) develop/maintain strong working relationships with community partners, (2) increase participation of minority populations as human subjects in clinical trials, and (3) promote timely dissemination of research findings to communities to help address their health-related concerns.
Describe how the RCMI CC will function to serve as the RCMI programs point-of-contact for linking the U54 centers with other NIMHD-funded centers, other major NIH extramural programs, and the broader scientific community to promote collaborations in priority areas of basic biomedical research, behavioral and social sciences, and clinical research, especially in topics related to minority health and health disparities.
Describe plans and mechanisms for informing and making visible scientific advances of RCMI investigators and affiliated scientists to the broader research community, policymakers, and other relevant stakeholders. Include plans for maintaining an up-to-date RCMI website with links to each RCMI U54 site and the NIMHD.
Describe the organizational plan and management structure for providing leadership and administrative support for RCMI CC activities and interactions with the U54 centers and NIMHD. Delineate the roles and responsibilities among key personnel atparticipating organizations. Include plans for ensuring accountability for achieving program objectives. Describe how the Steering Committee and any other advisory group(s) will be used to ensure successful completion of the stated aims. Applicants should avoid naming potential members of an advisory group, unless such persons have been consulted or contacted.
Describe the plans of the coordination center to centralize and harmonize study operations, coordinate data management, and provide biostatistical support to facilitate rapid implementation of minority health and health disparity studies conducted in the RCMI-CRNHE as well as manage a Network Steering Committee.
Applications must include a plan for evaluating all activities supported by the RCMI CC, in line with the broader RCMI program goals. The evaluation plan must specify baseline metrics to be included for the participating RCMI U54 centers, e.g., numbers of research grant applications submitted and funded, research publications and other forms of scientific dissemination, scientific collaborations and partnerships, utilization/expansion of shared research resources and databases, as well as measures to gauge the short- and long-term success of the RCMI CC in achieving its objectives.
Letters of Support: Applicants must provide letter(s) from the appropriate high-ranking institutional officials that:
Inclusion of Letters of Support in the application should adhere to the SF424 instructions and be combined into a single file attachment. The Letters of Support attachment should begin with a table of letter authors, their institutions, and the type of each letter (institutional commitment or resources; collaboration or role in the project; potential or current user of a resource or service provided in the application).
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 NIMHD, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
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 [email protected].
Applicants are required to follow the instructions for post-submission materials, as described 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. While any information in the application relevant to the program goals can be included as part of the review process, the race, ethnicity, or sex (including gender identity, sexual orientation, or transgender status) of PD/PIs, RCMI CC team members, or other participants may not, in and of themselves, be used as factors in the evaluation of applications.
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 proposed Coordinating Center address the needs of the research programs (i.e., the RCMI U54 Centers and the CRN-HEs) that it will coordinate? Is the scope of activities proposed for the Coordinating Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research programs?
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?
Are the PD(s)/PI(s) and other personnel well suited to their roles in the Coordinating Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing basic or clinical research? Do the investigators demonstrate significant experience with coordinating collaborative basic or clinical research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Coordinating Center? Does the applicant have experience overseeing selection and management of subawards, if needed?
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?
Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the research programs (i.e., the RCMI U54 Centers and the CRN-HEs) the Coordinating Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies or instrumentation 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 or clinical practice?
Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research programs (i.e., the RCMI U54 Centers and the CRN-HEs) the Coordinating Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the programs, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the program is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the program? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?
In addition, for applications involving clinical trials
Does the application adequately address the following, if applicable
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
Will the institutional environment in which the Coordinating Center will operate contribute to the probability of success in facilitating the research programs (i.e., the RCMI U54 Centers and the CRN-HEs) it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Coordinating Center proposed? Will the Coordinating Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?
In addition, for applications involving clinical trials
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
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.
Specific to applications involving clinical trials
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
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.
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 of all ages (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.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.
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.
Not Applicable
For Renewals, the committee will consider the progress made in the last funding period.
Not Applicable
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.
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Not Applicable
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.
For programs, projects, networks, consortia, and/or resources involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider 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 a Scientific Review Group convened by NIMHD in accordance with NIH peer review policy and procedures, 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.
Appeals of initial peer review will not be accepted for applications submitted in response to this NOFO.
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, consistent with applicable law:
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.
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
NIMHD will assign a Program Official, Project Scientist(s), and a Grants Management Specialist to the RCMI CC.
NIH Project Scientist(s) will have substantial scientific involvement during the conduct of this activity, through technical assistance, advice, and coordination. NIH Project Scientists(s) will:
An NIH Program Official will be responsible for the normal programmatic stewardship of the award and will be named in the award notice. The Program Official will:
Additionally, the NIH Program Official may recommend the termination or curtailment of an activity in the event the proposed activities fail to evolve within the intent and purpose of this initiative.
Areas of Joint Responsibility include:
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.
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: [email protected] (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: [email protected]
Rada K. Dagher, Ph.D., M.P.H.
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-451-2187
Email: [email protected]
Maryline Laude-Sharp, Ph.D.
Telephone: 301-451-9536
Fax: 301-451-4484
Email: [email protected]
Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: [email protected]
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.