EXPIRED
National Institutes of Health (NIH)
National Institute on Minority Health and Health Disparities (NIMHD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of Mental Health (NIMH)
National Cancer Institute (NCI)
National Eye Institute (NEI)
National Institute on Aging (NIA)
All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.
Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)
Office of Behavioral and Social Sciences Research (OBSSR)
Sexual and Gender Minority Research Office (SGMRO)
R01 Research Project Grant
See Notices of Special Interest associated with this funding opportunity
The purpose of this Funding Opportunity Announcement (FOA) is to support research that will advance the measurement and methodology of complex constructs relevant to minority health and health disparities.
Not Applicable
The following table includes NIH standard due dates marked with an asterisk.
Dates in bold and italics reflect changes per NOT-MD-24-010
Application Due Dates | Review and Award Cycles | ||||
New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
February 05, 2022 * | March 05, 2022 * | Not Applicable | July 2022 | October 2022 | December 2022 |
February 05, 2023 * | March 05, 2023 * | Not Applicable | July 2023 | October 2023 | December 2023 |
February 05, 2024 * | March 05, 2024 * | May 07, 2024 * | July 2024 | October 2024 | December 2024 |
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the 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.
Background
To identify, explain, and address health disparities and health inequities, measures that accurately capture these disparities and methods for collection and analysis of those measures are necessary. Much of the focus to date on measures and methods for health disparities has been on determining the presence and magnitude of disparities or validating and assessing individual-level social determinants of health. What is needed are measures that can better capture social disadvantage. For example, what is needed are measures and methods for constructs that reflect a complex interplay of cultural, social, and environmental factors that shape an individual’s or population’s lived experience and their impact on health behaviors and outcomes. In particular, methodological approaches are needed to best assess health determinants beyond the individual level, including those at the interpersonal, family, organizational, neighborhood, community, and societal levels (see https://www.nimhd.nih.gov/about/overview/research-framework/nimhd-framework.html) as well as methods that integrate health determinants across levels. With the increasing recognition of the importance of incorporating a life course perspective into health disparities research, there is a corresponding need for measures and methods that assess cumulative risk and resilience over time for individuals and population groups. An additional area for measurement and methods development is related to intersectionality, specifically understanding the lived experience and health impacts of belonging to more than one socially disadvantaged or marginalized population. Across these areas of particular importance is understanding the scientific utility of using comprehensive, granular measures (e.g., assessing every dimension of a construct or every occurrence of a specific phenomenon) versus more global, holistic measures with respect to the usefulness of information they produce, the usability of the data, resources required to analyze them, respondent acceptability and burden, and population relevance. Methods of data collection that are accessible and suitable for populations that experience health disparities are needed as are methods for analysis of measures collected at multiple levels.
Research Objectives
This initiative will support research to improve the measures and methods for complex social constructs that capture the lived experience of populations that experience health disparities. The NIH-designated U.S. populations with health disparities are racial and ethnic minority groups, sexual and gender minority groups, underserved rural populations, and socioeconomically disadvantaged populations of any race or ethnicity (https://www.nimhd.nih.gov/about/overview/).
The objective of this initiative is to produce knowledge that can inform the field about the types of measurement approaches that may be most suitable for different health disparities-related research questions or specific populations, settings, or contexts. Projects are expected to examine the performance and utility of specific measurement and/or methodological approaches. Projects that simply use new or existing measures or methods to answer health disparities-related research questions, without examining their performance or utility, are not responsive to this FOA. Projects are encouraged to use multiple data sources across different levels and across multiple sectors when appropriate. However, because this initiative emphasizes capturing the lived experiences of individuals and populations, all projects are expected to include self-report measures or data in some way. Projects should also include relevant diversity (e.g., with respect to age, gender, race/ethnicity, socioeconomic status, sexual or gender minority status, and/or geographic region) in sampling, enrollment, and data analysis needed to advance health disparities and health equity research and interventions development.
Examples of potential study designs include but are not limited to the following:
Areas of Research Interest
NATIONAL EYE INSTITUTEThe mission of the National Eye Institute (www.nei.nih.gov) is to eliminate vision loss and improve quality of life through vision research. The NEI supports basic and clinical research into diseases and disorders of the visual system and the special needs of people with impaired vision or who are blind. The NEI encourages innovative applications that will advance innovative development of new measures and methods, or testing and adaptation of existing measures and approaches, to address health disparities and health inequities in the prevention, diagnosis, treatment and management of eye and vision conditions.
NIMHD’s interests include, but are not limited to, the following:
National Cancer Institute
The National Cancer Institute seeks applications that advance innovative development of new measures and methods, or testing and adaptation of existing measures and approaches, to address health disparities and health inequities in cancer prevention and control and survivorship. Applications of interest may include:
National Institute of Environmental Health Sciences
The mission of the National Institute of Environmental Health Sciences (NIEHS) is to discover how the environment affects people to promote healthier lives. The NIEHS seeks applications that advance innovative development of new measures and methods, or validation and adaptation of existing measures and approaches, to address the complex interplay of the physical, chemical, cultural, social, and built environmental factors that contribute to or exacerbate environmental health disparities. Applications of interest may include, but are not limited to:
National Institute of Dental and Craniofacial Research
NIDCR is interested in funding research that will advance measurement, analysis, and monitoring of social determinants of health that contribute to dental, oral, and craniofacial (DOC) health disparities and inequities within the U.S. population over time and across settings. To this end, NIDCR will support research to examine the performance and utility of measures and methodologic approaches to improve the measurement and assessment of social determinants of DOC health. Specific areas of research interest include but are not limited to:
National Institute of Mental Health
NIMH encourages research that addresses Institute priorities and is aligned with these recommended areas for domestic and global mental health research. Applicants may consider using the Research Domain Criteria (RDoC; https://www.nimh.nih.gov/research/research-funded-by-nimh/rdoc) approach in their work. Areas of interest include, but are not limited to:
Applications on advancing methods for analyzing complex and dynamic systems that impact mental health disparities, including research on methods for estimating non-linear, dynamic, and time-varying relationships between SDOH and disparities in mental health service use, delivery and outcomes.
Research on advancing methods for multilevel models examining mutable factors associated with disparities in mental health service use, delivery, and outcomes.
Applications developing and/or refining methods for adequately powered analyses of mental health disparities experienced by smaller groups or subpopulations (e.g., when addressing intersectionality, conducting subgroup analyses) and low base rate mental health events (e.g., suicide deaths).
Research to develop and validate measures and methods for expanding data capacity to appropriately represent disparities populations, incorporate SDOH, and reduce algorithmic bias in artificial intelligence and machine learning approaches for understanding risk and optimizing mental health care for populations with mental health disparities.
Research to develop and validate measures and methods for integration of SDOH in health care decision-making processes and examine the impact of such integration on reducing disparities and achieving equity in mental health services outcomes.
Research to develop or refine causal inference methods within quasi-experimental designs (e.g. General Causal Model, Directed Acyclic Graphs, Deterministic Structural Equation Models, Probabilistic Causal Models, Instrumental Variables), to address research questions addressing mental health equity for mental health disparity populations.
Research to develop measures of quality of mental health care for mental health disparity populations.
Development and validation of mental health measures that can be submitted to and endorsed by the National Quality Forum (https://www.qualityforum.org/map/) for use to advance equity and quality in mental health care as part of the Healthcare Effectiveness Data and Information Set (HEDIS; https://www.cms.gov/Medicare/Health-Plans/SpecialNeedsPlans/SNP-HEDIS) or as a quality indicator for the Centers for Medicare and Medicaid Services (https://www.cms.gov/).
Metrics that elucidate mechanisms at the individual, community, and organizational levels that result in disparities in specific adverse mental health outcomes across the lifespan, especially those that can point towards therapeutic targets.
Assessments of how structural racism and discrimination impact trajectories of mental health disorders across the lifespan, particularly focusing on sequential and integrative relationships across neural, behavioral, and environmental factors that lead to disparities in mental health outcomes.
Measures that systematically and reliably quantify individual exposure to factors that drive mental health disparities, including rigorous, lifestage-appropriate, and repeatable measures of environmental and sociocultural factors like neighborhood effects, access to and quality of healthcare, food and resource security, intersectionality, and cultural beliefs.
Research on measures and approaches to be used in basic studies in healthy populations of interest addressing mechanisms of complex social, cognitive, affective and behavioral functioning.
National Institute on Aging (NIA)
NIA supports research to understand health differences and health inequities associated with race, ethnicity, gender, environment, socioeconomic status (SES), geography, access, and sociocultural factors over the life course and their impact on aging processes, and aging-relevant outcomes including Alzheimer’s disease and Alzheimer’s disease related dementias (AD/ADRD). The goals of this initiative are to (1) identify the environmental, social, cultural, and behavioral factors that drive disparities in health, well-being, healthcare, and mortality; and (2) develop strategies to reduce or eliminate those disparities and promote active life expectancy and improve the health status of diverse midlife and older adults. NIA's Health Disparities Research Framework reflects levels of analysis researchers might consider across each of the four domains, refines the causal pathways, and further refines potentially adaptable targets for interventions. Additionally, the framework reflects priorities and investments made in this important aging research area. The framework could also facilitate researchers identifying relevant expertise needed to expand their team and ultimately accomplish the proposed study’s goals and objectives.
NIA’s interests in PAR-22-072, “Measures and Methods to Advance Research on Minority Health and Health Disparities-Related Constructs” include, but are not limited to, development of, or enhancements to, measures or methods for assessing constructs related to minority health and health disparities, such as the following:
Applications Not responsive to the FOA:
Non-responsive applications will not be reviewed. Applicants are strongly encouraged to reach out to the relevant scientific contacts to discuss whether their applications are responsive.
See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
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.
Not Allowed: Only accepting applications that do not propose clinical trials.
Need help determining whether you are doing a clinical trial?
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Application budgets are limited to $500,000 direct costs annually, not including consortium F&A costs.
The scope of the proposed project should determine the project period. The expectation is that most projects will be completed within 3-4 years. Projects requesting the maximum project period of 5 years require strong justification requiring this longer project period.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
1. Eligible Applicants
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 Government
Other
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
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.
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 his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
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.
2. Cost Sharing
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
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. This means that the NIH will not accept:
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.
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
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.
All instructions in the SF424 (R&R) Application Guide must be followed.
R&R or Modular Budget
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.
Other Plan(s):
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.
All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy: Provide a justification for how the project will advance the measurement or methodology for complex constructs relevant to minority health and health disparities. Include a description of the gaps or limitations of relevant existing methods or measures. Provide a detailed plan for how the performance or utility of the measures or methods will be examined. Describe how sampling, enrollment, and data analysis will reflect relevant diversity (e.g., with respect to age, gender, race/ethnicity, socioeconomic status, sexual or gender minority status, geographic region) needed to produce generalizable findings.
For applications proposing foreign component(s), describe how the proposed activities at foreign site(s) will 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.
The following modifications also apply:
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.
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
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.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. 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 and responsiveness by components of participating organizations. Applications that are incomplete,non-compliant and/or non-responsive will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
1. Criteria
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
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.
Significance
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?
Specific to this FOA: If successful, will the project advance measures and methods for complex constructs relevant to minority health and health disparities research? Does the project address important gaps or limitations of existing methods or measures?
Investigator(s)
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?
Innovation
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?
Approach
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) 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), justified in terms of the scientific goals and research strategy proposed?
Specific to this FOA: Is a clear and appropriate plan provided for how the performance or utility of the measures or methods will be examined? Do the plans for sampling, enrollment, and data analysis reflect relevant diversity needed to produce generalizable findings with respect to age, gender, race/ethnicity, socioeconomic status, sexual or gender minority status, geographic region, or other relevant factors? For applications with foreign component(s), will the proposed activities at foreign site(s) improve minority health and/or help to reduce or eliminate health disparities in the United States?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Additional Review Criteria
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals 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.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewals
Not Applicable
Revisions
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.
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.
Applications from Foreign Organizations
Not Applicable.
Select Agent Research
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).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
Authentication of Key Biological and/or Chemical Resources:
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
2. Review and Selection Process
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened byCenter for Scientific Review, 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.
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. 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:
3. Anticipated Announcement and Award Dates
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.
1. Award Notices
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.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
Not Applicable
Data Management and Sharing
Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.
Consistent with the 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.
3. Reporting
When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.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.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
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: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Jimmy Le,Sc.D.
National Eye Institute (NEI)
Telephone: 301-435-8160
Email: Jimmy.Le@nih.gov
Nancy L. Jones, PhD, MS
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8945
Email:nancy.jones@nih.gov
Jennifer Alvidrez, PhD
Office of Disease Prevention
Telephone: 301-827-0071
Email: Jennifer.alvidrez@nih.gov
Lindsey Ann Martin, PhD
National Institute of Environmental Health Sciences (NIEHS)
Phone: 984-287-4036
E-mail: lindsey.martin@nih.gov
Melissa M Smarr, PhD
National Institute of Environmental Health Sciences (NIEHS)
Phone: 984-287-4507
E-mail: melissa.smarr@nih.gov
Hiroko Iida, DDS, MPH
National Institute Of Dental & Craniofacial Research (NIDCR)
Phone: 301-594-7404
E-mail: hiroko.iida@nih.gov
Janeth Sanchez, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5764
Email: janeth.sanchez@nih.gov
Roxanne Jensen, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7588
Email: roxanne.jensen@nih.gov
Frank Bandiera, Ph.D.
Division of Behavioral & Social Research (DBSR)
National Institute on Aging (NIA)
Phone: 301-402-7629
Email: frank.bandiera@nih.gov
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Karen Robinson Smith
National Eye Institute (NEI)
Telephone: 301-435-8178
Email: kyr@nei.nih.gov
Priscilla Grant, JD
National Institute on Minority Health & Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: grantp@mail.nih.gov
Jenny L Greer
National Institute Of Environmental Health Sciences (NIEHS)
Phone: 984.287.3332
E-mail: jenny.greer@nih.gov
Diana Rutberg, MBA
National Institute Of Dental & Craniofacial Research (NIDCR)
Phone: (301) 594-4798
E-mail: dr258t@nih.gov
Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: wolfreyc@mail.nih.gov
Ryan Blakeney
National Institute on Aging (NIA)
Telephone: 301-451-9802
Email: blakeneyr@mail.nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.