Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)

National Human Genome Research Institute (NHGRI)

National Institute on Aging (NIA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Allergy and Infectious Diseases (NIAID)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute on Deafness and Other Communication Disorders (NIDCD)

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

National Institute on Drug Abuse (NIDA)

National Institute of Environmental Health Sciences (NIEHS)

National Institute of Mental Health (NIMH)

National Institute of Neurological Disorders and Stroke (NINDS)

National Institute of Nursing Research (NINR)

National Institute on Minority Health and Health Disparities (NIMHD)

National Center for Complementary and Integrative Health (NCCIH)

National Heart, Lung, and Blood Institute (NHLBI)

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)

Office of Research on Women's Health (ORWH)

Funding Opportunity Title
Dissemination and Implementation Research in Health (R01 Clinical Trial Optional)
Activity Code

R01 Research Project Grant

Announcement Type
Reissue of PAR-19-274
Related Notices

    See Notices of Special Interest associated with this funding opportunity

  • NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022
  • July 18, 2022 - Notice of NHLBI Participation in PAR-22-105. See Notice NOT-HL-22-026.
  • July 7, 2022 - Notice of Correction for NOT-CA-22-014 "Notice of Special Interest (NOSI): Research on Interprofessional Teamwork and Coordination During Cancer Diagnosis and Treatment". See Notice NOT-CA-22-102
Funding Opportunity Announcement (FOA) Number
PAR-22-105
Companion Funding Opportunity
PAR-22-106 , R03 Small Research Grants
PAR-22-109 , R21 Exploratory/Developmental Grants
Assistance Listing Number(s)
93.399, 93.242, 93.172, 93.113, 93.279, 93.846, 93.121, 93.361, 93.213, 93.855, 93.866, 93.173, 93.865, 93.307, 93.853, 93.313, 93.273, 93.847, 93.837, 93.838, 93.839, 93.840, 93.233 Part 2. Section VII. Agency Contacts
Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to support studies that will identify, develop, and/or test strategies for overcoming barriers to the adoption, adaptation, integration, scale-up, and sustainability of evidence-based interventions, practices, programs, tools, treatments, guidelines, and policies. Studies that promote equitable dissemination and implementation of evidence-based interventions among underrepresented communities are encouraged. Conversely, there is a benefit in understanding circumstances that create a need to stop or reduce (“de-implement”) the use of practices that are ineffective, unproven, low-value, or harmful. In addition, studies to advance dissemination and implementation research methods and measures are encouraged. Applications that focus on re-implementation of evidence-based health services (e.g. cancer screening) that may have dropped off amidst the ongoing COVID pandemic are encouraged.

All applications must be within the scope of the mission of one of the Institutes/Centers listed above.

Key Dates

Posted Date
May 10, 2022
Open Date (Earliest Submission Date)
May 15, 2022
Letter of Intent Due Date(s)

30 days prior to the application due date

The following table includes NIH standard due dates marked with an asterisk.
Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
June 15, 2022 July 05, 2022 * September 07, 2022 * November 2022 January 2023 April 2023
October 05, 2022 * November 05, 2022 * January 07, 2023 * March 2023 May 2023 July 2023
February 05, 2023 * March 05, 2023 * May 07, 2023 * July 2023 October 2023 December 2023
June 05, 2023 * July 05, 2023 * September 07, 2023 * November 2023 January 2024 April 2024
October 05, 2023 * November 05, 2023 * January 07, 2024 * March 2024 May 2024 July 2024
February 05, 2024 * March 05, 2024 * May 07, 2024 * July 2024 October 2024 December 2024
June 05, 2024 * July 05, 2024 * September 07, 2024 * November 2024 January 2025 April 2025
October 05, 2024 * November 05, 2024 * January 07, 2025 * March 2025 May 2025 July 2025
February 05, 2025 * March 05, 2025 * May 07, 2025 * 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.

Expiration Date
May 08, 2025
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

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.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to support studies that will identify, develop, and/or test strategies for overcoming barriers to the adoption, adaptation, integration, scale-up, and sustainability of evidence-based interventions, practices, programs, tools, treatments, guidelines, and policies (herein referred to collectively as evidence-based interventions). Studies that promote equitable dissemination and implementation of evidence-based interventions among underrepresented communities are encouraged. Conversely, there is a benefit in understanding circumstances that create a need to stop or reduce (“de-implement”) the use of practices that are ineffective, unproven, low-value, or harmful. In addition, studies to advance dissemination and implementation research methods and measures are encouraged. Applications that focus on re-implementation of evidence-based health services (e.g. cancer screening) that may have dropped off amidst the ongoing COVID pandemic are encouraged.

Background

Each year, billions of U.S. tax dollars are spent on research and hundreds of billions are spent on delivery of health interventions, healthcare services, and public health programs in clinical and community settings. However, relatively little is spent on research to understand how best to ensure that the lessons learned from research are relevant to inform and improve the quality of health, delivery of services, and the utilization and sustainability of evidence-based interventions. For years, we have known of the limitations of research publications in leading to widespread uptake of evidence-based interventions, but too often the scientific pathway ends prematurely, before we can determine the best ways to improve equitable adoption, implementation, and sustainability. Given the interest and investment in intervention trials that seek to determine the optimal interventions to be used in clinical and community settings, it is essential that practitioners (e.g., healthcare providers, public health practitioners), consumers, families, caregivers, communities (e.g., workplace, school, place of worship), healthcare practice settings, and policymakers are equipped with empirically-supported strategies to integrate scientific knowledge and effective health interventions into everyday use. The National Institutes of Health has recognized that closing the gap between biomedical or basic behavioral discovery, population health, and healthcare delivery and public health is both a complex challenge and an absolute necessity if we are to ensure that all populations benefit from the Nation’s investments in scientific discoveries.

For many years, health researchers may have assumed that evidence-based interventions would be readily adopted and implemented; however, compelling evidence suggests that this has not been the case. Even when interventions have been tested within effectiveness studies, the development of knowledge to support their broader dissemination and implementation (e.g., cost and financing of the intervention, practitioner training, availability of resources, integration into community or healthcare systems, delivery to underserved or under-resourced populations, monitoring the quality or equity of intervention delivery) has often remained outside the scope of these large-scale clinical trials. This has also been the case for the dissemination and implementation of policies and guidelines.

Dissemination and implementation research intends to bridge the gap between research, practice, and policy by building a knowledge base about how health information, effective interventions, and new clinical practices, guidelines, and policies are communicated and integrated for public health and health care service use in specific settings.

For the purpose of this FOA, we make a distinction between "dissemination research" and "implementation research", as follows:

Dissemination research is defined as the scientific study of the targeted distribution of information and intervention materials to a specific public health, clinical practice, or policy audience. The intent is to understand how best to communicate and integrate knowledge and the associated evidence-based interventions.

We are currently missing critical information about how, when, by whom, and under what circumstances evidence spreads throughout communities, organizations, front line workers and consumers of public health and clinical services. As a prerequisite for unpacking how information can lead to intervention or service changes, we need to understand how and why information on physical and behavioral health, preventive services, disease management, decision making, and other effective interventions may or may not reach stakeholders. We need to understand what underlies the creation, transmission, and reception of information on evidence-based pharmacological, behavioral, psychosocial, genomic, policy, and systems interventions. Successful dissemination of evidence for effective health interventions may occur quite differently depending on whether the audience consists of consumers, caregivers, practitioners, policymakers, employers, administrators, or other stakeholder groups. Moving the field forward will require studies identifying mechanisms and approaches to package and convey the evidence necessary to improve public health, community, and healthcare services in ways relevant to local settings.

Implementation research is defined as the scientific study of the use of strategies to adopt and integrate evidence-based health interventions into clinical and community settings to improve individual outcomes and benefit population health.

Implementation research seeks to understand the behavior of practitioners and support staff, organizations, consumers and family members, and policymakers in context as key influences on the adoption, implementation, and sustainability of evidence-based health interventions. Implementation studies should not assume that effective interventions can be integrated into any service setting and for consumer groups and populations without attention to local context, nor that a unidirectional flow of information (e.g., publishing a recommendation, trial, or guideline) is sufficient to achieve practice change. Relevant studies should develop a knowledge base about "how" evidence-based interventions are integrated within diverse practice settings and patient populations, which likely will require more than the distribution of information about the interventions. This research announcement encourages studies to test models, theories, and conceptual frameworks of the implementation process that move away from an exclusively "top-down" or reductionist approach to a greater emphasis on the resources of local care settings and the needs of multiple stakeholders, including approaches such as systems science, team science, community engaged research, participatory action research, citizen science, and related approaches that engage stakeholders and end-users throughout the research process.

Dissemination and Implementation (D&I) Research: Broadly, studies in this field typically involve both interdisciplinary cooperation and transdisciplinary collaboration, utilizing theories, empirical findings, and methods from a variety of scientific disciplines. Relevant fields include but are not limited to: information science, organizational and management theory, health economics, behavioral science, public health, business and public administration, statistics, anthropology, epidemiology, decision science, engagement science, systems science, health equity research, engineering, and marketing. D&I research will often include significant and ongoing collaboration with stakeholders from multiple public health and/or clinical practice settings as well as consumers of services and their families/social networks. This FOA will support a variety of rigorous study designs including (but not limited to) observational, experimental, quasi-experimental, and simulation modeling that produce evidence on relevant outcomes (e.g., acceptability, feasibility, adoption, fidelity, penetration, sustainability), costs, and/or unanticipated consequences of dissemination and implementation efforts. The goal is to conduct dissemination and implementation studies utilizing research designs that are rigorous and measures that are relevant to stakeholders. Wherever possible, studies of dissemination or implementation strategies should build knowledge both on the overall effectiveness of the strategies, as well as "how and why" they work. Data on mechanisms of action, moderators and mediators, and costs of dissemination and implementation strategies will greatly aid decision-making on which strategies work for which interventions, in which settings, and for what populations.

For additional resources on dissemination and implementation research, including information on D&I training opportunities, funded studies, key references, past workshops and conferences, visit: http://cancercontrol.cancer.gov/is/; and https://prevention.nih.gov/research-priorities/dissemination-implementation.

Specific Objectives and Scope of this FOA

This FOA invites research grant applications that will identify, develop, and/or test strategies to disseminate and implement evidence-based interventions into public health, clinical practice, and community (e.g., workplace, school, place of worship) settings. Studies that promote equitable dissemination and implementation of evidence-based interventions are encouraged. In addition, studies to advance dissemination and implementation research methods and measures are encouraged. All applications should be within the scope of the mission of at least one of the participating Institutes/Centers.

Examples of relevant research topics include but are not limited to:

  • Studies on culturally-tailored implementation strategies to enhance the adoption and integration of health promotion, prevention, screening, early detection, and diagnostic interventions, as well as effective treatments, clinical procedures or guidelines into existing care systems.
  • Studies on the implementation of multiple evidence-based interventions within community or clinical settings (including community clinics, FQHCs, and primary care clinics) to meet the needs of complex patients and diverse systems of care.
  • Longitudinal and follow-up studies on the factors that contribute to the sustainability of evidence-based interventions in public health and clinical practice.
  • Studies testing dissemination or implementation strategies to eliminate health disparities and improve quality of care in underserved populations (based on their racial or ethnic group, religion, socioeconomic status, gender, age, mental health, cognitive, sensory or physical disability, sexual orientation or gender identity, geographic location (place/context) or other characteristics historically linked to discrimination or exclusion).
  • Studies conducting comparative economic evaluations of implementation strategies in a variety of settings and across phases of implementation.
  • Studies on measuring and tracking adaptations to evidence-based interventions and implementation strategies over time.
  • Studies on scaling-up evidence-based implementation strategies.
  • Studies on reducing or stopping ("de-implementing") the use of clinical and community practices that are ineffective, unproven, low-value, or harmful.
  • Studies on the relationship of context, including but not limited to the role of social determinants of health or social needs, and local capacity of clinical and community settings to adoption, implementation, and sustainability of evidence-based practices.
  • Prospective or retrospective studies of the adoption, implementation, and sustainability of health policies and their interaction with programs and contextual factors.
  • Studies of influences on the creation, packaging, transmission, and reception of evidence for effective health interventions.
  • Studies of strategies to impact organizational structure, climate, culture, and processes to enable dissemination and implementation of clinical/public health information and effective clinical/public health interventions.
  • Studies on the development of study designs, research methods, and analytic approaches for studying dissemination and implementation.
  • Studies that focus on the testing of theories, models, and frameworks for D&I processes.
  • Studies on developing and validating reliable D&I relevant outcome and process measures.
  • Studies on developing and validating pragmatic and actionable measures to guide selection, continuation, and discontinuation of implementation strategies over time.
  • Studies on developing and strengthening tools and techniques for conducting rapid and rigorous qualitative data collection and analysis, including approaches for comparisons of qualitative data across implementation contexts appropriate for accelerated implementation timelines.
  • Studies on policies and other contextual factors that influence the success of dissemination or implementation efforts.
  • Studies on collecting and sharing multi-level qualitative and quantitative D&I-related data.
  • Studies that examine policy implementation, specifically the implementation and dissemination of health care and public health policies across federal, state, local and organizational policies.

Key characteristics of dissemination and implementation (D&I) research that applicants could consider including in their applications (where applicable) include but are not limited to:

  • Description and justification of the evidence-based intervention and hypothesized strategies to improve implementation outcomes (e.g., acceptability, feasibility, adoption, fidelity, penetration, sustainability) as well as health service outcomes (e.g., quality, equity).
  • Understanding of contextual factors that can influence dissemination or implementation of the evidence-based intervention in various settings under investigation
  • Incorporation and justification of the use of theories, models, and/or frameworks that are relevant to understanding dissemination and implementation, to inform study hypotheses, measures, and outcomes.
  • Consideration of the extant literature on barriers to and facilitators of the dissemination and implementation of practices to improve health.
  • Identification of possible mediators, moderators, and mechanisms of action that explain the impact of dissemination or implementation strategies on relevant outcomes.
  • Consideration and characterization of the multi-level context and environment in which the proposed research will be conducted, including a description of the intended implementers.
  • Consideration of the use of qualitative and/or mixed methods approaches.
  • Development and/or use of appropriate D&I related outcomes, measures, and analyses. Applicants are encouraged to review available resources and use standard measures and validated instruments where possible, rather than developing their own measures for each study.
  • Attention to issues of resources expended, program costs, cost-effectiveness, or other economic outcomes related to dissemination and/or implementation.
  • Incorporatation of stakeholder-relevant outcomes (i.e., outcomes relevant to patients, consumers, families, practitioners, administrators, and/or policymakers).
  • Formation of transdisciplinary teams of researchers and stakeholders, given the range of expertise that may be needed for conducting dissemination and implementation research.
  • Adequate consideration and specification of the equity-related approach and outcomes.

Information relevant to Specific Institutes/Centers

In addition to the above description of the scientific objectives, resources communicating scientific interests of selected Institutes and Centers (I/Cs) are summarized below. Applicants are encouraged to contact the Scientific/Research contact of the intended I/C to ensure that the aims of the proposed project are consistent with I/C mission.

National Cancer Institute (NCI)

NCI seeks implementation science projects across the cancer control continuum. Areas of interest include prevention, detection, and in areas less represented in the NCI-funded portfolio, including in cancer diagnosis, treatment, and survivorship. Examples include (but are not limited to) studies that seek to understand and evaluate sustainable approaches to coordinate cancer treatment across fragmented systems; optimizing survivorship care among oncology and non-oncology providers; and survivorship care delivery in diverse settings (e.g.,community practices, rural settings). Additionally, NCI is interested in supporting applications that focus on understanding strategies to promote sustainability and scale up of effective cancer control interventions, studies that seek to understand de-implementation, and studies that seek to advance measures and methods. Policy implementation research studies are encouraged.

NCI is interested in applications that seek to advance health equity through implementation science. Areas of interest include projects that promote equitable reach, delivery, and implementation of evidence-based interventions in/with communities and populations experiencing health disparities. To advance the equitable implementation, the NCI is interested in implementation strategies that incorporate social determinants of health or social needs in developing and testing strategies to advance adoption, adaptation, fidelity, acceptability, cost, and sustainability of evidence-based interventions in cancer prevention and control. Implementation research aims should be guided by equity-oriented theoretical models and frameworks and the equity related outcomes or approaches clearly described. Multilevel approaches and transdisciplinary and intersectoral collaborations (e.g., transportation, housing, food systems) are encouraged. To the extent possible, studies may include an evaluation to assess that implementation projects are not inadvertently exacerbating health disparities or inequalities. Research that engages public health practitioners in community settings (e.g., health departments, coalitions, community organizations) as well as practice-based research are encouraged.

In efforts to advance the field, NCI launched the Consortium for Cancer Implementation Science (CCIS) which broadly focuses on cancer control priorities, cross-collaborations across disciplines and institutions, and innovative solutions to advance measures and methods in implementation science. Applications that advance scientific priorities of the CCIS action groups are encouraged. See annual meeting summaries at: https://cancercontrol.cancer.gov/is/initiatives/ccis.

We encourage applicants to contact program staff for assistance early in the application process.

National Human Genome Research Institute (NHGRI)

NHGRI will support the evaluation of approaches that will incorporate genomics to improve the effectiveness of healthcare. In general, NHGRI supports studies that provide generalizable methods and knowledge. Applications for studies relevant only to a particular disease or organ system should be directed to the appropriate Institute or Center. NHGRI strongly encourages potential applicants to contact program staff in the early stages of developing your application.

National Institute on Aging (NIA)

NIA is interested in research to identify and understand barriers to the adoption, adaptation, integration, scale-up, and sustainability of evidence-based health interventions, tools, and policies related to aging or older adults.

For clinical trial proposals, D&I strategies studied should be limited to strategies to disseminate and/or implement interventions that have evidence of efficacy/potency, as well as evidence that the intervention can be delivered in the community with fidelity. NIA is especially interested in receiving applications that fall within Stage V of the NIH Stage Model for Behavioral Intervention Development that focus on the mechanisms that promote the successful implementation and dissemination of interventions, consistent with the NIH Science of Behavior Change emphasis on mechanisms of change.

Information about the NIH Stage Model for Behavioral Intervention Development can be found at: https://www.nia.nih.gov/research/dbsr/stage-model-behavioral-intervention-development.

Information regarding NIH’s Science of Behavior Change (SOBC) program can be found at: https://commonfund.nih.gov/behaviorchange.

National Institute of Allergy and Infectious Diseases (NIAID)

Applicants applying to NIAID should identify partnerships with relevant policy and/or program leaders with a stated commitment to evaluate and incorporate changes which are proven to be both successful and cost-effective. Ideally, research teams will include local experts from an implementing organization and meaningfully incorporate input from community members.

NIAID will not accept clinical trials using new drugs or diagnostic tools, or using existing drugs/diagnostics for new purposes in response to this FOA. However, trial methodology to assess the impact of new strategies for disseminating and/or implementing accepted/validated interventions for prevention or treatment will be allowed.

Applicants seeking funding for clinical trials should refer to the following NIAID website: https://www.niaid.nih.gov/grants-contracts/investigator-initiated-clinical-trial-resources

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

The mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases is to support research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases. In the context of this FOA, the NIAMS is interested in research related to the dissemination and implementation of research finding from clinical and translational studies. Clinical research areas include rheumatology, orthopedics, dermatology, metabolic bone diseases, heritable disorders of bone and cartilage, inherited and inflammatory muscle diseases, and sports and rehabilitation medicine. Applicants are encouraged to discuss potential applications with the appropriate NIAMS program director.

National Institute of Mental Health (NIMH)

The National Institute of Mental Health (NIMH) is interested in applications relevant to dissemination and implementation (D&I) research that support the NIMH Strategic Plan for Research. All applications that propose clinical trials to test D&I strategies are required to include a study design using an experimental therapeutics approach, in which clinical trials test implementation effects on mental health outcomes as well as elucidate the implementation strategy’s mechanism(s) of action (see NIMH Clinical Trials FOAs). Applications must specify the target/mechanism and assess whether the implementation-induced changes in the target account for the hypothesized outcome (i.e., fidelity, acceptability, feasibility, appropriateness). It is recommended that investigators contact NIMH Scientific/Research staff well in advance of submitting applications to discuss the match to NIMH priorities.

National Institute on Minority Health and Health Disparities (NIMHD)

The mission of NIMHD is to lead scientific research to improve minority health and reduce health disparities in populations that experience health disparities (i.e., African Americans/Blacks, Hispanic/Latinos, American Indians/Alaska Natives, Asians, Native Hawaiians, and other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minority populations). In the context of this FOA, NIMHD is especially interested in domestic D&I research that utilizes the NIMHD Research Framework.

National Institute of Dental and Craniofacial Research (NIDCR)

The NIDCR is interested in D&I research applications relevant to dental, oral, or craniofacial health that align with the NIDCR Strategic Plan. Investigators proposing research that meets the NIH definition of a clinical trial should refer to NIDCR Clinical Trials FOAs. All investigators are encouraged to contact NIDCR Scientific/Research staff well before submission to discuss scientific priorities.

National Center for Complementary and Integrative Health (NCCIH)

For specific information about NCCIH priorities for dissemination and implementation research refer to the NCCIH strategic plan (https://www.nccih.nih.gov/about/nccih-strategic-plan-2021-2025), our priorities for implementation science (https://www.nccih.nih.gov/about/nccih-strategic-plan-2021-2025/top-scientific-priorities/implementation-science-for-complementary-and-integrative-health), and our website.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

The institute encourages D&I applications relevant to the NICHD mission, including (but not limited to) normal and abnormal human development, contraception, fertilization, pregnancy, childbirth, prenatal and postnatal development, childhood development through adolescence, intellectual and developmental disabilities, and rehabilitation medicine.

NICHD is interested in D&I applications relevant to the institute’s mission, especially studies that aim to promote broad implementation and adaptation of interventions with proven efficacy, as well as studies that aim to de-implement interventions that have been shown not to be efficacious.

Visit https://www.nichd.nih.gov/about/org/der/branches and https://www.nichd.nih.gov/about/org/ncmrr to get more information about NICHD research priorities.

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIDDK will support evaluation of approaches that improve the effectiveness of healthcare, improve uptake of evidence-based interventions in diverse populations and settings, reduce/eliminate disparities, and improve health equity for research areas within its mission, including diabetes, other endocrine and metabolic diseases, digestive diseases, nutritional disorders, obesity, kidney diseases, and urologic conditions. NIDDK strongly encourages potential applicants to contact program staff for assistance in the early stages of developing applications.

National Institute of Nursing Research (NINR)

The National Institute of Nursing Research (NINR) supports research that uses nursing’s holistic, contextualized perspective to improve individual and population health outcomes and advance health equity across clinical and community settings. NINR encourages research that integrates factors at multiple levels including social determinants to identify their role in health, health improvement, and health disparities. Applicants seeking funding for D&I research are referred to NINR’s policy on clinical trials and strongly encouraged to contact program staff in advance of a submission.

Office of Research on Women’s Health (ORWH)

The Office of Research on Women’s Health (ORWH) is part of the Office of the Director of NIH and works in partnership with the 27 NIH Institutes and Centers to ensure that women's health research is part of the scientific framework at the NIH, and throughout the scientific community. In general, ORWH is interested in research that considers the influence of sex and gender on health and disease, and the total health of women across the full spectrum of research. ORWH encourages interdisciplinary approaches and would be interested in partnering to support research that examines ways to integrate evidence-based practices, interventions, and policies into practice settings to improve the health of women, especially research on the consequences of pregnancy for the health of a woman across her life course. The Trans-NIH Strategic Plan for the Health of Women covering FY 2019 - 2023 is available on the ORWH website (https://www.nih.gov/women/strategicplan) for additional guidance.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed
New
Renewal
Resubmission
Revision

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget
Application budgets are not limited but need to reflect the actual needs of the proposed project.
Award Project Period

The maximum project period is 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Local Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
  • Non-domestic (non-U.S.) Entities (Foreign Institutions)
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed. 

Required Registrations

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.

  • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
    • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
    • Dun and Bradstreet Universal Numbering System (DUNS) – Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, after obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. 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.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

Gila Neta, PhD
National Cancer Institute (NCI)
Telephone: 240-276-6785
Email: netagil@mail.nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy: The Research Strategy should clearly describe the following within the appropriate section (i.e., Significance, Investigator(s), Innovation, Approach, Environment):

Significance

  • The estimated public health benefit of the research, and whether the existing data, public health and patient needs justify dissemination and implementation.
  • If the aims of the proposed project are achieved, how the study results will advance dissemination and implementation knowledge. The ability of potential adopters and organizations to determine the applicability of the results to their setting.
  • The reach (to the population that will benefit from the knowledge/intervention) that will be achieved and the equitability of the reach and likely outcomes through the knowledge/service delivery contexts selected.
  • The resource requirements and costs of the intervention.

Investigator(s)

  • Whether the investigators are part of stakeholder teams or have strong links and engagement of stakeholders necessary to accomplish the project aims.
  • Clear evidence of dissemination and implementation research expertise as part of the team.

Innovation

  • How the proposed dissemination or implementation research contributes new and innovative concepts, outcomes, measures, and/or design approaches to the field.
  • How the study proposed promises to speed the translation of research into practice and/or produce novel and robust findings.

Approach

  • Demonstrate an understanding of dissemination and implementation research principles. How the dissemination or implementation approach is appropriate to the problem and population using research methods that are relevant, rigorous and practical.
  • Justify the study design on the basis of the current state-of-the-art and or contextual factors relevant to dissemination and/or implementation.
  • How the procedures to assess and analyze the dissemination or implementation strategies are appropriate.
  • How the measurements and analysis plan are linked to the study aims, and whether the analysis incorporates the best available data to track dissemination or implementation process and impact, including cost-effectiveness.
  • Where applicable, how the proposed plan for analysis takes into account hierarchical relationships among multiple levels of outcomes (e.g. patient/consumer, provider, system).
  • The appropriateness of the plans to sustain effective dissemination and implementation approaches once the research-funding period has ended.

Environment

  • How the applicants are positioned to influence large or influential networks capable of taking the results of the proposed study to scale to achieve public health impact.
  • How the proposed approaches take advantage of unique features of the intervention delivery environment or employ useful, collaborative arrangements
  • Evidence of institutional support to sustain dissemination or implementation strategies once the research funding ends. 

Letters of Support: the letters of collaboration and institutional support should include the level of commitment to the project.

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:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide must be followed.

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the unique entity identifier (DUNS number or UEI as required) provided 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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

In order to expedite review, applicants are requested to notify the {IC} Referral Office by email at {xxxx@mail.nih.gov} when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

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.

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.

Overall Impact

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).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

 

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy?  For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Specific to this FOA:What is the estimated public health benefit of the research?Do the existing data, public health and patient needs justify dissemination and implementation? If the aims of the proposed project are achieved, how will dissemination and implementation knowledge be advanced? How broad a reach (to the population that will benefit from the knowledge/intervention) will be achieved and how equitable will reach and outcomes likely be through the knowledge/service delivery contexts selected? Has consideration been given to the resource requirements and costs of the intervention? Will potential adopters and organizations be able to determine the applicability of the results to their setting?

 

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Specific to this FOA: Are the investigators part of stakeholder teams or have strong links and engagement of stakeholders necessary to accomplish the project aims?Is there clear evidence of dissemination and implementation research expertise as part of the team?

 

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

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Specific to this FOA: Does the proposed dissemination or implementation research contribute new and innovative concepts, outcomes, measures, and/or design approaches to the field?Does the study proposed promise to speed the translation of research into practice and/or produce novel and robust findings?

 

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?

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?

Specific to this FOA: Does the applicant demonstrate an understanding of dissemination and implementation research principles? Has the applicant justified the study design on the basis of the current state-of-the-art and or contextual factors relevant to dissemination and/or implementation? Is the dissemination or implementation approach appropriate to the problem and population using research methods that are relevant, rigorous and practical? Are the procedures to assess and analyze the dissemination or implementation strategies appropriate? Are the measurements and analysis plan linked to the study aims, and does the analysis incorporate the best available data to track dissemination or implementation process and impact, including cost-effectiveness? Where applicable, does the proposed plan for analysis take into account hierarchical relationships among multiple levels of outcomes (e.g. patient, provider, system)? How appropriate are the plans to sustain effective dissemination and implementation approaches once the research-funding period has ended?  

 

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?

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?

Specific to this FOA: Are the applicants positioned to influence large or influential networks capable of taking the results of the proposed study to scale to achieve public health impact? Do the proposed approaches take advantage of unique features of the intervention delivery environment or employ useful, collaborative arrangements? Is there evidence of institutional support to sustain dissemination or implementation strategies once the research funding ends?  

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.

 

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 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.

 

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.

 

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.

 

For Renewals, the committee will consider the progress made in the last funding period.

 

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.

Additional Review Considerations

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.

 

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 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).

 

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.

 

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 by the Center for Scientific Review (CSR), 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 submitted in response to this FOA. 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:
  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.

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.

Section VI. Award Administration Information

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.

Recipients must comply with any funding restrictions described in Section IV.6. 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.

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).

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, including of note, but not limited to:

If a recipient is successful and receives a Notice of Award, 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.

Should the applicant organization successfully compete for an award, 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 (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. 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 https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/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 and 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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

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.

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. NIH FOAs 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 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients 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 the threshold.  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 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, 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 and 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

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: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Gila Neta, PhD
National Cancer Institute (NCI)
Telephone: 240-276-6785
Email: Gila.Neta@nih.gov

Robb Rowley, MD
National Human Genome Research Institute (NHGRI)
Telephone: 301-827-9126
E-Mail: Robb.Rowley@nih.gov

Laura Kwako, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-451-8507
Email: laura.kwako@nih.gov

Lindsey Ann Martin, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-4036
E-mail: lindsey.martin@nih.gov

Lori Ducharme
National Institute On Drug Abuse (NIDA)
Telephone: 301-827-6331
E-mail: lori.ducharme@nih.gov

Denise Pintello, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-451-1481
Email: denise.pintello@nih.gov/">denise.pintello@nih.gov

Shahnaz Khan, MPH
National Institute Of Arthritis And Musculoskeletal And Skin Diseases (NIAMS)
Telephone: 301-451-9893
E-mail: khanshah@mail.nih.gov

Elise Rice, PhD
National Institute Of Dental & Craniofacial Research (NIDCR)
Telephone: 301-594-4814
E-mail: elise.rice@nih.gov

Elizabeth L Neilson, PhD, MPH, MSN
Office of Disease Prevention (ODP)
Telephone: 301-827-5578
Email: Elizabeth.Neilson@nih.gov 

Lynn S. Adams, PhD
National Institute of Nursing Research (NINR)
Telephone: 301-594-8911
Email: adamsls@mail.nih.gov

Wendy Weber, N.D., Ph.D., M.P.H.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-402-1272
Email: weberwj@mail.nih.gov

Melanie Bacon, R.N.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3215
Email: mbacon@niaid.nih.gov

Lisa Onken, Ph.D.
National Institute On Aging (NIA)
Telephone: 30l- 496-3131
E-mail: lisa.onken@nih.gov

Lana O Shekim, Ph.D.
National Institute On Deafness And Other Communication Disorders (NIDCD)
Telephone: 301- 496-5061
E-mail: shekiml@nidcd.nih.gov

Shavon Artis Dickerson, Dr.P.H., M.P.H.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-435-3055
Email: shavon.artisdickerson@nih.gov

Damiya Eve Whitaker
Office Of Research On Women's Health (ORWH)
Telephone: 240-276-6170
E-mail: damiya.whitaker@nih.gov

Richard T. Benson, MD, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
E-mail: richard.benson@nih.gov

Marion Koso-Thomas, MD, MPH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6873
Email: Marion.Koso-Thomas@nih.gov

Crystal Barksdale, PhD, MPH
National Institute On Minority Health And Health Disparities (NIMHD)
Telephone: 301-402-1366
E-mail: crystal.barksdale@nih.gov

 

 

Dave Clark, DrPH
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-402-2486
Email: Dave.Clark@nih.gov

Peer Review Contact(s)

Wenjuan Wang, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-480-8667
Email: wenjuan.wang2@nih.gov

Financial/Grants Management Contact(s)

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 301-496-8634
Email: wolfreyc@mail.nih.gov

Deanna L Ingersoll
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-7858
E-mail: deanna.ingersoll@nih.gov

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4707
Email: jfox@mail.nih.gov

Jenny L Greer
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3332
E-mail: jenny.greer@nih.gov

Pamela G Fleming
National Institute On Drug Abuse (NIDA)
Telephone: 301-480-1159
E-mail: pfleming@mail.nih.gov

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: tamara.kees@nih.gov

Erik Edgerton
National Institute Of Arthritis And Musculoskeletal And Skin Diseases (NIAMS)
Telephone: 301-594-7760
E-mail: erik.edgerton@nih.gov

Diana Rutberg, MBA
National Institute Of Dental & Craniofacial Research (NIDCR)
Phone: (301) 594-4798
E-mail: dr258t@nih.gov

Todd Le
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7794
Email: todd.le@nih.gov

Kelli Oster
National Institute of Nursing Research (NINR)
Telephone: 301-594-2177
Email: osterk@mail.nih.gov

Shelley Headley
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-3788
Email: shelley.headley@nih.gov

Ann Devine
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2988
Email: ADevine@niaid.nih.gov

Ryan Blakeney
National Institute On Aging (NIA)
Phone: 301-451-9802
E-mail: blakeneyr@mail.nih.gov

Christopher Myers
National Institute On Deafness And Other Communication Disorders (NIDCD)
Telephone:301-435-0713
E-mail: myersc@nih.gov

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: ChiefGrantsManagementOfficer@ninds.nih.gov 

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: margaret.young@nih.gov

Priscilla Grant, JD
National Institute On Minority Health And Health Disparities (NIMHD)
Telephone: 301-594-8412
E-mail: pg38h@nih.gov

Anthony Agresti
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-8014
Email: agrestia@nhlbi.nih.gov

 

 

Section VIII. Other Information

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.

Authority and Regulations

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 and 2 CFR Part 200.

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