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)
National Institute on Deafness and Other Communication Disorders (NIDCD)
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)
Fogarty International Center (FIC)
National Center for Complementary and Integrative Health (NCCIH)

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 (R21 Clinical Trial Optional)

Activity Code

R21 Exploratory/Developmental Research Grant

Announcement Type

Reissue of PAR-18-017

Related Notices
  • September 4, 2019 - Notice of Change to Information relevant to Specific Institutes/Centers in PAR-19-275. See Notice NOT-AR-19-041.
  • August 23, 2019 - Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-137.
  • July 26, 2019 - Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-128.
Funding Opportunity Announcement (FOA) Number

PAR-19-275

Companion Funding Opportunity

PAR-19-274, R01 Research Project Grant;

PAR-19-276, R03 Small Grant Program

Catalog of Federal Domestic Assistance (CFDA) Number(s)

 93.242, 93.399, 93.213, 93.172, 93.866, 93.273, 93.855, 93.846, 93.173, 93.279, 93.853, 93.361, 93.113, 93.313, 93.989

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to support innovative approaches to identifying, understanding, and developing strategies for overcoming barriers to the adoption, adaptation, integration, scale-up and sustainability of evidence-based interventions, tools, policies, and guidelines. Conversely, there is a benefit in understanding circumstances that create a need to stop or reduce (“de-implement”) the use of interventions that are ineffective, unproven, low-value, or harmful. In addition, studies to advance dissemination and implementation research methods and measures are encouraged. All applications must be within scope of the mission of one of the Institutes/Centers listed above.

Key Dates
Posted Date

May 8, 2019

Open Date (Earliest Submission Date)

May 16, 2019

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

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.

AIDS Application Due Date(s)

Standard AIDS dates apply, by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates.

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.

Scientific Merit Review
Advisory Council Review
Earliest Start Date
Expiration Date

May 8, 2022

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow 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 the 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 1. Overview Information
    Part 2. Full Text of the Announcement

    Section I. Funding Opportunity Description
    Section II. Award Information
    Section III. Eligibility Information
    Section IV. Application and Submission Information
    Section V. Application Review Information
    Section VI. Award Administration Information
    Section VII. Agency Contacts
    Section VIII. Other Information

    Part 2. Full Text of Announcement
    Section I. Funding Opportunity Description
    Purpose

    The purpose of this Funding Opportunity Announcement (FOA) is to support innovative approaches to identifying, understanding, and developing strategies for overcoming barriers to the adoption, adaptation, integration, scale-up and sustainability of evidence-based interventions, tools, policies, and guidelines. Conversely, there is a benefit in understanding circumstances that create a need to stop or reduce (“de-implement”) the use of interventions that are ineffective, unproven, low-value, or harmful. In addition, studies to advance dissemination and implementation research methods and measures are encouraged.

    This FOA uses the R21 mechanism. The R21 activity code is intended to encourage new exploratory and developmental research projects. For example, such projects could assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance health-related research. Another example could include the unique and innovative use of an existing methodology to explore a new scientific area. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research.

    Applications for R21 awards should describe projects distinct from those supported through the traditional R01 activity code. For example, long-term projects, or projects designed to increase knowledge in a well-established area, will not be considered for R21 awards. Applications submitted to this FOA should be exploratory and novel. These studies should break new ground or extend previous discoveries toward new directions or applications. Projects of limited cost or scope that use widely accepted approaches and methods within well-established fields are better suited for the R03 small grant activity code.

    See more at: http://grants.nih.gov/grants/guide/pa-files/PA-15-125.html#sthash.wH2cgON5.dpuf

    Background

    Each year, billions of U.S. tax dollars are spent on research and hundreds of billions are spent on delivery of health, healthcare, and public health interventions 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 tools and approaches. For years, we have known of the limitations of research publications in leading to widespread uptake of evidence-based practices, but too often the scientific pathway ends prematurely, before we can determine the best ways to improve adoption, implementation, and sustainability. In the context of increased interest and investment in intervention trials that will help 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, community (e.g., workplace, school, place of worship) and 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 and basic behavioral discovery and population health and healthcare delivery 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 tools and interventions deemed efficacious within clinical or community-based trials would be readily adopted and implemented; however, compelling evidence suggests that this has not been the case. Even when added information, tools, and 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 vulnerable or difficult-to-reach populations, monitoring the quality 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 targeted distribution of information and intervention materials to a specific public health or clinical practice 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 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 and guidelines (e.g., Community Guide to Preventive Services, U.S. Preventive Services Task Force, and clinical and professional societies' recommendations and guidelines). Implementation research studies should assume neither 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" interventions are integrated within diverse practice settings and patient populations, which will likely 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" approach to a greater emphasis on the resources of local care settings and the needs of multiple stakeholders, including approaches such as team science, community engaged research, action research, citizen science, and related frameworks 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 trans-disciplinary collaboration, utilizing theories, empirical findings, and methods from a variety of fields. Relevant fields include but are not limited to: information science, clinical decision-making, organizational and management theory, economics, individual and systems-level behavioral change, public health, business and public administration, statistics, anthropology, epidemiology, learning theory, 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 approaches that produce relevant evidence on outcomes, costs, and/or unanticipated consequences of dissemination and implementation efforts. The goal is to conduct dissemination and implementation studies utilizing research designs that are both rigorous and relevant. 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 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:

    Specific Objectives and Scope of this FOA

    This FOA invites research grant applications that will identify, develop, test, evaluate, and/or refine strategies to disseminate and implement evidence-based practices (e.g. behavioral interventions; prevention, early detection, diagnostic, treatment and disease management interventions; quality improvement programs) into public health, clinical practice, and community (e.g., workplace, school, place of worship) settings. 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 of strategies to implement health promotion, prevention, screening, early detection, and diagnostic interventions, as well as effective treatments, clinical procedures or guidelines into existing care systems.
    • Studies of the implementation of multiple evidence-based practices within community or clinical settings to meet the needs of complex patients and diverse systems of care.
    • Studies of the local adaptation of evidence-based practices in the context of implementation.
    • 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 the effectiveness and cost-effectiveness of dissemination or implementation strategies to reduce health disparities and improve quality of care among rural, minority, low literacy and numeracy, and other underserved populations.
    • Studies on reducing or stopping ("de-implementing") the use of clinical and community practices that are ineffective, unproven, low-value, or harmful.
    • Studies of the relationship of context 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 that focus on the testing of theories, models, and frameworks for D&I processes.
    • Development of valid and reliable D&I relevant outcome and process measures.
    • Development of study designs, research methods, and analytic approaches for studying dissemination and implementation. 
    • Development and strengthening of tools and techniques for conducting rapid yet rigorous qualitative data collection and analysis.
    • Development of rigorous approaches for comparisons of qualitative data across implementation contexts appropriate for accelerated implementation timelines.
    • Studies of the dissemination and implementation of effective and cost-effective implementation strategies for incorporating genomic medicine, sequence-based diagnostics and therapeutics in clinical care.
    • Studies testing the implementation and use of genomic information, including family history risk information and/or pharmacogenetic information for improved diagnosis and treatment.
    • Studies of policies and other contextual factors that influence the success of dissemination or implementation efforts.

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

    • Understand how effective interventions work, particularly multi-level or multi-component interventions, to inform how those interventions can optimally be delivered when implemented in various settings.
    • Understand the relevance of health interventions, where applicable, to meet the needs of underserved populations and/or low-resource settings.
    • Incorporate theories, models, and/or frameworks appropriate for D&I to inform study hypotheses, measures, and outcomes.
    • Consider extant literature on barriers to and facilitators of the dissemination and implementation of practices to improve health.
    • Incorporate the identification of mediators, moderators, and mechanisms of action that explain the impact of dissemination or implementation strategies on relevant outcomes.
    • Consider and characterize of the multi-level context and environment in which the proposed research will be conducted.
    • Consider the use of qualitative and/or mixed methods approaches.
    • Develop and/or use 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.
    • Incorporate stakeholder-relevant outcomes (i.e., outcomes relevant to patients, consumers, families, practitioners, administrators, and/or policymakers).

    Collaborative Research: In addition, given the range of expertise that may be needed for conducting dissemination and implementation research, applicants are encouraged to form trans-disciplinary teams of scientists and stakeholders.

    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 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 interventions, tools, and policies. For D&I research, note that the NIA does not accept applications that include clinical trials in response to this FOA. Applicants proposing a clinical trial should refer to the following NIA websites: https://www.nia.nih.gov/research/dbsr, https://www.nia.nih.gov/research/dgcg/seeking-support-clinical-trials, and the NIH Stage Model website: https://www.nia.nih.gov/research/dbsr/stage-model-behavioral-intervention-development.

    National Institute of Allergy and Infectious Diseases (NIAID)

    The National Institute of Allergy and Infectious Diseases will not accept any clinical trials in response to an R21 FOA. Those interested in conducting clinical trials should review the NIAID website: 

    https://www.niaid.nih.gov/grants-contracts/investigator-initiated-clinical-trial-resources  https://grants.nih.gov/grants/guide/pa-files/PAR-18-633.html

    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, orthopaedics, dermatology, metabolic bone diseases, heritable disorders of bone and cartilage, inherited and inflammatory muscle diseases, and sports and rehabilitation medicine. Clinical trial applications will only be supported by NIAMS if submitted to a NIAMS clinical trials-specific FOA.  A current list of active NIAMS clinical trials FOAs is available at https://www.niams.nih.gov/grants-funding/conducting-clinical-research/grants. 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 encouraged to follow the NIMH’s experimental therapeutics approach to intervention development and testing (see NIMH Clinical Trials FOAs). It is recommended that investigators contact NIMH Scientific/Research staff well in advance of submitting applications to discuss the match to NIMH priorities. 

    National Center for Complementary and Integrative Health (NCCIH)

    For specific information about NCCIH priorities for dissemination and implementation research refer to the NCCIH website: http://nccih.nih.gov/grants/disseminationPAR.

    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
    Resubmission

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

    Clinical Trial?

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

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

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

    Award Budget

    The combined budget for direct costs for the two-year project period may not exceed $275,000. No more than $200,000 may be requested in any single year.

    Award Project Period

    The maximum period is 2 years. 

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

    Section III. Eligibility Information
    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)

    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)
    • 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.

    • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. 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.
    • 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. 
    • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons.  Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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 DUNS number and 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.  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 NOT-OD-11-101).
    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 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: 

    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, with the following modification:

    • 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.

    PHS Human Subjects and Clinical Trials Information

    When involving NIH-defined human subjects research, clinical research, and/or 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.

    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 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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

    Post Submission Materials

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

    For this particular announcement, note the following:

    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.

    The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

    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.

    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?

    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?     

    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?

    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?        

    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?

    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? 

    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? 

    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?  

    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? If clinical, community or public health settings are involved, are stakeholders sufficiently engaged throughout the phases of the proposed study? 

    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?   

    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.

    Study Timeline

    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)?

    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

    Not applicable.

    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.

    Applications from Foreign Organizations

    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.

    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 by the Center 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:

    • 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.
    • Will receive a written critique.

    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:

    • 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 grantee’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.

    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

    Per NOT-OD-19-055, recipients must provide NIH with a certification that all non-exempt human subjects research has been reviewed and approved by an appropriate IRB.  The date of final IRB approval is the date that all protocols in the proposed research application received IRB review and approval (i.e., the date of the last protocol approval).  When human subjects research is anticipated within the period of the award but definite plans for involvement of human subjects cannot be described in the application or proposal (referred to as "delayed onset human subjects research"), prior to the involvement of human subjects in non-exempt research, the recipient must submit to the NIH awarding IC for prior approval (1) detailed information as required in the Human Subjects and Clinical Trials Information Form of the application, as well as the certification and date of final IRB approval.    

    Under no circumstances may NIH-supported non-exempt human subjects research be initiated prior to meeting the requirements for conducting an IRB review of protocols as well as obtaining the date of final IRB approval. NIH will not allow any funds to be used by recipients where a certification and an IRB approval date has not been provided to the funding IC.

    Recipients are also reminded that any changes to study protocols that have been subject to peer review, as well as the addition of new study protocols, require the prior approval of the NIH awarding Institute or Center consistent with Section 8.1.2.5 of the NIHGPS.  Such requirements are also generally described in the Funding Opportunity Announcement and/or the Notice of Award.

    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, Grantees, 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 law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html.  Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. 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. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

    In addition, information on NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards can be found at https://grants.nih.gov/grants/policy/harassment.htm

    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.

    Cooperative Agreement Terms and Conditions of Award

    Not Applicable

    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.

    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: 301-945-7573

    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, Ph.D.
    National Cancer Institute (NCI)
    Telephone: 240-276-6785
    Email: gila.neta@nih.gov

    Wynne E. Norton, Ph.D.
    National Cancer Institute (NCI)
    Telephone: 240-276-6875
    Email: wynne.norton@nih.gov

    David Chambers, D.Phil.
    National Cancer Institute (NCI)
    Telephone: 240-276-5090
    Email:  dchamber@mail.nih.gov

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

    Chris Gordon, Ph.D. (for AIDS-related NIMH applications)
    National Institute of Mental Health (NIMH)
    Telephone: 301-443-1613
    Email:  cgordon1@mail.nih.gov

    Ebony Madden, Ph.D.
    National Human Genome Research Institute (NHGRI)
    Telephone: 919-541-0367
    Email: ebony.madden@nih.gov 

    Lisa Onken, Ph.D.
    National Institute on Aging (NIA)
    Telephone: 301-496-3136
    Email: Lisa.Onken@nih.gov

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

    Melanie Bacon, R.N., MPH
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 301-451-2747
    Email: mbacon@mail.nih.gov

    Faye Chen, Ph.D.
    National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
    Telephone: 301-594-5055
    Email: chenf1@mail.nih.gov

    Lana Shekim, Ph.D.
    National Institute on Deafness and Other Communication Disorders (NIDCD)
    Telephone: 301-496-5061
    Email: shekiml@nidcd.nih.gov

    Belinda Sims, Ph.D.
    National Institute on Drug Abuse (NIDA)
    Telephone: 301-443-6504
    Email: bsims@nida.nih.gov

    Symma Finn, Ph.D.
    National Institute of Environmental Health Sciences (NIEHS)
    Telephone: 919-541-4258 
    Email: symma.finn@nih.gov

    Peter Gilbert, Sc.M.
    National Institute of Neurological Disorders and Stroke (NINDS)
    Telephone: 301-496-0870
    E-mail: Peter.Gilbert@nih.gov

    Robin Conwit, MD
    National Institute of Neurological Disorders and Stroke (NINDS)
    Telephone: 301-496-9135
    E-mail: conwitr@ninds.nih.gov

    Augie Diana, Ph.D.
    National Institute of Nursing Research (NINR)
    Telephone: 301-402-6423
    Email: dianaa@mail.nih.gov  

    Dave Clark, Dr.P.H.
    National Center for Complementary and Integrative Health (NCCIH formerly NCCAM)
    Telephone: 301-827-1916
    Email: dave.clark@nih.gov

    Marya Levintova, Ph.D.
    Fogarty International Center (FIC)
    Telephone: 301-496-9535
    Email: levintovam@mail.nih.gov

    Keisha Shropshire, M.P.H.
    Office of Disease Prevention (ODP)
    Telephone: 301-827-5581
    Email: kshropsh@od.nih.gov

    Margaret Bevans, CAPT., Ph.D., RN, AOCN, FAAN
    Office of Research on Women's Health (ORWH)
    Telephone: 301-496-3934
    Email: margaret.bevans@nih.gov 

    Peer Review Contact(s)

    Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

    Yvonne Ferguson, PhD
    Center for Scientific Review (CSR)
    Telephone: 30-1827-3689
    Email: yvonne.ferguson@nih.gov

    Financial/Grants Management Contact(s)

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

    Rebecca Claycamp
    National Institute of Mental Health (NIMH)
    Telephone: 301-443-2811
    Email:  rclaycam@mail.nih.gov

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

    Nia Pree
    National Institute on Aging (NIA)
    Telephone: 301-827-6374
    Email: nia.pree@nih.gov

    Judy S. Fox
    National Institute on Alcohol Abuse and Alcoholism (NIAAA)
    Telephone: 301-443-4704
    Email: jfox@mail.nih.gov

    Ann Devine
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 301-402-5601
    Email:  adevine@niaid.nih.gov

    Andrew Jones
    National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
    Telephone: 301-435-0610
    Email: jonesan@mail.nih.gov

    Christopher Myers
    National Institute on Deafness and Other Communication Disorders (NIDCD)
    Telephone: 301-435-0713 
    Email: Myersc@mail.nih.gov

    Pamela Fleming
    National Institute on Drug Abuse (NIDA)
    Telephone: 301-435-1369
    Email: pfleming@nida.nih.gov

    Bryann Benton
    National Institute of Environmental Health Sciences (NIEHS)
    Telephone: 919-323-5577
    Email: bryann.benton@nih.gov  

    Tijuanna Decoster, PhD
    National Institute of Neurological Disorders and Stroke (NINDS)
    Telephone: 301-496-9231
    Email: tijuanna.decoster@nih.gov

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

    Shelley Carow
    National Center for Complementary and Integrative Health (NCCIH)
    Telephone: 301-594-3788
    Email: CarowS@MAIL.NIH.GOV

    Bruce Butrum
    Fogarty International Center (FIC)
    Telephone: 301-496-1670
    Email: butrumb@mail.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.

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