Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Mental Health (NIMH)

National Eye Institute (NEI)

National Institute on Aging (NIA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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 on Drug Abuse (NIDA)

National Institute of Nursing Research (NINR)

National Institute on Minority Health and Health Disparities (NIMHD)

National Center for Complementary and Integrative Health (NCCIH)

National Center for Advancing Translational Sciences (NCATS)

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)

Sexual and Gender Minority Research Office (SGMRO)

Funding Opportunity Title
Digital Healthcare Interventions to Address the Secondary Health Effects Related to Social, Behavioral, and Economic Impact of COVID-19 (R01 - Clinical Trial Optional)
Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices
None
Funding Opportunity Announcement (FOA) Number
PAR-20-243
Companion Funding Opportunity

None

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

93.242

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) aims to support research to strengthen the healthcare response to Coronavirus Disease 2019 (COVID-19) caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and future public health emergencies, including pandemics. While research related to the direct clinical effects of COVID-19 are supported by other funding opportunities, the purpose of this funding opportunity is to focus on the role and impact of digital health interventions [e.g., mobile health (mhealth), telemedicine and telehealth, health information technology (IT), and wearable devices] to address access, reach, delivery, effectiveness, scalability and sustainability of health assessments and interventions for secondary effects (e.g., behavioral health or self-management of chronic conditions) that are utilized during and following the pandemic, particularly in populations who experience health disparities and vulnerable populations.

Key Dates

Posted Date
June 26, 2020
Open Date (Earliest Submission Date)
July 20, 2020
Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

August 20, 2020, December 2, 2020, March 2, 2021

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

November 2020, March 2021, June 2021

Advisory Council Review

January 2021, May 2021, August 2021

Earliest Start Date

April 2021, July 2021, December 2021

Expiration Date
March 03, 2021
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

This funding opportunity announcement aims to support research to strengthen the healthcare response to Coronavirus Disease 2019 (COVID-19) caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and to future public health emergencies, including pandemics. While the direct clinical effects of COVID-19 are studied elsewhere, the pandemic has social, behavioral, and economic impacts on a wide range of health conditions. Thepurpose of this research is to focus on the role and impact of digital health interventions to address access, reach, delivery, effectiveness, scalability and sustainability, particularly in populations who experiencehealth disparitiesand vulnerable populations.

Background

Across the life span, the COVID-19 pandemic will result in behavioral, social, and economic changes that impact health. Both new cases of disease as well as worsening of existing health problems are anticipated and may include mental disorders (e.g. posttraumatic stress, anxiety, depression), increased alcohol and substance use, suicidal thoughts and behaviors, and sleep disturbances. Furthermore, based on data from prior disasters, this far-reaching global pandemic is likely to cause exacerbations of symptoms in individuals with pre-existing health conditions and related comorbidities and to reduce healthy behaviors that promote individual wellness for many. These adverse effects are compounded by disruptions in the provision and access to healthcare including access to allied health providers, such as therapists and visiting nurses.

Of particular concern are the effects of the pandemic on NIH-designated health disparity (racial/ethnic minorities, less privileged socioeconomic status, rural residents and sexual and gender minorities) and other populations with medical or social vulnerabilities. The latter includes people who are: residents of chronic care facilities, community-dwelling older adults, pregnant women, children, persons with cognitive impairment or dementia, homeless, incarcerated or involved with the criminal justice system, experiencing substance use disorder or severe mental illness, with visual, hearing, communication, or mobility impairment, and the uninsured. Other vulnerable groups specific to the current pandemic are medical personnel with direct patient care, other support staff, home health aides, as well as family and informal caregivers; emergency responders; and frontline workers in essential businesses or services.

The healthcare landscape in the United States and around the world has shifted dramatically to a rapid uptake of digital health technologies delivered online across a variety of platforms for addressing health and disease management, in many cases with uncertain reach to the aforementioned groups. Digital health incorporates mobile health (mHealth), telemedicine/telehealth, and health information technology (mobile phones, wearable sensors, internet platforms, and electronic health records) with biological, social, and behavioral data. These tools also have the potential to improve our understanding of health status, to track the course of illnesses and recovery, and to provide and enhance healthcare. Digital health interventions are treatments that aim to improve health and deliver the treatment as a standalone intervention or as an adjunct to face-to-face interventions via a digital health platform Digital health interventions offer the potential to bridge the treatment gap and provide evidence-based interventions to individuals who currently are unable to access treatments.

This initiative requires that investigators acquire and leverage partnerships with digital health developers and existing well-established digital health delivery platforms, so that the research follows a deployment-focused model of services design and testing. Partnership between academic investigators, health systems, professional organizations, private and community-based practitioners, practice organizations and allied systems (e.g. social services, criminal justice) that serve vulnerable populations at risk are strongly encouraged. Deployment-focused studies take into account the perspective of relevant stakeholders and key characteristics of settings intended to implement optimized digital health interventions to address the secondary health effects related to the social, behavioral, and economic impact of COVID-19. Potential stakeholders include, but are not limited to, federal agencies (e.g., Centers for Medicare and Medicaid Services, Substance Abuse and Mental Health Services Administration, Health Resources and Services Administration, Department of Defense, Department of Veterans Affairs); commercial health insurers/funders; public and commercial disability insurers; employers and other payers; delivery systems; professional/trade associations; accrediting and licensing organizations; medical education and other training programs; clinicians; vendors of information technology and other relevant products/services; service users; family members; and community organizations. The applicant should identify key stakeholders based on the characteristics of the proposed intervention and how the intervention will be deployed within service systems. Such communication and collaboration will not only facilitate the research process (e.g., by creating opportunities for research that is not otherwise feasible, by enabling stakeholders to anticipate relevant research initiatives in their planning and activities), but it will also yield more service-ready tools (e.g., by helping to ensure the results are relevant and actionable, by yielding tools that are acceptable to users and feasible for integration into clinical workflows). Where appropriate, it is strongly encouraged that applicants seek consultation from the Food and Drug Administration for guidance related to regulatory approval/certification of the digital health interventions that are being tested. These partnerships will enable research to be conducted at scale with large samples of participants and will leverage existing digital health platform infrastructures. Interventions may utilize phone delivery, app-based approaches, video delivery, web-based platforms, wearable devices, and/or new technologies. This initiative is not intended to support the development of novel digital health interventions.

Research Scope and Objectives

This FOA uses the R01 mechanism to address the secondary health effects related to the social, behavioral, and economic impact of the COVID-19 pandemic across the full lifespan, particularly among health disparate and vulnerable populations. Proposed studies should capitalize on existing infrastructure (e.g., existing evidence based digital health platforms) to increase the efficiency of participant recruitment, and data collection and management. Interventions selected should have theory and prior evidence for a proposed mechanism of action related to study outcome which is measured as part of the overall design. Platforms should be well established with a sufficient existing user base to support nimble intervention refinement and testing with appropriate sample size to achieve adequate statistical power. Of note, the goal of this FOA is not just to conduct pragmatic trials on digital health platforms. Rather, applicants are also expected to propose additional research beyond the primary effectiveness trial that capitalizes on the unique features of the proposed digital health platform. Such additional research might include but is not limited to: analyses of baseline characteristics of users to develop treatment matching algorithms, analyses of existing data to determine the optimal sequence and dose of the digital intervention, and development and testing of real time adaptive customized interventions that augment the base digital intervention.

Design, Analysis, and Sample Size for Studies to Evaluate Group-Based Interventions:

Investigators who wish to evaluate the effect of a digital health intervention on a health-related biomedical or behavioral outcome may propose a study in which (1) groups or clusters are assigned to study arms and individual observations are analyzed to evaluate the effect of the intervention, or (2) participants are assigned individually to study arms but receive at least some of their intervention in a real or virtual group or through a shared facilitator. Such studies may propose a parallel group- or cluster-randomized trial, an individually randomized group-treatment trial, a stepped-wedge design, or a quasi-experimental version of one of these designs. In these studies, special methods are required for analysis and sample size estimation. Applicants will need to show that their methods are appropriate given their plans for assignment of participants and delivery of interventions. Additional information is available at https://researchmethodsresources.nih.gov/.

Areas of High Program Priority

    • Applications that propose digital health interventions that address health disparities or focus particularly on vulnerable populations.
    • Digital health interventions being tested should be based on existing social and behavioral science theories as well as best practice healthcare approaches.
    • Interventions that take advantage of the unique functionality of mobile and wireless devices. Utilization of real-time data collection and feedback is encouraged where appropriate.
    • Studies designed to test if the proposed digital health intervention yields significant reductions in symptoms in individuals who exhibit clinically significant symptoms and/or functional impairment at baseline.
    • Studies that utilize software, devices, and systems that are interoperable with existing infrastructure such that resulting data is interoperable with relevant health information systems where applicable.
    • Studies that collect data via well-established assessments and measures and leverage common data elements.
    • Applications that test generalizable principles or approaches to using technology to improve the accuracy and efficiency of assessment and the effectiveness and quality of intervention and service delivery.
    • Studies that address known challenges with uptake and adherence/sustained use of technology-based approaches and attention to privacy and other safety/ethical considerations associated with the use of technology for research and clinical purpose.
  • Examples of responsive applications include, but are not limited to:
  • Strategies to increase the reach, access, engagement, efficiency, quality and sustainability of existing digital health interventions to accommodate individuals seeking screening, prevention, self-management, wellness behaviors and treatment both during and following the pandemic, particularly in health disparate and vulnerable populations where prior trials may not have focused on these populations of interest.
    • Clinical trials that incorporate strategies to address the digital divide (e.g., augmented digital interventions with non-digital components) as it relates to vulnerable populations, including low-income communities, older adults, as well as their caregivers, who cannot easily use or access many digital interventions
    • Studies that include a conceptual framework that clearly identifies the target mechanisms and the empirical evidence linking the mechanisms to the study outcomes, plans for assessing engagement of the target mechanisms, and analytic strategies that will examine target engagement and associations with clinical benefit. In the case of multi-component interventions, strategies would address the target mechanisms corresponding to each intervention component, as appropriate in the effectiveness context.
    • Approaches for matching individuals to digital health interventions of appropriate intensity, including studies that use existing data to rapidly identify and enroll participants, inform algorithms for intervention assignment, and strategies to increase treatment fidelity to Evidence Based Practices (EBPs).
    • Prospective trials that test the effectiveness of algorithm-based intervention delivery (e.g., stepped-care approaches). Artificial intelligence, machine learning, natural language processing may be useful, but investigators should use well established methods rather than plan development of new methodology.
    • Integration and analysis of data from multiple digital health platforms or systems leveraging common data elements to identify the long-term health impact and the cost effectiveness of providing digital health interventions at scale.
    • Studies that investigate the influence of sex and gender on the use of digital health interventions for disease prevention, presentation, management, and outcomes and that ultimately contribute to a more individualized approach to health care.
    • Studies that are designed to test whether digital interventions can mitigate racial/ethnic and gender disparities in access, service utilization, and health outcomes.
    • Strategies for promoting adherence to and sustained use of digitally-assisted interventions, including studies that use existing data to identify individual and intervention-level characteristics that are associated with discontinuation vs sustained use, including COVID-19 related stigma, and trials that test approaches to promoting sustained use and engagement.
    • Strategies to understand if changes in service delivery (e.g. replacement (or substitution) of face to face services with digital health ) as a result of the pandemic will yield durable and sustainable system level changes in practice that improve or maintain quality care.
    • Strategies to identify previously understudied or unknown services and care delivery pathways that emerged as a result of the pandemic and how to capitalize on these novel digital health pathways, such as ways to segment levels of care (e.g., crisis line support that could transfer to higher levels of telehealth psychiatric/ addiction care for more complex cases when in person treatment is not feasible), bridge interventions and therapy or treatment sessions and promote between-session skill practice/acquisition and facilitate the transition back to face to face care, when needed.
  • Refine and test adaptive interventions and just-in-time interventions that can be ‘pushed out’ via mobile technology based on information regarding the individual’s current state. For example, interventions that prompt users to complete an assessment at specific times during the day or passive ascertainment of changes in clinical status, immediately followed by provision of behavioral support, such as self-management strategies.
  • Utilize electronic health record data in conjunction with digital health interventions to examine the clinical epidemiology, service utilization, response to treatment, within or across large systems responsible for health service delivery in order to inform timing and targets for intervening.

Applications Not Responsive to this FOA

Areas that are not responsive to this FOA:

    • Testing of digital health interventions that do not focus on reducing the severity of clinically significant symptoms and/or functional impairments.
    • Proposed studies that do not plan to enroll participants with baseline levels of measurable clinically significant symptoms and/or functional impairment.
    • Applications that propose clinical trials with a non-active comparator.
    • Research to develop new digital health interventions; examine digital health tools or platforms and or non-validated treatments or adapt established interventions to new platforms are outside the goals of this initiative.
    • Proposing the use of digital health platforms with insufficient existing users to conduct rapid, appropriately powered studies to yield actionable changes in identification, treatment, or service delivery for secondary health effects related to the current pandemic among health disparate and vulnerable populations.
    • Applications that propose the translation of existing face-to-face treatments into digital health interventions.
    • Studies that propose the collection of study assessments and surveys in the absence of a conceptual model and accompanying analyses that address at least one of the above described scientific areas of interest.

Applications Not Responsive to the FOA will not be reviewed. Applicants are strongly encouraged to reach out to scientific contact to discuss.

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
Resubmission
New

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)

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

Not Applicable

Award Budget

Application budgets are limited to $750,000 direct costs per year andneed to reflect the actual needs of the proposed project.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 3 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
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not 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.
  • 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.

Investigators are required to include partnerships with digital health developers and existing well-established digital health delivery platforms

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 instructions in the Research (R) Instructions in the SF424 (R&R) Application Guideexcept 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.

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:

Significance

    • Describe the health disparity or vulnerable population health need secondary to the behavioral, social, and economic impact of COVID-19 that will be addressed.
    • Justify the practical effect of the digital health intervention in terms of the estimated hypothesized effect size (e.g., in terms of remediation of symptoms or functional impairment, sustained skill use, improved adherence), compared with already available approaches. Address the potential impact of the digital health intervention in terms of both (1) the empirical basis for the anticipated effect size (e.g., citing data regarding the magnitude of the association between the target and the clinical endpoint of interest and/or effect sizes obtained in prior efficacy studies), (2) the clinical meaningfulness of the anticipated increment in effects compared to existing approaches, and (3) available evidence for use of the proposed intervention in the health disparate or vulnerable population of interest where available or how you plan to address this research gap.
    • Address the degree to which the proposed digital health intervention is scalable and could be disseminated into practice, given typically available resources (e.g., trained, skilled providers), typical service structures (including health care financing), and typical service use patterns as well as the potential for use in disrupted healthcare systems.
    • Detail how the proposed research will generate data that will lead to a firm conclusion about the digital health intervention and provide information about the anticipated scope and goals of intended future work.

Investigator(s)

    • Describe expertise or experience with clinical trials and with the needs related to health disparities and vulnerable populations.
    • Describe plans to involve collaborations and/or input from community practice partners/providers, consumers, and relevant policy makers in a manner that informs the research (e.g., to help ensure the interventions/service delivery approaches are acceptable, feasible, and scalable) and helps to ensure the results will have utility for end-users.

Innovation

    • Highlight how innovative research strategies and design/analytic elements are incorporated, as appropriate, to enhance the study's potential for yielding practice-relevant information and enable the research to be conducted within a rapid time frame.
    • Highlight how the digital health platform capitalizes on the unique functionality of mobile and wireless devices, utilizes real-time data collection, incorporates regular software updates that are informed by the research and user feedback.
    • Describe how the proposed study will leverage mobile health and health information technology (smartphones, wearable sensors, internet platforms, and electronic health records) with biological, social, and behavioral data or bridge digital divide (e.g., augmented digital interventions with non-digital components) as it relates to vulnerable populations, including elderly and low-income communities that cannot easily use or access many digital interventions.

Approach

    • Describe partnerships with digital health companies, academic investigators, health systems, professional organizations, private and community-based practitioners, practice organizations and allied systems (e.g. social services, criminal justice) that serve populations at risk, and how the study follows a deployment-focused model of services design and testing.
    • Detail the rationale and empirical basis for the digital health intervention approach in terms of the intended target population, stage of intervention (e.g., acute care, continuation or maintenance treatment, transition to independent care management), corresponding goals and focus of the intervention (e.g., remediating symptoms or impairments; promoting sustained adherence), potential scalability, key window or timeframe over which the digital health intervention should be administered.
    • Include a clear description of the digital health platform and documentation describing the current number of daily users of the platform.
    • Provide an enrollment plan that documents the current user base of the digital platform andhow current users will be recruited, consented and randomized. Applicants are instructed to not to duplicate details provided in the PHS Human Subjects and Clinical Trials Information Form.
    • Describe the assessment and monitoring of the fidelity of intervention delivery via procedures that are feasible and valid.
    • Include outcome measures that are validated and generally accepted by the field, including stakeholder-relevant outcomes (e.g., individual functioning, health services use), as appropriate.
    • Justify the proposed period of observation (i.e., timing of assessments and length of follow-up), given the intent of the intervention (e.g., acute care, continuation therapy, skill generalization, maintenance of gains, adherence promotion).
    • Include the assessment of symptoms and related outcomes using strategies that can facilitate sharing of data as appropriate

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:

Consistent with achieving the goals of the program, a Data Sharing Plan is expected to be included and to describe how the investigators will:

    • Support efforts to ensure harmonization of collected covariates and outcomes using existing standard ontologies supported by NIH/NLM.
    • Align and share with national and international COVID-19 related genomics initiatives such as the COVID-19 Host Genetics Initiative (https://www.covid19hg.org/),as appropriate and consistent with achieving the goals of the program.

Sharing Data via the NIMH Data Archive:

  • To advance research through widespread data sharing among researchers, investigators funded under this NOSI are encouraged to share human subjects data via the NIMH Data Archive (NDA) (See (NOT-MH-19-033) Notice of Data Sharing Policy for the National Institute of Mental Health). Established by the NIMH, and supported by other NIH Institutes, the NDA is a secure informatics platform for scientific collaboration and data-sharing that enables the effective communication of detailed research data, results, tools, and supporting documentation.
  • Where possible, investigators funded under this FOA are expected to use NDA technologies to submit data in accordance with the NDA Data Sharing Terms and Conditions, incorporated by reference, which can be found at https://nda.nih.gov/contribute/sharing-regimen.html. A resource sharing plan, formulated in accordance with these NDA Data Sharing Terms and Conditions, should be included in the supplement application. The NDA links data across research projects through its Global Unique Identifier (GUID) and Data Dictionary technologies. Investigators funded under this FOA should use these technologies to submit and share their research data and results at the appropriate times. The NDA Cost Estimation Tool is a customizable Excel worksheet that can be used to calculate an estimate of the resources needed to submit and share data with the NDA. This resource estimate should be submitted as part of the application budget (http://nda.nih.gov/contribute_cost_estimation.html).
  • To minimize the proliferation of one-off survey items, encourage comparisons across samples, and facilitate data integration and collaboration, a trans-NIH working group is making existing COVID-19 survey items and investigator contact information publicly available through two NIH-supported platforms: the NIH Public Health Emergency and Disaster Research Response (DR2) [ https://dr2.nlm.nih.gov/ ] and the PhenX Toolkit [ https://www.phenxtoolkit.org/index.php ]. Researchers addressing COVID-19 questions, whether population-based or for clinical research, are encouraged to consider these COVID-19 specific survey item repositories and select existing survey items or protocol modules currently being fielded if consensus measures are not available elsewhere.
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 human subjects research, clinical research, and/or NIH-definedclinical 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.

Pre-award costs may be incurred from January 20, 2020 through the public health emergency period and prior to the date of the federal award.

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 and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive 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.

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

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?

Does the application sufficiently justify that successful completion of the aims will improve secondary effects of behavioral, social, and economic changes related to COVID-19 in health disparities and vulnerable populations?

How well does the application justify the practical effect of the digital health intervention in terms of the estimated hypothesized effect size (e.g., in terms of remediation of symptoms or functional impairment, reduced likelihood of relapse or re-hospitalization, improved adherence), compared with already available approaches? How well does the application address both (1) the empirical basis for the anticipated effect size (e.g., citing data regarding the magnitude of the association between the target and the clinical endpoint of interest and/or effect sizes obtained in prior efficacy studies), and (2) the clinical meaningfulness of the anticipated increment in effects compared to existing approaches?

Does the application have plans for potential scalability and dissemination into practice, if successful,given typically available resources, particularly in context of ongoing pandemic (e.g., trained, skilled providers), typical service structures (including health care financing), and typical service use patterns and current use and needs?

How likely is the proposed research to generate data that will lead to a firm conclusion about the digital health intervention and provide information about the anticipated scope and goals of intended future work?

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?

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?

Do the PD/PI(s) have experience addressing health needs of populations with health disparities or vulnerable populations?

How well does the study involve collaborations and/or input from community practice partners/providers, consumers, and relevant policy makers in a manner that informs the research (e.g., to help ensure that the intervention/service delivery approach is acceptable, practical, and scalable) and helps to ensure the results will have utility for end-users?

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?

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?

How well does the application leverage mobile health and health information technology (smartphones, wearable sensors, internet platforms, and electronic health records) with biological, social, and behavioral data or bridge digital divide (e.g., augmented digital interventions with non-digital components) as it relates to vulnerable populations, including elderly and low-income communities that cannot easily use or access many digital interventions?

Does the application include innovative research strategies and design/analytic elements to enhance the study's potential for yielding practice-relevant information, and enable the research to be conducted within a rapid time frame?

Does the proposed research capitalize on the unique functionality of mobile and wireless devices, utilize real-time data collection, and incorporate regular software updates that are informed by the research and user feedback?

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?

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?

    • How well do the partnerships with digital health companies, academic investigators, health systems, professional organizations, private and community-based practitioners, practice organizations and allied systems (e.g. social services, criminal justice) that serve populations at risk, reflect research that follows a deployment-focused model of services design and testing?
    • How well does the application clearly describe the digital health intervention, the rationale and empirical basis for the intervention approach in terms of the intended target population, stage of intervention (e.g., acute care, continuation or maintenance treatment, transition to independent care management), corresponding goals and focus of the intervention (e.g., remediating symptoms or impairments; promoting sustained adherence), potential scalability, key window or timeframe over which the digital health intervention should be administered?
    • How well does the application provide a clear justification for the type of experimental design chosen?
    • How well does the application include a clear description of the digital platform and documentation describing the number of daily users of the platform and a strong justification that the existing user base can be leveraged to support the proposed research?
    • Do the applicants provide an enrollment plan that documents how current users will be recruited, consented and randomized? Is the enrollment plan aligned with the proposed sample size and power analysis?
    • How clear is the rationale for the choice of methods proposed and how the results will inform the next stages of research or deployment?
    • How well does the application describe the assessment and monitoring of the fidelity of intervention delivery via procedures that are feasible and valid?
    • Does the application include outcome measures that are validated and generally accepted by the field, including stakeholder-relevant outcomes (e.g., individual functioning, health services use), as appropriate?
    • How well does the application justify the proposed period of observation (i.e., timing of assessments and length of follow-up), given the intent of the intervention (e.g., acute care, continuation therapy, skill generalization, maintenance of gains, adherence promotion)?
    • Does the application include the assessment of symptoms and related outcomes using strategies that can facilitate sharing of data as appropriate (see e.g., NOT-MH-19-033)?


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?

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?

How well doesthe application describe the proposed digital health platform including a clear description of the digital health intervention, the number of currently active daily users, and the necessary infrastructure to remotely administer and record assessments?

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?

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 thecategories 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

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by 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 will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriateNational 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

Institutional Review Board or Independent Ethics Committee Approval: Grantee 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 awardee 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, 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 laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

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 agreementsare 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 threatensubmission 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)

Adam Haim, Ph.D.
National Institute of Mental Health (NIMH)
Email: Haima@mail.nih.gov

Erica Rosemond, Ph.D.

National Center for Advancing Translational Sciences (NCATS)

Email: rosemonde@mail.nih.gov

Wendy Weber, N.D., Ph.D., M.P.H

National Center for Complementary and Integrative Health (NCCIH)

Email: wendy.weber@nih.gov

Cheri Wiggs, Ph.D.

National Eye Institute (NEI)

Email: wiggsc@nei.nih.gov

Luke Stoeckel, PhD

National Institute of Aging (NIA)

Email: luke.stoeckel@nih.gov

Laura Kwako, Ph.D.

National Institute on Alcohol Abuse and Alcoholism(NIAAA)

Email: laura.kwako@nih.gov

Sonie Lee, Ph.D.

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

Email: sonia.lee@nih.gov

Will Aklin, Ph.D.

National Institute of Drug Abuse (NIDA)

Email: aklinwm@nida.nih.gov

Kelly King, Au.D., Ph.D

National Institute on Deafness and Other Communication Disorders (NIDCD)

Email: Kingke@mail.nih.gov

Elise Rise , Ph.D.

National Institute of Dental and Craniofacial Research (NIDCR)

Email: elise.rice@nih.gov

Beda Jean-Francois, Ph.D.

National Institute on Minority Health and Health Disparities (NIMHD)

Email: beda.jean-francois@nih.gov

Rebekah Rasooly, Ph.D.

National Institute of Nursing Research (NINR)

Email: rebekah.rasooly@nih.gov

Erica Spotts, Ph.D.

Office of Behavioral and Social Sciences (OBSSR)

Email: spottse@mail.nih.gov

Jaqueline Lloyd, Ph.D., M.S.W.

Office of Disease Prevention (ODP)

Email: lloydj2@nih.gov

Rebecca DelCarmen-Wiggins, Ph.D.

Office of Research on Women's Health (ORWH)

Email: rdelcarm@mail.nih.gov

Christopher Barnhart, Ph.D.

Sexual Gender Minority Research Office (SGMRO)

Email: christopher.barnhart@nih.gov

Peer Review Contact(s)

Delia Olufokunbi Sam

Center for Scientific Review (CSR)

Email: olufokunbisamd@mail.nih.gov

Financial/Grants Management Contact(s)

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: tkees@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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