Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Drug Abuse (NIDA)

National Institute of Mental Health (NIMH)

National Center for Complementary and Integrative Health (NCCIH)

National Cancer Institute (NCI)

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

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)

Funding Opportunity Title
HEAL Initiative: Preventing Opioid Misuse and Co-Occurring Conditions by Intervening on Social Determinants (R01 - Clinical Trials Optional)
Activity Code

R01 Research Project Grant

Announcement Type
Reissue of RFA-DA-22-036
Related Notices

  • July - Notice of NICHD Participation in RFA-DA-23-051 “HEAL Initiative: Preventing Opioid Misuse and Co-Occurring Conditions by Intervening on Social Determinants (R01 - Clinical Trials Optional)”. See Notice NOT-HD-22-037.

Funding Opportunity Announcement (FOA) Number
RFA-DA-23-051
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.279, 93.242, 93.393, 93.213, 93.865
Funding Opportunity Purpose

Through the HEAL Initiative, NIH requests applications for studies designed to develop and test sustainable, scalable interventions to prevent opioid misuse, opioid use disorder, and co-occurring mental health conditions by intervening directly on social determinants of health (SDOH). This initiative aims to build an evidence base for preventive interventions that address inequities, social risks and/or social disadvantage. Interventions targeting social determinants may be structural (e.g. policy, regulatory, or systemic-wide changes) or designed to alter outcomes of individuals affected by contextual risk factors, and may be implemented in conjunction with psychosocial interventions designed to address behavioral risks.

Key Dates

Posted Date
July 13, 2022
Open Date (Earliest Submission Date)
January 02, 2023
Letter of Intent Due Date(s)

January 2, 2023

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
February 02, 2023 February 02, 2023 Not Applicable July 2023 August 2023 September 2023

All applications are due by 5:00 PM local time of applicant organization. 

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

Expiration Date
February 03, 2023
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

Scholars have endorsed efforts to advance health equity by intervening on social determinants of health and attending to root causes of health disparities. Various types of interventions can be employed within communities and service settings to to achieve these goals. These can involve modifying structural or policy factors (e.g., decriminalization of drug possession, policy changes to support affordable housing) or more individual-focused solutions (e.g., providing individuals with career training or a living wage). While these actions address SDOH, the potential for effects of such actions on substance use and co-occurring conditions is unclear, as are the mechanisms through which they may operate. Research is needed to determine the conditions under which an intervention would have meaningful and measurable impacts on key outcomes of interest. This initiative seeks research on the effectiveness and mechanisms of action of interventions that modify SDOH to address risk factors for opioid misuse and co-occurring mental health conditions.

HEAL Initiative

This study is part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative bolsters research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. More information about the HEAL Initiative is available at: https://heal.nih.gov/. The HEAL Prevention Initiative (HPI) is focused on four strategic areas: 1) risk identification, 2) social determinants, health equity, and policy, 3) intervention development, and 4) dissemination, implementation, scale-up, and sustainment of prevention services. This FOA addresses the HPI strategic area related to social determinants, health equity, and policy.

Background

Social Determinants of Health (SDOH) are the conditions in environments where people are born, live, learn, work, play, worship, and age that affect health, functioning, and quality-of-life outcomes (for more information on SDOH see: Social Determinants of Health - Healthy People 2030 | health.gov) Data show significant variation in opiod use and opioid use disorder by socioeconomic factors and other contextual factors, but relatively few research studies have tested interventions that directly address social determinants to affect meaningful improvements in individual or population-level opioid misuse, OUD, and related conditions, such as mental health disorders. In fact, the extent to which educational, persuasion-based, or other psychosocial prevention interventions are rendered ineffective or less effective because of the impact of social determinants, such as literacy, numeracy, or language barriers, unstable housing, food insecurity, or discriminatory practices etc., is poorly understood. While the need for improved drug treatment and pain management are well-recognized, more research is needed to understand the opportunities for and mechanisms of preventing the onset of opioid use disorders and co-occurring conditions before treatment is indicated.

SDOH are often discussed in the context of “upstream” vs. “downstream” causes of poor health outcomes; upstream causes typically are more foundational (often referred to as root causes) while downstream causes are more proximal and reflect the cumulative effects of upstream factors. SDOH can also be characterized as “structural” or “individual,” and measures of SDOH can be assessed at aggregate (e.g., community) or individual levels (see PhenX Tool kit SDOH Collection). In the response to the opioid crisis, many have called for a greater emphasis on upstream SDOH and on intervening on structural and/or systemic causes, both of which are aligned with prevention efforts.

Research Goals, Setting, and Participants

NIH seeks research that responds to the opioid crisis by testing whether strategies that directly address social determinants of health, specifically by reducing inequities, social risks and/or disadvantage, alone or in combination with psychosocial interventions, prevent opioid misuse, mental health conditions, and suicide. Applications should include a measure of opioid use or misuse as a distal outcome. As relevant to the intervention strategy, investigators may choose to study additional health-related outcomes as distal outcomes. Additional health-related outcomes should be closely linked to opioid use behavior and may include variables such as stimulant/other drug misuse, polysubstance use, initiation of injection drug use, depression, anxiety, and chronic pain. All studies should provide a plan for measurement and analysis of malleable, intermediate outcomes, selected based on the nature of the proposed intervention.

Applications should test scalable, high-impact strategies that will contribute to ending the opioid crisis. Research should be conducted within populations disproportionately affected by opioid use disorder, mental illness or death by suicide. Applications must involve populations disproportionately affected by opioid-related harms and take place within the U.S. and its territories. Investigators should clearly define the population for whom selected outcomes will be studied and provide a justification for focusing on the population group or subgroup.

The population can be defined geographically (e.g. zip-code, county), by another identifying characteristic (e.g., youth aging out of foster care, homeless individuals, individuals who do not complete high school, juvenile justice-involved youth), or by a combination of factors (homeless women; persons from racial and/or ethnic minoritie groups who reside in a specific geographic region). Research projects should be developed in consultation and partnership with collaborators and/or community partners, particularly individuals who can support intervention sustainability once the research study has ended, if the evidence supports this.

Applicants should demonstrate that they have access to the communities, systems, or populations that will be enrolled in the intervention. Community collaborators, local officials, and policymakers (as relevant) should be meaningfully engaged throughout the project period. Doing so will enhance the likelihood that the interventions are suitable for the context and will address the needs of the community. Applicants should clearly describe existing partnerships involving systems, organizations, communities, and policymakers that are needed to facilitate the conduct of the research study. Also, the project plan should involve a Community Advisory Board that includes individuals from the participant population.

Intervention Strategy

Intervention strategies must address inequities, social risks or social disadvantage, alone or in combination with an established psychosocial preventive intervention (e.g., screening and brief intervention). Below are examples of projects involving structural, systemic, or policy interventions (e.g. regulatory changes, policy changes, procedural changes) and interventions that are designed to directly address social needs among individuals with risk factors for opioid use disorder. As this effort seeks to build evidence for intervening on upstream social determinants of health, structural, systemic, and policy interventions are strongly encouraged. Note that all studies should include a measure of opioid use or misuse as a distal outcome.

Examples of studies to address structural, systemic, and policy interventions and associated mechanisms include but are not limited to:

  • Studies of effects of policies that enhance financial well-being within a population. Mediational analyses may detect impact on concentrated poverty, neighborhood violence, social capital. Distal impacts may include emergency department visits related to mental health or substance use or population-level indicators of drug use or drug harms.
  • Studies of community policing and other reforms to address discrimination against persons who are racial and/or ethnic minority and/or persons who with mental illness. Mediational analyses may examine perceived discrimination, crime reports, neighborhood safety, and/or community cohesion. Distal impacts may include substance availability, arrest of juveniles for a first offense.
  • Studies of changes to workplace policies and incentive structures to reduce worker stress and fatigue or improve employee compensation, benefits, or job security among workers in industries with high rates of medical and non-medical substance use. Mediational analyses may examine job insecurity, quality of life, or chronic stress. Distal impacts may include substance use problems, depressive symptomology, or chronic pain.
  • Studies to test the impact of changes to the neighborhood or community environment to address nutrition and food insecurity (e.g., new grocery stores, community markets, or food pantries). Mediational analysis may examine healthy food environment, healthy eating, gut microbiome measures, and community cohesion. Distal impacts may include anxiety, depressive symptomology, and substance use behaviors.

Examples of studies involving interventions designed to have direct effects on social needs include but are not limited to:

  • GED, high-school completion, or apprenticeship training program paired with mentorship for individuals aging out of child welfare, affected by regional job loss, or experiencing multigenerational poverty. Mediational analyses may examine youth social capital, income or employment. Distal impacts may include anxiety, depression, and substance use behaviors.
  • Intensive case management, counseling, tutoring, and career services, for high school youth in the juvenile justice system or at risk of school drop out in a geographic region affected by the opioid crisis. Mediational analyses may examine self-help involvement, income, or employment. Distal impacts may include criminal justice system involvement, victimization, post-traumatic stress disorder, and/or substance use behaviors.
  • Housing First, either alone or in combination with Assertive Community Treatment to assist people with serious mental illness. Mediational analyses may examine housing insecurity or general distress. Distal impacts may include access to medical and behavioral health services or substance use behaviors.
  • Programs to provide services to address trauma and/or basic needs of youth in schools that serve students affected by the opioid crisis (e.g., youth in kinship or foster care, youth with a parent who uses substances, youth who experienced overdose). Mediational analyses may examine coping, school attendance, and/or housing instability. Distal impacts may include anxiety, depression, high school completion, or substance use severity.
  • Interventions for persons from racial and/or ethnic minority groups or immigrant and/orrefugee community groups impacted by historical trauma, structural racism, discrimination, and/or micro-aggressions to link them to resources (e.g., social services, legal aid), provide training related to managing stressful situations, and provide supports for achieving academic or career goals. Mediational analyses may examine well-being and/or social support. Distal impacts may include juvenile/criminal justice system involvement, substance use behaviors, and/or anxiety/depression.
  • Comprehensive mental health and social services for child/youth abuse or trauma survivors. Mediational analyses may examine school retention, well-being and/or social support. Distal impacts may include self-harm behaviors, substance use behaviors and/or anxiety.

Applicants may choose to study a single intervention or a combination of interventions. The combination may occur at a single level or multiple levels. For example, a policy intervention to address structural inequities may be tested in combination with a person-centered intervention addressing social needs. Alternatively, an intervention strategy may involve pairing a SDOH-focused intervention (whether structural or individual) with a psychosocial prevention intervention (e.g., motivational interviewing protocol) designed to address behavioral risks for substance use and/or a co-occurring mental health condition. Applicants should provide a conceptual framework to illustrate the intervention components, distal outcomes, and hypothesized mediational pathways.

NIH seeks to support research that has the potential for timely, wide-spread adoption and sustainability once the funding period ends if the intervention is demonstrated to be effective. Priority will be given to research projects embedded in existing settings or systems where there is a clear commitment to incorporating successful strategies as standard practice. Applicants are requested to demonstrate local support for the sustainability of the intervention after the NIH award ends if the intervention outcomes are favorable.

Research Study Considerations

Applications are expected to use rigorous, scientific methods to examine the effectiveness of the intervention and the mechanisms of effects for the intervention(s) being tested. Pilot data to provide preliminary evidence of efficacy the proposed intervention are allowed but not required. However, applicants should provide specific details regarding the theoretical basis for the chosen approach and the operationalization of the intervention strategy. In addition, a detailed timeline that outlines intervention implementation and data collection time points (for both mediational and distal outcomes) is recommended.

Measures utilized for the research may be derived from a variety of sources such as survey data, biomarkers, and administrative data. Survey measures should be well-established whenever possible; plans for the development of new indicators should be well-justified. As establishing common data elements is a priority for the NIH and would facilitate future data sharing, applicants are strongly encouraged to utilize measures included in the Social Determinants of Health Collection of the PhenX Toolkit (www.phenxtoolkit.org) when appropriate.

Strong methodological and statistical expertise is needed to ensure that the research is rigorously planned and executed. Investigators may propose various types of trial designs, including parallel group- or cluster-randomized trials, individually randomized group-treatment trials, stepped-wedge design trials, or a quasi-experimental version of one of these designs. In these studies, special methods may be warranted for analysis and sample size estimation. Applicants conducting multi-level and multi-component interventions are encouraged to consider designs that inform sequencing of components of complex interventions. Analytical procedures for studying mediational processes and quantifying intervention effects should be appropriate given the plans for assignment of participants and delivery of interventions. Additional information is available at https://researchmethodsresources.nih.gov/.

Diversity: Study Investigators, Staff, Collaborators, and Community Partners

In addition to scientific diversity, applicants should strive to incorporate diversity in their team development plan. Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust. In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups that are underrepresented in the biomedical, clinical, behavioral and social sciences, such as: individuals from underrepresented racial and ethnic groups, individuals with disabilities, individuals from disadvantaged backgrounds, and women at senior faculty levels. Please refer to Notice of NIH's Interest in Diversity NOT-OD-20-031 for more details.

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Application Responsiveness Criteria

Applications must propose to test a preventive intervention strategy designed to address inequities, social risks and/or social disadvantage, alone or in combination with psychosocial interventions. The research project must take place within the U.S. or one of its territories. In addition, all applications must meet the following criteria:

  • include at least one intervention that directly addresses one or more social determinant of health.
  • include a measure of opioid use or misuse as a distal outcome.
  • test mediational processes that link the intervention with distal outcomes.

Submissions that do not meet these requirements will be considered non-responsive and will not be reviewed.

NIH HEAL Initiative Meeting Attendance

The NIH HEAL Initiative will require a high level of coordination and sharing between investigators. It is expected that NIH HEAL Initiative recipients will cooperate and coordinate their activities after awards are made by participating in Program Director/Principal Investigator (PD/PI) meetings, including an annual HEAL Investigators Meeting, as well as other activities.

National Institute on Drug Abuse

The National Institute on Drug Abuse (NIDA) is the lead federal agency supporting research on drug use and its consequences. NIDA’s mission is to advance science on the causes and consequences of drug use and addiction and to apply that knowledge to improve individual and public health. NIDA seeks applications to test scalable solutions to the opioid crisis that involve interventing directly on social determinants of health.

Data Sharing

NIDA strongly encourages investigators to share data with other investigators.? NIDA expects that applicants to NIDA funding opportunity announcements: 1) submit their data to one of the NIH data archives for sharing; 2) include specific required elements in the Resource Sharing Plan including a description of whether and how the consents that will be used to obtain that data will affect the research that can be done with that data; and 3) include costs attributed to data preparation and submission to a data archive in grant applications.

Points to Consider Regarding Tobacco Industry Funding of NIDA Applicants

The National Advisory Council on Drug Abuse (NACDA) encourages NIDA and its grantees to consider the points it has set forth with regard to existing or prospective sponsored research agreements with tobacco companies or their related entities and the impact of acceptance of tobacco industry funding on NIDA's credibility and reputation within the scientific community. Please see Points to Consider Regarding Tobacco Industry Funding of NIDA Applicants | National Institute on Drug Abuse (NIDA) (nih.gov) at https://nida.nih.gov/about-nida/advisory-boards-groups/national-advisory-council-drug-abuse-nacda/points-to-consider-regarding-tobacco-industry-funding-nida-applicants for details.

Data Harmonization for Substance Abuse and Addiction via the PhenX Toolkit

NIDA strongly encourages investigators involved in human subjects research studies to employ a common set of tools and resources that will promote the collection of comparable data across studies and to do so by incorporating the measures from the Core and Specialty collections, which are available in the Substance Abuse and Addiction Collection of the PhenX Toolkit (www.phenxtoolkit.org). Please see NOT-DA-12-008 (http://grants.nih.gov/grants/guide/notice-files/NOT-DA-12-008.html) for further details.

Establishment of a Standard delta-9-THC Unit to be used in Research

Applications proposing research on cannabis or its main psychotropic constituent delta-9-THC are required to measure and report results using a standard delta-9-THC unit in all applicable human subjects’ research. The goal is to increase the comparability across cannabis research studies. A standard delta-9-THC unit is defined as any formulation of cannabis plant material or extract that contains 5 milligrams of delta-9-THC. A justification should be provided for human research that does not propose to use the standard unit. Please see NOT-DA-21-049 at https://grants.nih.gov/grants/guide/notice-files/NOT-DA-21-049.html for additional details.

National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects

The National Advisory Council on Drug Abuse (NACDA) recognizes the importance of research involving the administration of drugs with abuse potential, and dependence or addiction liability, to human subjects. Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA's Web site at NACDA Guidelines for Administration of Drugs to Human Subjects | National Institute on Drug Abuse (NIDA) (nih.gov) at https://nida.nih.gov/research/clinical-research/nacda-guidelines-administration-drugs-to-human-subjects

National Institute of Mental Health

The National Institute of Mental Health (NIMH) is interested in applications relevant to priorities described in this RFA and that support the NIMH Strategic Plan for Research. NIMH is committed to supporting research that reduces disparities and advances equity in mental health interventions, services, and outcomes.

All applications that propose clinical trials should follow the NIMH’s experimental therapeutics approach to intervention development and testing (see https://www.nimh.nih.gov/funding/opportunities-announcements/clinical-trials-foas/index.shtml). That is, the scope of work must include specification of targets/mechanisms and assessment of intervention induced changes in the presumed targets/mechanisms that are hypothesized to account for the intervention’s outcomes. In this manner, the results of the trial will advance knowledge regarding therapeutic change mechanisms and be informative regardless of trial outcomes (e.g., in the event of negative results, information about whether the intervention was successful at engaging its targets can facilitate interpretation).

NIMH encourages a deployment-focused model of intervention and services design and testing that takes into account the perspective of relevant stakeholders (e.g., service users, providers, administrators, payers) and the key characteristics of the settings (e.g., resources, including workforce capacity; existing clinical workflows) that are intended to implement optimized mental health interventions. This attention to end-user perspectives and characteristics of intended clinical and/or community practice settings is intended to ensure: the resultant interventions and service delivery strategies are acceptable to consumers and providers, the approaches are feasible and scalable in the settings where individuals are served, and the research results will have utility for end users.

NIMH encourages effectiveness research on potentially scalable preventive, therapeutic, and services interventions that focuses on practice-relevant questions. Accordingly, collaborations between academic researchers and clinical or community practice partners or networks are encouraged. When possible, studies should capitalize on existing infrastructure (e.g., practice-based research networks such as the NIMH-sponsored Mental Health Research Network (MHRN), electronic medical records, administrative data bases, patient registries, institutions with Clinical and Translational Science Awards) to increase the efficiency of participant recruitment (i.e., more rapid identification and enrollment) and to facilitate the collection of moderator data (e.g., clinical characteristics, biomarkers), longer-term follow-up data, and broader, stakeholder-relevant outcomes (e.g., mental health and general health care utilization, value and efficiency of intervention approaches).

National Cancer Institute

The National Cancer Institute (NCI) is interested in supporting intervention research in the following areas that include, but are not limited to:

  • Utilizing a systems approach to intervene on social determinants and target pain management outcomes in addition to opioid misuse outcomes
  • Developing and testing multi-level strategies to ensure effective pain management for NIH-designated populations that experience health disparities
  • Testing pain reporting mechanisms that are culturally and linguistically tailored for cancer patients to improve pain management outcomes
  • Testing how intervening on SDOH impacts pain assessment, reporting, and management, in addition to opioid misuse outcomes
  • Pairing a non-pharmacological or cognitive-behavioral approach with a SDOH-focused intervention to manage pain in cancer survivors

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

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

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. Only those application types listed here are allowed for this FOA.

Clinical Trial?

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

Funds Available and Anticipated Number of Awards

The NIH HEAL Initiative intends to commit $10,000,000 in FY 2023 to fund up to 15 awards.

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

The maximum project period is 5 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Government

  • 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 not eligible to apply.

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

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • System for Award Management (SAM)– Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
    • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

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

The letter of intent should be sent to: NIDALetterofIntent@nida.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.

Applicants should budget for the following expenses:

  • Travel for at least one PI to the annual NIH HEAL Initiative Investigators meeting.
  • Time and support to participate in additional NIH HEAL Initiative collaborative activities.
  • Expenses to convene a Community Advisory Board and, as needed, a Data and Safety Monitoring Board.
  • Expenses related to sharing data and resources.
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:

Note: Letters of support should be included to document commitment of partners who will provide access to data or research resources. Applications should clearly detail:

Intervention Strategy

  • Theoretical underpinnings and/or justification for intervention(s)
  • Pilot or preliminary data, if available
  • Linkage between theory and selected intervention or intervention components
  • Intervention content and implementation details
  • Information or letters supporting the intervention’s potential for adoption after the study period ends

Research Plan

  • Description of the population or population subgroup proposed for the study and justification for its selection (e.g., data on trends in opioid use disorder, substance use overdose, or suicide risk)
  • Clearly defined dependent, mediator, moderator and control variables (as relevant) in addition to sources of data
  • As relevant, a description of the participant inclusion criteria, project recruitment and retention plan, intervention and comparison conditions, intervention delivery procedures, and fidelity assessment
  • Description of the measurement and analysis plan, including power analysis, and plan to study mechanisms of action
  • Timeline that reflects conduct of intervention, analyses, and research dissemination activities
  • Discussion of ethical considerations in the design and execution of the research

Research Team and Collaborators

  • Evidence of substantive expertise as appropriate (e.g., with regard to substance use prevention, prevention of mental disorers, social determinants of health, community-engaged research)
  • Involvement of individuals with the appropriate data management, methodological and/or analytical skills to execute the data analysis plan, including the analyses related to mechanisms of action of the intervention
  • Evidence of engagement scientists engaged in diverse disciplines and individuals who bring diverse perspectives to the science
  • Description of existing partnerships with systems, organizations, communities, etc. as needed to facilitate the conduct of the research study. As relevant, meaningful engagement of commuity partners clearly described.
  • Evidence of commitment to participate in the research from the organizations or entities responsible for implementation of the intervention(s)

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.

NIH intends to maximize the impact of HEAL Initiative-supported projects through broad and rapid data sharing. Consistent with the HEAL Initiative Public Access and Data Sharing Policy (https://heal.nih.gov/about/public-access-data), all applications, regardless of the amount of direct costs requested for any one year, are required to include a Data Management and Sharing Plan outlining how scientific data and any accompanying metadata will be managed and shared. The plan should describe data types, file formats, submission timelines, and standards used in collecting or processing the data. Data generated by HEAL Initiative-funded projects must be submitted to study-appropriate domain-specific or generalist repositories in consultation with the HEAL Data Stewardship Group to ensure the data is accessible via the HEAL Initiative Data Ecosystem. Guidelines for complying with the HEAL Public Access and Data Sharing Policy can be found at https://heal.nih.gov/data/complying-heal-data-sharing-policy. Resources and tools to assist with data related activities can be found at https://www.healdatafair.org/.

To maximize discoverability and value of HEAL datasets and studies, and facilitate data integration and collaboration, applications submitted in response to this FOA are strongly encouraged to incorporate standards and resources where applicable:

  • Applicants are encouraged to ensure that data collected by the study conform to Findable, Accessible, Interoperable, and Reusable (FAIR) principles.
  • Applicants are specifically encouraged to incorporate into their planning, an alignment with the guidelines, principles and recommendations developed by the HEAL Data Ecosystem, including but not limited to preparing data to store in selected specified repositories, applying minimal metadata standards, use of core HEAL Clinical Data Elements (CDEs, https://heal.nih.gov/data/common-data-elements), and other necessary requirements to prepare data to connect to the HEAL Data Ecosystem.
  • All new HEAL clinical pain studies are required to submit their case-report forms/questionnaires to the HEAL Clinical Data Elements (CDE) Program. The program will create the CDE files containing standardized variable names, responses, coding, and other information. The program will also format the case-report forms in a standardized way that is compliant with accessibility standards under Section 508 of the Rehabilitation Act of 1973 (29 U.S.C § 794 (d)), which “require[s] Federal agencies to make their electronic and information technology accessible to people with disabilities.” HEAL Initiative clinical studies that are using copyrighted questionaries are required to obtain licenses for use prior to initiating data collection. Licenses must be shared with the HEAL CDE team and the program officer prior to use of copyrighted materials. For additional information, visit the HEAL CDE Program.
  • To the extent possible, HEAL awardees are expected to integrate broad data sharing consent language into their informed consent forms and align study consent language with data access and re-use requirements as defined by repository HEAL investigators select to store their HEAL data long-term.

The NIH notices referenced below provide additional NIH guidance that should be considered in developing a strong data management and sharing plan. The list is instructive but not comprehensive.

  • Elements of an NIH Data Management and Sharing Plan (NOT-OD-21-014)
  • NIH has provided guidance around selecting a repository for data generated by NIH-supported research and has developed desirable characteristics for all data repositories (NOT-OD-21-016).
  • NIH encourages the use of data standards including the PhenX Toolkit (www.phenxtoolkit.org) (for example, see NOT-DA-12-008, NOT-MH-15-009)
  • Data should be organized according to a standard model that is widely accepted within the field. An example for the clinical research studies would be the OMOP Common Data Model, which has also been successfully adapted for use with observational (including survey) studies more generally. In addition, the HL7 FHIR® (Fast Healthcare Interoperability Resources) standard (NOT-OD-19-122) may facilitate the flow of data with EHR-based datasets, tools, and applications.
  • NIH encourages clinical research programs and researchers to adopt and use the standardized set of data classes, data elements, and associated vocabulary standards specified in the United States Core Data for Interoperability (USCDI) standards, as they are applicable (NOT-OD-20-146). Use of the USCDI can complement the FHIR® standard and enable researchers to leverage structured EHR data for research and enable discovery. In addition to USCDI, OMOP, and FHIR standards for enhanced interoperability, investigators and data centers should align their data collection and management practices with recommended guidance emerging from the HEAL CDE and Data Ecosystem programs.

Awardees conducting research that includes collection of genomic data should incorporate requirements under the NIH Genomic Data Sharing Policy (NOT-OD-14-124, NOT-OD-15-086).

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

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

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier 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 NIDA, 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.

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?

Specific to this FOA

Does this application rigorously test an intervention strategy with strong potential for achieving clinically meaningful prevention outcomes related to opioid misuse? Does the intervention have the potential for significant, distal impacts on disparities related to opioid misuse? Do the investigators document successful engagement of stakeholders and potential adopters of the intervention for the purpose of supporting long-term sustainment of effective strategies?

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?

Specific to this FOA

Does the team of investigators have appropriate expertise in substance use and/or mental health-related prevention intervention research? Does the team have a track record of research involving health disparities, social determinants of health, and/or community-engaged research? Is the team composed of scientists engaged in diverse disciplines and individuals who bring diverse perspectives to the science (as defined by NIH Guide Notice NOT-OD-20-031)? Is there appropriate methodological and analytical expertise for the conduct of the proposed intervention study and the proposed efficacy/effectiveness and mediational analyses?

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?

Specific to this FOA

Will the research proposed expand our understanding of the utility of intervening on social risks or disadvantage to address health inequities related to opioid misuse? Will the research inform our current understanding of the mechanisms of action of social determinants of health?

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?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA

Are community collaborators and/or stakeholders meaningfully engaged across the duration of the research study? Are the recruitment and retention plans for the proposed intervention(s) well-conceived and/or well-justified? Is the timeline for achieving stated goals reasonable and justified? Are the research design and analyses proposed for the study of the intervention(s) appropriate to achieve the stated aims? Do the investigators provide a detailed analytic plan to address the research questions proposed? ? Are reasonably rigorous analyses planned for the study of mediational processes? Is there a Data Management and Sharing Plan that offers an effective strategy for managing and sharing scientific data and any accompanying metadata in accordance with HEAL Data Ecosystem requirements? Are procedures articulated to enable broad data access and re-use to the extent possible?

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?

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 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

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

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 convened by The National Institute on Drug Abuse (NIDA), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

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

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Drug Abuse. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.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: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

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

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

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $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: 301-637-3015

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

Scientific/Research Contact(s)

Aria Davis Crump, Sc.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-0881
email: aria.crump@nih.gov

Jacqueline Lloyd, PhD, MSW
Senior Advisor for Disease Prevention
Office of Disease Prevention (ODP)
Phone: 301-443-8892
E-mail: lloydj2@mail.nih.gov

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

Eve E. Reider, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-1496
Email:ereider@mail.nih.gov

Alexis Bakos, PhD, MPH, RN
National Cancer Institute (NCI)
Phone: 301-921-5970
Email: alexis.bakos@nih.gov

Michele Walsh, MD MSc
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-402-7886
Email: michele.walsh@nih.gov

 

Peer Review Contact(s)

Dharmendar Rathore, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-6965
Email: dharmendar.rathore@nih.gov

Financial/Grants Management Contact(s)

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

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

Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: debbie.chen@nih.gov

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

Sean Hine
National Cancer Institute (NCI)
Phone: 240-276-6291
Email: hines@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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