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 on Alcohol Abuse and Alcoholism (NIAAA)

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.

Office of Behavioral and Social Sciences Research (OBSSR)

Funding Opportunity Title

HEAL Initiative: Justice Community Opioid Innovation Network (JCOIN) Clinical Research Centers (UG1 Clinical Trial Optional)

Activity Code

UG1 Clinical Research Cooperative Agreements - Single Project

Announcement Type

New

Related Notices
  • December 19, 2018 - Notice of Pre-Application Information Webinar and Frequently Asked Questions (FAQs) for RFA-DA-19-025, RFA-DA-19-024, RFA-DA-19-023. See Notice NOT-DA-19-014.

NOT-DA-18-034

NOT-DA-18-035

NOT-DA-18-036

Funding Opportunity Announcement (FOA) Number

 RFA-DA-19-025

Companion Funding Opportunity

RFA-DA-19-023, U2C Resource-Related Research Multi-Component Projects and Centers Cooperative Agreements

RFA-DA-19-024, U2C Resource-Related Research Multi-Component Projects and Centers Cooperative Agreements

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

   93.279, 93.273

Funding Opportunity Purpose

 The intersection of justice and community-based health systems is a critical target for addressing the opioid crisis. The National Institute on Drug Abuse intends to establish the Justice Community Opioid Innovation Network (JCOIN) using the cooperative agreement mechanism. The purpose of the network is to establish a national consortium of investigators examining promising interventions and other approaches that can improve the capacity of the justice system to effectively respond to the opioid epidemic.

The structure of the network must consist of three highly integrated components - (1) Clinical Research Centers (each center will propose a study to be executed in at least 5 research performance sites), (2) a single, central Coordination and Translation Center, and (3) a single, central Methodology and Advanced Analytics Resource Center.

This FOA solicits applications for Clinical Research Centers. This FOA runs in parallel with companion FOAs that seek applications for a single Coordination and Translation Center (RFA-DA-19-024), and a single Methodology and Advanced Analytics Resource Center (RFA-DA-19-023). 

Key Dates

 

Posted Date

December 10, 2018

Open Date (Earliest Submission Date)

January 27, 2019

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

February 27, 2019, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

No late applicable will be accepted for this Funding Opportunity Announcement.

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

June/July 2019

Advisory Council Review

October  2019

Earliest Start Date

September 2019

Expiration Date

February 28, 2019

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

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

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
  4. Table of Contents

    Part 1. Overview Information
    Part 2. Full Text of the Announcement

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


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

     Overview

    Opioid use disorder (OUD) and opioid misuse consequences exist at the intersection of health and justice systems. Illicit opioids, including fentanyl and heroin, accounted for more than 60% of opioid-related overdose deaths in 2016. The intersection of justice and community-based health systems is a critical target for addressing the opioid crisis. At this nexus of public safety and public health, collaboration is essential to increasing access to—and retention in—evidence-based services for opioid misuse and OUD. Successfully targeting this nexus can reduce negative impacts on families and communities associated with the opioid crisis. 

    Through the NIDA Justice Community Opioid Innovation Network (JCOIN), NIH will establish a network of research investigators to rapidly conduct studies on quality care for opioid misuse and OUD in justice populations by facilitating partnerships between local and state justice systems and community-based treatment providers. Specifically, this work will include (1) conducting studies on the effectiveness and adoption of new medications, prevention and treatment interventions, and technologies in justice system settings; (2) conducting ongoing research on dynamic changes in policy and practice; (3) leveraging existing data sources and developing innovative research methods to address the opioid crisis; (4) fostering partnerships to ensure effective dissemination of lessons learned to the justice system and community-based provider stakeholders; and (5) conducting research on the most effective strategies for disseminating lessons learned to ensure scalable, sustainable solutions. These efforts are expected to offer novel insights into addressing gaps in the continuum of care for justice-involved populations in the United States.

    This funding opportunity is intended to solicit Clinical Research Centers to be part of NIDA’s Justice Community Opioid Innovation Network (JCOIN).

    HEAL Initiative

    This study will be part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed the development and implementation of scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative will bolster research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. More information and periodic updates about the HEAL Initiative is available at:  https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative

    Public Law 115-141, the Consolidated Appropriations Act of 2018 (signed March 23, 2018) includes a requirement that grantees from for-profit applicant organizations must provide a 50% match and/or in-kind contribution of all federally awarded dollars under the grant award (direct costs, as well as facilities and administrative costs) for research related to opioid addiction, development of opioid alternatives, pain management and addiction treatment.


    Matching Requirement: A grantee from a for-profit organization funded under this funding opportunity announcement must match funds or provide documented in-kind contributions at a rate of not less than 50% of the total-Federally awarded amount, as stipulated by Public Law 115-141, the Consolidated Appropriations Act of 2018.The applicant will be required to demonstrate that matching funds and/or in-kind contributions are committed or available at the time of, and for the duration of, the award. Applications must identify the source and amount of funds proposed to meet the matching requirement and how the value for in-kind contributions was determined. All matching funds and/or in-kind contributions must be used for the portion of allowable project costs not paid by Federal funds under the grant award.  NIH will not be the recipient, nor serve as a pass-through entity, of any such matching funds and/or in-kind contributions required under this announcement.  See 45 CFR 75.306 for additional details.

    Network Structure and Objectives

    The Justice Community Opioid Innovation Network (JCOIN) is intended to facilitate transdisciplinary collaborations that can create actionable, translatable insights for the justice system and community-based organizations that work with justice-involved populations who use illicit opioids or who are at high risk of misusing prescription opioids.

    To accomplish this objective, NIDA intends to establish a national consortium of investigators examining promising interventions and other approaches that can improve the capacity of justice systems to effectively respond to the opioid epidemic.

    The structure of the network must consist of (1) Clinical Research Centers, (2) a single, central Coordination and Translation Center, and (3) a single, central Advanced Analytics and Methodology Resource Center. A Steering Committee will include (a) a representative from each Clinical Research Center, (b) one representative from the Coordination and Translation Center, (c) one representative from the Advanced Analytics and Methodology Resource Center, and (d) a NIDA Project Scientist.  Senior leaders from justice- and community-based settings named as key personnel in Clinical Research Center applications will also play a role in the Steering Committee. NIDA will appoint one Steering Committee Chairperson with expertise in justice and substance use disorders to coordinate the activities of the Steering Committee (described below). NIDA will have an active role in the activities of the network, including the development and approval of research protocols through the involvement of one or more appointed Project Scientists and Program Officials.

    A. Clinical Research Centers: Clinical Research Centers will conduct clinical research and clinical trials, including implementation, effectiveness, and hybrid implementation-effectiveness studies. The goal of studies proposed by Clinical Research Centers should be to improve public health and public safety outcomes for justice-involved individuals who use or are at risk for using opioids. Public health outcomes are inclusive of illicit opioid use, opioid misuse, opioid-related overdoses and mortality among justice-involved populations. An opioid use disorder cascade or behavioral health cascade framework should be used to guide outcome selection. A behavioral health cascade framework includes screening for opioid use, referral to treatment, treatment engagement and retention in behavioral and pharmacological treatments for OUD. Relevant implementation outcomes such as penetration, scalability, and sustainability should also be considered.

    B. Coordination and Translation Center: A single Coordination and Translation Center will manage logistics, stakeholder engagement, and dissemination of findings and products from the JCOIN network. This will include establishing infrastructure to support research education and rapid response and pilot research. Additional information about this component can be found at: [RFA-DA-19-024]

    C. Methodology and Advanced Analytics Resource Center: A single Methodology and Advanced Analytics Resource Center will provide data infrastructure support across the network and will conduct foundational research to support the work of the clinical sites, including modeling studies, national surveys, and/or systematic collection and analysis of relevant policies and laws. Additional information about this component can be found at: [RFA-DA-19-023]

    Clinical Research Centers: Scope of Activities and Purpose

    It is imperative that applicants for the Clinical Research Centers carefully review the companion JCOIN FOAs for the Coordination and Translation Center (U2C) (RFA-DA-19-024) and Methodology and Advanced Analytics Resource Center (U2C) (RFA-DA-19-023) to understand the full mission of the JCOIN.

    Definition of a Clinical Research Performance Site

    Clinical Research Center applications must propose a multisite research project to be executed in five or more geographically distinct clinical research performance sites (i.e., five or more communities). A clinical research performance site (i.e., community) is defined as a partnership between a justice setting (e.g., jail, prison, drug court) and one or more community-based service providers (e.g., hospital, treatment center, other relevant service provider). Both the justice setting and the service provider must engage with a shared population of justice-involved individuals who live or receive services in a defined geographic area (i.e., community). Each of the five proposed clinical research performance sites must be geographically distinct and non-overlapping from the perspective of the population of patients engaging with services.  

    Justice Setting Definition

    For the purposes of this FOA, justice setting is broadly defined and is inclusive of prisons, jails, drug courts and other problem-solving courts (e.g., Driving While Impaired (DWI), family courts, veterans courts), policing and police diversion programs, transitions to secure settings from communities, transitions from secure settings to communities (i.e., re-entry), probation and parole, child welfare (particularly when there is concurrent involvement in other parts of the justice system), and juvenile justice.  A key area of interest is models to bring medications for opioid use disorder (MOUD) to justice settings and to link justice-involved patients with community-based treatment services and other healthcare support upon release from secure settings (i.e., jails, prisons, detention centers).

    Community-Based Services Definition

    For the purposes of this FOA, a community-based service provider is inclusive of any setting where a justice-involved patient may engage with medical or behavioral health services that address illicit opioid use, opioid misuse, or related treatment and other service needs. This includes, but is not limited to behavioral health service providers, HIV service providers, Federally Qualified Health Centers (FQHCs), integrated primary care and behavioral health settings, office-based opioid agonist treatment providers, needle exchange sites, housing providers, opioid treatment programs, etc.

    Outcome Selection and Example Research Questions for Clinical Research Centers

    Proposed research projects for Clinical Research Centers can leverage effectiveness, implementation, and hybrid implementation-effectiveness designs. 

    Effectiveness study designs may examine evidence-based medications, behavioral interventions, digital therapeutics, and comprehensive, patient-centered intervention packages. Key outcomes of interest include treatment engagement and retention, remission, relapse, mortality, and recidivism. Indicators of reduced opioid and substance use and criminal activity are also relevant outcomes. Applicants are strongly encouraged to utilize an opioid used disorder (OUD) or behavioral health care cascade framework as a guide for selecting outcomes. Public safety and public health outcomes should be included.

    Rigorous economic evaluations, especially cost-effectiveness analyses, such as those following the recommendations of the Second Panel on Cost-Effectiveness in Health and Medicine, are encouraged. Economic evaluations that consider relevant economic outcomes of proposed interventions from a societal perspective (e.g., costs of treatment, crime, etc.) are especially encouraged.

    Effectiveness questions should include a follow up period of six months or longer, though applicants are strongly encouraged to include follow-up periods of one year or longer if feasible. Examples of effectiveness questions include, but are not limited to:

    • Effectiveness and comparative effectiveness of existing and newly FDA-approved medications for opioid use disorder (MOUD) on mortality, use of opioids and other substances, and criminal recidivism
    • Effectiveness of offering multiple MOUDs vs. offering a single medication for justice-involved populations
    • Effectiveness of technology and digital therapeutics at improving outcomes for justice-involved populations
    • Effectiveness of just-in-time adaptive interventions for enhancing treatment outcomes
    • Effectiveness of emerging strategies such as law enforcement deflection/diversion models
    • Effectiveness of treatment intervention based on special populations (e.g., adolescents, women)

    Implementation questions should include a follow up period of one year or longer. Examples of implementation questions include, but are not limited to:

    • What are the best implementation strategies for improving collaboration between community health and justice systems to increase engagement and retention in addiction treatment?
    • What implementation strategies are effective in facilitating the development of data-driven learning healthcare approaches in justice-public safety collaborations?
    • What is the role of technology as an implementation tool for facilitating collaborative relationships between public health and public safety?
    • What approaches can support the implementation and adaptation of innovative care delivery models (e.g., hub and spoke, patient navigation) that can enhance the ability of patients to receive continuity of care as they transition between justice and community settings?
    • What implementation models can support the development of trans-organizational learning healthcare systems in public health and public safety partnerships?

    Examples of hybrid implementation-effectiveness questions include, but are not limited to:

    • What implementation strategies are most effective at facilitating the adoption of technology-driven interventions to improve patient- and system-level outcomes?
    • How can multi-level interventions be leveraged to enhance treatment engagement and cross-system data sharing?

    Areas of special interest include:

    • Examination of interventions, practices, or implementation strategies that are widely used, but for which there is limited evidence (e.g., peer navigation models, police deflection models).
    • Implementation science approaches and hybrid implementation-effectiveness designs are strongly encouraged.
    • Studies targeting understudied justice-involved populations or settings are strongly encouraged. Examples include, but are not limited to, rural settings, women, American Indian/Alaskan Native populations, concurrent multi-generational involvement in justice systems.
    • Studies that, in addition to substance use treatment needs, consider and target the complex needs of justice-involved populations, including mental and physical health comorbidities, housing, recovery supports, and employment.
    • Research designs that can inform policy and payment models.

    Special Considerations:

    Applications with the following specifics will be considered non-responsive and will not be reviewed:

    • Clinical Research Centers that do not emphasize prevention and/or treatment of illicit opioid use or opioid misuse in justice settings. Opioid-relevant outcomes must be included.
    • Research sites with communities outside the US and its territories
    • Clinical Research Centers involving fewer than five communities
    • Applications that do not include letters of support from proposed justice settings and community service settings (i.e., a minimum of 10 letters of support are needed)
    • Applications that do not include one or more senior-level collaborators from both justice and community-based settings
    • Applications not providing a PD/PI committing a minimum of two person-months annually over the life of the grant award

    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 (http://ww2.drugabuse.gov/about/organization/nacda/points-to-consider.html) for details.

    Data Harmonization for Substance Abuse and Addiction via the PhenX Toolkit:  NIDA strongly encourages investigators involved in human-subjects 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.

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

    Section II. Award Information

     

    Funding Instrument

    Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

    Application Types Allowed

    New

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

    Clinical Trial?

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

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    NIDA intends to commit $23.5 million in FY 2019 to fund 8-12 awards.

    Award Budget

     Application budgets are limited to $1,500,000 per year in direct costs. Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation.

    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:

    o   Hispanic-serving Institutions

    o   Historically Black Colleges and Universities (HBCUs)

    o   Tribally Controlled Colleges and Universities (TCCUs)

    o   Alaska Native and Native Hawaiian Serving Institutions

    o   Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

    Nonprofits Other Than Institutions of Higher Education

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

    For-Profit Organizations

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

    Governments

    • State Governments
    • County Governments
    • City or Township Governments
    • Special District Governments
    • Indian/Native American Tribal Governments (Federally Recognized)
    • Indian/Native American Tribal Governments (Other than Federally Recognized)
    • Eligible Agencies of the Federal Government
    • U.S. Territory or Possession

    Other

    • Independent School Districts
    • Public Housing Authorities/Indian Housing Authorities
    • Native American Tribal Organizations (other than Federally recognized tribal governments)
    • Faith-based or Community-based Organizations
    • Regional Organizations
    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 not allowed.

    Required Registrations

    Applicant Organizations

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

    • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
    • System for Award Management (SAM)– Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
    • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons.  Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
    • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

    Eligible Individuals (Program Director/Principal Investigator)

    Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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

    2. Cost Sharing

    For grantees from a for-profit organization, this FOA does require cost sharing, as defined in the NIH Grants Policy Statement.  More information on cost matching requirements is in Section IV.2 R&R or Modular Budget.

    3. Additional Information on Eligibility
    Number of Applications

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

    The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

    • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
    • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
    • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).
    Section IV. Application and Submission Information
    1. Requesting an Application Package

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

    2. Content and Form of Application Submission

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

    Letter of Intent

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

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

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

    The letter of intent should be sent to: NIDALetterofIntent@mail.nih.gov.

    Applicants are encouraged to send the letter of intent by email to the email address above but as an alternative, the letter may also be sent to:

    Office of Extramural Policy and Review

    National Institute on Drug Abuse/NIH/DHHS

    6001 Executive Boulevard, Suite 4243, MSC 9550

    Bethesda, MD 20892-9550

    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.

    Facilities & Other Resources: Applicants should provide an explanation of resources available from each project/performance site on the "Facilities and Resources" attachment

    Specifically:

    • Data should be presented on the nature, severity, and trends in opioid use, opioid-related morbidity and mortality, or other opioid-related outcomes for the targeted communities. If available, data on opioid use in the targeted justice setting specifically should be presented, though not required. This may be presented broadly for the pool of sites and/or specifically for each proposed site, depending on study design.
    • Capacity to recruit additional sites, if needed, should be described.
    • As noted in the Research Strategy Instructions, for each proposed community, letters of support from both the (a) targeted justice entity(ies) and (b) community-based service provider entity(ies) should be provided. If a study design proposes recruiting sites as part of a study design, strong justifications demonstrating feasibility of recruitment (e.g., letters of support from a state government official overseeing a system with multiple potential sites) and a strong justification for the selection of this strategy must be included.
    SF424(R&R) Senior/Key Person Profile

    All instructions in the SF424 (R&R) Application Guide must be followed.  Biosketches should describe Senior/Key Personnel recent experience and participation in randomized clinical trials, preferably of a multisite nature. Applicants are expected to provide evidence of their unique strengths, accomplishments and capabilities to contribute to shared activities across the JCOIN network. Applicants should provide evidence of expertise in the conduct of clinical trials, particularly cooperative, pragmatic, randomized clinical trials. Persons responsible for participant recruitment, enrollment, data collection and data management should be shown to have extensive experience and high qualifications.

    Biosketches must be included for one or more senior leaders from (a) a relevant justice setting and (b) a relevant community-based treatment setting relevant to the proposed study to be included as key personnel. Senior leaders do not have to be from one of the targeted communities if not appropriate for the study design, but should have relevant expertise and demonstrate the ability to provide guidance to the research team on pragmatic and practice-related issues relevant to research in the targeted setting.

    PD/PIs, senior investigators, and other investigators with substantial time commitments to JCOIN should expect to actively participate in a wide variety of network activities, including, but not limited to: providing mentorship to participants in the Coordination and Translation Center Research Education Core (see Coordination and Translation Center FOA for more detail), participating in reviews of network publications, actively engaging in harmonization activities, making data from their study available to others, serving as a reviewer for Coordination and Translation Center Rapid Response and Pilot Research Project proposals (see Coordination and Translation Center FOA for more detail). Participation in such network activities may be included among outcomes that may be tracked and reported to NIDA by the Coordination and Translation Center and/or Methodology and Advanced Analytics Resource Center.

    R&R Budget

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

    Requirements for Senior Personnel

    PD/PIs must expend two (2.0) person-months effort annually on the award over the entire period of support. In a multi-PI application, at least one PD/PI must commit a minimum of 2.0 person-months annually over the life of the grant award.

    One or more senior leaders from (a) a relevant justice setting AND (b) a relevant community-based treatment setting should be named as Key Personnel and should each expend a minimum of .6 person-months effort annually on the award over the entire period of support.

    Requirements for Participating in JCOIN Network Activities

    Budgets should include funds for travel for the PD(s)/PI(s), the justice and community agency staff named as key personnel, and up to three additional project staff to participate in in-person Steering Committee meetings twice per year, every year of the award, in Rockville, MD. An additional in-person kickoff meeting to be held in Rockville, MD should be included in the year one budget of the award.

    In addition to executing the proposed protocol, applicants will be expected to participate in efforts to harmonize data collection and participate in other trans-JCOIN activities. Time should be budgeted to participate in such activities.

    Cost Matching Requirement for For-profit Applicants

    Cost matching or documented in-kind contributions is required for for-profit organizations responding to this FOA.  The for-profit awardee is required to match funds or provide at least a 50% matching of funds or documented in-kind contributions at a rate of not less than 50% of the for the total-Federally awarded amount (direct costs, as well as facilities and administrative costs), as stipulated by Public Law 115-141, the Consolidated Appropriations Act of 2018.   

    Federal funds may not be used as a source of matching funds. Generally, cost matching requirements may not be met from the following sources:

    a) Costs borne by another Federal grant or sub award;

    b) Costs or contributions toward cost sharing on another Federal grant, a Federal procurement contract, or any other award of Federal funds;

    c) Cost of services or property financed by income earned by contractors under a contract from the recipient (or sub recipient);

    (d) Program income; and

    (e) Patient incentives.

    The for-profit organization will be required to demonstrate that matching funds and/or in-kind contributions are committed or available at the time of, and for the duration of, the award. Applicants must submit budgets that clearly document the total costs, the source and amount of matching funds, and how valuation was determined in the case of in-kind contributions, as well as the Federal and Institutional (non-Federal) components of the budget. All matching funds and/or in-kind contributions must be used for the portion of allowable project costs not paid by Federal funds under the grant award.  NIH will not be the recipient, nor serve as a pass-through entity, of any such matching funds and/or in-kind contributions required under this announcement.  See 45 CFR 75.306 for additional details.

    Budget Justification: All for-profit applicants must document the matching (non-Federal) component and the federal (non-matching) component in the total project budget. That is, the requested budget plus the cost-matching budget must be detailed in tabular format to document the cost-matching (non-Federal) component and the federal (non-cost matching) component. The amount of matching is subject to adjustment based on total allowable costs incurred.  All costs and contributions used to satisfy the matching requirement must be documented by the recipient, including how the value for in-kind contributions was determined, and are subject to audit. The cost matching requirement is not negotiable for for-profit organizations.

    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: 

    Specific Aims: Specific Aims are required.

    Research Strategy:  

    Each Clinical Research Center should propose a multi-site research project. All proposed projects must engage five or more performance sites (i.e., communities). The number of sites engaged should be appropriate to the goals of the proposed study and the study should be adequately powered to detect proposed outcomes.

    The research strategy section should be organized as follows:

    Section A: Research Strategy:

    Applicants are requested to develop and propose a research concept that lays out a theoretically grounded, hypothesis-driven study design to address gaps in the continuum of care for justice-involved individuals. Applications should advance delivering or optimizing evidence-based interventions to prevent and treat opioid use, misuse, and addiction in justice-involved populations.

    Applications are expected to include services delivered in communities as a primary target, thus applications should involve stakeholders and clinical research performance sites from both justice settings and community-based service providers. A focus on community-based settings is inclusive of transitions from secure settings and communities, so may include, for example, a focus on continuing medications during entry into secure settings and resuming or maintaining medications during community re-entry.

    Applicants are encouraged to consider relevant issues such as comorbid mental health and physical health issues, polysubstance use, trauma-informed approaches, etc. Designs may engage a variety of community-based providers who provide services targeting common comorbid issues. Primary outcomes, however, must include opioid-relevant outcomes.

    Applications should provide a detailed overview of the research design and sample of the proposed study. This overview should include:

    • A detailed description of the proposed research project, including a clear specification of the proposed justice system target and the community-based provider;
    • A rigorous study design, appropriate to the goals of the proposed research;
    • Description of study outcomes. As described above, study outcomes should include relevant opioid, public health, and public safety outcomes. Applicants are strongly encouraged to define outcomes across a full continuum of care, using standardized measures that leverage the concept of a behavioral health services cascade and/or opioid use disorder cascade. Economic outcomes are also strongly encouraged;
    • A strong justification for the selected follow-up period. Applicants are strongly encouraged to plan for follow-ups for one year or longer in both effectiveness and implementation studies.
    • Where possible, additional measures should be compatible with data-harmonization efforts (e.g., PhenX Toolkit) and ongoing studies of substance use should be included;
    • A brief description of proposed clinical performance sites, including: (1) Detailed plans for ensuring high rates of recruitment and retention; and (2) Justification of the selected number of sites including power analyses appropriate to targeted outcomes and study design. Please see notes below for additional guidance regarding proposed clinical performance sites.
    • Potential sustainability of the proposed intervention. The research project should be of sufficient priority to these stakeholders that that there is potential for positive findings from the study to be sustainably incorporated into standard practice after the study concludes.
    • Generalizability of these sites to other settings should be discussed.

    Selection and Justification of Proposed Clinical Research Performance Sites:

    A minimum of five clinical research performance sites are required. Letters of Support and required details for each research performance site should be provided in Project/Performance Site Location section. The following guidelines should be followed with respect to selecting clinical performance sites:

    • A clinical research performance site is defined as a geographically distinct community, and must include: (a) one or more partners from the targeted justice setting in the community, and (b) one or more community-based service providers. Definitions of the scope of the justice system and community-based service providers are outlined in Part 2, Section I of this announcement.
    • If there is any ambiguity with regard to the geographic distinctness of the proposed clinical research performance sites, applicants must provide a clear justification for their site selection approach.
    • Although a minimum of five clinical research performance sites must be engaged, the actual number of clinical performance sites should be justified scientifically based on power analyses appropriate to the design and outcomes of interest in the proposed study.
    • In general, it is anticipated that in all five performance sites, justice settings will be of the same general type (e.g., jails), but applicants can make a case for other designs with a compelling justification.
    • In general, it is expected that applicants will be able to pre-specify their expected clinical research performance sites. If there is a compelling reason why this cannot or should not be done, applicants should provide similar detail to that described below regarding potential sites and what approach will be used in ultimately selecting sites.
    • Additional detail should be included on planned performance sites as detailed in the SF424(R&R) Project/Performance Site Locations

    Section B: Clinical Research Center Collaboration Capacity

    The research strategy section should also include a general discussion of the Clinical Research Center’s capacities to engage with the rest of the JCOIN network, including capacity to:

    • Participate in data harmonization and other collaborative efforts within the network;
    • Contribute unique expertise and research capacity to the network; and
    • Demonstrate a track record of collaboration in similar multi-site and multi-center efforts. 
    • If multiple organizations will collaborate as part of the proposed Clinical Research Center, a plan for collaboration within the center must be presented as well.
    • Commit to provide the Coordination and Translation Center (CTC) and the Methodology and Advanced Analytics Resource Center (MAARC) with timely, accurate data to facilitate the ability of the CTC and MAARC to provide NIDA with accurate data-driven updates of network progress.

    Letters of Support: For each proposed community, letters of support from both the (a) targeted justice entity(ies) and (b) community-based service provider entity(ies) must be provided. If a study design proposes recruiting sites as part of a study design, strong justifications demonstrating feasibility of recruitment (e.g., letters of support from a state government official overseeing a system with multiple potential sites) and a strong justification for the selection of this strategy must be included.

    For-profit applicants must include a letter(s) of support confirming that the required secured cost matching (cash; in-kind commitments such as salary, consultant costs, equipment) is available and confirm that the essential personnel have the authority within the organization to allocate resources. 

    Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

    • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
    • Data Sharing Plan should explicitly acknowledge understanding that nearly all data collected as part of the JCOIN initiative will be expected to be shared with the Methodology and Advanced Analytics Resource Center for trans-JCOIN activities. Plans for transmitting this data and ensuring appropriate sensitivities with regard to personally identifying information (PII) should be outlined.

    Appendix:

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

    PHS Human Subjects and Clinical Trials Information

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

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

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Delayed Onset Study

    Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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

    PHS Assignment Request Form

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

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

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

    4. Submission Dates and Times

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

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

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

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

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

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

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

    7. Other Submission Requirements and Information

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

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

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

    Important reminders:

    All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

    The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

    See more tips for avoiding common errors.

    Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review 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 Center 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 Center 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 Center 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 Center rigorous? If the aims of the Center are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  

    In addition, for applications involving clinical trials

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

    Specific to this FOA: Does the Center address questions related to preventing opioid-related morbidity and mortality for justice-involved populations? Does the Center address scalable, generalizable treatment models in justice settings? Does the Center generate novel information about how to improve collaborations between justice and community settings to improve public health and public safety outcomes?  Does the research plan address potential sustainability?

    Investigator(s)

    Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center? 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 Center 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 Center? 

    In addition, for applications involving clinical trials

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

    Specific to this FOA: Is the time commitment of the PD/PI (s) and the investigators with decision making authorities appropriate for the stated study goals?  Is there clear description of roles for each major key personnel involved in the research site? Are Key Personnel from relevant (a) justice settings AND (b) community-based service providers included? If key personnel do not have a history of collaboration, is an appropriate plan in place to ensure successful coordination and communication?

    Innovation

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

    In addition, for applications involving clinical trials

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

    Specific to this FOA: Does this design test interventions or strategies that are potentially generalizable to other communities or settings? Does this design test a practice or intervention that is widespread, but for which limited evidence is available? 

    Approach

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed Center? 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 Center is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? 

    In addition, for applications involving clinical trials

    Does the application adequately address the following, if applicable

    Study Design

    Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

    Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

    Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

    Data Management and Statistical Analysis

    Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

    Specific to this FOA: Is the study design rigorous and appropriate to the level of evidence for the targeted intervention?

    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?  

    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 Center proposed? Will the Center 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 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 Center 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 Center 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 Center 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

    Not Applicable

    Renewals

    Not Applicable

    Revisions

    Not Applicable

    Additional Review Considerations

    As applicable for the Center 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.

    Specific to this FOA:

    How likely is it that the plans for cost matching will be adequate?

    2. Review and Selection Process

    Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by 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:

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

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

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

      Additionally, ICs may specify any special reporting requirements for the proposed clinical trial to be included under IC-specific terms and conditions in the NoA.  For example: If the proposed clinical trial has elevated risks, ICs may require closer programmatic monitoring and it may be necessary to require the awardee to provide more frequent information and data as a term of the award (e.g., to clarify issues, address and evaluate concerns, provide documentation). All additional communications and information related to programmatic monitoring must be documented and incorporated into the official project file. 

    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 of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/ 

    Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as 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). 

    Special award condition specific to this FOA: A grantee from a for-profit organization funded under this announcement must match funds or provide documented in-kind contributions at a rate of not less than 50% of the total-Federally awarded amount, as stipulated by Public Law 115-141, the Consolidated Appropriations Act of 2018.  See 45 CFR 75.306 for additional details.   Matching funds must be non-Federal funds set aside for this project and are available from the source(s) identified in the application, as committed to by the recipient. Cost matching will be evaluated by the awarding office to ensure that this requirement is being met. Compliance with the matching requirement must be verified on an annual basis and must be documented in the annual and final FFR.

    2. Administrative and National Policy Requirements

    All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

    Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

    For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html.  Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

    In 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

     The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

    The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

    The PD(s)/PI(s) will have the primary responsibility for:

    • Organizing a local Executive Committee for day-to-day management of the study
    • Ensuring cooperation and coordination with the Coordination and Translation Center (CTC) and the Methodology and Advanced Analytics Resource Center (MAARC). This includes ensuring progress on recruitment, data cleaning, and other activities is reported in a timely fashion.
    • Serving as a member of the JCOIN Steering Committee and participating in required activities, including primary responsibility for organizing regular conference calls and 1-3 annual JCOIN face-to-face meetings.
    • Participating in the overall coordination of NIH research efforts in justice settings; this participation may include collaboration and consultation with other NIH awardees, the appropriate sharing of information, data, and research materials, and participation in NIH efforts to standardize and harmonize pre-clinical and clinical data collection.

    Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

    NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

    • The NIH Project Scientist(s) will work closely with the PD(S)/PI(S), the Steering Committee, and the PIs of all JCOIN network components in order to ensure proper conduct of the Coordination and Translation Center. Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
    • The NIH Project Scientist(s) will have one (1) vote on the Steering Committee, regardless of how many NIH Project Scientists participate across the network
    • The assigned Project Scientist(s) will be responsible for: (1) providing advice and guidance to the clinical research center to assure the study is run in accordance with NIH policies and procedures, and is consistent with the mission of the NIH to improve public health; (2) serving as a point of contact for investigators with the NIH; and (3) coordinating with other components of the JCOIN network to ensure overall success of the network.
    • NIDA, as the primary funder and administrator, reserves the right to phase out or curtail the award (or an individual component of the award) in the event of inadequate progress or data reporting. NIH support of this study is contingent upon adequate study progress based on the Grantee’s Milestone Plan submitted at the time of funding.

    Areas of Joint Responsibility include:

    • The SC is the primary governing body of the Cooperative. Awardees must participate in the SC. The SC reviews and approves the research agenda, develops and monitors policies and procedures guiding the research activities, and oversees communications. Awardees agree to abide by the procedures and policies established by the SC.
    • Data Management, Analysis, and Access: Data generated are the property of the awardee. Research sites must provide requested data to the CTC and MAARC in a timely fashion in accordance with the policies and procedures established in study protocols and by the SC.  In addition, the CTC, MAARC and all research sites must provide NIDA with access to all data generated under this award, subject to rules specified in any Certificates of Confidentiality obtained by awardees. Data must be shared upon request with the SC and subcommittees reporting to the SC when appropriate. 
    • JCOIN is intended to be a national resource, and as such, each Clinical Research Center must be prepared to share their data under provisions that safeguard the privacy and confidentiality of respondents.
    • Awardees and NIDA will jointly develop appropriate confidentiality procedures for data collection, processing, storage and analysis to ensure the confidentiality of data.
    • All awardees and NIDA will cooperate to ensure the timely and broad dissemination of lessons learned, to inform researchers and health care systems engaged in research and beyond. 
    • The SC, with the support of the CTC, will facilitate these joint activities and, in particular, development of research protocols, human subjects and other regulatory protocols, data harmonization, manuscript and other information dissemination planning, and initial clearance of manuscripts or other dissemination products.

    Dispute Resolution:

    Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

    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 Research Performance Progress Report (F-RPPR), invention statement, and the expenditure data portion of the Federal Financial Report, including Federal and non-Federal share for cost matching, are required for closeout of an award, as described in the NIH Grants Policy Statement.

    The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

    In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

    Section VII. Agency Contacts

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

    Application Submission Contacts

    eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

    Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

    General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-945-7573

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

    Scientific/Research Contact(s)

    Tisha Wiley, Ph.D.
    National Institute on Drug Abuse (NIDA)
    Telephone: 301-594-4381
    Email: jcoin@mail.nih.gov

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

    Peer Review Contact(s)

    Gerald McLaughlin, PhD
    National Institute on Drug Abuse (NIDA)
    Telephone: 301-827-5819
    Email: gmclaughlin@nida.nih.gov

    Financial/Grants Management Contact(s)

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

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