Part 1. Overview Information

Key Dates

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

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

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

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

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



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of 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. Notice of Funding Opportunity Description

Background 

NIH Helping to End Addiction Long-Term® (HEAL) Initiative: This study is part of the NIH’s HEAL initiative to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative® bolsters research across NIH to (1) improve treatment for opioid misuse and addiction, and (2) enhance pain management. More information about the HEAL Initiative is available at https://heal.nih.gov.

The Justice Community Overdose Innovation Network (JCOIN): The JCOIN has two broad, complementary goals: to build the evidence base for the delivery of substance use disorder (SUD) treatment services for individuals involved in the criminal-legal system, and to build capacity to implement effective services for SUD, overdose prevention, and related co-occurring conditions. Phase I of JCOIN supported a consortium of practitioner-partnered research projects focused primarily on testing strategies to connect individuals with effective opioid use disorder (OUD) treatment at key transition points between the criminal-legal system and community-based healthcare. Phase I supported 13 multi-site clinical trials and more than 50 additional research protocols including surveys, modeling, dissemination, pilot studies and other projects. The network was supported by a Coordination and Translation Center (CTC) and a Methodology and Advanced Analytics Resource Center (MAARC).

Given the recent evolution of both the epidemiology of the overdose crisis and public policies intended to support overdose prevention efforts, new research is needed to take effective interventions to scale in jails, courts, and community corrections, and to rigorously test new and emerging models for effectively addressing the complex needs of individuals with SUD and/or high overdose risk. Of particular importance is the coordination of services between public health and public safety agencies, to ensure continuity of care for individuals as they transition between these systems. 

To support research on effective interventions and implementation strategies for addressing SUD, overdose risk, and common co-occurring conditions in these populations and systems, the National Institute on Drug Abuse (NIDA) seeks applications for JCOIN Phase II. The purpose of Phase II is to bring together a national network of investigators and practitioner partners to conduct an array of research and capacity building activities to improve the delivery of effective interventions for adults and youth, spanning the key points of the sequential intercept model (i.e., crisis intervention, emergency response, law enforcement diversion/deflection, pre-trial services, courts, jail, prison, re-entry services, probation, parole).

Network Structure and Objectives

The structure of the network will include multiple research centers, working in collaboration with four complementary resource and support centers. Clinical Research Hubs (RFA-DA-25-025) are expected to conduct large multi-site studies; Innovation Hubs (RFA-DA-25-062) are intended to support smaller-scale studies. Both the Clinical Research and Innovation Hubs will have the capacity to conduct collaborative pilot studies with other awardees. The CTC (RFA-DA-24-069) will facilitate collaboration among the Hubs, conduct novel dissemination and implementation research, and engage in an array of capacity building activities to engage practitioners and other key stakeholder organizations. The MAARC (RFA-DA-24-068) will provide infrastructure for data submission, data sharing, and analytic support, while conducting novel survey and modeling studies. An Economics Resource Support Center (ERRC; RFA-DA-25-061) will facilitate collaboration across Hubs on the collection, analysis, and comparison of cost data; conduct original research; and develop tools to support practitioners and decision-makers. The Community Engaged Research Resource Center (CERRC; this NOFO) will directly engage persons with lived experience (PWLE) and provide additional support to the Hubs on effectively engaging affected communities in the research process. 

A visual depiction of the structure and organization of this initiative can be found at this link: https://nida.nih.gov/sites/default/files/images/JCOINPhase2.jpg 

It is imperative that prospective applicants read the NOFOs associated with each of these components, in order to fully understand the intended structure and operation of the network, the scope of the component awards, and the expectations for awardees.

An informational webinar for potential applicants will be held on July 25 at 2:00pm EDT. When available, a registration link and more information will be posted at: https://nida.nih.gov/news-events/meetings-events/2024/07/jcoin-phase-ii-informational-webinar-potential-applicants

This NOFO seeks applications for one JCOIN Phase II Community Engaged Research Resource Center. 

JCOIN PHASE II COMMUNITY ENGAGED RESEARCH RESOURCE CENTER: Scope of Activities and Purpose

The primary purpose of the JCOIN Phase II CERRC is to provide expertise and leadership in meaningfully and thoughtfully engaging individuals with a history of justice involvement in research. This includes, but is not limited to (a) elucidating key outcomes of interest to individuals with lived experience; (b) exploring strategies for enhancing the effectiveness of interventions by better tailoring to needs of this population; (c) enhancing capacity to translate research findings back to impacted populations; (d) addressing challenges in hiring people with a history of justice involvement in peer intervention models; and (e) considering pathways to contributing to and conducting research for PWLE . In collaboration with the rest of the network, the CERRC’s activities are intended to help identify and address a wide range of issues for JCOIN's focal population (e.g., stigma, disparities, social determinants of health, environmental justice, patient-centered outcomes), thereby enhancing the relevance and impact of JCOIN’s research.

The CERRC will be one of four coordination and resource centers providing support to JCOIN Phase II grantees. Collaboration and coordination among these entities is essential to ensure clear communication, avoid duplication of effort, and promote the overall objectives of the network.

In support of these goals, the CERRC will perform four required sets of activities:

1. Engage Persons with Lived Experience (PWLE) in SUD and Criminal Legal Involvement

The CERRC will be responsible for engaging PWLE both inside and outside the JCOIN network. In the context of JCOIN, “lived experience” includes SUD and related experiences (overdose, recovery), as well as histories of incarceration. Activities to engage PWLE must include three specific tasks:

1a: Create a Community Advisory Board (CAB) for the network

The CAB should primarily engage individuals with lived experience in SUD and criminal legal involvement. The CAB will serve in a consulting role to the Steering Committee (SC), the JCOIN Hubs, and the network as a whole. The specific activities of the CAB will be defined post-award once the Hubs and their projects are known, and in response to input from the SC. Activities may include but are not limited to identifying research topics or research gaps of priority interest from a patient/client perspective; providing consultation to JCOIN hubs on recruitment strategies, patient-centered outcomes, and/or dissemination/messaging strategies; providing review and recommendations on JCOIN products and resources (e.g., courses, infographics, podcasts) to broaden their reach to include affected communities; and articulating best practices for engaging PWLE in research.

The final roster of the CAB will be determined post-award; members need not be named in the application. The CERRC should solicit nominations for potential CAB members from the JCOIN hubs, coordinating and support centers, and NIDA post-award, but membership need not be limited to these nominations. Applicants are encouraged to describe a proposed process for recruitment of external CAB members, including via partnership with outside organizations. Applicants must articulate a plan for engaging and fairly compensating CAB members. This should include a plan for minimizing up-front, out-of-pocket costs to attend any in-person meetings. 

1b: Assessing and assisting JCOIN research hubs in engaging PWLE

JCOIN Clinical Research Hubs are encouraged but not required to engage PWLE, and this will vary in part based on the nature of the proposed research. During the first 6 months post-award, the CERRC will hold (virtual) introductory “needs assessment” meetings with each of the Clinical Research Hubs, and with the Innovation Hubs as appropriate. In these meetings, the CERCC will learn about Hubs’ plans to engage PWLE; their roles in the research projects (e.g., CAB members, research staff, delivering the study intervention [e.g., peer navigators]); any administrative hurdles anticipated or encountered in hiring or retaining these individuals; and other related needs or concerns. The CERCC should have the expertise and experience to assist Hubs with problem-solving around these challenges. In particular, because “lived experience” in the context of JCOIN includes histories of incarceration, applicants should demonstrate capacity to hire people with histories of incarceration, and should articulate a plan for collaborating with Clinical Research Hubs when necessary to accomplish the goals of hiring PWLE as research project staff.

1c: Provide supportive infrastructure for PWLE engaged across the network

Research is strengthened when it is informed by the perspectives of PWLE . JCOIN hubs are likely to include PWLE in a variety of roles on their research teams, including project-specific CAB members, peer navigators, and/or research staff. The CERRC will provide resources to connect and support these individuals across the network. Activities may include, but are not limited to, periodic or recurring (virtual) meetings, listservs or online discussion forums, connections with mentors, and addressing other needs and interests raised by participants that will ensure they are best able to succeed in their roles while providing a supportive peer network.

2. Provide capacity and leadership related to diversity, equity, and inclusion (DEI) 

The CERRC will develop and lead initiatives that address the impact of diversity and equity issues on JCOIN research. The goal of these activities should be enhancing innovation, creativity, relevance and excellence of JCOIN-supported science. The CERRC will serve as a resource to promote diversity, inclusion, and belonging among JCOIN research teams and the organizations and universities affiliated with JCOIN. Specific activities will depend on the staffing, capacities, and needs of the JCOIN Phase II awardees, which should be assessed in meetings with each Hub during Year 1. Potential activities may include and are not limited to:

• developing recommendations to the SC for procedural or structural changes to the JCOIN network to promote a diverse and multicultural workforce at all levels of the network to better reflect the diversity of JCOIN research participants;
• promoting inclusive and meaningful educational, mentoring, and research opportunities that engage PWLE, research team members, early career investigators, and practitioner partners from diverse backgrounds;
• providing capacity (through key personnel or project consultants) for mentoring of early career investigators from traditionally underrepresented groups, thereby supporting the development of a well-trained and diverse research workforce;
• promoting inclusive and safe workplaces within the JCOIN research community such that all members feel welcomed, valued, and respected;
• in collaboration with the MAARC and with JCOIN researchers, offering input on strategies to ensure ethical and responsible secondary analysis of JCOIN study data to avoid disclosure and to prevent further stigmatization and marginalization of individuals because of criminal legal involvement and racial, ethnic, or gender minority status;
• developing recommendations or guidelines on the dissemination of results from analyses of JCOIN data, considering potentially harmful impacts that misinterpretation or misuse of these data could have on individuals and communities, as well as on public opinion and policy.

3. Create public-facing resources to support community-engaged research in criminal legal settings and populations

While community engaged research is a growing component of NIH-funded research, relatively little of this work focuses specifically on persons with criminal legal involvement. JCOIN can be a model for other researchers and networks.

The CERRC will engage with other NIDA-funded projects sharing conceptually similar goals around community engagement. These projects include but are not limited to awards funded through the HEAL Recovery Research Network, as well as NIDA-funded Patient Engagement Resource Centers awarded under RFA-DA-24-016 and RFA-DA-24-022. Meetings with these other awardees should aim to identify best practices for community engagement, lessons learned, and potential shared resources. The JCOIN CERRC must not duplicate activities/resources of these other awards.

The CERRC will develop public-facing resources to support responsible, high-quality community engaged research. These resources may include but are not limited to publications, webinars, short courses, podcasts, or other media. Topics may include, but are not limited to, principles of community engaged research with criminal legal populations; best practices for hiring/retaining PWLE; addressing common human resource policy barriers to hiring PWLE; and other topics identified in discussions with the JCOIN research hubs or other NIDA-funded networks. A workplan for these activities should be developed during Year 1 and updated regularly with input from the SC and NIDA. Applicants should anticipate working with the JCOIN CTC to disseminate these products. The CTC has the capacity to host online courses, webinars, podcasts, and similar activities targeting general or specific audiences, and has the expertise to develop brief explainers, infographics, and other tools that effectively translate complex concepts for broad reach. CERRC applicants should coordinate with and not duplicate these translation and dissemination efforts.

Applicants should plan to attend at least one relevant professional conference or analogous event per year, as presenters or exhibitors, to share, demonstrate, or disseminate these products.

4. Conduct rapid turnaround research projects

Applicants must plan to conduct four “rapid turnaround” research projects over the 5-year project performance period. “Rapid turnaround” implies that the project could feasibly be conducted within 12 months from its start.

Each of these projects must include community engaged research related to some aspect of the overdose crisis in the broad context of criminal legal systems. The first of these projects, to be conducted in Year 1, must engage individuals in a “patient journey mapping” exercise – that is, collecting narrative descriptions and detailed “virtual walk-throughs” of individuals’ experiences navigating the intersection of the criminal legal and substance use treatment systems. These may include, for example, methods to obtain a deeper understanding of the challenges of accessing community-based treatment services upon discharge from jail; challenges of navigating competing demands from probation, treatment, housing, and employer commitments at re-entry; and/or structural barriers impeding treatment attendance or medication compliance. Applicants must specify a plan for this project in the application.

The remaining rapid turnaround research projects will be developed post-award. The Year 2 project is anticipated to include a focus on identifying modifiable barriers to screening and treatment for common co-occurring conditions in this population, with particular attention to Hepatitis C. This and the remaining studies should be informed by engagement with the JCOIN Phase II Hubs, the CAB, and NIH staff, in consideration of emerging policy, financing, or other systemic changes that could be productively addressed through a community engaged research project. All rapid turnaround projects should consider overarching issues that align with the goals of the CERRC, such as stigma toward PWLE, misinformation about SUD treatments, disparities in access to SUD services, social determinants of health, environmental justice, and/or common barriers to patient engagement in SUD research. The goal of all of these projects is to help elucidate modifiable barriers to treatment engagement for individuals in the criminal legal system, to inform both the JCOIN Hubs and future NIDA research.

Special Considerations: NIDA applicants are strongly encouraged to review the guidelines and adhere to the requirements applicable to their research listed in the Special Considerations for NIDA Funding Opportunities and Awards. Upon award, these considerations will be included in the Notice of Grant Award.

Commons IDs for Senior/Key Personnel: Applicants are reminded that NIH requires all individuals listed on the R&R Senior/Key Person Profile (Expanded) Form to have an eRA Commons username (Commons ID). This includes non-academic collaborators meeting the definition of Senior/Key Personnel. See NOT-OD-21-109 and NOT-OD-24-042. Information about how to obtain Commons IDs for non-academic collaborators is included in FAQs at: https://grants.nih.gov/faqs#/applying-electronically.htm.

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

Network Participation: All JCOIN Phase II investigators are expected to participate in monthly SC or work group calls with the research hubs and coordinating and support centers. One annual in-person meeting for the Network, in the Washington DC area, to include key project staff from the CERRC (assume up to 3 team members), should be anticipated. The CERRC should also anticipate monthly (virtual) coordination meetings with the CTC, MAARC, and ERRC throughout Year 1, and quarterly meetings thereafter.

During the first year, JCOIN Phase II grantees will collaborate to identify a set of common measures to be used, as relevant, across studies, and will determine policies and processes for data sharing and collaborative analysis. All participants in the Network will have opportunities to collaborate on emergent, shared priorities.

Pre-Application Consultation: Potential applicants are strongly encouraged to consult with NIDA program staff early in the application development process. This early contact will provide an opportunity to discuss and clarify NIH policies and guidelines, including the scope of the project relative to the intent of this NOFO. See Scientific/Program Contacts in Section VII.

Applications Not Responsive to this NOFO

The following types of studies are not responsive to this NOFO and will not be reviewed:

• Applications that do not include plans for conducting all four required activities (engaging PWLE ; providing leadership in equity, diversity and inclusion; creating public resources; and rapid research projects).

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

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

All organizations administering an eligible parent award may apply for a supplement under this NOFO.

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Government

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

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

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

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information. 

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

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

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

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 their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - 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: [email protected] 

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed.

R&R Budget

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Travel and Meetings: JCOIN Phase II will be supported by multiple coordination and resource centers; frequent communication and clear lanes of activity among all components will be essential. For budget and planning purposes, anticipate monthly (virtual) coordination meetings with the CTC, MAARC, and ERRC throughout Year 1, and quarterly meetings thereafter.

For budgeting purposes, assume travel for up to three project staff to attend one in-person JCOIN SC meeting per year (assume meetings are 2 days, held in Bethesda, Maryland). One CERRC PI is also expected to attend the HEAL Scientific Meeting annually (assume 2 days in Bethesda, Maryland).

Research Projects: The required rapid turnaround research project in Year 1 should not exceed $100,000 direct costs. In Years 2-4, allocate an additional $100,000 direct costs per year to support the required delayed onset rapid turnaround research projects.

Staffing: In addition to the project team, allocate one additional bachelor’s level, full-time equivalent (FTE) position (designate as To Be Named) to support JCOIN Hubs in activities to be determined post-award and after completion of required needs assessment meetings.

R&R Subaward Budget

All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Research Strategy:

Use subheadings within the Research Strategy to clearly identify each of the four required components of the proposed work: Engaging PWLE; Leadership of DEI Activities; Creating Resources for Community-Engaged Research; Rapid Turnaround Research Projects.

1. Engaging People with Lived Experience (required):

Describe an overall plan for recruiting, engaging, fairly compensating, and managing a CAB for JCOIN. Describe a proposed approach to identifying, recruiting, and selecting not less than 12 individuals to serve on the CAB. Give consideration to constructing a panel that is as broadly representative as possible of JCOIN’s focal population – that is, individuals with histories of incarceration and SUD. CAB members should not be limited to a specific institution or geographic community. The opportunity for JCOIN Hubs, resource centers, and NIDA to nominate members should be provided. Provide a clear recruitment plan along with evidence of the applicant's ability to successfully engage community members in advisory roles, including through partnerships with other organizations as appropriate. Final composition of the CAB is to be determined after award.

Articulate a vision for how the CAB can best engage with the Network, and describe a process for ongoing evaluation of the success of this model, including its impact on the participants, researchers' projects/studies, and JCOIN products.

Describe a plan and timeline for conducting needs assessment meetings with each of the JCOIN Clinical Research Hubs (and Innovation Hubs as appropriate). Describe a process for systematically identifying Hubs’ needs and capacity for engaging PWLE, and how this will inform the development of support plans. Describe the team’s experience serving in analogous support roles.

Describe a plan for identifying, connecting, and supporting PWLE across the network. The plan should be mindful of the variety of roles that PWLE are likely to hold across the Hubs and support centers. Describe activities to engage participants, and a process for continuously evaluating the success and impact of these activities for the participants. Demonstrate experience and expertise in conducting analogous peer learning and peer support activities for non-researcher/nonacademic participants.

2. Leadership of DEI Activities (required):

Articulate an overall vision for serving as a resource to JCOIN to promote diverse, inclusive, and safe working relationships, and to address the impact of diversity and equity issues for JCOIN-supported research. Describe the team’s capacity and experience to provide mentoring, educational, coaching, or similar resources to engage researchers and practitioners from diverse backgrounds and roles.

Describe a plan for meeting with JCOIN Clinical Research Hubs and Innovation Hubs to assess interests, needs, capacity, and priorities for addressing issues related to equity, diversity and inclusion in their teams and in their research.

Provide evidence that the CERRC applicant institution (or partnering institution(s)) has the ability to hire individuals with histories of incarceration, and can provide advice and assistance to serve as a resource for Hubs in addressing institutional hiring restrictions specific to their JCOIN projects.

Describe a proposed approach to identifying, evaluating and mitigating risks (e.g., disclosure, stigmatization, marginalization) to research participants and the broader community in the selection, analysis, sharing, and dissemination of JCOIN research results (including in secondary data analyses), and for serving as a resource to the JCOIN SC and individual investigators on this topic.

3. Creating Resources for Community Engaged Research (required):

Articulate a vision for engaging with other NIDA-funded community engagement projects with a focus on individuals with incarceration histories and/or those with or in recovery from SUD. Propose a structure for identifying and sharing best practices among these projects and with the research community as appropriate.

Describe a plan for developing public-facing resources that can support high-quality community engaged research, that complements and does not duplicate other ongoing work. Offer examples of potential resources that the CERRC could develop, both specific to JCOIN and for addiction health services researchers generally, including intended audiences and potential impact. Demonstrate the team’s experience and expertise developing similar resources. Describe a plan for leveraging participation in professional conferences or similar events to disseminate these resources to communities of interest.

4. Rapid Turnaround Research Projects (required):

Describe a plan for one rapid turnaround research project to be conducted in Year 1. This project must use a “patient journey mapping” approach to elicit and document individuals’ experiences navigating the intersection of the criminal legal and substance use treatment systems. The project should result in a better understanding of the challenges individuals face when attempting to access services, or when this access is stymied by competing demands or requirements. Describe a proposed approach to recruiting and engaging participants in this activity; methods to be used; and a timeline and analysis plan. Identify staff with specific expertise and experience to lead this research project.

Include a plan for identifying three additional potential research projects in the remaining years, and ensure availability of staff with requisite research skills to conduct an array of studies. These should be treated as delayed onset studies for the purpose of this application, using the budget limits described above.

Resource Sharing Plan:

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide. 

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

The HEAL Initiative has additional requirements that must be addressed in the Data management and Sharing plan. All HEAL-generated data must be shared through the HEAL Initiative Data Ecosystem following HEAL’s compliance guidance (https://heal.nih.gov/data/complying-heal-data-sharing-policy). Specifically, HEAL applicants must include:

• Plans to submit data and metadata (and code, if applicable) to a HEAL-Compliant data repository (https://www.healdatafair.org/resources/guidance/selection) and follow requirements of the selected repository
• Plans to register your study with the HEAL platform within one year of award (https://heal.github.io/platform-documentation/study-registration/) 
• Plans to submit HEAL-defined study-level metadata within one year of award (https://github.com/HEAL/heal-metadata-schemas/blob/main/for-investigators-how-to/study-level-metadata-fields/study-metadata-schema-for-humans.pdf) and https://heal.github.io/platform-documentation/slmd_submission/.
• HEAL pain clinical studies must include plan to use HEAL core Common Data Elements (https://heal.nih.gov/data/common-data-elements). HEAL Initiative clinical studies that are using copyrighted questionaries are required to obtain licenses for use prior to initiating data collection. Licenses must be shared with the HEAL CDE team and the program officer prior to use of copyrighted materials. 
• To the extent possible, all other (non-pain) HEAL studies conducting clinical trials or research involving human subject are expected to use questionnaires by the HEAL Clinical Data Elements (CDE) Program (https://heal.nih.gov/data/common-data-elements) if applicable and relevant to their research. 
• Studies using CDEs, regardless of whether they are part of the HEAL repository, will be required to report which questionnaires are being used.
• To the extent possible, HEAL awardees are expected to integrate broad data sharing consent language into their informed consent forms.  

HEAL has developed additional details and resources to fulfill these requirements (https://www.healdatafair.org/resources/road-map). 

HEAL Public Access and Data Sharing Policy: 

NIH intends to maximize the impact of HEAL Initiative-supported projects through broad and rapid data sharing and immediate access to publications (https://heal.nih.gov/about/public-access-data). Guidelines for complying with the HEAL Public Access and Data Sharing Policy can be found at https://heal.nih.gov/data/complying-heal-data-sharing-policy. Resources and tools to assist with data related activities can be found at https://www.healdatafair.org/. For more detail and specific data sharing requirements, see Section 4. Other plans.  

Publications resulting from NIH HEAL Initiative funded studies must be immediately publicly available upon publication. 

• For manuscripts published in journals that are not immediately open access, authors should arrange with journals in advance to pay for immediate open access 
• Costs to ensure manuscripts are immediately publicly available upon publication should be included in budget requests

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - 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 How to Apply - 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 How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed.

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

See Part 2. 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

Part I. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply – Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

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 Section 7.9.1 Selected Items of Cost.

Applications must be submitted electronically following the instructions described in the How to Apply - 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 form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NIDA, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

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

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

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

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

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

Significance

Does the proposed Resource Center address the needs of the research network that it will serve? Is the scope of activities proposed for the Resource Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research network?

In addition, for applications involving clinical trials

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

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Resource Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing community engaged research? Do the investigators demonstrate significant experience with coordinating collaborative clinical research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, plans for conflict resolution, and organizational structure appropriate for the Resource Center? Does the applicant have experience overseeing selection and management of subawards, if needed?

In addition, for applications involving clinical trials

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

Specific to this NOFO:

• To what extent is there evidence that the team has experience and expertise in engaging individuals with lived experience in SUD and criminal legal involvement?
• To what extent does the applicant demonstrate experience and expertise in successfully promoting and supporting diverse and inclusive research teams?
• To what extent does the applicant demonstrate the ability to provide leadership to the network on issues of diversity, equity, and inclusion in research relevant to JCOIN’s mission?
• To what extent does the applicant have expertise in conducting community engaged research? 

Innovation

Does the application propose novel community engagement processes and strategies in coordinating the research network the Resource Center will serve? Are the processes and strategies novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of community engagement processes or strategies 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?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research network the Resource Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the network, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the projects are in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the network? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

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

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

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

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

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

Data Management and Statistical Analysis

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

Specific to this NOFO:

Engaging and Supporting People with Lived Experience (PWLE)

• To what extent does the application articulate a reasonable plan for meeting with the JCOIN research hubs, identifying needs, and providing a variety of supports related to engaging PWLE?
• To what extent does the team demonstrate expertise and experience addressing institutional hiring practices to support hiring of PWLE?
• To what extent does the applicant articulate a clear and feasible approach to connecting and supporting PWLE across the network?

Providing Capacity and Leadership for Diversity, Equity, and Inclusion

• To what extent does the applicant provide a thoughtful and feasible plan to engage JCOIN research hubs in activities to promote and support diversity, equity and inclusion in their research teams and analysis of JCOIN data?
• To what extent does the applicant demonstrate familiarity and willingness to engage with other NIDA-funded projects sharing similar community engagement goals?

Creating Public-Facing Resources for Community-Engaged Research

• To what extent does the applicant offer a thoughtful and feasible plan for developing and disseminating public-facing resources to support high-quality community engaged research? Does this plan integrate an understanding of best practices for engaging PWLE in research?
• To what extent is there a plan to collaborate with the CTC on dissemination strategies?

Rapid Turnaround Research Projects

• To what extent does the applicant describe a well-articulated plan for a research project involving “patient journey mapping”? Is that project likely to lead to a nuanced understanding of the challenges of navigating SUD services for people engaged in the criminal legal system?

Environment

Will the institutional environment in which the Resource Center will operate contribute to the probability of success in facilitating the research network it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Resource Center proposed? Will the Resource Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Specific to this NOFO:

• To what extent does the applicant team demonstrate capacity and experience in hiring people with histories of incarceration?
• To what extent does the applicant have the necessary infrastructure and resources to support PWLE working in various roles across the JCOIN network?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals 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.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIDA, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

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

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

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. 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 2.4.4 Disposition of Applications.

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. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

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

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

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

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

2. Administrative and National Policy Requirements

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

• Federal-wide Standard Terms and Conditions for Research Grants
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

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

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website. 

HHS recognizes that NIH 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 NOFO.

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 System for Award Management (SAM.gov) requirements. SAM.gov requires Federal agencies to review and consider information about an applicant in the designated integrity and performance system (currently SAM.gov) prior to making an award. An applicant can review and comment on any information in the responsibility/qualification records available in SAM.gov. NIH will consider any comments by the applicant, in addition to the information available in the responsibility/qualification records in SAM.gov, 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 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

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 (HHS) grant administration regulations at 2 CFR Part 200, 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 recipients 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 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 recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

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

• Serving as project director(s) responsible for the overall management of activities within the CERRC.
• Representing the CERRC as a member of the JCOIN SC.
• Participating as appropriate in activities to coordinate among NIDA community engaged research efforts involving justice-involved populations. This participation may include collaboration and consultation with other NIH award recipients; the appropriate sharing of information, data, and research materials; and participation in NIH efforts to standardize and harmonize pre-clinical and clinical data collection, as appropriate.
• Data Management, Analysis, and Access: Data generated are the property of the award recipient. The awardee must provide NIDA with access to all research data generated under this award, subject to rules specified in any Certificates of Confidentiality. Data must be shared upon request with the SC and any subcommittees reporting to the SC, when appropriate.
• Recipients 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 HHS, 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) of the CERCC, the other JCOIN Phase II coordination and resource centers, and the Clinical Research Hubs to ensure integration and coordination among these components in performing their intended roles in the network.
• The NIH Project Scientist(s) will have one (1) vote on the SC, regardless of how many NIH Project Scientists participate across the network.
• The assigned Project Scientist(s) will be responsible for: (1) overseeing the activities of the CERRC, along with the other entities delineated above, to ensure that activities and services are coordinated and supportive of the functioning of the network; (2) providing advice and guidance on the research and network support activities to be provided by the CERRC, to ensure that these meet the needs of the network and are of high scientific priority and utility; (3) facilitating contact between the CERRC and other JCOIN-funded projects and relevant NIH-funded projects; and (4) regular communication with CERRC leadership to ensure smooth operation and early identification and correction of problems.
• 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 notice of award.

Areas of Joint Responsibility include:

• The SC is the primary governing body of the Cooperative. Award recipients must participate in the SC. The SC or its designated committees develops policies and procedures guiding the network and serves as a forum to facilitate collaboration, identify research gaps and opportunities, and integrate insights from practitioners. Award recipients agree to abide by the procedures and policies established by the SC.
• JCOIN is intended to be a national resource, and as such, the CERRC must be prepared to share their data under provisions that safeguard the privacy and confidentiality of respondents, consistent with its Data Management and Sharing Plan, as approved by NIDA.
• The PD(s)/PI(s) provide, in concert with the NIDA staff, support necessary to ensure that sites and investigators, and NIH and other research partners fully comply with federal regulatory requirements, including but not limited to those relating to human subjects protections, informed consent, and reporting of adverse events.
• Award recipients and NIDA will jointly develop appropriate confidentiality procedures for data collection, processing, storage and analysis to ensure the confidentiality of data.
• All award recipients 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 will facilitate these joint activities and, in particular, development of collaborative research protocols, human subjects and other regulatory protocols, data harmonization, publication and dissemination plans, and other network policies and procedures as needed.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the SC 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 recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

The HEAL Initiative has additional requirements that must be addressed in the Data management and Sharing plan. All HEAL-generated data must be shared through the HEAL Initiative Data Ecosystem following HEAL’s compliance guidance (https://heal.nih.gov/data/complying-heal-data-sharing-policy). Specifically, HEAL applicants must include:

• Plans to submit data and metadata (and code, if applicable) to a HEAL-Compliant data repository (https://www.healdatafair.org/resources/guidance/selection) and follow requirements of the selected repository
• Plans to register your study with the HEAL platform within one year of award (https://heal.github.io/platform-documentation/study-registration/) 
• Plans to submit HEAL-defined study-level metadata within one year of award (https://github.com/HEAL/heal-metadata-schemas/blob/main/for-investigators-how-to/study-level-metadata-fields/study-metadata-schema-for-humans.pdf) and https://heal.github.io/platform-documentation/slmd_submission/.
• HEAL pain clinical studies must include plan to use HEAL core Common Data Elements (https://heal.nih.gov/data/common-data-elements). HEAL Initiative clinical studies that are using copyrighted questionaries are required to obtain licenses for use prior to initiating data collection. Licenses must be shared with the HEAL CDE team and the program officer prior to use of copyrighted materials. 
• To the extent possible, all other (non-pain) HEAL studies conducting clinical trials or research involving human subject are expected to use questionnaires by the HEAL Clinical Data Elements (CDE) Program (https://heal.nih.gov/data/common-data-elements) if applicable and relevant to their research. 
• Studies using CDEs, regardless of whether they are part of the HEAL repository, will be required to report which questionnaires are being used.
• To the extent possible, HEAL awardees are expected to integrate broad data sharing consent language into their informed consent forms.  

HEAL has developed additional details and resources to fulfill these requirements (https://www.healdatafair.org/resources/road-map). 

HEAL Public Access and Data Sharing Policy: 

NIH intends to maximize the impact of HEAL Initiative-supported projects through broad and rapid data sharing and immediate access to publications (https://heal.nih.gov/about/public-access-data). Guidelines for complying with the HEAL Public Access and Data Sharing Policy can be found at https://heal.nih.gov/data/complying-heal-data-sharing-policy. Resources and tools to assist with data related activities can be found at https://www.healdatafair.org/. For more detail and specific data sharing requirements, see Section 4. Other plans.  

Publications resulting from NIH HEAL Initiative funded studies must be immediately publicly available upon publication. 

• For manuscripts published in journals that are not immediately open access, authors should arrange with journals in advance to pay for immediate open access 
• Costs to ensure manuscripts are immediately publicly available upon publication should be included in budget requests

4. Reporting

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

Report and ensure immediate public access to HEAL-funded publications  

Publications resulting from NIH HEAL Initiative funded studies must be immediately publicly available upon publication.  

• For manuscripts published in journals that are not immediately open access, authors should arrange with journals in advance to pay for immediate open access  
• Costs to ensure manuscripts are immediately publicly available upon publication should be included in budget requests   

Prior to publication, HEAL expects investigators to alert their program officers of upcoming manuscripts to ensure coordination of communication and outreach efforts.  

Award recipients and their collaborators are required to acknowledge HEAL Initiative support by referencing in the acknowledgment sections of any relevant publication:

“This research was supported by the National Institutes of Health through the NIH HEAL Initiative (https://heal.nih.gov) under award number [include specific grant/contract/award number; with NIH grant number(s) in this format: R01GM987654].” 

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

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

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (Responsibility/Qualification in SAM.gov, formerly 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 2 CFR Part 200 – 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.

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: https://www.era.nih.gov/need-help (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: [email protected] (preferred method of contact)
Telephone: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Julia Zur, Ph.D.
National Institute on Drug Abuse (NIDA)
Email: [email protected]

Behnoosh Momin, DrPH, MS, MPH
National Cancer Institute
Telephone: 240-789-3981
Email: [email protected]

Dharmendar Rathore, Ph.D.
National Institute on Drug Abuse (NIDA)
Email: [email protected]

Ericka Wells
National Institute on Drug Abuse (NIDA)
Email: [email protected]

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: [email protected]

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.

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 2 CFR Part 200.