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 Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the NOFO) 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.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

The NIH HEAL Initiative: This study is part of the NIH’s Helping to End Addiction Long-term^(R) (HEAL) initiative to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative^(R) 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) has two broad, complementary goals: to build the evidence base for the delivery of substance use disorder treatment services for individuals involved in the criminal-legal system, and to build capacity to implement effective services in both criminal-legal and treatment settings. Phase I of JCOIN established a consortium of practitioner-partnered research projects focused primarily on testing strategies to connect individuals to evidence-based opioid use disorder (OUD) treatment at key transition points between the criminal-legal system and the community. Phase I supported 13 multisite clinical trials and more than 50 additional distinct research protocols including surveys, modeling, dissemination, and pilot studies, supplements, and ancillary projects. The Network was supported by a Coordination and Translation Center (CTC) and a Methodology and Advanced Analytics Resource Center (MAARC).

Given recent evolution of both the epidemiology of the overdose crisis and public policy 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 at earlier points of the sequential intercept model.

JCOIN Phase II will consist of three highly integrated components: multiple Research Hubs that will each execute multisite implementation or effectiveness trials in one or more segments of the criminal-legal system; a CTC, which will provide logistical support, capacity building, national stakeholder engagement, and broad dissemination of research results; and a MAARC, which will provide a wide array of data and analytic support services.

This Notice of Funding Opportunity solicits applications for a CTC.

Coordination and Translation Center (CTC): Scope of Activities and Purpose

It is imperative that applicants for the CTC carefully review the companion NOFO for the JCOIN Phase II MAARC (UM1) (RFA-DA-24-068) and the Notice of Intent to Publish a NOFO for Research Hubs (NOT-DA-25-025) to understand the full mission of JCOIN - Phase II.

The JCOIN CTC is expected to provide coordination, infrastructure, and other supports for the network. This includes support in the day-to-day operations and coordination of the network; providing infrastructure for funding pilot research grants; providing research education infrastructure; disseminating research from the cooperative to a wide variety of external audiences; engaging external stakeholders and facilitating bidirectional communication between external stakeholders and network investigators; conducting dissemination/implementation research to complement what is being conducted by Research Hubs; and providing technical assistance to practitioners in the criminal-legal field.

JCOIN’s Phase I included 12 Research Hubs, each conducting an independent clinical trial, with multiple workgroups supporting cross-hub collaborations. The JCOIN Steering Committee (SC) had representation from each Hub PI, along with a criminal justice agency partner and treatment agency partner for each hub; CTC and MAARC PI’s were also voting members. The CTC provided logistical and communication infrastructure to facilitate the work of the network, along with a public-facing website (jcoinctc.org) to promote and disseminate JCOIN products, resources, and research results. An analogous level of support is intended for Phase II, with variations depending on the final composition of Research Hubs.

The JCOIN Phase II CTC will provide services and resources to the network via the following six cores. Cores may be located at different institutions as long as there is a strong plan for communication and collaboration. Investigators are encouraged to convene a diverse, multidisciplinary, skilled team that provides synergy to JCOIN by working together with the Research Hubs and the MAARC.

Administrative Core:?The Administrative Core will provide overall infrastructure support to the cooperative as a whole. This includes: establishing and maintaining an external-facing website and communications infrastructure; supporting an internal collaboration and communication infrastructure (e.g., grantee online portal, online project management tool, network calendars, file sharing service, HIPAA-compliant Zoom or equivalent licenses); providing logistical support for in-person and virtual meetings; tracking and synthesizing key outputs (e.g., publications, presentations) from studies across the network; and supporting a JCOIN SC chairperson.?

Rapid Response and Pilot Research core:?Policies and practices are rapidly changing and many opportunities for generating insights into the effectiveness of emerging policies and practices go un-captured. The Rapid Response and Pilot Research Core will establish a process for soliciting, reviewing, and funding applications from researchers and practitioners both within and outside the network to conduct research on: (a) the impact of newly emerging policies and practices, or pilot studies of new, promising approaches to addressing overdose and related issues in criminal-legal systems; and (b) conducting rigorous secondary analyses of JCOIN Phase I data.

Dissemination and Stakeholder Engagement Core:?The purpose of the Dissemination and Stakeholder Engagement Core is to translate network findings from both Phase I and Phase II research projects into resources of interest to external stakeholders. To achieve this goal, this Core is responsible for facilitating bidirectional communication and translation between network investigators and external stakeholders.?External stakeholder groups include practitioners and policy makers at local, state, and federal levels across a range of criminal-legal and community-based service settings that work with individuals involved with the criminal-legal system. This Core also has responsibility for engaging communities not formally involved in JCOIN and identifying strategies for assisting those communities in applying insights that emerge from research supported by JCOIN. This core will also support and promote the use of a researcher and practitioner collaboration platform to facilitate research and programmatic relationships across health and criminal-legal fields.

Research Education Core:?The goal of the Research Education Core is to build capacity for researchers to engage productively with criminal-legal systems, and for criminal-legal practitioners to engage in, and apply the findings of, NIH-funded research. Training should support researchers at all levels interested in working in criminal-legal settings and facilitate engagement with the broader JCOIN network.?

Implementation and Translation Research Project Core:?The goal of the Implementation and Translation Research Project Core is to provide a flexible mechanism for supporting research projects that generate evidence about effective approaches to translating scientific findings into practice through dissemination and implementation research. The vision of this Core is that it will be responsive to emergent research opportunities over the course of the project duration. This will support the overall goal of JCOIN to facilitate the effective translation of scientific insights into practice.

Technical Assistance Core: The goal of the Technical Assistance Core is to provide technical assistance regarding research and evaluation designs, methods, and measures. The audience for this core includes criminal-legal systems and related community-based organizations or stakeholders working at the intersection of substance use services and justice-involved populations. Success of this core depends on awareness of and communication with technical assistance providers for other national programs and networks (e.g., BJA’s COSSAP program; SAMHSA’s Addiction Technology Transfer Centers; the Opioid Response Network) to ensure a coordinated and non-duplicative response.

Collectively, these activities are expected to help ensure maximum public health impact of the collective activities of the JCOIN network.

Pre-Application Consultation:

Potential applicants are strongly encouraged to consult with National Institute on Drug Abuse (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.

Special Considerations

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

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.

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

Plan for Enhancing Diverse Perspectives (PEDP).

• This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP) as described in NOT-MH-21-310, submitted as Other Project Information as an attachment (see Section IV).
• Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material. The PEDP will be assessed as part of the scientific and technical peer review evaluation, as well as considered among programmatic matters with respect to funding decisions.

Engaging People with Lived Experience and Other Collaborators: People with lived experience (e.g., patients, patient advocates, caregivers, families, community leaders) have important insights that can improve meaningful outcomes, uptake of research findings, and health equity across the continuum of research from basic through implementation studies. The perspectives of other relevant collaborators (e.g., health service providers, payors, public health agencies, community-based organizations, biotech, pharma) can further improve research impact. The NIH HEAL initiative strongly encourages applicants to specify their plan for meaningful engagement of people with lived experience and other collaborators in the research process. Meaningful engagement will vary with the focus of the research but should at minimum ensure that researchers are connecting with relevant collaborators and incorporating their perspectives throughout the conception, implementation, and dissemination of the research. Meaningful engagement should address what the researchers will learn and how the people with lived experience and/or collaborators will benefit from the partnership. To promote health equity, as is relevant for the research proposed, it is recommended that at least two people with lived experience from populations who experience health disparities should be meaningfully engaged in these efforts.

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.

Clinical Trial Accrual:

This NOFO will support applications that include a series of milestones for completion of the clinical trial and provide contingency plans to proactively confront potential delays or disturbances in attaining the milestones. Continuation of the award is conditional upon satisfactory progress, availability of funds, and scientific priorities of the HEAL Initiative. If, at any time, recruitment falls significantly below the projected milestones for recruitment, NIH will consider ending support and negotiating an orderly phase-out of the award. NIH retains the option of periodic external peer review of progress. NIH program staff will closely monitor progress at all stages for milestones, accrual, and safety.

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

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

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

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

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

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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their 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 his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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 or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing a multi-component application.

Overall Component

When preparing the application, use Component Type Overall .

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Other Attachments:

Plan for Enhancing Diverse Perspectives (PEDP)

In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicant(s) should align their description with these required elements within the research strategy section. The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured. The PEDP may be no more than 1-page in length and should include a timeline and milestones for relevant components that will be considered as part of the review. Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:

• Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Description of any planned partnerships that may enhance geographic and regional diversity.
• Plan to enhance recruiting of women and individuals from groups traditionally under-represented in the biomedical, behavioral, and clinical research workforce.
• Proposed monitoring activities to identify and measure PEDP progress benchmarks.
• Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers.
• Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds.
• Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s).
• Publication plan that enumerates planned manuscripts and proposed lead authorship.
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from under-represented backgrounds.

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp

Project/Performance Site Locations (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research and Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

PEDP implementation costs

• Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7: https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm).

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims:?Specific aims should comprehensively address the goals of this NOFO, which are to design and implement research infrastructure that will enable the CTC to support and advance the work of the overall JCOIN network.? ????

Research Strategy:?Applicants should describe the overall structure of their proposed CTC. This should include unique advantages or capabilities of the proposed center and how it will interact with the broader JCOIN network. In the Overall section, applicants should address how the various cores will be coordinated to establish the research resource.

The CTC should be viewed as interrelated Cores that provide support to individual Research Hubs, to the network as a whole, and to the greater community of criminal-legal and community-based stakeholders engaged in working with populations involved with the criminal-legal system.?

Because each Core should be strong individually and complementary to the other Cores and the network, it is important to describe the synergy across Cores.?Provide justification in the application that key personnel will collaborate effectively. Describe the organizational structure of the CTC including the Cores. Explain how different components of the organization, including key personnel, will interact, why they are essential to accomplishing the overall goals of the JCOIN, and how combined resources create capabilities that are more than the sum of the parts.

If Cores will be located at different institutions, provide a strong plan for communication and collaboration. Investigators are encouraged to convene a diverse, multidisciplinary, skilled team that provides synergy to JCOIN.

Describe work-flow plans and timelines.? ??

Letters of Support: Include letters of support/agreement for any collaborative/cooperative arrangements, subcontracts or consultants. For activities to be conducted at an institution other than the applicant institution, a letter of assurance or comparable documentation, signed by the collaborator as well as the institutional officials, must be submitted with the application. Only letters relevant to the entire application should be submitted in this component. Letters specific to a core or project should be submitted in the relevant component.

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.

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.

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. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

All instructions in the SF424 (R&R) 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 subjects 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).

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

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 (Overall)

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

Core

When preparing your application, use Component Type Admin Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

Applicant Information

Type of Applicant (optional)

Descriptive Title of Applicant’s Project

Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects:?Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals:?Answer only the Are Vertebrate Animals Used? question.

Project Narrative:?Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.???

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

Steering Committee Meetings: Budgets should include funds for travel for the PD(s)/PI(s), including each Core Lead, and as many support staff as needed to coordinate all in-person SC meetings. For planning purposes, assume two (2) planning and coordination meetings with NIDA and the CTC will be held in Rockville, Maryland during Year 1, and that one (1) in person JCOIN SC meetings will be held in Rockville, Maryland in each of years 2 through 5. Anticipate all SC meetings are 2 days in length and involve approximately 100 persons from across the network. One virtual SC meeting will also be held in years 2-5 with up to 250 attendees.

Steering Committee Chair Support: The budget for the Administrative Core should include a line item for travel and salary support for an SC Chair, to be named by NIDA at a later time. The SC Chair will lead all SC meetings. For budgeting purposes assume the equivalent of 2 months effort annually at a senior investigator level salary. Budget for the SC Chair should also include reimbursement for travel expenses to all in-person SC Meetings. For the purposes of budgeting, assume an indirect cost rate of 50% for SC Chair's institution.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administrative Core)

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Specific Aims: Specific Aims should identify general objectives planned for the Administrative Core along with the main benchmarks that would indicate the accomplishment of these objectives.???

Research Strategy:?The Administrative Core of the CTC provides overarching resources and organizational structure and management of the Cores and Projects.

As part of this section, applicants should describe their plan for completing the following activities:

Maintaining and Enhancing External-Facing Communications Infrastructure established in Phase I:

• Maintaining external facing communications infrastructure for public audiences, ensuring it maintains the highest standards of usability and accessibility (e.g., attend to 508 compliance, Search Engine Optimization). Applicants should assume the existing JCOIN website (https://jcoinctc.org) and all related accounts and documentation will be provided to a newly awarded CTC.
• Identifying and executing functional and content enhancements to improve overall impact of website infrastructure.
• Support a coordinated communication strategy across audiences and functions, including dissemination of research findings to academic audiences, practitioners, and the general public. Examples of activities include, but are not limited to: (a) assisting with tracking and promoting research conference presentation opportunities and tracking publications resulting from JCOIN-funded projects; (b) developing training resources aimed at practitioner and policy-maker audiences (e.g., judges, drug courts, jail administrators, treatment providers, state and local policy makers); (c) developing social media communication strategies; (d) developing press releases, and other communication strategies and approaches as needed.

Providing Internal Collaboration and Communication Infrastructure and Logistical Support:

• Maintaining network-only website for internal collaboration.
• Maintaining and regularly updating listserv(s) to include all JCOIN members, including PIs, co-Is, research staff, and associated practitioners.
• Providing file sharing, project management, and communications infrastructure for the network as a whole.
• Tracking and reporting internal network activities and outputs, including publications, subcommittee or workgroup meetings, etc., and facilitating dissemination of updates and emerging findings within the Network.
• Support all SC and related committees through logistical support inclusive of, but not limited to note taking, meeting facilitation, convening, and other support services for all in-person and virtual SC meetings and for trans-network Workgroup meetings as requested.
• Support the SC through close coordination with an SC Chair, to be named by NIDA.
• Provide logistical support (including providing or securing meeting space) and meeting planning support for all in-person SC meetings. For planning purposes, assume two (2) planning and coordination meetings with NIDA and the CTC will be held in Rockville, Maryland during Year 1, and that one (1) in-person JCOIN SC meetings will be held in Rockville, Maryland and one (1) virtual SC meeting in each of years 2 through 5.

Monitoring Network Outputs:

• Tracking and synthesizing key outputs (e.g., publications, presentations) from studies across the network. This may include close coordination with the Dissemination and Stakeholder Engagement Core to generate synthesis products such as publications, presentations, or webinars. This also includes responsibility for being able to provide real-time metrics to NIDA on overall network outputs.

Letters of Support: Include signed letters of support/agreement for any collaborative/cooperative arrangements, subcontracts, or consultants. For program activities to be conducted off site, i.e., at an institution other than the applicant institution, a letter of assurance or comparable documentation, signed by the collaborator as well as the off-site institutional officials, must be submitted with the application.

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:

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. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Administrative Core)

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

Rapid Response and Pilot Research Core

When preparing your application, use Component Type Rapid Rsps Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Rapid Response and Pilot Research Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Rapid Response and Pilot Research Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Rapid Response and Pilot Research Core)

Human Subjects:?Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals:?Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Rapid Response and Pilot Research Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Rapid Response and Pilot Research Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.???

Budget (Rapid Response and Pilot Research Core)

Budget forms appropriate for the specific component will be included in the application package.

The following budget guidelines must be followed for the Rapid Response and Pilot Research Core:

• Awards through the Rapid Response and Pilot Research Core may not be issued by the U2C as fixed price subawards. These awards may not exceed $150,000 in total costs and may not be longer than 24 months in duration.
• $500,000 in total costs should be made available in years 1-5 for the awards through the Rapid Response and Pilot Research Core.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Rapid Response and Pilot Research Core)

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Specific Aims: Describe the overall goals of the JCOIN Rapid Response and Pilot Research Core and how it will contribute to the overall objectives of JCOIN.

Research Strategy:?

The Rapid Response and Pilot Research Core is intended to provide rapid, flexible infrastructure to solicit, review, select, and fund research projects on newly emerging policies and practices at the intersection of the overdose epidemic and the criminal-legal system. In addition, this Core is intended to support pilot projects, which may be used to collect data on new and promising interventions; to take advantage of novel research opportunities; to capture implementation data on newly emerging policies or programs; and to support new, early stage, or independent investigators. Projects funded through this core may take advantage of policy changes and newly emerging practices or may include developmental pilots, feasibility studies, or other pilot work, broadly defined, as foundation work for further research. Finally, this core will also support applications for well-defined secondary analyses of JCOIN Phase I data. Funds for these projects may not be used to supplement or prolong ongoing research; are not a substitute for administrative supplements to existing grants; and should not be used as bridge funds when other research support is no longer available.?

The research strategy section for the Rapid Response and Pilot Research Core should describe a vision for the structure of this program, including ensuring capacity and expertise to solicit, review, and select applications for funding; ensure broad dissemination of notice of funding opportunities to the research and practice communities; and ensure appropriate representation of practitioners in the review process.

Details in the plan should include:

• A detailed plan for parameters of award program, including policies, procedures, priority areas, approach to engaging all components of JCOIN, etc.
• A plan for convening an advisory committee to oversee process.
• The process for providing rapid, rigorous review, selection, and oversight of applications.
• A description of how the process will be communicated to potential applicants.
• The timeline and workflow for application process. Applications must be received at least one time in Year 1 and multiple times per year in Years 2-5, with funding awarded within 3 months of application submission.?
• A plan for encouraging and supporting applications for pilot awards that support research in or collaboration with criminal-legal settings not currently part of JCOIN.
• A plan for ensuring that practitioners are able to submit successful applications, regardless of how much research experience they have.

Please note the following guidelines that must be incorporated into all plans for the Rapid Response and Pilot Research Core:

• All awards must observe regulations and policies that would apply if the award was made directly by NIH, including, but not limited to, clinical trials registration, IRB approval, Office for Human Research Protections approval, public access compliance for manuscripts, etc.
• Awards through the JCOIN Rapid Response and Pilot Research Core may not exceed $150,000 in total costs per award and may not be longer than 24 months in duration. The CTC will determine what proportion of the total costs will be for direct costs and what proportion will be for indirect costs, as long as the indirect rate is not higher than the negotiated indirect rate at the grantee institution. If the grantee institution does not have a negotiated rate, the indirect rate cannot exceed 10%.
• Individual investigators may not receive pilot funds from more than 2 awards total through this mechanism during the entire course of the JCOIN award.
• Process for applications and all awards made via this activity must be made publicly available via the public-facing JCOIN website.
• All publications resulting from these awards must acknowledge funding from NIDA via the CTC grant award number. All publications must also be included in the annual progress report submitted by the CTC.
• All awarded applications must provide a reporting of the outcomes of their pilot funds to the CTC within 3 months of the completion of their study. This information must be made available within 1 month of receipt on the public-facing JCOIN website.
• NIDA must be made aware of and provide input on all awards to be made through this Core.
• For budgeting purposes, allocate $500,000 in direct costs to be made available in Years 1-5 as awards through the Rapid Response and Pilot Research Core.

Applicants must also adhere to the following guidelines:

• Participants in the Research Education Training Core are not eligible for pilot funds until the completion of their training activities. That is, Rapid Response and Pilot Research Core funds should not be used to support the research activities specified in the Research Education Core. After successful completion of Research Education training, participants may be eligible to apply for funding through the Rapid Response and Pilot Research Core.

The Research Strategy for the Rapid Response and Pilot Research Core should not specify any planned projects. All projects are expected to emerge across JCOIN after the award has been made. All studies should be treated as delayed onset studies.

Letters of Support: Include signed letters of support/agreement for any collaborative/cooperative arrangements, subcontracts, or consultants. For program activities to be conducted off site, i.e., at an institution other than the applicant institution, a letter of assurance or comparable documentation, signed by the collaborator as well as the off-site institutional officials, must be submitted with the application.

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:

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. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Rapid Response and Pilot Research Core)

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

Dissemination and Stakeholder Engagement Core

When preparing your application, use Component Type Dissem Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Dissemination and Stakeholder Engagement Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Dissemination and Stakeholder Engagement Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Dissemination and Stakeholder Engagement Core)

Human Subjects:?Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals:?Answer only the Are Vertebrate Animals Used? question.

Project Narrative:?Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Dissemination and Stakeholder Engagement Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Dissemination and Stakeholder Engagement Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.???

Budget (Dissemination and Stakeholder Engagement Core)

Budget forms appropriate for the specific component will be included in the application package.

Although members of external advisory groups should not be pre-specified, budgets may include placeholders for payment of members of these groups to participate in both in-person and virtual meetings. Use the instructions in the announcement in conjunction with the application guide to prepare your application. If instructions conflict, follow the NOFO.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Dissemination and Stakeholder Engagement Core)

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Specific Aims:?Identify general objectives planned for the development and functioning of the Dissemination and Stakeholder Engagement Core along with the main benchmarks that would indicate the accomplishment of these objectives.

Research Strategy:?

External Stakeholders for JCOIN are inclusive of, but not limited to, leadership and front-line practitioners at local, state, and federal levels in organizations that represent individuals or groups that (a) directly engage with justice-involved populations in criminal-legal or community-based settings; (b) make policies or provide guidance on interactions with justice-involved populations; (c) provide funding to support research or practice improvements that affect justice-involved populations, especially concerning the overdose crisis or substance use more generally, or (d) directly represent the perspectives of people with lived experience in the criminal legal system. External stakeholders also include groups that represent families of individuals who are justice involved as well as individuals with a history of justice involvement. External stakeholders may also include leadership and participants in other justice-focused initiatives that engage multiple communities and stakeholders.

The research strategy section should provide details on the planned approach in the following four areas as detailed below: (1) Stakeholder Engagement with Network Leadership; (2) Outreach and Training for Stakeholders; (3) Rapid Translation of Research Findings for Stakeholder Audiences; and (4) Identifying and Engaging Potential Sites for Future JCOIN Network Activities.

Stakeholder Engagement with Network Leadership

Research plan should outline an approach to engage key stakeholders at national, state, and local levels with JCOIN network leadership. Describe a vision for identifying, selecting, recruiting, and engaging key agencies and thought leaders, and fairly compensating them for involvement in recurring meetings or other activities. Creativity in this approach is encouraged, but should involve a minimum of 2 formal meetings (online or in person) each year. Applicants should outline clearly how they will ensure that people with lived experience, are represented in these activities.

Other activities that should be specified with regard to stakeholder engagement with JCOIN include:

• Each Phase II Research Hub will be required to formally name representatives from a criminal-legal agency and a public health agency as partners on their projects who will sit on the JCOIN SC. Outline a plan for facilitating active engagement and coordination of these JCOIN partners. Plan should emphasize ensuring these stakeholders have opportunities to provide meaningful and broad input on network development and direction.
• Facilitating bidirectional communication between external stakeholders and JCOIN investigators with an explicit goal of enhancing capacity of network investigators to be responsive to emergent priorities and areas of interest in policy and practice.

Outreach and Training for Stakeholders

Research plan should outline approach to identifying training and supervision needs in key stakeholder communities and leverage JCOIN findings and materials to create and disseminate training resources (e.g., courses, webinars, podcasts) regularly. Targets for training should include justice system stakeholders (e.g., judges, probation officers, attorneys), community-based treatment providers (e.g., addiction psychiatrists, social workers, behavioral health providers, researchers), and the general public. Applicants should prioritize reaching audiences from diverse backgrounds and should draw on the expertise of people with lived experience when developing materials.

Trainings and courses should be delivered via easy to use, engaging online platforms, and should be free for users to access.

Applicants are strongly encouraged to create synergies between the Dissemination and Stakeholder Engagement and the Research Education Cores.?

Dissemination and training activities should be tracked and included in metric-based reporting to NIDA. In addition, applicants are strongly encouraged to leverage outreach and training activities conducted as part of the Dissemination and Stakeholder Engagement Core in the design and execution of the Implementation and Translation Research Project Core.

Rapid Translation of Research Findings for Stakeholder Audiences

The Dissemination and Stakeholder Engagement Core should collaborate closely with the MAARC to rapidly translate emerging findings into user-friendly materials for a variety of audiences, including researchers; justice and community-based practitioners; local, state and federal policy makers; patients; and families. Examples of materials include, but are not limited to:

• Systematic evidence reviews written with a pragmatic, practitioner-oriented focus;
• Menus of evidence-based practices, cost calculators, and electronic tools and templates designed for community-based practitioners;
• Explainers or other products that break down complex studies or findings;
• Practitioner-focused training webinars and courses.

Plans for providing on-demand training and technical assistance related to these products should be addressed in the required Technical Assistance Core.

The Research Strategy should outline approach to rigorously evaluating usability and be responsive to the researcher and stakeholder needs. A plan for monitoring uptake and engagement with these materials should be included.

Identifying and Engaging Potential Sites for Future JCOIN Network Activities

In the course of engaging with stakeholders, the CTC will likely identify criminal-legal settings or treatment providers that express interest in engaging as potential sites for future JCOIN studies. The Research Strategy section should describe an approach to how these sites will be monitored, engaged, and provided access to JCOIN resources as needed.

The Dissemination and Stakeholder Engagement Core should also develop strategies to facilitate new partnerships between researchers and community-based practitioners, including, but not limited to supporting and promote the use of electronic collaboration platforms.

Letters of Support: Letters of Support: Letters of support should not be included from potential stakeholder groups. Rather, a plan for identifying and engaging these groups should be included in the Research Strategy Section, as specified above. No letters should be sought or included from potential external stakeholder advisory groups as part of the Dissemination and Stakeholder Engagement Core. NIDA will work closely with the CTC to appoint the eventual External Advisory Committee. Include signed letters of support/agreement for any collaborative/cooperative arrangements, subcontracts, or consultants. For program activities to be conducted off site, i.e., at an institution other than the applicant institution, a letter of assurance or comparable documentation, signed by the collaborator as well as the off-site institutional officials, must be submitted with the application.

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:

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. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Dissemination and Stakeholder Engagement Core)

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

Implementation and Translation Research Project Core

When preparing your application, use Component Type Impl Project

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Implementation and Translation Research Project Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Implementation and Translation Research Project Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information Implementation and Translation Research Project Core)

Human Subjects:?Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals:?Answer only the Are Vertebrate Animals Used? question.

Project Narrative:?Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Implementation and Translation Research Project Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Implementation and Translation Research Project Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.???

Budget (Implementation and Translation Research Project Core)

Budget forms appropriate for the specific component will be included in the application package.

Applicants should specify a budget appropriate to the project proposed in Year 1 of the project. Since all subsequent projects will be treated as delayed onset, in Years 2-5, the budget should reflect staffing and leadership for this core as well as funds required to execute future studies of similar scope and scale as described in the Research Strategy section for this Core.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Implementation and Translation Research Project Core)

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Specific Aims:?Specific aims must be included and must specify aims for at least one hypothesis-driven project as well as a broader strategy for how this Core will function within the broader context of the CTC and JCOIN.? ???

Research Strategy:?

The goal of the Implementation and Translation Research Project Core is to provide a flexible mechanism for supporting research projects that generate evidence regarding effective approaches to translating scientific findings into wide-spread practice via dissemination and implementation research. The vision of this Core is that it will be responsive to emergent research opportunities over the course of the project duration.

Applicants should outline a rigorous approach to closing the science-to-service gap in the context of the overall scientific goals of JCOIN.?This approach should include plans for leveraging resources generated by the network and propose strategies to ensure those resources and/or findings are disseminated widely and utilized within the targeted settings.

The research strategy should describe one project to be executed in the first year of the award. This project should leverage recently emerging findings or resources and directly address a question relevant to enhancing the efficiency or effectiveness of dissemination or implementation strategies. This projects may be clinical trials, but this is not required.

Subsequent projects will be executed in years 2-5, but should be treated as delayed onset and will be determined in collaboration with NIDA post-award and must be approved by the NIDA Program Official before proceeding.

The research strategy should articulate an understanding of how dissemination or implementation research could support the broader goals of JCOIN, and outline an approach for identifying priorities for studies in years 2-5. This approach should also demonstrate an understanding of how these projects will serve as research infrastructure to complement the activities of the Research Hubs and the Dissemination and Stakeholder Engagement Core. Applicants are strongly encouraged to specify one or more implementation science frameworks that will guide the overall approach to the activity of this Core.

This Core should reflect a blend of innovative implementation science approaches with pragmatic-real world focus and should synergistically interact with all components of the Coordinating Center, with a particular emphasis on the Dissemination and Stakeholder Engagement Core.

Letters of Support: Include signed letters of support/agreement for any collaborative/cooperative arrangements, subcontracts, or consultants. For program activities to be conducted off site, i.e., at an institution other than the applicant institution, a letter of assurance or comparable documentation, signed by the collaborator as well as the off-site institutional officials, must be submitted with the application.

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:

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. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Implementation and Translation Research Project Core)

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

Research Education Core

When preparing your application in ASSIST, use Component Type Research Education .

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Research Education Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Project /Performance Site Location(s) (Research Education Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Other Project Information (Research Education Core)

Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

Human Subjects. Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals. Answer only the Are Vertebrate Animals Used? question.

Project Narrative. Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Application guide states that Project Narrative is required. However, it is only required for the Overall component.

Facilities & Other Resources. Describe the educational environment, including the facilities, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program. List all thematically related sources of support for research training and education following the format for Current and Pending Support.

Other Attachments. Provide a plan for the appointment of an Advisory Committee to monitor progress of the research education program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. The Advisory Committee should draw from the membership of the JCOIN Network, but applicants can propose an initial core set of members for the Advisory Committee. Describe how the Advisory Committee will evaluate the overall effectiveness of the program. Proposed Advisory Committee members should be named in the application if they have been invited to participate at the time the application is submitted. Please name your file Advisory_Committee.pdf

The filename provided for each Other Attachment will be the name used for the bookmark in the electronic application in eRA Commons.

Research & Related Senior/Key Person Profile (Research Education Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Research Education Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

• Include all personnel other than the PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.
• Use the section on Participant/Trainee Support Costs to include all allowable categories of funds requested to support participants in the program.

Budgets for the Research Education Core are limited to $500,000 in direct costs annually plus applicable F&A.

PHS 398 Cover Page Supplement (Research Education Core)

Follow all instructions provided in the SF424 (R&R) Application Guide.

PHS 398 Research Plan (Research Education Core)

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Specific Aims

The Research Education Core is intended to build capacity of researchers to engage productively with criminal-legal systems to conduct state-of-the-art services research, and of criminal-legal and public health practitioners to engage in conducting research studies and implementing the results of research in routine practice. Specific Aims should outline a vision for achieving this goal, providing an overview of specific activities planned, targeted audience for training, priority content areas, and plan for evaluation of the success of the research education activities.

Research Strategy

The Research Strategy section must be used to upload the Research Education Program Plan, which must include the following elements described below.

• Proposed Research Education Program
• Core Leads
• Program Faculty
• Program Participants
• Institutional Environment and Commitment
• Recruitment Plan to Enhance Diversity
• Plan for Instruction in the Responsible Conduct of Research
• Evaluation Plan
• Dissemination Plan

Research Education Plan

Proposed Research Education Program. While the proposed research education program may complement ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. When research training programs are on-going in the same department, the applicant organization should clearly distinguish between the activities in the proposed research education program and the research training supported by the training program.

The research education program plan should provide programmatic detail and a timeline on the program's objectives and specific activities proposed (e.g., courses, curricula, seminars, short-term research experiences), and how these objectives align with the overall objectives of the JCOIN network.

Examples of key domains that should be covered in the education program include, but are not limited to:

• Ethics of working with justice-involved populations
• Working across justice systems and behavioral health settings, with a special emphasis on addressing challenges in data sharing and collaboration across systems
• Overcoming challenges in designing, fielding, and analyzing pragmatic trials in justice settings
• Applying implementation science tools and frameworks in justice settings???

The research education plan should provide for a plan for facilitating the engagement of participants with JCOIN. Specific activities for participants must include:

• Ensuring participants have an opportunity to engage in a research experience or activity that leverages the resources of the JCOIN network
• Ensuring participants have an opportunity to receive individualized mentoring from one or more JCOIN investigators they have not previously worked with
• Ensuring participants can attend at least one face-to-face JCOIN network meeting
• Ensuring opportunity for participants to engage in at least one face-to-face training activity

In addition, the research education plan should also address the capacity to create resources that can be readily disseminated to the JCOIN research network and to relevant external stakeholders (e.g., virtual grand rounds lectures accessible via platforms such as YouTube or similar).

Core Lead(s).?Describe arrangements for administration of the program.?Provide evidence that the Program Director/Principal Investigator is actively engaged in research and/or teaching in the areas of clinical effectiveness and/or implementation research in justice settings and with justice-involved populations. Further, evidence should be provided that the Core Lead(s) can organize, administer, monitor, and evaluate the research education program. For programs proposing multiple Leads, describe the complementary and integrated expertise of the Leads their leadership approach, and governance appropriate for the planned project .?At least one Core Lead for each Core should have experience leading a similar program and a track record of receiving NIH funding.??

Program Faculty.?Researchers from diverse backgrounds, including individuals from underrepresented racial and ethnic groups, persons with disabilities, and women are encouraged to participate as program faculty. The JCOIN Research Education Core is expected to utilize the human resources available through the JCOIN network i.e., Principal Investigators, researchers, and practitioner partners affiliated with the Research Hubs. Applicants should propose program faculty who will be considered Core Faculty as well as outlining a plan for how investigators participating in the JCOIN network more broadly will be approached and engaged as part of the Research Education program. Proposed Core Faculty should have research expertise and experience in the domain of clinical and/or implementation research in justice settings and with justice-involved populations.??

Program Participants.?Applications must describe the intended participants, and the eligibility criteria and/or specific educational background characteristics that are essential for participation in the proposed research education program. Identify the career levels for which the proposed program is planned.

Eligibility to participate should be made available to individuals with appropriate educational backgrounds, irrespective of whether they are affiliated with any JCOIN network components.

The proposed research education program must include a focus on building the capacity of research investigators to conduct rigorous research in justice settings, and on building the capacity of research staff embedded in justice and behavioral health organizations to conduct scientifically rigorous, pragmatic studies and evaluation activities . Research education activities involving research staff embedded in justice and/or relevant behavioral health settings, must interface with and be non-duplicative of efforts planned in the Dissemination and Stakeholder Engagement Core. The primary emphasis of training for research staff embedded in justice and/or relevant behavioral health settings in the Research Education Core must be on building capacity to conduct research or engage in data-driven evaluation activities.

Recruitment Plan to Enhance Diversity (NOT-OD-20-031):

The applicant must provide a Recruitment Plan to Enhance Diversity. Include outreach strategies and activities designed to recruit prospective participants from diverse backgrounds, e.g., those from groups described in the Notice of NIH's Interest in Diversity. Describe the specific efforts to be undertaken by the program and how the proposed plan reflects past experiences in recruiting individuals from underrepresented groups.

Applications lacking a Recruitment Plan to Enhance Diversity will not be reviewed.

Plan for Instruction in the Responsible Conduct of Research. All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). The plan must address the five, required instructional components outlined in the NIH policy: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. See also NOT-OD-10-019 and NOT-OD-22-055. The plan should be appropriate and reasonable for the nature and duration of the proposed program. Renewal (Type 2) applications must, in addition, describe any changes in formal instruction over the past project period and plans to address any weaknesses in the current instruction plan. All participating faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period must be named in the application.

Applications lacking a plan for instruction in RCR will not be reviewed .

Evaluation Plan: Applications must include a plan for evaluating the activities supported by the award. The application must specify baseline metrics (e.g., numbers, educational levels, and demographic characteristics of participants), as well as measures to gauge the short or long-term success of the research education award in achieving its objectives. Wherever appropriate, applicants are encouraged to obtain feedback from participants to help identify weaknesses and to provide suggestions for improvements.

Dissemination Plan. A specific plan must be provided to disseminate nationally in conjunction with components of the JCOIN CTC any findings resulting from or materials developed under the auspices of the research education program, e.g., sharing course curricula and related materials via web postings, presentations at scientific meetings, workshops. This section should specifically address how information will be leveraged in other components of the JCOIN CTC.

Letters of Support

A letter of institutional commitment must be attached as part of Letters of Support. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program.

Resource Sharing Plans

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 Guide, with the following modification:

• 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. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

When relevant, applications are expected to include a software dissemination plan if support for development, maintenance, or enhancement of software is requested in the application. There is no prescribed single license for software produced. However, the software dissemination plan should address, as appropriate, the following goals:

• Software source code should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories. Users should be permitted to modify the code and share their modifications with others.
• The terms of software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
• To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

Appendix

Only limited Appendix materials are allowed. Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information (Research Education Core)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials 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 a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

Delayed Onset Study

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

Technical Assistance Core

When preparing your application, use Component Type Tech Asst Core

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Technical Assistance Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Technical Assistance Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Technical Assistance Core)

Human Subjects:?Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals:?Answer only the Are Vertebrate Animals Used? question.

Project Narrative:?Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Technical Assistance Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Technical Assistance Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.???

Budget (Technical Assistance Core)

Applicants should specify a budget that outlines the anticipated number of courses, trainings, webinars, and toolkits developed each year and the estimated costs for developing these resources.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Technical Assistance Core)

Specific Aims:?Applicants should outline the types of technical assistance that will be provided to community-based organizations and other stakeholders supporting populations involved with the criminal-legal system as well as strategies for ensuring that stakeholders are aware of the availability of this technical assistance.

Research Strategy:?The Technical Assistance Core of the CTC will provide technical assistance to community-based organizations and other stakeholders supporting populations involved with the criminal legal system. The primary focus of this technical assistance is to assist with evaluation designs, research methods, and appropriate measures for entities seeking to conduct local research or program evaluation activities, as well as to establish researcher-practitioner partnerships to support such activities. Technical assistance may also involve collaboration with the Dissemination and Stakeholder Engagement Core in translating research to practice and sharing JCOIN translation products, materials, and resources to support the research and evaluation needs of local agencies.

As part of this section, applicants should provide a vision for this core and a detailed description of the types of technical assistance that will be provided and the capacity of project staff to provide this service. Examples of activities for the Technical Assistance Core include but are not limited to:

• Soliciting, managing and responding to on-demand requests from the field related to research and evaluation
• Developing and delivering courses, trainings, and webinars based on the needs from the field, including themes that emerge from on-demand requests (in collaboration with the Dissemination and Stakeholder Engagement Core)
• Creating tool kits for community-based organizations and other stakeholders to support their research and evaluation efforts
• Providing research support to practitioners applying for grants through the Rapid Response and Pilot Research Core
• Providing referrals to other existing JCOIN resources
• Outreach and coordination with other national technical assistance centers working at the intersection of substance use and criminal-legal systems (e.g., BJA’s COSSAP program, SAMHSA’s Addiction Technology Transfer Centers, the Opioid Response Network).

Applicants should also describe how they will disseminate their resources and should include a plan outlining how individuals in need of technical assistance will be informed about and take advantage of these resources.

Letters of Support: Include signed letters of support/agreement for any collaborative/cooperative arrangements, subcontracts, or consultants. For program activities to be conducted off site, i.e., at an institution other than the applicant institution, a letter of assurance or comparable documentation, signed by the collaborator as well as the off-site institutional officials, must be submitted with the application.

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:

• 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. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information

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

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) using ASSIST or other electronic submission systems. 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 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.

For information on how applications will be automatically assembled for review and funding consideration after submission, refer to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads 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.

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

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 or non-responsive will not be reviewed.

Applications must include annual milestones. Applications that fail to include annual milestones will be considered incomplete and will be withdrawn. Applications must include a PEDP submitted as Other Project Information as an attachment. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn before review.

Post Submission Materials

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.

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).

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

To what extent do the efforts described in the Plan for Enhancing Diverse Perspectives further the significance of the project?

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 CTC? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing criminal-legal 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 plans for governance and conflict resolution appropriate for the CTC? Does the applicant have experience overseeing selection and management of subawards, if needed?

To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives strengthen and enhance the expertise required for the project?

In addition, for applications involving clinical trials

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

Innovation

Does the application propose novel approaches for coordinating the research network the CTC will serve? Are the approaches novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of these approaches proposed?

To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives meaningfully contribute to innovation?

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 CTC 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 networks 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?

Specific to this NOFO:

• To what extent are the proposed strategies and processes for the Administrative Core appropriate for scientific administration, fiscal administration, procurement, property and personnel management, planning, budgeting etc.?
• How effective are the plans for maintaining an external-facing website, internal collaboration, and communication infrastructure; providing required logistical support; and executing progress monitoring across the JCOIN network as outlined in the NOFO?
• How will they establish and maintain effective communication and cooperation among the CTC cores? With the MAARC? With JCOIN Research Hubs? Across a network as a whole?
• How comprehensive is the plan for executing the Rapid Response and Pilot Research Core?
• To what extent does the plan provide a transparent process to ensure fairness in the awarding of the Rapid Response and Pilot Research Core funds?
• To what extent will the plan for stakeholder engagement ensure a wide, representative array of stakeholder groups?
• How comprehensive is the plan for disseminating and evaluating materials and trainings in the Dissemination and Stakeholder Engagement Core?
• To what extent will they be able to successfully recruit participants for the Research Education Core, both within and external to JCOIN?
• To what extent will the proposed Research Education Core result in an increase in the availability of well-trained researchers who can execute complex studies in justice settings and reach a broad group of trainees?
• How well will they be able to leverage other resources of the network to identify novel approaches to conducting pragmatic implementation studies in the Implementation and Translation Research Project Core?
• How rigorous is the proposed research study for Implementation and Translation Research Project Core?
• How effective is their plan to ensure that people in need of technical assistance will take advantage of the resources provided in the Technical Assistance Core?
• Are the timeline and milestones associated with the Plan for Enhancing Diverse Perspectives well-developed and feasible?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

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

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

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

Data Management and Statistical Analysis

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

Environment

Will the institutional environment in which the CTC 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 CTC proposed? Will the CTC benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

• To what extent will features of the environment described in the Plan for Enhancing Diverse Perspectives (e.g., collaborative arrangements, geographic diversity, institutional support) contribute to the success of the project?

In addition, for applications involving clinical trials

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

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

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

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

Additional Review Criteria - Overall

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

Study Timeline

Specific to applications involving clinical trials

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

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate 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

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable

Additional Review Considerations - Overall

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.

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)?

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) (e.g., 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.

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 NOFO. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

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

3. Anticipated Announcement and Award Dates

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

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

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: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the 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).

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.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS Assurance of Compliance form (HHS 690)) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

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

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.htmlandhttps://www.lep.gov.
• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/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.

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

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 45 CFR Part 75 and 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 Core Director(s) responsible for the integration and management of activities within the Coordination and Translation Center (CTC).
• Organizing a local Executive Committee for day-to-day management of the CTC, coordinating across all of the CTC components,
• Serving as a member of the Justice Community Overdose Innovation Network (JCOIN) Steering Committee (SC).
• Participating in the overall coordination of NIH research efforts in justice settings; 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.
• Data Management, Analysis, and Access: Data generated are the property of the award recipient . 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.
• Award 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 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’s C , and the PIs of all JCOIN network components in order to ensure proper conduct of the CTC.
• The NIH Project Scientist(s) will have one (1) vote on the’s C , 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 CTC, along with the other entities delineated above, to ensure that activities and services are properly conducted and completed in a timely fashion; (2) providing advice and guidance to ensure that the CTC runs in accordance with NIH policies and procedures, and is consistent with the mission of the NIH to improve public health; (3) serving as a point of contact for investigators with the NIH; and (4) communicating with Center leadership to ensure that the CTC operates smoothly.
• 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 reviews and approves the research agenda, develops and monitors policies and procedures guiding the research activities, and oversees communications. 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 CTC must be prepared to share their data under provisions that safeguard the privacy and confidentiality of respondents. Thus, the CTC proposal should include explicit indications of how they will make their data available for broad use and on what timetable. The CTC will provide for data sharing 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 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 recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the’s C 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

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the 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. If additional Data Management and Sharing requirements need to be added, please insert what requirements are desired.

HEAL Data Sharing Requirements

NIH intends to maximize the impact of HEAL Initiative-supported projects through broad and rapid data sharing. All HEAL Initiative award recipients, regardless of the amount of direct costs requested for any one year, are required to comply with the HEAL Public Access and Data Sharing Policy. HEAL award recipients must following all requirements and timelines developed through the HEAL Initiative Data Ecosystem (https://heal.nih.gov/about/heal-data-ecosystem), as described in HEAL’s compliance guidance (See Already Funded section: https://heal.nih.gov/data/complying-heal-data-sharing-policy):
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1. Select a HEAL Compliant data repository (https://www.healdatafair.org/resources/guidance/selection)

• Data generated by HEAL Initiative-funded projects must be submitted to study-appropriate, HEAL-compliant, data repositories to ensure the data is accessible via the HEAL Initiative Data Ecosystem.
• Some repositories require use of specific data dictionaries or structured data elements, so knowing your repository’s requirements up front can help reduce the burden of preparing data for submission.
• HEAL-funded recipients must follow requirements for selected repository

2. Within one year of award, register your study with the HEAL platform (https://heal.github.io/platform-documentation/study-registration/)

• This process will connect the Platform to information about your study and data, including metadata, and identify the selected repository. HEAL requests initial submission within one year of award, with annual updates, and to be updated in accordance with any release of study data.

3. Within one year of award, submit HEAL-specific study-level metadata.

• Some of the required study-level metadata (https://github.com/HEAL/heal-metadata-schemas/blob/main/for-investigators-how-to/study-level-metadata-fields/study-metadata-schema-for-humans.pdf) will be auto-populated as part of the registration process.
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4. Submit data and metadata (and code, if applicable) to HEAL-Compliant repository

• At the completion of the study and/or when prepared to make the final data deposits in the repositor(ies) of choice, ensure your study registration (https://heal.github.io/platform-documentation/study-registration/) is complete.
• The NIH HEAL Initiative expects data used in publications to be submitted to repositories at the time of or prior to publication, and no later than the end of the project period.

5. Additional Requirements for HEAL Initiative studies conducting clinical research or research involving human subjects.

These studies must meet the following additional requirements:

• HEAL Initiative trials that are required to register in clinicaltrials.gov should reference support from and inclusion in the HEAL Initiative by including the standardized terms the HEAL Initiative (https://heal.nih.gov/) in the Study Description Section.
• All new HEAL clinical pain studies are required to use core questionnaires required by the HEAL Clinical Data Elements (CDE) Program (https://heal.nih.gov/data/common-data-elements). Outside of the core questionnaires, studies should select questionnaires from among the repository of supplemental questionnaires that are already being used by other HEAL clinical pain studies. The program has created the CDE files containing standardized variable names, responses, coding, and other information for all of these questionnaires The program has also formatted the case-report forms in a standardized way that is compliant with accessibility standards under Section 508 of the Rehabilitation Act of 1973 (29 U.S.C 794 (d); https://www.govinfo.gov/content/pkg/USCODE-2011-title29/html/USCODE-2011-title29-chap16-subchapV-sec794d.htm) which require[s] Federal agencies to make their electronic and information technology accessible to people with disabilities.
• Studies that wish to use questionnaires not already included in the HEAL CDE repository should consult with their program official and the HEAL CDE team. New questionnaires will be considered for inclusion in the repository on a case-by-case basis and only when appropriate justification is provided.
• HEAL Initiative clinical studies that are using copyrighted questionaries are required to obtain licenses for use prior to initiating data collection. Licenses must be shared with the HEAL CDE team and the program officer prior to use of copyrighted materials. For additional information, visit the HEAL CDE Program (https://heal.nih.gov/data/common-data-elements).
• 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.
• To the extent possible, HEAL recipients are expected to integrate broad data sharing consent language into their informed consent forms.

Additional details, resources, and tools to assist with data related activities can be found at https://www.healdatafair.org/.

All data collected as part of the NIH HEAL Initiative are so collected under a Certificate of Confidentiality and entitled to the protections thereof. Institutions who receive Data and/or Materials from this award for performance of activities under this award are required to use the Data and/or Materials only as outlined by the NIH HEAL Initiative, in a manner that is consistent with applicable state and federal laws and regulations, including any informed consent requirements and the terms of the institution’s NIH funding, including NOT-OD-17-109 and 42 U.S.C. 241(d). Failure to adhere to this criterion may result in enforcement actions.

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. Awardees will provide updates at least annually on implementation of the PEDP.

Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.

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 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. 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 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 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 (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 75and 2 CFR Part 200 Award Term and Condition 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: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075

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

Julia Zur, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-2261
Email:julia.zur@nih.gov

Valerie Maholmes, PhD, CAS
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-1514
Email: maholmev@mail.nih.gov

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

Ericka Wells
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-6705
Email: Wellse2@nida.nih.gov

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

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 45 CFR Part 75 and 2 CFR Part 200.