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.

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from 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

The US cannot end the HIV epidemic without attending to the risks and service needs of individuals involved with the criminal-legal system. Populations identified in the federal Ending the HIV Epidemic Initiative (EHE) are over-represented in the criminal-legal system, although the initiative does not specifically address justice-related settings. These over-represented populations include people who inject drugs, as well as key populations when drug use often contributes to sexual risks such as sex workers and members of sexual and gender minorities. NIDA has a long and productive history of conducting research on addiction services in justice settings. At the same time, a robust toolkit of clinical interventions to diagnose, treat, and prevent HIV exists (see CDC Compendium), but more research is needed to address significant service delivery gaps at all points of the HIV care cascade, particularly for justice-involved populations.

Network Structure and Objectives

Three interrelated Notices of Funding Opportunities (NOFOs) will collectively support a research network focused on addressing the need for integrated HIV and substance use disorder (SUD) services in justice-involved populations: RFA-DA-24-015 seeks multiple Regional Research Hubs (RRHs); RFA-DA-24-023 will support one Data Coordination and Dissemination Center (DCDC); and RFA-DA-24-022 will support one Patient Engagement Resource Center (PERC). Collectively, this HIV/Justice Research Network will focus on developing scalable models for delivering HIV diagnostic, prevention and treatment services for individuals with substance use disorders (not limited to opioid use disorders) who are involved in the criminal-legal system, including both adults and juveniles, whether within carceral settings (jails and prisons); under community supervision (probation and parole); or at earlier intercept points (e.g., diversion, deflection, courts). Intervention approaches to address HIV should be focused on the EHE strategies (diagnose, treat, prevent, respond), as appropriate to the needs of the population and study design. The Data Coordination and Dissemination Center will facilitate collaboration among the Research Hubs and ensure translation and dissemination of study findings and related resources to key audiences best positioned to influence practice change. The PERC will directly engage persons with lived experience in HIV, SUD, and the criminal-legal system and ensure that patient perspectives are broadly represented across the entirety of the network’s activities.

Patient Engagement Resource Center: Scope of Activities and Purpose

This NOFO invites applications to provide research resource support for the HIV/Justice Research Network. This NOFO will support the development of a single U24 PERC that will effectively engage patients (including prospective patients, families of individuals with SUD, and persons in recovery) in meaningful dialogue to inform the design and interpretation of research trials that reflect patients’ needs, preferences and priorities. The PERC will embrace a user-centered design approach to identify and articulate patient perspectives on HIV/SUD treatment, with a particular focus on challenges related to continuity of care in the transition between incarceration and the community.

There are many challenges to delivering timely, effective, equitable, affordable treatment for HIV and SUD to individuals involved in the criminal-legal system, both during the detention period and in transition back to the community. Much of the services research to address these challenges has focused on increasing the availability of services, e.g., by encouraging clinicians and programs to offer a full array of evidence-based practices. Yet patient-level barriers remain unaddressed. A better understanding of patients’ perceptions, preferences, and practical challenges could inform the redesign of both research and practice. Research studies that ask and answer questions of high salience and priority for patients could both lead to the development of more desirable interventions and increase trust in science. Various structures have been tested in other areas of healthcare to effectively engage patients in an advisory capacity to inform research studies. This NOFO seeks to adapt and apply a similar model to address the additional complexities encountered by individuals with HIV/SUD who are transitioning between criminal-legal and community settings.

The PERC will engage and provide research training support for a patient advisory panel who will serve in a consultative role in support of the RRHs. The PERC will connect members of the patient advisory panel with funded RRH teams to review and provide meaningful input into the design, interpretation, and dissemination of trials and pilot studies. The overarching goal is to test a model of meaningful patient engagement in research that can yield more relevant and actionable results.

The project will also conduct original research with patients and closely related stakeholders to identify salient and high-priority issues that prevent patients from finding and receiving evidence-based HIV and SUD prevention and treatment services, particularly during the transition from carceral settings to the community. The PERC will also conduct pilot tests of potential patient-identified solutions to these issues.

Scope

The PERC will have three primary functions:

A. Form a patient advisory panel for the HIV/Justice Research Network

Recruit and engage an advisory panel of not less than 12 persons with lived experience in HIV, SUD, and incarceration. The PERC advisory panel should include a broadly representative group of individuals that span demographic and socioeconomic groups and geographic areas.

Each RRH is likely to have its own stakeholder board, consultants, or other advisory group tailored to its particular region, segment(s) of the criminal-legal system, and research question. PERC panel members will serve in an advisory or consultant capacity intended to supplement and complement existing RRH advisors. The PERC advisory panel is intended to bring a broader and more diverse set of perspectives reflecting the larger patient community, with the goal of ensuring the research questions are broadly relevant to patients and potentially scalable beyond any individual study. It is also intended to take a holistic view across the HIV/Justice Research Network’s entire portfolio, considering common or complementary themes across studies and identifying priority gap areas for future research.

During the first 2 years of the award, and as needed thereafter, the PERC will provide training and educational experiences to build panel participants’ knowledge about the research process, enhancing their capacity to engage meaningfully as consultants on RRH projects and to formulate patient-centered research questions that may become the basis for RRH or PERC pilot projects. Where practicable, educational modules, recordings, or other resources developed for this training activity should be made available to patient communities outside of the PERC project to promote broader public familiarity with and trust in research.

In Years 2-5 of the award, the PERC will establish a process and structured opportunities for the patient advisory panel to engage in bi-directional discussions with all RRHs about their R61 findings, planned collaborative pilot projects, and R33 plans and results, including, for example, allowing for meaningful input on research questions and outcome measures that are relevant and important to patients; recommendations to enhance participant recruitment; and consultation on dissemination messages and strategies to effectively communicate study results to affected patient populations. Design of this process should be flexible to match the composition and needs of the RRHs – e.g., PD(s)/PI(s) leading individual projects may meet with the entire panel, or smaller teams of panel members could be paired with thematic groups of projects, etc. Likewise, RRHs may present their entire project for comment, or bring a specific set of issues/questions to the panel for input. The final design of this process should occur post-award with the direct involvement of the PERC advisory panel members.

During Years 2-5, where feasible and of mutual benefit, the PERC should identify opportunities for individual PERC advisory panel members to be more deeply engaged in an RRH study as a member of the research team or as a paid consultant for a discrete activity. This involvement could be with an R61 project or as part of a collaborative pilot study. It is not an expectation that every advisory panel member would be matched with an RRH study, nor that every RRH would be a suitable match for one of the advisory panel members.

B. Conduct research to document patient experiences and identify potential solutions

As a separate activity, conduct qualitative, survey, or other research with patients and others impacted by HIV/SUD/criminal-legal involvement relevant to prevention or treatment service delivery. The term “patients” in this context includes current, former, and potential patients in HIV or SUD care who also have past or present criminal-legal involvement. One or more studies, or a study with multiple phases or elements, may be proposed. The purpose of this research is to better understand – in a nuanced and actionable fashion – how patients do or do not perceive, understand, and access available services; structural and other barriers to treatment access/service utilization; the perceived acceptability/feasibility of available evidence-based practices for HIV/SUD; perspectives on preferable or ideal services (i.e., user-centered design approach to service delivery); and issues related to stigma and misinformation. This research should be designed to broadly inform the development of more effective education and/or dissemination strategies that would help prospective patients and their families understand and access treatment options, and/or to inform providers/payers about patient barriers and preferences.

Participants in these studies should include current or recent patients or participants in HIV/SUD prevention or treatment services, and individuals with current or recent criminal-legal involvement. Inclusion may be extended to family members and service providers, so long as the primary focus is on understanding patient experiences and barriers to care from the patient perspective. Where appropriate and of mutual benefit, PERC advisory panel members (described in A above) may be engaged in the design, execution, and analysis of these studies, but the advisory panel should not be the primary pool of subjects for the studies.

C. Conduct pilot research projects

Informed by data gathered in the patient experience studies described in B above, applicants should  propose to conduct at least two pilot studies to test strategies to address issues raised by patients. These may include tests of dissemination strategies, educational modules, misinformation correction, alternative service delivery processes/structures (e.g., outreach or intake protocols), or other approaches. A concept for at least one study should be briefly outlined in the application. Where appropriate and of mutual benefit, PERC advisory panel members may be engaged in the design, execution, and analysis of these pilot studies.

Network Participation: The PERC PD(s)/PI(s) will be expected to participate in monthly steering committee or workgroup calls with the RRH investigators and the DCDC. Network activities will also include regular workgroups and one annual (two-day) in-person meeting for the Network, in the Washington DC area. The PERC will collaborate as outlined herein with other members of the network. All participants in the Network will have opportunities to collaborate on activities stemming from emergent, shared priorities.

Plan for Enhancing Diverse Perspectives (PEDP). This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP) as part of the application (see further below). Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material. Applications must include a Plan for Enhancing Diverse Perspectives (PEDP) submitted as Other Project Information as an attachment (see Section IV). 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.

Pre-Application Consultation. Potential applicants are strongly encouraged to contact Scientific/Research staff listed in Section VII to discuss potential projects prior to submission of an application.

Special Considerations

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

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 Government

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

Other

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

Non-domestic (non-U.S.) Entities (Foreign 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 Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

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

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

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

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

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

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

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

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

The letter of intent should be sent to: [email protected]

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this NOFO.

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

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

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

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

In the biosketches, highlight the experience of the PD(s)/PI(s) in engaging with patients and others directly affected by HIV, SUD, and criminal-legal involvement. Describe the roles of PD(s)/PI(s) and describe how they are suited to those roles given their experience and training, especially that related to engaging patients with lived experience, and research education for non-scientists. 

R&R Budget

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

Network Meetings:

Applicants should budget costs associated with travel to annual in-person meetings for up to two team members. Assume these will be 2-day meetings that will take place in or around Bethesda, Maryland.?

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).

R&R Subaward Budget

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

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

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

Research Strategy:

At minimum, use subheadings within the Research Strategy for each of the three major parts of the proposed work: PERC Advisory Panel, Research on Patient Experiences, and Pilot Research Projects.  

Applicants must describe an overall plan for supporting a patient advisory panel and facilitating interactions with funded RRHs. This must include a proposed approach to identifying, recruiting, and selecting not less than 12 individuals to serve on the PERC patient advisory panel. Outline how these plans will consider representation of persons with lived experience in HIV and/or SUD and/or criminal-legal involvement. (All three groups must be represented, but each individual patient advisory panel member need not have all three forms of lived experience.) Outline how the plans will consider diversity in members' sociodemographic and geographic characteristics. It is not required that any or all of the panel members be recruited at the time of application, but provide a clear plan along with evidence of the applicants’ ability to successfully engage community members in analogous roles.

Applicants must describe a plan for providing appropriate training/education and ongoing mentoring of panel participants as needed to support their intended role as research project consultants. Describe specific plans and the team's prior experience in supporting research education activities; these may include, for example, coursework, mentoring, hands-on research experience (“shadowing”), etc., and an introduction to key features of studies likely to be proposed under this initiative. Describe how panel members will gain a basic understanding of research ethics, study designs, common data collection methods used in HIV/SUD health services research, and special considerations for conducting research in criminal-legal systems or with individuals who are incarcerated or under community supervision. Use of existing courses, webinars, and online resources is encouraged. Also describe a plan for ongoing mentoring of the panelists and continuous evaluation of the program. Where practical, the PERC is encouraged to share any educational resources (webinars, courses, etc.) with the RRHs' community advisory board members who may benefit from them.

Applicants must describe a proposed structure for the PERC patient advisory panel to engage in bi-directional discussions with the RRHs throughout Years 2-5 of the award, including examples of consultation scenarios. Because the Hub projects will be unknown at the time of application, provide flexible plans to adapt as needed to best fit the set of funded awards. Outline plans to consult with the Hubs, the Data Coordination and Dissemination Center (DCDC), and the NIDA Science Officer on the final structure and process for implementing this consultation model. Plan for each Hub project to have at least annual contact with the PERC advisory board. These meetings may be held virtually. The PERC will work with the DCDC when determining scheduling and logistics.

Applicants must describe a process for identifying opportunities for individual PERC advisory panel members to be more deeply engaged in an RRH study as a member of the research team or as a paid consultant for a discrete activity during Years 2-5.  Address potential selection criteria including an assessment of mutual benefit to both the PERC advisor and the RRH team. Compensation for that work will be paid by the PERC, unless other mutually beneficial arrangements are made with a specific Hub. Given common institutional hiring barriers for individuals with active SUD or prior incarceration histories, describe feasible, ethical, and equitable plans for compensating PERC advisors for this work.

Describe a fair process for recruiting, engaging, compensating, and training/supervising PERC advisory committee members, and for facilitating their engagement with the Hubs. Also describe a process for evaluating the success of the PERC advisory panel program, including its impact on the panelists, projects, and products.

Applicants must describe plans to conduct original research with patients and others impacted by HIV/SUD/criminal-legal involvement relevant to their access and utilization of prevention or treatment services, barriers, and preferences for alternative options. Research may include qualitative interviews, surveys, or other approaches but be designed to allow for a nuanced understanding of patient perspectives.

Applicants must propose to conduct at least two pilot studies to test strategies to address issues raised by patients in the research described above. These may include tests of dissemination strategies, educational modules, misinformation correction, alternative service delivery processes/structures (e.g., outreach or intake protocols), or other approaches. Include a brief outline of one potential study to demonstrate applicants’ vision for these projects and their capacity for executing them. The proposed study is likely to change post-award in response to input from stakeholders and the NIDA Science Officer. Propose and budget these as delayed onset studies on the PHS Human Subjects and Clinical Trials Information form; the investigator may not proceed without the approval of the NIDA Program Official.

Multiple PD/PI Leadership Plan:  For applications proposing multiple PDs/PIs, describe the PDs/PIs’ complementary and integrated experience and skills to lead the proposed PERC. 

Letters of Support: For those patient advisory panel members who have been identified and agreed to participate at the time of application (if any), include letters of support from those individuals and a description of their planned participation in the project. Also include letters of support from other relevant stakeholders, including consultants, who will facilitate one or more aims of the proposed project 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. 

Other Plan(s):

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

All instructions in the 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.

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

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

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.

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

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.

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.

For this particular announcement, note the following:

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

Overall Impact

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

Scored Review Criteria

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

Significance

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

In addition, for applications involving clinical trials

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

Specific to this NOFO:

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

Investigator(s)

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

In addition, for applications involving clinical trials

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

Specific to this NOFO:

How adequate is/are the PD(s)/PI(s) demonstrated experience engaging with patients and others directly affected by HIV, SUD, and criminal legal involvement? How appropriate is the team's skill and capacity to provide adequate research education training and ongoing mentoring to support the patient advisory panel?

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

Innovation

Does the application propose novel management strategies in coordinating the research projects the Resource Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of management strategies proposed?

In addition, for applications involving clinical trials

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

Specific to this NOFO:

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

Approach

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

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

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

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

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

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

Data Management and Statistical Analysis

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

Specific to this NOFO:

How well-conceived is the proposed approach to recruiting, engaging, training, and supervising patient advisory panel members? How well does the proposed approach to identifying, recruiting, and selecting the members of the PERC advisory panel as a whole consider representation of persons with lived experience in HIV and/or SUD and/or criminal-legal involvement? How well-reasoned are the strategies to ensure broad representation across demographic and geographic characteristics? How well considered are the ethical issues required to protect PERC panel members and research participants?

How well-conceived is the proposed approach for connecting individual patient advisory panel members with RRCs in ongoing consulting/partnership roles? How appropriate are the proposed plans to ensure fairness in making these opportunities available, providing compensation, as well as training or supervision to ensure that these partnerships are mutually beneficial?

How meaningful an impact will the proposed patient advisory panel have on the Regional Research Hub projects? How well considered are mutual benefits to the RRHs and the patient advisors?

How adequate and appropriate are the plans to coordinate with the Regional Research Hubs and the Data Coordination and Dissemination Center??

How adequate is the proposed process for ongoing evaluation of the success of the advisory panel program, including its impact on the participants as well as the RRH projects?

How likely is it that the proposed research projects will be able to solicit participation from patients/families that will lead to a nuanced understanding of patient experiences and barriers to engaging in care?

Are the timeline and milestones associated with the Plan for Enhancing Diverse Perspectives well-developed and feasible?

Environment

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

In addition, for applications involving clinical trials

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

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

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

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

Specific to this NOFO:

To what extent 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?

Additional Review Criteria

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

Study Timeline

Specific to applications involving clinical trials

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

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

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

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

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

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

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

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

Recipients must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

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

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

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

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

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

2. Administrative and National Policy Requirements

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

• Federal wide Research Terms and Conditions
• 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 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.”

Cooperative Agreement Terms and Conditions of Award

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

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the 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 award recipient(s) 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 recipient(s) for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

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

The PD(s)/PI(s) of the HIV/Justice Patient Engagement Resource Center (PERC) in consultation with the NIH Project Scientist will support a patient advisory panel to serve in a consultative role in support of the Regional Research Hubs (RRHs). The PERC will connect members of the patient advisory panel with funded RRH teams to review and provide meaningful input into the design, interpretation, and dissemination of their trials and pilot studies. The PD(s)/PI(s) of the PERC will collaborate with the HIV/Justice Data Coordination and Dissemination Center as appropriate to ensure efficient communication among these elements, and provide coordinated and non-duplicative support to the research projects. Each RRH acts independently to accomplish its research goals.

• The PD(s)/PI(s) agrees to accept close coordination, cooperation, and participation of NIH staff in those aspects of scientific and technical management of the PERC as stated in these terms and conditions.
• The PD(s)/PI(s) of the PERC will have the primary responsibility to establish a process and structured opportunities for the patient advisory panel to engage in bi-directional discussions with the RRHs about their projects (R61 and R33 phases), including opportunities for the panel to advise on research questions, recruitment, measures, dissemination, and other topics of mutual interest.
• The PD(s)/PI(s) of the PERC will have the primary responsibility to establish a process and equitable opportunities for individual PERC advisory panel members to engage as part of an RRH research team, either in the R33 project or as part of a collaborative pilot study, and ensure fair and appropriate compensation for that work.
• The PD(s)/PI(s) will have the primary responsibility for conducting research to document patient experiences and identify potential solutions to address the treatment gap, and for planning and executing two or more pilot research studies building on this work.
• The PD(s)/PI(s) of the PERC will ensure ongoing coordination with the Data Coordination and Dissemination Center to ensure coordinated, timely, and non-duplicative communication with the Regional Research Hubs.
• The PD(s)/PI(s) of the PERC will serve as a representative on the Network's Executive Committee (EC) along with representatives from the Regional Research Hubs and the Data Coordination and Dissemination Center. The purpose of the EC is to provide overall coordination of research activities and to promote collaboration across funded projects. Appropriate representatives from the PERC will be expected to participate in recurring workgroups formed by the Network if/as appropriate.
• Provide updates at least annually on implementation of the PEDP.
• 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 cooperative agreement will be assigned to one or more Project Scientists (PS). The PS will have substantial programmatic involvement that is above and beyond the normal stewardship role in the award and will be named in the award notice. The responsibilities of the PS include involvement during conduct of the activity, through technical assistance, advice, coordination, and/or other assistance activities that is above and beyond normal program stewardship for grants. The PS will participate in the definition of objectives and approaches used by the PERC in the development of the pilot research projects, coordination with the other HIV/Justice Network components, and connecting with other NIDA-funded programs in HIV and/or justice system research as appropriate.

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

The PD(s)/PI(s) and the PS will work closely in evaluating the most appropriate methods used to support the PERC advisory panel members, including broad exposure to the full range of research activities supported by the HIV/Justice Research Network, and other educational opportunities as appropriate. They will also jointly monitor and continuously assess the nature, quantity, quality, and mutual benefit of the patient advisory panelists’ collaboration with the Regional Research Hubs, and implement changes as necessary.

Given the nature of the activities of this award, where the PERC will work with multiple Regional Research Hubs each executing their own independent studies, it is recognized that timelines, activities, and interim objectives may require revision and renegotiation during the course of the project period. The PERC’s PD(s)/PI(s) and NIH Program Officer must agree to all such revisions.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three academic members who are not involved in the study will be convened. The first member will be named by the PERC PD/PI; the second will be named by NIH; and a third individual with relevant expertise will be named by the other two appointees. 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 DHHS 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.

4. Reporting

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

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 $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

Section VII. Agency Contacts

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

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

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

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

Lori Ducharme, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-6331
Email: [email protected]

Dharmendar Rathore, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-6965
Email: [email protected]

Carol Alderson
National Institute on Drug Abuse (NIDA)
Phone: 301-827-6685
Email: [email protected] 

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.