Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

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

National Institute on Drug Abuse (NIDA)

National Institute of Mental Health (NIMH)

Funding Opportunity Title
Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) Scientific Leadership Center (UM2 Clinical Trial Optional)
Activity Code

UM2 Program Project or Center with Complex Structure Cooperative Agreement

Announcement Type
New
Related Notices

NOT-OD-22-018 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available

NOT-OD-21-181 - Updates to the Non-Discrimination Legal Requirements for NIH Recipients

NOT-OD-21-169 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022

NOT-OD-21-170 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements

NOT-OD-21-109 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel

Funding Opportunity Announcement (FOA) Number
RFA-HD-23-020
Companion Funding Opportunity
RFA-HD-23-021 , UM2 Program Project or Center with Complex Structure Cooperative Agreement
Assistance Listing Number(s)
93.865, 93.279, 93.242
Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites applications to participate in a research program cooperative agreement to support the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN). The Network will have the capacity to develop and conduct innovative behavioral, community-based, translational, therapeutic, microbicide and vaccine trials in youth ages 13-24 years at-risk for HIV and living with HIV, with a focus on the inclusion of minors. Investigators with innovative approaches to address the public health issues facing adolescents are encouraged to apply.

Key Dates

Posted Date
December 01, 2021
Open Date (Earliest Submission Date)
February 28, 2022
Letter of Intent Due Date(s)

December 1, 2021

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
Not Applicable Not Applicable March 31, 2022 July 2022 October 2022 December 2022

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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

Expiration Date
April 01, 2022
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

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

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



  3. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

This Funding Opportunity Announcement (FOA) invites applications to participate in a research program cooperative agreement to support the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN). The Network will have the capacity to develop and conduct innovative behavioral, community-based, translational, therapeutic, microbicide and vaccine trials in youth ages 13-24 years at-risk for HIV and living with HIV, with a focus on the inclusion of minors. Investigators with innovative approaches to address the public health issues facing adolescents are encouraged to apply.

This Initiative calls for a cooperative, multi-component project grant with focused interventional studies, conducted collaboratively and independently, aimed at the reduction of new HIV infections among at-risk youth and improvements in numbers across the HIV care continuum among adolescents and young adults living with HIV who are medically underserved, of low socio-economic status, sexual and gender minority (lesbian, gay, bisexual, and transgender populations, as well as those whose sexual orientation, gender identity and expressions, or reproductive development varies from traditional, societal, cultural, or physiological norms), and/or racial/ethnic minority constituency including African-American, American Indian, Alaska Native, Asian, Native Hawaiian or other Pacific Islander, Hispanic, and/or substance abusing youth. Research projects will target highly impacted geographic regions and leverage cross-sector collaborations with community and public health authorities, and Federal agencies.

Research studies must focus on all five high priority topic areas that aim to address substantial and disproportionate gaps in health outcomes across the HIV prevention and care continuum for youth:

Priority Areas

  1. Undiagnosed HIV infection
  • Evaluation of novel approaches & strategies to increase knowledge of HIV status and early diagnosis in youth living with HIV, and facilitate durable linkage to care (e.g. phylogenetic sequencing; leveraging bioinformatics, machine learning and artificial intelligence (AI) and electronic health record connections between health departments and clinics/hospitals; social/sexual networks, new self-testing platforms, etc.), HIV risk reduction tools, services and interventions that are delivered by health care providers, especially for hard-to-reach youth populations (e.g., youth who use drugs, youth with mental health conditions), including the capacity to engage and deliver services to youth outside of clinical settings. Strategies should facilitate inclusion of minors.
  1. Persistent new HIV infections
  • Evaluation of safety, PK/PD, acceptability, usability, and desirability of novel HIV biomedical products, including long-acting formulations and alternative delivery systems (e.g. injectables, implantables, transdermal, and multipurpose prevention technologies (MPTs)), to prevent HIV infection that align and maintain pace with youth and provider demands at the local level.
  • Interventions which are provider, health facility/systems-based and telehealth-friendly, that improve uptake and use of efficacious biomedical prevention products and which leverage cross-sector collaborations, including collaborations with settings that are outside of clinical sites.
  • Integrated approaches to addressing HIV risk, including incident STIs (e.g. multipurpose prevention technologies), and persistence (long-term adherence) to efficacious biomedical prevention products, including delivery outside of infectious disease specialty settings.
  • Evaluation of multi-level interventions and strategies developed for HIV prevention and retention in care, including community engagement and youth participation/input.
  1. Poor HIV care engagement
  • Evaluation of novel interventions and strategies to improve engagement in HIV care (e.g. same day ART) leveraging cross-sector collaborations, including primary care and venues outside of medical center settings.
  • Evaluation of multi-level interventions and strategies, including those leveraging collaborations with community and public health authorities and data tracking systems, to improve engagement and long-term consistent retention in HIV care which minimize drop-out and re-engagement cycles that lead to interruptions in treatment and poor health outcomes.
  • Evaluation of individual and health-systems strategies, of evidence informed interventions that target co-occurring transitions involving medical care to facilitate health-seeking behaviors and enhance/facilitation transition to and/or retention in adult clinic settings.
  1. Poor ART adherence and viral suppression
  • Evaluation of safety, PK/PD, acceptability, usability and desirability of novel HIV biomedical products, including long-acting formulations and delivery systems, to treat HIV infection that strategically align and maintain pace with youth and provider demands.
  • Evaluation of integrated treatment approaches to HIV infection and its therapy, which address substance use and mental health issues, including depression, trauma, PTSD, stigma and violence designed to improve adherence and viral suppression.
  • Evaluation of novel strategies to predict non-adherence and poor viral response using health bioinformatics, digital health platforms and AI to target and optimize multi-level adherence interventions.
  • Evaluation of novel approaches to promoting and sustaining ART adherence among youth who are not consistently engaged with health care and reimbursement systems.
  1. Adverse HIV health outcomes from COVID-19
  • Evaluations of safety and effectiveness of COVID-19 biomedical prevention modalities among youth living with HIV.
  • Assessment of multilevel interventions addressing poor HIV health outcomes and related health disparities exacerbated by COVID-19, including increased barriers to access to and engagement in care.

Structure of the Network

The ATN is newly composed of a Scientific Leadership Center (SLC) and an Operations and Collaborations Center (OCC) (see companion RFA-HD-22-016) which will work collaboratively to achieve the mission of the ATN. Each will be funded through an independently-solicited FOA and each will contribute essential functions necessary to support a large-scale, complex clinical research program. While the emphasis of each network is on clinical trials, clinical research studies that are not NIH-defined clinical trials are also in scope when undertaken to support the program. For the purpose of this FOA, the term "clinical study" refers to both clinical trials and clinical research studies, and "clinical trial" is used to refer to clinical trials only.

In this new structure, the SLC consists of multiple interdependent functional components and research activities and will be responsible for the overall scientific leadership and governance of the network and its activities. The SLC consists of the ATN Scientific Leadership Group (ASLG) in developing and refining the research agenda, convening working groups as needed, prioritizing emerging research projects, efficiently managing the development of clinical protocols, implementing and completing clinical trials and ensuring timely publication and communication of results. The ASLG will provide the necessary multidisciplinary expertise to set, prioritize and manage the ATN scientific agenda. It will draw on the statistical and data management leadership and coordination expertise of the Statistical and Data Management Core (SDMC) to design and implement Research Projects proposed for this FOA and future research to address emerging scientific priorities during the project cycle. The ATN research agenda will ensure capacity for rapid response to evolving scientific priorities through recurring competitive open solicitations. These solicitations will be developed and published by the ASLG in collaboration with NIH project scientists and supported by the coordination and operational infrastructure of the Operations and Collaboration Center (OCC), which will 1) receive and convene reviews for applications, 2) coordinate and support application prioritization by the ASLG, and 3) implement funded meritorious research through OCC supported Site Consortiums. Finally, the Research Projects will be conducted through the site consortia’s multidisciplinary, cross-sectoral collaborative relationships with various participant recruitment venues in their communities (e.g. academic, clinic, health department, community-based organizations, online, social media and other virtual health platforms, etc.).

  • ATN Executive Committee (EC)

The ATN Executive Committee (EC) will have representation from the SLC, the ATN OCC PD(s)/PI(s), NIH ICs, and other selected scientific experts. Additionally, a community representative will bring an added layer of community participation and engagement in the research agenda. The ATN EC will oversee the integration of efforts across the Network though leadership, efficient communication, coordination and scientific collaboration across the multiple participating research institutions, as well as close interaction with NIH program staff members. Furthermore, the ATN EC will oversee the network and SLC with identifying emergent scientific priorities and will govern the implementation of research studies and funding decisions, with assistance from the ATN OCC. It will also help develop and facilitate collaborations with other networks and investigators. In consultation with NIH scientists, the EC will also consult with an External Scientific Panel (ESP), as needed.

  • Single Institutional Review Board (sIRB)

In order to reduce the burden on local IRBs, to streamline the protocol approval process, and to standardize the oversight of human subjects’ protection in the ATN Studies, the use of a single IRB is required (see NOT-OD-16-094 and NOT-OD-20-058).

  • External Scientific Panel (ESP)

An Independent External Advisory Group (ESP) will be convened by the ATN EC with assistance from the ATN OCC and in consultation with the SLC, as needed, to review the scientific progress and activities of the Network, as well as for other collaborations with the Network, with the goal of maintaining the highest level of scientific progress and relevance of proposed and ongoing projects. The ESP may recommend new directions as appropriate. Members will have the scientific expertise but not be affiliated with components of the Network. The ESP will meet yearly at an ATN Meeting coordinated by the ATN OCC. Following these meetings, the ESP will make recommendations in writing regarding scientific progress and activities of the Network to the NIH and the ATN Executive Committee (EC).

Essential Features of the ATN Scientific Leadership Center

SLC Project Director(s)/Principal Investigator(s) and Component Parts

SLC PD(s)/PI(s)

The SLC PD(s)/PI(s) should be established investigator(s) with a record of scholarly achievements and publications, demonstrated leadership and administrative capabilities, and a proven track record designing and leading multidisciplinary research projects that may include formative basic and clinical research. They will be responsible for the projects and cores within the SLC and for communication, collaboration and coordination with the ATN OCC. The SLC PD/PI(s) will participate and collaborate with the Research Project leads, SDMC lead(s), and others within the SLC to discuss, develop plans for and assist the ATN EC in guiding the Network in implementing scientific and administrative decisions. They should demonstrate a track record of proactive community engagement in development of research activities and ensure that the Research Projects proposed will be informed by ongoing input.

ATN Scientific Leadership Group (ASLG)

The Scientific Leadership Group is the component that provides the necessary scientific leadership and support for the ATN. The SLC PD(s)/PI(s) is responsible for assembling the necessary multidisciplinary team of established investigators from within and outside of the PI’s home institute to participate in the Core and to set the research agenda for the network, and clearly outline the priority areas, plans, processes, and timelines for achieving the implementation of the proposed agenda. The proposed research agenda should address the full spectrum of trials included in the purpose for establishing the ATN. The ASLG establishes and maintains collaborative relationships with other research networks in order to implement the full research agenda. The ASLG should include investigators who are experienced with service delivery outside of medical center or clinic settings, as well as experience with enrolling and maintaining minors in care.

Statistical and Data Management Core (SDMC)

The SDMC will be responsible for the statistical and data management leadership and coordination critical to the ATN. Strong data management and statistical leadership and expertise, and robust, flexible data management systems that support a large number of clinical studies are essential. The SDMC will play a central role in harmonizing statistical and data management activities (including the collection of common data elements) across studies and clinical trials networks, both to allow cross-study data analyses and to maximize the efficiency with which studies can be developed and implemented. The SDMC provides the network in-depth understanding of statistical and epidemiological theory, and broad practical experience in the design and analysis of clinical trials. The SDMC collaborates and coordinates with the ASLG and OCC to support the research priority areas of the network through development, implementation, and sharing the results of clinical studies. The SDMC provides leadership, services and systems for clinical and laboratory data collection and management required for complete, high-quality data, and leadership and services for biostatistical analysis, study design, analysis, interpretation and publication of results, including innovative statistical methods.

The Statistical and Data Management Core provides scientific and analytic resource availability and supervision. The SDMC is responsible for the integrity of study design and statistical analysis for all clinical studies. The SDMC is responsible for compliance with all applicable federal regulatory standards and international guidelines that apply to studies conducted under an Investigational New Drug or Device Exemption (IND/IDE). The SDMC has a central role in standardizing and harmonizing data management and statistical activities within the network and coordinating with other NIH-sponsored programs. Other SDMC responsibilities for governance include:

  • Supporting the overall management, integration and coordination of all SDMC activities with the SLC and OCC.
  • Aligning SDMC priorities with the network research agenda as coordinated by the SLC.
  • Tracking and reporting protocol status data using project management software to allow transparent network and NICHD resource planning and real-time communication and adjustment.
  • Promoting mentorship and involvement of early-stage investigators and under-represented minorities in SDMC activities.

Study Design, Data Analysis, Data Reporting

The SDMC provides leadership and expertise for protocol selection and development, informing experimental study designs, and providing statistical advice concerning issues such as approach, power, sample size, and impact of interim analyses. The biostatisticians support early-phase and late-phase, multi-institutional clinical trials including integral and integrated biomarker/correlative science studies. When needed, the SDMC develops new applications of statistical or information science theory.

  • For each protocol the SDMC has the primary role in the performance of analyses including interim analyses, analysis in support of Safety Monitoring Committees (SMCs), Data Safety Monitoring Boards (DSMBs), final statistical analyses, and preparing information for ClinicalTrials.gov results reporting requirements. (Submission of the information to ClinicalTrials.gov will depend on the entity that is the responsible party.)
  • The SDMC has a central role in data analysis for preparation of abstracts, journal articles, scientific presentations, Clinical Study Reports, and Annual Reports.
  • The SDMC provides capacity to conduct ad hoc analyses, including analyses on datasets not generated by the network when requested by NICHD and IC partners.

Statistical and Data Management Core (SDMC) Lead(s)

The SDMC will provide comprehensive data management and data analyses for network clinical studies in compliance with regulatory standards. The SDMC will provide leadership and services for biostatistics, study design, analysis, interpretation and publication of results, including innovative statistical methods, along with state-of-the-art clinical trial management systems and laboratory information management systems to ensure complete, high-quality data.

Research Project Components

Each Research Project should be designed as an NIH-defined clinical trial and contribute to the specific goals and objectives of the Network by addressing all priority research areas, either individually or in combination, Each project should contribute expertise and/or resources toward the aims of the Network, include plans for data sharing as appropriate, and emphasize collaboration across all components of the ATN in order to meet the objectives of the FOA.

Each Research Project should contain the scientific vision which anticipates the ongoing evolution of the field and an emerging scientific agenda by briefly addressing the current state of knowledge on adolescent HIV prevention and care, the significant scientific gaps and opportunities, and the research, tools and resources needed to progress toward the reduction of new infections and improvement of health outcomes in HIV-infected youth. The vision will lead to strategies to achieve the scientific goals, and the processes/approaches implemented to design, prioritize and conduct an emerging scientific agenda, including high priority studies generated from the ATN Network or in collaboration with other networks, agencies and other outside sources.

Research Project Lead(s)

The Research Project Lead(s) should be experienced investigators from backgrounds in a variety of disciplines/specialties, at varying career levels, with or without prior ATN experience, with a track record of PHS supported research with youth, and will participate and collaborate with the SLC PD(s)/PI(s) to discuss and help guide the administration and science of the network. They will also participate and collaborate in the execution of pertinent clinical trial protocols and will be expected to collaborate productively within and outside of the ATN so that new scientific information may be freely exchanged and can be effectively applied by others.

All Senior/Key Personnel (PD(s)/PI(s), Research Project Lead(s) and Core Lead(s) should contribute to, and share in, fulfilling the program objectives, through regular meetings.

Partnerships

A key component of this initiative is the formation of partnerships between academia and the community to facilitate the design and implementation of novel, innovative interventions that leverage new and existing relationships (e.g. academic-based clinical and research sites, and community based organizations, public health authorities and other private organizations providing services to youth at risk for and infected by HIV) to optimize impact on the epidemic. The SLC will be strongly encouraged to collaborate with other NIH-supported networks and other Federal and private sector clinical research programs, and to interact with government, non-government and community organizations (including the private and non-profit sector), to effectively develop and implement a clinically relevant, comprehensive, interdisciplinary and cost-efficient research agenda. Such a collaborative research agenda should utilize the strengths, experience and expertise of the various collaborating organizations. The sharing of expertise, resources and procedures is expected in key areas, including: harmonization of laboratory resources and specimen management; harmonization of common data elements and data entry interfaces; experience with youth including delivery of services outside of traditional clinical settings; community engagement, including development, training and support of community advisory boards. In addition, the SLC is expected to ensure maximal use of the specimens collected during the course of NIH-supported clinical studies by providing guidelines and processes for use during the conduct of the study and by coordinating access to the scientific research community after the study is completed.

Non-responsive Applications

  • Applications not including partnerships/collaborations with community entities on the research proposed will be considered non-responsive and will not be reviewed.

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

Section II. Award Information

Funding Instrument

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

Application Types Allowed
New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

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

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NICHD and partner components intend to commit an estimated total of $11M to fund 1 award.

Award Budget

Budgets up to $6.875M direct costs per year may be requested.

Award Project Period

Project period is 7 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

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

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

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

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed. 

Required Registrations

Applicant organizations

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

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement 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:

Sonia Lee, PhD
Telephone: 301-594-4873
Email: Sonia.Lee@nih.gov

Page Limitations

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

Component Component Type for Submission Page Limit Required/Optional Minimum Maximum
Overall Overall 12 Required 1 1
Scientific Leadership Group Core Sci Ldrshp Grp Core 12 Required 1 1
Statistical and Data Management Core Stat-Data Mgmt Core 12 Required 1 1
Research Project Research Project 12 Required 5 8

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 your 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.

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 FOA) for the entire application.

The SLC PD(s)/PI(s)

  • should be established investigator(s) with a record of scholarly achievements and publications, demonstrated leadership and administrative capabilities, a proven track record designing and leading multidisciplinary research projects that may include formative basic and clinical research;
  • will be responsible for the research projects and cores within the SLC and for communication, collaboration and coordination with the OCC;
  • will participate and collaborate with the Research Project leads, Core leads and others within the Network to discuss, develop plans for and assist the ATN EC in guiding the Network in implementing scientific and administrative decisions;
  • should demonstrate a track record of proactive community engagement in development of research activities and provide plans to ensure that the Research Projects proposed will be informed by ongoing community input and to conduct ongoing monitoring for impact the research may have on the community.

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.

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)

Specific Aims: List and describe the scientific aims of the Scientific Leadership Center for the ATN.

Research Strategy:

Describe the goals and objectives, background information and the overall importance of the SLC. Explain the strategy for achieving the goals defined for the overall program and how the ASLG, SDMC and each Research Project relate to that strategy. Explain how the different aspects of the organization, including key personnel, will coordinate and communicate, why they are essential to accomplishing the overall goal of the research. Explain the strategy for facilitating efficient communication, coordination of organizational efforts and scientific collaboration across multiple research projects potentially spanning multiple research institutions. Include all necessary tables, graphs, figures, diagrams and charts in this section. In addition, provide the following information:

Purpose, and Objectives of the Program

Discuss the overall SLC program's objectives and general plans for the proposed project period, including relevant research experience that contribute to the objectives of the Program.

Administration, Organization, and Operation

Describe organizational framework and provide an organizational chart. In addition, the following elements should be included:

  • Plans to support Research Projects to enhance the research objectives of the Network
  • Describe the approach to governance of the SLC, including establishment of decision-making committees and their composition, roles, responsibilities and decision-making authorities.
  • Describe the processes for high-level scientific and administrative decision for the network, including research prioritization, reassessment, and redirection, including specific information about key contributors.
  • Describe the approach to coordinating the functions of the SLC (including the ASLG and SDMC) and plans for coordinating with the OCC.
  • A plan for adherence to a network operations manual for staff training, quality assurance procedures, the operation and integrity of the ATN study databases including remote data capture capacity and study development

Research Program

Discuss the proposed research program.

Demonstrate how partnerships between academia and the community have influenced and will continue to facilitate the design and implementation of novel, innovative interventions that leverage new and existing relationships (e.g. academic-based clinical and research sites, and community based organizations, public health authorities and other private organizations providing services to youth at risk for and living with HIV) to optimize impact on the epidemic. Also provide plans for the establishment of performance-based subcontracting where appropriate.

The following elements should be included in an application:

An overview should explain the scientific vision which anticipates the ongoing evolution of the field and an emerging scientific agenda by briefly addressing the current state of knowledge on adolescent HIV prevention and care, the significant scientific gaps and opportunities, and the research, tools and resources needed to progress toward the reduction of new diagnoses and improvement of health outcomes in youth living with HIV. Studies will target highly impacted geography and leverage cross-sector collaborations with community and public health authorities, and Federal agencies, and must focus on all five high priority topic areas that aim to address substantial and disproportionate gaps in health outcomes across the HIV prevention and care continuum for youth.

Letters of Support: Include letters of support/agreement for any collaborative/cooperative arrangements, subcontracts, or consultants. Letters of support for the SLC should be included with the Overall Component. Letters of support for the ASLG, the SDMC, and the individual Research Projects should be included with those components of the application. 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.

NICHD Plans for Sharing Human and Non-Human Data and/or Biospecimens

NICHD requires that data, biospecimens, and results of NICHD-funded research will be shared with the wider scientific community to the extent feasible and in a timely manner. NIH Data Sharing Policy expects the timely release and sharing of data to be no later than the acceptance for publication of the main findings from the final dataset. All NICHD applications, regardless of the amount of direct costs requested for any one year, are expected to include a Sharing Plan that addresses sharing of data as well as biospecimens, if applicable. Ideally, this plan would include submitting data or biospecimens to an appropriate repository. These plans will also be considered by program staff as award decisions are being made as appropriate and consistent with achieving the goals of the program.

Specifically, for human data, the NICHD encourages the use of the Data and Specimen Hub (DASH), a centralized resource for researchers to store and access de-identified data from studies funded by NICHD. They can also submit information about the location and availability of biospecimens to DASH, if applicable. Submission of data to the NICHD DASH is one way that grantees may meet the requirements of the NIH Data Sharing Policy and make study data available for secondary analyses. Information about DASH may be obtained at https://dash.nichd.nih.gov/.

If use of DASH is not feasible, NICHD expects awardees to share data and/or biospecimens through other equivalent broad-sharing data and/or biospecimen repositories. For projects generating large-scale human genetic data, applicants should provide a Provisional or Institutional Certification specifying whether the individual-level data can be shared through an NIH approved repository, such as dbGaP, in line with the NIH Genomic Data Sharing Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html).

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.

Scientific Leadership Group Core

When preparing your application, use Component Type ‘Sci Ldrshp Grp Core.’

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

SF424 (R&R) Cover (Scientific Leadership Group 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 (Scientific Leadership Group Core)

Enter Human Embryonic Stem Cells in each relevant component.

 

Research & Related Other Project Information (Scientific Leadership Group 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) (Scientific Leadership Group 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 (Scientific Leadership Group 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 (Scientific Leadership Group 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.

PHS 398 Research Plan (Scientific Leadership Group Core)

 

Specific Aims: List and describe the scientific aims of the Scientific Leadership Group Core.

Research Strategy: The ATN Scientific Leadership Group Core provides the necessary scientific leadership and support for the ATN. The SLC PD(s)/PI(s) is responsible for assembling the necessary multidisciplinary team of established investigators from within and outside of the PI’s home institution to participate in the Core and to set the research agenda for the network and clearly outline the priority areas, plans, processes, and timelines for achieving the implementation of the proposed agenda. The proposed research agenda should address the full spectrum of trials included in the Purpose of Section I for establishing the ATN. The ASLG establishes and maintains collaborative relationships with other research networks in order to implement the full research agenda.

The Research Strategy for the ASLG should include a description of:

  • Governance: Integral to the success of the network is establishing clear governance structures, including effective communication and decision-making plans lines of authority, plans for coordinating and collaborating effectively with external collaborators, as well as with NICHD and IC partners, and the Executive Committee.
  • Research Agenda: The ASLG articulates the network’s scientific agenda, establishes a framework for the initial studies, and plans for future studies. A research agenda is the broad strategic plan to address the stated research priority areas. The ASLG is expected to actively engage researchers and communities within and outside of the network in establishing and refining the research agenda. The ASLG will also work closely with NIH Program Staff to ensure that the research remains aligned with NICHD and partner IC’s research priorities. The Core Leads of the SLC are responsible for assembling the necessary multidisciplinary team of established and junior investigators from within and outside of the PI’s home institute to participate in the ASLG and to set the research agenda for the network, and clearly outline the priority areas, plans, processes, and timelines for achieving the implementation of the proposed agenda. Include a plan and process for developing new protocols for use within the Network as the science continues to evolve.
  • Working Groups: The ASLG may convene additional scientific working groups (e.g., focused on substance use, mental health, or data harmonization) or subcommittees that may expand and contract as the scientific needs of the network evolve to ensure that the ATN research objectives and scope will be achieved.
  • Oversight of Research Projects: Initially, the ASLG will oversee 5-8 R01-like Research Projects. All research projects should directly focus on the research priorities delineated above, including primary prevention and/or continuum of care among adolescents in the US. The research Network will be facilitated by the sharing of ideas, data, and specialized resources, and must include a sufficient number of scientifically meritorious Research Projects.

Letters of Support: Include letters of support/agreement for the ATN SLG.

Resource Sharing Plan:

Not Applicable; a Resource Sharing Plan is only required 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 (Scientific Leadership Group 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.

 

Statistical and Data Management Core

When preparing your application in ASSIST, use Component Type ‘Stat-Data Mgmt Core’.

SF424(R&R) Cover (Statistical and Data Management 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 (Statistical and Data Management Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Statistical and Data Management 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) (Statistical and Data Management 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 (Statistical and Data Management Core)

  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project 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.

Each application must include a Statistical and Data Management Core headed by a Core Lead(s) with experience in modern analytic methods. The Core Lead(s) may also be the PD(s)/PI(s) of the application. The Core Lead(s) is responsible for ensuring that shared scientific and analytic resources/facilities are available and utilized to the maximum extent possible and that procedures are developed to ensure that such resources are available to members of the research team in a timely manner.

The Lead(s) of the Core is responsible for working with the research team to assemble all methodological and analytical expertise necessary, including in bioinformatics for advanced digital health systems, machine learning and predictive technologies like artificial intelligence, and to evaluate their scientific progress.

Budget (Statistical and Data Management 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.

PHS 398 Research Plan (Statistical and Data Management Core)

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

Specific Aims: Describe the scientific aims, objectives and functions of the Statistical and Data Management Core.

Research Strategy:

Provide the following information:

  • Objectives of the Statistical and Data Management Core
  • Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the SDMC.
  • Administration: Coordination of Program components, problem identification and resolution, prioritization of resources, and the establishment of a strong collaborative environment for the Program. The SDMC will provide analytic capacity and will promote coordination and collaboration within the program and with investigators and organizations within the Network as well as outside the program.
  • Provide a general overview of the SDMC and describe the general features and operations of the SDMC. Based upon the two primary functions of the SDMC, (1) data collection, quality and integrity, and (2) biostatistical leadership: provide a diagram illustrating the organizational structure of the SDMC. Discuss how the structure promotes effective leadership of data management and statistical functions and integration with site consortiums. Tables, diagrams, flow charts and organizational charts are strongly recommended.
  • Staffing: Structure of the core, roles of SDMC leader and core staff, and lines of authority within the core. Discuss how the proposed structure and the individual strengths of the key personnel will facilitate designing and implementing statistical analyses and the development, validation and utilization of data systems designed to support research.
  • Broadly describe data management, information technology (IT) and statistical analysis systems.
  • Broadly describe the IT support for central storage, security, analysis and retrieval of clinical data.
  • Describe the approach to project management needed to plan, balance, track, manage and report protocol activities in a timely manner.
  • Resources: Description of how SDMC resources will contribute to the objectives of the Research Projects.This section of the application should present a clear picture of the facilities, techniques, and skills that the core will provide.
  • Services provided: Description of the services that will be provided to the Research Projects, including general plans for collaborations.Plans for the identification and assembly of the necessary analytic capacity, including experts who have demonstrated the development and application of innovative and cutting-edge methodologies and statistical analytics.
  • The Research Strategy should describe the planning and coordination of research activities, the integration of cross-disciplinary research, allocation of funds, management of resources and quality control, the maintenance of ongoing communication, and plans for evaluation by the ATN Executive Committee.Indicate who will be responsible for each of these activities.
  • Describe how the sharing of expertise, resources, and procedures will be encouraged, including the harmonization of common data elements and data entry interfaces.
  • Provide plans for statistical and data management mentoring opportunities and involvement of early-stage investigators, under-represented minorities, and investigators from resource-limited settings.
  • Include tables or organizational charts for the Core, if appropriate.

Letters of Support: Include letters of support specific to the SDMC.

Resource Sharing Plan:

Not Applicable; a Resource Sharing Plan is only required in the Overall Component.

Appendix:

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

PHS Human Subjects and Clinical Trials Information (Statistical and Data Management Core)

When involving human subjects research, clinical research, and/or NIH-definedclinical 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.

 

Research Projects

When preparing your application, use Component Type ‘Research Project.’

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

SF424 (R&R) Cover (Research Projects)

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 (Research Projects)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Projects)

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) (Research Projects)

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 (Research Projects)

  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project 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.

The Research Project Lead(s)

  • should be experienced investigators from backgrounds in a variety of disciplines/specialties, at varying career levels, with or without prior ATN experience, with a track record of PHS supported research
  • will participate and collaborate with the SLC PD(s)/PI(s) to discuss and help guide the administration and science
  • will work with SLC PD(s)/PI(s) to proactively engage the community in development of proposed research projects and in their implementation
  • will work with the OCC PD(s)/PI(s) to ensure participant recruitment
  • will be expected to collaborate productively within and outside of the ATN so that new scientific information may be freely exchanged and can be effectively applied by others
  • should demonstrate a capacity to ensure subject recruitment and retention based on demonstrated prior site experience and performance

Budget (Research Projects)

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.

 

PHS 398 Research Plan (Research Projects)

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

Clinical trials will target highly impacted geography and leverage cross-sector collaborations with community and public health authorities, and Federal agencies and must focus on all five high priority topic areas (delineated above) that aim to address substantial and disproportionate gaps in health outcomes across the HIV prevention and care continuum for youth.

Specific Aims: Provide the Specific Aims for the Research Project.

Research Strategy: Following the instructions in the SF424 (R&R) Application Guide, start each section with the appropriate section heading—Significance, Innovation, Approach. Cite published experimental details and provide the full reference in the Bibliography and References Cited section.

Clearly describe the Research Project, including the project's objectives, and explain its relevance and contribution to the overall Network. Discuss the significance of the work proposed and its scientific contribution to HIV primary prevention and/or the continuum of care among adolescents in the US. Such plans must include a clearly articulated and justified developmental timeline with milestones and contingency plans for anticipated challenges. As part of the Research Strategy, include information on preliminary studies and/or data pertinent to this application.

Describe the Research Project's use of the SDMC, including why the services are needed and the advantages and cost effectiveness of the SDMC for the Project. Describe how community engagement will help inform the work proposed and ongoing activities. Describe the Research Project’s anticipated use of the Site Consortiums in the OCC.

Letters of Support: Provide letters of support specific to the Research Project.

Resource Sharing Plan:

Not Applicable; a Resource Sharing Plan is only required in the Overall Component.

Appendix:

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

PHS Human Subjects and Clinical Trials Information (Research Projects)

When involving human subjects research, clinical research, and/or NIH-definedclinical 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.

 

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 Policy on Late Application Submission.

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

For information on how your application will be automatically assembled for review and funding consideration after submission go 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 fieldof the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). 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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

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

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

 

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

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

For this particular announcement, note the following:

Peer review of NICHD Cooperative Program Project applications focuses on three areas: (1) review of the UM2 Program Project as an integrated Network and collaboration of Cores and Projects, and the overall scientific and technical merit of the program; (2) review of the individual Cores; and (3) review of the individual Research Projects.

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

Overall Impact - Overall

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 - Overall

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

In addition, for applications involving clinical trials

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

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Specific to this FOA:

Do the PD/PI(s) and other key personnel have documented experience in directing clinical research projects of comparable size and scope required to address the objectives and scope of the network? Do they demonstrate appropriate expertise in protocol design, regulatory compliance, study implementation and coordination? Does the application identify investigators and staff experienced with operations for large multisite trials? Does/Do the PD(s)/PI(s) plan to devote sufficient effort to perform his/her role(s)? Is there experience with health care or public health research, including collaboration with non-clinical settings and community collaborators?

In addition, for applications involving clinical trials

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

Innovation

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

In addition, for applications involving clinical trials

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

Approach

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

Do the research plans demonstrate material and intellectual contribution to the specific goals and objectives of the SLC, as well as the overall Network, contribute expertise and/or resources toward the aims of the SLC, demonstrate an explicit and detailed plan for data sharing as appropriate, and emphasize collaboration across the ATN with the ATN OCC?

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?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

In addition, for applications involving clinical trials

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

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

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

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

Additional Review Criteria - 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 Animal Section.

Biohazards

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

Resubmissions

Not applicable

Renewals

Not applicable

Revisions

Not applicable

Additional Review Considerations - 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.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Sharing Model Organisms; and (2) Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

Review Criteria for Scientific Leadership Group Core

For this component, reviewers will provide an assessment of its strengths and weaknesses. In particular, the following items should be evaluated while determining scientific and technical merit, and in providing an Impact Score for the Core. However, separate criterion scores will not be given for these items.

  • Is there an appropriate and clear organizational structure for the ASLG?
  • Are there adequate lines of authority and strong, feasible governance plans for the ASLG?
  • Are the proposed members qualifications adequate? Is there experience with health care or public health research with youth, including collaboration with non-clinical settings and community collaborations?
  • Are plans for the identification and assembly of the members, including experts who have demonstrated the development and application of innovative and cutting-edge expertise to the field of HIV research, appropriate?
  • Are the ASLG members' contribution to the objectives of the Research Projects adequate?
  • Have coordination of the Network’s components, problem identification and resolution, prioritization of resources, and the establishment of a strong collaborative environment for the Network been addressed adequately?

Review Criteria for Statistical and Data Management Core

For this component, reviewers will provide an assessment of its strengths and weaknesses. In particular, the following items should be evaluated while determining scientific and technical merit, and in providing an Impact Score for the Core. However, separate criterion scores will not be given for these items.

  • Is theorganizational structure for the SDMC clear and appropriate?
  • Are the lines of authority adequate and are the governance plans for the SDMC strong and feasible?
  • Are the plans and procedures for providing data management services required by the network, including database design, security, confidentiality and administration, participant randomization/registration, data collection, quality control, data retrieval, report generation, and site training strong and feasible?
  • Are the plans for continuous refinement of the data management infrastructure and approaches appropriate?
  • Does the application demonstrate evidence of collaboration and experience in harmonizing processes to allow data analyses and approaches beyond individual trials?

Review Criteria for Research Projects

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

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?

Innovation

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

In addition, for applications involving clinical trials

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

Approach

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

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

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable?

Study Design

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

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

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

Data Management and Statistical Analysis

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

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

In addition, for applications involving clinical trials

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

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

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

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

2. Review and Selection Process

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

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

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

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the 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 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 theNIH 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 FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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

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

Institutional Review Board or Independent Ethics Committee Approval: 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).

Prior Approval of Pilot Projects

Awardee-selected projects that involve clinical trials or studies involving greater than minimal risk to human subjects require prior approval by NIH prior to initiation.

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: Generaland Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

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

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

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

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

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

Cooperative Agreement Terms and Conditions of Award

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

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

The structure of this cooperative agreement encourages interaction between NIH staff and investigators and among investigators leading to more robust and innovative research methods and strategies with clinical trials that enroll and retain vulnerable adolescent/young adult populations living with HIV or at high risk for HIV. Substantive and ongoing day-to-day scientific and administrative involvement of the NICHD and co-funding IC (NIMH, NIDA, OAR) Project Scientists will assist the investigators in developing the scientific agenda, refining study protocols, monitoring the progress of the clinical research and participant safety, and coordinating the activities of the Network. The cooperative agreement mechanism will also serve to facilitate cross-Network and multi-agency Collaborations (e.g., HHS “Ending the HIV Epidemic in the US”), including necessary co-endorsement of several research protocols and other efforts to ensure adolescents are prioritized in behavioral and biomedical clinical trials.

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

ATN Scientific Leadership Center

The ATN SLC consists of the Principal Investigator(s), Project Director(s), and supporting staff. The duties of the PD(s)/PI(s) include, but are not limited to, the following:

  • Provide administrative and scientific leadership expertise for the Center and to specific Research Projects, and collaboratively engage Research Project leads as well as any other independent investigators (e.g. at subject recruitment venues; at institutions external to ATN, etc.) to implement a scientific agenda that is feasible and appropriate for ATN youth;
  • Implement all ATN-approved study protocols, where feasible, in coordination with the OCC, the recruitment and monitoring of study participants, associated data collection, and study-associated quality control measures at the clinical site including but not limited to identifying local CLIA-certified laboratory support in facilities participating in NIAID-supported quality assurance programs when indicated; these activities may be coordinated by the site(s) study coordinator(s) at the direction of the Principal Investigator;
  • Obtain Institutional Review Board (IRB) approval of all ATN study protocols implemented locally and comply with both IRB and ATN policies and procedures;
  • Collaborate and coordinate, as necessary, across the Network and with the ATN OCC to implement Research Projects of relevance and significance to the ATN mission across the US;
  • Participate and collaborate with the other Research Project Lead(s), ASLG, SDMC and others to discuss, develop plans for and assist in guiding the Network in implementing scientific and administrative decisions;
  • Identify, with the assistance of the NICHD staff, as well as the ATN OCC, resources within the Network to support subject recruitment, enrollment, retention, data collection, specimen shipping, and negotiated protocol monitoring costs for ATN-approved protocols and recommend to NICHD the use of funds for such support;
  • The PD(s)/PI(s) with the assistance of Research Project Leads collaborates with the ATN OCC which will ensure expedient and safe subject recruitment based on demonstrated prior site experience and performance, as appropriate; promptly adheres to recommendations of EC and NIH to address performance insufficiencies.
  • The PD(s)/PI(s) with the assistance of Research Project Leaders should ensure appropriate community engagement to inform development and implementation of research activities, and should implement any planned monitoring for potential impact of the research projects on the community;
  • Establish and support Data and Safety Monitoring Board (DSMB) when instructed by NICHD, in conjunction with the SDMC;
  • Participate in resource management decisions and scientific leadership of the network along with the ATN OCC PD(s)/PI(s), and NIH ICs on the ATN Executive Committee (EC);
  • Provide counsel and guidance to the ATN Executive Committee through its elected representatives on the feasibility of proposed research, implementation strategies, and subsequent data collection as well as further inform perceived gaps in the ATN agenda;
  • Participate in regular conference calls and attend ATN EC meetings to be held at least semi-annually;
  • Ensure optimal dissemination of research results by expedient data analysis and key publications within 1 year of study completion and implement explicit data sharing policy for public use thereafter;
  • The PD(s)/PI(s) is responsible for the timely presentation/publication of work supported in part or in whole by this Cooperative Agreement.Prior notification of the NICHD regarding any presentations or publications and appropriate acknowledgement of NICHD support are required.

ATN Scientific Leadership Group (ASLG)

The ASLG will provide the necessary scientific leadership and support for the ATN. The SLC PD(s)/PI(s) is responsible for assembling the necessary multidisciplinary team of established investigators from within and outside of the PI’s home institute to participate in the ASLG and to set the research agenda for the network, and clearly outline the priority areas, plans, processes, and timelines for achieving the implementation of the proposed agenda. The proposed research agenda should address the full spectrum of trials included in the purpose for establishing the ATN. The ASLG establishes and maintains collaborative relationships with other research networks in order to implement the full research agenda.

Specifically, the ASLG will:

  • Draft, review and maintain all current ATN-wide policies and procedures in the ATN Manual of General Operations; any ATN Executive Committee-approved and NICHD-acceptable revisions of the Manual during the project period of these awards will supersede the provisions of these specified terms of award;
  • Implement and enforce, either directly or through delegation to other ATN-supported personnel, a Conflict of Interest (COI) Policy acceptable to the Maternal and Pediatric Infectious Disease Branch, NICHD, that addresses any COI that may occur or may be perceived to occur through financial interest or other associations between members of the ATN and the private sector to ensure compliance with all Federal regulations and NIH policies applying to the conduct of research involving human subjects (these include, but are not limited to, Title 42 CFR 50 and Title 45 CFR 46). NICHD notes that the primary regulatory authority for enforcement of the COI Policy belongs to the grantee institution and NICHD does not intend by this term of award to abrogate that responsibility. Rather, NICHD is imposing on the ATN an additional responsibility to protect the integrity of the research produced by the ATN. Therefore, if either the ASLG or the grantee institution identifies a real or perceived COI, both the ASLG and the grantee institution must address the COI and inform NICHD of the resulting action;
  • Work to adopt and, if necessary, revise the current ATN policies and procedures for elected terms of office and voting procedures, protocol development and review, authorship and publication, collaboration, site and, where indicated, laboratory monitoring, repository requirements, and related issues and review these for approval;
  • Work with the ATN OCC PD(s)/PI(s) and NIH Project Scientists to identify the most efficient and scientifically sound mechanisms for developing the research agenda as needs emerge during the project cycle, deciding if the specific agenda items are best pursued independently in the ATN, given resources, implement high priority protocols in collaboration with existing research networks;
  • Evaluate all ATN-sponsored research studies from the previous project period for the ethics, feasibility, and utility of their continuation.

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

NIH Project Scientists will represent each of the institutes co-sponsoring the FOA.

The NIH Project Scientists will:

  • Facilitate the exchange of information between the ATN and other existing research networks to support collaborative efforts;
  • Participate in the ATN EC that oversees the establishment, maintenance and collaborative scientific efforts of the ATN and its progress in achieving program goals;
  • Assist the ATN EC in monitoring the progress of ongoing studies, including field data collection, standardization of methods across study sites, and adherence to protocol and quality control measures;
  • Assist the ATN EC in the selection of research topics, and the development or review of protocols for specific studies and interventions;
  • Assist the ATN EC in identifying ATN resources required for the successful implementation of collaboratively developed research protocols;
  • Arrange Program and/or peer review of all new ATN protocols developed during the project cycle and, when necessary, the external peer review of the protocols, clearing these studies for implementation;
  • Assist in data analyses, interpretation, and publication of study results;
  • Assist in identifying the need to terminate or curtail the study (or an individual award) in the event of nonparticipation in the committee/group activities, substantial shortfall in participant recruitment, follow-up, data reporting, quality control, or other major breach of protocol, or substantive protocol changes without prior approval from NIH Program or the ATN Executive Committee.

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

The duties of the agency Program Official include:

  • Carry out continuous review of all activities to ensure that the objectives are being met and that all regulatory, fiscal, and administrative matters are handled according to NIH guidelines.
  • Have the option to withhold support to a participating institution if technical performance requirements are not met.
  • Perform other duties required for normal program stewardship of grants.

Areas of Joint Responsibility include:

ATN Executive Committee (EC)

The ATN EC will consist of the PD(s)/PI(s) from the SLC, the PD(s)/PI(s) from the ATN OCC, the NIH project scientists and other selected scientific experts as agreed to by the EC. Additionally, a community representative will bring an added layer of community participation and engagement in the research agenda. The ATN EC will oversee the integration of efforts through leadership, efficient communication, coordination and scientific collaboration across the multiple participating research institutions, as well as close interaction with NIH program staff members. The ATN EC will have the primary responsibility for identifying emerging scientific priorities, defining the other collaboration research agenda, and implementing these in the network, and initiating and maintaining collaboration with other NIH-funded HIV-related research networks within the guidelines of this FOA. The EC will retain custody of and have primary rights to the data and software developed under such collaborations, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

Each full member will have one vote. Each NIH IC project scientist will also have one vote.

Recipientmembers of the ATN Executive Committee will be required to accept and implement policies approved by the ATN Executive Committee.

Specifically, the EC will:

  • Assist the ASLG in the identification of adolescent HIV/AIDS research objectives;
  • Approve the direction of the research effort including any reconfiguration of working groups to better address the direction of the scientific agenda;
  • Approve the ATN policies and procedures adopted, revised, or developed by the ASLG;
  • Critically evaluate and approve the research agenda specific to its scientific merit, feasibility, clinical relevance, and implications as well as advise on the development of implementation strategies;
  • Establish timelines for the completion of tasks and monitor progress;
  • Execute all Memoranda of Understanding or Agreement with other entities to conduct ATN developed or co-endorsed research;
  • Coordinate ATN collaboration with investigators with funding from sources other than NIH-funded networks;
  • Be responsible for the fiscal management and tracking of all network resources, either directly or through establishment of a specific subcommittee tasked with this function in an iterative and continuous manner, through a collaborative effort with the ATN OCC;
  • Approve use of discretionary funds as recommended by NIH;
  • Develop a formal liaison with leaders of other appropriate HHS-supported HIV prevention and clinical trial networks to facilitate early interaction and communication in protocol design that address key questions in the adolescent population;
  • Develop formal communication and liaison with existing HHS-supported prevention and clinical trials networks to inform the ATN leadership on protocols of interest; to define and resolve key logistical issues (e.g. data collection and transfer, drug repository and regulatory requirements; negotiate shared study costs;) which must be addressed to facilitate adolescent enrollment in collaboratively developed research protocols;
  • Supervise progress, with the assistance of the NICHD staff, in identifying resources within the ATN to support subject recruitment, enrollment, retention, data collection, specimen shipping, and negotiated protocol monitoring costs for ATN-approved protocols and in recommending to NICHD the use of funds for such support;
  • Participate in regular conference calls and attend ATN meetings to be held at least semi-annually.

For other collaborations, and high priority protocols responding to emerging needs, the EC will:

  • Retain the primary responsibility for defining and prioritizing the research agenda in collaboration with the NIH Project Scientists;
  • Approve the direction of the research effort including any reconfiguration of research subgroups or working groups to better address the direction of the scientific agenda, and oversee the conduct and monitoring of the studies;
  • Interact, coordinate, and, where indicated, contract with immunology and virology laboratories participating or willing to participate in NIH-supported quality assurance programs in order to provide the ATN with necessary laboratory support for independent ATN studies;
  • Take responsibility for optimizing the Network’s collaboration through the overall scientific merit of components of the research agenda;
  • Negotiate any ATN rights to data and authorship with executive bodies of collaborating networks and external investigators;

Dispute Resolution:

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

3. Reporting

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

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

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over 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 75.113and 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.

Application Submission Contacts

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

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

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

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

Scientific/Research Contact(s)

Sonia Lee, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-594-4783
Email: LeeSonia@mail.nih.gov

Richard A Jenkins
National Institute On Drug Abuse (NIDA)
Phone: 301-443-6504
E-mail: jenkinsri@mail.nih.gov

Susannah Allison, PhD
National Institute of Mental Health (NIMH)
Telephone: 240-627-3861
Email: allisonsu@mail.nih.gov


Peer Review Contact(s)

Sherry Dupere, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-451-3415
Email: duperes@mail.nih.gov

Financial/Grants Management Contact(s)

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

Pamela G Fleming
National Institute On Drug Abuse (NIDA)
Phone: 301-480-1159
E-mail: pfleming@mail.nih.gov

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email: siscor@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

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

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