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)

Fogarty International Center (FIC)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Behavioral and Social Sciences Research (OBSSR)

Funding Opportunity Title
PATC3H Implementation Science Network (PATC3H-IN) Coordination, Translation and Advanced Methods and Analytics Center (UM2 Clinical Trial Optional)
Activity Code

UM2 Program Project or Center with Complex Structure Cooperative Agreement

Announcement Type
New
Related Notices
  • NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022
  • August 11, 2022 - Notice of Pre-Application Webinar for the Prevention and Treatment through a Comprehensive Care Continuum for HIV-affected Adolescents in Resource Constrained Settings Implementation Science Network (PATC³H-IN) Funding Opportunity Announcements. See Notice NOT-HD-22-041.

Funding Opportunity Announcement (FOA) Number
RFA-HD-23-014
Companion Funding Opportunity
RFA-HD-23-013 , UG1 Clinical Research Cooperative Agreements - Single Project
Assistance Listing Number(s)
93.865, 93.989, 93.279, 93.242
Funding Opportunity Purpose

This FOA invites applications to participate in a research program cooperative agreement to support the Prevention and Treatment through a Comprehensive Care Continuum for HIV-affected Adolescents in Resource Constrained Settings Implementation Science Network (PATC3H-IN). The Network will expand and/or improve successes achieved by PATC3H to new geographic settings with limited implementation science (IS) research capacity and/or risk populations who are poorly represented in international adolescent HIV research (e.g. sexual and gender minorities; commercial sex workers; drug users) and stimulate much needed IS research in a neglected area of public health significance: prevention of new HIV infections among adolescents at risk and the identification of, and linkage and retention to care of and long-term viral suppression among youth living with HIV in low-to-middle income countries (LMICs). These settings must have an HIV epidemic density defined by UNAIDS estimates as either a country 1) in which at least 200,000 people are living with HIV and the number has not decreased by more than 5% over the last 2 consecutive years of available data or 2) has an HIV incidence among youth ages 10 to 24 years of 0.01% or more.

The structure of PATC3H-IN shall consist of two highly integrated components - (1) Clinical Research Centers (CRC) (each center will propose a study to be executed in at least 5 research performance sites); and (2) a single Coordination, Translation and Advanced Methods and Analytics Center (CTAMAC).

This FOA solicits applications for a single Coordination, Translation and Advanced Methods and Analytics Center (CTAMAC). There is a parallel companion FOA that seeks applications for Clinical Research Centers (CRC) (RFA-HD-23-013).

Key Dates

Posted Date
July 22, 2022
Open Date (Earliest Submission Date)
November 06, 2022
Letter of Intent Due Date(s)

November 06, 2022

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 December 06, 2022 March 2023 May 2023 July 2023

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

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

Expiration Date
December 07, 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 Prevention and Treatment through a Comprehensive Care Continuum for HIV-affected Adolescents in Resource Constrained Settings Implementation Science Network (PATC3H-IN). The Network will expand and/or improve on successes achieved by its predecessor, PATC3H, to new geographic settings and/or risk populations and stimulate much needed implementation science (IS) research in a neglected area of public health significance: prevention of new HIV infections among adolescents at risk and the identification of, and linkage and retention to care of and long-term viral suppression among youth living with HIV in low-to-middle income countries (LMICs). These settings must have an HIV epidemic density defined by UNAIDS estimates as either a country 1) in which at least 200,000 people are living with HIV and the number has not decreased by more than 5% over the last 2 consecutive years of available data or 2) has an HIV incidence among youth ages 10 to 24 years of 0.01% or more.

Rates of successful achievement of milestones on the HIV prevention and/or HIV care continuum (PHCC) must be improved to address the youth HIV epidemic most effectively. This requires rigorous IS research, the most critically needed next step to optimally differentiating successful interventions to meet the needs of adolescents who typically experience challenges with adherence behaviors and adjusting to health systems not well adept with providing for their care. IS research is the study of methods to promote the integration of research findings and evidence into public health, clinical practice, and community settings. It seeks to understand the behavior of healthcare professionals and other stakeholders as a key variable in the sustainable uptake, adoption, and implementation of evidence-based interventions. PATC3H-IN will establish a network of investigators with expertise on the youth-specific PHCC and in IS research to evaluate promising prevention innovations contextually and developmentally tailored for HIV uninfected at-risk youth, and also treatment and care interventions for youth living with HIV which have demonstrated efficacy and/or effectiveness in adolescent or adult populations.

The Network will conduct coordinated scientific inquiry to (1) improve understanding of the process of integration of research findings and evidence into public health, clinical practice and community settings and elucidate how to sustain uptake, adoption, and implementation of evidence-based interventions for youth who are at risk for or living with HIV in LMICs; (2) increase the scientific capacity and knowledgebase for IS research on at-risk, uninfected adolescents and those living with HIV in new geographies with limited IS research capacity and risk populations who are poorly represented in international adolescent HIV research (e.g. sexual and gender minorities; commercial sex workers; drug users); and (3) translate findings to inform national and global guidelines on the clinical management of at-risk, uninfected adolescents and those living with HIV in these regions. It is expected that the critical collaborative relationships with policy makers and key stakeholders needed for these applications will also lay the foundation for large scale implementation and sustainability after the grant cycle is over.

This FOA solicits applications for a single Coordination, Translation and Advanced Methods and Analytics Center (CTAMAC) to be part of PATC3H-IN. There is a parallel companion FOA that seeks applications for Clinical Research Centers (CRC) (RFA-HD-23-013).

Background

Adolescents and young adults (AYA, 10-24 years old) represent over a quarter of the world’s population and 90% live in LMICs. The Joint United Nations Programme on HIV/AIDS (UNAIDS) estimated 3.9 million people aged 15-24 years old are living with HIV infection. Each day, approximately 1,600 AYA acquire HIV infection and approximately 144 AYA die from an AIDS-related illness. The increasing number of youth coming of age in the next 20 years in LMICs underlines the urgency of HIV prevention and treatment in this demographic group.

Over the past decade, the HIV research arena has experienced numerous triumphs across the PHCC in adults, including several groundbreaking milestones in biomedical prevention of infection as well as the adaptation and implementation of a systematic approach to address and improve health outcomes among those with HIV infection. Noteworthy among these successful interventions, is their dependence on excellent adherence and engagement in care, areas which are particularly challenging for adolescents. Despite the advances made, many of which were undertaken in internationally-based resource constrained settings, adolescent representation in these research activities has been scant to non-existent. This has resulted in tremendous gaps for youth populations affected by HIV in these settings in biomedical prevention interventions and among critical milestones within the youth-specific HIV care continuum which are critical to ensure improved health outcomes.

The context of HIV care varies incredibly due to resources, healthcare provision and policies and geographical settings. Striving for healthy outcomes during adolescence must encompass consideration of the complex developmental, psychosocial and cultural issues facing children and adolescents at risk of HIV and with HIV as they transition to adulthood. Recently, several investigators have tailored some successful adult interventions to young people and demonstrated preliminary effectiveness among AYA in some sub-Saharan African countries with their large scale effectiveness trials ongoing; However, many gaps remain unfulfilled in LMICs across the world, especially where training in and capacity for IS research is very limited to non-existent.

IS research that advances and optimizes the successful implementation of interventions with demonstrated efficacy and/or effectiveness in addressing the health needs of AYA who are at risk for or living with HIV in these settings are a critically needed. There is also an urgent need for training researchers who are adept in caring for adolescents impacted by HIV but have limited knowledge or local capacity to conduct rigorous IS research to develop and test interventions that can achieve long-term viral suppression among youth living with HIV and reduce onward transmission to and acquisition of HIV in at-risk youth. HIV researchers must possess the capacity for evaluating scalable and sustainable efficacious interventions that can be successfully implemented by programs serving these vulnerable young populations in LMICs globally.

 

Network Structure and Mission

Essential Features of PATC3H-IN

PATC3H-IN is a cooperative, multi-component project grant that is newly composed of Clinical Research Centers (CRC) (see companion RFA-HD-23-013) and a Coordination, Translation and Advanced Methods and Analytics Center (CTAMAC), which will work collaboratively to achieve the mission of PATC3H-IN. The Network will expand and/or improve on successes achieved by its predecessor, PATC3H, to new geographic settings and/or risk populations and stimulate much needed implementation science (IS) research in the prevention of new HIV infections among adolescents at risk and the identification of, and linkage and retention to care of and long-term viral suppression among youth living with HIV in low-to-middle income countries (LMICs). PATC3H-IN will establish a network of investigators with multidisciplinary expertise on the youth-specific PHCC and in IS research, whose mission will be to evaluate promising prevention innovations contextually and developmentally tailored for HIV uninfected at-risk youth, and treatment and care interventions for youth living with HIV which have demonstrated efficacy and/or effectiveness in adolescent or adult populations and to translate them into public health practices.

The structure of PATC3H-IN will consist of multiple interdependent functional components: (1) Clinical Research Centers (CRC), (2) a single Coordination, Translation and Advanced Methods and Analytics Center (CTAMAC), and (3) a Scientific Leadership Committee (SLC). The SLC will be responsible for PATC3H-IN governance, oversight and coordination, and will develop and implement the network 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.

 

Clinical Research Centers (CRC)

Clinical Research Centers will conduct clinical research and clinical trials, including implementation, effectiveness, and hybrid implementation-effectiveness studies at their participating Clinical Research Performance Sites (CRPS). The goal of studies proposed by Clinical Research Centers should be to improve health outcomes across all milestones on the PHCC for at-risk AYA and those living with HIV. PHCC health outcome milestones, among at-risk uninfected AYA, include proportions who are tested for HIV, assessed for risks and prevention needs, linked to and engaged in prevention services, prescribed biomedical prevention interventions (e.g. topical or oral PrEP), adherent to PrEP, and retested HIV negative, and among youth with HIV, include proportions who are diagnosed with HIV, linked to and retained in HIV care and achieved long-term viral suppression. Relevant implementation outcomes such as penetration, scalability, and sustainability should also be considered. Additional information about this component can be found at: [RFA-HD-23-013].

 

Coordination, Translation and Advanced Methods and Analytics Center (CTAMAC)

A single Coordination, Translation and Advanced Methods and Analytics Center will manage logistics, stakeholder engagement, and dissemination of findings and products from PATC3H-IN. It will also provide data infrastructure support across PATC3H-IN and will conduct foundational research to support the work of the clinical sites, including modeling studies, national surveys, and/or systematic collection and analysis of relevant policies and laws. This will include establishing infrastructure to support research education and rapid response and emerging research pilots (ERPs).

 

Scientific Leadership Committee (SLC)

The Scientific Leadership Committee (SLC) will be responsible for PATC3H-IN governance, oversight and coordination, and will develop and implement the network research agenda. The SLC will provide the necessary multidisciplinary expertise to set, prioritize and manage the PATC3H-IN scientific agenda. It will draw on the statistical and data management leadership and coordination expertise in CTAMAC to design and implement future research solicited to address emerging scientific priorities during the project cycle. The PATC3H-IN research agenda will ensure capacity for rapid response to evolving scientific priorities through recurring competitive open solicitations for Emerging Research Pilots (ERPs). These solicitations will be developed and published by the CTAMAC in collaboration with NIH project scientists and supported by the coordination and operational infrastructure of the CTAMAC, which will 1) receive and convene reviews for applications, 2) coordinate and support application prioritization by the SLC, and 3) implement funded meritorious research through CRC-supported Clinical Research Performance Sites (CRPS) after approval by the NICHD Director or her designee. Finally, the ERPs 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.).

The SLC will include a single representative from each CRC, up to three from the CTAMAC, two site coordinators, two youth advisory board members and the NIH Project Scientists. A chairperson of the SLC will be appointed by NICHD, as will any additional members the institute has deemed necessary after awards are issued.

External Scientific Advisory Board (ESAB)

An independent external advisory board (ESAB), or an equivalent body of investigators who are not current collaborators of the funded programs, is expected to be constituted by the PD/PI(s) of the CTAMAC in consultation with the SLC. The advisory board will meet at least biannually to review the progress in achieving the goals of all research projects participating in the program at a PATC3H-IN meeting coordinated by the CTAMAC. Following these meetings, the ESAB will make recommendations in writing to PATC3H-IN and the SLC for the continuation or re-direction of any or all projects and activities.

Semi-Annual Programmatic Meetings

A one or two-day semi-annual meeting will be held, and each research project will be responsible for the meetings' organization at least once over the award period. These meetings are anticipated to be held at a location at or near Bethesda, MD or at another NICHD-approved site or may be held virtually as needed.

NIH PATC3H-IN Management and Oversight Committee (NIH PMOC)

PATC3H-IN is co-funded by multiple NIH Institutes, however, NICHD administers the award. Thus, PATC3H-IN will be programmatically managed by the NIH PMOC, which will consist of the NICHD program director, and the Program Official, and a representative from each NIH institute.

Coordination, Translation and Advanced Methods and Analytics Center (CTAMAC): Objectives and Scope

All applicants for the Coordination, Translation and Advanced Methods and Analytics Center must carefully review the companion PATC3H-IN FOA for the Clinical Research Centers (CRC) (UG1) [RFA-HD-23-013] to understand the complete mission of PATC3H-IN.

Definitions

Clinical Research Performance Site (CRPS)

Clinical Research Center applications must propose a multisite research project to be executed in five or more geographically distinct clinical research performance sites (i.e., five or more communities). A clinical research performance site (CRPS) is defined as a partnership between a national and/or regional health ministry or other local health authority and one or more community-based HIV-related service providers (e.g., hospital, clinic, non-government organization (NGO) or other relevant service provider). The health authority or authorities and the service provider must engage with a shared population of AYA who live or receive services in a defined geographic area (i.e., community). Each of the five proposed clinical research performance sites must be geographically distinct and non-overlapping from the perspective of the population of patients engaging with services and must possess 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.).

 

Community-Based HIV-Related Services

For the purposes of this FOA, acommunity-based HIV-related service provideris inclusive of any setting, academic or non-academic, where an at-risk AYA or patient living with HIV may engage with medical or behavioral health services that provide primary preventive measures, including PrEP, and/or HIV treatments and address myriad psychosocial determinants impacting health outcomes, including but not limited to mental illness, substance use and other service needs. This includes, but is not limited to HIV service providers, integrated primary HIV care and behavioral health settings, and other settings where HIV-related services are provided to at-risk AYA or patients living with HIV with co-existing needs (e.g. office-based opioid agonist treatment providers, behavioral health service providers, needle exchange sites, housing providers, opioid treatment programs, etc).

Scientific Objectives of the CTAMAC

The PATC3H-IN Coordination, Translation and Advanced Methods and Analytics Center (CTAMAC) is expected to provide coordination, infrastructure, statistical and data management leadership, and other supports for the PATC3H-IN network. These supports include support in the day-to-day operations and coordination of the network; providing infrastructure for rapid response and pilot trials; providing research education and capacity building infrastructure; disseminating research from the cooperative to a wide variety of external stakeholders; engaging external stakeholders and facilitating bidirectional communication between external stakeholders and network investigators; and conducting hypothesis-driven implementation research to support effective translation of network outputs. Additional supports include analytic and data support for the network, which will include 4-5 Clinical Research Centers. The CTAMAC will also conduct novel empirical research to ensure timely understanding of changes in current practices across regions where PATC3H-IN CRCs are working to address the youth-specific PHCC to improve health outcomes for at-risk adolescents and youth living with HIV. Activities will include providing overall leadership and coordination of data storage; data collection and harmonization activities; providing resources for advanced methodological and analytical techniques across the network; conducting research on dynamic changes in HIV policy and practice in regional health ministries or other local health authorities and relevant community-based HIV-related service settings; and conducting novel studies applying cutting edge analytical techniques to existing data and data collected across PATC3H-IN.

The CTAMAC will provide services and resources to the network through the following cores. Cores may be located at different locations as long as there is a strong plan for communication and collaboration. Investigators are encouraged to convene a diverse, multidisciplinary, skilled team that provides synergy to PATC3H-IN by working together with individual Clinical Research Centers and the Coordination, Translation and Advanced Methods and Analytics Center:

 

Administrative Core (AC)

The Administrative Core (AC) will provide overarching resources and organizational structure and management to the CTAMAC and overall organizational infrastructure support to the PATC3H-IN SLC and the cooperative network as a whole. This includes establishing an external-facing website and communications infrastructure; establishing internal collaboration and communication infrastructure and logistical support; and responsibility for monitoring progress across studies within the network and will provide monthly reporting on progress to the SLC and NICHD.

 

Data and Analytics Core (DAC)

The purpose of the Data and Analytics Core (DAC) is to facilitate the collection, archiving, storage, and access within the network and for external stakeholders.

 

Advanced Methodology and Emerging Science Core (AMES)

The Advanced Methodology and Emerging Science Core (AMES) will provide methodological consultation in novel analytical techniques and will leverage these advanced analytical approaches to conduct novel research using existing data and data acquired through the network. Applicants should propose one or more novel research projects that leverage expertise in these areas and available existing data sources. At least one research project must be included that uses modeling techniques which incorporate the youth-specific PHCC to provide insights into the complex dynamics of optimally addressing the AYA HIV epidemic in at least one LMIC, as defined above.

AMES will provide opportunities for research education, capacity building and engagement with the network. Training should support post-doctoral trainees interested in working with HIV-affected AYA in LMICs. AMES will also support the design and implementation of future research solicited by PATC3H-IN to address emerging scientific priorities during the project cycle through recurring competitive open solicitations for Emerging Research Pilots (ERPs).

 

Dissemination and Community Engagement Core (DCEC)

The Dissemination and Community Engagement Core (DCEC) will translate network findings into resources of interest to external stakeholders. To achieve this goal, the DCEC is responsible for facilitating bidirectional communication and translation between network investigators and external stakeholders. External stakeholder groups include practitioners and policy makers at local, provincial, and national levels across a range of health sectors, including health ministries or other local health authorities and relevant community-based HIV-related service settings (e.g., hospital, clinic, non-government organization (NGO) or other relevant service provider) that work with populations of AYA at risk for and those living with HIV. The DCEC will also support the PATC3H-IN Youth Advisory Board which will be comprised of representatives from each CRC.

The DCEC will work with AMES to provide methodology and scientific expertise, and support one or more hypothesis-driven research projects that generate evidence regarding the most effective dissemination and implementation research approaches that facilitate the effective translation of scientific insights into routine practice. The research project(s) may include those proposed by the modeling activities under AMES that hold promise for translation, or research that emerges during the project cycle through the ERPs at a similarly advanced stage. Finally, the DCEC will provide the necessary consultative and collaborative capacity for projects from the CRC that may benefit from translation and scale-up.

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

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

Section II. Award Information

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).

Funds Available and Anticipated Number of Awards

NICHD and partner components intend to commit an estimated total of $4,000,000 to fund one award for fiscal year 2023, subject to funding availability. Future amounts will depend on annual appropriations.

Award Budget

Application budgets are limited to $2,500,000 per year in direct costs.

Award Project Period

The scope of the proposed project should determine the project period and may be up to 5 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

  • 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

Other

  • Non-domestic (non-U.S.) Entities (Foreign Institutions)
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

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

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

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

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

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

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

2. Cost Sharing

This 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:

Bill G. Kapogiannis, MD
Telephone: 301-402-0698
Fax: 301-496-8678
Email: kapogiannisb@mail.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
Admin Core (Administrative Core) Admin Core 12 Required 1 1
Data Core (Data and Analytics Core) Data Core 12 Required 1 1
Methods-Science Core (Advanced Methodology and Emerging Science Core) Methods-Science Core 12 Required 1 1
Dissemination Core (Dissemination and Community Engagement Core) Dissemination Core 12 Required 1 1
Modeling Project (Advanced Methodological Research Project) Modeling Project 12 Required 1 2
Translation Project (Translation Research Project) Translation Project 12 Required 1 2

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 additional instructions apply:

The CTAMAC 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 CTAMAC and for communication, collaboration and coordination with all PATC3H-IN CRCs
  • will participate and collaborate with the Research Project leads, Core leads and others within the Network to discuss, develop plans for and assist the PATC3H-IN SLC 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.

The biosketch should detail the PD/PI's experience overseeing selection and management of sub-awards, and the management of multi-component projects.

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:

Specific Aims should comprehensively address the goals of the Coordination, Translation and Advanced Methods and Analytics Center (CTAMAC), which is to collaboratively design and implement additional research infrastructure, and provide coordination, statistical and data management leadership, and other supports to advance the mission of the PATC3H-IN network.

Research Strategy:

 

Describe the structure, goals and objectives, background information and the overall importance of the CTAMAC, its Cores and Research Projects, and unique advantages or capabilities of the proposed center. Include all necessary tables, graphs, figures, diagrams and Gantt charts in this section.

The research strategy section should be organized as follows:

 

Section A: Overview, Purpose, and Objectives of the Program

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

Explain the strategy for achieving the goals defined for the overall program and how the AC, DAC, AMES, DCEC and each Research Project relate to that strategy.

 

  • The Cores of CTAMAC are interrelated and interdependent, and provide support to the Clinical Research Centers, to the network as a whole, and to the greater community of AYA affected by HIV and community-based stakeholders engaged in working with these youth.
  • Explain how the different aspects of the organization, including key personnel, will coordinate and communicate, why they are essential to establish the research resource and accomplishing the overall goals of the research in PATC3H-IN.
  • Explain the strategy for facilitating efficient communication, coordination of organizational efforts and scientific collaboration across multiple research projects spanning multiple research institutions.

Section B: 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, including collaborative studies with the CRCs, and Emerging Research Pilots (ERPs) and, in collaboration with the Clinical Research Centers (CRCs), to build adolescent HIV IS research capacity in one or more LMICs to enhance the research objectives of the Network
  • Describe the approach to supporting the 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 CTAMAC (including the AC, DAC, AMES, DCEC and each Research Project) and plans for coordinating with all PATC3H-IN CRCs.
  • A plan for development of and adherence to a network operations manual for staff training, quality assurance procedures, the operation and integrity of the PATC3H-IN study databases including remote data capture capacity and study development
  • A plan for a performance-based, centralized, equitable, and efficient method for coordinating the distribution of protocol-restricted funds to site consortia based on actual subject accrual.
  • Describe a Project Management Plan that articulates the strategies and processes that will be used to manage the CTAMAC and achieve the overall goals, including monitoring progress on achievement of Milestones, implementation of the Plan, and proposed Timelines.

Section C: Research Program Infrastructure

Describe the research program infrastructure, including the collaborative design and implementation of additional research infrastructure and capacity building with the CRCs and the SLC to address an emerging scientific agenda, and engagement of external stakeholders in the translation and dissemination of network outputs. Incorporate work-flow plans and timelines using appropriate figures and Gantt charts into the following additional elements:

 

  • 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 in LMICs. Studies should target highly impacted geography that is and/or risk populations who are poorly represented in international adolescent HIV research (e.g. sexual and gender minorities; commercial sex workers; drug users), and leverage cross-sector collaborations with community and public health authorities, and must address substantial and disproportionate gaps in health outcomes across the HIV prevention and care continuum for youth (PHCC).
  • Demonstrate how partnerships between academia and the community have influenced and will continue to facilitate the design and implementation of 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.
  • Because each Core should be strong individually and complementary to the other Cores and the network, it is important to describe the synergy across Cores. Provide justification in the application that key personnel will collaborate effectively. Using the organizational framework above, explain how different components of the organization, including key personnel, will interact, why they are essential to accomplishing the overall goals of PATC3H-IN, and how combined resources create capabilities that are more than the sum of the parts.
  • If Cores will be located at different locations, provide a strong plan for communication and collaboration. Investigators are encouraged to convene a diverse, multidisciplinary, skilled team that provides synergy to the network.

Letters of Support:

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

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

The following modifications also apply:

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. This plan must include procedures, milestones, and timelines to make the data and bio specimens available for access and analysis by the research community as appropriate. 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.

Administrative Core (AC)

When preparing your application, use Component Type ‘Admin Core.’

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

  • Applicant Information

  • Type of Applicant (optional)

  • Descriptive Title of Applicant’s Project

  • Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

 

Research & Related Other Project Information (Administrative Core)

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

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

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

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

List all performance sites that apply to the specific component.

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

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

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

Budget (Administrative Core)

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

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.

Scientific Leadership Committee (SLC) Meetings: Budgets should include funds for travel for the PD(s)/PI(s), including each Core Lead, and as many support staff as needed to coordinate all in-person SLC meetings. For planning purposes, assume that three (3) SLC meetings will be held in year 1 in Rockville, MD. In subsequent years, two (2) SLC meetings to be held in Rockville, MD annually. All SLC meetings are expected to last 2 days, with the exception of a kickoff meeting to be held in late fall 2023, which is expected to last 3 days. The CTAMAC is responsible for identifying space to convene these in-person meetings. Whenever possible, NICHD staff will work with CTAMAC to identify federal space that can be used for free. CTAMAC applicants should include plans, however, for when federal spaces cannot be identified to meet the requirements of the SLC.

SLC Chair Support: The budget for the Administrative Core should include a line item for travel and salary support for a Scientific Leadership Committee (SLC) Chair, to be named by NICHD at a later time. The SLC Chair will lead all SLC meetings. For budgeting purposes assume the equivalent of 2 months effort annually at a senior investigator level salary. Budget for the SLC Chair should also include reimbursement for travel expenses to all in-person SLC Meetings. Budget does not need to consider indirect costs specific to the SLC Chair's institution.

External Scientific Advisory Board (ESAB) meetings: Although members of external advisory groups should not be pre-specified, budgets may include placeholders for payment of members of these groups. Use the instructions in the announcement in conjunction with the application guide to prepare your application. If instructions conflict, follow the FOA.

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

PHS 398 Research Plan (Administrative Core)

Specific Aims:

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

Research Strategy:

The overview of the Administrative Core (AC) should articulate the strategy that the CTAMAC will adopt to achieve the scientific objectives of the Center to fulfill the mission of PATC3H-IN. This should describe the processes/approaches that will be used in decision-making and implementation of activities, including the establishment of CTAMAC organizational infrastructure, and strategies used to manage and support the CTAMAC, Cores, the PATC3H-IN Scientific Leadership Committee (SLC), and its working groups or committees, and the PATC3H-IN cooperative as a whole. The research strategy should define the scope, direction, and means, outline strategies used to redirect science or resources, describe efficient communication, frequency and means, articulate plans to promote and facilitate collaboration in the Network via the PATC3H-IN SLC, and provide a complete description of the constitution and roles of the PATC3H-IN SLC and of the External Scientific Advisory Board (ESAB) or other groups/persons engaged in decision-making activities.

For the Administrative Core (AC), provide the following information:

Objectives

  • Describe how the objectives of the AC will be achieved by incorporating the main benchmarks.

Staffing

  • Describe administrative, scientific, technical, and support staff who are not designated as Key Personnel, how those individuals will interact, and mechanisms of supervision/coordination by the AC Lead.

Governance and Coordination within the CTAMAC

  • Explain how the AC will establish and implement the basic governance, operational and policy structures. This includes setting up committees and coordinating their execution.

  • Describe the plan for establishing and maintaining the PATC3H-IN SLC and related cores and projects.

  • Describe the plan for the establishment and maintenance, including the expansion and contraction, of any necessary scientific multidisciplinary specialty working groups of the SLC required to expediently address emerging scientific priorities within the scope and budget of PATC3H-IN.

  • Articulate plans to support all SLC meetings and related subgroups through logistical support inclusive of, but not limited to note taking, meeting facilitation, convening, and other support services for all in-person and virtual SLC and cross-network Workgroup meetings. Include support of the SLC through close collaboration with a SLC Chair, to be named by NICHD.

  • Providing logistical support and meeting planning support for all in-person SLC meetings. For planning purposes, assume that three (3) Steering Committee meetings will be in year 1 in Rockville, MD. In subsequent years, two (2) SLC meetings to be held in Rockville, MD annually. All SLC meetings are expected to last 2 days, with the exception of a kickoff meeting to be held in late fall 2023, which is expected to last 3 days.

  • Provide information on how the AC will provide oversight of the Cores and Research Projects and will promote coordination and collaboration within the program and with investigators and organizations outside the program.

  • Explain how the AC will interface with the other Cores and Research Projects, describing AC resources will contribute to the objectives of the Research Projects.

  • Describe plans for fiscal monitoring and accountability.

 

Administration, Coordination and Collaboration within PATC3H-IN

  • Describe the strategies and processes from the CTAMAC Project Management Plan that will be used to manage the AC and achieve the overall goals, including monitoring progress on achievement of Milestones, implementation of the plan and proposed Timelines.

  • Explain how AC staff will lead the proposed program and interact with any other program and organizational components within and outside the institution, including interfacing with the rest of the PATC3H-IN network, with a particular emphasis on collaboration and coordination with the CTAMAC.

  • Describe a plan for providing support and coordination for the External Scientific Advisory Board (ESAB), including how the AC will work with the SLC to identify and recruit the appropriate subject matter expertise. Plans should also include how the AC will coordinate with the Dissemination and Community Engagement Core (DCEC) to contribute appropriate and complementary representation on the External Scientific Advisory Board (ESAB). Applicants should not pre-specify or name members of the ESAB, rather focus on the expertise provided. ESAB is an independent advisory body whose members may not collaborate with the network.

  • Describe a plan for providing support and coordination for Data Safety and Monitoring Boards, as needed.

  • Describe a plan for fostering and maintaining internal collaboration and communication infrastructure and logistical support, including developing and maintaining a network-only website for internal collaboration and access to data portals, with appropriate sensitivities to data privacy. Plans must address file sharing, project management, and communications infrastructure for the network as a whole, and tracking as well as reporting internal network activities and outputs, including publications, subcommittee meetings, etc., and facilitating dissemination of updates and emerging findings within the Network

  • Describe a plan for providing training infrastructure for data set utilization, data archiving support, and analytic techniques both within the PATC3H-IN network and to external stakeholders (including previous PATC3H research studies).

  • Describe a plan for working collaboratively with the Clinical Research Centers, NIH staff, and relevant public data/resource repositories to ensure the dynamic dissemination of network data as well as long-term archiving and distribution of the most important datasets and resources developed by the network beyond its funding period.

  • Describe a plan for developing and supporting, in coordination with the Data and Analytics Core (DAC), creative approaches to data dissemination to promote collaboration between PATC3H-IN study investigators and investigators outside of the PATC3H-IN network to promote utilization of PATC3H-IN data and resources (e.g., Hackathons, trainings, webinars, etc.).

Ensuring Rigor and Quality

  • Describe internal evaluations, self-assessment processes, and progress reporting activities that have the ability to assess and anticipate needs of PATC3H-IN network stakeholders.

  • Describe a plan for performing site visits to address emergent problems in data collection or study execution, if needed.

  • Articulate a plan for establishing and coordinating a progress and performance monitoring working group or committee to monitor progress and evaluate performance of network activities and provide monthly, data-driven reporting of these to the PATC3H-IN SLC and NICHD.

  • Reporting to the PATC3H-IN SLC and NICHD is inclusive of, but not limited to, progress toward recruitment, retention, data quality benchmarks, and participation of network investigators and centers in overall network activities. Reporting also must include near real-time updates on data collection progress, harmonization activities, and key outcomes and metrics, to the SLC and NICHD via a user-friendly data portal. Applicants should identify a relevant framework (e.g., Results Based Accountability) they will use to guide the tracking and reporting of progress and milestone achievement across the network.

Facilitating Public Dissemination and Engagement with Data

  • Describe a plan for creating and maintaining an external facing website and communications infrastructure for public audiences, including data portals, with appropriate sensitivities to data privacy.

  • Plans must ensure the highest standards of usability and accessibility (e.g., 508 compliance, Search Engine Optimization) and articulate the design and implementation of a coordinated communication strategy across audiences and functions, including dissemination of research findings to academic audiences, practitioners, and the general public.

  • Examples of activities include, but are not limited to: (a) assisting with tracking and submitting research findings to academic research conferences; (b) developing training and sessions aimed at practitioner and policy-maker audiences (e.g., regional health ministries and authorities, treatment providers, state and local policy makers), (c) developing social media communication strategies, (d) developing press releases, and other communication strategies and approaches as needed.

 

Letters of Support:

Letters of support should not be included from potential External Scientific Advisory Board (ESAB) members. Rather, a plan for identifying and engaging these groups should be included in the Research Strategy Section, as specified above. NICHD will work closely with the Coordination, Translation and Advanced Methods and Analytics Center (CTAMAC) to appoint the eventual ESAB.

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

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

All applications, regardless of the amount of direct costs requested for any one year, must address a Data Sharing Plan in the Overall component.

Appendix:

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

PHS Human Subjects and Clinical Trials Information (Administrative Core)

When involving 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.

 

Data and Analytics Core (DAC)

When preparing your application, use Component Type ‘Data Core’.

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

SF424 (R&R) Cover (Data and Analytics 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 (Data and Analytics Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Data and Analytics 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) (Data and Analytics 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 (Data and Analytics 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 (Data and Analytics Core)

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

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 (Data and Analytics Core)

Specific Aims:

Specific Aims should identify general objectives planned for the Data and Analytics Core along with the main benchmarks that would indicate the accomplishment of these objectives.

Research Strategy:

The overview of the Data and Analytics Core (DAC) should articulate the strategy that the CTAMAC will adopt to achieve the scientific objectives of the Center and the mission of PATC3H-IN. Specifically describe how the strategy will facilitate the development of a management system for the collection, storage and quality control of data; promote the use of data standards; and provide a portal for data use and sharing, as appropriate and consistent with achieving the goals of the program.The strategy should address not only the delivery of services or materials, but also the processes for ensuring the consistent quality of the services or materials, fair access by users and efficient use of the resources. This section of the application should present a clear picture of how DAC resources will contribute to the objectives of PATC3H-IN studies and describe the facilities, techniques, and skills that the core will provide.

For the Data and Analytics Core (DAC), the Research Strategy must address all of the following elements:

Coordination across PATC3H-IN

  • Ensuring coordinated, comprehensive monitoring of all trials and data collection activities funded through PATC3H-IN.

  • Establishing and supporting state-of-the-art common tools and systems for the collection, management, storage and archiving of quantitative and qualitative data across studies funded through the Clinical Research Centers and the CTAMAC.

  • Establishing core measures for harmonization and establishing common data elements for both quantitative and qualitative data collection across the network.

  • Developing data sharing and data use agreements to support harmonization and data use among research sites and the eventual creation of public use datafiles.

Data Security and Standards

  • Anticipating data usage needs with consideration of data sensitivity and privacy concerns, particularly with regard to protection of personally identifiable information.

  • Developing a rigorous approach to information security and data sharing, including attending to the highest standards of data security.

Ensuring Data Quality

  • Establishing a Good Data Practices work group with representatives from each Clinical Research Center.

  • Reviewing and monitoring the quality of study data.

  • Promoting the use of clinical and research data that are machine readable and that adhere to the FAIR (findable, accessible, interoperable, and re-useable) principles.

Analytic Support and Coordination

  • The DAC should provide expertise and support across a broad range of analytic techniques and approaches. Areas of preferred expertise for the DAC include: economic and cost-effectiveness analyses; big data analytics; multi-level modeling; longitudinal data analysis; administrative data management and analysis; electronic health record data analysis; missing data techniques; analysis of randomized controlled trial data; data visualization and visual analytics; and qualitative data analysis. Applicants should include a description of the team's analytic expertise and capacity to provide expert consultation to members of the PATC3H-IN network in these and any other domains of specialized expertise.

  • Providing comprehensive data analytics strategies for cross-cutting research questions in the network.

  • Planning and performing statistical analyses.

  • Providing expertise, support and assistance with rigorous qualitative coding and analysis for Research Projects proposed by the Cores and Emerging Research Pilots (ERP) solicited by the network.

  • Providing support to the Clinical Research Centers in conducting sophisticated statistical analyses in a range of areas.

 

Integration with other Data Sources

  • Identifying relevant sources of data external to the PATC3H-IN network (including previous PATC3H research studies) and establishing protocols and linkages between those data sources and PATC3H-IN data to advance the overall scientific goals of the network.

  • Providing expertise in processes for linking administrative data across systems (e.g., public health systems and clinical care service providers) with appropriate considerations for privacy, as well as expertise in analyzing this kind of linked data.

Data sharing under this FOA is expected to increase the value of the significant public investment in the creation and operation of the Network. Consistent with achieving the goals of the program, NIH expects that PATC3H-IN datasets will be widely shared with the scientific community for research, while carefully observing standards of patient privacy, confidentiality, and management of health information. Information such as study protocols, descriptions, bioinformatics tools, and publications is expected to be made available through a public-facing portal and publication in the scientific literature.

 

Letters of Support:

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

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

All applications, regardless of the amount of direct costs requested for any one year, must address a Data Sharing Plan 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 (Data and Analytics 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.

 

Advanced Methodology and Emerging Science Core (AMES)

When preparing your application, use Component Type ‘Methods-Science Core’

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

SF424 (R&R) Cover (Advanced Methodology and Emerging Science 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 (Advanced Methodology and Emerging Science Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Advanced Methodology and Emerging Science 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.

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

Other Attachments:Provide a plan for the appointment of an Advisory Committee to monitor progress of the Research Education, Training and Capacity Building program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. The Advisory Committee should draw from the membership of the PATC3H-IN Network, but applicants can propose an initial core set of members for the Advisory Committee. Describe how the Advisory Committee will evaluate the overall effectiveness of the program. Proposed Advisory Committee members should be named in the application if they have been invited to participate at the time the application is submitted. Please name your file “Advisory_Committee.pdf”

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

Project /Performance Site Location(s) (Advanced Methodology and Emerging Science 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 (Advanced Methodology and Emerging Science 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 (Advanced Methodology and Emerging Science Core)

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

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.

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.

Budget Limits for the Advanced Methodology and Emerging Science (AMES) Core

The following budget guidelines must be followed for the Advanced Methodology and Emerging Science (AMES) Core for the 1) Emerging Research Pilots, and 2) Research Education, Training and Capacity Building activities:

Emerging Research Pilots

  • Awards through the AMES Core for Emerging Research Pilots (ERPs) may be issued by the UM2 as fixed price subawards. These ERP awards will may not exceed $110,000 in total costs and may not be longer than 24 months in duration.

  • No more than $375,000 in total costs will be made available annually for the Emerging Research Pilot (ERP) awards through the AMES Core.

Research Education, Training and Capacity Building

  • Include all personnel other than the PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.

  • Use the section on Participant/Trainee Support Costs to include all allowable categories of funds requested to support participants in the program.

  • Budgets for the Research Education, Training and Capacity Building are limited to $500,000 in direct costs annually plus applicable F&A.

 

PHS 398 Research Plan (Advanced Methodology and Emerging Science Core)

Specific Aims:

Specific Aims should identify general objectives planned for the Advanced Methodology and Emerging Science Core along with the main benchmarks that would indicate the accomplishment of these objectives.

 

Research Strategy:

The Advanced Methodology and Emerging Science Core (AMES) will provide methodological consultation in novel analytical techniques and will leverage these advanced analytical approaches to conduct novel research using existing data and data acquired through the network. AMES will provide opportunities for research education, capacity building and engagement with the network. Training should support post-doctoral trainees interested in working with HIV-affected AYA in LMICs. AMES will also support the design and implementation of future research solicited by PATC3H-IN to address emerging scientific priorities during the project cycle through recurring competitive open solicitations for Emerging Research Pilots (ERPs).

The research strategy section for AMES should be organized as follows:

Section A: Advanced Methodological Research Modeling

Please provide all of the following:

  • Describe the analytic expertise and infrastructure that will be a resource to the Clinical Research Centers and all PATC3H-IN investigators to provide consultation in novel analytic techniques and advanced analytical methods to conduct novel inquiry with existing data (e.g. PATC3H; other HIV research networks, consortia or studies based in LMICs) and data acquired through PATC3H-IN. Detail any prior significant accomplishments, including novel techniques developed and important advances.

  • Describe the methods, tools and techniques and how they will be leveraged to provide insights into the complex dynamics that impact discrete, youth-specific health outcomes on the PHCC.

  • Examples of preferred modeling techniques that could be used include, but are not limited to: simulation modeling, agent-based modeling, system science, network analysis, or similar.

  • Examples of other techniques that could be leveraged in addition to those preferred above include, but are not limited to: geospatial modeling, technological infrastructure development, data visualization and visual analytics, and social media surveillance or analytics.

  • Up to two Advanced Methodological Research Projects may be proposed using the Advanced Methodological Research Project component, but a project leveraging one or more preferred modeling techniques must be included and must address youth-specific PHCC outcomes in at least one LMIC. Only a brief overview of these projects may be included in this component.

  • Describe how the CTAMAC cores and infrastructure, including the Data and Analytics Core (DAC) and Dissemination and Community Engagement Core (DCEC), will be leveraged and integrated to contribute to the objectives of the Research Project(s)

Section B: Research Education, Training and Capacity Building

The main objective of the research education and training activities is to increase the scientific capacity and knowledgebase for IS research on at-risk, uninfected adolescents and those living with HIV in new LMIC geographies with limited IS research capacity and risk populations who are poorly represented in international adolescent HIV research (e.g. sexual and gender minorities; commercial sex workers; drug users). Training and educational activities involving program participants outside of LMICs (e.g. United States), are beyond the scope of this program and must not be included.

This section must be used to describe the Research Education, Training and Capacity Building Plan (Research Education Plan), which must include the following elements described below.

  • Proposed Research Education Program

  • Program Leads

  • Program Faculty

  • Program Participants

  • Plan for Instruction in the Responsible Conduct of Research

  • Evaluation Plan

  • Dissemination Plan

Proposed Research Education Program

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

The research education program plan should provide programmatic detail and a timeline on the program's objectives and specific activities proposed (e.g., courses, curricula, seminars, short-term research experiences), and how these objectives align with the overall objectives of the PATC3H-IN network.

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

  • Ethics of working with AYA populations at risk for and living with HIV, including populations who are poorly represented in international adolescent HIV research (e.g. sexual and gender minorities; commercial sex workers; drug users).

  • Working across public health systems and clinical care settings, with a special emphasis on addressing challenges in data sharing and collaboration across systems

  • Overcoming challenges in designing, fielding, and analyzing pragmatic trials of improving health outcomes in AYA populations affected by HIV in LMICs.

  • Applying implementation science tools and frameworks incorporating youth-specific health outcomes across the PHCC in LMICs.

The research education plan should provide for a plan for facilitating the engagement of participants with the PATC3H-IN network. Specific activities for participants must include:

  • Ensuring participants have an opportunity to engage in a research experience or activity that leverages the resources of the PATC3H-IN network.

  • Ensuring participants have an opportunity to receive individualized mentoring from one or more PATC3H-IN investigators they have not previously worked with.

  • Ensuring participants can attend at least one face-to-face PATC3H-IN network meeting.

  • Ensuring opportunity for participants to engage in at least one face-to-face training activity.

In addition, the research education plan should also address the capacity to create resources that with the intent of sharing these resources for utilization by the broader PATC3H-IN network and/or readily disseminated to relevant external stakeholders (e.g., virtual grand rounds lectures accessible via platforms such as YouTube or similar).

Program Lead(s)

Describe arrangements for administration of the program. Provide evidence that the Program Director/Principal Investigator is actively engaged in research and/or teaching in the areas of clinical effectiveness and/or implementation research in AYA populations who are at risk for or living with HIV in LMICs. Further, evidence should be provided that the Program Lead(s) can organize, administer, monitor, and evaluate the research education program. For programs proposing multiple Leads, describe the complementary and integrated expertise of the Leads their leadership approach, and governance appropriate for the planned project.

Program Faculty

Researchers from diverse backgrounds, including individuals from underrepresented racial and ethnic groups, persons with disabilities, and women are encouraged to participate as program faculty. The PATC3H-IN AMES Core is expected to utilize the resources available through the PATC3H-IN network. Applicants should propose program faculty who will be considered Core Faculty as well as outlining a plan for how investigators from the Clinical Research Centers and throughout the PATC3H-IN network more broadly will be approached and engaged as part of the Research Education program. Proposed Core Faculty should have research expertise and experience in the domain of clinical and/or implementation research in AYA populations who are at risk for or living with HIV in LMICs.

Program Participants

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

Eligibility to participate should be made available to participants with appropriate educational backgrounds, irrespective of whether they are affiliated with any PATC3H-IN network components. However, participants must be from and/or primarily work in LMICs to be eligible.

The proposed research education program must include a focus on building the capacity of research investigators to conduct rigorous research in AYA populations who are at risk for or living with HIV in LMICs. Applicants have the option of including an additional focus on building the capacity of research staff embedded in public health and clinical care services organizations to conduct scientifically rigorous, pragmatic studies and evaluation activities. If included, the primary emphasis of training for research staff embedded in these settings must be on capacity to conduct research or engage in data-driven evaluation activities.

 

Plan for Instruction in the Responsible Conduct of Research

All applications must provide an overview for instruction to ensure the Responsible Conduct of Research (RCR) which addresses format (workshops, lectures, etc), topics, length, and frequency, as appropriate.

Evaluation Plan

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

Dissemination Plan

A specific plan must be provided to disseminate in conjunction with components of the PATC3H-IN CTAMAC any findings resulting from or materials developed under the auspices of the research education program, e.g., sharing course curricula and related materials via web postings, presentations at scientific meetings, workshops. This section should specifically address how information will be leveraged in other components of the PATC3H-IN CTAMAC.

Section C: Emerging Scientific Agenda and Research Pilots

The evolving HIV landscape requires that the network maintain a nimble ability to respond with science that may inform clinical care of youth affected by HIV. AMES will support the design and implementation of future research solicited by PATC3H-IN to address emerging scientific priorities during the project cycle through recurring competitive open solicitations for Emerging Research Pilots (ERPs). These solicitations will be developed and published by the CTAMAC with direction and collaboration from the PATC3H-IN SLC and NIH project scientists. The solicitations will be supported by the coordination and operational infrastructure of the CTAMAC, which will 1) receive and convene reviews for applications, 2) coordinate and support application prioritization by the SLC, and 3) implement funded meritorious research through CRC-supported Clinical Research Performance Sites (CRPS) after approval by the NICHD Director or designee. Finally, the ERPs 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.).

The AMES Core is intended to support ERP projects, which may be used for collection of data on new, promising interventions addressing AYA populations who are at risk for or living with HIV in LMICs; to take advantage of novel research opportunities focused on these AYA populations; to capture implementation data on newly emerging policies or programs affecting the health of these AYA populations; or support for new, early stage, or independent investigators focusing research on this vulnerable group of young people. Projects funded through this core may take advantage of policy changes; newly emerging practices; or may include developmental pilots, feasibility studies, or other pilot work broadly defined as foundation work for further research. Pilot projects may not be used to supplement or prolong ongoing research and should not be used as bridge funds when other research support is no longer available.

A detailed plan for how the CTAMAC will structure this program to ensure capacity to provide flexible infrastructure across the PATC3H-IN network to support emergent research opportunities.

Details in the plan should include:

  • Detailed plan for parameters of award program, including policies, procedures, priority areas, approach to engaging all components of PATC3H-IN, etc.

  • Describe process for receiving and providing rapid, rigorous review, and selection of proposals for review by the SLC and NICHD.

  • Describe the plan for coordinating with the SLC and NICHD to oversee the plans and process, and prioritize meritorious applications for funding.

  • Describe how the process will be communicated to potential applicants.

  • Timeline and workflow for application process. Applications must be received multiple times per year, with funding awarded within 3 months of application submission.

  • Provide a plan for encouraging and supporting applications for ERPs that support novel collaborations between settings not currently part of the PATC3H-IN network and PATC3H-IN investigators. This may include providing a platform for matchmaking between PATC3H-IN investigators and potential research sites without formal partnerships with experienced investigators.

Please note the following guidelines that must be incorporated:

  • All awards must observe regulations and policies that would apply if the award was made directly by NIH, including, but not limited to, clinical trials registration, IRB approval, OHRP approval, public access compliance for manuscripts, etc.

  • Awards through the AMES Core may not exceed $100,000 in direct costs per award and may not be longer than 24 months in duration.

  • Individual investigators may not receive pilot funds from more than 2 awards total through this mechanism during the entire course of the PATC3H-IN award.

  • Process for applications and all awards made via this activity must be made publicly available via the public-facing PATC3H-IN website.

  • All publications resulting from these awards must acknowledge funding from NICHD via the PATC3H-IN CTAMAC AMES Core. All publications must also be included in the annual progress report submitted by the CTAMAC.

  • All awarded applications must provide a reporting of the outcomes of their ERP funds to the CTAMAC within 3 months of the completion of their study. This information must be made available within 1 month of receipt on the public-facing PATC3H-IN website.

  • NICHD must be made aware of and provide input on all awards to be made through the AMES Core.

  • No more than $350,000 in direct costs may be made available annually as awards through the AMES Core.

The following guidelines should also be observed in structuring how the AMES Core will interact with other components of the CTAMAC and the broader PATC3H-IN network:

  • All applications should involve one or more PATC3H-IN investigators. PATC3H-IN investigators may sponsor applications from investigators not otherwise affiliated with the network.

  • Modeling studies may be funded through this Core, but must take advantage of the Advanced Methodological Research Modeling infrastructure and resources available through this Core.

  • Participants in the Research Education Training Core are not eligible for pilot funds until the completion of their training activities. That is, Emerging Research Pilot (ERP) funds must not be used to support the research activities specified for Research Education, Training and Capacity Building. After successful completion of research education and training, participants may be eligible for funding of potential ERP projects, if sponsored by a PATC3H-IN investigator.

The Research Strategy for the AMES Core's Emerging Scientific Agenda and Research Pilots should not specify any planned projects. All Emerging Research Pilot (ERP) projects are expected to emerge across the PATC3H-IN network after the award has been made. All ERP studies should be treated as delayed onset studies.

 

Letters of Support:

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

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

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

  • Software source code should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories. Users should be permitted to modify the code and share their modifications with others.

  • The terms of software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.

  • To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

Appendix:

Only limited 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 (Advanced Methodology and Emerging Science Core)

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

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

 

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

 

Dissemination and Community Engagement Core (DCEC)

When preparing your application, use Component Type ‘Dissemination Core’

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

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

Complete only the following fields:

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

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

Enter Human Embryonic Stem Cells in each relevant component.

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

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

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

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

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

List all performance sites that apply to the specific component.

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

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

  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.

  • Leadership of this Core should include investigators with extensive experience in multi-site implementation science research studies. Leadership of this Core should also include one or more collaborators with extensive experience working with practitioners in real-world implementation settings. This Core should reflect a blend of innovative implementation science approaches with pragmatic-real world focus and should synergistically interact with all components of the CTAMAC, with a particular emphasis on the Dissemination and Community Engagement Core.

  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.

  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.

  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Dissemination and Community Engagement Core)

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

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.

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

PHS 398 Research Plan (Dissemination and Community Engagement Core)

Specific Aims:

Specific Aims should identify general objectives planned for the Dissemination and Community Engagement Core along with the main benchmarks that would indicate the accomplishment of these objectives.

Research Strategy:

The Dissemination and Community Engagement Core (DCEC) will translate network findings into resources of interest to external stakeholders. To achieve this goal, the DCEC is responsible for facilitating bidirectional communication and translation between network investigators and external stakeholders. External Stakeholders are inclusive of, but not limited to, leadership and front-line practitioners at local, provincial and national levels in organizations that represent individuals or groups that (a) directly engage with AYA populations at risk for or living with HIV in community-based settings; (b) make policies or provide guidance on interactions with AYA populations at risk for or living with HIV; or (c) provide funding to support research or practice improvements that affect these populations. External stakeholders also include groups that represent families of individual AYA who are at risk for or living with HIV and their communities, including AYA. External stakeholders may also include leadership and participants in other initiatives focused on AYA at risk for or living with HIV that engage multiple communities and stakeholders.

The DCEC will work with AMES to provide methodology and scientific expertise, and support one or more hypothesis-driven research projects that generate evidence regarding the most effective dissemination and implementation research approaches that facilitate the effective translation of scientific insights into wide-spread, routine practice. Applicants should outline a rigorous approach to closing the science-to-service gap in the context of the overall scientific goals of the PATC3H-IN network.The research project(s) may include those proposed by the modeling activities under AMES that hold promise for translation, or research that emerges during the project cycle through the ERPs at a similarly advanced stage. Finally, the DCEC will provide the necessary consultative and collaborative capacity for projects from the CRC that may benefit from translation and scale-up.

The research strategy section should provide details on the planned approach in the following the areas as detailed below and organized as follows:

Section A: Stakeholder Engagement in Network Leadership

Please provide the following:

  • Plans for community engagement that describe the experience, expertise, and track record of working collaboratively with communities and community-based organizations and that demonstrate how communities of youth, and adults as appropriate, will be actively engaged in all aspects of the research.

  • Approach to conducting activities to ensure engagement of key stakeholders at national, provincial and local levels with PATC3H-IN network leadership. Specifically, this should include recruitment of members to the Stakeholder Advisory Group (SAG), with representatives from national and/or regional health ministry or other local health authority(ies), and HIV-related service provider entity(ies) and plans to coordinate with the Administrative Core (AC) to contribute appropriate and complementary representation on the External Scientific Advisory Board (ESAB).

  • Applicants should not pre-specify or name members of the SAG; rather, they should outline a plan for how they will approach identifying relevant stakeholders, establishing relationships with the SAG, and convening relevant external stakeholders to engage with PATC3H-IN in synergistic ways. Applicants are strongly encouraged to include perspectives of individual AYA who are at risk for or living with HIV and their families. A description of the approach to engaging this group of stakeholders should also be included.

  • Plans for facilitating active engagement and coordination of stakeholders from representative senior leaders from (a) a relevant national and/or regional health ministry or other local health authority(ies) and (b) a relevant community-based HIV-related service provider entity(ies) named as Key Personnel in awarded Clinical Research Center applications. Plan should emphasize ensuring these stakeholders have opportunities to provide meaningful and broad input on network development and direction.

  • Details on how DCEC will support the PATC3H-IN network-wide Youth Advisory Board (YAB) which is distinct from the SAG and will be comprised of AYA representatives from each CRC YAB, and adults as appropriate.

  • Plans for the establishment and support of regular meetings of the PATC3H-IN YAB or equivalent will be required. Must include plans for development, structure, and coordination of the PATC3H-IN YAB, representation from each participating CRC YAB, and how the PATC3H-IN YAB will be used, how often they will meet, and how they will meaningfully contribute to the research of the PATC3H-IN network.

  • Plans for facilitating bidirectional communication between external stakeholders and PATC3H-IN network investigators with an explicit goal of enhancing capacity of network investigators to be responsive to emergent scientific priorities and areas of interest in policy and practice.

Section B: Outreach and Training for Stakeholders

Please provide the following:

  • Outline the approach to identifying training and supervision needs in key stakeholder communities and leverage PATC3H-IN findings and materials to create and disseminate training materials regularly. Targets for training should include stakeholders from national and/or regional health ministries or other local health authorities and community-based HIV-related service provider entities (e.g., hospital, clinic, non-government organization (NGO) or other relevant service provider).

  • Trainings should be conducted in person when possible, as well as disseminated via comprehensive, easy to use, engaging online platforms, including on-demand training and support.

  • The DCEC should collaborate closely with the Advanced Methodology and Emerging Science (AMES) Core to rapidly interpret emerging findings into user-friendly materials for a variety of audiences, including researchers; public health and community-based practitioners; local, provincial and national policy makers; patients; and families. Examples include, but are not limited to, systematic evidence reviews written with a pragmatic, practitioner-oriented focus; evidence-based menus and electronic tools and templates designed for community-based practitioners; practitioner-focused training webinars and courses.

  • Outline the approach to rigorously evaluating usability and responsiveness of the materials generated to the researcher and stakeholder needs. A plan for monitoring uptake and engagement with these materials must be included.

  • Dissemination and training activities should be tracked and included in metric-based reporting to NICHD.

Section C: Translation of Science-to-Service Program

Please provide the following:

  • Describe the analytic expertise and infrastructure that will be a resource to the Clinical Research Centers and all PATC3H-IN investigators to provide consultation in analytic techniques and appropriate methods to conduct novel inquiry into translating scientific findings in to wide-spread practice via dissemination and implementation research. Detail any prior significant accomplishments, including novel techniques developed and important advances.

  • Describe the methods, tools and techniques and how they will be leveraged to provide insights into the complex dynamics that impact discrete, youth-specific health outcomes on the PHCC.

  • Explain how existing data (e.g. PATC3H; other HIV research networks, consortia or studies based in LMICs) and data acquired through PATC3H-IN may be leveraged to inform dissemination and implementation research, if appropriate.

  • Detail how this Core will serve as a resource that evolves for investigators as the work of PATC3H-IN matures, including how it will collaborate with the Advanced Methodology and Emerging Science (AMES) Core to provide complementary methodologic and scientific expertise, and support for research projects sufficiently mature for translation.

  • Up to two Translation Research Projects may be proposed using the Translation Research Project component, but projects must address youth-specific PHCC outcomes in at least one LMIC. Only a brief overview of these projects may be included in this component.

  • Describe how the CTAMAC cores and infrastructure, including the Data and Analytics Core (DAC) and AMES Core, will be leveraged and integrated to contribute to the objectives of the Research Project(s).

 

Letters of Support:

Letters of support should not be included from potential stakeholder groups. Rather, a plan for identifying and engaging these groups should be included in the Research Strategy Section, as specified above. No letters should be sought or included from the potential external Stakeholder Advisory Group (SAG) as part of the Dissemination and Stakeholder Engagement Core. NICHD will work closely with the Coordination, Translation and Advanced Methods and Analytics Center (CTAMAC) to appoint the eventual external Scientific Advisory Group (SAG) and determine SAG representation needed on the External Scientific Advisory Board (ESAB).

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

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

All applications, regardless of the amount of direct costs requested for any one year, must address a Data Sharing Plan in the Overall component.

Appendix:

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

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

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

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

 

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

 

Advanced Methodological Research Projects

When preparing your application, use Component Type ‘Modeling Project’

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

SF424 (R&R) Cover (Advanced Methodological 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 (Advanced Methodological Research Projects)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Advanced Methodological 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) (Advanced Methodological 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 (Advanced Methodological 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.

Budget (Advanced Methodological Research Projects)

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

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.

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 (Advanced Methodological Research Projects)

Specific Aims:

Specify a set of aims for a project that leverages one or more advanced methodological techniques to address youth-specific health outcomes on the PHCC to yield a unique contribution to the PATC3H-IN network.

Research Strategy:

Advanced Methodological Research Projects proposed must leverage one or more preferred modeling techniques described in the AMES Core must be included and must address youth-specific PHCC outcomes in at least one LMIC.

Detail the methods, tools and techniques and how they will be leveraged to provide insights into the complex dynamics that impact discrete, youth-specific health outcomes on the PHCC.

Applicants must propose at least one, but no more than two, Projects that leverage expertise in these areas and available data sources. Clinical Trials are not allowed for this component, so proposed projects should leverage existing data sources (e.g. prior PATC3H studies) and/or observational data only.The research project(s) may also collaborate and synergize with the Dissemination and Community Engagement Core (DCEC) to include dissemination and implementation research activities informed by modeling studies proposed.

The research strategy section for each Advanced Methodology Research Project should address the following:

  • How the proposed project will be a unique and valuable contribution to the PATC3H-IN network;

  • Justification for selection of data sources and analytical techniques;

  • Plans for participant recruitment and retention, if proposed;

  • Detailed timeline for data acquisition and analysis;

  • It is expected that the proposed project will not take 5 years, but applicants should provide a plan and framework for how the methodologies developed and applied in the proposed project could lead to additional projects utilizing data that will be collected and available later from the Clinical Research Performance Sites (CRPS) and can be leveraged as an integral infrastructure component for the network.

  • Describe how this project will function in tandem with the Data and Analytics Core (DAC) and/or the Dissemination and Community Engagement Core (DCEC), as appropriate, to provide consultation with investigators across the PATC3H-IN network to develop, apply, and test novel and advanced analytic and methodological approaches in the context of PATC3H-IN-supported studies.

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

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

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan 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 (Advanced Methodological Research Projects)

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.

 

Translation Research Projects

When preparing your application, use Component Type ‘Translation Project’

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

SF424 (R&R) Cover (Translation 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 (Translation Research Projects)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Translation 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) (Translation 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 (Translation 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.

Budget (Translation Research Projects)

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

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.

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 (Translation Research Projects)

Specific Aims:

Specify a set of aims for at least one hypothesis-driven dissemination and implementation research project that will translate scientific insights into routine practice addressing youth-specific health outcomes on the PHCC.

Research Strategy:

The Translation Research Project must be hypothesis-driven and must generate evidence regarding effective approaches to translating scientific findings in to wide-spread practice via dissemination and implementation research. One challenge with implementation science is that, to date, findings from rigorous implementation science studies rarely lead to actionable lessons that can speed the translation of research findings into widespread practice. Applicants should outline a rigorous approach to closing the science-to-service gap using the infrastructure described in the Dissemination and Community Engagement Core (DCEC) in the context of the specific aims of the Project and the overall scientific goals of the PATC3H-IN network.

Examples of specific research projects include, but are not limited to:

  • Testing innovative dissemination techniques, such as web-based approaches, social network dissemination, and other approaches using experimental designs to expand knowledge about the most effective ways to disseminate information broadly and enhance implementation in practice;

  • Embedding research questions into activities planned as part of the DCEC;

  • Conducting brief, low-cost pragmatic trials in the design of dissemination implementation activities.

 

The research strategy section for each Translation Research Project should address the following:

  • Applicants must propose at least one, but no more than two, Translation Projects that leverage expertise in these areas and available data sources. The research project(s) may also collaborate and synergize with the Advanced Methodology and Emerging Science (AMES) Core to include modeling activities and/or results that can inform and hold promise for translational studies proposed. A clinical trial can be proposed as part of the Translation Research Project, but is not required.

  • Translation Research Projects must describe how the DCEC's Translation of Science-to-Service Program will be leveraged to address youth-specific PHCC outcomes in at least one LMIC.

  • Detail the methods, tools and techniques and how they will be leveraged to provide insights into the complex dynamics that impact discrete, youth-specific health outcomes on the PHCC.

  • Incorporate IS frameworks or theories to guide the design and/or evaluation of implementation strategies

  • Describe the conceptual models appropriate for dissemination and implementation (D & I) research that will be used and how potential mediators and moderators that may explain the impact of D & I strategies on improving these outcomes will be identified and measured. Include a description of how strategies will be adapted for youth developmental trajectory and local context, and a description of how program costs and other economic outcomes will be incorporated into evaluations that will help address scalability and sustainability.

 

Letters of Support:

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

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

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan 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 (Translation Research Projects)

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.

 

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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 field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

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.

 

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

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?

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?

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

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

Review Criteria for Cores

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

Review Criteria for the Administrative Core

  • Is the proposed Administrative Core well matched to the needs of the CTAMAC?

  • Are the proposed strategies and processes in the CTAMAC Project Management Plan that will be used to manage the CTAMAC appropriate for scientific administration as well as fiscal administration, procurement, property and personnel management, planning, study progress and safety monitoring, budgeting etc.?

  • Is the CTAMAC structure sufficient, including its internal and external procedures for managing the activities of the CTAMAC and PATC3H-IN?

  • Are there appropriate plans for establishing an external-facing website, internal collaboration and communication infrastructure; providing required logistical support; and executing progress monitoring across the PATC3H-IN network as outlined in the FOA?

  • Does the Core Lead have the leadership and research qualifications to lead the Administrative Core? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing and coordinating collaborative, multidisciplinary clinical research? Is there experience with health care or public health research, including collaboration with non-clinical settings and community collaborations?

  • Are the plans for establishing and maintaining the scientific multidisciplinary leadership of the Scientific Leadership Committee (SLC) and any proposed specialty working groups among the SLC, appropriate and nimble enough to address an evolving, emerging scientific agenda?

  • Does the research plan include administrative support for the Scientific Leadership Committee (SLC), and for members who will be named at a later date by NICHD, including the SLC Chair and the External Scientific Advisory Board (ESAB)? If investigators for different Cores will be located at different institutions, is a strong plan for coordination presented?

  • Is there an appropriate plan for establishing and maintaining effective communication and cooperation among the CTAMAC cores? With the PATC3H-IN Clinical Research Centers? Across the SLC and the network as a whole?

  • Is the environment for the Administrative Core adequate and appropriate to support the overall CTAMAC? Is there evidence of institutional support for the management of the CTAMAC?

Review Criteria for the Data and Analytics Core

  • Does the Core provide a comprehensive and detailed plan for providing data management and supports to ensure smooth coordination around data across the entire PATC3H-IN network?

  • Does the plan adequately address data security and data standards?

  • Is the plan sufficiently rigorous for ensuring data quality?

  • Is there a strong plan for providing analytic support, coordination and breadth of expert consultation as defined in the FOA to fulfill the mission of the CTAMAC and its Cores and Research Projects, the PATC3H-IN Clinical Research Centers and the network as a whole?

  • Does the Core Lead have the leadership and research qualifications to lead the Data and Analytics Core? Does the Core Lead have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing and coordinating collaborative, multidisciplinary clinical research? Is there experience with health care or public health research, including collaboration with non-clinical settings and community collaborations?

  • Does the Data and Analytics Core include investigators with a breadth of relevant areas of quantitative analytic expertise?

  • Does the Data and Analytics Core include investigators with relevant areas expertise in qualitative data analysis?

  • Does the team have experience in supporting large-scale multi-site studies and/or networks?

  • Is there a strong plan for integration with existing data sources (including, but not limited to, previous PATC3H research studies)?

  • Does the application demonstrate evidence of collaboration and experience in harmonizing processes to allow data analyses and approaches beyond individual studies?

Review Criteria for the Advanced Methodology and Emerging Science Core

  • Does the research strategy propose appropriate analytic expertise and infrastructure to support innovative modeling techniques and for use as a resource to help accelerate the work of the Clinical Research Centers, and the CTAMAC, its Cores and Research Projects, and all PATC3H-IN investigators?

  • Is there a strong plan for how the methods, tools and techniques of this Core will be leveraged to provide insights into the complex dynamics that impact discrete, youth-specific health outcomes on the PHCC?

  • Does the Core Lead have the leadership and research qualifications to lead the Advanced Methodology and Emerging Science Core? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing and coordinating collaborative, multidisciplinary clinical research? Is there experience with health care or public health research, including collaboration with non-clinical settings and community collaborations?

  • Is the plan on how this Core will interface and integrate with other components of PATC3H-IN of sufficient quality to ensure meaningful contributions to the research objectives of PATC3H-IN?

  • Is a strong plan set forth for recruiting program participants in the Research Education, Training and Capacity Building program, both within and external to the PATC3H-IN network?

  • Is the proposed Research Education, Training and Capacity Building program likely to result in an increase in the availability of well-trained researchers who can execute complex studies among AYA who are at risk and living with HIV in LMIC settings?

  • Are the plans for appointing and maintaining the Advisory Committee to monitor the progress of the Research Education, Training and Capacity Building program adequate?

  • For applications requesting support for development, maintenance, or enhancement of software, are the requirements for software dissemination (resource sharing) adequately addressed?

  • Does the Core provide a comprehensive and detailed plan for how the Emerging Scientific Agenda and Research Pilots program will be established and executed in collaboration with the SLC and NIH?

  • Does the plan outline an appropriate approach for soliciting and rigorously evaluating the scientific merit of proposed projects on a recurring basis?

  • Does the plan adequately delineate how the Core will coordinate and assist SLC to prioritize meritorious Emerging Research Pilots (ERPs)?

  • Does the plan provide a transparent process to ensure fairness in the awarding of these funds and implementing the ERPs?

  • What is the likelihood of novel collaborations between settings not currently part of the PATC3H-IN network responding to research solicitations in this plan?

  • Does the plan incorporate all required guidelines and parameters as specified in Research Strategy section for the Emerging Scientific Agenda and Research Pilots?

Review Criteria for the Dissemination and Community Engagement Core

  • Does the research strategy propose appropriate analytic expertise and infrastructure to support the conduct of novel dissemination and implementation inquiry and for use as a resource to help accelerate the work of the Clinical Research Centers, and the CTAMAC, its Cores and Research Projects, and all PATC3H-IN investigators?

  • Does the Core Lead have the leadership and research qualifications to lead the Dissemination and Community Engagement Core? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing and coordinating collaborative, multidisciplinary clinical research? Is there experience with health care or public health research, including collaboration with non-clinical settings and community collaborations?

  • Does the investigative team include one or more collaborators with expertise in multi-site implementation studies? Does the investigator team include one or more collaborators with experience working with practitioners in real world settings?

  • Does the approach include a plan for identifying, convening and consistently engaging relevant stakeholder groups among a wide, representative array of stakeholders described in the Research Strategy Section?

  • Does the research plan include administrative support for members who will be named at a later date by NICHD, including the Stakeholder Advisory Group (SAG)? Are there sufficient plans to coordinate with the Administrative Core (AC) to contribute appropriate and complementary representation on the External Scientific Advisory Board (ESAB)?

  • Are there distinct plans for a administrative and coordination support for a PATC3H-IN network-wide Youth Advisory Board (YAB) that include appropriate representation from the YAB of each Clinical Research Center? Are sufficient details provided on the development, constituency, structure, objectives of and frequency of meetings?

  • Is a strong plan for developing practitioner-oriented materials based on research findings presented? Is there a strong evaluation plan for examining the utilization and usability of materials developed for practitioners?

  • Is there a strong plan for training practitioner audiences?

  • Is there a strong plan for how the methods, tools and techniques of this Core will be leveraged to conduct pragmatic implementation studies that provide insights into the complex dynamics that impact discrete, youth-specific health outcomes on the PHCC?

  • Is the plan on how this Core will interface and integrate with other components of PATC3H-IN of sufficient quality to ensure meaningful contributions to the research objectives of PATC3H-IN?

  • Does the application outline a rigorous strategy for approaching implementation and translation research as the Network matures?

Review Criteria for the Advanced Methodological 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?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Project? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing advanced methods and modeling research?

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?

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?

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?

Review Criteria for the Translation 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?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Project? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing advanced methods and modeling research?

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?

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 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 National Advisory Child Health and Human Development Council (NACHHD). 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.
  • Compliance with data and resource sharing policies.
  • NIH discretion with application selection to ensure a synergistic and equitable range of topics specific to this FOA are addressed (i.e., prevention approaches and specific parts of the continuum of care, diverse populations, and geographic distribution) and which have maximal likelihood of scalability and sustainability of impact.

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

Recipient-selected projects that are prioritized for funding and implementation by the PATC3H-IN SLC from competitive open solicitations for Emerging Research Pilots (ERPs) and those 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.

Should the applicant organization successfully compete for an award, 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 (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. 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 https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

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

Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.htmlandhttps://www.lep.gov.

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 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

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

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

PATC3H-IN Coordination, Translation and Advanced Methods and Analytics Center (CTAMAC)

The PATC3H-IN CTAMAC will consist of the Principal Investigator(s), project manager, and staff deemed necessary to carry out the mission of the CTAMAC, and its Cores and Research Projects. The CTAMAC project manager will coordinate the activities of the CTAMAC, and its Cores and Research Projects at the direction of the Principal Investigator(s). The PI(s) of the CTAMAC will be responsible for:

  • Organizing a local Executive Committee for day-to-day management of the CTAMAC, coordinating the PATC3H-IN Scientific Leadership Committee (SLC), and organizing several external stakeholder groups with appropriate scientific, clinical, patient and community stakeholder representation including the External Scientific Advisory Board (ESAB), Stakeholder Advisory Group (SAG) and the PATC3H-IN Youth Advisory Board (YAB) with representation from each CRC YAB. These Committees will contribute to the PATC3H-IN mission through oversight, review, and evaluation of the CTAMAC, and input into the selection and prioritization of projects that will use resources and services that are provided through the PATC3H-IN.
  • Administering and supporting opportunities for research education, capacity building and engagement with the network through the Research Education, Training and Capacity Building program.
  • Organizing and maintaining an Advisory Committee to monitor progress of the Research Education, Training and Capacity Building program.
  • Implementing the operational and coordination infrastructure of the CTAMAC to support PATC3H-IN's Emerging Scientific Agenda and Research Pilots. This includes supporting recurring open competitive Emerging Research Pilots (ERPs) solicitations developed and published by the CTAMAC with direction and collaboration from the PATC3H-IN SLC and NIH project scientists, receiving and convening reviews for applications, coordinating and logistically supporting application prioritization by the SLC, and implementing funded meritorious research through CRC-supported Clinical Research Performance Sites (CRPS) after approval by the NICHD.
  • Serving as a member of the PATC3H-IN Scientific Leadership Committee (SLC) and participating in required activities, including primary responsibility for organizing regular conference calls and 1-2 annual PATC3H-IN face-to-face meetings to focus on study initiation, progress and results.
  • Participating in the overall coordination of NIH research efforts on AYA and HIV in LMIC settings; this participation may include collaboration and consultation with other NIH awardees, the appropriate sharing of information, data, and research materials, and participation in NIH efforts to standardize and harmonize pre-clinical and clinical data collection.
  • Establishing and supporting Data and Safety Monitoring Boards (DSMB), protocol safety monitoring committees and other functional groups for PATC3H-IN projects, including those supported by the Clinical Research Centers and the CTAMAC, when instructed by NICHD.
  • Establishing a performance-based, centralized, equitable, and efficient method for coordinating the distribution of protocol-restricted funds to site consortia and/or necessary consultants based on actual subject accrual, as needed or directed by NICHD.
  • Planning, directing, executing and monitoring the proposed research, including: definition of objectives and approaches; implementation; data management, storage and analysis, interpretations and publication of results
  • Providing training, including the development and updating of study manuals of operation, to all personnel related to acceptable quality control and quality assurance procedures at all participating CRPS as well as protocol-training where indicated
  • Ensuring cooperation and coordination with each Clinical Research Center (CRC) and its clinical research performance sites (CRPS). This includes ensuring progress on recruitment, data cleaning, and other activities is reported in a timely fashion.
  • Providing on-site monitoring for those studies being performed at a particular CRPS on a schedule dictated by the SLC, its authorized subcommittee or NICHD, as needs arise
  • For clinical research projects administered by the CTAMAC, managing plans for study participants at any stage across the PHCC (e.g. referrals for adolescents who seroconvert during the project for HIV treatment, including the care provider or providers to which they will be referred and a description of how they will be followed to obtain information on their subsequent treatment for HIV and tracking of their PHCC outcomes; referrals for high-risk exposures among HIV-uninfected youth to HIV prevention services like post-exposure ART prophylaxis (PEP) and/or PrEP and descriptions of how their PHCC outcomes will be tracked). These plans should include necessary and relevant collaborations and agreements with local and national agencies to facilitate the successful achievement of the research objectives. Information about management status of all subjects on study is also required in annual progress reports
  • Collaboratively building adolescent HIV IS research capacity in one or more LMICs in partnership with the Clinical Research Centers (CRCs) and their CRPS units.
  • Providing outreach and user-friendly training to practice-oriented audiences and stakeholders.
  • Planning, supporting and conducting all recurring SLC and PATC3H-IN meetings in collaboration with all CRCs and working with the PATC3H-IN SLC and NIH to assemble and convene the PATC3H-IN External Scientific Advisory Board (ESAB) at least annually
  • Supporting the Leadership of the PATC3H-IN YAB and provide logistical support to any PATC3H-IN YAB-associated meetings at the in-person PATC3H-IN meetings.
  • Making drafts of manuscripts available for review (electronically) to the NIH Project Scientists and other NIH staff at the time they are circulated to coauthors and when the final manuscripts are submitted for publication. This ensures the program can maintain an up-to-date summary of program accomplishments and can prepare for press releases of findings, if warranted
  • Taking administrative responsibility to work with the PATC3H-IN SLC and each CRC to produce, maintain and manage documentation of Network manual of operations which includes but is not limited to standard operating procedures, publications and data sharing policies, and study training manuals
  • Develop and maintain a website to publicize Network activities and provide a venue for public access to available Network resources and an internal network-restricted website for internal collaboration and access to data portals.
  • Agreeing to abide by the procedures and policies established by the SLC
  • Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

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

The NIH Project Scientist(s) will:

  • Participate in the PATC3H-IN SLC that oversees the establishment, maintenance and collaborative scientific efforts of PATC3H-IN and its progress in achieving program goals
  • Assist the PATC3H-IN SLC 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
  • Work closely with the PATC3H-IN CRC and CTAMAC PD(S)/PI(S), the SLC, and the PD(s)/PI(s) of all PATC3H-IN network components in order to ensure proper conduct of all research activities to achieve the mission of the network
  • Assist the PATC3H-IN SLC in the selection of research topics, and the development or review of protocols for specific studies and interventions
  • Assist the PATC3H-IN SLC in identifying PATC3H-IN resources required for the successful implementation of collaboratively developed research protocols
  • Arrange Program and/or peer review of all new PATC3H-IN 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 PATC3H-IN SLC.

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 NIH 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.
  • Phase out or curtail the award (or an individual component of the award) in the event technical performance requirements are not met.
  • Perform other duties required for normal program stewardship of grants.

Areas of Joint Responsibility include:

The PATC3H-IN Scientific Leadership Committee (SLC)

The PATC3H-IN SLC is the primary governing body of the Cooperative and will consist of PD(s)/PI(s) and other representatives from each component the PATC3H-IN network, the NIH project scientists and other scientific experts as agreed to by the SLC, as follows: a single representative from each CRC, up to three from the CTAMAC, two site coordinators, two youth advisory board members and the NIH Project Scientists. A chairperson of the SLC will be appointed by NICHD, as will any additional members the institute has deemed necessary after awards are issued.

The PATC3H-IN SLC 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 PATC3H-IN SLC will have the primary responsibility for identifying emerging scientific priorities, defining the collaboration research and capacity building agenda, and implementing these in the network within the guidelines of this FOA. The PATC3H-IN SLC 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 Project Scientist will also have one vote.

Awardee members of the PATC3H-IN SLC will be required to accept and implement policies approved by the PATC3H-IN SLC.

Specifically, the SLC will:

  • Identify adolescent-specific HIV research objectives to address the PHCC
  • Approve the direction of the research effort including any reconfiguration of working groups to better address the direction of the scientific agenda
  • Approve the policies and procedures developed, adopted or revised by the network
  • 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 PATC3H-IN developed or co-endorsed research
  • Coordinate PATC3H-IN 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 PATC3H-IN CTAMAC
  • Approve use of discretionary funds as recommended by NIH
  • Develop a formal liaison with the Adolescent HIV Prevention and Treatment Implementation Science Alliance (AHISA), where geographically appropriate, to conduct research and capacity-building activities
  • Supervise progress, with the assistance of the NICHD staff, in identifying resources within PATC3H-IN to support subject recruitment, enrollment, retention, data collection, specimen shipping, and negotiated protocol monitoring costs for PATC3H-IN approved protocols and in recommending to NICHD the use of funds for such support
  • Participate in regular conference calls and attend PATC3H-IN meetings to be held at least semi-annually
  • Facilitate, with the support of the CTAMAC, development of research protocols, human subjects and other regulatory protocols, data harmonization, manuscript and other information dissemination planning, and initial clearance of manuscripts or other dissemination products
  • Adhere to policies and procedures on Data Management, Analysis, and Access: Data generated are the property of the awardee. Research sites must provide requested data to the CTAMAC in a timely fashion in accordance with the policies and procedures established in study protocols and by the SLC. In addition, the CTAMAC and all research sites of the CRC must provide NICHD with access to all data generated under this award, subject to rules specified in any Certificates of Confidentiality obtained by awardees. Data must be shared upon request with the SLC and subcommittees reporting to the SLC when appropriate.
  • Cooperate to ensure the timely and broad dissemination of lessons learned, to inform researchers and health care systems engaged in research and beyond.

Dispute Resolution:

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

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

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH 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: 301-637-3015

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)

Bill G. Kapogiannis, MD
Eunice Kennedy ShriverNational Institute of Child Health and Human Development (NICHD)
Telephone: 301-402-0698
Email: kapogiannisb@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

Geetha Parthasarathy Bansal
Fogarty International Center (FIC)
Phone: (301) 496-1653
E-mail: geetha.bansal@nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Mario Martinez, MPH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-402-4078
Email: martinem@mail.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: rita.sico@mail.gov

Bruce R Butrum
Fogarty International Center (FIC)
Phone: 301-451-6830
E-mail: butrumb@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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