October 8, 2019 - Notice of Pre-Submission Technical Assistance Webinar and Frequently Asked Questions for NHLBI RFA-HL-20-026 . See Notice NOT-HL-19-721.
October 8, 2019 - Notice of Pre-Submission Technical Assistance Webinars and Frequently Asked Questions for NHLBI RFA-HL-20-025. See Notice NOT-HL-19-720.
NOT-HL-17-520, Notice of Intent to Publish a Funding Opportunity Announcement for Heart, Lung, and Blood Co-morbiditieS Implementation Models in People Living with HIV (HLB SIMPLe) (U01)
NOT-OD-19-128, Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research
NOT-OD-19-137, Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research
93.840, 93.837, 93.838, 93.839, 93.233, 93.989
This Funding Opportunity Announcement (FOA) seeks applications that propose late-stage implementation research strategies to optimally and sustainably deliver proven-effective prevention and treatment interventions for heart, lung, blood, and sleep (HLBS) comorbid diseases and disorders in people living with HIV (PLHIV) in World Bank designated low- and middle-income countries (LMICs) and Small Island Developing States (SIDS). For the purposes of this FOA, late-stage implementation research is defined as research to identify strategies to achieve sustainable uptake of proven-effective interventions in routine clinical, public health, and community-based settings and maximize the positive impact on population health. Each awarded project is to conduct late-stage implementation research within one or more of the following geographical regions: East Asia and the Pacific, Europe and Central Asia, Latin America and the Caribbean, Middle East and North Africa, South Asia, and Sub-Saharan Africa. As a group, awardees will constitute a collaborative alliance for HLBS late-stage (T4) implementation research on comorbid HLBS diseases and disorders among PLHIV living in LMICs. The collaborative alliance is anticipated to have complementary capabilities for answering research questions (within and across regions) aimed at improving population health outcomes.This FOA is intended to support applications from Foreign Institutions only to conduct research that, while carried out in LMICs, results in outcomes that apply to low-resource settings globally.
This FOA utilizes a bi-phasic, milestone-driven cooperative agreement (UG3/UH3) mechanism consisting of a start-up (UG3) phase with possible transition to an implementation (UH3) phase, and runs in parallel with a companion FOA (RFA-HL-20-026) Research Coordinating Center (RCC) that will coordinate the efforts of the collaborative alliance of funded UG3/UH3 phased cooperative agreements. Awards made under this FOA will support a maximum project period of 5 years, consisting of a 2 year UG3 phase and 3 year UH3 phase. Only UG3 projects that successfully complete the scientific performance milestones proposed and award requirements for the UG3 phase of the application may transition to the UH3 phase. Applications submitted in response to this FOA must address both the UG3 and UH3 phases and are expected to use project management principles as appropriate.
October 2, 2019
November 10, 2019
December 10, 2019, by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates.
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.
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.
This Funding Opportunity Announcement (FOA) seeks grant applications to optimally and sustainably address late-stage implementation research questions to address the delivery of proven-effective prevention and treatment interventions for heart, lung, blood, and sleep (HLBS) comorbid diseases and disorders in people living with HIV (PLHIV) in World Bank designated low- and middle-income countries (LMICs) and Small Island Developing States (SIDS). The NHLBI recognizes that LMICs that have been reclassified as high-income in the past eight years may continue to have low-resource regions and population sub-groups like those in LMICs. Consequently, the NHLBI also encourages applications from these re-classified countries. Throughout the rest of this FOA, the term LMIC is used broadly to denote countries currently designated as LMICs, those countries designated as LMICs prior to January 1, 2011 that have since been re-categorized as high-income by the World Bank, and SIDS. For the purposes of this FOA, late-stage implementation research is defined as research to identify strategies to achieve sustainable uptake of proven-effective interventions in routine clinical, public health, and community-based settings and maximize the positive impact on population health. Each awarded project is to conduct late-stage implementation research within one or more of the following geographical regions: East Asia and the Pacific, Europe and Central Asia, Latin America and the Caribbean, Middle East and North Africa, South Asia, and Sub-Saharan Africa. As a group, awardees will constitute a collaborative alliance for HLBS late-stage implementation research on comorbid diseases and disorders in PLHIV in LMICs with capabilities for answering research questions (within and across regions) aimed at improving population health outcomes. This FOA is intended to support applications from Foreign Institutions only to conduct research that, while carried out in LMICs, results in outcomes that apply to low-resource settings globally.
Globally, an estimated 36.9 million people were living with HIV in 2017. New infections are decreasing worldwide and deaths due to AIDS have also decreased. HIV/AIDS, however, will remain among the top five leading causes of death in low- and middle-income countries (LMICs) for the foreseeable future. With a call to end the global AIDS epidemic by the year 2030, WHO, UNAIDS, PEPFAR and others have called for an increase in the number of persons on antiretroviral therapy (ART) to combat the disease. There is now a push for rapid scale-up of ART utilization in LMICs, and over 70% of the adult population with known HIV status in these countries could be on ART as early as 2020. While this treatment is vital for proper management of HIV symptoms and complications, transmission ability, and viral progression, ART has been shown to increase the risk of heart failure and other cardiopulmonary conditions in high-income countries (HICs). The early appearance of chronic heart, lung, blood, and sleep (HLBS) comorbid disorders in PLHIV in HICs suggests similar HLBS comorbid complications will occur in LMICs and low-resource settings as ART uptake increases, especially as ART-related viral suppression continues to drive a significant increase in the average lifespan of PLHIV around the world. In comparison to those without HIV, PLHIV have a higher prevalence of smoking, and thus the occurrence of pulmonary complications such as COPD and other pulmonary conditions are also increased. Sleep disturbances are also prevalent in PLHIV, along with the increased risk for other comorbid disorders such as stroke, and diabetes. There is a need to strengthen the evidence base on implementation of scalable interventions that have proven effectiveness to promote HLBS health management in PLHIV in LMICs, identify individuals in need of care early in the disease process, intervene early to preempt disease progression, and treat and manage illness and care in these individuals while considering the varying needs of different population groups across the life course. As global health paradigms continue to transition from acute to chronic treatment, integration of care and person-centered care is of increasing interest for creating sustainable health systems, especially with regard to HLBS comorbid care in PLHIV in LMICs. Further opportunities for decreasing siloes between the non-communicable disease (NCD) and infectious disease communities are vital as the burden of NCDs rises disproportionately in LMICs. This requires diverse scientific communities to work closely together and learn new skills across platforms, disciplines, countries, and regions to address integrated health needs.
Implementation research is a vital component of the evolving healthcare paradigm in LMICs for effective, sustainable, contextualized treatment of comorbid diseases. Implementation research evaluates salient research outcomes for evidence-based interventions including acceptability, affordability, and appropriateness of interventions, including feasibility, fidelity, penetration, and sustainability of the intervention in specific contexts. Proven-effective interventions and guidelines exist for HLBS diseases and disorders for PLHIV, (e.g., using chronic care models to manage patients, promoting aspirin therapy, smoking cessation). However, globally these interventions have not been fully implemented and/or scaled up due to a multitude of factors. Because of the earlier and more pronounced onset of non-communicable diseases (NCDs) increasingly being seen in PLHIV, the HIV population presents an ideal opportunity to gain an understanding of how to promote sustainable uptake of proven interventions and integrated care programs that could then be translated to broader populations, including non-HIV populations with NCDs. In addition, the ongoing, highly visible, and widely supported international efforts (e.g., PEPFAR, UNAIDS, WHO’s HIV program, etc.) to rapidly scale-up adequate treatment for PLHIV present a unique opportunity for large-scale, multi-site, multidisciplinary collaborations and integrated care networks to more sustainably address management of HLBS and comorbid chronic illnesses in PLHIV.
Scope and Objectives
The objective of this FOA is to support late-stage (T4) implementation research projects to test strategies for the optimal uptake and continued sustainability of proven-effective interventions that will provide generalizable knowledge to address the delivery of proven-effective prevention and treatment interventions for HLBS comorbid diseases and disorders in PLHIV globally. Applications are expected to propose projects that: (1) capitalize on and leverage current knowledge of the most prevalent HLBS comorbid complications in PLHIV; (2) leverage ongoing global efforts, in combination with NIH-supported research opportunities, to conduct implementation research and study delivery of high priority, proven-effective, evidence-based programs to improve the health of PLHIV in low-resource settings; (3) identify barriers to and facilitators for uptake of proven intervention strategies; and (4) enhance implementation research capacity.
Research partnerships are key to enhancing resources and improving capacity for global health research in LMICs. A partnership model of research in which LMIC PIs lead research projects with any needed technical support from colleagues in HICs can lead to ownership, sustainability, and the development of local and national research capacity. Cultural and national influences play a large role in the interpretation and application of research findings. Similarly, local and national researchers in LMICs have critical knowledge of the cultural and national influences regarding health problems and systems. Thus, in global health research conducted in LMICs, local and national researchers should engage in partnerships as needed, to provide technical assistance, enhance resources, and build research capacity.
The NIH expects research supported by this FOA to be designed and planned in collaboration with in-country government agencies, non-governmental organizations (NGOs), and health care institutions and organizations so as to be responsive to local needs, interests, and capacities; embrace cultural and health system factors; and to increase likelihood of long-term sustainability. The NIH expects research supported by this FOA to align with commitments or planned commitments at a regional or national level to implement evidence-based interventions (including evidence of cost-effectiveness and affordability) and services for HLBS comorbid diseases and disorders in PLHIV across health or other sectors (e.g., education, information technology). Efforts to make evidence-based health care for HLBS comorbid disorders in PLHIV equitably available at a national, regional, or local level require both infrastructure and partnerships, especially collaborations among researchers, HLBS and HIV/AIDS health service users, HLBS and HIV/AIDS health service providers, non-governmental organizations, and government agencies that will implement and sustain services. As such, this FOA intends to support applications that propose partnerships with representatives from: (1) one or more LMIC research institutions; (2) one or more LMIC non-governmental organizations and/or health care institutions or systems that provide access to service provider and service user viewpoints so as to be responsive to local needs, interests, and capacities; and (3) one or more representatives of an LMIC government agency with a health-related function (e.g., Ministry of Health, Ministry of Social Welfare, Ministry of Public Health, National AIDS Control Program/Agency/Council, etc.) and that have a policy-making, evaluation, or research role within the agency. In addition, the NIH expects the proposed research to provide participating countries, regions, and/or local jurisdictions with the knowledge, tools, and strategies needed to maximize the positive effects of HLBS- and HIV/AIDS-related interventions, to enable and/or strengthen HIV/NCD integrated care systems, to scale up services to broader populations, to sustain delivery of evidence-based care, and/or to foster evidence-based policy and program development for meeting the needs of individuals with HLBS comorbid disorders in PLHIV.
Applications are expected to utilize existing or planned research collaborations in the region of interest (eligible regions defined below) and with relevant expertise. To be considered responsive to this FOA, applications are expected to utilize partnerships within and/or across the geographic region(s) and foster partnerships between the HIV and NCD research and implementation communities.
Applicants must demonstrate that a research partnership currently exists (or can be developed and maintained) between the applicant and the partnership entities listed above via official documentation of the partnership (i.e., letter of support). Partnerships are intended to ensure that the viewpoints of multiple stakeholders contribute to the development and conduct of the research, thereby increasing the likelihood of public health-relevant research findings, and ultimately the uptake and sustainability of the research findings. Partnerships are expected to be integral to the conduct of the research proposed in the application.
The NIH expects the proposed research to take place in World Bank-designated LMICs, Small Island Developing States (SIDS), and previously designated LMICs re-categorized by the World Bank as high-income (from LMIC) on or after January 1, 2011. This program is not intended to support research that will be conducted primarily in and/or by the United States or other high-income institutions that do not meet eligibility criteria, although partnership with high-income country collaborators is encouraged. The NIH recognizes that countries reclassified as high-income (from LMIC) in the past eight years may continue to have low-resource regions and population sub-groups like those in LMICs. Consequently, the NIH also encourages countries from these re-classified countries. Throughout this FOA, the term LMIC is used broadly to denote countries currently designated as LMICs, those countries designated as LMICs prior to January 1, 2011 that have since been re-categorized as high-income by the World Bank, and SIDS. Research is expected to take place in the following World Bank regions:
Implementation Research Elements:
The NIH expects that applications will propose a project focused on an implementation aspect of delivering, scaling up, or sustaining proven-effective, evidence-based interventions to prevent or treat HLBS comorbid diseases and disorders in PLHIV at the national, regional, or local level within designated LMIC(s). Projects focused on deimplementation of ineffective practices or other areas of implementation research such as systems modeling are also encouraged.
This FOA is intended to support applications that propose to: (1) employ validated, theoretical, or conceptual implementation research frameworks (e.g., Consolidated Framework for Implementation Research (CFIR); Promoting Action on Research Implementation in Health Services (PARiHS); Pragmatic-Explanatory Continuum Indicator summary (PRECIS); Reach Effectiveness Adoption Implementation Maintenance (RE-AIM); PRECEDE-PROCEED, K2A, etc.); (2) include implementation measures as primary outcome measures (e.g., acceptability, adoption, appropriateness, affordability, costs, feasibility, fidelity, penetrance, scale-up, sustainability, etc.); (3) include implementation research study designs (e.g., experimental, quasi-experimental, observational, modeling, cluster randomization, stepped-wedge; Type III hybrid effectiveness, etc.); and (4) inform understanding of key mediators and mechanisms of action of the implementation, scale-up, or sustainment effort.
The NHLBI encourages research activities that leverage other service delivery systems or platforms (e.g., infectious disease care and treatment, maternal and child health care, education, justice, work places) for delivering evidence-based services for HLBS diseases and disorders. The NHLBI also encourages the use and enhancement of existing, sustainable databases, where possible, in answering study questions.
Research Skills Development:
This FOA will support applications that include plans/strategies/models for future skills/career development designed to increase research capacity to conduct late-stage (T4) implementation research in LMICs, especially to address the HIV epidemic and comorbid HLBS diseases and disorders. It is expected that this capacity building/skills development will allow researchers to conduct late-stage (T4) implementation research in LMICs within the country and/or region in which the research project is proposed to be conducted. As different countries and regions may have various levels of research capacity and readiness for research participation, responsive applications are expected to clearly describe a principled approach to engagement and subsequent skills development activities. Research capacity-building/skills development elements are expected to be suited to the needs of the region, with the goal of significantly enhancing the future capacity for HLBS implementation science research within the region by the end of the project period. These efforts will be aligned throughout the alliance of funded HLB SIMPLe awards, as is feasible, and co-facilitated by the companion HLB SIMPLe Research Coordinating Center (RCC).
Applicants are encouraged to propose innovative models of mentoring, skills development, and career development for investigators from within the region. Skills development activities, in turn, may focus on the development of independent researchers by providing mentorship and supporting research development projects for graduate students, advanced post-doctoral candidates, early career faculty, and investigators who may wish to refocus their careers on HLBS or late-stage (T4) implementation research. Skills development may also focus on clinicians, staff of regional NGOs or Ministries of Health, community health workers, or other technical personnel to learn specialized skills in late-stage (T4) implementation research. While applications should not propose to support an academic degree program, leveraging existing educational infrastructure, such as regional schools of public health, and aligning appropriate areas of emphasis to drive sustained implementation research efforts is appropriate. Additionally, utilization of existing, validated skills development materials and resources is encouraged.
Research skills development activities may include, but are not limited to:
This FOA utilizes a bi-phasic, milestone-driven cooperative agreement (UG3/UH3) mechanism consisting of a study start-up and needs assessment (UG3) phase with possible transition to an implementation (UH3) phase. Awards made under this FOA will support a maximum project period of 5 years, consisting of a 1-2 year UG3 phase and 3-4 year UH3 phase, based on the needs of the proposed research. Only UG3 projects that meet the scientific performance milestones and award requirements of the UG3 phase may transition to the UH3 phase. Applications submitted in response to this FOA must address both the UG3 and UH3 phases and are strongly encouraged to use project management principles as appropriate.
Phases of Award:
The UG3 phase will support planning activities focused on sustainable uptake of proven-effective interventions throughout the community of interest. This phase should include activities such as the identification of the population in which the strategies to deliver and scale up proven-effective interventions will be tested, establishment of collaborative relationships, identification of the strategies to be tested during the UH3 implementation phase, conduct of a health needs assessment, and preparation of all details required for conducting a clinical trial, such as finalization of the protocol and the informed consent/assent document; the development of the manual of operations and procedures, case report forms and other resources necessary to the performance of the protocol; Data and Safety Monitoring Board (DSMB) review of the protocol; and Institutional Review Board approval of the trial
The UH3 phase will support implementation of the proposed research and/or clinical trial beyond the necessary planning and study start-up activities of the UG3 phase. Subject to NHLBI funding availability and scientific priorities, UH3 awards will be made after administrative review with specific attention to the extent to which agreed-upon milestones have been met. If the UH3 is funded, an additional administrative review will be scheduled within the first two years of the UH3 to assess progress toward UH3 milestones or enrollment milestones.
Milestones and Transition to UH3 Phase:
Delineation of milestones is a key characteristic of this FOA. The application is expected to propose a well-defined set of milestones for the UG3 phase as well as the UH3 phase. A milestone is defined as a scheduled event in the project timeline that signifies the completion of a major project stage or activity. Milestones must be performance-based to enhance the likelihood that the project will be completed on-time and on-budget. It is understood that the proposed milestones for the UH3 phase may be revised as activities in the UG3 phase progress. In the event of an award, the PD/PI and NIH staff will negotiate the final list of milestones for each year of support. At the completion of the UG3 planning phase, which may consist of one or two years of support based on the needs of the proposed research, the applicant will be required to submit a detailed transition request for the UH3 phase. Satisfactory completion of UG3 milestones will be assessed administratively to determine eligibility to transition to the UH3 implementation phase, which may consist of three or four years of support, based on the needs of the proposed research; a maximum project period of five years will apply for all efforts proposed under the UG3/UH3 phased award. The quality of the planning, design, and documentation products for the UH3 phase will be given key consideration when the NIH considers the transition to the UH3 implementation phase. NHLBI policies regarding milestones and relevant clinical research/studies policies are described in NHLBI Accrual of Human Subjects (Milestones) Policy, NHLBI Policy for Inclusion of Women and Minorities in Clinical Research, and NHLBI Policy for Data and Safety Monitoring of Extramural Clinical Studies). If at any time the project fails to make progress toward meeting milestones (e.g., developing a final protocol and/or manual of procedures including a detailed description of study procedures and process details; completing training of study staff, etc.), the NIH may consider ending support and negotiating an orderly close-out of the award.
Applicants and recipients of UG3 funding should note that the UG3 award does not guarantee subsequent UH3 funding.
Examples of projects that are responsive to this FOA
Examples of projects that are of interest to the NHLBI and responsive to this FOA include, but are not limited to those that propose:
Applications proposing projects that are considered non-responsive will not be reviewed. Non-responsive applications are those that:
This FOA runs in parallel with a companion FOA (RFA-HL-20-026) that encourages applications for an HLB SIMPLe Research Coordinating Center (RCC). Close interaction with the NIH and with the RCC will be required to accomplish the goals of this program. The RCC will assist in dissemination of policies and enable research in partnership with other research sites across the global alliance.
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.
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
NHLBI intends to commit total costs of up to $5,216,000 in FY2020 to fund up to 7 awards .
Application budgets should reflect actual needs of the proposed project.
Application budgets must not exceed direct costs of $690,000 per year in FY2020 through FY2024.
The scope of the proposed project should determine the project period. The project period is up to 2 years for the UG3 phase and up to 3 years for the UH3 phase. The maximum project period is 5 years.
Only direct applications from foreign institutions in World Bank-designated low- and middle-income countries (LMICs), Small Island Developing States (SIDS), and previously designated LMICs re-categorized by the World Bank as high-income on or after January 1, 2011 will be accepted. Applicants are encouraged to engage partners from any country, including the U.S., that can assist them in meeting the goals of this FOA.
To determine country income categories, please see: http://data.worldbank.org/country
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.
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.
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.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
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:
The letter of intent should be sent to:
Director, Office of Scientific Review
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute (NHLBI)
The attachment listed below must be provided.
1. Milestone Plan. The filename "Milestone Plan" should be used for this attachment. A milestone is defined as: a scheduled event in the project timeline that signifies the completion of a major project stage or activity. The Milestone Plan must describe objective, measurable milestones with separate milestones for the UG3 and UH3 phases. The milestone plan must include clearly stated annual milestones that will be reached at the end of the UG3 planning phase and annual milestones that will be completed during the UH3 implementation phase. The milestone plan should address anticipated challenges to meeting milestones and propose potential mitigation or corrective action strategies.
Milestones may be refined and finalized in consultation with NIH Program Staff at the time of the UG3 phase of the award and before the UH3 phase award, if granted.
Provide evidence that the PD(s)/PI(s) and Key Personnel have:
Document the relevant experience of each PD/PI and all key personnel, and clearly define their roles and responsibilities in the program.
Applicant teams must include investigators from:
All instructions in the SF424 (R&R) Application Guide must be followed.
The operational budget including 8% Facilities and Administrative (F&A) costs should include, but not be limited to the following items:
Applicants should also budget for the cost of the PD/ PI and another key person to attend a three-day start-up meeting held by the NHLBI during Year 1 of the award.
Applicants must budget for annual costs of having a PD/PI and two additional team members participate in an annual three-day face-to-face meeting of the global implementation research alliance (international meeting location to vary annually; for budgeting purposes, assume Zurich, Switzerland). Attendance at this meeting is required for the PD/PI and two additional individuals from each awardee team, with participants from the LMIC preferred. Teams are also encouraged to include a junior team member in each annual meeting.
Funds for Skills Development/Research Capacity-Building should not exceed $50,000 in direct costs per year.
If applicable, budgets should include supplemental costs associated with Data Safety and Monitoring Board (DSMB) activities, including preparing materials and/or reports for the DSMB. The associated HLB SIMPLe RCC will convene and manage a global DSMB for oversight of all HLB SIMPLe research programs and oversee clinical study and site monitoring for proper oversight of clinical trials proposed under the HLB SIMPLe FOA.
The specific aims must be relevant to the NHLBI mission. Describe how the project proposes to design and test optimal and sustainable T4 implementation strategies for the delivery of proven-effective prevention and treatment interventions for HLBS comorbid diseases and disorders in PLHIV in LMICs. Aims must also describe how the proposed project will build T4 implementation research capacity through the development of an in-country cadre of researchers, clinicians, and/or community health workers with the necessary skills to sustainably address the rising burden of non-communicable diseases in PLHIV.
Applications should address the following:
UG3 Planning Phase:
UH3 Implementation Phase:
Without repeating information from individual biosketches, describe plans for the multi-disciplinary teams of scientists, clinicians, and stakeholders to work together to develop and test models of implementation that are feasible and applicable across diverse community and practice settings and populations of patients. Identify the collaborative process for engagement and involvement of stakeholders and how the expertise and resources of stakeholders will be leveraged.
Clearly describe primary outcomes and outcome measures relevant to implementation research (e.g., acceptability, adoption, appropriateness, affordability, etc.) that are appropriate for studying and assessing HLBS care among PLHIV in LMICs. Clinical outcomes are secondary outcomes and can be used to assist in determining fidelity. Identify key factors at the provider, healthcare system, community, and patient levels that determine successful implementation of specific evidence-based treatments and strategies for HLBS among PLHIV in LMICs.
Skills Development/Capacity Building:
Applications must describe a plan for outreach, engagement, and collaboration with regional partners in building research capacity. As different countries and regions may have various levels of research capacity and readiness for research participation, applications should clearly describe a principled approach to engagement and subsequent skills development activities. Research capacity building/skills development elements should be suited to the needs of the region, with the goal of significantly enhancing the future capacity for HLBS implementation science research within the region by the end of the project period. Applications should describe the process for recruitment, review, and selection of candidates. Individuals participating in the skills development component must have a mentor and devote at least 6 person months (CY) effort (e.g., at least 50% of a 12-month calendar appointment) to the proposed research project. Do not include descriptions of individual candidate projects in the application.
Letters of Support
To be considered complete, applications must include letter(s) of support from relevant community- based partners, Ministries, NGOs, healthcare provider(s), and other organization(s) related to the proposed project indicating their relevant expertise and commitment to participate.
If partial funding is to be provided by sources other than NHLBI, provide Letter(s) of Support signed by an authorized representative.
The following modifications also apply:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
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 (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.
Applications from foreign organizations must:
In addition, for applications from foreign organizations:
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
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.
In addition, for applications involving clinical trials:
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
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?
Specific to this FOA:
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?
Specific to this FOA:
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?
Specific to this FOA:
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?
In addition, for applications involving clinical trials:
Does the application adequately address the following, if applicable?
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
Specific to this FOA:
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?
Specific to this FOA:
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?
Specific to this FOA:
In addition, for 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)?
Are the listed milestones for each phase appropriate for the goals of the project? To what extent are the milestones relevant, measurable, achievable, result-focused and time-bound? How effectively do the risk assessment and management plans identify and describe risks to implementation and how well are contingency plans described?
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.
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.
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.
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.
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).
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.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NHLBI, 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.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this 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.
Specific to applications proposing clinical trials
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 of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee 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).
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. 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.
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 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.
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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award 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 awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
2.A.1. Awardee and Principal Investigator Rights and Responsibilities
The PD(s)/PI(s) will have primary authority and responsibility for defining objectives, approaches, and details of the research within the guidelines of this FOA and retain primary responsibility for the performance of all UG3/UH3 supported research activities. The PD/PI will be responsible for:
PD(s)/PI(s) agree to participate in the cooperative research program, including serving on the Steering Committee, participating in Steering Committee meetings and teleconferences, adhering to Steering Committee policies and decisions, attending annual meetings or workshops, and accepting the close coordination, cooperation, participation and assistance of NIH staff in accordance with the guidelines described in Section VI.2.A. “Cooperative Agreement Terms and Conditions of Award: NIH Responsibilities.”
All awardees proposing clinical research must comply with federal, state, and local regulations regarding clinical research and monitoring of clinical trials and oversee that all training requirements for the protection of human subject are in compliance. All clinical research performed outside of the U.S. must, in addition to U.S. Federal regulations, comply with the host country regulations for protection of human subjects and conduct of clinical research.
The PD/PI will ensure that on-site administrative structure, scientific capacity, and training are available to enable the research team, including local research investigators and partners, to perform the research activities proposed in this grant application.
The PD/PI will ensure that research and associated activities conducted under this cooperative agreement employ an approach that identifies optimal and sustainable strategies to deliver proven-effective interventions into routine clinical and public health practice and community-based settings to achieve maximal population health impact. The PDs/PIs will provide a process for assessing ongoing research and research capacity-building projects and modifying, redirecting, and/or curtailing ongoing research activities to reflect local changes/shifts based on emerging needs or changing epidemiological conditions.
The PD/PI will be responsible for the timely submission of all abstracts, manuscripts and reviews (co)authored by members of the grant and supported in part or in total under this cooperative agreement. Manuscripts shall be submitted to the NIH Program Official within two weeks of acceptance for publication and must comply with the NIH Public Access Policy. Publications or oral presentations of work performed under this cooperative agreement will require appropriate acknowledgement of NIH support. Timely publication of major findings is encouraged.
Awardees 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.
2.A.2 NIH Responsibilities
An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. The role of the NIH Project Scientist will be to facilitate and not to direct the activities. It is anticipated that the NIH Project Scientist will offer advisory input. The NIH Project Scientist will facilitate liaison activities for partnerships and aid with access to NIH-supported resources and services. Other appropriate NIH program staff assistance will be coordinated by the NIH Project Scientist, which may include Medical Officer(s), clinical operations and regulatory specialists, biostatisticians, and other expertise as required. The NIH Project Scientist, with support of the appropriate staff and expertise, may provide coordination and assistance to the awardees to meet the requirements for clinical protocol content and conduct. The NIH Project Scientist with substantial programmatic involvement may:
A network Scientific Advisory Group (NSAG) may be appointed and supported by NIH to review the progress and provide scientific advice for the intersecting and joint activities of all grants that receive funding under this FOA. The NSAG will be comprised of no more than seven federal and non-federal experts selected by the NIH to participate in NSAG activities in an advisory capacity, when appropriate. When convened, the NSAG will meet at the annual meeting of awardees.
The NIH Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The assigned NIH Program Official may not also serve as an NIH Project Scientist. The NIH Program Official will periodically report award progress to NIH leadership including the Directors of the NHLBI and FIC; PD(s)/PI(s) will provide timely assistance in providing relevant updates, documents, and other materials for NIH reporting purposes.
The NIH Program Official will conduct at least two administrative reviews to determine progress toward achievement of milestones included in the mutually-agreed upon milestone plan, one toward the end of the UG3 phase, and one within the first two years of the UH3 phase. If the milestones have not been satisfactorily met, subsequent funding years may not be approved. NIH reserves the right to phase-out or curtail the study (or an individual award) in the event of (a) failure to develop or implement a mutually agreeable protocol, (b) substantial shortfall in subject recruitment milestones, core milestones mutually agreed upon by the recipient organization and PD/PI and the NIH, consortium participation and collaboration with other awardees, (c) substantive changes in the agreed-upon methodologies and tools with which NIH cannot concur, (d) human subject ethical issues that may dictate a premature termination, or (e) results that substantially diminish the scientific value of study continuation.
The government, via the NIH Program Official, will have access to all data generated under this Cooperative Agreement and may periodically review the data and progress reports. NHLBI staff may conduct data analyses and use information obtained from the data for the preparation of internal reports on the activities of the study.
An NIH intramural scientist may not serve as the PD(s)/PI(s) of a project awarded under this FOA but may participate as a collaborator or consultant. An intramural scientist, however, may not receive salary, equipment, supplies, or other remuneration from this FOA. The intramural scientist must obtain written approval of his/her NIH Institute Scientific Director for the amount of resources that may be allocated to the project; this amount must be specified in the letter, and cannot exceed $200,000 in direct costs of intramural resources. The approval must also specify that the conduct of the project will comply with the DHHS regulations for research involving human subjects and with the PHS policy on vertebrate animal research (if applicable). For applications that include NIH intramural components, the involvement of intramural scientists needs to be consistent with NIH policy.
The NHLBI reserves the right to withhold funding for an individual award in the event of a substantive change in, or failure to make sufficient progress toward, the agreed-upon work scope with which the NIH cannot concur or when there are ethical issues that may dictate a premature close-out.
2.A.3 Collaborative Responsibilities
A Steering Committee (SC) will serve as the governing board for awardees. All participants in the program are bound by the policies and procedures developed by the SC; adoption of such policies and procedures requires a majority vote. Awardees under this FOA will be required to accept and implement policies approved by the SC. Membership on the SC will include the PI of each award, or a designated representative in the case of a Multiple PI award. Each member will have one vote. The NIH Project Scientist will be a voting member of the SC. The chair will be chosen by a majority vote of the SC, with years of service as chair determined by the committee. The chair, in collaboration with the associated program coordinating center staff, is responsible for preparing meeting agendas, for scheduling and chairing meetings, and for preparing concise minutes which will be delivered to SC members within 14 days of the meeting. Virtual meetings are appropriate. The NIH Project Scientist may not serve as Chair of the SC.
Steering Committee responsibilities will include:
2.A.4 Dispute Resolution Process
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. The three members will be: 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 awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
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Contact Center Telephone: 800-518-4726
Brad Newsome, PhD
National Heart, Lung, and Blood Institute (NHLBI)
Geetha P. Bansal, PhD
Fogarty International Center (FIC)
Director, Office of Scientific Review
National Heart, Lung, and Blood Institute (NHLBI)
National Heart, Lung, and Blood Institute (NHLBI)
Fogarty International Center (FIC)
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