Department of Health
and Human Services (HHS)
and Human Services (HHS)
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
UM1 Research Project with Complex Structure Cooperative Agreement
None
The purpose of this funding opportunity announcement (FOA) is to support consortia to conduct research toward the prevention and cure of HIV. The Consortium for Innovative HIV Vaccine and Cure Research will establish a collaborative and integrated research program built around two areas of scientific focus: identification of the correlates and the mechanism(s) of protection of preventive vaccine(s) and the use of vaccines or other immune modalities in advancing cure research. Preclinical studies in nonhuman primate (NHP) models will be supported to investigate the mechanism(s), by which efficacious AIDS vaccines protect NHPs from initial infection or establishment of systemic infection, and will incorporate vaccines or other immune interventions into cure strategies in SIV or SHIV-infected NHPs with the objective of eliminating virus reservoirs or establishing elite control of virus replication. Research findings can be applied to improve HIV vaccines and cure strategies and further advancement toward evaluation in human clinical trials.
30 days prior to the application due date
| 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 | August 04, 2021 | December 2021 | January 2022 | June 2022 |
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from 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.
Purpose
The prevention and cure of HIV infection are high priority goals of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH). The Consortium for Innovative HIV Vaccine and Cure Research will establish a collaborative and integrated research program built around two areas of scientific focus: identification of the correlates and the mechanism(s) of protection of preventive vaccine(s) and the use of vaccines or other immune modalities in advancing cure research. The Consortium will conduct preclinical studies in nonhuman primate (NHP) models to investigate the mechanism(s), by which efficacious AIDS vaccines protect NHPs from initial infection or establishment of systemic infection after virus exposure, and will incorporate vaccines or other immune interventions into cure strategies in SIV or SHIV-infected NHPs with the objective of eliminating virus reservoirs or establishing elite control of virus replication. Consortium preclinical research findings can be applied to improve HIV vaccines and cure strategies and further advancement toward evaluation in human clinical trials.
Background
The objective of this FOA is to support highly collaborative research programs focused on the development and mechanistic understanding of specific strategies for 1) vaccine protection from HIV infection and 2) achieving either a sustained viral remission or complete eradication of persistent HIV reservoirs. The rationale for combining vaccine approaches with cure efforts is to stimulate innovative collaborations toward both. In addition, immunological approaches, including vaccines, adjuvants, or monoclonal antibodies, can be applied to cure research as potential ways to improve immunological control of virus replication, reduce viral rebound when antiretroviral treatment is discontinued, or reduce viral reservoirs. Moreover, mechanisms of vaccine protection can provide insight into immunological responses that need to be generated or restored in cure studies. Conversely, vaccine studies can include evaluation of the effect of vaccines on the size of tissue proviral reservoirs in immunized, infected animals to determine how their impact can be improved.
NHP models are uniquely suited for mechanistic studies needed to understand responses to candidate vaccines and interventions to eliminate the HIV reservoir. The models enable testing of candidate vaccine and therapeutic concepts for toxicities and efficacy prior to clinical studies and allow for extensive sampling of blood and tissues to evaluate vaccine-induced immune responses and the re-emergence and spread of viruses after anti-retroviral treatment is stopped. NHP models replicate most of the important features of HIV pathogenesis in humans and allow for prolonged therapeutic treatment interruption in cure studies and testing of innovative, experimental prophylactic and cure interventions.
NHP models have been employed to evaluate the immunogenicity and efficacy of a wide variety of candidate HIV and SIV vaccines, including purified envelope protein vaccines, recombinant viral vectors expressing HIV or SIV genes, DNA or RNA vaccines encoding and expressing viral genes, and combinations of vaccines used in prime/boost immunization regimens. Several candidate vaccines comprised of or expressing viral envelope proteins can induce neutralizing antibodies in the immunized NHPs. However, these antibodies are able to neutralize only viruses with envelopes matched to the vaccine or viruses that are very sensitive to antibody neutralization. Conversely, NHP models have shown that non-neutralizing antibodies with other functions, such as the ability (through their Fc region) to mediate the lysis or phagocytosis of virus-infected cells by natural killer (NK) cells, monocytes, or other cells may play a role in the reduction of the risk of infection. Antibodies directed to the V2 region of the viral envelope, together with antibody-dependent cellular cytotoxicity (ADCC activity) targeting infected cells, were determined to be correlates of reduction of risk in both NHP and human efficacy studies of the canarypox vector prime (ALVAC-Env/Gag/Pro)/gp120 protein boost examined in the RV144 clinical trial. A follow-up ALVAC/gp120 protein (subtype C) human efficacy trial, with a change in adjuvants to enhance effectiveness, did not repeat the results of the RV144 trial, emphasizing the need not just to identify correlates of protection, but to understand their underlying mechanisms.
Other NHP studies, also involving non-neutralizing antibodies as a possible correlate, supported the HIV-1 candidate vaccine clinical efficacy trials with an Ad26 vector expressing optimized HIV-1 mosaic Env/Gag/Pol antigens and boosted with alum-adjuvanted gp140. NHP studies showed significant efficacy, supporting the mosaic Ad26-Env/Gag/Pol prime, Ad26 plus high-dose gp140 boost vaccine advancement into a Phase 2b clinical efficacy trial. Preliminary efficacy results are expected in 2021. While classical MHC-I restricted CD8+ CTL cells have long been associated with control, but not clearance of virus infection in NHPs and humans, new studies indicate that other T cell populations may play an important role in viral clearance: ongoing NHP studies indicate that other, less conventional (non-classical) T cell responses appear to be necessary (but not sufficient) for the ability of immunized NHPs to eventually clear SIV infection in animals immunized with a rhesus CMV vector expressing SIV genes.
The second focus of this FOA, therapeutic approaches towards a functional cure or eradication of HIV, has gained renewed momentum when encouraging data emerged from studies in SIV monkey models and recent results from human clinical trials. However, many questions remain to be addressed, including how to eliminate most of the latent viral reservoir, how to boost the host immune response to the virus, and what the hurdles are to target tissue viral reservoirs. Advances have been made by identifying agents that can reactivate the latent virus in vivo and by boosting the cellular and humoral immunity, but it remains unclear whether any of these strategies awaken a large fraction of the viral reservoir and whether the boosted immune response can prevent rapid viral rebound after antiretroviral treatments are stopped. The current clinical pipeline consists mainly of adoptive immunotherapies, antibodies, anti-inflammatory and anti-proliferative therapies, cytokines, dual-affinity re-targeting molecules, immune checkpoint blockers, latency-reversing agents, therapeutic vaccines, and combination studies. Except for treatment intensification and early treatment, no HIV cure approach has entered Phase III clinical trials.
Research Objectives and Scope
The research objectives of this FOA are two-fold: (1) to characterize vaccine-induced responses shown to reduce the rate of acquisition or prevent establishment of infection after mucosal challenge of NHPs with SIV or SHIV in order to identify the correlates of protection and understand the underlying mechanisms of that protection, and (2) to develop immunological interventions, including vaccines, immunotherapies, as well as combination strategies, with the goal of eliminating viral reservoirs (cure) or generating antiviral responses that control virus replication in the absence of antiretroviral drug therapy.
Vaccine research proposed for this initiative must employ well-developed SIV/SHIV NHP models using a mucosal route of exposure. Although the main emphasis of research should be based on models using intravaginal transmission, additional studies using intrarectal and/or penile infection models may be included. Vaccine protection efforts must include a vaccine previously demonstrated to provide at least partial protection.
Cure research approaches must employ NHP models where the SI.V/SHIV load can be fully suppressed with the proposed combination antiretroviral therapy (cART) regimen and will rebound, in control animals, after discontinuation of cART, to near pre-cART levels. Only in rare circumstances when the intervention is administered very early and is intended to modulate the viral setpoint, can the lack of cART administration be justified.
It is expected that state-of-the art, well developed assays will be used to quantify the viral load and viral reservoirs, especially in tissues, and to assess immune responses. Assays may be improved or refined but must not be developed de novo to accomplish the research aims.
Examples of research intended to identify mechanisms of vaccine protection include, but are not limited to, the study of:
Examples of cure research include, but are not limited to, the study of:
The following areas of research will be considered non-responsive and will not be reviewed:
Consortium Structure
In addition to the Research Program, each Consortium will include Management and Operations Support (MOS) and two coordinating groups to provide guidance and recommendations to the PDs/PIs on issues related to internal Executive Committee (EC) and external Scientific Advisory Board (SAB) assessments of research progress performed under the Consortium.
Research Program: The Research Program will be the primary driver of all research conducted by the Consortium in support of the research agenda. The research will fall into two major foci – Vaccine Research and Cure Research – that will be developed as collaborative, synergistic research activities. There should be clear evidence of collaboration and synergy both within each Research Focus and across the two Foci. The program may include centralized research resources that provide coordinated services across the consortium for activities, such as specialized assays, data management, or collection storage and sharing of samples and materials, virology services, NHP facilities, immunology support, systems biology, and statistical support.
Management and Operations Support (MOS): MOS will provide the overall administrative coordination for Research Program activities, such as monitoring budget and subcontracts, communications, data sharing activities, strategic planning, establishment of and adherence to timelines, resource allocation, tracking of publications and other metrics, and establishing efficient processes for coordination across multiple institutions. The MOS will also coordinate the EC and SAB meetings and facilitate communication among Consortium members.
Executive Committee (EC): The EC is an internal committee that will serve as the governing body of the Consortium, providing advice and guidance to the PD/PI(s) in setting the direction of scientific activities based on ongoing evaluations of research priorities and opportunities developing policies and procedures to support operations and scientific progress, considering reallocation of funds, proposing working groups, engaging of new collaborators and/or technical resources for evolving scientific priorities, and establishment of guidelines for presentation and publications. The EC will be comprised of the PD/PI (as Chair), key personnel representing vaccine research and cure research efforts and management and operations. Each member of the EC will have one vote. NIAID Project Scientists participating in the EC will be non-voting member(s). Members of the EC are required to accept and implement policies approved by the EC.
Scientific Advisory Board (SAB): The SAB is an external body that acts as a resource for the EC. The SAB provides an annual review of research productivity, progress toward the proposed goals, adherence to timelines, and the continued relevance of the research approach to meet the goals. The SAB provides an annual written report of recommendations to the PDs/PIs and EC regarding scientific directions or re-prioritization of research considering the presentations and reports of the annual program progress meeting. The SAB will be composed of a minimum of four (4) individuals representative of the scientific community with no conflicts of interest with Consortium staff and not affiliated with the applicant institution(s), or other institutions receiving funds from the award. NIAID staff will approve the nominated SAB members.
NOTE: Do not name candidates for SAB members in the application or solicit them prior to award.
Note: All NHP facilities must be located in the United States and its territories, have AAALAC accreditation, and comply with federal and NIH requirements.
Applicants are strongly encouraged to contact the Scientific/Research Contacts to discuss their application prior to submission.
Applicants are encouraged to leverage other resources and develop creative collaborations where possible to support the overall goals of the Consortium. Institutional support is highly encouraged.
New Investigators as well as Early Stage Investigators are encouraged to participate in this research program.
See Section VIII. Other Information for award authorities and regulations.
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.
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.
Not Allowed: Only accepting applications that do not propose clinical trials.
Need help determining whether you are doing a clinical trial?
NIAID intends to commit $6.0 million in FY 2022 to fund 1-2 awards.
The scope of the proposed project should determine the project period. The maximum project period is 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.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
Non-domestic (non-U.S.) entities are permitted as collaborators to provide scientific, reagent or assay support.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
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. 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.
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:
The letter of intent should be sent to:
John C. Pugh, Ph.D.
Telephone: 301-518-7257
Email: pughjohn@niaid.nih.gov
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
, with the following additional instructions.
The Research Strategy should consist of the following sub-sections with the indicated page limits:
Subsection A: Consortium Overview - one required – 12 pages
Subsection B: Research Program - one required –30 pages
Subsection C: Management and Operations Support – one required – 12 pages
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
with the following additional instructions:
Facilities & Other Resources: In addition to the information requested, the Facilities & Other Resources attachment should also address the following:
For each research site describe unique infrastructure for the research proposed, such as laboratory, animal, and data management and data analytics facilities, available unique resources for laboratory testing, and institutional support.
Applicant must demonstrate the availability of Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) accredited NHP facilities with adequate housing and caging at the time of application and award.
Since the proposed work involves the use of NHPs, which are USDA-regulated species, each organization is required to register with the USDA and agree to comply with the AWA and annual inspections. Please provide the license or registration number for each animal facility.
Provide a detailed description of the NHP facility, including floor plan, clinical and support areas, security, and safety features. Provide a detailed description of the animal husbandry practices, including environmental enrichment practices.
Describe available laboratory space and the ability to perform the following NHP studies and testing:
Describe the provision of safe and reliable NHP transport to and from the site for accrual and evaluations in compliance with USDA AWA transportation regulations.
Other Attachments:
Not applicable.
All instructions in the SF424 (R&R) Application Guide must be followed.
R&R Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
with the following additional instructions:
Within the appropriate budget sections, include funds for the following items in support of the research program:
Within the budget justification section, indicate which costs are associated with vaccine efforts, cure-related efforts, or associated with the program overall. The budgets for out-years should represent best estimates for the general research plan. Resource allocations are expected to change over time from what is initially proposed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Specific Aims: Outline in priority order the broad overarching long-range objectives and goals of the proposed NHP Consortium program. Concisely and realistically describe the scientific problem(s), the hypotheses to be tested, and the plans to address the primary research questions. Specific Aims are expected to address current vaccine and cure research priorities and needs.
Research Strategy: The Research Strategy must consist of the clearly marked sub-sections A-C described below, uploaded as a single attachment:
Subsection A. Consortium Overview
Summarize the Scientific Agenda and Strategic Plan for the NHP Consortium and how interrelated and complementary research efforts will contribute to achieving the specific aims.
Scientific Agenda: Provide a narrative description of knowledge gaps relevant to the achievement of a protective vaccine and to the control and eradication (cure) of persistent HIV infection. Discuss how the goals of the Consortium address the gaps through collaborative and synergistic research strategies. Define the overall scientific questions to be addressed and the conceptual framework for how the program will move the field forward and facilitate better mechanistic understanding. Describe the expertise, activities, resources, and processes of the program that will facilitate translation of research findings toward practical application.
Scientific Strategic Plan: Provide a comprehensive scientific overview for implementing the overall aims through innovative, interdisciplinary approaches. The Strategic Plan will demonstrate how the Consortium will function to achieve the goals, including strategies for effective collaboration and decision-making, as new findings emerge. Identification of potential bottlenecks and anticipated strategies to overcome major challenges should be included. The evolution of science in this area is expected to result in changes in research priorities and significant funding reallocation over the award period. The Strategic Plan must describe the following:
Subsection B. Research Program
Each Consortium should be organized around a single, complex research program that allows for flexibility in research direction as the program progresses and new findings, technologies, and opportunities arise. As such, the Research Program Section must clearly delineate two areas of Research Foci, written as integrated goals of a single research program. State the relationship of the Research Focus to the complex program goals and how it relates to other research foci or support components. Use this section to describe how the proposed research (focus by focus) will contribute to meeting the consortium's goals and objectives and explain the rationale for selecting the methods to accomplish the Specific Aims. Indicate the project's relevance to the Scientific Agenda of the application.
B.1 Research Focus 1 – Vaccines: Describe the research plan to address the mechanism by which a vaccine that demonstrates statistically significant efficacy protects NHPs from initial infection, from the establishment of persistent infection, or from persistent virus replication following mucosal exposure to the virus. Include criteria for selection of vaccine(s) proposed for the studies.
B.2 Research Focus 2 - HIV cure: Describe the research plan to incorporate immunological strategies, such as vaccines, antibodies, innate immunity approaches, that require the expertise of vaccine scientists.
Describe the rationale for the NHP model(s) selected and address the ability to fully suppress SIV/SHIV load in the experimental plan. If an intervention is not tested in the presence of cART or during treatment interruption, provide strong justification.
B.3 Centralized Research Resources - Identify and describe the need for each centralized research resource proposed, including the advantages of providing as a centralized resource. Discuss the special skills, services, facilities, equipment, individuals, or resources that are necessary to implement each research resource. Describe the general methods, approaches or techniques that are required. Describe how these research support or service areas support the common Consortium goals and objectives.
Applicants should also address the following:
Subsection C. Management and Operation Support (MOS)
The MOS serves the entire Consortium for overall management, regular communication and information sharing, coordination of activities, data management, and supervision of the administrative portions of the Program.
NOTE: do not name within the application or contact prior to award any candidates for the external SAB.
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:
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
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.
Important reminders:
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.
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.
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.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
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?
Specific to this FOA: Does the application integrate the dual objectives of this program to enhance the outcome of each? Is it likely that the research findings will have application that may lead to testing in subsequent human clinical trials?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Specific to this FOA: Does the PD(s) /PI(s) have a record of leading multi-institutional complex research efforts requiring iterative communication with a governance group and external advisors?
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?
Specific to this FOA: Does the application propose to apply information to improve the efficacy of vaccines and to impact the HIV reservoir?
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?
Specific to this FOA: Is the proposed Consortium organizational structure, including the Research Program, research resources (as applicable), MOS, and the EC appropriate to achieve the goals of the project?
Are the proposed milestones and timelines described feasible and measurable?
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?
Specific to this FOA: To what extent will the NHP facilities and other research environment(s) facilitate the successful implementation of the NHP research program? Are the containment measures for the NHP facilities appropriate for the studies proposed?
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.
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
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
Not Applicable.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) 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.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by convened by the National Institute of Allergy and Infectious Diseases (NIAID), 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 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 Allergy and Infectious Diseases Council . The following will be considered in making funding decisions:
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.
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.
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that 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.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipientsis anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipientsfor the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
Two NIH Project Scientists will be assigned to this program. The role of the NIH Project Scientists will be to facilitate and not to direct the activities of the awardees:
Areas of Joint Responsibility include:
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the 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.
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.
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.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Nancy Miller, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-292-6178
Email: nmiller@niaid.nih.gov
Brigitte Sanders, Ph.D., D.V.M
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3209
Email: sandersbe@niaid.nih.gov
John C. Pugh, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-518-7257
Email: pughjohn@niaid.nih.gov
Parvathy Panakal
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3505
Email: Parvathy.panakal@nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.
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