and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Institute of Allergy and Infectious Diseases (NIAID) |
|
Funding Opportunity Title |
HIV Vaccine Research and Design (HIVRAD) Program (P01) |
Activity Code |
P01 Research Program Projects |
Announcement Type |
Reissue of PAR-09-134 |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
PAR-12-087 |
Companion FOA |
None |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.855, 93.856 |
FOA Purpose |
Support of multi-component, multi-disciplinary projects that address important scientific questions relevant to AIDS prophylactic vaccine discovery research. Extensive modeling of vaccine concepts in non-human primates may be included. |
Posted Date |
January 31, 2012 |
Letter of Intent Due Date |
May 13, 2012; May 13, 2013; May 13, 2014 |
Application Due Date(s) |
June 13, 2012; June 13, 2013; June 13, 2014 |
AIDS Application Due Date(s) |
Not Applicable |
Scientific Merit Review |
October 2012; October 2013; October 2014 |
Advisory Council Review |
January 2013; January 2014; January 2015 |
Earliest Start Date(s) |
April 2013; April 2014; April 2015 |
Expiration Date |
(Now Expired April 8, 2014 per NOT-AI-14-042), Originally June 14, 2014 |
Due Dates for E.O. 12372 |
Not Applicable |
Required Application Instructions
It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, 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.
Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.
Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
Background
Rates of infection with human immunodeficiency virus (HIV), the virus that causes Acquired Immunodeficiency Disease Syndrome (AIDS), have not abated and another 2.8 million new infections are estimated to have occurred worldwide in 2009. The continuing human and economic toll of HIV/AIDS requires a redoubled effort to develop a preventive HIV vaccine. Encouragingly, several recent results have bolstered enthusiasm for achieving this goal. The RV144 trial in a low-risk heterosexual population in Thailand was reported to show that the vaccine actually prevented infection in 31% of vaccinees during the scheduled three-year follow-up period, and that the vaccine effect appeared even stronger in the first year after completion of the immunization regimen. Non-human primate (NHP) studies with repeat-exposure mucosal challenge that transmits one or two SIV variants, just as observed for HIV in human sexual transmission, have shown that some vaccines can likewise induce abortive infection or prevent acquisition of virus in this analog model. In addition, multiple potent and broad neutralizing antibodies defining new targets on HIV gp120 have been isolated from HIV-infected individuals.
These recent results have opened new horizons and hypotheses that can be exploited for vaccine design and evaluation. The partially successful RV144 trial has introduced new ways to think about protection against HIV. Prior to RV144, because inducing broad neutralizing antibodies to produce sterilizing immunity was such an elusive goal, an interim goal had been to rely on T-cell immunity to suppress plasma viremia after exposure and infection. It now appears that vaccination can tip the balance against the virus in the early events after exposure, so the important time frame to focus on shifts from the weeks-long period it takes to establish and maintain setpoint plasma viremia to the first days after exposure, when the track and fate of the first penetrating virions are established. The case-control analysis of RV144 has implicated the level of IgG antibodies to a conformational V1V2 epitope(s) as affecting infection risk, though the function that may be performed by these antibodies to prevent infection is unclear at present. Since blocking the acquisition of infection is also observed in several NHP studies, these models can effectively investigate the generation, localization and mechanism of protective responses that operate early after transmission. Whether transmitted-founder viruses have properties that differentiate them in significant ways from the chronic viruses that have been used until now as sources of vaccine antigens is only beginning to be investigated. And the new epitopes described by recent antibody discoveries enlarge the options for focusing the generation of protective antibody responses. These developments provide fertile new avenues of research for improving vaccine design.
Objective
The HIVRAD program is designed to fund projects that further address hypotheses crucial to the design of an efficacious HIV/AIDS prophylactic vaccine. Applications for five years of support should include plans that have advanced past the exploratory stage and include preliminary data. Less fully developed applications can request less than 5 years of support to establish feasibility. Applications aimed at developing or optimizing a specific vaccine platform should lay out a research pathway with clear decision points. Extensive modeling of vaccine concepts in non-human primates may be included.
Clinical studies involving human subjects or vaccine research focused solely on therapeutic applications are not considered appropriate and will not be funded under this FOA. For information on programs that support therapeutic vaccine development, please contact program staff.
Applications may address, but need not be limited to:
Funding Instrument |
Grant |
Application Types Allowed |
New The OER Glossary and the PHS398 Application Guide provide details on these application types. |
Funds Available and Anticipated Number of Awards |
NIH intends to fund an estimate of 1-3 awards, corresponding to a total of $5M, for fiscal year 2013. Future year amounts will depend on annual appropriations. |
Award Budget |
Application budgets are not limited, but need to reflect actual needs of the proposed project. |
Award Project Period |
Scope of the proposed project should determine the project period. The maximum period is 5 years. |
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to 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
Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH
Grants Policy Statement, are allowed.
Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.
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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 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.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the PHS398 Application Guide.
Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.
It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
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:
Peter R. Jackson, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3133, MSC-7616
6700B Rockledge Drive
Bethesda MD 20892-7616 (U.S. Postal Service or
regular mail)
Bethesda MD 20817 (for express/courier service;
non-USPS service)
Telephone: 301-496-8426
Email: [email protected]
Applications must be prepared using the PHS 398 research
grant application forms and instructions for preparing a research grant
application. Submit a signed, typewritten original of the application,
including the checklist, and three signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
At the time of submission, two additional paper copies of
the application and all copies of the Appendix files must be sent to:
Peter R. Jackson, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3133, MSC-7616
6700B Rockledge Drive
Bethesda MD 20892-7616 (U.S. Postal Service or
regular mail)
Bethesda MD 20817 (for express/courier service;
non-USPS service)
Telephone: 301-496-8426
Email: [email protected]
All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed.
All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:
The following section supplements the instructions found in Form PHS 398 for preparing a multi-project grant application. Additional instructions are required because the Form PHS 398 is designed primarily for individual, free-standing research project grant applications, and has no specific instructions for multi-project applications consisting of research projects interrelated by a common theme.
The supplemental instructions for multi-project applications below are divided as follows:
A. General Instructions addresses collaborative efforts among research projects, the administrative and organizational structure as well as the overall facilities and environment, and the overall budget.
B. Specific Instructions for Individual Research Projects describes modifications to PHS Form 398 instructions on selected items to address the collaborative or interactive role of the Project.
C. Specific Instructions for Cores Describes modifications to PHS Form 398 instructions on selected items to address the collaborative or interactive role of the Core.
A. General Instructions
All applications must be submitted on Form PHS 398. The multi-project grant
application should be assembled and paginated as one complete document.
Items 1 - 14: complete these items as instructed. This should be the first page of the entire application and all succeeding pages should be numbered consecutively.
Using Page 2 of Form 398; provide a succinct but accurate description (abstract) of the OVERALL multi-project application addressing the major, common theme of the program. Do not exceed the space provided.
List the performance sites where the research will be conducted.
Under "Key Personnel", list the PD/PI of the
multi-project application, followed by the Project and Core Leaders of the
component research projects and cores, and other key personnel and then other
significant contributors.
Do not use Form Page 3 of the PHS 398; a more comprehensive
table of contents is needed for a multi-project application.
Bearing in mind that the application will be scientifically reviewed project by
project and core by core, prepare a detailed Table of Contents that will enable
reviewers to readily locate specific information pertinent to the overall
application as well as to each component research project and core. A page
reference should be included for the budget for each project and each core.
Further, each research project should be identified by number (e.g. Project 1),
title, and responsible Project Leader, and each Core should be identified by
letter (e.g. Core A), title, and responsible Core Leader. The page location of
a COMPOSITE BUDGET should be indicated in the "Table of Contents."
Do not use Form Page 4 of PHS Form 398. Instead, using the suggested format presented below, prepare a Composite Budget for All Proposed Years of Support. (Justification for budget elements should not be presented here but in the individual budgets of the projects and cores.)
SAMPLE: Consolidated Direct Cost Budget for All Proposed Years of Support
Component |
Year 1 |
Year 2 |
Year 3 |
Year 4 |
Year 5 |
All Years |
Project 1. Invest. |
125,000 |
130,000 |
135,200 |
140,608 |
146,232 |
677,040 |
Project 2. Study |
125,000 |
130,000 |
135,200 |
140,608 |
146,232 |
677,040 |
Project 3. Develop. |
100,000 |
104,000 |
108,160 |
112,486 |
116,985 |
541,631 |
Core A. Admin. Core. |
50,000 |
52,000 |
54,080 |
56,243 |
58,493 |
270,816 |
Core B. DNA |
25,000 |
50,000 |
52,000 |
54,080 |
56,243 |
237,323 |
Totals |
425,000 |
466,000 |
484,640 |
504,025 |
524,185 |
2,403,850 |
Complete the Total Direct Cost line entries for all
requested budget periods (years) and the Total Direct Cost for Entire Period of
Support entry. Detailed budgets are required within the descriptions of each
project and core (see below). If the FOA allows for budget requests beyond 5
years, use a second Form Page 5 to reflect the additional budget years
requested.
Biographical sketches of all professional personnel for all components should
be placed at the end of the application with the PI/PD first, followed by those
of other key personnel in alphabetical order.
Do not complete. Essential information is to be presented
in the individual research project and core sections of the application.
Specific Aims (Limited to 1 page.)
List in priority order, the broad, long-range objectives and goals of the proposed program. Concisely and realistically describe the hypothesis or hypotheses to be tested.
Overall Research Strategy (Limited to 12 pages)
This narrative section summarizes the overall research plan for the multi-project application and is limited to 12 pages. The multi-project application should be viewed as a confederation of interrelated research projects, each capable of standing on its own scientific merit, but complementary to one another. This is an important section for it provides the group of investigators an opportunity to give conceptual wholeness to the overall program by giving a statement of the general problem area and by laying out a broad strategy for attacking the problems. As the strategy develops, each project and core should be cited briefly as to its place in the overall scheme. Summarize the special features in the environment and/or resources that make this application strong or unique.
One Checklist, placed at the end of the application, is to
be submitted for the entire application.
Refer to Section IV.6. Appendix Materials below, for instructions on submitting appendix materials.
For each project or core in the multi-project application, 3 publications plus other approved material are allowed.
Except for the requirements below, follow the PHS 398 Specific Instructions found at http://grants1.nih.gov/grants/funding/phs398/phs398.doc#_Toc130797900 in preparing each research project.
For each individual Research Project, include:
Face page (see special instructions, below)
Description & Key personnel (PHS 398 Form Page 2)
Table of Contents (PHS 398 Form Page 3)
Budget Pages (PHS 398 Form Pages 4 and 5); with budget justifications
Research Plan
Resources
The Face Page of the 398 Form should not be used as a cover page for individual research projects within a multi-project application. Instead, use the PHS 398 continuation page to create a "Cover Page" containing selected data about each individual research project. This Cover Page will demarcate each individual research project and should contain the following information items (these are a subset of the information provided on a PHS 398 Face Page):
Provide a Description (abstract) of the research proposed in the individual research project according to the instructions on Form Page 2 of PHS Form 398. In addition, the abstract should contain a brief description of how the individual research project will contribute towards attainment of the multi-project objectives.
List the performance sites where the research will be conducted.
Under "Key Personnel", list the Project Leader, followed by other key project personnel, and then other significant contributors.
Prepare a Table of Contents for the research project using Form Page 3 of the PHS 398.
Prepare a detailed budget and justification for the research project using Form Pages 4 and 5 of the PHS 398.
(A minimum of two individual research projects are required)
Specific Aims (Limited to 1 page.)
List, in priority order, the broad long-range objectives and goals of the proposed project. Concisely and realistically describe the hypothesis or hypotheses to be tested. In addition, state the individual research project's relationship to the program’s goals and how it relates to other projects or cores.
Research Strategy (Limited to 12 pages.)
Use this section to describe how the proposed research will contribute to meeting the Project’s goals and objectives and explain the rationale for selecting the methods to accomplish the specific aims. In addition to stating the biological significance of the research, indicate the project's relevance to the primary theme of the application.
Organize the Research Strategy in the specified order as stated in the PHS 398 Instructions, Section 5.5. Make sure to start each section with the appropriate section heading in order, Significance, Innovation, Approach, and include the appropriate information. Experimental details should be cited using the Bibliography and Reference Cited section and need not be detailed in the Research Strategy. Preliminary Studies for new projects or progress reports for renewals must be included as part of the approach section, and must be contained within the page limits of the Research Strategy section.
Describe the research design conceptual procedures, and analyses to be used to accomplish the specific aims of the project. Describe any new methodology and its advantage over existing methodologies. Describe any novel concepts, approaches, tools, or technologies for the proposed studies. Discuss associations with clinical project(s). Discuss the potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the aims. As part of this section, provide a tentative sequence or timetable for the project.
Provide information on resources available for the project. Describe how the scientific environment in which the research will be done contributes to the probability of success (e.g., institutional support, physical resources, and intellectual rapport.) For Early Stage Investigators, describe institutional investment in the success of the investigator. If there are multiple performance sites, describe the resources available at each site. Describe any special facilities used for working with biohazards or other potentially dangerous substances.
Do not repeat the biographical sketches of participating investigators since this information will be included at the end of the overall application (and therefore will be referenced in the Overall Table of Contents).
Note: An Administrative Core is required.
Except for the requirements below, follow the PHS 398 Specific Instructions found at http://grants1.nih.gov/grants/funding/phs398/phs398.doc#_Toc130797900 in preparing each proposed core.
For each individual Core, include:
Cover page (see special instructions, below)
Description & Key personnel (PHS 398 Form Page 2)
Table of Contents (PHS 398 Form Page 3)
Budget Pages (PHS 398 Form Pages 4 and 5); with budget justifications
Core Services Plan
Resources Format Page
The Face Page of the 398 Form should not be used as a cover page for cores within a multi-project application. Instead, use the 398 continuation page to create a "Cover Page" containing selected data about each individual core. This Cover Page will demarcate each core and should contain the following information items (which are a subset of the information provided on a Face Page - see PHS 398):
The following are specific instructions for sections of the PHS 398 application form that are to be completed differently than usual. For all other items in the core application, follow the usual PHS 398 instructions.
Provide a Description (abstract) of the core activities and services according to the instructions on Form Page 2 of the PHS 398. In addition, the abstract should contain a brief description of how the core services will contribute towards attainment of the objectives.
List the performance sites where the core activities and services will be conducted.
Under "Key Personnel", list the Core Leader, followed by other key core personnel, and then other significant contributors.
Prepare a Table of Contents for the core using page 3 of Form PHS 398.
Prepare a detailed budget and justification for the core using Form Pages 4 and 5 of the PHS 398. Include the cost of travel and any proposed costs for attendance of the to-be-named members of the Scientific Advisory Board to the annual meetings in the Administrative Core budget.
Specific Aims (Limited to 1 page.)
List in priority order, the broad, long-range objectives and goals of the proposed core(s). Concisely and realistically describe the hypothesis or hypotheses to be tested, if applicable. In addition, state the core’s relationship to the program’s goals and how it relates to the individual research projects or other cores in the application.
Adminsitrative Core (limited to 6 pages)
An administrative core is a resource to the multi-project grant, providing overall management, coordination and oversight for the program. As part of the administrative core, provide an administrative plan that includes a description of the structure and roles of administrative staff, including the training and experience of proposed staff and the functions to be performed; how fiscal and other resources will be prioritized, allocated and managed; how communications will be facilitated; and how research-related travel and training will be budgeted. Funding for the overall administrative efforts, including secretarial, and/or other administrative services, publication expenses resulting from collaborative efforts, and communication expenses, should be requested in this core. A fully developed and well-described Administrative Core plan is required even if no additional funds for the core are requested in the overall budget.
In addition within the Administrative core include the following:
Scientific Advisory Board
Plans for a Scientific Advisory Board (SAB), consisting of 3-4 independent subject matter experts, should be proposed in the application. However, the names of proposed SAB members should not be included in the application. It is expected that the SAB members will attend annual meetings sponsored by the grantee to assist with interpretation of results and planning of future studies, and to assist NIAID Program Staff with assessing progress during the course of the project.
Annual Meetings
Plans for Annual site visits for the Program Officer, NIAID Program Staff and SAB, should be proposed in the application. All co-investigators should attend this meeting. During these visits it is expected that an update and summary of results generated from each project will be presented by the PD/PI, co-investigators and/or all pertinent staff. These presentations will be expected to include summaries of all goals and milestones achieved during the review period and a description of all problems encountered that may have an impact on the future direction of the scientific hypotheses. Budgets for the cost of travel and attendance by the to-be-named members of the SAB should be included in the budget for the Administrative Core.
Core Services (limited to 6 pages)
Use this section to describe how the proposed core activities will contribute to meeting the program goals and objectives and explain the rationale for selection of the general methods and approaches proposed to accomplish the specific aims. In addition, this section should indicate the relevance of the core to the primary theme of the application. Each Core Service must support two or more projects in the program.
Organize the Plan in the specified order as stated in the PHS 398 Instructions, Section 5.5. Make sure to start each section with the appropriate section heading in order, Significance, Innovation, Approach, and include the appropriate information. Experimental details should be cited using the Bibliography and Reference Cited section and need not be detailed in the Research Strategy. Preliminary Studies for new cores and progress reports for renewals must be included as part of the approach section and must be contained within the page limits of the Core Services Plan section.
Provide information on resources available for the core. Describe how the scientific environment in which the research will be done contributes to the probability of success (e.g., institutional support, physical resources, and intellectual rapport.) For Early Stage Investigators, describe institutional investment in the success of the investigator. If there are multiple performance sites, describe the resources available at each site. Describe any special facilities used for working with biohazards or other potentially dangerous substances.
Do not repeat the biographical sketches of participating investigators since this information will be included at the end of the overall application (and therefore will be referenced in the Overall Table of Contents).
Resource Sharing Plan
Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the PHS398 Application Guide, with the following modification:
Appendix
Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.
Foreign (non-US) Institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the PHS398 Application Guide.
Part I. Overview Information contains information about Key Dates.
Information on the process of receipt and determining if
your application is considered on-time is described in detail in the PHS398
Application Guide.
Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants
administration.
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 received on or before the due dates in Part I. Overview Information. If an
application is received after that date, it will not be reviewed.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115 .
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the program 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 program proposed).
Is the program as a whole scientifically compelling? Are there coordination and synergy of the individual research projects and cores towards the achievement of the central objectives of the program? Are the overall program goals significant and focused on studies that significantly address hypotheses crucial to the design of an efficacious HIV/AIDS prophylactic vaccine? Will the integration of the individual projects into a single program be more beneficial than pursuing each project independently? Does the Program Director(s)/Principal Investigator(s) have the leadership and scientific ability to develop an integrated and focused research program? Will the PD(s)/PI(s) devote adequate time and effort to the program? Is there adequate evidence of sufficient institutional support for the PD(s)/PI(s)? For applications designating multiple PD(s)/PI(s), are there adequate and appropriate coordination and communication among the PD(s)/PI(s)?
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance
Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Investigator(s)
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project ? If Early Stage Investigators or New Investigators, or 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(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Do the PD(s)/PI(s) possess demonstrated abilities to develop a program of integrated research projects with a well-defined central research focus? Do the investigators commit adequate time and effort to the program? Do the investigators possess the qualifications and experience necessary for the individual research projects?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project ? 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?
If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
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/priority 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 six 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 six 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 Human
Subjects Protection and Inclusion Guidelines.
Inclusion of Women, Minorities, and Children
When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewals
For Renewals, the committee will consider the progress made in the last funding period.
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/priority score.
Applications from Foreign Organizations
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources..
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
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.
Administrative Core: Reviewers will consider each of the criteria below in the determination of scientific and technical merit. Is the administrative and organizational structure appropriate and adequate to the attainment of the objective(s) of the proposed program? Is the management plan for fiscal accountability and communication within the program appropriate? Are the plans for coordination, problem identification and resolution, and the establishment of a strong collaborative environment for the program appropriate? Are the experience, level of commitment, and availability of the Administrative Core Leader and administrative staff adequate to manage the program?
Scientific Cores (if applicable): Reviewers will consider each of the criteria below in the determination of scientific and technical merit: Is provision of resources and core services for the individual Research Projects critical and justified? Is the relationship of a scientific core to the central focus of the overall program strong? Is the quality of the relevant facilities or services provided and criteria for prioritization and usage appropriate? Are the qualifications, competence, and commitment of the Core Leader and key personnel appropriate?
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s)convened by the NIAID in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications . 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:
After the peer review of the application is completed, the PD(s)/PI(s) will be able to access his or her Summary Statement (written critique) via the eRA Commons.
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 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 the DUNS,
CCR Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants website.
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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Not Applicable.
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, 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.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]
eRA Commons Help Desk(Questions regarding eRA Commons
registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]
Alan M Schultz, Ph.D.
Division of AIDS
National Institute of Allergy and Infectious Diseases (NIAID)
Room 5138, MSC-7628
6700B Rockledge Drive
Bethesda MD 20892-7616 (U.S. Postal Service or regular
mail)
Bethesda MD 20817 (for express/courier service; non-USPS
service)
Telephone: 301-594-2518
Email: [email protected]
Peter R. Jackson, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3133, MSC-7616
6700B Rockledge Drive
Bethesda MD 20892-7616 (U.S. Postal Service or regular mail)
Bethesda MD 20817 (for express/courier service; non-USPS
service)
Telephone: 301-496-8426
Email: [email protected]
Regina Kitsoulis
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
Room 2244, MSC-7614
6700B Rockledge Drive
Bethesda, Maryland 20892-7614 (U.S. Postal Service or
regular mail)
Bethesda MD 20817 for express/courier service; non-USPS
service)
Telephone: 301-402-6245
Email: [email protected]
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 Parts 74 and 92.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
|
| ||||||
|
|
|
Department of Health and Human Services (HHS) |
|
|||
|
NIH... Turning Discovery Into Health® |
||||||