and Human Services (HHS)
EXPIRED
Department of
Health and Human Services
Participating Organizations
National
Institutes of Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
National Institute of Allergy and Infectious Diseases
(NIAID), (http://www.niaid.nih.gov)
Title: Consortia
for AIDS Vaccine Research in Nonhuman Primates (P01)
Announcement Type
New
Update: The following update relating to this announcement has been issued:
Request for Applications (RFA) Number: RFA-AI-10-004
Catalog of Federal
Domestic Assistance Number(s)
93.855,
93.856
Key Dates
Release/Posted Date: April 1, 2010
Letters of Intent
Receipt Date: October 1, 2010
Application Due Date: November 3, 2010
Peer Review Date: March
2011
Council Review Date: May
2011
Earliest Anticipated Start Date: July 2011
Additional Information To Be
Available Date (Activation Date): Not
Applicable
Expiration Date: November 4, 2010
Due Dates for E.O. 12372
Not Applicable
Additional
Overview Content
Executive Summary
Table of Contents
Part I
Overview Information
Part II Full Text of
Announcement
Section I. Funding
Opportunity Description
1. Research Objectives
Section II.
Award Information
1.
Mechanism(s) of Support
2.
Funds Available
Section III.
Eligibility Information
1.
Eligible Applicants
A.
Eligible Institutions
B.
Eligible Individuals
2.Cost
Sharing or Matching
3.
Other - Special Eligibility Criteria
Section IV.
Application and Submission Information
1.
Address to Request Application Information
2.
Content and Form of Application Submission
3.
Submission Dates and Times
A.
Receipt, Review and Anticipated Start Dates
1. Letter of Intent
B.
Sending an Application to the NIH
C.
Application Processing
D. Application Assignment
4.
Intergovernmental Review
5.
Funding Restrictions
6.
Other Submission Requirements
Section V. Application
Review Information
1.
Criteria
2.
Review and Selection Process
3.
Anticipated Announcement and Award Dates
Section VI. Award
Administration Information
1.
Award Notices
2.
Administrative and National Policy Requirements
3.
Reporting
Section
VII. Agency Contact(s)
1.
Scientific/Research Contact(s)
2.
Peer Review Contact(s)
3.
Financial/ Grants Management Contact(s)
Section
VIII. Other Information - Required Federal Citations
Part
II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Purpose
This Funding Opportunity Announcement (FOA), Consortia for AIDS Vaccine Research in Nonhuman Primates, issued by the National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Health (NIH), invites Program Project applications to investigate SIV mucosal infection in nonhuman primate (NHP) models to provide a better understanding of events that occur during sexual transmission of HIV in humans and to gain insight into the immune responses that must be generated by AIDS vaccines to block infection at mucosal sites, prevent establishment of systemic infection, or dramatically reduce the pathogenic effects of infection.
Background
The identification of a safe and effective prophylactic vaccine against HIV/AIDS is among the highest priorities of the NIAID. The recent vaccine efficacy trial completed in Thailand, testing a recombinant poxvirus vector combined with a recombinant envelope protein, has demonstrated that it is possible to confer a modest degree of protection against HIV in humans and gives the AIDS vaccine research community optimism that a highly efficacious HIV vaccine is possible. Given that the level of efficacy achieved was low, the vaccine regimen tested most likely will not be considered as a public health control measure. The most important contribution this trial may offer is the identification of a correlate of immune protection. The establishment of a correlate of immunity is one of the fundamental questions in AIDS vaccine development and will most certainly have a profound effect on the design of future AIDS experimental vaccines. While studies are already underway to define the correlate of immunity responsible for the protection observed in this trial, this may ultimately require additional clinical testing of the vaccine with a far more exhaustive collection and testing of post vaccination clinical specimens including mucosal tissues and requiring many years of research. Deciphering a correlate of immunity for HIV in humans may ultimately require the use of animal models in a controlled setting where it is possible to obtain optimal sampling of mucosal fluids and tissues. Once such a correlate is established, it may be easier to confirm that correlate in future human efficacy trials.
More than 90% of all HIV infections worldwide occur via a mucosal route with the predominant mode of transmission through sexual contact at the genital and lower gastrointestinal tract mucosa. The time-frame for the crucial interactions that take place between virus and host during initial mucosal infection is so short that for practical reasons they cannot easily be studied in-depth in humans. At the time HIV-infected individuals begin experiencing the symptoms of acute HIV infection they are already in the later stages of infection. Therefore, defining the crucial events that take place at the earliest stages of infection requires the use of model systems. There is no ideal animal model for HIV infection of humans. However, the infection of macaques with SIV results in a very similar clinical outcome, and as with HIV infection of humans, the lymphoid tissues of SIV-infected macaques are the reservoirs of virus production, virus persistence, CD4+ T-cell depletion and pathogenesis. Moreover, for vaginal infection macaque models can reasonably approximate the anatomy, target-cell population and immunology of the human host. For these reasons and others, the macaque/SIV system has emerged as the model of choice for AIDS research, including that of investigating protection strategies with vaccines.
Designing a highly efficacious HIV vaccine may require a thorough understanding of the virus transmission process, including the precise identification of the cells infected at the earliest stages of infection, together with a thorough understanding of the immune responses that prevent or otherwise impact infection of these target cells. It may be possible to model the efficacy observed in the Thai trial with versions of the vaccine expressing or containing the analogous SIV antigens to gain insights on the immune correlate. In addition, there have been other SIV vaccines that have shown limited success in macaques challenged with SIV (via both IV and mucosal routes), ranging from the lowering of peak and set point virus load (often with reduced pathology and disease), to abortive infection, to apparent sterilizing protection in a subset of immunized animals. In each case, researchers have had difficulty identifying the precise correlate of immunity. Even when the correlate of protection (the presence of neutralizing antibodies in the serum of immunized macaques) was known, the mechanism of antibody action at mucosal surfaces was not clearly understood.
Thus, while human clinical trials have provided tantalizing evidence that the development of an efficacious vaccine is possible, there is a vital need to exploit macaque NHP model systems to gain a better understanding of the earliest events in virus transmission and establishment of infection and the immune responses that can alter these events, with the ultimate goal of using this information to design a vaccine that will provide a high degree of efficacy against HIV in humans. Further, the research effort in this regard calls for multidisciplinary synergistic consortia that can wisely apply the most advanced tools and considerable NHP resources.
For the purposes of this FOA, acute infection refers to a relatively broad period of early viral kinetics from the first infection of virus susceptible target cells to that of propagation and dissemination of virus first to local lymph nodes and then to intestinal lymphoid tissue and inclusive of the period when virus has spread systemically and set-point blood plasma virus load has been established. In describing the kinetics of HIV infection in humans, the earliest stage of acute infection is sometimes referred to as the eclipse stage, a relatively narrow range of time from the very first infection of virus susceptible cells to that of local propagation but prior to dissemination of virus systemically. Evidence suggests that this is a period represented by approximately the first 10 days of infection just prior to initial detection of plasma vRNA in the blood. Staging of these acute infection events has not been as firmly defined in macaques infected with SIV (or SHIV or HIV) as it has for humans infected with HIV. However, because interventions (such as with vaccines) in the eclipse stage are likely to have the greatest impact on establishment of virus infection, control of virus replication, prevention of CD4+ T cell depletion, and the subsequent events leading to disease, this early stage is the primary focus of this FOA.
Research Objectives and Scope
Applicants are required to assemble a multidisciplinary team of investigators who will propose a research plan designed to conduct a collaborative, interactive, and comprehensive investigation of acute mucosal SIV infection (including initial infection and spread to local lymph nodes and intestinal lymphoid tissue), and to determine which vaccines and which immune responses can block or modulate these early events of SIV infection to prevent infection or disease. It is essential that the proposed teams have demonstrated experience and expertise in SIV biology and molecular biology, nonhuman primate immunology, mucosal immunology, virology, vaccinology, systems biology, cellular biology, and the technologies needed to conduct the investigations requested under this FOA. Applications must include (1) a component that investigates aspects of events of acute SIV mucosal-route exposure and infection, in particular those events within the eclipse stage as defined above, and (2) a component that investigates the generation of mucosal immune responses by SIV vaccines and the effect these immune responses have on the initiation and spread of SIV infection. These studies must be conducted in cervico-vaginal models of SIV infection of macaques. Studies involving intrarectal and/or penile infection models may also be included. Applications may include (a) the development of assays required to detect virus and virus-specific immune responses in mucosal tissue, (b) the development of reagents and optimization of NHP model systems needed for the research of the consortium, and (c) investigation of events in early, nonpathogenic SIV infection of natural hosts when used in comparison with acute events in pathogenic SIV infection.
The following list of research areas that could be addressed under each of the major areas of investigation for this FOA is not intended to be comprehensive, and all of the topics do not have to be addressed, but the list is intended to serve as a basis for the development of a comprehensive research program that will improve understanding of mucosal infection and immunity and lead to the identification of a vaccine or vaccines that induce protection against this route of virus challenge.
I. Investigations of the basic biology of early events:
II. Investigation of the effect of vaccines on early events in SIV mucosal route infection of macaques:
III. Understanding nonpathogenic SIV infection in natural NHP host species (e.g., in African Green monkeys infected with SIVagm, or Sooty Mangabeys infected with SIVsm):
IV. Investigation of virus/macaque host models:
Note: Although the primary focus of this FOA is to support research in macaque/SIV infection models, research that also includes either or both SHIV and HIV (HIV-1 and HIV-2) infection models in macaques may be considered within the research areas listed in sections I, II, and IV above.
Applicants will be expected to:
DAIDS encourages the inclusion of new and/or early-career investigators (e.g., who are in the first five years of a faculty position) for positions within the consortium.
Additional Information for Multi-Project Applications
Research Project: If submitting a multi project P01 application, at least two research projects must be proposed for the application to be considered responsive.
Administrative Core (required): An administrative core is a resource to the multi-project grant, providing for the overall management, coordination and supervision of the Program. As part of the administrative core, provide an administrative plan that includes:
Funding for the overall administrative efforts, including secretarial, and/or other administrative services, expenses for publications demonstrating collaborative efforts, and communication expenses, should be requested here.
The following topics will not be supported by this FOA and will be considered non-responsive:
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
1. Mechanism
of Support
This FOA will use the P01 award mechanism. The Project
Director/Principal Investigator (PD/PI) will be solely
responsible for planning, directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
2. Funds Available
NIAID intends to commit approximately $5.0M for this FOA for fiscal year 2011 to fund 1 to 2 applications.
Consortium facilities and administrative costs are not included in the direct cost cap.
Additional funds will not be provided for acquisition of major instrumentation exceeding $25,000. However, funds can be requested if adequately justified, for modification of existing equipment such as expansion of optical detection capabilities needed to facilitate the project. It is expected that a request for additional funds will not exceed $25,000.
Because the nature and scope
of the proposed research will vary from application to application, it is
anticipated that the size and duration of each award will also vary. Although
the financial plans of the IC(s) provide support for this program, awards
pursuant to this funding opportunity are contingent upon the availability of
funds.
Facilities and Administrative
(F&A) costs requested by consortium participants are not included in the
direct cost limitation. See NOT-OD-05-004.
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.
Section III. Eligibility Information
1. Eligible Applicants
1.A.
Eligible Institutions
The
following organizations/institutions are eligible to apply:
1.B. Eligible Individuals
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI 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 program support.
More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
2. Cost Sharing or Matching
This program does not require cost
sharing as defined in the current NIH Grants Policy Statement.
3. Other-Special Eligibility Criteria
Number of Applications: Applicants may submit more than one application, provided each application is scientifically distinct.
Resubmissions: Resubmission applications are not permitted in response to this FOA.
Renewals: Renewal applications are not permitted in response to this FOA.
Section IV. Application and Submission Information
1. Address to Request Application
Information
The
current PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. For further assistance contact GrantsInfo, Telephone (301)
710-0267, Email: [email protected].
Telecommunications
for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Prepare
all applications using the PHS 398 application forms and in accordance with the
PHS 398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html).
Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.
The title and number of this funding
opportunity must be typed in item (box) 2 only of the face page of the
application form and the YES box must be checked.
The
exceptions from the PHS 398 instructions and detailed information on the
application structure and components are provided in Section IV.6 Other Submission
Requirements . All applicants must follow the
specific instructions in that section.
Foreign Organizations (Non-domestic (non-U.S.) Entity)
NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Applications from foreign organizations must:
In addition, for applications from foreign organizations:
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.
Applications with Multiple PDs/PIs
When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a 3h for all PD/PIs. NIH requires one PD/PI be designated as the contact PD/PI for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the Contact PD/PI, et. al. The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.
All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the section of the Research Plan entitled Multiple PD/PI Leadership Plan must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.
Additional information is available in the PHS 398 grant application instructions.
3. Submission Dates and Times
Applications
must be received on or before the receipt date described below (Section
IV.3.A). Submission times N/A.
3.A. Submission, Review, and Anticipated Start Dates
Letters
of Intent Receipt Date: October 1, 2010
Application Due Date: November 3, 2010
Peer
Review Date: March 2011
Council Review Date: May 2011
Earliest Anticipated Start Date: July
2011
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
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.
The
letter of intent is to be sent by the date listed in Section IV.3.A.
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
6700-B Rockledge
Drive
Bethesda, MD 20892-7616
Bethesda, MD 20817-7616 (for express mail)
Telephone: 301-496-8426
Fax: 301-480-2310
Email: [email protected]
3.B. Sending an
Application to the NIH
Applications must be prepared using the
forms found in the PHS 398 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)
Personal deliveries of applications are no
longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At
the time of submission, two additional copies of the application and all copies
of the appendix material must be sent to:
Peter R. Jackson, Ph.D.
Division of
Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3133, MSC-7616
6700-B Rockledge
Drive
Bethesda, MD 20892-7616
Bethesda, MD 20817-7616 (for express mail)
Telephone: 301-496-8426
Fax: 301-480-2310
Email: [email protected]
3.C. Application
Processing
Applications must be received on or before the
application receipt date described above (Section
IV.3.A.). If an application is received after that
date, the application may be delayed in the review process or not reviewed.
Upon receipt, applications will be evaluated for completeness by the CSR and
for responsiveness by the reviewing Institute. Incomplete and/or non-responsive
applications will not be reviewed.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.
Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.
4.
Intergovernmental Review
This
initiative is not subject to intergovernmental
review.
5. Funding Restrictions
All
NIH awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable. A grantee
may, at its own risk and without NIH prior approval, incur obligations and
expenditures to cover costs up to 90 days before the beginning date of the
initial budget period of a new award if such costs: 1) are necessary to conduct
the project, and 2) would be allowable under the grant, if awarded, without NIH
prior approval. If specific expenditures would otherwise require prior
approval, the grantee must obtain NIH approval before incurring the cost. NIH
prior approval is required for any costs to be incurred more than 90 days
before the beginning date of the initial budget period of a new award.
The
incurrence of pre-award costs in anticipation of a competing or non-competing
award imposes no obligation on NIH either to make the award or to increase the
amount of the approved budget if an award is made for less than the amount
anticipated and is inadequate to cover the pre-award costs incurred. NIH
expects the grantee to be fully aware that pre-award costs result in borrowing
against future support and that such borrowing must not impair the grantee's
ability to accomplish the project objectives in the approved time frame or in
any way adversely affect the conduct of the project (see the NIH Grants Policy Statement).
6. Other Submission Requirements
Supplemental Instruction for the Preparation of Multi-Project Applications
The following section supplements the instructions found in Form PHS 398 for preparing a multi-project grant application (P01). 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 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 Core Units Describes modifications to PHS Form 398 instructions on selected items to address the collaborative or interactive role of the project.
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.
1. Form Page 1 - Face Page
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.
When
multiple PDs/PIs are proposed, use the Face Page-Continued page to provide
items 3a-3h for all PDs/PIs. The Contact PI should be listed on block 3
of Form Page 1-Face Page, with additional PDs/PIs listed on the Face
Page-Continued.
2. Form Page 2
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(s)/PI(s) 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.
3. Form Page 3 - Table of Contents
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."
4. Composite Budget
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. Biostat. Core |
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 |
5. Form Page 5
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.
6. Biographical Sketch Format Page
Biographical sketches of all professional personnel for all
components should be placed at the end of the
application with the PI(s)/PD(s) first, followed by those of other key
personnel in alphabetical order.
7. Resources Format Page
Do not complete. Essential information is
to be presented in the individual research project and core sections of the application.
8. Program Overview (Research Objectives and
Strategic Plan)
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.
9. Leadership Plan for Multiple PDs/PIs (required if applicable)
Applications designating multiple PDs/PIs for the overall Program must include a new section, entitled Multiple PD/PI Leadership Plan , as part of the Program Overview. This Plan must describe: a rationale for choosing a multiple PD/PI approach; the governance and organizational structure of the leadership team and the research projects and cores; communication plans, processes for making decisions on scientific direction, and procedures for resolving conflicts; the administrative, technical, and scientific roles and responsibilities for the PDs/PIs and other collaborators. If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should also be delineated. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.
Please note: A separate leadership plan is not required within individual project(s) and core(s) that designate multiple Project/Core Leaders.
10. Checklist
One Checklist, placed at the end of the application, is to
be submitted for the entire application.
11. Appendix Materials
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.
B. Specific Instructions for Individual Research Projects
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:
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
Research Plan
Resources
1. Cover Page
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):
Project Number and Title: (e.g., 1. Preclinical Evaluation of HIV Microbicides)
Name of Project Leader: (e.g., Jones, Roberta A.)
Human Subjects: (Yes or No)
If Yes, exemption number:
(or)
IRB Approval Date: (e.g., 12/13/2006,or "Pending")
(and)
Federalwide Assurance (FWA) number:
Vertebrate Animals: (Yes or No)
If Yes, IACUC Approval Date: (e.g., 11/17/2006, or Pending)
(and)
Animal welfare assurance number:
Proposed Period of Support:
From: (mmddyy - e.g., 07/01/2007)
To: (mmddyy - e.g., 06/30/2112)
Costs Requested for Initial Budget Period: (e.g. 07/01/2007-06/30/2008)
Direct Costs: (e.g., $ 150,000)
Total Costs: (e.g., $162,000)
Costs Requested for the Entire Budget Period: (e.g., 07/01/2007-06/30/2112)
Direct Costs: (e.g., $700,000)
Applicant Organization (full address)
2. Form Page 2
Provide a Description (abstract) of the research proposed in the 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 research
project will contribute towards attainment of the multi-project program
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.
3. Form Page 3
Prepare a Table of Contents for the research project using Form Page 3 of the PHS 398.
4. Budget Pages (PHS 398 Form Pages 4 and 5)
Prepare a detailed budget and justification for the research project using Form Pages 4 and 5 of the PHS 398.
5. Research Plan
Introduction (For Resubmission or Revision Projects within a Resubmission or Revision Application Only. Limited to 1 page.)
See specific instructions in 2.7 Resubmission Applications and 2.8 Revision Applications on the content of the Introduction. New applications and projects should not include an Introduction.
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 project's relationship to the multi-project program 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 program'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 and progress reports for renewal and revision projects as part of a renewal or revision application must be included as part of the approach section.
6. Resources
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.
7. Biographical Sketches
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).
8. Select Agent Research (if applicable)
As directed in the PHS 398 Instructions, provide a description of all facilities where the Select Agent(s) will be used in the project. Describe the procedures that will be used to monitor possession, use and transfer of the Select Agent(s). Describe plans for appropriate biosafety, biocontainment, and security of the Select Agent(s). Describe the biocontainment resources available at all performance sites.
C. Specific Instructions for Core(s)
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
Research Plan
Resources Format Page
1. Cover 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):
Core Letter and Core Title: (e.g., A. Monoclonal Antibody Production Core)
Name of Core Leader: (e.g., Smith, Robert A.)
Human Subjects (Yes or No)
If Yes, Exemption Number:
(or)
IRB Approval Date: (e.g., 5/14/06, or Pending)
(and)
Federalwide Assurance (FWA) number:
Vertebrate Animals (Yes or No)
If Yes, IACUC Approval Date: (e.g., 4/15/07, or Pending)
(and)
Animal welfare assurance number:
Proposed Period of Support:
From: (mmddyy, e.g., 07/01/2007)
To: (mmddyy, e.g., 06/30/2012)
Costs Requested for Initial Budget Period:
Direct Costs (e.g. $50,000)
Total Costs (e.g. $70,000)
Costs Requested for the Entire Budget Period:
Direct Costs (e.g. $212,323)
Total Costs (e.g. $297,252)
Applicant Organization:
(ABC University; 111 Main Street; Anywhere, Else 99999)
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.
2. Form Page 2
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 multi-project program 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.
3. Form Page 3
Prepare a Table of Contents for the core using page 3 of Form PHS 398.
4. Budget Pages (PHS 398 Form Pages 4 and 5)
Prepare a detailed budget and justification for the core using Form Pages 4 and 5 of the PHS 398.
5. Research Plan
Introduction (For Resubmission or Revision Projects within a Resubmission or Revision Application Only. Limited to 1 page.)
See specific instructions in 2.7 Resubmission Applications and 2.8 Revision Applications on the content of the Introduction. New applications and cores should not include an Introduction.
Specific Aims (Limited to 1 page.)
List in priority order, the broad, long-range objectives and goals of the proposed core. Concisely and realistically describe the hypothesis or hypotheses to be tested. In addition, state the core’s relationship to the multi-project program goals and how it relates to the research projects or other cores in the application.
Core Research Strategy (Limited to (6) pages.)
Use this section to describe how the proposed core activities will contribute to meeting the program's 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 multi-project 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 cores and progress reports for renewal and revision cores in a renewal or revision application must be included as part of the approach section.
6. Resources
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.
7. Biographical Sketches
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).
8. Select Agent Research (if applicable)
As directed in the PHS 398 Instructions, provide a description of all facilities where the Select Agent(s) will be used with respect to the core. Describe the procedures that will be used to monitor possession, use and transfer of the Select Agent(s). Describe plans for appropriate biosafety, biocontainment, and security of the Select Agent(s). Describe the biocontainment resources available at all performance sites.
PHS398 Research Plan Sections
All application instructions outlined in the PHS398 Application Instructions are to be followed, with the following additional requirements:
Budget
This FOA uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
Appendix Materials
All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.
Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may be delayed in the review process or not reviewed.
See Section IV.2, Content and Form of Application Submission and additional text above for page limitations associated with multi-project applications.
Resource Sharing Plan(s)
NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.
Foreign Applications (Non-Domestic [non-U.S.] Entities)
All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096.
Section V. Application Review Information
1. Criteria
Only the review criteria described below will be considered in the review process.
2. Review and Selection Process
Review Process
Applications that are complete and responsive to this FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIAID and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.
As part of the scientific peer review, all applications will:
The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Overall Impact
Reviewers will provide an overall impact/priority 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 five scored review criteria, and additional review criteria (as applicable for the project proposed).
Scored Review Criteria
Reviewers will consider each of the five review criteria below in the determination of scientific and technical 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/PIs, 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/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
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? Specifically, is the proposed facility for housing and conducting animal studies adequate?
In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the impact/priority score.
Overall Impact of the Multi-Project Application: 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 meet the objectives of the FOA? Will the integration of the individual projects into a single program be more beneficial than pursuing each project independently? Does the PI/PD(s) have the leadership and scientific ability to develop an integrated and focused research program? Will the PI/PD(s) and other Project/Core Leaders devote adequate time and effort to the program? Is there adequate evidence of sufficient institutional support for the PD/PI(s) in terms of laboratory space, equipment and other resources? For applications designated multiple PDs/PIs, is the Leadership Plan both adequate and appropriate to ensure that there will be sufficient coordination and communication among the PDs/PIs? Are the administrative plans for the management of projects, including plans for resolving conflicts, appropriate? Are the central objectives of this FOA addressed with required studies in cervico-vaginal models of SIV infection of macaques?
Administrative Core: 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? Are plans adequate and appropriate for how data will be collected, managed, and distributed across the component organizations?
Additional Review Criteria
As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, 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.
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.
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, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.
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.
Resubmission Applications. Resubmissions are not allowed for this FOA.
Renewal Applications. Renewals are not allowed for this FOA.
Revision Applications. Revisions are not allowed for this FOA.
Additional Review Considerations
As applicable for the project proposed, reviewers will address 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 Agents 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 (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).
Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Selection Process
Applications submitted in response to this FOA will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:
3. Anticipated Announcement and Award
Dates
Not Applicable
Section
VI. Award Administration Information
1. Award Notices
After the peer review of the application is completed, the PD/PI will be able
to access his or her Summary Statement (written critique) via the NIH eRA Commons.
If the application is under consideration
for funding, NIH will request "just-in-time" information from the
applicant. For details, applicants may refer to the NIH Grants Policy
Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.
A
formal notification in the form of a Notice of Award (NoA) will be provided to
the applicant organization. The NoA signed by the grants management officer is
the authorizing document. Once all administrative and programmatic issues have
been resolved, the NoA will be generated via email notification from the
awarding component to the grantee business official.
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. See Section IV.5.,
Funding Restrictions.
2. Administrative and
National Policy Requirements
All
NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the Notice of Award. For these terms of award, see the
NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
3. Reporting
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 Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research (program), peer review, and financial or grants management issues:
1. Scientific/Research Contact(s):
Jon Warren, Ph.D.
Division of AIDS
National Institute of
Allergy and Infectious Diseases
Room 5135, MSC-7628
6700-B Rockledge
Drive
Bethesda, MD 20892-7628
Telephone: (301)
402-0633
Fax: 301-402-3684
Email: [email protected]
2. Peer Review Contact(s):
Peter R. Jackson, Ph.D.
Division of
Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3133, MSC-7616
6700-B Rockledge
Drive
Bethesda, MD 20892-7616
Bethesda, MD 20817-7616 (for express mail)
Telephone: 301-496-8426
Fax: 301-480-2310
Email: [email protected]
3. Financial/Grants Management Contact(s):
Jane Paull
Division of
Extramural Activities
National Institute of
Allergy and Infectious Disease
Room 2119r, MSC-7614
6700-B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: 301-594-1544
Fax: 301-493-0597
Email: [email protected]
Section VIII. Other Information
Required Federal Citations
Use
of Animals in Research:
Recipients
of PHS support for activities involving live, vertebrate animals must comply
with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects Protection:
Federal
regulations (45CFR46) require that applications and proposals involving human
subjects must be evaluated with reference to the risks to the subjects, the
adequacy of protection against these risks, the potential benefits of the
research to the subjects and others, and the importance of the knowledge gained
or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data
and safety monitoring is required for all types of clinical trials, including
physiologic toxicity and dose-finding studies (phase I); efficacy studies
(Phase II); efficacy, effectiveness and comparative trials (Phase III).
Monitoring should be commensurate with risk. The establishment of data and
safety monitoring boards (DSMBs) is required for multi-site clinical trials
involving interventions that entail potential risks to the participants (NIH
Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators
submitting an NIH application seeking $500,000 or more in direct costs in any
single year are expected to include a plan for data sharing or state why this
is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators
should seek guidance from their institutions, on issues related to
institutional policies and local IRB rules, as well as local, State and Federal
laws and regulations, including the Privacy Rule.
Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in
advancing genome-wide association studies (GWAS) to identify common genetic
factors that influence health and disease through a centralized GWAS data
repository. For the purposes of this policy, a genome-wide association study is
defined as any study of genetic variation across the entire human genome that
is designed to identify genetic associations with observable traits (such as
blood pressure or weight), or the presence or absence of a disease or
condition. All applications, regardless of the amount requested, proposing a
genome-wide association study are expected to provide a plan for submission of
GWAS data to the NIH-designated GWAS data repository, or provide an appropriate
explanation why submission to the repository is not possible. Data repository
management (submission and access) is governed by the Policy for Sharing of
Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/.
Access to Research Data through the Freedom
of Information Act:
The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a project
that is supported in whole or in part with Federal funds and (2) cited publicly
and officially by a Federal agency in support of an action that has the force
and effect of law (i.e., a regulation) may be accessed through FOIA. It is
important for applicants to understand the basic scope of this amendment. NIH
has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
Sharing of Model Organisms:
NIH
is committed to support efforts that encourage sharing of important research
resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the application/proposal
a description of a specific plan for sharing and distributing unique model
organism research resources generated using NIH funding or state why such
sharing is restricted or not possible. This will permit other researchers to
benefit from the resources developed with public funding. The inclusion of a
model organism sharing plan is not subject to a cost threshold in any year and
is expected to be included in all applications where the development of model
organisms is anticipated.
Inclusion of Women And Minorities in Clinical Research:
It
is the policy of the NIH that women and members of minority groups and their
sub-populations must be included in all NIH-supported clinical research
projects unless a clear and compelling justification is provided indicating
that inclusion is inappropriate with respect to the health of the subjects or
the purpose of the research. This policy results from the NIH Revitalization
Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing
clinical research should read the "NIH Guidelines for Inclusion of Women
and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans to
conduct analyses, as appropriate, to address differences by sex/gender and/or
racial/ethnic groups, including subgroups if applicable; and b) investigators
must report annual accrual and progress in conducting analyses, as appropriate,
by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical
Research:
The
NIH maintains a policy that children (i.e., individuals under the age of 21)
must be included in all clinical research, conducted or supported by the NIH,
unless there are scientific and ethical reasons not to include them.
All
investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as
participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human Subject
Participants:
NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH applications for research involving human
subjects and individuals designated as key personnel. The policy is available
at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria
for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov).
It is the responsibility of the applicant to provide in the project description
and elsewhere in the application as appropriate, the official NIH identifier(s)
for the hESC line(s) to be used in the proposed research.
NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them
their final, peer-reviewed manuscripts that arise from NIH funds and are
accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months
after publication. As of May 27, 2008, investigators must include the PubMed
Central reference number when citing an article in NIH applications, proposals,
and progress reports that fall under the policy, and was authored or
co-authored by the investigator or arose from the investigator’s NIH award.
For more information, see the Public Access webpage at http://publicaccess.nih.gov/.
Standards for Privacy of Individually
Identifiable Health Information:
The
Department of Health and Human Services (DHHS) issued final modification to the
"Standards for Privacy of Individually Identifiable Health
Information", the "Privacy Rule", on August 14, 2002. The
Privacy Rule is a federal regulation under the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 that governs the protection of individually
identifiable health information, and is administered and enforced by the DHHS
Office for Civil Rights (OCR).
Decisions
about applicability and implementation of the Privacy Rule reside with the
researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within
specified page limitations. For publications listed in the appendix and/or
Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for the review because reviewers are
under no obligation to view the Internet sites. Furthermore, we caution
reviewers that their anonymity may be compromised when they directly access an
Internet site.
Healthy
People 2010:
The
Public Health Service (PHS) is committed to achieving the health promotion and
disease prevention objectives of "Healthy People 2010," a PHS-led
national activity for setting priority areas. This FOA is related to one or
more of the priority areas. Potential applicants may obtain a copy of
"Healthy People 2010" at http://www.health.gov/healthypeople.
Authority
and Regulations:
This
program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372. 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 52 and 45 CFR Parts 74 and 92. All awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy Statement. The
NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
The
PHS strongly encourages all grant recipients to provide a smoke-free workplace
and discourage the use of all tobacco products. In addition, Public Law
103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities
(or in some cases, any portion of a facility) in which regular or routine
education, library, day care, health care, or early childhood development
services are provided to children. This is consistent with the PHS mission to
protect and advance the physical and mental health of the American people.
Loan
Repayment Programs:
NIH
encourages applications for educational loan repayment from qualified health
professionals who have made a commitment to pursue a research career involving
clinical, pediatric, contraception, infertility, and health disparities related
areas. The LRP is an important component of NIH's efforts to recruit and retain
the next generation of researchers by providing the means for developing a
research career unfettered by the burden of student loan debt. Note that an NIH
grant is not required for eligibility and concurrent career award and LRP
applications are encouraged. The periods of career award and LRP award may
overlap providing the LRP recipient with the required commitment of time and
effort, as LRP awardees must commit at least 50% of their time (at least 20
hours per week based on a 40 hour week) for two years to the research. For
further information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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