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: B Cell Immunology for Protective HIV-1 Vaccines (U01)
Announcement Type
New
Request For Applications (RFA) Number: RFA-AI-07-014
Catalog of Federal Domestic Assistance Number(s)
93.855,
93.856
Key Dates
Release
Date: March 13, 2007
Letters
of Intent Receipt Date(s): May 29, 2007
Application
Receipt Date(s): June 29, 2007
Peer
Review Date(s): October 2007
Council
Review Date(s): January 2008
Earliest
Anticipated Start Date: February 2008
Additional Information To Be Available Date (Url
Activation Date): http://www.niaid.nih.gov/ncn/budget/qa/
Expiration
Date: June 30, 2007
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 and Review and Anticipated Start Dates
1.
Letter of Intent
B.
Sending an Application to the NIH
C.
Application Processing
4.
Intergovernmental Review
5.
Funding Restrictions
6. Other
Submission Requirements
Section
V. Application Review Information
1.
Criteria
2.
Review and Selection Process
A.
Additional Review Criteria
B.
Additional Review Considerations
C.
Sharing Research Data
D.
Sharing Research Resources
3.
Anticipated Announcement and Award Dates
Section
VI. Award Administration Information
1. Award
Notices
2.
Administrative and National Policy Requirements
A.
Cooperative Agreement Terms and Conditions of Award
1.
Principal Investigator Rights and Responsibilities
2.
NIH Responsibilities
3.
Collaborative Responsibilities
4.
Arbitration Process
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
The goal of this FOA is to support high impact basic immunology studies and innovative methods that may lead to induction of broadly reactive, neutralizing antibodies that can prevent infection by a wide spectrum of clinically relevant HIV-1 virus strains. The program will create new research enterprises focused on a key parameter for HIV-1 vaccine development: defining the basic immune mechanisms by which an effective and robust neutralizing antibody response can be elicited in uninfected individuals to protect against a broad range of HIV-1 strains. Broadly neutralizing antibodies are defined for the purpose of this FOA as those with the ability to block multiple, diverse primary isolates of HIV-1 from infecting cells, such that the antibodies prevent or substantially limit infection in vitro or in vivo.
This U01 cooperative agreement grant program will support well developed basic immunology research on B cell and antibody regulation as a foundation for the future development of novel HIV-1 vaccine candidates. Expertise in both basic immunology and the HIV-1 virus should be evident on the research team. In parallel with this announcement, the NIAID is also soliciting R21 exploratory/development grant applications to support innovative research projects, focused on the same high impact scientific area, which do not yet have supporting preliminary data (RFA-AI-07-015).
Background
Identifying approaches that induce effective and broadly neutralizing antibodies is a priority of the Global HIV/AIDS Vaccine Enterprise (http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0020025). Despite a large international investment of research funds, expertise, and innovative thinking over the past two decades, the prospects for an effective HIV-1 vaccine in the near future remain uncertain. The immune correlates of protection against HIV-1 are still unknown, in part because protective immunity has not been observed after natural infection. The immune responses known to be induced by infection are not able to sufficiently contain viral replication, and the virus has proved to be extraordinarily adept at mutating to escape responding immune cells and mediators. Extensive variability in pathogenic HIV-1 viruses dictates the need for a vaccine that can protect against most if not all of the circulating strains. Certain vaccine formulations were found to activate CD8 and CD4 T cell responses in nonhuman primates, but vaccines based primarily on T cell activation have not prevented infection in those models. On the other hand, the passive administration of defined neutralizing antibodies was found to block infection in nonhuman primates when virus was given either by mucosal or intravenous challenge. These results provide a strong impetus to refocus efforts on the antibody response, which, together with a strong T cell response, may be needed for a successful vaccine.
Clearly, the requirements for a protective antibody response are unusually difficult to fulfill in the case of the HIV-1 virus, which has extensive genetic variability and is constantly evolving with passage through human populations. A successful vaccine may need to generate systemic and mucosal antibodies and memory B cells reactive with conserved regions of the virus. Furthermore, given evidence that a single free gp120 trimer on a virion is sufficient to bind to and mediate entry into a CD4+CCR5+ cell, vaccine-generated antibodies should have high affinity for the envelope protein as well as broad cross-reactivity within and across HIV-1 clades.
Targeting the conserved regions of the HIV-1 envelope for antibody responses has proven to be extremely difficult, as a number of mechanisms combine to make these regions either non-immunogenic or poorly accessible to antibodies. For example, approximately 50% of the gp120 mass consists of carbohydrate groups that are synthesized by host cell enzymes and therefore resemble host glycoproteins to which the individual is immunologically tolerant. This glycan shield is surprisingly flexible in that many mutants with altered glycosylation sites resulting from antibody-mediated viral selection still retain significant pathogenicity. The five variable loops on the surface of gp120 can be highly immunogenic but they generally induce only strain specific and not broadly neutralizing antibodies.
Importantly, key conserved regions required for viral entry into cells are effectively masked by gp120 conformation to prevent antibody binding. The gp120 site that engages the CD4 cellular receptor to initiate cell binding is relatively conserved, but is recessed on the protein and is hidden on the gp120 trimer such that most antibodies are unable to bind. After engaging CD4, the gp120 trimer undergoes a major conformational change that exposes the binding site for the coreceptor (CCR5 or CXCR4) and also exposes the fusion domain of gp41. Thus, these conserved envelope domains crucial for cell binding and entry are only transiently available for antibody blockade. Although antibodies reactive with the coreceptor binding site have been observed in HIV-1-infected individuals, they are non-neutralizing in vitro, although Fab or single chain Fv fragments of the same antibodies can have neutralizing activity.
Finally, there is evidence that some of the conserved regions of HIV-1 may mimic epitopes on human antigens and therefore would not elicit effective antibody responses due to B cell tolerance to self antigens. Helper T cell tolerance to autoantigens might also prevent robust antibody responses to these epitopes.
Despite the many mechanisms by which HIV-1 can preclude or evade antibody responses to conserved domains, and despite its extraordinary capacity to generate mutant variants that retain pathogenicity, there is still optimism for an antibody-inducing vaccine strategy, based on the description of a small group of monoclonal antibodies that do have broadly neutralizing activity. These antibodies were isolated from human sources and shown to neutralize diverse primary isolates of HIV-1 in vitro. Several were also shown to protect against virus challenge in nonhuman primate model systems when administered singly or in combination. Examples of such antibodies include 2G12, which binds oligomannose chains on the gp120 trimer; IgG1b12, which binds to the CD4 contact site; 47e and 412d, which react with the coreceptor binding site of gp120 that is exposed only after CD4 binding; and 2F5 and 4E10, that bind membrane proximal gp41 epitopes. IgG1b12, 2F5, and 4E10 were recently shown to crossreact with certain human autoantigens, and structural features of 2F5 and 4E10 suggest the possibility that they might derive from polyreactive B cells of the B-1 or marginal zone subsets. Furthermore, some sera from HIV-1 infected persons are broadly neutralizing. Thus, although broadly neutralizing antibodies have not been found in most infected individuals, the existence of these monoclonal antibodies and antisera demonstrates that broadly neutralizing antibodies can be produced in humans and provides important clues about structures useful for broadly neutralizing activity. Recent advances in defining HIV-1 envelope protein structures either alone or complexed with such antibodies provide important information that may lead to new methods of inducing broadly neutralizing antibody responses by vaccination.
In addition, advances in understanding the basic immunology of B cell regulation, as well as helper T cells, dendritic cells, and innate immune mechanisms important for initiating and defining antibody responses, provide a strong foundation for renewed efforts to define the immunological requirements to develop a successful HIV-1 vaccine. In particular, the more sophisticated understanding of B cell biology that has evolved over the past several years supports the hope that innovative immunological approaches will result in successful HIV-1 vaccine development. Recent advances include a better understanding of the molecular mechanisms responsible for B cell tolerance; the checkpoints in B cell differentiation at which tolerance may be broken or imposed; improved methods for B cell antigen receptor repertoire analysis; the differential activation requirements of B cell subsets; definition of the surface receptors and intracellular signaling pathways that promote or inhibit B cell proliferation, survival, somatic mutation, and antibody production; the immunoregulation of plasma cells; and the mechanisms by which robust B cell memory is induced and maintained.
Research Objectives
This program will focus on B cell immunology and the basic mechanisms by which a broadly protective anti-HIV-1 antibody response may be induced and maintained. Examples of several specific areas of interest are described below. These and other research areas may be addressed in response to this FOA to define new antibody-focused immunological approaches relevant to the development of a successful HIV-1 vaccine.
Targets of broadly neutralizing antibodies. Epitopes for many of the known broadly neutralizing antibodies have been described, and it is not clear why HIV-1 vaccine candidates have been unsuccessful at inducing these types of antibodies. It would be useful to identify and characterize additional broadly neutralizing antibodies to provide a more comprehensive picture of the epitope and antibody structures involved. The potential HIV-1 specificities of the human pre- and post-selection B cell antigen receptor repertoires can be defined using current immunological methods, and examples of such antibodies can be tested for broadly neutralizing activity. The possibility that most of the conserved epitopes of the HIV-1 envelope may mimic human autoantigens should be further explored to determine whether immune self tolerance limits the repertoires of B or helper T cell specificities available to combat HIV-1. Should this be the case, studies to define neutralizing antibody induction that bypass tolerance without generating serious autoimmune reactions may be undertaken. For conserved epitopes that are not crossreactive with human antigens but are hidden from antibodies by gp120 structural features, strategies are needed that activate and expand B cells producing antibodies with properties that enable access to the site.
Relevant B cell subsets. Characteristic features of some of the known broadly neutralizing monoclonal antibodies suggest that they might derive from B-1 or marginal zone B cells, which often express polyreactive immunoglobulins. Studies in this area might provide insight on the specific B cell types that are the most promising targets for vaccine development. A related area is the study of the most appropriate isotypes of antibodies to target for protective responses.
Other immune cell types. The activation and expansion of helper T cells and inhibitory regulatory T cells are important parameters to study in the generation of an effective antibody response. The efficiency of uptake, processing, and presentation of HIV-1 immunogens by antigen-presenting cells will help dictate the magnitude and quality of the antibody response, and there may be value in specifically targeting antigens to particular dendritic cell subsets or to different antigen-presenting cell types. Study of the roles of HIV-1 specific B cells as antigen-presenting cells may also provide important information for vaccine design.
Innate immune responses and adjuvants. The stimulation of innate immune responses in the presence of appropriate antigens might allow activation of relevant B cells as well as generate a quantitatively greater response. The detection of functional Toll-like receptors on B cells suggests that there may be direct effects of innate immune stimulators on antigen responsive B cells as well as indirect effects resulting from dendritic cell maturation and cytokine secretion. Studies in this area could provide important new information to support adjuvant development for broadly neutralizing antibody responses.
Immune memory. Clearly, an HIV-1 vaccine will be most useful if the protection induced by priming can be maintained by a limited number of boosting immunizations. Immune memory must be maintained in both the CD4 helper T cell and B cell compartments, and creative research is needed in this area to define the requirements for the maintenance of immune memory for a broadly neutralizing antibody response.
Mucosal immunity. Most new HIV-1 infections occur via mucosal routes, and vaccine elicited antibody responses should block infection at mucosal surfaces as well as through systemic immunity. Little is known about the requirements for induction of broadly neutralizing antibodies that can function effectively at mucosal surfaces, and the activation and regulation of secretory IgA and IgG isotypes will be fruitful areas for further study. In addition, work is needed on adjuvants that target appropriate mucosal innate responses to foster productive B cell responses; approaches that bypass immune tolerance mechanisms unique to mucosal compartments; and methods to promote robust and long lasting mucosal B cell memory.
EXCLUDED from this RFA are applications that include research in the following areas; such applications will not be accepted for review:
Program Scope
Steering Committee. A synergistic network of B cell immunology research teams funded under this program will be established to foster interactive multidisciplinary approaches to advance progress in this area. The research network will be governed by a Steering Committee to coordinate and facilitate research activities for the overall program, and to ensure optimal research flexibility, synergy, and efficiency. Steering Committee members will include each Principal Investigator of awarded U01 grants, and will cooperate within the program to share resources, methods, and data to facilitate progress. The network investigators will also be provided opportunities to access resources from other NIAID-funded programs and to collaborate on research projects as appropriate. All research groups will share responsibility for program development and resource coordination through the Steering Committee, which will be established upon award of the grants. When appropriate, and in accordance with NIH policies (http://grants.nih.gov/grants/policy/data_sharing and http://www.ott.nih.gov/policy/rt_guide_final.html), U01 awardees will be expected to collaborate; share novel reagents, assays, animal models, and human samples; and share both positive and negative results that would help guide the research activities of other network members. The NIAID, in concert with the Steering Committee, will have the option to redirect research activities within the grants if it is considered beneficial to the overall program.
Milestones of Progress. This U01 program is milestone-based, and annual funding will depend on reasonable progress in meeting negotiated milestones.
Clinical Studies. Clinical trials will not be supported by this FOA; applications that include clinical trials are non-responsive and will not be accepted for review. However, studies on human tissues may be included and samples obtained from independently-funded clinical trials may be used in the proposed work. Applicants should describe how such studies will help to identify and characterize the underlying immune mechanisms and contribute to the goals outlined in this solicitation. Methods to address all regulatory requirements and the protection of human subjects must be described in the application.
See Section VIII, Other Information
- Required Federal Citations, for policies related to this announcement.
Section
II. Award Information
1. Mechanism(s) of Support
This
funding opportunity will use the U01 award mechanism.
As
an applicant, you will be solely responsible for planning, directing, and
executing the proposed project.
This
funding opportunity uses the just-in-time budget concepts. It also uses the
non-modular budget format described in the PHS 398 application instructions
(see http://grants.nih.gov/grants/funding/phs398/phs398.html).
A detailed categorical budget for the "Initial Budget Period" and the
"Entire Proposed Period of Support" is to be submitted with the application.
The
NIH U01 is a cooperative agreement award
mechanism. In the cooperative agreement mechanism, the Principal Investigator
retains the primary responsibility and dominant role for planning, directing,
and executing the proposed project, with NIH staff being substantially involved
as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements,
"Cooperative Agreement Terms and Conditions of Award".
Essential elements of the U01 include: (1) a single research project that may include consortium agreements, but does not include Core resources and facilities; (2) a single Principal Investigator who will be scientifically and administratively responsible for the research project; and (3) a single applicant institution that will be legally and financially responsible for the use and disposition of funds awarded.
This FOA is a one-time solicitation.
2. Funds Available
NIAID intends
to commit approximately $2.5 million in FY 2008 to fund 4-5 new grants in response to this FOA.
An applicant may request a project period of up to 5 years under this FOA, and a budget for direct costs up to $400,000 per year. The anticipated
start date is March 2008.
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 NIAID provide support for this
program, awards pursuant to this funding opportunity are contingent upon the
availability of funds and the receipt of a sufficient number of meritorious
applications.
Facilities
and administrative costs requested by consortium participants are not included
in the direct cost limitation, see NOT-OD-05-004.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You
may submit (an) application(s) if your organization has any of the following
characteristics:
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution 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. Established Principal Investigators leading research teams with expertise in both basic immunology and the HIV-1 virus, as evidenced by research experience and relevant publications, are particularly encouraged to apply.
2. Cost Sharing or Matching
This program does not require cost sharing or matching
funds.
The
most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing
3. Other-Special Eligibility Criteria
Applicants may submit
more than one application, but the applications must clearly be scientifically
distinct.
Clinical
Studies. Clinical
trials will not be supported by this FOA; applications that include clinical
trials are non-responsive and will not be accepted for review.
Section IV. Application and Submission Information
1. Address to Request Application Information
The
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
Applications
must be prepared using the most current PHS 398 research grant application
instructions and forms. 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 on line 2 of the face page of the
application form and the YES box must be checked.
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:
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.
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. Receipt, Review and Anticipated Start Dates
Letters
of Intent Receipt Date(s): May 29, 2007
Application
Receipt Date(s): June 29, 2007
Peer
Review Date(s): October 2007
Council
Review Date(s): January 2008
Earliest
Anticipated Start Date: February 2008
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 at
the beginning of this document.
The
letter of intent should be sent to:
Priti Mehrotra, Ph.D.
Division of
Extramural Activities
National Institute of
Allergy and Infectious Diseases
Room
Number 3138, MSC 7616
6700B Rockledge Drive
Bethesda, MD 20892-7616
Bethesda, MD 20817 (for express/courier
service; non-USPS service)
Telephone: (301)
435-9369
FAX: (301) 402-2638
Email: [email protected]
3.B. Sending an
Application to the NIH
Applications
must be prepared using the research grant applications 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:
Priti Mehrotra, Ph.D.
Division of
Extramural Activities
National Institute of
Allergy and Infectious Diseases
Room
Number 3138, MSC 7616
6700B Rockledge Drive
Bethesda, MD 20892-7616
Bethesda, MD 20817 (for express/courier
service; non-USPS service)
Telephone: (301) 435-9369
FAX: (301) 402-2638
Email: [email protected]
Using
the RFA Label: The RFA label available in the PHS
398 application instructions must be affixed to the bottom of the face page of
the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach
the review committee in time for review. In addition, the RFA title and number
must be typed on line 2 of the face page of the application form and the YES
box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.
3.C. Application
Processing
Applications
must be received on or before the application receipt date(s) described
above (Section IV.3.A.). If an application is
received after that date, it will be returned to the applicant without review.
Upon receipt, applications will be evaluated for completeness by the CSR and
responsiveness by the NIAID. Incomplete and 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. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
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 or competing
continuation award if such costs: are necessary to conduct the project, and
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 or competing continuation 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 NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission Requirements
Milestones and Timelines. Applicants must include a description of the milestones that will be met by the proposed work and corresponding timelines (may not exceed 5 pages). This section is to follow the Research Plan, but will not be counted in the page limit for the Research Plan. It shall include a detailed description of the milestones to be met each year, the criteria to be used to evaluate the satisfactory completion of each milestone, and a timeline to achieve the goals and milestones of the project. It is recognized that milestones may require revision and re-negotiation during the course of the project period.
External Advisory Groups (optional). Applicants may propose to include an external advisory group, but are not required to do so. If proposed, the applicant should explain the duties of that group and include costs for meetings of the group within the proposed budget. NOTE: applicants should not name specific potential members of an external advisory group in the application and potential members should not be contacted prior to award.
Scientific Meetings and Steering Committee Meetings. Each awardee will participate in a kickoff meeting of all awardees to be held soon after award in the Bethesda, MD area, and will participate in scientific meetings of all awardees to be held annually thereafter. All Principal Investigators are required to attend these meetings, together with additional scientific staff from their grants when appropriate. A Steering Committee will be established to serve as the governing board of the U01 group during the funding period. Voting members of this Committee will be the Principal Investigators of each U01 grant and the NIAID Project Scientist (Section VI.2.A.2). The Steering Committee will meet annually in conjunction with the annual Scientific Meetings.All travel costs for U01 personnel will be borne by the Principal Investigators and must be included in the requested budgets.
Information that May Be Included in the Application. Published manuscripts and/or abstracts that are publicly available in a free, online format may be referenced in the application. These publications may not be included in the appendix. URLs or NIH PubMed Central (PMC) submission identification numbers may be included along with the full reference in the Literature Cited (PHS 398) section, the Progress Report Publication List section and/or the Biographical Sketch section. While there is no limit to the number of URLs or PMC submission identification numbers that can be cited, applicants should be both judicious and concise.
Appendix. Follow the PHS 398 instructions. See http://grants1.nih.gov/grants/funding/phs398/phs398.html
Plan for Sharing Research Data
The
precise content of the data-sharing plan will vary, depending on the data being
collected and how the investigator is planning to share the data. Applicants
who are planning to share data may wish to describe briefly the expected
schedule for data sharing, the format of the final dataset, the documentation
to be provided, whether or not any analytic tools also will be provided,
whether or not a data-sharing agreement will be required and, if so, a brief
description of such an agreement (including the criteria for deciding who can
receive the data and whether or not any conditions will be placed on their
use), and the mode of data sharing (e.g., under their own auspices by mailing a
disk or posting data on their institutional or personal website, through a data
arcHIV-1e or enclave). Investigators choosing to share under their own auspices
may wish to enter into a data-sharing agreement. References to data sharing may
also be appropriate in other sections of the application.
All
applicants must include a plan for sharing research data in their application.
The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing.
All investigators responding to this funding opportunity should include a
description of how final research data will be shared, or explain why data
sharing is not possible.
The
reasonableness of the data sharing plan or the rationale for not sharing
research data will be assessed by the reviewers. However, reviewers will not
factor the proposed data sharing plan into the determination of scientific
merit or the priority score.
Sharing Research
Resources
NIH
policy expects that grant recipients make unique research resources readily
available for research purposes to qualified individuals within the scientific
community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan for
sharing research resources addressing how unique research resources will be
shared or explain why sharing is not possible.
The
adequacy of the resources sharing plan and any related data sharing plans will
be considered by Program staff of the funding organization when making
recommendations about funding applications. The effectiveness of the resource
sharing will be evaluated as part of the administrative review of each
non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm).
See Section VI.3. Reporting.
Section
V. Application Review Information
1. Criteria
Only
the review criteria described below will be considered in the review process.
The
following will be considered in making funding decisions:
2. Review and Selection Process
Applications
that are complete and responsive to the FOA will be evaluated for scientific
and technical merit by an appropriate peer review group convened by NIAID in accordance with the review criteria
stated below.
As
part of the initial merit review, all applications will:
The goals of NIH supported research are to advance our
understanding of biological systems, to improve the control of disease, and to
enhance health. In their written critiques, reviewers will be asked to comment
on each of the following criteria in order to judge the likelihood that the
proposed research will have a substantial impact on the pursuit of these goals.
Each of these criteria will be addressed and considered in assigning the
overall score, weighting them as appropriate for each application. Note that an
application does not need to be strong in all categories to be judged likely to
have major scientific impact and thus deserve a high priority score. For
example, an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.
Significance: Does this
study address an important problem? If the aims of the application are
achieved, how will scientific knowledge or clinical practice be advanced? What
will be the effect of these studies on the concepts, methods, technologies,
treatments, services, or preventative interventions that drive this field? Does
this study address an important aspect of how to induce broadly reactive
anti-HIV-1 neutralizing antibody? If the Aims of the application are achieved,
how will scientific knowledge or community/clinical practice be advanced?
Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Does the application reflect clear integration of expertise in B cell immunology and HIV such that advances in B cell immunology are applied to the problem of HIV-1 vaccine design? Is the approach designed to overcome a defined problem in eliciting broadly reactive anti-HIV-1 neutralizing antibody?
Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in developing a preventive HIV-1 vaccine? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?
Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the Principal Investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)? Does the research team comprise and benefit from generally recognized experts in B cell immunology and HIV who are considered to be uniquely qualified to address the goals of this FOA?
Environment: Does the scientific environment in
which the work will be done contribute to the probability of success? Do the
proposed studies benefit from unique features of the scientific environment, or
subject populations, or employ useful collaborative arrangements? Is there
evidence of institutional support?
2.A. Additional
Review Criteria:
In
addition to the above criteria, the following items will continue to be
considered in the determination of scientific merit and the priority score:
Protection
of Human Subjects from Research Risk: The involvement of human subjects
and protections from research risk relating to their participation in the
proposed research will be assessed (see the Research Plan, Section E on Human
Subjects in the PHS Form 398).
Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include
subjects from both genders, all racial and ethnic groups (and subgroups), and
children as appropriate for the scientific goals of the research will be
assessed. Plans for the recruitment and retention of subjects will also be
evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form
398).
Care
and Use of Vertebrate Animals in Research: If
vertebrate animals are to be used in the project, the five items described
under Section F of the PHS Form 398 research grant application instructions
will be assessed.
Biohazards: If
materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is
adequate.
2.B. Additional
Review Considerations
Budget: The reasonableness of the proposed
budget and the requested period of support in relation to the proposed
research. The priority score
should not be affected by the evaluation of the budget.
Milestones and Timelines. The appropriateness and feasibility of the defined milestones and timelines. The priority score should not be affected by the evaluation of the milestones and timelines.
Applications from Foreign Organizations: Whether the project presents 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 will be assessed but will not be considered in the priority score.
2.C.
Sharing Research Data
Data Sharing
Plan: The reasonableness of the data sharing plan or the rationale for not sharing
research data will be assessed by the reviewers. However, reviewers will not
factor the proposed data sharing plan into the determination of scientific
merit or the priority score. The presence of a data sharing plan will be part
of the terms and conditions of the award. The funding organization will be
responsible for monitoring the data sharing policy.
2.D. Sharing
Research Resources
NIH policy expects
that grant recipients make unique research resources readily available for
research purposes to qualified individuals within the scientific community
after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators
responding to this funding opportunity should include a sharing research
resources plan addressing how unique research resources will be shared or
explain why sharing is not possible.
Program staff will
be responsible for the administrative review of the plan for sharing research
resources.
The adequacy of the
resources sharing plan will be considered by Program staff of the funding
organization when making recommendations about funding applications. Program
staff may negotiate modifications of the data and resource sharing plans with
the awardee before recommending funding of an application. The final version of
the data and resource sharing plans negotiated by both will become a condition
of the award of the grant. The effectiveness of the resource sharing will be
evaluated as part of the administrative review of each non-competing Grant
Progress Report (PHS 2590). See Section VI.3. Reporting.
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 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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
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 (designated in
item 12 on the Application Face Page). If a grantee is not email enabled, a hard
copy of the NoA will be mailed to the 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 Also 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 NoA. 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).
The
following Terms and Conditions will be incorporated into the award statement
and will be provided to the Principal Investigator as well as to the
appropriate institutional official, at the time of award.
2.A. Cooperative
Agreement Terms and Conditions of Award
The
following special terms of award are in addition to, and not in lieu of,
otherwise applicable OMB administrative guidelines, HHS grant administration
regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and
local Governments are eligible to apply), and other HHS, PHS, and NIH grant
administration policies.
The
administrative and funding instrument used for this program will be the
cooperative agreement (U01), an "assistance" mechanism (rather than
an "acquisition" mechanism), in which substantial NIH programmatic
involvement with the awardees is anticipated during the performance of the
activities. Under the cooperative agreement, the NIH purpose is to support and
stimulate the recipients' activities by involvement in and otherwise working
jointly with the award recipients in a partnership role; it is not to assume
direction, prime responsibility, or a dominant role in the activities.
Consistent with this concept, the dominant role and prime responsibility
resides with the awardees for the project as a whole, although specific tasks
and activities may be shared among the awardees and the NIH as defined below.
2.A.1. Principal Investigator Rights and Responsibilities
The
Principal Investigator will have the primary responsibility for: defining the research plan and goals;
overseeing/performing the scientific activities of the plan; monitoring the
accomplishment of successful completion of milestones within the timeframe and
budget proposed; cooperating with NIAID programmatic, technical and
administrative staff; and administratively managing the U01. Each Principal
Investigator will be a voting member of the Steering Committee, will
participate in all Steering Committee activities, and will follow the policies
and procedures developed by the Steering Committee.
Awardees
will retain custody of and have primary rights to the data and software
developed under these awards, subject to Government rights of access consistent
with current HHS, PHS, and NIH policies. However,
awardees must be committed to making research samples and tools, methods, data
and materials that they develop under this program available to other U01
members of this program as well as the research community.
If clinical studies are a component of the research proposed, NIAID policy requires that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study. An updated NIAID policy was published in the NIH Guide on July 8, 2002 and is available at: http://grants.nih.gov/grants/guide/notice-files/NOT-AI-02-032.html. The full policy, including terms and conditions of award, is available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf.
All clinical research activities performed under this award must be in compliance with all U.S. Federal regulations, guidance and NIH policies applying to the conduct of research involving human subjects and regulatory applications for new drug or biological licenses when applicable. These include, but are not limited to: U.S. Code of Federal Regulations (CFR) Title 21, Parts 11, 50, 54, 56, 312, 314, 601 and Title 45, Part 46; ICH guidance for Good Clinical Practice (GCP); and NIH grants policy (refer to http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). In addition, the awardee must assure that all sites in the U.S. and outside the U.S. comply with the following:
a. Each institution engaged in human subjects research has a current, approved Assurance Number on file with the DHHS Office for Human Research Protections (OHRP).
b. Each protocol and informed consent document is approved by the responsible Institutional Review Board (IRB)/Ethics Committee (EC) prior to subject entry.
c. For Investigational New Drug (IND) studies, each local Investigator of Record has supplied a completed FDA Form 1572 to NIAID for each protocol conducted at each site.
d. Each study investigator and sub-investigator has provided current curriculum vitae to NIAID.
e. Each study participant (or legal representative) will sign an IRB/EC-approved protocol consent prior to entry on study as part of the Informed Consent Process.
All
clinical research activities performed outside of the U.S. must, in addition to U.S. Federal regulations, comply with the host country regulations for
human subjects.
2.A.2. NIH
Responsibilities
An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.
The NIAID Division of Allergy, Immunology and Transplantation (DAIT) will serve as a liaison between pharmaceutical companies, the Food and Drug Administration (FDA) and program investigators when appropriate. In accordance with NIH policy, all clinical studies performed through this program must be conducted in accordance with applicable Federal regulations.
A program official from DAIT will serve as NIAID’s Project Scientist for this program. In conjunction with other NIAID scientific program staff and the Steering Committee, the NIAID Project Scientist will provide advice and guidance on technical issues, such as reviewing progress or approving changes in proposed milestones. Administrative assistance will be provided by the NIAID Project Scientist in conjunction with the NIAID Grants Management Office.
The NIAID Project Scientist will review the performance of each awardee through consideration of annual reports, site visits and compliance with Steering Committee procedures.
Additionally, a NIAID program official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. This Program Officer will monitor program progress, approve changes, have access to data generated under these awards and may periodically review the data and progress reports. NIAID staff may use information obtained from the data for the preparation of internal reports on the activities of the study. The Program Officer may also serve as the NIH Project Scientist.
2.A.3. Collaborative ResponsibilitiesSteering Committee
A Steering Committee will be established to serve as the governing board of the U01 group during the funding period. This Committee will comprise the Principal Investigator of each U01 grant and the NIAID Project Scientist, and may also include other individuals with expertise in the areas of basic B cell biology, antibodies, and the HIV-1 virus, as well as Program Officers from the NIAID Division of Allergy, Immunology and Transplantation and the NIAID Division of AIDS. Only the U01 Principal Investigators and the NIAID Project Scientist will be voting members of the Steering Committee. The first Steering Committee meeting will be scheduled by the NIH Project Scientist. A Steering Committee Chair will be elected by majority vote from among the U01 group at the first Steering Committee meeting. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee. All travel costs for U01 personnel to attend the Steering Committee meeting will be borne by the Principal Investigators and must be included in the proposed budget. NIAID will arrange quarterly Steering Committee teleconferences.
Responsibilities of the Steering Committee will include:
NIAID intends to support the peer-reviewed studies proposed in the awarded grant applications. However, under special circumstances, the Steering Committee will establish guidelines and review procedures to evaluate and determine opportunities for redirection or modification of the peer-reviewed projects, which will not require new peer review. This policy is in keeping with the terms and conditions of the cooperative agreement mechanism.
Scientific Meetings
Each awardee will participate in a kickoff meeting, arranged by the NIH Project Scientist, to be held soon after award in the Bethesda, MD area, and will participate in scientific meetings to be held annually thereafter. All Principal Investigators are required to attend these meetings, together with additional scientific staff from their grants when appropriate. All travel costs for U01 personnel to attend the Scientific Meetings will be borne by the Principal Investigators and must be included in the proposed budget. The annual scientific meeting is open to members of this program and NIH extramural staff, and is a forum for members to provide the latest update on their research, exchange ideas and information, and discuss collaborations among program members. Meeting participants will identify the group’s tangible resources, capabilities and needs to advance overall program goals. The Principal Investigators are required to make oral presentations on current and planned activities and projects.
2.A.4. Arbitration ProcessIn addition to the usual information required in Form 2590, awardees shall include an executive summary and a detailed description of the work done to achieve the specific milestones for that funding year. If milestones have not been met, an explanation of what has been accomplished and the alternatives, solutions and/or problems that exist must be provided. If the milestones need to be modified, updated milestones and associated timelines should be included in the report and will be reviewed with the Program Officer. The Program Officer, in conjunction with the Steering Committee, will determine if major changes are appropriate, and will provide approval.
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, peer
review, and financial or grants management issues:
1. Scientific/Research Contacts:
Helen Quill Ph.D.
Division of Allergy, Immunology and Transplantation
National Institute of Allergy
and Infectious Diseases
6610
Rockledge Drive, Room 3013
Bethesda, MD 20892-6601
Telephone: (301) 496-7551
FAX: (301) 480-2381
Email: [email protected]
Anthony J. Conley, Ph.D.
Division of Acquired
Immune Deficiency Syndrome
National Institute of Allergy
and Infectious Diseases
6700B Rockledge Drive, Room 4100
Bethesda, MD 20892-7626
Telephone: (301) 496-8197
Fax: (301) 402-3211
Email: [email protected]
2. Peer Review Contacts:
Priti Mehrotra, Ph.D.
Division of
Extramural Activities
National Institute of
Allergy and Infectious Diseases
Room
Number 3138, MSC 7616
6700B Rockledge Drive
Bethesda, MD 20892-7616
Bethesda, MD 20817 (for
express/courier service; non-USPS service)
Telephone: (301) 435-9369
FAX: (301) 402-2638
Email: [email protected]
3. Financial or Grants Management Contacts:
Ms. Victoria Connors
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6700B Rockledge Drive, Room 2122
Bethesda, MD 20892-7614
Telephone: (301) 402-5065
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. Reviewers will consider the data
sharing plan but will not factor the plan into the determination of the scientific
merit or the priority score.
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 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 arcHIV-1e, 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 arcHIV-1ing 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-02-005.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. Applications that do not provide
this information will be returned without review.
NIH Public Access Policy:
NIH-funded
investigators are requested to submit to the NIH manuscript submission (NIHMS)
system (http://www.nihms.nih.gov) at
PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part
with direct costs from NIH. The author's final manuscript is defined as the
final version accepted for journal publication, and includes all modifications
from the publishing peer review process.
NIH
is requesting that authors submit manuscripts resulting from 1) currently
funded NIH research projects or 2) previously supported NIH research projects
if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award
mechanisms, cooperative agreements, contracts, Institutional and Individual
Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural
research studies. The Policy applies to peer-reviewed, original research
publications that have been supported in whole or in part with direct costs from
NIH, but it does not apply to book chapters, editorials, reviews, or conference
proceedings. Publications resulting from non-NIH-supported research projects
should not be submitted.
For
more information about the Policy or the submission process please visit the
NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual
(http://publicaccess.nih.gov/publicaccess_manual.htm).
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/, in the following
citations: 93.855, Immunology, Allergy, and Transplantation Research and
93.856, Microbiology and Infectious Diseases Research, and is not subject to
the intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. 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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