and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes of
Health (NIH), (http://www.nih.gov)
Title: Web Portal for Nonhuman Primate
Research Models (U24)
Announcement Type
New
Request For Applications (RFA) Number: RFA-RR-08-013
Catalog of Federal Domestic Assistance Number(s)
93.389
Key Dates
Release Date: October 10, 2008
Letters of
Intent Receipt Date: Not applicable
Application Receipt Date: January 5, 2009
Peer
Review Date: February to April 2009
Council Review
Date: May 2009
Earliest
Anticipated Start Date: July 2009
Additional Information To Be Available Date (Url
Activation Date): Not applicable
Expiration Date: January 6, 2009
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 and Information
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review
Considerations
C. Resource Sharing Plan(s)
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
The
successful grantee will construct a widely accessed web portal to information
regarding both research using nonhuman primates (NHPs) and basic data regarding
NHPs at various research locations in the United States and Puerto Rico.
The initial effort in Phase I will be directed at AIDS research, with later
integration during Phase II of similar efforts in other scientific
fields.
Recent scientific results and meetings regarding AIDS vaccines have illuminated the likely benefit of enlarging the research community that investigates AIDS through the use of animal models. Constructing a web portal for one-stop-access that provides information regarding availability of monkeys, assay services, reagents, genetic tests, and other relevant information should assist investigators engaged in AIDS research and other scientific disciplines. Additional investigators who could assist in development of AIDS vaccines could be employees of or funded by private foundations, biotech and pharma corporations, or international academic institutions. Scientists in relevant scientific fields will include basic immunologists and vaccinologists currently focused on other microorganisms.
There is increased interest in translational research as a bridge between basic research and traditional clinical trials. New programs such as the Clinical and Translational Science Institutes (CTSIs, http://www.ctsaweb.org/) from NCRR will benefit from the creation of a web portal on NHP models of various human diseases. Investigators seeking to transition from basic or clinical to translational projects, and teams seeking additions to collaborative efforts, will benefit from access to the new portal.
Currently, a significant amount of publicly accessible information regarding NHPs is available for research. For example, each of the eight National Primate Research Centers has a web site accessible to researchers and the public, as does the NCRR (http://www.ncrr.nih.gov/comparative_medicine/resource_directory/). Another example comprises several databases containing genetic data regarding NHPs (i.e., those listed in the annual Nucleic Acids Research database issue at http://nar.oxfordjournals.org/content/vol36/suppl_1/index.dtl). Additional examples include AIDS-related databases maintained by various components of NIH. However, there is no single web site from which an investigator can easily and systematically access all of these sources of information. The problem is that there are a large number of different web sites and it is challenging for an investigator to find them, and decide which ones are relevant to his/her specific interests. The proposed web portal should provide reliable information. The ability to clearly and logically navigate through the portal's web pages and its associated linked sites will be a major factor in the portal's use by the various user communities. Later integration of other scientific fields to the portal during Phase II will pose challenges.
There are some primate research facilities that do not currently provide web sites. The applicant for this funding opportunity will need to propose appropriate methods to identify these facilities, as well as other information of interest, e.g., assays, reagents, and highly specialized technical capabilities; obtain the appropriate information; synthesize what the web portal's user community may need to know; and provide the information in a form that is easily navigable by a variety of scientific users.
The portal will include the following information in an easily navigable format: an overview of publicly funded resources that provide NHPs for research, including capabilities in respect to the types of animals available and other functions, such as viral and genetic testing, etc.; links to all publicly available web sites related to the research uses of NHPs, with an overview of each web site; information on the availability of SPF animals at the facilities funded by the NCRR; assay services; reagents; informational web sites; NHP tissue and DNA banks; highly specialized technical capabilities at various primate facilities; links to AIDS-specific databases that concentrate on human patients but that are relevant to NHP AIDS research (e.g., http://www.iedea-hiv.org/about/, http://www.ncbi.nlm.nih.gov/RefSeq/HIVInteractions/ and https://www.clinicalresearchnetworks.org/IECRNProject.asp);and funding opportunities highly relevant to NHP research (e.g., NIH, Gates Foundation). The applicant will be responsible for appropriate expansion to include similar sources of information relevant to other scientific fields during Phase II. No data on individual NHPs (e.g., research histories) are to be archived at this portal.
The web portal must be well organized, easily navigable, yet comprehensive. After construction of the AIDS-related web portal in Phase I by the end of grant year 1, the grantee will expand the range of scientific fields to include all scientific fields during Phase II for which NHP-related research articles appear in PubMed. The application must describe the proposed timing and mechanism for this expansion that will provide an operating Phase II web portal by the end of grant year 2. Scientific fields that will likely be appropriate, but will not be limited to, include the following: 1. Infectious diseases and immunology (e.g., vaccines, virology, bacteriology, mycology, parasitology, immunogenetics, transplantation); 2. General reference information regarding NHPs (e.g., sex and age related variations in blood chemistries); 3. Neurosciences and behavioral research (e.g., neurobiology, neurochemistry, visual sciences, addiction sciences, psychobiology, cognitive sciences, psychology, behavior); 4. Reproduction and development (e.g., regenerative medicine and stem cell biology, transgenic technologies, cryopreservation, aging, reproductive biology, developmental biology, endocrinology); 5. Other research in NHPs (e.g., cardiovascular diseases, pulmonary diseases, diabetes, metabolic diseases, urology, nutrition, bioengineering, structural biology, molecular biology, genomics, proteomics, pathology, systems biology, phenotyping); and 6. Breeding and colony management (e.g., special animal colonies such as SPF animals, colony-health related research, animal welfare).
The grantee is expected to be proficient in collecting, synthesizing and presenting information about NHP species used in AIDS research as well as the wide variety of NHP species used in other scientific fields.
The extensive use of web feeds (e.g., RSS, Atom) from existing web sites is recommended when appropriate to reduce the amount of data to be continually updated by the grantee.
Appropriate use of the NCRR Comparative Medicine Resource Directory (http://www.ncrr.nih.gov/comparative_medicine/resource_directory/), PubMed http://www.ncbi.nlm.nih.gov/sites/entrez , NIH CRISP (http://crisp.cit.nih.gov/), Primate Info Net (http://pin.primate.wisc.edu/), and American Society of Primatologists (http://www.asp.org/) information is expected. The web portal should link to these and other relevant sites, and provide brief instructions for their use when needed.
If a formal ontology/taxonomy is needed to develop the portal, one or more widely used schemes should be employed (e.g., NLM's MeSH (http://www.nlm.nih.gov/mesh/meshhome.html) or The National Center for Biomedical Ontology http://bioontology.org/)
Whenever appropriate, a Federated approach is preferred. Sign-ins should be secure yet simple. The applicant should carefully consider and propose an appropriate level of interoperability via appropriate use of NCI's caBIG (http://www.ncrr.nih.gov/informatics_support/biomedical_informatics_research_network/), NCRR's BIRN (http://www.ncrr.nih.gov/informatics_support/biomedical_informatics_research_network/), and i2b2 (https://www.i2b2.org/), if construction of new databases or writing open-access software is required to achieve the goals of this funding opportunity.
The applicant must propose methods to promote the use of the Phase I web portal by investigators in AIDS research, and must propose extension during Phase II to investigators in all scientific fields identified by PubMed as using NHPs. Counting "Hits" to the web portal, user surveys, and reaching out to the user community (e.g., via the Annual Nonhuman Models of AIDS Symposium) are all expected.
Milestones must be proposed in the grant application. These must include an operating web portal for AIDS-related research by the end of grant year 1, and an operable web portal for all scientific fields relevant to NHP research by the end of grant year 2. Milestones may be updated as necessary later in the award period via negotiation with the NCRR program official. NCRR may recommend withholding future year funds for the project if the project substantially fails to meet its milestones or to remain state-of-the-art.
A steering committee will serve as the governing board for the award. The steering committee evaluates the progress of the web portal and reports to the NCRR program official within the Division of Comparative Medicine, NCRR. The steering committee will evaluate the web portal on the content and quality of the data, the presentation of the web site, and the overall responsiveness to user needs, as well as any other criteria that may arise during this project and are deemed critical by the steering committee. The application should not specifically name potential members, nor should the potential members be contacted before review. However, the application should describe the number, types, and likely stature of proposed steering committee members. The steering committee will meet quarterly by tele- or video-conference, and yearly face to face. Funds for these meetings should be included in the budget request.
For the January 5, 2009 due date, U24 applicants must use the paper PHS398 application and the instructions available from http://grants.nih.gov/grants/funding/phs398/phs398.doc. Cooperative agreements do not use modular budgets, so a detailed budget proposal should be submitted.
See Section VIII, Other
Information - Required Federal Citations, for policies
related to this announcement.
Section
II. Award Information
1. Mechanism of Support
This funding
opportunity will use the U24 cooperative agreement award mechanism
This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) 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".
After the initial 3 year award, the goals of the new award are expected to be subsumed into one or more larger knowledge environment(s) under development that will be applicable to AIDS and all other scientific fields for a wide variety of mammalian and non-mammalian models. Thus, it is expected that the award made in FY09 will be non-noncompetitively continued in FY2010 and FY2011 but funding will end in FY2012. The grantee could use the expertise and data developed under this FOA as preliminary data for a related application for a different FOA from one or more of the NIH Institutes and Centers.
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
The NCRR will fund one cooperative agreement, with a maximal duration of three years. The single cooperative agreement will be funded with a budget justified by the application, but not more than $500,000 direct costs per year for three years, and for a maximum of $1,500,000 direct costs over a maximal three-year project period.
The estimated amount of funds available for support of one project awarded as a result of this announcement is $500,000 for fiscal year 2009. Future year amounts will depend on annual appropriations.
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 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.
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 with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her 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.
More than one PD/PI, or 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, 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 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 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. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, 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.
The proposed research team for Phase I must be proficient in constructing a web portal for AIDS research conducted in NHPs. In Phase II, the evolving research team as a whole should be able to understand, distill, and provide a web-based portal that will be extended to a wide variety of research areas using NHPs.
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
Renewal
or revision applications for existing projects are NOT eligible to compete with
applications for new awards.
Applicants may not submit a resubmission application.
Applicants may not submit a renewal application.
Applicants may NOT submit more than one application.
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 in item (box) 2 only of the face page of the application form and the
YES box must be checked.
SPECIAL INSTRUCTIONS
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, a new 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. Receipt, Review and Anticipated Start Dates
Letter
of Intent Receipt Date: N/A
Application Receipt Date: January 5, 2009.
Peer Review Date: February to April 2009.
Council Review Date: May 2009.
Earliest
Anticipated Start Date: July 2009.
3.A.1.
Letter of Intent
A
letter of intent is not required for the funding opportunity.
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:
Dr.
John Glowa, Ph.D.
Office of Review
National Center for Research Resources
6701 Democracy Boulevard
Bethesda, MD 20892-4874
Telephone: (301) 435-0807
FAX: (301) 480-3660
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. The Grants Policy Statement can
be found at 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 NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)
6. Other Submission Requirements and Information
Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information"
Research Plan Page Limitations
Applicants are limited to the typical 25 pages for Items 2-5 in the Research Plan.
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 of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
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: Regardless of the amount requested, investigators 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. The application should describe which portions (if any) of the web portal would not be available to the public. If proposed, a description of the areas to be restricted to credentialed users and the process to be used for credentialing must be included in the application. The reviewers will score the plan either as acceptable or not acceptable, and the merit of the Data Sharing Plan will not affect the priority score. If the plan is judged unacceptable, a revised plan will be negotiated with NCRR program staff before an award is made.
(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/.
After the initial 3 year award, the goals of the new award are expected to be subsumed into one or more larger knowledge environment(s) under development by the Division of Comparative Medicine of NCRR that will be applicable to AIDS and all other scientific fields, and a wide variety of animal models including NHPs. Thus, it is expected that the award made in FY09 will be non-noncompetitively continued in FY2010 and FY2011 but funding will end in FY2012. At the time of the transition, NIH will have the right to use the data and approaches developed in this funding opportunity to benefit the larger and continuing informatics effort described above. In addition, the grantee could use their data and methods to apply for other NIH funding opportunities with expanded or different goals.
Section V. Application Review Information
1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).
Only the review
criteria described below will be considered in the review process.
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 NCRR 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 following will be considered in making funding decisions:
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, and weighted 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 meritorious 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?
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? For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs?
In addition, specific to “Approach” for this FOA: Will the proposed web portal be well organized, easily navigable, yet comprehensive? Will the applicant's proposed approach to web portal development benefit the multiple potential users? After the web portal for AIDS research becomes operable by the end of grant year 1, will NIH-funded investigators already using NHP animal models benefit? Will the new portal benefit HIV investigators at CTSIs or other sites, who may have new ideas applicable to studies using NHPs? Will established scientists in fields of microbiology not directly related to AIDS, or those with special capabilities in state-of-the-art technologies benefit from a better understanding of the SIV/monkey AIDS model system or from recruiting new members to a collaborative team? Will other scientific fields benefit as a result of Phase II? Will the expanded portal remain easily navigable yet comprehensive?
Will the proposed plan result in a web portal that is resistant to cyber attacks, including the potential need to keep individual provider's and user's identities in confidence?
Has the application proposed appropriate plans for the numbers, types, and capabilities of steering committee members, and the structure and function of the committee?
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 the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?
Investigators: Are the PD/PI(s) and other key personnel 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? Do the PD/PI(s) and investigative team bring complementary and integrated expertise to the project (if applicable)?
Environment: Do(es) the scientific environment(s) 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 rating:
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 on Human
Subjects in the PHS 398 instructions).
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 on Human Subjects in the
PHS 398 instructions).
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to
be used in the project, the five points described in the Vertebrate Animals
section of the Research Plan 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.
2.C. Resource Sharing Plan(s)
When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.
3. Anticipated Announcement and Award
Dates
July 2009
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.
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 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 Investigation (PI) will have the primary responsibility for defining the details of the web portal within the guidelines of this funding opportunity and for performing the scientific activities. The PI will agree to accept close coordination, cooperation, and participation of NCRR staff in those aspects of scientific and technical management of the project as described under "NIH Program Staff Responsibilities."
The PI of the web portal will:
The PI will lead the effort to develop an operable web portal regarding AIDS-related research by the end of grant year 1, and expand to an operable web portal for all relevant scientific fields by the end of grant year 2. During grant year 3, the web portal will be updated at least monthly until the conclusion of grant support.
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. In addition, see Section IV.6 of this funding opportunity for plans to transition to another system at the end of the maximal three years of funding.
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 NIH Project Scientist will have substantial scientific
and programmatic involvement during the conduct of this activity through
technical assistance, advice, and coordination. However, the role of NCRR staff will be to facilitate and
not to direct the activities. It is anticipated that decisions in all
activities will be reached by consensus between the Principal Investigator and
the NCRR staff. The NIH Project Scientist will:
Additionally, an NCRR program official (a.k.a.
program director) will be responsible for the normal scientific and
programmatic stewardship of the award and will be named in the award
notice. The NCRR program official will work together with the PI to
select members of the steering committee, attend steering committee meetings,
approve original and replacement (if necessary) members during grant years 1-3,
and approve or disapprove reports submitted by the committee. The
assigned program official may not also serve as the NIH Project Scientist for
the award.
2.A.3. Collaborative Responsibilities
(optional)
The awardee and the NCRR program official
together will be responsible for:
A steering committee will be assembled to serve as the governing board for the award. The steering committee evaluates the progress of the web portal and reports to the NCRR program official within the Division of Comparative Medicine, NCRR. Membership of at least five persons will include: the PI; an expert in bioinformatics; an expert from a widely used scientific web portal or database; one or more experts in NHP research who will be or are users of the web portal; and the NIH Project Scientist (who is a non-voting ex-officio member and who should not serve as the Chair). Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee. The steering committee will evaluate the web portal on the content and quality of the data, the presentation of the web site, and the overall responsiveness to user needs, as well as any other criteria that may arise during this project and are deemed critical by the steering committee.
The steering committee will meet quarterly by tele- or video-conference, and yearly face to face, to review the progress of the web portal and to interact directly with the PI of the web portal. Funds for these meetings should be included in the budget request. Annually, the steering committee will formally report their recommendations regarding progress of the web portal and present advice about changes, if any, which may be necessary in the web portal to the NCRR program official within the Division of Comparative Medicine, NCRR.
2.A.4.
Arbitration Process
Any disagreements that
may arise in scientific or programmatic matters (within the scope of the award)
between award recipients and the NIH may be brought to arbitration. An
Arbitration Panel composed of three members will be convened. It will have
three members: a designee of the Steering Committee chosen without NIH staff
voting, one NIH designee, and a third designee with expertise in the relevant
area who is chosen by the other two; in the case of individual disagreement,
the first member may be chosen by the individual awardee. This special
arbitration procedure in no way affects the awardee's right to appeal an adverse
action that is otherwise appealable in accordance with PHS regulations 42 CFR
Part 50, Subpart D and HHS regulations 45 CFR Part 16.
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, peer review, and financial or grants
management issues:
1. Scientific/Research Contacts:
Ray O'Neill, Ph.D.
Division of Comparative Medicine
National Center for Research Resources
6701 Democracy Boulevard
Bethesda, MD 20892-4874
Telephone: (301) 435-0744
FAX: (301) 480-3819
Email: [email protected]
2. Peer Review Contacts:
John Glowa, Ph.D.
Office of Review
National Center for Research Resources
6701 Democracy Boulevard
Bethesda, MD 20892-4874
Telephone: (301) 435-0807
FAX: (301) 480-3660
Email: [email protected]
3. Financial or Grants Management Contacts:
Joshua Murray
Office of Grants Management
National Center for Research Resources
6701 Democracy Boulevard
Bethesda, MD 20892-4874
Telephone: (301) 435-0857
FAX: (301) 480-3777
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.
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-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 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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