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 General Medical Sciences (NIGMS), (http://www.nigms.nih.gov)
Title: Modeling of
Infectious Disease Agent Study Information Technology Resource (U24)
Announcement Type
New
Update: The following update relating to this announcement has been issued:
Key Dates
Release
Date: April 8,
2008
Letters
of Intent Receipt Date: June 2, 2008 (Changed to June 17, 2008 per NOT-GM-08-128)
Application Receipt Date: July
1, 2008 (Changed to July 17, 2008 per NOT-GM-08-128)
Peer Review Date(s): October -
November, 2008
Council Review Date: January,
2009
Earliest
Anticipated Start Date: April 1, 2009
Additional Information To Be
Available Date (Url Activation Date): Not Applicable
Expiration Date: July 2,
2008 (Changed to July 18, 2008 per NOT-GM-08-128)
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
Background
The threat of emergence or re-emergence of infectious disease epidemics continues to be a concern of policymakers and the public health services. Better resources, knowledge, and tools are needed to improve our knowledge of the dynamics of emergence, surveillance and detection of events, and the effectiveness and implications of prevention and mitigation efforts. The variety of possible scenarios complicates the challenge of confronting these threats. An important role of science is to create a rational picture of the alternatives by collecting, analyzing, and interpreting relevant data and by developing models. The models themselves can guide the collection of further data. In addition, good models can reveal important patterns in the data, allow investigators to examine scenarios, and to understand likely consequences of interventions. These capabilities can help responsible parties plan for and respond to an emerging epidemic or a bioterrorist threat.
The existing MIDAS network began in May 2004 with the funding of three research groups and an informatics group. In February of 2006 four additional research groups were added. As a result of a formal formative evaluation and a white paper developed by the infectious disease modeling community, NIGMS initiated a change in the structure of MIDAS, which this FOA reflects. The restructured MIDAS Network will be composed of research groups, Centers of Excellence, and an information technology resource. The Network will continue to be a multidisciplinary, multicomponent effort, comprising an important component of an overall public health strategy for managing emerging infectious diseases.
Information on current and previous MIDAS activities, publications, and reports can be found on the MIDAS website at https://www.epimodels.org/midas/about.do or, http://www.nigms.nih.gov/Initiatives/MIDAS/
This FOA solicits applications for an information technology resource that will support and extend the work of the MIDAS Centers of Excellence and research groups by (1) providing the infrastructure and resources for hardening and testing software; (2) collecting, managing, and generating data relevant to the systems they are studying; (3) providing support for dissemination of information and for outreach; and (4) providing logistical support for MIDAS activities. The information technology resource is expected to act in partnership with the MIDAS Centers of Excellence and research groups. Partnerships are expected to be highly interactive and collaborative in defining needs, planning and carrying out projects, and disseminating results and products.
The role of the information technology resource will encompass:
Software Development. Opportunities are expected to arise for the development or improvement of computational tools for specialized audiences (e.g., public health officials, Epidemic Intelligence Service officers, researchers) or for general purposes (e.g., educational use, visualization). Examples of projects include, but are not limited to, data analysis tools; visualization of real-time data and model results; representation and management of data and results; and integration of geographic, historical, evolutionary, ecological, and demographic information. Software to improve model verification and validation by, for example, characterizing the statistical properties of model results, may also be required as determined by Network needs.
All software development projects will be subject to review and approval by the MIDAS executive committee and steering committee to ensure that they address a need and meet high scientific standards.
The final software products must meet the high standards expected of contemporary biological software. These standards include:
First, software projects must be guided by oversight groups that are responsive to the needs of developers, production teams, and end users. Applications should specify how oversight groups will be assembled and utilized throughout a software project.
Second, software must be fully documented and easy to access, modify, and extend. Users who experience problems should be able to report and resolve issues with minimal effort. Problems should be tracked and appropriate changes incorporated into the software. It is particularly important that software be able to evolve as needs change.
Third, where possible, software packages relevant to infectious disease modeling and data management should be interoperable and portable to a variety of common platforms.
Fourth, software should be consistent with existing ontologies and controlled vocabularies. Where needed, software development projects should include (1) defining vocabularies and terms, (2) defining relationships among terms and functions, (3) defining data models, (4) defining data requirements and uses, and (5) similar activities.
Fifth, software must be tested, verified, and maintained. The final product should include user manuals and other training devices (e.g., workshops, online training, help desk).
Applicants should describe the approach and methods to be employed in the software development process. Applicants must demonstrate their experience in developing software using these approaches and methods.
Data. Infectious diseases are an outcome of a complex, interconnected system, including pathogens, hosts, vectors, social organization, social behavior, climate, genetics, ecology, evolution, immunity, and other factors. Much of this information is maintained in a distributed manner and needs to be integrated selectively for specific modeling exercises. Other information may be generated by modeling exercises and must be collected, organized, and disseminated to other modeling groups.
To address data needs the MIDAS information technology resource will design, implement, and manage systems to collect, store, and disseminate data to modelers, both within the MIDAS Network as well those in the wider research community. The information technology resource is expected to be proactive in identifying, collecting, and disseminating the types of data needed by infectious disease modelers. Data sources could include existing databases, real-time data, literature reviews, simulations, satellite images, and/or other sources as deemed relevant to a modeling exercise. An important consideration is cross-referencing stored information. Data gathering and dissemination exercises will be undertaken on the basis of modeling needs and in collaboration with the NIGMS Project Scientists, whose roles are defined in Section VI.2.A.2.
The MIDAS information technology resource will monitor the overall structure and operation of the database for data quality, accuracy, completeness, specificity, and non-redundancy and will define format and document files, as appropriate, to facilitate the comprehensive sharing of data within the scientific community and across federal agencies and to ensure connectivity with other databases.
In the pilot phase, the MIDAS program developed a historical data and document catalog containing a variety of historical reports from the scientific literature, historical documents, and reports. Applicants for the MIDAS information technology resource are expected to continue to develop this catalog as a resource for infectious disease modelers. Applicants must document their experience in constructing and maintaining searchable databases of complex information and propose a plan to gather, organize, and maintain the MIDAS data source.
Also in its pilot phase, MIDAS supported generation of a preliminary set of synthetic human and animal populations base on spatial and temporal data that represent (but are not) real demographics and dynamics. Expanding synthetic data sets to include global human populations, agricultural animals, and wildlife (e.g., mammals, birds, insect vectors) will be a high priority of the MIDAS information technology resource.
Applicants must propose a data release policy and a separate plan that addresses intellectual property rights, both of which will be reviewed and approved by the MIDAS steering committee post award. (For more detail, see Section IV.6 Other Submission Requirements. )
Dissemination and Outreach. Computational and mathematical models play important roles in planning and preparedness, surveillance, logistical and operations analyses, as well as in study design and research on infectious disease dynamics. MIDAS plays a leading role in generating methods, approaches, resources, and knowledge needed for model development and is responsible for disseminating information to a wide variety of users. This effort is critical to advance the field of infectious disease modeling.
The MIDAS information technology resource will make available to the scientific community, policymakers, and public health officials the products and results of the MIDAS Network. The information technology resource will develop interfaces suitable for members of the research groups, for other research scientists, for public health officials, for policymakers, and others.
An important function of the MIDAS information technology resource is informing potential users of the availability of resources, tools, and opportunities. Outreach activities could include, for example, preparation of fliers and brochures, presentations and booths at relevant conferences, development and maintenance of the MIDAS Web site and portal, and use of Wikis and other electronic media.
Logistics. Collaboration among MIDAS investigators and with non-MIDAS experts is fundamental to stimulating research and building a strong infrastructure for infectious disease modeling. The information technology resource will, at the direction of appropriate NIGMS staff, support mission-related meetings and consultations. For planning purposes, the logistics component should include planning and logistical support for three meetings each year of the MIDAS research network, one meeting per year of the MIDAS steering committee, and one meeting per year with outside experts. Meetings will be held at various U.S. locations.
Additional Information: Organizational Structure of MIDAS
The reorganized MIDAS Network will have five components: a steering committee, an executive committee, Centers of Excellence, an information technology resource, and research groups.
The steering committee is the main oversight body for MIDAS and makes recommendations to NIGMS regarding scientific direction, resources, concerns and issues, evaluation, and similar topics. The committee includes representation from user groups such as public health officials, representatives of the research community, and NIH scientist administrators with relevant expertise. Outside expertise ensures sufficient breadth and balance on the committee. NIH scientist administrators will not comprise more than 40% of the voting members of the steering committee.
The executive committee coordinates and manages the MIDAS Network, including coordination of multi-group projects. It is made up of the principal investigators of grants funded through the MIDAS program and will meet monthly by videoconference or conference call.
The research groups are teams of multidisciplinary, collaborating scientists from one or more institutions who have expertise in fields relevant to MIDAS. Research groups conduct research in computational, mathematical, and engineering approaches to modeling data on emerging infectious diseases.
The Centers of Excellence will provide national and international leadership in four major thematic areas infectious disease research; computational, statistical, and mathematical research; education and outreach; and public health policy.
The information technology resource will support and extend the work of the MIDAS Centers of Excellence and research groups by providing the infrastructure and resources for hardening and testing software, collecting, managing, and generating data relevant to the systems they are studying, providing support for dissemination of information and for outreach, and providing logistical support for MIDAS activities. The resource is expected to act in partnership with the MIDAS Centers of Excellence and research groups.
Each funded project must make a commitment to focus MIDAS research on specific tasks of national importance and to participate fully in collaborative Network research. The MIDAS Network requires a commitment to cooperative interactions that must be detailed in the application. Specific domains of interaction can be found in Section IV.6 Other Submission Requirements.
Projects funded through MIDAS use existing sequence, genetic, epidemiological, clinical, climate, etc. information to conduct research. They will not generate primary data using MIDAS funding, with the exception of synthesized data.
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 Cooperative
Agreement U24 award mechanism(s).
The Project
Director/Principal Investigator (PD/PI) will be solely responsible for planning,
directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
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". Awards made under this program will continue as Cooperative Agreements throughout the term of award.
2. Funds Available
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.
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
Applicants may submit more than one application, provided
each application is scientifically distinct.
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: GrantsInfo@nih.gov.
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: June 2, 2008 (Changed to June 17, 2008 per NOT-GM-08-128)
Application Receipt Date: July 1, 2008 (Changed to July 17, 2008 per NOT-GM-08-128)
Peer Review Date(s): October - November, 2008
Council Review Date: January 2009
Earliest
Anticipated Start Date(s): April 1, 2009
3.A.1.
Letter of Intent
Prospective
applicants are asked to submit a letter of intent that includes the following
information:
Although a letter of
intent is not required, is not binding, and does not enter into the review of a
subsequent application, the information that it contains allows IC staff to
estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed
in Section IV.3.A.
The letter of intent
should be sent to:
James
J. Anderson, Ph.D.
Center for Bioinformatics
and Computational Biology
NIGMS
45 Center Drive MSC6200
Building 45, Room 2AS-25A
Bethesda, MD 20892
Telephone: (301) 594-0943
FAX: (301) 480-2228
Email:
andersj@mail.nih.gov
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:
Helen
Sunshine, Ph.D.
Office of Scientific
Review
NIGMS
45 Center Drive MSC6200
Building 45, Room 3AN12F
Bethesda, MD 20892
Telephone: (301) 594-2881
FAX: (301) 594-8506
Email:
sunshinh@mail.nih.gov
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".
The MIDAS Network relies on collegial and cooperative interactions among its constituent members, particularly for MIDAS special initiatives that may emerge as a result of urgent national needs. Applicants with any prior experience working with the Network should describe these interactions.
NIGMS has adopted several policies that are applicable to the MIDAS Network. Applicants must present plans to adhere to the policies, where appropriate.
Data Sources. Research groups will use existing or simulated datasets, as well as real-time information, to build computational models relevant to the goals of MIDAS. Research groups will not use MIDAS funds to generate primary data, except in the case of simulations.
Relationship to the MIDAS Information Technology Resource. Each research group and Center will identify a data liaison person to interact with the information technology resource. This basic or bioinformatics scientist will advise the information technology resource on the management and display of data generated or used by the research group or Center, and will coordinate any joint software development. The information technology resource will identify one or more people to interact with Centers and research groups on data collection and management and software development.
Databases. The information technology resource is the repository of choice for data related to infectious disease modeling, and such a repository should distinguish between confidential information, restricted information (e.g., pre-publication data and results), and information accessible by the entire research community. Research groups and Centers may develop their own (local) databases to meet their computational needs. They may request funds to support the design, testing, and validation of bioinformatics tools and the storage of data needed to accomplish their research objectives. If relevant, each research group and Center is required to use the standard data exchange format established by the information technology resource, in consultation with the executive committee, for transmitting information among projects.
Data, Software, and Intellectual Property. Each research group, Center, and the information technology resource must propose a data and software release policy as described in IV.6., Resource Sharing Plan(s) section (a), Data Sharing Plan, and section (d), Software Development. Each research group, Center, and information technology resource must also provide a separate plan that addresses intellectual property rights. These plans may be further negotiated prior to funding.
Meetings and Reports. The Principal Investigator of the information technology resource serves, along with principal investigators of research groups and Centers, as a member of the MIDAS executive committee and will participate in monthly videoconferences or conference calls. In addition, the information technology resource is expected to present its activities and progress at annual meetings of the steering committee, and at no more than three Network consultations per year. Funds for travel of the Principal Investigator(s) and relevant staff to these meetings should be included in the proposed budget.
National Emergencies. In the event of an attack or the emergence of an infectious disease, NIGMS may ask the principal investigators of MIDAS groups, including MIDAS Centers of Excellence, research groups, and the information technology resource, to apply their expertise to the public health emergency. Should this occur, NIGMS will be flexible in allowing the principal investigators to reorganize and reorient specific project goals and to renegotiate the scope of the grant to include new objectives. The awardees may also be able to request additional funding to cover costs that were not included in the initial application.
Research Plan Page Limitations
Applicants must adhere to the standard 25 page limitation for Research Plan.
Appendix Materials
All paper PHS 398 applications submitted for May 25, 2008 and subsequent due dates must provide appendix material on CD only, and include five identical CDs in the same package with the application. Paper applications submitted for due dates prior to May 25, 2008 may voluntarily provide the appendix on five identical CDs; if submitting CDs it is not necessary to include a paper appendix. (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.
(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/.
(d) Software Development: Applications must include a statement that software developed through MIDAS funding will be deposited, in a timely manner, in the MIDAS repository maintained by the information technology resource; this repository will have restricted access to MIDAS grantees and Federal agencies. And, if the MIDAS steering committee recommends that a particular application should be made available for public use, the applicant will cooperate with the research group(s) and Center(s) of Excellence in producing and maintaining a user-friendly instrument.
Section V. Application Review Information
1. Criteria
Only the review
criteria described below will be considered in the review process.
2. Review and Selection Process
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 NIGMS 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, 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 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? Does
the application exhibit knowledge of the informatics and procedural needs of a
diverse group of investigators and projects?
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? Does 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?
In addition to the above review criteria, the following criteria will be addressed and considered in the determination of scientific merit and the rating.
Cooperation: Does the information technology resource application demonstrate its willingness and capability to work with other members of the MIDAS Network to enhance the project's productivity?
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
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.
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
Certain policies that pertain to the MIDAS Network will be
required. These are listed in Section IV.6, Other Submission
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.
An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.
NIH Project Scientists with expertise in
relevant areas will (a) serve as voting members of the steering committee as
representatives of the NIH extramural staff; (b) help guide the development of
the MIDAS Network by providing overall advice and coordination; (c) facilitate
a partnership among NIH, the Centers of Excellence, research groups, and the
information technology resource; (d) ensure that the directions taken by MIDAS
are consistent with NIH missions and goals; (e) make recommendations regarding
support, to maintain a scientific balance between accomplishing the goal and
objectives of MIDAS and addressing emerging research opportunities; and (f)
facilitate, not direct activities. Decisions will be reached, where
possible, through consensus with the principal investigators and the MIDAS
steering committee.
Additionally, an agency
program official or IC program director will be responsible for the normal
scientific and programmatic stewardship of the award and will be named in the
award notice.
The steering committee decides on the schedule of meetings, once each year, usually in Bethesda, MD. The steering committee may also call meetings to address urgent national needs, and will participate in Network meetings and teleconferences as needed. The steering committee may establish subcommittees as necessary. The steering committee also may add members, with the approval of the NIGMS Director.
Specifically, the steering committee will
(a) serve as the main oversight board of the MIDAS Network; (b) communicate the
views and needs of the scientific and public health communities; (c) recommend
refinements of software developed by MIDAS researchers to meet Public Health
needs; (d) set overall milestones for MIDAS; (e) assess progress within the
MIDAS Network; (f) develop guidelines and policies for data and software
sharing and release to public domains; (g) reflect the views of other
researchers; (h) contribute to the development of a cohesive effort; and (i)
alert NIH to scientific opportunities, emerging needs, and impediments.
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:
James J.
Anderson, Ph.D.
Center for Bioinformatics
and Computational Biology
NIGMS
Building
45, Rm 2AS-25A
45 Center Drive MSC6200
Bethesda, MD 20892-6200
Telephone: (301) 594-0943
Fax: (301) 480-2228
Email: andersj@mail.nih.gov
2. Peer Review Contacts:
Helen R.
Sunshine, Ph.D.
Office of Scientific
Review
NIGMS
Building 45, Rm 3AN-12F
45 Center Drive MSC6200
Bethesda, MD 20892-6200
Telephone: (301) 594-2881
Fax: (301) 480-8506
Email:sunshinh@mail.nih.gov
3. Financial or Grants Management Contacts:
Ms.
Grace Olascoaga
Grants Administration Branch
NIGMS
Building 45, Room 2AN 32C
45 Center Drive MSC6200
Bethesda, MD 20892
Telephone: (301) 594-5520
FAX: (301) 480-2554
Email: olascoag@mail.nih.gov
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 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
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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