and Human Services (HHS)
EXPIRED
PILOT PROJECTS FOR MODELS OF INFECTIOUS DISEASE AGENT STUDY (MIDAS)
RELEASE DATE: March 13, 2003
RFA: GM-03-008 (Mission has been modified, see NOT-GM-06-106)
(see reissue RFA-GM-05-011)
National Institute of General Medical Sciences (NIGMS)
(http://www.nigms.nih.gov/)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS:
93.113, 93.172, 93.242, 93.273, 93.837, 93.859, 93.862
PUBLIC BRIEFING DATE: APRIL 23, 2003, 9 AM-12 PM, NATCHER CONFERENCE
CENTER, NIH
LETTER OF INTENT RECEIPT DATE: May 19, 2003
APPLICATION RECEIPT DATE: June 18, 2003
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The National Institute of General Medical Sciences (NIGMS) encourages
applications for pilot research projects and database development for a
new initiative, Models of Infectious Disease Agent Study (MIDAS).
MIDAS will consist of a centralized database and a network of
multidisciplinary scientists conducting computational and mathematical
research to improve the ability to detect, control, and prevent
emerging infectious diseases caused by naturally occurring or
intentionally released pathogens, including those relevant to
biodefense.
The overall goal of this research initiative is to improve the nation's
ability to respond to biological threats promptly and effectively. The
two main objectives are (1) to develop computational tools to (a) model
exposure to pathogens and their products, (b) carry out identification
and surveillance of infectious diseases in a timely and cost-effective
manner, (c) model the effectiveness and consequences of different
intervention strategies, and (d) model the decontamination of
facilities from pathogens and their products; and (2) to establish a
centralized database to store, display, and make publicly available the
tools and information developed, for the practical use of policymakers,
public health professionals, and researchers.
NIGMS will support multidisciplinary research teams that will develop
mathematical and computational tools applied to the identification,
control, prevention and treatment of emerging infectious diseases,
including those of biodefense relevance. The MIDAS Network will
comprise multiple Research Groups and an Informatics Group. It will be
governed by a MIDAS Steering Committee consisting of members of the
Research Groups and Informatics Group and scientists, from the National
Institutes of Health (NIH) and other research institutions, who
represent relevant fields of expertise.
This initiative is a pilot effort in the organization of research
centers for the modeling of emerging infectious diseases and biodefense
responses. NIGMS is soliciting applications for Research Groups and
the Informatics Group. Applicants may submit applications for support
of a Research Group, the Informatics Group, or both.
RESEARCH OBJECTIVES
Background
Policymakers and the public are increasingly concerned about
bioterrorism and the emergence of new pathogens. The variety of
scenarios possible in this arena complicates the challenge of
confronting these threats. An important role of science is to
rationalize the scenarios by collecting, analyzing, and interpreting
relevant data and by developing models that can help responsible
parties respond effectively to an emerging epidemic or a bioterrorist
threat.
The National Institute of Allergy and Infectious Diseases (NIAID) has a
well-developed plan for biodefense research that includes six target
areas: biology of the microbe, host response, vaccines, therapeutics,
diagnostics, and research resources. The MIDAS Network and Database
that will be supported by NIGMS will complement the experimental
research supported by NIAID by adding a modeling component to the NIH
research agenda in biodefense.
MIDAS will rely on a network of researchers with demonstrated expertise
in computational and mathematical methods, the biology of infectious
disease systems, social networks, and environmental modeling. This
type of interdisciplinary network is the most efficient approach for
developing useful knowledge and tools to respond to a public health
emergency involving emerging infectious diseases, either naturally
occurring or bioterrorism-related. Details of the MIDAS organizational
structure and the tasks and responsibilities of participants are
described in detail under "Special Requirements."
The U.S. scientific and public health communities need to improve their
ability to identify and prevent the spread of diseases resulting from
the emergence or intentional release of pathogens and their products.
Epidemiological data collected during natural outbreaks in the past may
be of limited use in the event of an attack, and new parameters for
disease surveillance and control need to be identified. Overexposure to
pathogens (or pathogen-related products), single and multiple
introductions, genetic manipulation of the pathogen's virulence genes,
or novel transmission routes may dramatically affect how a disease
manifests itself and how it is transmitted. We might expect changes in
the disease's initial signs and symptoms, incubation period,
transmission rate, and morbidity and mortality. Development of new
mathematical and computational tools to simulate novel complex
scenarios will help researchers, public health professionals and
policymakers improve their methods of disease identification,
surveillance and forecasting, and their strategies for short- and long-
term interventions.
Specific Research Objectives
To improve management of the identification and control of emerging
infectious diseases that may arise naturally or from intentionally
released pathogens, scientists and public health officials need a
variety of models to understand and simulate the variety of complex
scenarios possible. Specific research objectives for the MIDAS Network
are to develop, validate, and implement use of the following:
o Models of the transmission of bioterrorism agents or naturally
occurring infectious disease agents, which include relevant and complex
parameters such as environmental data and social networks
o Models of the release, spread, and detection of naturally occurring
agents and bioterrorism agents
o Models for differential diagnosis of naturally occurring outbreaks
and bioterrorism attacks, aimed to promote accurate detection of common
infectious diseases, non-specific signs and symptoms, and shared
symptoms among emerging infectious diseases and intentionally released
pathogens
o Models of interventions, such as quarantine, vaccination, and
antimicrobial and antitoxin treatments
o Models for the distribution of stockpiles and inventories of
treatments, scheduling of response activities, and allocation and use
of manpower and other resources
o Models for evaluating the long-term consequences of response
strategies, including the decontamination of facilities from pathogens
and their products.
This RFA invites the Research Groups to prepare proposals addressing
two of the three major thematic areas, which are described below. Data
relevant to the research will be integrated by the Informatics Group
(see "Special Requirements").
Thematic Research Areas
Awards made as a result of this RFA will be MIDAS pilot projects.
NIGMS expects that these pilot projects will evolve into a large-scale
research network. This MIDAS Network will focus on scientific
knowledge and expertise in computational biology and mathematics
applied to three thematic research areas: (I) Modeling of Host-
Pathogen Systems, (II) Modeling of Disease Epidemiology and Forecasting
Systems, and (III) Modeling of Response Systems.
To promote cross-disciplinary research and develop multiple areas of
expertise, NIGMS requests applicants to focus on mathematics and
computational methods for the modeling of systems in at least two of
the three thematic areas. Listed below are suggested, but not
required, research topics for each area.
I. MODELING OF HOST-PATHOGEN SYSTEMS
Possible research topics include, but are not limited to:
A. Modeling of microbial population structure, ecology, natural
history, genome structure and evolution, of microbes relevant to
biodefense (their model counterparts and engineered strains). Please
refer to http://www.bt.cdc.gov/agent/agentlist.asp for a list of
organisms that the Centers for Disease Control and Prevention (CDC) has
placed in Category A, B, and C lists of biological threats. Applicants
may choose to use data from these organisms or from other model
systems.
o Development of new and improved computational methods for
phylogenetic reconstruction and analysis; modeling tools to achieve
accurate population sampling.
o Modeling of the evolution of microbial traits such as virulence,
pathogenicity, immunogenicity, and drug resistance.
B. Modeling of host factors that may play a role in disease onset and
progression; modeling within host infectious agent dynamics.
C. Modeling of the host response to overexposure to pathogens and
their products.
II. MODELING OF DISEASE EPIDEMIOLOGY AND FORECASTING SYSTEMS
Examples of research topics include, but are not limited to:
A. Modeling of climatic, geographic, epidemiological, entomological,
and ecological data to evaluate disease transmission dynamics.
o Exploration of the relationships among climate variability,
geographic disease patterns, and pathogen, vector, reservoir, and host
ecology and its impact on disease emergence and maintenance.
o Use of remote sensing technology to characterize and monitor spatial
and temporal patterns of emerging infectious diseases.
B. Modeling of the evolution and adaptation of known pathogens,
evolving pathogens, and engineered strains to new hosts and new
environments.
C. Modeling of insect migration patterns and disease transmission in
vector-borne diseases.
III. MODELING OF RESPONSE SYSTEMS
Examples of research topics include, but are not limited to:
A. Early Response:
o Simulation and virtual environments to understand the dynamics of
intentionally released pathogens and their products
o Modeling of early detection of epidemics using unconventional
parameters
o Modeling transmission dynamics using simple and complex transmission
routes, and single and multiple biological agents
o Modeling structure and dynamics of social networks in disease
transmission
o Modeling differential diagnostic tools (including modeling
parameters for establishing criteria to discriminate between
intentionally released pathogens and naturally occurring outbreaks)
B. Mid-term Response:
o Modeling strategies for vaccination and treatment with
antimicrobials and antitoxins, and methods for evaluating these
strategies
o Modeling deployment and administration of stockpiles of vaccines,
antimicrobials, and antitoxins to affected areas; allocation of
resources and manpower
C. Long-term Response:
o Modeling quantitative and qualitative effects of radiation- and
chemically-induced damage to biological processes in viruses,
prokaryotes, and eukaryotes from decontamination and inactivation
procedures
o Modeling dispersion of pathogens and their products in confined and
open environments (e.g., office buildings, subway systems, hospitals,
others)
The specific roles of Research Groups and the Informatics Group are
described in "Special Requirements" below.
MECHANISM(S) OF SUPPORT
The NIH U01 is a cooperative agreement award mechanism in which the
Principal Investigator retains the primary responsibility and dominant
role for planning, directing, and executing the proposed project, with
NIH staff being substantially involved as a partner with the Principal
Investigator, as described under the section "Cooperative Agreement
Terms and Conditions of Award."
The earliest anticipated award date is April 2004. Based on continuing
assessment of the need for and success of the program, NIGMS may
reissue this announcement to add new components to the network.
Institutions may submit applications for a Research Group, an
Informatics Group, or both. If an institution chooses to apply for
both a Research Group and the Informatics Group, it should submit two
separate applications. To maintain its flexibility, NIH may choose to
award one or the other application, or both.
FUNDS AVAILABLE
NIGMS intends to commit approximately $7 million in FY 04 to fund up to
three new pilot projects and a database in response to this RFA. An
applicant for a Research Group may request a project period of up to
five years and a budget of up to $0.5 million direct costs per year,
including direct costs for equipment and subcontracts. An applicant
for an Informatics Group may request a project period of up to five
years and a budget of up to $3 million direct costs per year, including
direct costs for equipment and subcontracts. Because the nature and
scope of the proposed research will vary from application to
application, it is anticipated that the size of each award will also
vary. Although the financial plans of NIGMS provide support for this
program, awards pursuant to this RFA are contingent upon the
availability of funds and the receipt of a sufficient number of
meritorious applications.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) if your institution has any of the
following characteristics:
o Domestic institutions
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges,
hospitals, and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government.
Foreign institutions may participate only as collaborating
institutions.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Individuals with the skills, knowledge, and resources necessary to
carry out the proposed research are invited to work with their
institution to develop applications for support. Individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH programs.
SPECIAL REQUIREMENTS
Organizational Structure
The MIDAS Network will comprise three components: a Steering
Committee, Informatics Group, and Research Groups.
The Steering Committee will be the main managing body for MIDAS. The
committee will include representation from each of the Research Groups
and the Informatics Group, as well NIH Scientist Administrators with
relevant expertise. Outside expertise may be added as needed to ensure
sufficient breadth and balance on the committee. NIH Scientist
Administrators will not comprise more than 40% of the voting members
of the Steering Committee. NIGMS will form the Steering Committee soon
after awards are made.
The Informatics Group is responsible for the design, development,
implementation, and maintenance of the MIDAS database. The database
will contain (a) comprehensive information about the systems being
studied by the Research Groups and (b) results, tools, and models
developed by the Research Groups. The group will consist of
computational biologists, bioinformatics scientists, mathematicians,
and statisticians. The Informatics Group will name its own advisory
committee, which will consist of scientists from institutions outside
the MIDAS Network who have appropriate expertise to evaluate the
progress made toward achieving the MIDAS informatics goals and
objectives.
The Research Groups will be teams of multidisciplinary, collaborating
scientists from one or more institutions who have expertise in fields
relevant to the thematic areas in which they are conducting research.
Research Groups will conduct research in computational, mathematical,
and engineering approaches to modeling data on emerging infectious
diseases. Research Groups will not generate primary data; rather they
will use existing sequence, genetic, epidemiological, clinical,
climate, etc. information to conduct research. Each MIDAS Research
Group should make a commitment to focus MIDAS research on specific
tasks of national importance, should the need arise.
Description and Tasks of the MIDAS Research Network
Steering Committee
The Steering Committee will oversee the organization and progress of
MIDAS. The committee will make recommendations on how data should be
collected and displayed and will encourage uniform and complete
collection of data. The Steering Committee will oversee the
development of the MIDAS Database and seek common guidelines and
procedures for depositing information. The committee will set
standards for data formats and nomenclatures and make recommendations
for submitting data produced outside the MIDAS Network to the MIDAS
Database. The Steering Committee also will identify scientific issues
that need to be addressed and can establish information-gathering
subcommittees to follow up on particular issues or needs.
NIGMS may ask the MIDAS Network to conduct research related to
scenarios, policy decisions, or events involving an emerging infectious
disease or intentionally released pathogen. The Steering Committee
will oversee implementation of these MIDAS tasks and may request
additional resources for components of the Network.
The Steering Committee will coordinate communications among all members
of the MIDAS Network regarding data sharing, scientific and database
issues, and other issues related to the MIDAS goal and objectives. The
committee will coordinate the monthly telephone conference calls during
which the Research Groups and the Informatics Group will present
progress reports. The Steering Committee also will plan the annual
meeting at NIH during which the members of the MIDAS Network will
present their findings and address problems.
The Steering Committee will establish policies for disseminating the
models and results of MIDAS research to the larger scientific,
policymaking, and public health communities. The committee will
suggest time frames for making different datasets publicly available
and will recommend restricted access to data when issues of national
security are involved.
The Steering Committee will establish data release policies, taking
into consideration the plans proposed by the Research Groups and the
Informatics Group. A comprehensive policy will be implemented
throughout the MIDAS network.
NIGMS expects applicants to define time frames for depositing data in
public-domain databases as determined by the Steering Committee.
Release policies may take into account the need for further
experimentation to validate data, models, scripts, neural networks, and
computational tools. Different time constraints may be defined for
different datasets.
Research Groups
Research Groups will use existing or simulated datasets, as well as
real-time information, to build computational models relevant to the
goals of MIDAS. Because the components of host-pathogen systems are
numerous and complex, models need to elucidate and predict their
dynamic interactions. Modeling is needed to design new and improved
parameters for disease surveillance and forecasting. In the absence of
real data to support strategic planning for a bioterrorist attack,
mathematical modeling is fundamental to the design of alternative
intervention strategies and will help to guide training exercises,
scenario building, risk assessment, resource allocation, health care
management, and other activities. Ultimately, theoretical and
practical frameworks will be used to anticipate, prevent, and plan
responses to bioterrorist attacks. The same principles apply to the
control and prevention of, or response to, emerging infectious
diseases.
As a self-assembled, cross-disciplinary team of investigators, each
Research Group offers a unique blend and breadth of complementary
research expertise. A Research Group will conceive, develop, and
conduct research to improve knowledge relevant to the goal and
objectives of MIDAS. Each Research Group must focus on developing and
applying mathematical and computational tools to promote understanding
of complex biological systems and their interactions. Research Groups
will not generate primary data, except in the case of simulations.
Each Research Group must identify a data liaison person to interact
with the Informatics Group. This basic or bioinformatics scientist
will advise the Informatics Group on the management and display of data
generated or used by the Research Group. Research Groups are likely to
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. Each Research Group will be required to use
the standard data exchange format established by the Informatics Group
for transmitting information among projects.
Each Research Group must propose a data release policy and a separate
plan that addresses intellectual property rights, both of which will be
reviewed and may be modified by the Steering Committee. (For more
detail on intellectual property, see the section under "Special
Requirements.")
Each Research Group will present monthly progress reports via a
telephone conference convened by the Steering Committee for all members
of the MIDAS Network. In addition, each Research Group will present
its research findings at annual meetings of the network, which will be
held in Bethesda, MD.
Each Research Group is encouraged to have an independent advisory group
to provide advice on scientific issues unique to the group's research
program. Such a group should not be established until after an award
is made.
The Informatics Group
The Informatics Group will support and extend the work of the Research
Groups by collecting, organizing, and curating data relevant to the
systems they are studying, providing computational and analytical
tools, establishing data standards, creating simulations, designing
tests to validate data and models, and making the results and models of
the Research Groups publicly available. These tasks are described
below.
The Informatics Group will design, implement, and manage a centralized
database to store and display information for the MIDAS Network and for
allowing complex queries of data relevant to the Research Groups. The
Informatics Group will work with the Research Groups and Steering
Committee to identify, gather, organize, and curate information
relevant to the MIDAS research projects. Research Groups may identify
or submit this information; however, the Informatics Group should be
proactive in identifying and working with other data sources. Data
should be managed so that it will be accessible and interpretable by
users outside the Network who may be interested in this resource.
Data will be obtained from a variety of sources, some from public
databases. For example, the National Aeronautics and Space
Administration compiles remote sensing and geodesy data (e.g., indices
of spectral vegetation, land surface temperatures, and atmospheric
moisture and rainfall) that have epidemiological and public health
applicability. The Informatics Group must demonstrate its ability to
obtain information for the MIDAS Database and provide links to other
useful databases.
The Informatics Group will establish, within six months of the award, a
standard data exchange format that can be used by all members of the
MIDAS Network and that will allow for maximum interoperability with
other databases containing information relevant to the MIDAS goal and
objectives. The Informatics Group also may establish links to other
databases which may contain information that is relevant to MIDAS
Research Groups.
The Informatics Group also will deposit computational tools for data
analysis for use by the MIDAS Research Groups and by the scientific
community. These tools may include data mining and analysis tools,
multidimensional classification tools, data clustering tools,
visualization tools, scripts, computer algorithms, artificial networks,
and computer software.
The Informatics Group will make available to the scientific community,
policymakers, and public health officials the products and results of
the MIDAS Network. The Informatics Group will develop interfaces and
tools suitable for members of the Research Groups, for other research
scientists, for public health officials, for policymakers, and others.
The MIDAS Database may be constructed, implemented, and utilized in a
modular fashion as data become available. NIGMS does not plan to
define the structure and content of the database. The MIDAS Network
will be responsible for identifying the relevant information,
structure, and supporting tools for the database. The Steering
Committee will provide oversight for construction of the database and
implementation of analytical tools. When recommended by the Steering
Committee, data that are relevant to MIDAS Research Groups, but
produced outside the MIDAS Network, can be submitted to the MIDAS
Database. These data must meet the same standards of integrity,
quality, and curation that are defined for the MIDAS Database.
Although the MIDAS data can be organized in various ways, the database
must provide data and computational resources for the three thematic
research areas. Information for the modeling of host-pathogen systems
will include data on biological, genetic, and disease systems of
organisms related to emerging infectious diseases and biological
weapons or their model counterparts. Information for the modeling of
disease epidemiology and forecasting systems will include data on the
natural history, ecology, population dynamics, evolution, and
biogeography of emerging infectious disease agents and intentionally
released pathogens and their model counterparts. The construction and
validation of models of response systems will depend on establishment
of an integrated connectivity between the host-pathogen and disease
epidemiology and forecasting systems. Ideally, it will be possible to
establish functional relationships among the data developed across the
three thematic systems. The database should be designed to serve as a
foundation for future hypothesis-driven experiments, which could
uncover previously unsuspected correlations and perhaps help to
identify new and accurate predictors of epidemics. The goal is to
manage complex, interconnected data with unknown patterns and
relationships, and to integrate these data while retaining their
biological meaning.
The Informatics Group will monitor the overall structure and operation
of the database for data quality, accuracy, completeness, specificity,
and non-redundancy. The group 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. The Informatics Group will make
available to the public extensive documentation about the data and
computational tools, including statistical reports and analyses, as
well as supporting documentation for analytical tools.
The Informatics Group will be required to curate data according to
guidelines established by the Steering Committee. The Steering
Committee will conduct periodic reviews and may require frequent
updates to ensure that the data are of high quality and relevance.
Implementation of Web-based tools and public access to the database are
crucial parts of the overall effort.
The Informatics Group 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 Steering Committee. (For more detail, see
the section under "Special Requirements.")
The Informatics Group may be called upon to generate sophisticated
simulated data to test models and to collect real data to validate
models.
The Informatics Group will present monthly progress reports via a
telephone conference call convened by the Steering Committee for all
members of the MIDAS Network. In addition, the Informatics Group will
report progress at annual meetings of the Network, which will be
convened in Bethesda, MD.
Definitions
AWARDEE: The institution awarded a cooperative agreement.
COOPERATIVE AGREEMENT (U01): A mechanism of support that allows NIH
staff to have substantial programmatic involvement in coordination with
awardees during the performance of planned activities.
MODELS OF INFECTIOUS DISEASE AGENT STUDY (MIDAS): Research Groups and
an Informatics Group, each funded by a separate cooperative agreement,
working together to develop and promote use of computational biology
and mathematical tools to better understand emerging infectious
diseases (naturally occurring or resulting from the intentional release
of pathogens) and response measures.
MIDAS NETWORK: The Steering Committee, Research Groups, and Informatics
Group. These groups will work cooperatively to meet the goals of the
program; set and meet milestones; and produce and make available
information, research results, and models to the scientific community,
policymakers, and public health community.
STEERING COMMITTEE: The main governing body of MIDAS. The members
include representation from each of the Research Groups and the
Informatics Group; NIH Scientist Administrators with appropriate
scientific expertise; and selected scientists outside the MIDAS
Network, as needed to provide additional expertise and breadth and
balance on the committee. NIH representation on the Steering Committee
will never compose a majority of the members.
RESEARCH GROUP: A team of multidisciplinary, collaborating biological
scientists, epidemiologists, clinical and health care managers,
mathematicians, computational biologists, and statisticians (at one or
several sites) employing a state-of-the-art, comprehensive approach to
the study of emerging infectious diseases (naturally occurring or
resulting from the intentional release of pathogens).
INFORMATICS GROUP: A team of computational biologists, bioinformatics
scientists, mathematicians, computer software engineers, and computer
programmers responsible for the design, development, implementation,
and maintenance of MIDAS information management.
MIDAS DATABASE: A comprehensive database containing biological,
epidemiological, and operations management information and
computational tools and methods for appropriate storage, management,
and display of this information.
PRINCIPAL INVESTIGATOR: The person who assembles the project (for a
Research Group or the Informatics Group) and is responsible for
submitting the application in response to this RFA and for performance
of the project.
NIGMS PROGRAM DIRECTOR: NIGMS extramural staff person who provides
stewardship for the awards, evaluates and implements the advice of the
Steering Committee regarding allocation of NIH support, and coordinates
the administrative management of MIDAS.
NIH SCIENTIST ADMINISTRATORS: NIH extramural staff who, as voting
members of the MIDAS Steering Committee, have a substantial role in
coordinating the scientific activities of MIDAS and making
recommendations based on their knowledge of other related NIH-supported
research and resource activities.
ARBITRATION PANEL: A panel formed as needed to review scientific or
programmatic disagreements (within the scope of the award) that may
arise between MIDAS investigators and NIH. The panel will be composed
of three members: a designee of the Steering Committee chosen without
NIH staff voting, one NIH designee, and a designee who has expertise in
the relevant area who is chosen by the other two designees. When
disagreements are between individuals, the awardee seeking arbitration
may choose the first member of the panel.
General Issues
NIGMS has adopted several policies that are applicable to the MIDAS
Network. Applicants must present plans to adhere to the policies,
where appropriate.
Research Training. In many cases, the research projects envisioned at
this stage of MIDAS may not be appropriate as research training
projects. Applicants planning to employ graduate students and/or
postdoctoral research assistants on their project should address this
training issue in their applications. NIGMS will give consideration to
training opportunities if the project proposed involves substantial
experimental work.
Intellectual Property. Institutions and investigators are expected to
share background technology and intellectual property on a non-
exclusive and royalty-free basis with all participating institutions,
as required to achieve the scientific goals of the collaborative
research. In case an invention involves multiple institutions, the co-
inventors are expected to cooperate in the filing of any resulting
patent applications and in developing a plan to achieve commercial
application of the technology. Applicants should present plans related
to intellectual property rights, which should comply with the
regulations mentioned above. Guidance for extramural investigators
regarding intellectual property issues is available at
http://ott.od.nih.gov. These plans will be reviewed by the MIDAS
Steering Committee subsequent to an award. Plans may be modified to
bring them into compliance with MIDAS policy.
Data Release and Sharing of Results and Resources. The MIDAS Network
will generate virtual and collected data and mathematical and
computational tools. Grantees should plan on sharing theoretical and
experimental findings with other members of the MIDAS Network at annual
MIDAS meetings and at scientific meetings. Results and models will be
made available through the MIDAS Database. Applicants must include in
their applications a detailed description of their proposed guidelines
for data release. The final data release policy will be established by
the MIDAS Steering Committee. Because of the potential benefits of
MIDAS to the larger research and public health community, NIGMS will
enforce a policy for timely release of data, which will be implemented
in consultation with the MIDAS Steering Committee. The data release
policy proposed for the MIDAS Network will be subject to future
modifications, to comply with evolving NIH guidelines. The data
release policy for the MIDAS Network will be stated clearly on the
Network's website. NIGMS expects that users of the released data will
appropriately acknowledge their source. All data should be made
publicly available no later than the submission for publication. The
release of information on host-pathogen interactions, disease
transmission, diagnosis, surveillance, forecasting, and control, and
antimicrobial treatments for emerging infectious diseases should follow
NIH guidelines. Because information on strategies for response
preparedness, which include advanced planning and crisis planning, may
involve issues of national security, some parts of the MIDAS Database
may contain confidential or secure data, models, and tools.
Management Plan. Management of the MIDAS Network will involve a
significant commitment by Principal Investigators. NIGMS expects each
Principal Investigator to devote substantial effort to the project.
Applicants must propose a management plan that takes into account
changes in focus and effort that may be needed during the three-year
term of the award. In the event of an attack or the emergence of an
infectious disease, NIGMS may ask the Principal Investigators of MIDAS
Research Groups to apply their expertise to the public health
emergency. In this case, the Principal Investigators may need to
dedicate considerable effort to help resolve the crisis. Should this
occur, NIGMS will be flexible in allowing the Principal Investigator to
reorganize and reorient specific project goals and to renegotiate the
scope of the grant to include new objectives. The awardee may also be
able to request additional funding to cover costs that were not
included in the initial application.
The National Institute of Allergy and Infectious Diseases (NIAID) may
take advantage of the MIDAS infrastructure to further its mission in
biodefense by directly supporting MIDAS sites. The grantee institution
will be eligible to receive such an award if the Principal
Investigator's percentage of effort requested does not exceed 50
percent of his or her time and the scientific objectives of the
projects funded by NIGMS and NIAID do not overlap. The NIAID and NIGMS
Program Officers will carefully analyze these exceptional situations
and, together with the MIDAS Steering Committee, make recommendations
concerning additional funding or additional awards.
Annual Meeting. NIGMS expects grantees in the MIDAS Network to attend
an annual meeting in Bethesda, MD, to discuss their progress and
results. Applications should include travel funds for the Principal
Investigator and scientific team to attend these meetings.
Monthly Conference Calls. NIGMS expects grantees in the MIDAS Network
to hold monthly telephone conference calls to exchange and update
information and to discuss scientific and database issues. The
Steering Committee will coordinate conference calls, which will include
the Principal Investigators of each Research Group the Informatics
Group, and the NIGMS Program Director.
Cooperative Agreement Terms and Conditions of Award
The following terms and conditions will be incorporated into the award
statement and will be provided to the Principal Investigator and the
appropriate institutional official at the time of award. The following
special terms of award are in addition to, and not in lieu of,
otherwise applicable Office of Management and Budget (OMB)
administrative guidelines, DHHS 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 DHHS, PHS, and NIH grant
administration policies:
The administrative and funding instrument used for this program will be
the cooperative agreement (U01), an "assistance" mechanism (rather than
an "acquisition" mechanism) of support when NIH anticipates having
substantial programmatic involvement with awardees during performance
of the activities. Under a cooperative agreement, the NIH aims to
support and stimulate awardees' activities by involvement in and
otherwise working jointly with the awardees in a partnership role. NIH
does not assume direction, prime responsibility, or a dominant role in
grant activities. Awardees have the dominant role and prime
responsibility for the project as a whole, although responsibility for
specific tasks and activities may be shared by awardees and the NIH
through their participation on the MIDAS Steering Committee.
1. Principal Investigator Rights and Responsibilities
The Principal Investigator will coordinate project activities
scientifically and administratively at the grantee institution. The
Principal Investigator will have primary responsibility for defining
the details of the projects within the guidelines of this RFA GM-03-008
and for performing scientific activities. The Principal Investigator
will agree to accept the close coordination, cooperation, and
participation of NIH staff in the aspects of project management
described under "NIH Scientist Administrators Responsibilities."
Awardees agree to accept and implement the policies and guidelines of
the MIDAS Steering Committee. Awardees will retain custody of, and
have primary rights to, data developed under these awards, subject to
Government rights of access consistent with current federal, DHHS, and
NIH policies. Awardees should comply with their institution's policies
and practices concerning intellectual property, as approved in the
award.
The Principal Investigator of a Research Group or the Informatics Group
will:
o Determine and coordinate research approaches and procedures
o Set project milestones for the Research Group or Informatics Group
o Implement policies and guidelines approved by the MIDAS Steering
Committee
o Submit data to the MIDAS Database according to policies established
by the Steering Committee
o Attend Steering Committee meetings
o Contribute to the cooperative nature of the effort.
2. NIH Scientist Administrators Responsibilities:
NIH Scientist Administrators with expertise in relevant areas will
serve on the Steering Committee as representatives of the NIH
extramural staff and will be substantially involved above and beyond
normal stewardship. They will help guide the development of the MIDAS
Network by providing overall advice and coordination. They will
facilitate a partnership among NIH, the Research Groups, and the
Informatics Group, and they will ensure that the directions taken by
MIDAS are consistent with NIH missions and goals. The Scientist
Administrators will make recommendations regarding support, to maintain
a scientific balance between accomplishing the goal and objectives of
MIDAS and addressing emerging research opportunities. NIH staff will
facilitate, not direct, activities. Decisions will be reached through
consensus with the Principal Investigators and other members of the
MIDAS Steering Committee.
The NIH Scientist Administrators will:
o Share relevant expertise and overall knowledge
o Help to coordinate activities among awardees
o Be the information source for NIH-supported research and resources
o Attend Steering Committee meetings
o Contribute to the cooperative nature of the effort
o Promote MIDAS research, results, tools, and methods to the
scientific community, policymakers, and the public health community
o Help to implement recommendations for allocating NIH support to
grantees.
3. NIGMS Program Director
The Program Director has day to day responsibility for administration
of the project and stewardship of funds. The Program Director is a
central contact for all scientific and fiscal issues and serves as a
resource to the project regarding DHHS, NIH, and NIGMS recommendations
and policies. The Program Director or designate will attend all
Steering Committee meetings but is not a voting member of the Steering
Committee.
The Program Director will:
o provide stewardship for the awards
o evaluate and implement the advice of the Steering Committee
regarding allocation of NIH support
o ensure compliance with DHHS, NIH, and NIGMS policy
o coordinate the administrative management of MIDAS
4. Collaborative Responsibilities the MIDAS Steering Committee
The MIDAS Steering Committee is the managing body for MIDAS. Voting
members will include representation from each Research Group and the
Informatics Group, NIH Scientist Administrators with appropriate
scientific expertise (e.g., computational biology, mathematics,
epidemiology), and selected scientists from outside the MIDAS Network,
as needed, to gain additional expertise and breadth and balance on the
committee. NIH representation (Scientist Administrators) will not
comprise more than 40% of the voting members on the Steering Committee.
The NIGMS Program Director is not a member of the Steering Committee,
but will facilitate formation of the group and will attend all
meetings. Members of the Steering Committee who are MIDAS awardees
must accept and implement guidelines and policies approved by the
Steering Committee.
Within approximately one month after NIGMS awards the cooperative
agreements for MIDAS, the NIH Scientist Administrators and the
Principal Investigators will meet (in person or by telephone conference
call) to select the outside members of the Steering Committee and to
elect a Chair for the committee. NIH staff may not serve as Chair.
The NIGMS Program Director will schedule the first meeting of the
Steering Committee. The Chair will be responsible for developing
meeting agendas and chairing meetings. At the first meeting, the
Steering Committee will decide on the schedule of meetings. The
committee will meet twice each year, usually in Bethesda, MD. At
approximately the same time as these meetings, the data liaison persons
of the Research Groups and a representative of the Informatics Group
also will meet, possibly in Bethesda, MD, or at the MIDAS Database
site. The Steering Committee may establish subcommittees as necessary.
The Steering committee also may add members, with the approval of the
NIGMS Program Director.
The Steering Committee will:
o Serve as the main governing board of the MIDAS Network
o Set milestones for the MIDAS Network
o Assess progress within the MIDAS Network
o Standardize the data format and nomenclature for the MIDAS database
o Develop guidelines and policies for data sharing and release to
public domains
o Consider the views of other researchers
o Contribute to the development of a cohesive effort
o Alert NIH to scientific opportunities, emerging needs, and
impediments.
5. Arbitration Process
Any disagreements about scientific or programmatic matters within the
scope of the award between award recipients and the NIH may be brought
to arbitration. NIGMS will convene an Arbitration Panel composed of
three members: a designee of the Steering Committee, who is chosen
without NIH staff voting; one NIH designee; and a designee who has
expertise in the relevant area and who is chosen by the other two
designees. For disagreements between individuals, the awardee seeking
arbitration may choose the first member of the panel. This special
arbitration procedure does not affect 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 DHHS regulation 45 CFR Part
16.
6. Milestones and Evaluations
Applicants should define yearly milestones in their applications.
Awardees will have an opportunity to modify their milestones when they
receive their awards. NIGMS will provide the awardees' milestones to
the Steering Committee. NIGMS expects that milestones will be adjusted
annually, at the anniversary dates of the award, to incorporate
scientific accomplishments and progress in the field and to reflect
recommendations of the Steering Committee. NIH Scientist
Administrators may recommend augmenting any project, as discussed with
the Steering Committee, or reducing or withholding funds for any
project that substantially fails to meet milestones or to remain state-
of-the-art.
The Director, NIGMS, retains the right to call a meeting of advisors,
which would most likely be members of the National Advisory General
Medical Sciences Council or their designee(s), at any time to consult
on the scientific progress of the MIDAS Network. As part of its fact
finding, the advisors may want to attend a meeting of the Steering
Committee. NIGMS will share any information or reports with other ICs
participating in this initiative and with the Director, NIH.
7. Issues in Research Involving Human Subjects
Human Subjects Research must meet the requirements of 45 CFR 46
"Protection of Human Subjects". Research supported in response to this
initiative may include clinical and epidemiological data obtained from
patients of different racial, ethnic, and socio-cultural populations or
from individuals and families affected by particular infectious
diseases. The study of emerging infectious diseases can lead to
valuable knowledge of appropriate measures to identify, control,
prevent, and treat these diseases. This value will be diminished if
information is misinterpreted or misused to stigmatize or discriminate
against defined populations. It is of paramount importance that the
symptomatic or asymptomatic carrier statuses of all individuals remain
strictly confidential. NIGMS expects awardees to ensure that the
potential impact of the research on individuals and groups
participating in the study, the potential risks of stigmatization and
discrimination, the confidentiality of the data, and the benefits of
the knowledge to be gained are addressed in the study protocol and
informed consent process, and receive IRB approval. Investigators must
obtain from all participants thorough, current, and clear informed
consent and subjects must be informed that information generated from
their samples may be deposited into the MIDAS Database. Before
submitting data to public databases and/or the MIDAS Database, awardees
must remove any information that would identify the individuals to whom
the data pertain.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA 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.
o Direct your questions about scientific/research issues to:
Irene Eckstrand, Ph.D.
Division of Genetics and Developmental Biology
National Institute of General Medical Sciences
45 Center Drive, Room 2AS.25K, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-0943
FAX: (301) 480-2228
Email: [email protected]
o Direct your questions about peer review issues to:
Helen R. Sunshine, Ph.D.
Chief, Office of Scientific Review
National Institute of General Medical Sciences
45 Center Drive, Room 3AN.12F, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-2881
FAX: (301) 480-8506
Email: [email protected]
o Direct your questions about financial or grants management matters to:
Joe Ellis
Grants Administration Branch
National Institute of General Medical Sciences
45 Center Drive, Room 2AN.32C, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-5135
FAX: (301) 480-2554
Email: [email protected]
PUBLIC BRIEFING
Prospective applicants are invited to attend a public briefing on the
MIDAS Research Network on April 23, 2003 in Bethesda, MD. NIH staff
will explain the purpose of this RFA, provide instructions regarding
the application process, and answer questions. Potential applicant
institutions are urged to send a representative to this briefing, both
to gather information and to exchange ideas with other potential
applicants. Anyone who cannot attend the pre-application meeting will
be provided with any distributed materials and a summary of the
discussion. The meeting will be held as follows:
April 23, 2003, 9 AM 12 PM
Natcher Conference Center
National Institutes of Health
For further information about this meeting, contact the NIGMS Program
Staff listed under INQUIRIES.
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that
includes the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does
not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review
workload and plan the review.
The letter of intent is to be sent by the date listed at the beginning
of this document. The letter of intent should be sent to:
Irene Eckstrand, Ph.D.
Division of Genetics and Developmental Biology
National Institute of General Medical Sciences
45 Center Drive, Room 2AS.25K, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-0943
FAX: (301) 480-2228
Email: [email protected]
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant
application instructions and forms (rev. 5/2001). The PHS 398 is
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in
an interactive format. For further assistance contact Grants Info,
Telephone (301) 710-0267, Email: [email protected].
SUPPLEMENTAL INSTRUCTIONS: Applicants may propose a Research Group or
an Informatics Group by submitting an integrated application for either
group. Applicants proposing both a Research Group and the Informatics
Group must prepare separate applications for each group. Applicants
should also address the information required in the SPECIAL
REQUIREMENTS section above.
Applicants should present a comprehensive and interdisciplinary team
approach to the problem identified for study. The application should
include a face page, description, consolidated budget, list of key
personnel, biographical sketches, existing resources and facilities,
and letters of collaboration. The page limit for the research plan
(which should include specific aims, background and significance,
preliminary studies, research design, and methods) is 60 pages.
Applicants must include a proposed timeline and plan that set forth
specific goals (milestones) to be achieved in the first, second, and
third year of the award. Applicants should request resources
commensurate with the goals they have proposed.
Following the instructions in the PHS 398, section e. Human Subjects,
plans for recruitment, informed consent, and protection of privacy and
confidentiality of human subjects must be addressed clearly in the
application, and reviewers will consider these plans during the review
process. Other resources are the OPRR Institutional Review Board
Guidebook Chapter 5 - Human Genetics Research
(http://www.hhs.gov/ohrp/irb/irb_chapter5.htm) and other
applicable sections, and the Ethical, Legal, and Social Issues (ELSI)
Program of the National Human Genome Research Institute (NHGRI)
(http://www.genome.gov/page.cfm?pageID=10001618), for information on
protection of human subjects related to research in infectious
diseases. NIH program staff (listed below) also can provide guidance
on current NIH policies and practices in this area. Applicants may
consider obtaining Certificates of Confidentiality and are encouraged
to look at the Kiosk http://grants.nih.gov/grants/policy/coc/index.htm.
Certificates of Confidentiality may be granted for studies collecting
information that if disclosed could have adverse consequences for
subjects or damage their financial standing, employability,
insurability, or reputation.
All applicants should provide sufficient detail in all parts of the
application to enable reviewers to readily and completely understand
the proposed project and approach.
Applications for a Research Group should include an overview section
that defines the scope, research goals and objectives, and describes
the rationale for selecting the particular areas of scientific
concentration (i.e., at least two of the three thematic research areas
previously defined in this RFA). Some components of a research project
may be cores or resources that are integral to the entire group.
Applications for the Informatics Group should include an overview
section that defines the scope, research goals and objectives and
describes a strategy for creating the MIDAS Database. Applicants
should specify how they will design and develop the database and how
they will make it available to users.
Applicants for the Informatics Group should address all aspects of the
database design, clearly explain and justify their proposed approaches,
and give examples whenever possible. Specific issues to address
include: optimal database design, timetable for database development,
most appropriate nomenclature determined as possible and in advance,
conditions for collecting biological information, timing for the
submission of information, stages in the development of the database
(e.g., raw versus finished data, validated versus invalidated data),
validation of deposited information, mechanism(s) for correcting errors
in the database, obtaining peer or editorial reviews of data,
coordination of comments from scientific users, and identification and
installation of appropriate database links. The applicant's plan also
should describe in detail the computational tools and specific
supporting documentation that the Informatics Group will design and
make available to all members of the Network.
In addition, applicants should address the following areas, as
appropriate, in their applications:
For a Research Group:
o Describe the group's policies for data release into the MIDAS
Database or other databases.
o Identify a data liaison person who has appropriate expertise and who
will interact with the Informatics Group
o Describe how the reviews and comments of MIDAS scientists will be
incorporated into the scope of the research project
For the Informatics Group:
o Describe the timing and method desired for receipt of information
into the Database.
o Provide evidence of communication or links with a proposed Research
Group or similar site and assurance that appropriate expertise is
available for interactions.
For a Research Group or Informatics Group:
o Describe your institution's intellectual property policies and
practices, including policies for commercialization of discoveries, and
the implications of these policies for the MIDAS project.
o Identify any unique institutional resources, services, or facilities
that would benefit the program
o Describe any other support or projects that have a significant
impact on this application
o Describe plans for sharing any materials (e.g., software tools,
microbiological samples) with other researchers.
o Describe the mechanisms for administration of research activities
within the group (e.g., regular meetings, staffing, data exchange,
external evaluations).
o Request funds for the Principal Investigator or designate to attend
two Steering Committee meetings annually in Bethesda, MD.
o Request funds for the database liaison person to meet with a
representative of the Informatics Group two times annually in Bethesda,
MD, or at the Informatics Group site.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev.
5/2001) application form must be affixed to the bottom of the face page
of the application. Type the RFA number on the label. Failure to use
this label could result in delayed processing of the application such
that it may not reach the review committee in time for review. In
addition, the RFA title and number must be typed on line 2 of the face
page of the application form and the YES box must be marked. The RFA
label is also available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
SENDING AN APPLICATION TO THE NIH: 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
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application
must be sent to:
Helen R. Sunshine, Ph.D.
Chief, Office of Scientific Review
National Institute of General Medical Sciences
45 Center Drive, Room 3AN.12F, MSC 6200
Bethesda, MD 20892-6200
APPLICATION PROCESSING: Applications must be received by the
application receipt date listed in the heading of this RFA. If an
application is received after that date, it will be returned to the
applicant without review.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and
funding assignment within 8 weeks.
The Center for Scientific Review (CSR) will not accept any application
in response to this RFA 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 an RFA, it is to be prepared as a NEW
application. That is the application for the RFA must not include an
Introduction describing the changes and improvements made, and the text
must not be marked to indicate the changes. While the investigator may
still benefit from the previous review, the RFA application is not to
state explicitly how.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR
and for responsiveness by the NIGMS. Incomplete and/or non-responsive
applications will be returned to the applicant without further
consideration. Applications that are complete and responsive to the
RFA will be evaluated for scientific and technical merit by an
appropriate peer review group convened by NIGMS in accordance with the
review criteria stated below. As part of the initial merit review, all
applications will:
o Receive a written critique
o Undergo a process in which only those applications deemed to have
the highest scientific merit, generally the top half of the
applications under review, will be discussed and assigned a priority
score
o Receive a second-level review by the National Advisory General
Medical Sciences Council.
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.
In the written comments, reviewers will be asked to discuss the
following aspects of the application in order to judge the likelihood
that the proposed research will have a substantial impact on the
pursuit of these goals:
o Significance
o Approach
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these
criteria in assigning the application's overall score, weighting them
as appropriate for each application. The application does not need to
be strong in all categories to be judged likely to have major
scientific impact and thus deserve a high priority score. For example,
an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.
SIGNIFICANCE: Does this study address an important problem? If the aims
of the application are achieved, how will scientific knowledge be
advanced? What will be the effect of these studies on the concepts or
methods that drive this field?
APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of
the project? Does the applicant acknowledge potential problem areas and
consider alternative tactics?
INNOVATION: Does the project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does the project
challenge existing paradigms or develop new methodologies or
technologies?
INVESTIGATOR: Is the investigator 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
(if any)?
ENVIRONMENT: Does the scientific environment in which the work will be
done contribute to the probability of success? Do the proposed
experiments take advantage of unique features of the scientific
environment or employ useful collaborative arrangements? Is there
evidence of institutional support?
COOPERATION: Does the team demonstrate its willingness and capability
to work with other members of the MIDAS Network to enhance the
project's productivity? Are the plans for sharing research findings,
tools, and methods among Network members adequate?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the
following items will be considered in the determination of scientific
merit and the priority score:
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of
human subjects and protections from research risk relating to their
participation in the proposed research will be assessed. (See criteria
included in the section on Federal Citations, below).
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. Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria in the
sections on Federal Citations, below).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals
are to be used in the project, the five items described under Section f
of the PHS 398 research grant application instructions (rev. 5/2001)
will be assessed.
ADDITIONAL CONSIDERATIONS
DATA SHARING: The adequacy of the proposed plan to share data.
BUDGET: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: May 19, 2003
Application Receipt Date: June 18, 2003
Peer Review Date: October/November 2003
Council Review: January 2004
Earliest Anticipated Start Date: April 2004
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities
o Program balance
The NIH retains the flexibility to select and assemble components of
the MIDAS Research Network that optimally blend the applicants'
research areas, experience, creativity, collective knowledge, and
combined expertise in the background sciences.
REQUIRED FEDERAL CITATIONS
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.
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 Amended, October, 2001," published in the NIH Guide
for Grants and Contracts on October 9, 2001
(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 RESEARCH INVOLVING HUMAN
SUBJECTS: The NIH maintains a policy that children (i.e., individuals
under the age of 21) must be included in all human subjects research,
conducted or supported by the NIH, unless there are scientific and
ethical reasons not to include them. This policy applies to all
initial (Type 1) applications submitted for receipt dates after October
1, 1998.
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 that is available at
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 proposals for research
involving human subjects. You will find this policy announcement in the
NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, 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://grants.nih.gov/grants/stem_cells.htm 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 (see
http://escr.nih.gov). It is the responsibility of the applicant to
provide 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.
PUBLIC 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 RFA 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.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and
proposals for NIH funding must be self-contained within specified page
limitations. Unless otherwise specified in an NIH solicitation,
Internet addresses (URLs) should not be used to provide information
necessary to 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 RFA 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 Nos. 93.113, 93.172, 93.242, 93.273,
93.837, 93.859, 93.862, and is not subject to the intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency
review. Awards are made under authorization of Sections 301 and 405 of
the Public Health Service Act as amended (42 USC 241 and 284) and
administered under NIH grants policies described at
http://grants.nih.gov/grants/policy/policy.htm and under Federal
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.
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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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