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: eckstrai@mail.nih.gov  

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: sunshinh@nigms.nih.gov 

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: ellisj@mail.nih.gov

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:  eckstrai@mail.nih.gov  

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) 435-0714, Email: GrantsInfo@nih.gov. 

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.

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NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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