Pilot Projects for Models of Infectious Disease Agent Study (MIDAS)

RFA Number: RFA-GM-05-011

Part I Overview Information

Components of Participating Organizations
National Institute of General Medical Sciences (NIGMS), (http://www.nigms.nih.gov/)

Announcement Type
This is a reissue of RFA-GM-03-008 which was previously released March 13, 2003

Update: The following update relating to this announcement has been issued:

• April 16, 2008 - This RFA has been reissued as (RFA-GM-09-001).
• February 3, 2006 (NOT-GM-06-106) - The purpose of this Notice is to announce that the NIGMS is modifying the mission of RFA-GM-03-008 and RFA-GM-05-011.

Catalog of Federal Domestic Assistance Number(s)
93.859

Key Dates
Release Date: November 8, 2004
Letters Of Intent Receipt Date(s): January 24, 2005
Application Receipt Dates(s): February 23, 2005
Peer Review Date(s): July 2005
Council Review Date(s): September 22-23, 2005
Earliest Anticipated Start Date: December 1, 2005
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: February 24, 2005

Due Dates for E.O. 12372
Not Applicable

Executive Summary
The National Institute of General Medical Sciences (NIGMS) reannounces the Request for Applications for Research Groups for the Models of Infectious Disease Agent Study (MIDAS). MIDAS consists of a centralized informatics resource 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. In May 2004, NIGMS funded three research groups and one informatics group to initiate the MIDAS Network. This reannouncement seeks to expand the scope and expertise of the Network by adding up to three new pilot projects (but not a new informatics group) for a commitment of approximately $2 million in FY 06. The U01 Cooperative Agreement mechanism will be used and each award is expected to be approximately $600,000 total costs. Eligible institutions include domestic institutions, for-profit or non-profit organizations, public or private institutions, such as universities, colleges, hospitals, and laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions may participate only as collaborating institutions. An applicant institution may submit more than one application. 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. 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].

Telecommunications for the hearing impaired: TTY 301-451-5936.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Merit Review Criteria
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources

Section VI. Award Administration Information
1. Award Notices
2. Administrative Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilites
4. Arbitration Process
3. Award Criteria
4. Reporting

Section VII. Agency Contact(s)

1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

1. Research Objectives

The overall goal of MIDAS 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 model exposure to pathogens and their products, carry out identification and surveillance of infectious diseases in a timely and cost-effective manner, model the effectiveness and consequences of different intervention strategies, and model the decontamination of facilities from pathogens and their products; and (2) to establish a centralized informatics resource to store and make publicly available the tools, models, and documentation for the practical use of policymakers, public health professionals, and researchers.

The MIDAS Network, currently comprised of three Research Groups and an Informatics Group, is directed by the 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 provide additional scientific expertise.

This initiative is a pilot effort in the organization of a research network for the modeling of emerging infectious diseases and biodefense responses. NIGMS is soliciting applications for additional Research Groups that will complement and expand the research scope of the existing groups.

Background

Policymakers and the public are increasingly concerned about bioterrorism and the emergence of new pathogens. The U.S. scientific and public health communities need better resources, knowledge, and tools to improve their ability to identify and prevent the spread of diseases resulting from the emergence or intentional release of pathogens and their products. The variety of scenarios possible complicates the challenge of confronting these threats. An important role of science is to create a rational picture of the alternatives by collecting, analyzing, and interpreting relevant data and by developing models. The models themselves can guide the collection of further data. In addition, good models can reveal important patterns in the data, allow investigators to examine scenarios, and ultimately to make predictions. These capabilities can help responsible parties respond effectively to an emerging epidemic or a bioterrorist threat.

MIDAS relies on a network of researchers with demonstrated expertise in computational and mathematical methods, the biology of infectious disease systems, social networks, population dynamics, genetic variation and evolution, and environmental modeling. Such an interdisciplinary network is an important component of an overall public health strategy for managing emerging infectious diseases.

In March 2003, NIGMS published the first Request for Applications for MIDAS and subsequently funded three Research Groups and one Informatics Group in May 2004. The MIDAS Steering Committee met for the first time on May 3-4, 2004 to provide guidance and oversight to the project. Information on the funded projects and the Steering Committee are available on the MIDAS Web site at http://www.nigms.nih.gov/research/midas.html.

Among the Steering Committee's recommendations was that NIGMS expand the scientific scope of MIDAS by soliciting research projects that add new expertise and resources. That is the purpose of this announcement.

The Steering Committee also concluded that it would be valuable for the MIDAS scientists to work collectively on a research problem, in addition to their primary interest areas. The Steering Committee believed that this would quickly develop collaborations and resources within MIDAS, but more important, would address an issue of real concern to the public health community. The committee chose to focus on modeling pandemic influenza, specifically a pandemic resulting from antigenic shift. Collaboration on research projects will continue to be a cornerstone of MIDAS, although the questions, model systems, and datasets may change as the Network's capabilities mature. Pandemic influenza is an example of the infectious disease systems that MIDAS researchers may study.

Influenza experts have argued that another outbreak of pandemic influenza is almost certain. When it happens, the public health system will need information about effective surveillance and forecasting methods, efficient short- and long-term intervention strategies, and allocation of resources. The MIDAS influenza project has two objectives (1) to replicate local and global spread of known outbreaks in the absence of intervention and (2) to create scenarios exploring the efficacy of strategies to slow or halt local and global spread of the virus.

All MIDAS projects are expected to participate in the influenza exercise as well as other collaborative projects designed by the Network.

Organizational Structure of MIDAS

The MIDAS Network has three components: a Steering Committee, Informatics Group, and Research Groups.

The Steering Committee is the main managing body for MIDAS. The committee includes representation from each of the Research Groups and the Informatics Group, as well as NIH Scientist Administrators with relevant expertise. Outside expertise ensures sufficient breadth and balance on the committee. NIH Scientist Administrators will not comprise more than 40% of the voting members of the Steering Committee.

The Informatics Group provides computational capacity and informatics support to MIDAS Research Groups. It is responsible for developing and managing databases, analyzing and verifying models, identifying and documenting relevant data, developing simulated data, and creating a portal for access to models, tools, and other information. This award has already been made.

The Research Groups are teams of multidisciplinary, collaborating scientists from one or more institutions who have expertise in fields relevant to MIDAS. Research Groups conduct research in computational, mathematical, and engineering approaches to modeling data on emerging infectious diseases.

Research Groups use existing sequence, genetic, epidemiological, clinical, climate, etc. information to conduct research. They will not generate primary data.

Each MIDAS Research Group should make a commitment to focus MIDAS research on specific tasks of national importance and to participate fully in collaborative Network research.

Description and Tasks of the MIDAS Research Network

Steering Committee

The Steering Committee oversees the organization and progress of MIDAS. The committee makes recommendations on data collection and distribution and seeks common guidelines and procedures for depositing information. The committee sets standards for data formats and nomenclatures and makes 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 coordinates 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 coordinates the monthly telephone conference calls during which the Research Groups and the Informatics Group present progress reports. The Steering Committee also plans the annual meeting at NIH during which the members of the MIDAS Network present their findings and address problems.

The Steering Committee and NIGMS have established policies for disseminating the models and results of MIDAS research to the larger scientific, policymaking, and public health communities. All models and tools, including source code, will ultimately be made available for both use and downloading and modification through the MIDAS portal.

The Steering Committee and NIGMS have established data release policies, requiring that all data used for the development of MIDAS models must be made publicly available through the MIDAS portal. 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.

NIGMS expects applicants to define time frames for depositing data, models, and other relevant information and documentation in the MIDAS network. 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. Research Groups will not generate primary data, except in the case of simulations.

As a self-assembled, cross-disciplinary team of investigators, each Research Group offers a unique blend and breadth of complementary scientific research expertise. Each Research Group must focus on developing and applying mathematical and computational tools to promote understanding of complex biological systems and their interactions. Because the components of host-pathogen systems are numerous and complex, models must elucidate and predict their dynamic interactions.

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 may develop their own (local) databases to meet their computational needs. They may request funds to support the design, testing, and validation of bioinformatics tools and the storage of data needed to accomplish their research objectives. Each Research Group is 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, each of which may be further negotiated prior to funding.

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.

Informatics Group

The Research Triangle Institute constitutes the Informatics Group. It is 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.

Specific Research Objectives

This RFA invites applications from Research Groups which will address two of the three major thematic areas, which are described below.

THEMATIC RESEARCH AREAS

Research groups funded as a result of this RFA will be fully integrated into the MIDAS Network. The MIDAS Network will focus on scientific knowledge and expertise in computational biology and mathematics applied to three thematic research areas: (1) Modeling of Host-Pathogen Systems, (2) Modeling of Disease Systems, and (3) 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. A particular challenge in the MIDAS program is multiscale modeling. Listed below are suggested, but not required, research topics for each area.

Applicants may choose particular model systems to illustrate their approaches and expertise. Although pandemic influenza currently is a shared interest of the MIDAS network, and it will be helpful for applicants to indicate how they would apply their methods and expertise to this problem, applicants should understand that MIDAS has broad interests in emerging diseases and bioterrorism. Applicants should demonstrate an ability to apply methods to new systems.

(1) Modeling of Host-Pathogen Systems

Research topics include, but are not limited to the following:

A. Modeling of microbial population structure, ecology, natural history, and genome structure and evolution of microbes relevant to biodefense and emerging diseases. For example:

• Development and application of computational methods for phylogenetic reconstruction and analysis; modeling tools to achieve accurate population sampling
• Modeling of the evolution of microbial traits such as virulence, pathogenicity, immunogenicity, and drug resistance
• Modeling the impact of various infectious disease parameters and life history strategies

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.

(2). Modeling of Disease Systems

Research topics include, but are not limited to:

Modeling of climatic, geographic, epidemiological, entomological, and ecological data to evaluate disease transmission dynamics. For example:

• 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.
• Use of remote sensing technology to characterize and monitor spatial and temporal patterns of emerging infectious diseases.

B. Modeling of the genomics, 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.

(3). Modeling of Response Systems

Research topics include, but are not limited to:

A. Study of the population and transmission dynamics of intentionally released pathogens and their products, including dispersion of pathogens and their products in confined and open environments (e.g., office buildings, subway systems, hospitals, others)

B. Modeling deployment and administration of stockpiles of vaccines, antimicrobials, and antitoxins to affected areas; allocation of resources and manpower

C. Modeling quantitative and qualitative effects of radiation- and chemically-induced damage to biological processes in viruses, prokaryotes, and eukaryotes from decontamination and inactivation procedures

1. Mechanism(s) of Support

This funding opportunity will use the U01 Cooperative Agreement award mechanism. As an applicant, you will have the primary responsibility for planning, directing, and executing the proposed project.

This funding opportunity uses just-in-time concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format described in the PHS 398 application instructions. Otherwise follow the instructions for non-modular research grant applications.

The NIH U01 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the section VI. 2. Administrative and National Policy Requirements, "Cooperative Agreement Terms and Conditions of Award". Plans for the project mechanism beyond the current funding period are indefinite.

2. Funds Available

The NIGMS intends to commit approximately $2 million dollars in FY 06 to fund two or three new grants in response to this RFA. An applicant may request a project period of up to five years and a budget for direct costs up to $500,000 dollars per year, exclusive of subproject Facilities and Administrative costs (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html) . Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the 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.

1. Eligible Applicants

1.A. Eligible Institutions

You may submit applications if your organization has any of the following characteristics:

• For-profit organizations
• Non-profit organizations
• Public or private institutions, such as universities, colleges, hospitals, and laboratories
• Units of State government
• Units of local government
• Eligible agencies of the Federal government

Foreign Institutions are not eligible to apply. Foreign institutions may participate only as collaborating institutions.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

2. Cost Sharing
Cost sharing is not required.

3. Other-Special Eligibility Criteria
There is no limit to the number of applications submitted from a sponsoring institution.

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: January 24, 2005
Application Receipt Date(s): February 23, 2005
Peer Review Date: July, 2005
Council Review Date: September 22-23, 2005
Earliest Anticipated Start Date: December 1, 2005

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed research
• Name, address, and telephone number of the Principal Investigator
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

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:

James J. Anderson, Ph.D.
Center for Bioinformatics and Computational Biology
National Institute of General Medical Sciences
45 Center Drive, Room 2AS-25A, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-0943
FAX: (301) 480-2228
Email: [email protected]

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]

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review.

The NIH 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 from the previous unfunded version of the application.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

4. Intergovernmental Review
This initiative is not subject to intergovernmental review

5. Funding Restrictions

All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm (See also Section VI.3. Award Criteria)

6. Other Submission Requirements

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. See also Plan for Data Sharing and Plan for Resource Sharing.

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 five-year term of the award.

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.

National Emergency Plan . 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.

Data and Resource Sharing Plans . The MIDAS Network will generate collected and simulated data sets and mathematical and computational tools. These materials must be made available both to Network investigators and to the scientific community, but on different schedules. NIGMS expects that users of the released data will appropriately acknowledge their source.

• Data Sharing Within the Network. Grantees must share data sets and tools as well as theoretical and experimental findings with other members of the MIDAS Network in order to facilitate the rapid development and dissemination of models. The schedule for sharing data sets and tools will be set by the Steering Committee.

• Data Sharing Outside the Network. Grantees are expected to present their findings at MIDAS meetings and at scientific meetings. Data sets, models and tools, including source code, will be made publicly available through the MIDAS portal according to NIH policy as listed below in Plan for Sharing Research Data, and Sharing Research Resources.

Because of the potential benefits of MIDAS to the larger research and public health community, NIGMS will enforce a policy for timely release of information, 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 current data release policy for the MIDAS Network is available on the Network's website.

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; access of the public to these might be restricted.

Plan for Sharing Research Data

All applicants must include a plan for sharing research data with the public in their application . The plan for sharing data within the MIDAS Network is described above under Section IV #6, Other Submission Requirements, and should be referred to in the overall plan. The NIH data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. The MIDAS refinement of this policy is listed at the MIDAS Network website , http://www.nigms.nih.gov/research/midas.html. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants should refer to the MIDAS Network website listed above for guidance. Describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing. Investigators may chose to share under their own auspices, in addition to providing data to the MIDAS website, by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave. Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application. See Section IV, 6. Other Submission Requirements.
The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps and http://www.ott.nih.gov/policy/rt_guide_final.html . Investigators responding to this funding opportunity should include a plan for sharing research resources with the public addressing how unique research resources will be shared or explain why sharing is not possible. The MIDAS requirement for sharing resources within the Network, described above under Section IV #6, Other Submission Requirements , should be referred to as part of the overall plan.

The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report. (PHS 2590). See Section VI.3. Award Criteria.

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. 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.

2. Review and Selection Process

Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NIGMS. Incomplete applications will not be reviewed.

As part of the initial merit review, all applications will:

• Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.
• Receive a written critique
• Receive a second level of review by the National Advisory General Medical Sciences Council

3. Merit Review Criteria

The goals of NIH-supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

2. Approach. Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

3. Innovation. Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

4. Investigators. Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

5 . Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

3.A. 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 the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Cooperation: Does the research team demonstrate its willingness and capability to work with other members of the MIDAS Network to enhance the project's productivity?

3.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

3.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

3.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps and http://www.ott.nih.gov/policy/rt_guide_final.html. Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible. The reasonableness of the research resources sharing plan will be assessed by the reviewers. However, reviewers will not factor the proposed research resources sharing plan into the determination of scientific merit or the priority score.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the Principal Investigator before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report. (PHS 2590). See Section VI.3. Award Criteria.

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.

Certain policies that pertain to the MIDAS Network will be required. These are listed in Section IV, part 6: Other Submission Requirements.

All NIH Grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm.

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement U01 , an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined above.

2.A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator of a Research Group will:

• Determine and coordinate research approaches and procedures
• Set project milestones for the Research Group
• Implement policies and guidelines approved by the MIDAS Steering Committee
• Submit data to the MIDAS Database according to policies established by the Steering Committee
• Attend Steering Committee meetings
• Contribute to the cooperative nature of the effort

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.

2.A.2. NIH Responsibilities

NIH Project Scientists will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

NIH Project Scientists with expertise in relevant areas will serve on the Steering Committee as representatives of the NIH extramural staff and 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 NIH Project Scientists 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.

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The 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.

2.A.3. Collaborative Responsibilities

The MIDAS Steering Committee is the managing body for MIDAS. Voting members will include representation from each Research Group and the Informatics Group, NIH Project Scientists 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 Project Scientists 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. NIH staff may not serve as Chair. The Chair is responsible for developing meeting agendas and chairing meetings. The Steering Committee decides on the schedule of meetings, 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 meet 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:

• Serve as the main governing board of the MIDAS Network
• Set milestones for the MIDAS Network
• Assess progress within the MIDAS Network
• Standardize the data format and nomenclature for the MIDAS database
• Develop guidelines and policies for data sharing and release to public domains
• Consider the views of other researchers
• Contribute to the development of a cohesive effort
• Alert NIH to scientific opportunities, emerging needs, and impediments.

Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

2.A.4. Arbitration Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Award Criteria

The following will be considered in making funding decisions:

• Scientific merit of the proposed project as determined by peer review
• Availability of funds
• Relevance of program priorities

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.

4. Reporting

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 Project Scientists 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 and with the Director, NIH.

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually:
http://grants.nih.gov/grants/funding/2590/2590.htm and financial statements as required in the NIH Grants Policy Statement.

James J. Anderson, Ph.D.
Center for Bioinformatics and Computational Biology
National Institute of General Medical Sciences
45 Center Drive, Room 2AS-25A, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-0943
FAX: (301) 480-2228
Email: [email protected]

2. Peer Review Contacts:

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]

3. Financial or Grants Management Contacts:

Ms. Patrice Molnar
Grants Administration Branch
National Institute of General Medical Sciences
45 Center Drive, Room 2AN.32C, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-5136
FAX: (301) 480-2554
Email: [email protected]

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