Modeling of Infectious Disease Agent Study Research Projects (R01)

Modeling of Infectious Disease Agent Study Research Projects (R01) is sponsored by National Institutes of Health (NIH). Supports innovative research developing computational tools and methods for modeling interactions between infectious agents and hosts.

Expired PA-16-107: Modeling of Infectious Disease Agent Study Research Projects (R01) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) of Participating Organizations National Institute of General Medical Sciences ( NIGMS ) National Institute of Allergy and Infectious Diseases ( NIAID ) Funding Opportunity Title Modeling of Infectious Disease Agent Study Research Projects (R01) R01 Research Project Grant July 03, 2018 - This PA has been reissued as PAR-17-267 .

Reminder: FORMS-E Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2018. - Updates to Active Funding Opportunity Announcements to Prepare for Policy Changes Impacting Due Dates On or After January 25, 2018. May 10, 2017 - New NIH "FORMS-E" Grant Application Forms and Instructions Coming for Due Dates On or After January 25, 2018.

See NOT-OD-17-062 . May 05, 2017 - This PA has been reissued as PAR-17-267 . May 05, 2017 - Notice of Reissuance of the "Modeling of Infectious Disease Agent Study Research Projects (R01)" Funding Opportunity Announcement.

See Notice NOT-GM-17-006 . May 31, 2016 - Notice of NIAID's Participation in PA-16-107. See Notice NOT-AI-16-057 .

- NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015) Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity Additional Information on Eligibility .

Catalog of Federal Domestic Assistance (CFDA) Number(s) Funding Opportunity Purpose The purpose of this funding opportunity announcement (FOA) is to support innovative research that will develop and apply computational tools and methods for modeling interactions between infectious agents and their hosts, disease spread, prediction systems and response strategies.

The models should be useful to researchers, policymakers, or public health workers who want to better understand and respond to infectious diseases.

This research opportunity encourages applications from institutions/organizations that propose to provide the scientific and public health communities better resources, knowledge, and tools to improve their ability to prepare for, identify, detect, control, and prevent the spread of infectious diseases caused by naturally occurring or intentionally released pathogens, including those Open Date (Earliest Submission Date) Letter of Intent Due Date(s) dates apply, by 5:00 PM local time of applicant organization.

All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. AIDS Application Due Date(s) AIDS dates apply, by 5:00 PM local time of applicant organization.

All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. New Date July 03, 2018 per issuance of PAR-17-267 .

(Original Expiration Date: PAR-17-267 ) Required Application Instructions It is critical that applicants follow the instructions in (R&R) Application Guide , except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information Part 2. Full Text of the Announcement I.

Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Full Text of Announcement Section I. Funding Opportunity Description The threat of emergence or re-emergence of infectious disease epidemics continues to be a concern of policymakers and the public health services.

Better tools and methods are needed to improve our knowledge of the dynamics of emergence, surveillance and detection of events, and the effectiveness and implications of prevention and mitigation efforts. The variety of possible scenarios complicates the challenge of confronting these threats.

An important role of science is to create a rational picture of the alternatives by collecting, analyzing, and interpreting relevant data and by developing models. The models themselves can guide the collection of further data. In addition, good models can reveal important patterns in the data which allow investigators to examine scenarios and to understand likely consequences of interventions.

These capabilities can help responsible parties plan for and respond to an emerging epidemic or a bioterrorist threat. The Models of Infectious Disease Agent Study (MIDAS) is a collaboration of research and informatics groups to develop computational models of the interactions between infectious agents and their hosts, disease spread, prediction systems and response strategies.

The models can be useful to policymakers, public health workers and other researchers who want to better understand and respond to emerging infectious diseases. MIDAS has produced a number of software packages to help local, state and federal public health officials prepare for and respond to infectious disease emergencies.

MIDAS trains public health officials in using modeling tools to understand how to prepare for and respond to infectious disease threats. Information on current and previous MIDAS activities, publications, and reports can be found on the MIDAS website at https://www. epimodels.

org/midas/about. do, or http://www. nigms.

nih. gov/Initiatives/MIDAS/. Areas of research could include, but are not limited to: I.

Infectious Disease Research Preparedness. Preparedness for outbreaks is a critical task for public health. Modeling is one approach to identifying components of preparedness and their interactions.

Preparedness occurs at the levels of household, community, and nation. Modeling strategies may help improve how public health systems at many levels interact to protect the public. Surveillance and Detection.

A critical step in responding to an event is the ability to correctly identify and characterize it. In some cases, the speed and accuracy of a response (e.g., antimicrobials, vaccines, isolation, and community containment measures) may determine whether an outbreak will be contained or a crisis averted.

Technological advances in disease detection will continue to provide considerable data, and statistical and modeling methods are needed to search for and characterize signals in the presence of highly variable background information. In addition, models may contribute to recognizing, identifying, and responding to intentionally released and/or engineered pathogens.

These issues are relevant at many levels of organization from individual hospitals to communities, metropolitan areas, Dynamics of Infectious Diseases. Infectious diseases are dynamic across temporal, spatial, and biological dimensions.

Infectious disease systems provide an opportunity for modeling host / parasite coevolution, microbial population structure and the evolution of natural history parameters relevant to the spread of infectious diseases. Epidemiological modeling has and will continue to provide insights into how infectious diseases spread geospatially, temporally, and through social networks.

Electronic social networking systems and continued widespread use of the Internet provide new data on both disease dynamics as well as responsive behaviors, which may contribute to epidemiological modeling. Response Strategies. MIDAS uses modeling approaches to study the implications of various response strategies.

When there are urgent national needs MIDAS research groups with pertinent expertise may be required to focus MIDAS research on specific tasks of national importance.

For example, MIDAS has studied the spatial and temporal deployment of antivirals and vaccines in response to an influenza outbreak and contributed to assessing the impact of community containment on the spread of pandemic influenza in the U.S. In addition to national response strategies, local, community, regional, and global plans should be considered. Antimicrobial Resistance and Vaccine Escape.

Modeling may contribute to understanding the evolution, sources, and spread of resistance in microbial populations and to understanding the dynamics of pathogen escape from vaccines. This subject is relevant at many levels, including individuals, hospitals, public health systems, and communities. Behavior.

Individual and social behavior contributes greatly to the dynamics of infectious disease emergence and spread as well as to compliance with public health policies. Issues include implications of social organization, migrations, decision-making, beliefs, norms, health practices, and trust.

Research could address, for example, the impact of behavioral changes on the course of an outbreak (and vice versa), how to measure behavior, heterogeneity in behavioral response, and representation of Domestic, Agricultural, and Wild Animals. Although the major focus of this announcement is human disease, one cannot ignore the relevance of animals as reservoirs, hosts and vectors of infectious agents.

For example, bird movements via migration or illegal trafficking facilitate the spread of avian influenza. Population dynamics of arthropod vectors are highly relevant to the spread of infectious disease. Zoonoses are also critical, and have been documented for several diseases, including HIV-AIDS and influenza.

Studies of animal populations should focus on issues or modeling approaches relevant to human health. Virtual reality. There has been considerable interest in using Web-based virtual reality systems to study behavior, transmission characteristics, social organization, and other factors relevant to the emergence and spread of infectious diseases.

Research using virtual reality systems may be especially useful to validate models or estimate parameters. Applicants may propose to use virtual communities to advance modeling of II.

Computational, Mathematical, and Statistical Model Since the purpose of the FOA is to support research that will develop, improve, and apply computational tools and methods, proposals should focus on the development and improvement of mathematical, computational, and statistical methods for studying infectious disease that will assist public health decision makers.

Applicants should take account of the needs of the public health and research communities in designing and producing models. Areas of focus include, but are not limited to: Conceptual development of models. Underlying theories, including assumptions and approaches, strengths and weaknesses, should be clearly explained.

Applicants should take into account the needs of the communities (i.e., public health, policy and decision making) that will be end users of the products of the research.

Other potential areas of research include (1) tools for archiving, managing, integrating querying, retrieving, and visualizing model results; (2) analytical and statistical tools for interpreting and using large data sets or model results; and/or (3) platform-independent translational tools for data exchange, interoperability, and exchange of models, tools, and results.

Computational, mathematical, and statistical research proposed should be future-oriented, fill an area of need or projected need, and exceed the current state of the art. Model verification and validation. The applicant must propose steps to verify that methods employed behave as expected, that is, that the software or equations have been reviewed, tested, and documented.

Validation is an important goal but may or may not be possible, depending on the nature of the model. Indeed, approaches to validation of stochastic dynamic models is an important research topic. Applicants should explain how they will approach model validation.

Dissemination. One product of MIDAS research groups may be software tools that are of value to the public health, research, and policy and decision making communities. Software tools developed with MIDAS support will be available, where feasible, to researchers, educators, the public health community, and government organizations.

Software tools should be designed and developed in collaboration with the user community, and with the MIDAS Information Technology Resource. Include a plan for software dissemination. Software products must meet the high standards expected of contemporary biological software.

These standards include: First, software must be fully documented and easy to access, modify, and extend. Users who experience problems should be able to report and resolve issues with minimal effort. Problems should be tracked and appropriate changes incorporated into the software.

It is particularly important that software be able to evolve as needs change. Second, where possible, software packages relevant to infectious disease modeling and data management should be interoperable and portable to a variety of common platforms. Third, software should be consistent with existing ontologies and controlled vocabularies.

Where needed, software development projects should include (1) defining vocabularies and terms, (2) defining relationships among terms and functions, (3) defining data models, (4) defining data requirements and uses, and (5) similar activities. Fourth, software must be tested, verified, and maintained. The final product should include user manuals and other training resources (e.g., workshops, online training, help desk).

Data Sources. Research groups will use existing or simulated datasets, as well as real-time information, to build computational models relevant to the goals of MIDAS. Research groups will not use MIDAS funding to generate primary data, except in the case of simulations.

Databases and Software. 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.

If relevant, each research group is required to use the standard data exchange format for transmitting information among projects. Software developed with MIDAS funding is expected to be shared among MIDAS investigators and the research community according to policies determined by the MIDAS consortium, consistent with achieving the goals of this program. See Section VIII.

Other Information for award authorities Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed The OER Glossary and the SF424 (R&R) Application Guide provide details on these application Clinical Trials Not Allowed for due dates on or after January 25, 2018: Only accepting applications that do not propose clinical trials Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Application budgets are not limited but need to reflect the actual needs of the proposed project. The maximum project period is 5 years.

Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to Foreign components, as defined in the NIH Grants Policy Statement , are allowed. Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted.

Registration can take 6 weeks or more, so applicants should begin the registration process as soon as Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number.

After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application. System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually .

The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.

must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants. gov registration.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to must have an active DUNS number and SAM registration in order to complete the Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account.

PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 This FOA does not require cost sharing as defined in the NIH Grants Policy Statement . 3.

Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The NIH will not accept duplicate or highly overlapping applications under review at the same time.

This means that the NIH will A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101 ). Section IV. Application and Submission Information Applicants must obtain the SF424 (R&R) application package associated with this funding opportunity using the "Apply for Grant Electronically" button in this FOA or following the directions provided at Grants.

gov . 2. Content and Form of Application Submission It is critical that applicants follow the instructions in (R&R) Application Guide , including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise.

Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant All page limitations described in the SF424 Application Page Limits must be followed.

Instructions for Application Submission The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an All instructions in the SF424 (R&R) Application Guide SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide SF424(R&R) Other Project Information All instructions in the SF424 (R&R) Application Guide SF424(R&R) Senior/Key Person Profile All instructions in the SF424 (R&R) Application Guide All instructions in the SF424 (R&R) Application Guide must be followed.

The MIDAS program holds up at least one meeting per year which includes a meeting of the MIDAS organizational committee. Each research group will present its research findings at annual meeting. Funds for travel of the Program Director(s)/Principal Investigator(s) and relevant staff to these meetings should be included in the proposed budget.

All instructions in the SF424 (R&R) Application Guide PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) Application Guide All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Strategy: Applicants should describe the approach and methods to be employed in the software development process.

Applicants must demonstrate their experience in developing software using these approaches and The applicant must propose steps to verify that methods employed behave as expected, that is, that software or equations have been reviewed, tested, and documented. Applicants should explain how they will approach model validation.

The MIDAS network relies on collegial and cooperative interactions among its constituent members, particularly for MIDAS special initiatives that may emerge as a result of urgent national needs. The MIDAS network requires a commitment to cooperative interactions that must be addressed in the application. NIGMS has adopted several policies that are applicable to the MIDAS network.

As described in Section IV. 7, applicants must present plans to adhere to the policies, where Each research group is also expected to provide a plan that addresses intellectual property rights. These plans may be further negotiated Plans for Meetings and Reports.

The Program Director(s)/Principal Investigator(s) of each research group must actively participate in the MIDAS organizational committee and will participate in monthly videoconferences or conference calls. In addition, each research group will present its research findings at annual meetings.

Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:. All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Investigators should address plans for dissemination of useful products of the research, including approaches, technologies, methods, and tools, to the relevant research and user communities. Include a plan for Software Development: Consistent with achieving the goals of this program, applications are expected to include a statement that software developed through MIDAS funding will be freely available.

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application PHS Inclusion Enrollment Report Form only available in FORMS-D application packages for use with due dates on or before January 24, 2018.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 PHS Human Subjects and Clinical Trials Information Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions: If you answered "Yes" to the question "Are Human Subjects Involved?"

on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study: All instructions in the SF424 (R&R) Application Guide must be followed. Foreign (non-U.S.) institutions must follow policies Grants Policy Statement , and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide. 3.

Unique Entity Identifier and System for Award Management (SAM) See Part 1. Section III. 1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Part I.

Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next Organizations must submit applications to Grants.

gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , NIH's electronic system for grants administration. NIH and Grants.

gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants. gov on or before the application due date and time.

If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide. 5. Intergovernmental Review This initiative is not subject to intergovernmental All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .

Pre-award costs are allowable only as described in the NIH Grants Policy Statement . Requirements and Information Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission Electronically . If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must for Applicants Experiencing System Issues . For assistance with application submission, contact the Application Submission Contacts in Section VII .

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package . Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization's profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide. See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will National Emergencies.

In the event of an attack or the emergence of an infectious disease, the NIGMS Program Director, upon request of the Project Scientist, may ask the Program Directors/Principal Investigators to coordinate their efforts with other relevant researchers, policy makers, or public health officials to apply their expertise to the public health emergency.

Should this occur, NIGMS will be flexible in allowing the Program Director/Principal Investigator to redirect the specific aims, provided that they are within the scope of their original proposals..

Requests of $500,000 or more for direct costs in any year Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide .

Post Submission Materials Applicants are required to follow our Post Submission Application Materials policy. Section V. Application Review Information Only the review criteria described below will be considered in the review process.

As part of the NIH mission , all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each.

An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field. Does the project address an important problem or a critical barrier to progress in the field?

Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?

If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?

Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?

Have the investigators presented strategies to ensure a robust and unbiased approach,