NLM Research Grants in Biomedical Informatics and Data Science

NLM Research Grants in Biomedical Informatics and Data Science is sponsored by National Institutes of Health (NIH) - National Library of Medicine (NLM). This program supports innovative research and development in biomedical informatics and data science.

Expired PAR-25-238: NLM Research Grants in Biomedical Informatics and Data Science (R01 Clinical Trial Optional) This notice has expired. For NIH, in limited situations, applications may be accepted on a case-by-case basis for a short period after expiration to accommodate NIH late or continuous submission policies . Contact the eRA Service Desk for any submission issues.

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 ) Components of Participating Organizations National Library of Medicine ( NLM ) All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers.

The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Data Science Strategy ( ODSS ) Funding Opportunity Title NLM Research Grants in Biomedical Informatics and Data Science (R01 Clinical Trial Optional) R01 Research Project Grant Notices of Special Interest associated with this funding opportunity May 20, 2025 - Notice to Extend the Expiration Date of PAR-25-238 NLM Research Grants in Biomedical Informatics and Data Science (R01 Clinical Trial Optional).

See Notice NOT-LM-25-004 . March 31, 2025 - This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission.

April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 . August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023.

See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189 .

Funding Opportunity Number (FON) Companion Funding Opportunity See Part 2, Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s) Funding Opportunity Purpose The National Library of Medicine (NLM) supports innovative research and development in biomedical informatics and data science.

This funding opportunity focuses on biomedical discovery and data-powered health, integrating streams of complex and interconnected research outputs that can be translated into scientific insights, clinical care, public health practices, and personal wellness.

The scope of NLM's interest in these research domains is broad, with emphasis on new and innovative methods and approaches to foster data driven discovery in the biomedical and clinical health sciences as well as domain-independent, scalable, and reusable/reproducible approaches to discovery, curation, analysis, organization, and management of health-related digital objects.

Funding Opportunity Goal(s) To meet a growing need for investigators trained in biomedical informatics research and data science by training qualified pre- and post-doctoral candidates; to conduct research in biomedical informatics, bioinformatics and related computer, information and data sciences; to facilitate management of electronic health records and clinical research data; to prepare scholarly works in biomedicine and health; to advance biocomputing and bioinformatics through participation in Federal initiatives relating to biomedical informatics, bioinformatics and biomedical computing; and to stimulate and foster scientific and technological innovation through cooperative research development carried out between small business concerns and research institutions, through Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grants.

Open Date (Earliest Submission Date) The following table includes NIH standard due dates marked with an asterisk. Dates in bold and italics reflect changes per NOT-LM-25-004 .

Application Due Dates Review and Award Cycles New Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed Scientific Merit Review Advisory Council Review Earliest Start Date February 05, 2025 * March 05, 2025 * May 07, 2025 * July 2025 October 2025 December 2025 June 05, 2025 * July 05, 2025 * September 07, 2025 * November 2025 January 2026 April 2026 October 05, 2025 * November 05, 2025 * January 07, 2026 * March 2026 May 2026 July 2026 February 05, 2026 * March 05, 2026 * Not applicable July 2026 October 2026 December 2026 All applications are due by 5:00 PM local time of applicant organization.

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 March 06, 2026 per NOT-LM-25-004 (Prior Date January 08, 2026).

Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the NOFO) 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 Announcement Section I.

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

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

Agency Contacts Section VIII. Other Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description NLM supports innovative research projects focused on biomedical data that combine elements of computer science and information technology to optimize the use of information and technology to improve individual and public health and biomedical research.

Research areas of interest to NLM include, but are not limited to: Development of novel approaches enabling analysis and discovery at scale across biomedical domains and health care sectors, including those leveraging high-performance cloud computing and federated learning Development and demonstration of innovative informatics methods and data science techniques for informing biological, clinical, public health, and social science research.

Computational approaches integrating structured and unstructured data, natural language processing, automated metadata assignment.

Advanced information retrieval and knowledge discovery from very large and/or heterogeneous data sets Multi-level, reusable, data analytic models, simulations, information visualization, and presentation approaches to enhance decisions, learning or understanding of biological and clinical processes Approaches to assess and address algorithmic bias and/or fairness Innovative analytic methods to advance decision support that are generalizable within and across underserved populations Applying natural language processing to unstructured health-related data, including Electronic Health Record (EHR) data, to increase provider-patient health care understanding Informatics approaches that translate basic biomedical research to clinical methods to support patient and provider decision making Data science methods and approaches that enhance the quality, security, understandability and utility of data, information, or knowledge related to health and biomedicine Informatics methods and approaches to improve public health and population-level health outcomes Using biomedical informatics and data science to address health disparities Research in biomedical informatics and data science is inherently multidisciplinary, including mathematics, statistics, information science, computer science and engineering, and social/behavioral sciences.

Applications that propose team science approaches are encouraged. NLM expects that investigators will employ rigorous, scientifically defensible research techniques leading to sound empirical and reproducible evidence.

These techniques may include quantitative and qualitative approaches, in silico experiments, simulation studies, model generation and testing, computer-based analytical techniques supporting clinical and non-clinical decisions through novel uses of computational analytics, text mining and natural language processing, network inference and pathway analyses, ontologies, and other advanced approaches.

For NLM support, a research project's innovation should be centered in the development and testing of novel data science or biomedical informatics methods and approaches. Applications submitted to this funding opportunity should focus on a well-defined research problem, a rigorous research design, based on preliminary studies, and advance the field of informatics or data science to improve human health.

NLM will consider supporting projects where the primary focus of informatics or data science is applied to a clinical or disease domain when the approach is novel and will benefit findings in the domain, although priority will be placed on funding applications that propose to develop tools and approaches that can be reproduced, generalized, and scaled to ensure maximum benefit is achieved.

NLM will not support infrastructure or product development or continued development of existing software tools or knowledge resources as an endpoint of research funded through this NOFO. Potential applicants are strongly encouraged to discuss their proposed project with one of the Scientific/Research Contacts listed in Section VII for advice about the application process and suitability of the project for support by NLM.

NOTE : Under this NOFO, NLM will support applications involving small, early-stage to Phase I clinical trials that are part of the evaluation component of the proposed research project.

Applicants whose applications may include a clinical trial are strongly encouraged to contact one of the NLM Scientific Contacts listed in this FOA for guidance in advance of applying to ensure that their proposed project follows NIH clinical trials policies ( https://grants. nih. gov/policy/clinical-trials.

htm ) and consistent with the types of clinical trial applications that NLM supports.

Office of Data Science Strategy ODSS is interested in stimulating early-stage investigators into biomedical research careers to employ novel or advanced data science approached in broad domain knowledge to ensure meaningful, interpretable, and scalable from individual to community, and /or population-level health implications and/or biomedical discovery. ODSS does NOT award grants.

Please contact the relevant NIH ICO program contact listed for questions related to NIH ICO research priorities and funding. Need help determining whether you are doing a clinical trial? Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

See Section VIII. Other Information for award authorities and regulations. Section II.

Award Information Grant: A financial assistance 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 How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Optional: Accepting applications that either propose or do not propose clinical trial(s). 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 limited to $250,000 per year in direct costs and need to reflect the actual needs of the proposed project. The scope of the proposed project should determine the project period. The maximum project period is 4 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO. Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) 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 Recognized).

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 Organizations) Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. 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 How to Apply- 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 possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications for additional information.

System for Award Management (SAM) – 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 CAGE Code.

NATO 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. Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM. gov registration process.

The same UEI must be used for all registrations, as well as on the grant application. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants. gov registrations; all registrations must be in place by time of submission.

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 submit an application. Grants. gov – Applicants must have an active SAM registration in order to complete the Grants.

gov registration. Program 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 Investigator) 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 their organization to develop an application for 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 How to Apply-Application Guide. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1. 2 Definition of Terms .

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, per NIH Grants Policy Statement Section 2.

3. 7. 4 Submission of Resubmission Application .

This means that the NIH will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application. 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 NIH Grants Policy Statement 2. 3. 9.

4 Similar, Essentially Identical, or Identical Applications ). Section IV. Application and Submission Information 1.

Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants. gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.

gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution. 2.

Content and Form of Application Submission It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity 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 review. All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed. Instructions for Application Submission The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

All instructions in the How to Apply - Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply- Application Guide must be followed. SF424(R&R) Other Project Information All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply-Application Guide must be followed.

PHS 398 Cover Page Supplement All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions: Significance: If the application focus is to solve a problem, explain how the lack of an existing solution impedes the field of interest.

Identify how the proposed research will fill key gaps in understanding the area of interest. If the application focus is to verify a novel hypothesis, substantiate that it is critical for the field that the hypothesis be verified or disproved. Approach: The approach should be innovative, scalable, generalizable, and provide a well-defined rationale for its use.

Knowledge-based evidence of other current work on the problem should be addressed. Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.

The following modifications also apply: Applicants are expected to include a general plan for timely dissemination and sharing of data and resources, e.g., code, widely, as appropriate, and consistent with achieving the goals of the program in concert with NIH and NLM policies. A software dissemination plan, with appropriate timelines, is expected to be included to meet the goals of this initiative.

There is no prescribed single license for software produced through grants responding to this announcement. However, reviewers will be instructed to evaluate the dissemination plans relative to these goals: A major goal of this NOFO is the development of data science and biomedical informatics methods and tools that enable healthcare decision-making.

Applicants should therefore include detailed plans for open dissemination of methods, software, and tools to the community such that they are readily usable and extensible, where applicable. These should be made freely available to biomedical researchers and educators.

There is no prescribed license for software produced by applications responding to this announcement, but any software license selected by applicants should allow for unrestricted redistribution and modification of software. Methods, tools, and software should be well documented and where applicable made available via version-controlled public repositories.

Where applicable, applicants should describe solutions for portable implementations to cloud computing environments. Solutions that enhance reproducibility when used by the community and ability of the community to integrate into automated pipelines should be emphasized.

Any developed software should be freely available to biomedical researchers, curators, and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories. The terms of software availability should include the ability of outside researchers to modify the source code and to share modifications with other colleagues as well as with the investigators.

The terms should also permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages. To preserve utility to the community, the software should be transferable such that another individual or team can continue development if the original investigators are unwilling or unable to do so.

Resource sharing should focus on the following to ensure scalability and reusability: All applications, regardless of the amount of direct costs requested for any one year, should address a Data Management and Sharing Plan for the purpose of reusability Software or other resources resulting from the research must include a plan for resource sharing the resources including coding methods and code editing upon post publication use Data Management and Sharing Plans must be consistent with the funding agency’s current Data Management & Sharing Policy Considerations should be given to how and where data will be housed and shared with other researchers All instructions in the How to Apply-Application Guide must be followed, with the following additional instructions: All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan.

All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply- Application Guide.

No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- 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 Delayed Onset Study record. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the How to Apply- Application Guide must be followed.

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed. PHS Assignment Request Form All instructions in the How to Apply- Application Guide must be followed.

Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement , and procedures for foreign organizations described throughout the How to Apply- Application Guide. 3. Unique Entity Identifier and System for Award Management (SAM) See Part 2.

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 Grants. gov 4.

Submission Dates and Times Part I. 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 business day. 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 Grants Policy Statement Section 2. 3. 9.

2 Electronically Submitted Applications . Applicants 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 How to Apply-Application Guide.

5. Intergovernmental Review (E. O.

12372) This initiative is not subject to intergovernmental review. 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 Section 7.

9. 1 Selected Items of Cost. 7.

Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the How to Apply 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 process, visit How to Apply – Application Guide .

If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. 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 form .

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 NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply 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 not be reviewed. NOTE: Applications with proposed budget beyond the budget ceiling and the proposed project period beyond 4 years will be deemed non-responsive and, therefore, be withdrawn.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200. 113 and NIH Grants Policy Statement Section 4.

1. 35 . Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected] .

Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described in the policy Section V. Application Review Information Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

The focus of this funding opportunity is the use and application of biomedical informatics for data-driven discovery. Emphasis is on innovation and novel methods in biomedical and clinical health sciences that are reusable/reproducible, and use FAIR principles. Multidisciplinary teams are expected.

Proposed clinical trial applications must include study design, methods, and intervention that address important questions or unmet needs. Clinical trial results may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Infrastructure development or continued development of existing software or knowledge resources as an endpoint, would be considered non-responsive. A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs.

Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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 scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Reviewers will consider Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate factor score. Factor 1.

Importance of the Research (Significance and Innovation) Evaluate the importance of the proposed research in the context of current scientific challenges and opportunities, either for advancing knowledge within the field, or more broadly. Assess whether the application addresses an important gap in knowledge in the field, would solve a critical problem, or create a valuable conceptual or technical advance.

Evaluate the rationale for undertaking the study, the rigor of the scientific background for the work (e.g., prior literature and/or preliminary data) and whether the scientific background justifies the proposed study. Evaluate the extent to which innovation influences the importance of undertaking the proposed research.

Note that while technical or conceptual innovation can influence the importance of the proposed research, a project that is not applying novel concepts or approaches may be of critical importance for the field. Evaluate whether the proposed work applies novel concepts, methods or technologies or uses existing concepts, methods, technologies in novel ways, to enhance the overall impact of the project. Factor 2.

Rigor and Feasibility (Approach) Evaluate the scientific quality of the proposed work. Evaluate the likelihood that compelling, reproducible findings will result (rigor) and assess whether the proposed studies can be done well and within the timeframes proposed (feasibility). Evaluate the potential to produce unbiased, reproducible, robust data.

Evaluate the rigor of experimental design and whether appropriate controls are in place. Evaluate whether the sample size is sufficient and well-justified. Assess the quality of the plans for analysis, interpretation, and reporting of results.

Evaluate whether the investigators presented adequate plans to address relevant biological variables, such as sex or age, in the design, analysis, and reporting. For applications involving human subjects or vertebrate animals, also evaluate: the rigor of the intervention or study manipulation (if applicable to the study design). whether outcome variables are justified.

whether the results will be generalizable or, in the case of a rare disease/special group, relevant to the particular subgroup. whether the sample is appropriate and sufficiently diverse to address the proposed question(s). For applications involving human subjects, including clinical trials, assess the adequacy of inclusion