Computational Approaches to Curation at Scale for Biomedical Research Assets (R01 Clinical Trial Not Allowed)

Computational Approaches to Curation at Scale for Biomedical Research Assets (R01 Clinical Trial Not Allowed) is sponsored by U.S. Department of Health and Human Services; National Library of Medicine. This funding opportunity supports the development of automated computational approaches for biomedical data curation to enhance data accessibility and FAIR principles.

Research involving AI for curating mental health-related biomedical data could be a fit.

Expired PAR-20-304: Computational Approaches to Curation at Scale for Biomedical Research Assets (R01 Clinical Trial Not Allowed) 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 ) Components of Participating Organizations National Library of Medicine ( NLM ) Funding Opportunity Title Computational Approaches to Curation at Scale for Biomedical Research Assets (R01 Clinical Trial Not Allowed) R01 Research Project Grant October 29, 2024 - Computational Approaches to Curation at Scale for Biomedical Research Assets (R01 Clinical Trial Not Allowed).

See Notice PAR-25-131 . August 12, 2024 - Notice of Intent to Publish a Funding Opportunity Announcement for Computational Approaches to Curation at Scale for Biomedical Research Assets (R01 Clinical Trial Not Allowed). See Notice NOT-LM-24-003 .

February 16, 2023 - Notice to Extend the Expiration Date for PAR-20-304 "Computational Approaches to Curation at Scale for Biomedical Research Assets (R01 Clinical Trial Not Allowed)".

See Notice NOT-LM-23-002 NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022 October 28, 2021 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available.

See Notice NOT-OD-22-018 . September 13, 2021 - Updates to the Non-Discrimination Legal Requirements for NIH Recipients. See Notice August 5, 2021 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022.

August 5, 2021 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements. See Notice NOT-OD-21-170 April 20, 2021 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel. See Notice NOT-OD-21-109 December 10, 2020 - Notice of Change in Scientific/Research Contact for PAR-20-304.

See Notice NOT-LM-21-003 . Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity See Section III. 3.

Additional Information on Eligibility . Catalog of Federal Domestic Assistance (CFDA) Number(s) Funding Opportunity Purpose NLM wishes to accelerate the availability of and access to secure, complete data sets and computational models that can serve as the basis of transformative biomedical discoveries by improving the speed and scope of the curation processes.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to the application due date. The first standard due date for this FOA is February 5, 2021. All applications are due by 5:00 PM local time of applicant organization.

All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s). 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) Standard AIDS dates apply.

The first AIDS application due date for this FOA is May 7, 2021. All applications are due 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 the listed date(s).

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 May 08, 2024 (Original Date: May 08, 2023) per issuance of NOT-LM-23-002 Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide ,except where instructed to do otherwise (in this FOA or in a Notice from 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 Announcement Section I. 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. Funding Opportunity Description Digital curation involves characterizing, annotating, managing, and preserving digital assets such as research data sets, computational and other types of models, reusable visualization tools, and other digital assets.

Proficient curation of digital assets maximizes their reuse potential, mitigates risk of obsolescence, reduces the likelihood that their long-term value will diminish or be lost, and helps assure reproducibility of research. The evolving digital ecosystem supports data-driven biomedical discovery by providing access to large quantities of biomedical and health-related data, to computational models and to open source software and code.

The scope, scale and heterogeneity of digital data alone are vast, ranging from genome sequences to biomedical images, from observational health findings to environmental measurements, from family histories to sensor readings from personal trackers. As the amount and complexity of digital assets continue to grow, manual curation will not scale to meet future needs.

At the same time, as researchers make research data sets, models and other tools available for new uses or re-analysis, it is important to minimize duplication and simplify the process of finding, managing, visualizing and mining all types of digital assets.

To help researchers who want to find, interoperate and use these data sources to make new discoveries, and to share their findings so others can build upon them, the purpose of this funding announcement is to encourage applications for new approaches that (1) increase the speed and assure quality and security of storage techniques, retrieval strategies, annotation methods, data standards, visualization tools and other advanced data management approaches and (2) improve our ability to make biomedical data and other digital research assets findable, accessible, interoperable and reusable (FAIR).

Today’s curation processes are a mix of computational and manual activities, involving specialized technical and professional staff. Public and private data repositories exist, and open source tools are widely available via GitHub and similar sites. Successful examples of semi-automated digital curation exist, employing processes that require varying degrees of human intervention to annotate the digital asset.

However, to achieve FAIR access to huge collections of biomedical digital data assets, new or improved approaches for automated curation and management of digital assets must be designed, tested, validated, and widely adopted. An important component of this approach involves beginning the process of curation early in the data life cycle, ideally before the collection of new research data begins.

Generation and curation of biomedical data sets often involve a mix of people at different steps, including scientists at all career levels, technical support staff, IT specialists, annotators, and librarians.

Approaches are needed that can be used by this decentralized and heterogeneous workforce to help them monitor and assess the accuracy, completeness, quality and efficiency of the automated curation of local digital assets, and of assets housed at other locations. Proposed approaches should identify the type of asset, intended user and expected improvements to be achieved over present curation and management of the asset.

Applications may propose development of new computational methods, or extend existing open-source tools and pipelines in order to enhance automation, improve efficiency, quality and security, and control costs. The improvements over comparable existing management or curation approaches must be documented. During the project period, applicants are expected to test the approach with one or more groups of targeted users.

Approaches should be applicable to more than one subject domain. All awardees are expected to disseminate widely the results of their research including software.

Potential topics to be addressed include but are not limited to: Fully automated curation that meets community-defined standards for metadata Automated approaches to integration of disparate or heterogeneous data sets that map components to common data elements Automated annotation via extraction from text or other digital sources, linking the extracted information to a data set or other digital asset Automated quality control approaches that increase the completeness, accuracy or quality of a data set or model Automated research pipeline that begins at data capture or model development and is self-documenting See Section VIII.

Other Information for award authorities and regulations. Section II. Award Information 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 types. Only those application types listed here are allowed for this FOA. Not Allowed: 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 limited to $250,000 direct costs per year 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 FOA. Section III.

Eligibility Information 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 Institutions (AANAPISIs) 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 Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not 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 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 possible. The NIH 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 late submission.

Dun and Bradstreet 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) 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. eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.

gov registration, but 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 DUNS number and 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 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 (R&R) Application Guide.

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 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 NOT-OD-11-101 ) 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 FOA. 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 SF424 (R&R) Application Guide 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 review. 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. By the date listed in Part 1.

Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information: Descriptive title of proposed activity Name(s), address(es), and telephone number(s) of the PD(s)/PI(s) Names of other key personnel Participating institution(s) Number and title of this funding opportunity The letter of intent should be sent to: National Library of Medicine (NLM) All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages.

For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages. The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA. All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide must be followed. SF424(R&R) Other Project Information All instructions in the SF424 (R&R) Application Guide must be followed. SF424(R&R) Senior/Key Person Profile All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) Application Guide must be followed. PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) Application Guide must be followed.

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.

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.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Research Strategy: As part of the Research Strategy Section, applications should clearly address the following aspects: 1. Identify the curation process(es) and domain of interest being addressed and how the proposed approach will make digital data assets more findable, accessible, interoperable or reusable. 2.

Describe who would use this approach, e.g., curator, data manager, and/or scientist, and describe when use of the proposed approach is most helpful, e.g., data generation, data deposition in the research/data lifecycle. 3.

Define the challenging problem for computational curation of biomedical data or models within the chosen area of use, giving particular emphasis to the specific aspects of the problem that create the challenge and the shortcomings of existing approaches. 4. Describe current tools and approaches available to address this problem area and how the proposed approach differs.

5. Describe the proposed approach (e.g., what tools or methods will be developed, what the basis of comparison will be, and how the proposed approach will be tested). Applicants should make clear whether the proposed work is an improvement of an existing tool or a new development, and they should include a timeline that lays out steps for design, testing and dissemination.

6. For a new tool, the applicant should justify the need for the tool, and must provide baseline data and compare the tool to the existing approaches. For improvements to an existing tool, the applicant should describe the innovation, and undertake comparative testing to show the benefits of changes made to the original tool.

Describe the metrics that will be used to assess the proposed approach (e.g., efficiency, effectiveness, accuracy, quality). The final tool or approach should include appropriate metrics for tracking curation work, such as completeness, accuracy, production time, quality of metadata, utility for re-use or integration, cost effectiveness and similar factors. 7.

For applications that incorporate the aggregation of public or non-controlled-access data, applicants are expected to address methods for mitigating privacy concerns that may arise from such aggregated data. 8. Describe the approach for dissemination and testing by the user community.

Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

The following modifications also apply: In addition to the dissemination and testing plan outlined above, applicants are expected to include a general plan for sharing the resource widely, with appropriate timelines, as appropriate and consistent with achieving the goals of the program. 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: 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 in the event that the original investigators are unwilling or unable to do so. Applicants are expected to propose a plan to manage and disseminate the improvements or customization of their tools and resources that are contributed by others.

This application may include a plan to incorporate the enhancements into the "official" core software, may involve the creation of an infrastructure for plug-ins, or may describe some other solution. Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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 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 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.

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 SF424 (R&R) Application Guide must be followed. PHS Assignment Request Form All instructions in the SF424 (R&R) Application Guide must be followed.

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 Grants. gov 4. Submission Dates and Times 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 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 Policy on Late Application Submission.

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 SF424 (R&R) 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 . 7.

Other Submission 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 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 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 not be reviewed. Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described in the policy .

Any instructions provided here are in addition to the instructions in the policy. Section V. Application Review Information Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.

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.

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 project proposed).

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 the prior research that serves as the key support for the proposed project rigorous? 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 ? Is the proposed work likely to improve the efficiency or effectiveness of digital curation processes in a measurable way? If the aims of the application are achieved, is it likely that the approach will be widely adopted?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or 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 project leadership include expertise in digital curation and data management? If the project focuses on a biomedical domain or audience, does the investigative team include representation from that audience?

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? If the applicant proposes to develop a new tool, is there a strong justification of need? If the applicant proposes to enhance an existing tool or approach, does the enhancement constitute a novel addition or modification to the existing tool?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?

Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

Are members of the target audience involved in design and testing? Are the timeline and milestones for building, testing and implementing the proposed tool