NCMRR Early Career Research Award (R03 Clinical Trial Optional)

NCMRR Early Career Research Award (R03 Clinical Trial Optional) is sponsored by National Cancer Institute (NCI). Supports early career researchers in rehabilitation research.

PAR-25-124: NCMRR Early Career Research Award (R03 Clinical Trial Optional) 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. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD ) Funding Opportunity Title NCMRR Early Career Research Award (R03 Clinical Trial Optional) Notices of Special Interest associated with this funding opportunity 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 Section III. 3.

Additional Information on Eligibility . Assistance Listing Number(s) Funding Opportunity Purpose The National Center for Medical Rehabilitation Research (NCMRR) Early Career Research (ECR) Award (R03) is intended to support both basic and clinical research from rehabilitation scientists who are establishing independent research careers. The research must be focused on one or more of the areas within the mission of NCMRR.

The intent of the NCMRR ECR Award R03 is for the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) to obtain sufficient preliminary data for a subsequent R01 application. Open Date (Earliest Submission Date) The following table includes NIH standard due dates marked with an asterisk.

Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed 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.

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.

There are several options available to submit your application through Grants. gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

Use the NIH ASSIST system to prepare, submit and track your application online. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants. gov and eRA Commons to track your application.

Check with your institutional officials regarding availability. Workspace to prepare and submit your application and eRA Commons to track your application. 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 The NCMRR Early Career Research (ECR) Award is different from other NIH R03 programs, including the Parent R03 Announcement ( PA-20-200 ) .

It is restricted to clinical and basic scientists who are in the early stages of their independent career in rehabilitation research. For projects supported by an ECR R03 Award, successful results should provide a solid foundation for further research under the R01 funding mechanism.

Given that the goal is to collect preliminary data, R03 projects may be less immediately impactful or significant compared to the typical R01 or other NIH-funded projects. It is not an expectation that this R03 project will likely "move the field forward" at this stage.

The research must be focused on one or more of the areas within the biomedical and behavioral mission of NCMRR: pathophysiology and management of chronically injured nervous and musculoskeletal systems (including stroke, traumatic brain injury, spinal cord injury, and orthopedic conditions); repair and recovery of motor function; functional plasticity, adaptation, and windows of opportunity for rehabilitative interventions; rehabilitative strategies involving pharmaceutical, stimulation, and neuroengineering approaches, exercise, motor training, and behavioral modifications; pediatric rehabilitation; secondary conditions associated with chronic disabilities; improved diagnosis, assessment, and outcome measures; and development of orthotics, prosthetics, and other assistive technologies and devices.

The proposed project may be technology design-directed, discovery-driven, or hypothesis-driven with the goal of collecting the necessary preliminary data sufficient to apply for an R01 grant. The project may aid in the formulation of hypotheses and may be milestone-driven or descriptive in scope. Preliminary data are not required or expected.

However, if available, preliminary data are allowed. A 1-page attachment titled “Plan for Inclusion of People with Lived Experience” must be included with the application or the application will be withdrawn prior to review . (see Section IV; further below).

The Plan will be assessed as part of the scientific and technical peer review evaluation, as well as at the programmatic level with respect to funding decisions. Investigators proposing clinical research are encouraged to use the common data elements (CDEs) ( https://cde. nlm.

nih. gov/home ) or justify not using CDEs for rehabilitation if they are not included. For those applications that generate clinical data, investigators are encouraged to share data via the NICHD DASH (data and specimen hub) Center ( https://dash.

nichd. nih. gov/ ).

Applicants are strongly encouraged to contact the Scientific/Research contact for this NOFO for guidance in advance of submitting an application to ensure their proposed project is in compliance with new NIH human subjects research and clinical trials policies ( https://grants. nih. gov/policy/clinical-trials.

htm) and consistent with the types of clinical trial projects that NCMRR supports.

Non-Responsive Applications: The following topics are non-responsive and will be withdrawn prior to review: Projects focusing on cognitive rehabilitation without a physical rehabilitation component Sports medicine rehabilitation for people without physical disabilities (i.e. Projects targeting indications for sports or athletic performance by able-bodied athletes; treatment, recovery and prevention of injuries related to sports and exercise by people without physical disabilities.)

Development of animal models for specific diseases or injury conditions For applications submitted to this NOFO that propose clinical trials, NCMRR will only support applications proposing early stage clinical trials through Phase I, first-in-human, safety, feasibility, or other small clinical trials that inform the early stage technology development in the submitted application.

NCMRR will not support applications proposing Phase II, III, IV or pivotal clinical trials, or trials in which the primary outcome is efficacy, effectiveness, or a post-market concern. Applicants to this NOFO are encouraged to reach to program staff when planning a submission. See Section VIII.

Other Information for award authorities and regulations. Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. 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 The combined budget for direct costs for the entire project period may not exceed $200,000.

No more than $100,000 in direct costs may be requested in any single year. The scope of the proposed project should determine the project period. The maximum period of support is 2 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 targets Early Career Investigators interested in rehabilitation research. The PD/PI must be an independent investigator, not a postdoctoral fellow, at the time of submission.

The PD/PI must be no more than 8 years beyond the date that the first professional, advanced professional, or terminal academic degree was awarded, whichever is most recent. The 8-year eligibility period will be calculated based on the MM/DD/YYYY the degree was awarded and the published application receipt date, regardless of whether it is a new or resubmission application.

Attainment of an additional Master’s degree after receipt of a doctoral level degree does not extend the timeline. Formal years of clinical training (Internship, Residency, and Fellowship) are not counted as part of the 8-year limit. The exemption of years for clinical training is not limited to physicians.

Recipients of the Federally-funded National Research Service Award fellowships and traineeships (i.e. F- and T- series awards) or mentored career development awards (i.e. K awards) are eligible for the NCMRR ECR Award grant program, provided there is no overlap in professional commitment or budget.

The following are NOT Eligible: Individuals who, at the time of submission, have served as PD/PI on a peer-reviewed NIH research award (R series) over $100,000 direct costs per year or non-NIH research grants over $150,000 total costs per year, Project Leaders on sub-projects of NIH program project (P01) or center (P50) grants or the equivalent Recipients of the NIH K99/R00 award For Multi-PI applications, all of the PDs/PIs must meet the above eligibility criteria.

Questions regarding eligibility should be addressed prior to beginning to prepare the application by contacting the Scientific/Research contact listed in Section VII. Agency Contacts. 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 ). Only one NCMRR ECR Award (R03) application may be submitted as a single PD/PI or one of Multiple PDs/PIs per due date. 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.

Other Attachments: Plan for Inclusion of People with Lived Experience: A 1-page attachment titled “Plan for Inclusion of People with Lived Experience” is required. The Plan will be considered as part of the scientific and technical peer review evaluation, as well as at the programmatic level with respect to funding decisions.

Investigators are encouraged to engage the consumers and/or users in a way that informs the scientific aims of the application and increases or validates the potential impact of the application. The “Plan for Inclusion of People with Lived Experience” details a plan to incorporate the experience and expertise of People with Lived Experience (PWLE) living with disabilities.

The Plan will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured. Some methods of incorporating PWLE can include key personnel, collaborators, individuals in paid advisory roles, focus groups, patient and community advocates, community engagement boards, parent/care partner engagement boards, and other methods or a combination of methods.

It is expected that PWLE will be compensated for their efforts as appropriate. For a basic science project not directly involving PWLE users, a plan to inform future translation (e.g., through engaging an expert in translational science) and/or clinical perspective is appropriate.

Applications to develop rehabilitation or assistive devices should include people with relevant lived experience throughout the project as a member of the research team or in a paid advisory role. There are special review criteria in the Factor 1 component regarding inclusion of Plan for Inclusion of People with Lived Experience (PWLE) .

SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply- Application Guide must be followed. Any PD/(s)/PI(s) with formal years of clinical training who wish to have those years excluded from the 8-year limit of eligibility should document those years of clinical training in their Biographical Sketch.

The MM/DD/YYYY the terminal degree was awarded, specific dates of clinical training, i.e., from MM/DD/YYYY to MM/DD/YYYY, as well as the title and location of the clinical training should be specified in the PD/PI's Biographical Sketch. Questions regarding eligibility should be addressed prior to beginning to prepare the application by contacting the Scientific/Research contact listed in Section VII. Agency Contacts.

All instructions in the How to Apply- Application Guide must be followed. The effort dedicated to the NCMRR ECR Award R03 project must be commensurate with the aims of the project. It is anticipated that the PD/PI will commit at least 3 person-months (25%) effort to the project unless a compelling justification for less is provided in the budget justification section of the application.

PD/PI effort may be as high as 9 person-months (75%). Effort dedicated to the project reflects time commitment and may be more than the grant-supported salary. For example, the PD/PI may devote 3 person-months effort with only 1 person-month salary derived from the NCMRR ECR Award R03.

Any PD/PI already supported by a mentored K award must adhere to the NIH policies on salary supplementation and concurrent support (see NOT-OD-17-094 ). Applicants may reduce their effort on the K-award to no less than 50% (6 person-months based on a 12 month calendar) during the last two years of the K-award in order to become PD/PI on the NCMRR ECR Award R03 (see NOT-OD-18-157 ).

The PD/PI’s total level of effort must remain at 9 person-months or more across the K-award and the R03 award. Questions regarding eligibility should be addressed prior to beginning to prepare the application by contacting the Scientific/Research Contact listed under Section VII. Agency Contacts.

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: Research Strategy: Preliminary data are not required for the NCMRR ECR R03 application.

However, the applicant PD/PI should provide sufficient information to give confidence to the reviewers that the proposed work is feasible, and that data derived from the project would likely be suitable as preliminary data for a subsequent R01 application. If preliminary data are available, it is recommended that they be included.

Preliminary data are defined as material which the applicant has independently produced and not yet published in a peer-reviewed journal. 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.

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. Applications without a Data Management and Sharing Plan will be considered incomplete. The Plan is expected to follow the NIH Policy for Data Management and Sharing: Elements of an NIH Data Management and Sharing Plan ( NOT-OD-21-014) .

Data preservation and sharing timelines should make scientific data accessible as soon as possible and no later than the time of an associated publication or the end of the award period, whichever comes first. The Plan will be reviewed and approved by NIH Program Staff prior to award. Awardees will be required to comply with their approved Plan and any approved updates.

Additional information on NICHD data sharing requirements is available on the NICHD Office of Data Science and Sharing website . Appendix: Only limited Appendix materials are allowed. 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 and responsiveness by NICHD, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

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.

For this particular announcement, note the following: The R03 small grant supports discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding. Because the research project usually is limited, an R03 grant application may not contain extensive detail or discussion. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem.

Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.

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 evaluate 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 criterion 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.

Evaluate how likely it is that the project will lead to a successful R01 application Evaluate to what extent the Plan for Inclusion of PWLE (People with Lived Experience) engages the consumers and/or users in a way that informs the scientific aims of the application and whether that engagement increases or validates the potential impact of the application. 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