NIDCD Early-Stage Dissemination and Implementation Research in Communication Disorders (R21 Clinical Trial Optional) is sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD) / National Institutes of Health (NIH). This funding opportunity supports early-stage dissemination and implementation (D&I) research projects in NIDCD mission areas of hearing, balance, taste, smell, voice, speech, and language.

RFA-DC-26-001: Early-Stage Dissemination and Implementation Research in Communication Disorders (R21 Clinical Trial Optional) Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute on Deafness and Other Communication Disorders ( NIDCD ) Funding Opportunity Title Early-Stage Dissemination and Implementation Research in Communication Disorders (R21 Clinical Trial Optional) R21 Exploratory/Developmental Research Grant Check for any recent Notices of NIH Policy Changes that may impact application requirements.

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

Assistance Listing Number(s) Funding Opportunity Purpose NIDCD invites applications for early-stage dissemination and implementation (D&I) research projects (e.g., during development and evaluation of the evidence-based innovation, EBI) in the NIDCD mission areas of hearing, balance, taste, smell, voice, speech, and language.

Funding Opportunity Goal(s) To investigate solutions to problems directly relevant to individuals with deafness or disorders of human communication in the areas of hearing, balance, smell, taste, voice, speech, and language.

The National Institute on Deafness and Other Communication Disorders (NIDCD) supports research and research training, including investigation into the etiology, pathology, detection, treatment, and prevention of disorders of hearing and other communication processes, primarily through the support of basic and applied research in anatomy, audiology, biochemistry, bioengineering, epidemiology, genetics, immunology, microbiology, molecular biology, the neurosciences, otolaryngology, psychology, pharmacology, physiology, psychophysics, speech-language pathology, and other scientific disciplines.

The NIDCD supports: (1) Research into the evaluation of techniques and devices used in diagnosis, treatment, rehabilitation, and prevention of disorders of hearing and other communication processes; (2) research into prevention and early detection and diagnosis of hearing loss and speech, voice, and language disorders and research into preventing the effects of such disorders by means of appropriate referral and rehabilitation; (3) research into the detection, treatment, and prevention of disorders of hearing and other communication processes in the elderly population and its rehabilitation to ensure continued effective communication skills; and (4) research to expand knowledge of the effects of environmental agents that influence hearing or other communication processes.

Open Date (Earliest Submission Date) 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.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO). 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. Use Grants.

gov 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 Much research is devoted to developing evidence-based innovations (EBIs) that improve a person’s health and quality of life. To impact people’s lives, EBIs need to be adopted in clinical practice and everyday life.

Unfortunately, wide-scale adoption of EBIs is lengthy and rare. Dissemination and implementation (D&I) science is the field of research that seeks to close the gap between research and practice. Dissemination research is defined as the scientific study of the targeted distribution of information and materials about EBI to a specific audience (e.g., practitioners, patients, policymakers).

The intent is to understand how best to communicate and integrate knowledge associated with a given EBI. Implementation Science refers to a broader array of active and planned efforts to integrate evidence into practice. Implementation research focuses on understanding why clinical and community settings are not adopting and sustaining a particular EBI.

In turn, implementation research uses this understanding of barriers and facilitators to develop and evaluate different strategies (or collections of strategies) to increase adoption and integration of an EBI into practice. Many fields have applied D&I research theories, approaches, and outcome measures to improve adoption and sustainment of EBIs.

To better understand the landscape of D&I in NIDCD mission areas, a 2-day virtual workshop was held on October 24-25, 2023. One insight from this workshop was the need to increase early-stage D&I research at the start of clinical research (e.g., during development and evaluation of the EBI) to set a solid foundation for later, high-quality, D&I-focused research.

That is, there is a need to create readiness for D&I research early in the translational research pipeline, including activities such as building collaborative partnerships, understanding the context for disseminating and implementing the EBI, and evaluating preliminary D&I strategies using D&I outcome measures.

This funding opportunity aims to support early-stage D&I research (e.g., during development and evaluation of the EBI) in NIDCD mission areas of hearing, balance, taste, smell, voice, speech, and language. Resulting findings should set a sufficient foundation for a high-quality, D&I focused R01 in NIDCD mission areas.

Given the focus of this funding opportunity on creating readiness for future, high-quality, D&I focused research, investigators are required to integrate a D&I process model ( Nilsen, 2015 ) as a core component of their application.

D&I process models outline activities that need to be accomplished at different points in the research process to set the foundation for subsequent activities, moving efficiently through the various stages of translational research.

Many process models include a description of activities that should be accomplished prior to D&I research (e.g., Getting-to-Outcomes, Active Implementation, Quality Implementation Framework, EPIS-Exploration-Preparation-Implementation-Sustainment, Intervention Mapping, Knowledge-to-Action). No specific model is required for this funding opportunity.

Investigators should select a D&I process model that is appropriate for their current and future translational research goals. Applicants are highly encouraged to consult with a D&I expert in identifying and applying an appropriate D&I process model.

In addition to a D&I process model, other aspects of D&I research, like those listed below, should be included in the application to strongly address the aims of the application and the purpose of this funding opportunity.

Examples of core D&I research elements include but are not limited to: D&I theories, models and frameworks (e.g., theories or frameworks that guide understanding of the multi-level contextual factors that influence dissemination and implementation) D&I strategies (i.e., methods or techniques used to enhance the dissemination, adoption, implementation, and sustainability of a clinical program or practice) D&I outcomes and outcome measures (e.g., acceptability, appropriateness, cost, feasibility, adoption, fidelity, reach/penetration, maintenance/sustainment/sustainability) as well as health service outcomes and outcome measures (e.g., quality, disparity) Community engaged research approaches (i.e., research approaches that involve community partners to assist in guiding the research project, such as community advisory boards, co-design approaches, and community-based participatory research), including effective methods of involving individuals with communication disorders Qualitative and mixed methods, including methods appropriate for data from individuals with communication disorders Theories and methods to understand and reduce or eliminate health disparities, improving care and outcomes A D&I process model and other core D&I research elements should guide the research goals of the application.

Examples of relevant early-stage D&I research goals, identified in multiple D&I process models, include, but are not limited to studies that aim to use: A community-engaged research approach along with qualitative methods to understand the health needs of individuals and/or service-delivery needs of organizations and identify potential EBIs to address those needs A determinants framework and a mixed-methods approach to identify potential individual- and systems-level barriers and facilitators to implementing an EBI in one or more real world contexts A community-engaged research approach along with qualitative methods to co-develop and evaluate preliminary D&I strategies intended to support integration of an EBI into practice The core functions and forms framework along with qualitative methods to differentiate underlying active ingredients in an EBI and then use a community-engaged research approach to develop and evaluate a community-adapted version of the EBI A mixed-methods approach to identify which D&I outcomes and health service delivery outcomes are meaningful to partners and use a community-engaged research approach to co-develop and execute a measurement plan to establish baseline performance A community-engaged research approach along with mixed methods to identify and quantify health disparities and identify or develop EBIs to reduce disparities A determinants framework and a mixed-methods approach to identify potential individual- and systems-level barriers and facilitators related to disparities in implementation of an EBI in one or more real world contexts Clinical trials are optional for this funding opportunity.

Responsive applications include those that (1) don't include clinical trials, (2) include low-risk clinical trials, or (3) include Basic Science Experimental Studies involving Humans (BESH). Low-risk clinical trials must meet ALL the following criteria: meet the budget limits of this NOFO, not require FDA oversight, are not intended to formally establish efficacy and have low risks to potentially cause physical or psychological harm.

BESH clinical trials meet the NIH definition of a clinical trial and also meet the definition of basic research.

Consultation with NIDCD Staff Highly Encouraged Prior to Application Given the required elements outlined above, prospective applicants are strongly encouraged to communicate with the scientific/research contact listed at the end of this NOFO as early as possible to discuss how their application will incorporate all required elements.

Non-responsive applications (i.e., those that do not include all required elements) will be withdrawn prior to review.

Non-Responsive Applications The following studies will be considered non-responsive for this funding opportunity and will not be reviewed: Studies that fail to integrate a D&I process model into the application Studies that fail to use other core D&I research elements (e.g., D&I theories/models/frameworks, D&I strategies, D&I outcomes/outcome measures, community engaged research, qualitative/mixed methods, health disparity theories/methods) Studies that focus solely on efficacy or effectiveness research without any D&I elements Studies outside NIDCD mission areas 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 NIDCD intends to commit approximately $1 million per year for this Notice of Funding Opportunity.

Awards issued under this funding opportunity are contingent upon the availability of funds, fiscal and programmatic interests and priorities of NIDCD, and the submission of a sufficient number of meritorious applications. The combined budget for direct costs for the two-year project period may not exceed $275,000. No more than $200,000 direct costs may be requested in any single year The total project period may not exceed 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 - Includes all types 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) Foreign Organizations/International Collaborations 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. NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts.

All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. This new requirement was effective, May 1, 2025. Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding.

This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components , funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

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 (in this NOFO, in a policy notice , or other notice from NIH Guide for Grants and Contracts ). 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. Specific to this NOFO , applicants should provide evidence that the research team has the required D&I expertise to conduct the research. This can be demonstrated in a variety of ways, including D&I training, experience leading D&I research projects, and authorship on D&I publications.

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: Research Strategy: Specific to this NOFO , (1) a dissemination and implementation (D&I) process model and (2) other core D&I research elements are required (e.g., D&I theories/models/frameworks, D&I strategies, D&I outcomes/outcome measures, community engaged research, qualitative/mixed methods, health disparity theories/methods).

Subsequent findings should set a sufficient foundation for a high-quality, D&I focused R01 in an NIDCD mission area(s). Thus, the research strategy should justify the choice of D&I process model, locate the proposed research within the step(s) or phase(s) of the process model, and describe how the proposed work will set the foundation for the future step(s) or phase(s) of the process model.

The approach should justify incorporation of core D&I research elements (e.g., D&I theories/models/frameworks, D&I strategies, D&I outcomes/outcome measures, community engaged research, qualitative/mixed methods, health disparity theories/methods) and demonstrate how those elements strongly address the aims.

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. 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 and responsiveness by components of participating organizations, 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 grantdisclosures@oig.

hhs. gov . 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 R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information.

Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

Specific to this NOFO: This funding opportunity aims to support early-stage D&I research (e.g., during development and evaluation of the EBI) in NIDCD mission areas of hearing, balance, taste, smell, voice, speech, and language. Resulting findings should set a sufficient foundation for a high-quality, D&I focused R01.

Given the focus of this funding opportunity on creating readiness for future, high-quality, D&I focused research, investigators are required to integrate a D&I process model ( Nilsen, 2015 ) as a core component of their application.

D&I process models outline activities that need to be accomplished at different points in the research process to set the foundation for subsequent activities, moving efficiently through the various stages of translational research.

In addition, investigators are encouraged to incorporate core D&I research elements, such as other D&I theories/models/frameworks, D&I strategies, D&I outcomes and outcome measures, community engaged research approaches, qualitative and mixed methods, and theories and methods relevant to health disparities.

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