Advancement and Innovation in Measurement of Language Development and Predictors (R01 Clinical Trial Not Allowed)

Advancement and Innovation in Measurement of Language Development and Predictors (R01 Clinical Trial Not Allowed) is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH). This funding opportunity encourages community-engaged research that broadens the conceptualization of environmental qualities supporting language development in children and focuses on developing novel measures of children's language development.

PAR-25-112: Advancement and Innovation in Measurement of Language Development and Predictors (R01 Clinical Trial Not Allowed) 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 ) National Institute on Deafness and Other Communication Disorders ( NIDCD ) November 25, 2024 - Participation added ( NOT-DC-25-014 ) Funding Opportunity Title Advancement and Innovation in Measurement of Language Development and Predictors (R01 Clinical Trial Not Allowed) R01 Research Project Grant 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. November 25, 2024 - Notice of Participation of National Institute on Deafness and Other Communication Disorders in PAR-25-112 (R01) and PAR-25-113 (R21) Advancement and Innovation in Measurement of Language Development and Predictors. See Notice NOT-DC-25-014 .

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 Exploratory/Developmental Grants See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s) Funding Opportunity Purpose The purpose of this notice of funding opportunity (NOFO) is to encourage community-engaged research that broadens the conceptualization of qualities of the environment that can support language development in children and that focuses on the development of novel measures of children’s language development.

The overall goal is to build the number of strengths-focused, culturally and linguistically responsive, and generalizable tools to further our understanding of children’s language development and/or impairment, and predictors thereof. This NOFO requires a Community Engagement (CE) Plan, which will be assessed as part of the scientific and technical peer review evaluation.

Applications that fail to include a CE Plan will be considered incomplete and will be withdrawn. 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 For the past three decades, a predominant paradigm in the field of language development research has been exploration and amelioration of the “30 million word gap”, the phenomenon that children from families with lower socioeconomic status (SES) are exposed to millions fewer words in the first few years of life as compared to their higher SES peers.

This paradigm has led to a consistent focus on measuring the quantity of language input a child experiences (e.g., total number of words, total number of unique words, or total number of conversational turns). Quantity of input is a significant and consistent predictor of child language.

However, the predominant focus on quantity of input has narrowed the scope of what is considered an optimal language environment and has shaped how both the language environment and children’s language development are measured and described.

Further, research and dialogue around the “word gap” has potentially negative consequences for caregivers and children from lower SES backgrounds, framed as lacking compared to those from higher SES backgrounds, while ignoring the strengths and qualities unique to caregivers and children from different cultural and language backgrounds.

An expanded repertoire of measures and methods that better capture the wide range of caregiver behavior and other environmental factors that can support language development will allow the field to pinpoint those factors that will be most malleable and most tractable.

In addition to better understanding the language environment, it is imperative to understand the broad range of trajectories of language development in order to most accurately determine who might benefit from intervention to support optimal language development and when intervention might be most effective.

Current consensus on normative milestones has largely been gleaned from data collected from convenience and homogenous populations, thus lacking generalizability and limiting predictive value. Indeed, despite the growing diversity of languages and dialects, including signed languages, in the United States, current assessment tools lack adequate sensitivity and specificity to identify children within and outside of the normative range.

This is particularly true for children from groups that are under-represented in research as they are more likely to be both over and underdiagnosed with speech and language delays. Further, existing measures of language skill are not uniformly predictive of later language development or academic success across different populations of children.

As with the language environment, an expanded catalog of features of children’s language skills and associated objective measurement tools will support the ability to more accurately identify those children, across culturally and linguistically disparate backgrounds, who truly need support, as well the types of supports that would be most impactful.

Community-engaged research (CEr) is a standard research practice that can support generalizable research by incorporating input from the people and communities that the research outcomes will impact and involving them as equal partners in the research process.

Community-engaged research requires community engagement (CE), defined as the “process of working collaboratively with and through groups of people affiliated by geographic proximity, special interest, or similar situations to address issues affecting the wellbeing of those people” (CDC Principles of Community Engagement).

Community-engaged research can take myriad forms but essentially involves the bidirectional, meaningful relationship between community partners and the research team in guiding the research project, such as by co-developing research questions, designing studies, supporting recruitment and retention, collecting data, interpreting results, and/or disseminating findings (see the National Academy of Medicine’s Advancing Health Equity and Systems Transformation through Community Engagement strategy for assessing meaningful engagement which outlines core principles of community engagement).

Community-engaged research approaches have the potential to make research more relevant to the partners who will use the research and provide an opportunity to enhance the participation of communities typically under-represented in research but at high risk for health disparities. Effective CEr will include plans to engage community partners and incorporate their input throughout the research process.

CEr contributes to study design that integrates community partner beliefs and perspectives across and within all parts of the research continuum and ensures culturally and linguistically appropriate research approaches, tools, and communication strategies are employed in a respectful and impactful way.

New ways of describing both the language environment and language development are needed for new paradigms and perspectives to take hold in the field today. The objective of this NOFO is to encourage research that broadens the conceptualization of qualities of the environment that can support language development in children and that focuses on the development of novel measures of children’s language development.

The overall goal is to build the number of strengths-focused, culturally and linguistically responsive, and generalizable tools to further our understanding of children’s language development and/or impairment, and predictors thereof.

A secondary intent of this funding opportunity is to develop the tools to more accurately identity children who may benefit from intervention, and malleable factors in the environment that may serve as effective intervention targets.

This funding opportunity is aligned with the NIH TALK Initiative, which seeks to support activities to better understand early language learning and delay, but applications need not focus specifically on late talkers and language delay. The R01 activity code supports long-term projects or projects that have sufficient preliminary data, evidence base, or theory to justify a large, multi-year project.

Projects that are exploratory, developmental, or generate pilot data in preparation for a larger study are well-suited for the companion R21 Exploratory/Developmental Research Grant NOFO, PAR-25-113 .

The goals of this initiative are to broaden the conceptualization of qualities of the environment that can support language development in children and to prioritize the development of novel measures of children’s language development, and to build the number of strengths-focused, culturally and linguistically responsive, and generalizable tools to further our understanding of children’s language development and predictors thereof.

For the purpose of this NOFO, the use and definition of the terms ‘language environment’ and ‘language development’ should be construed broadly and inclusive of the whole communicative context and all communicative behaviors, not limited to spoken language.

Applications at both the conceptual level (e.g., contributing to or expanding theoretical frameworks) and practical level (e.g., tool development) are within scope of this announcement.

Activities that could be supported include, but are not limited to: Validating adaptations of existing or newly created measures of language development that are linguistically and culturally responsive for different populations; Developing dynamic assessment for the capacity to develop language skills, as a complement to static measures of language ability; Comparing the predictive value of specific metrics of the communicative environment within and across different populations; Developing tools to objectively measure communicative input beyond direct communication between the caregiver–child dyad (e.g., peer interactions, overheard speech) and its impact on child language development; Creating or refining assessments of narrative skills or other metrics of language development not constrained to academic language; Improving feasibility of time-consuming measures of language development and/or the environment through automation techniques (e.g., artificial intelligence, natural language processing, adaptive testing); Developing measures to capture multiple and varied forms of communication that may support or replace spoken language (e.g., gesture, augmentative and alternative communication, prelinguistic communication, American Sign Language); Developing and evaluating approaches to integrating multiple aspects of the communicative environment and interactions (e.g., physical proximity, eye gaze, etc., in combination with linguistic input) to better understand the full communicative context; Developing language measures that are sensitive to change over time and avoid floor or ceiling effects to better measure naturalistic growth as well as meaningful changes resulting from support programs; Validating adaptations of existing measures or newly created measures of person-centered language outcomes to reflect what aspects of language and communication are valued by invested parties (e.g., the individual, a teacher, a caregiver); Evaluating the relationship between traditional measures of language and person-centered measures of language.

Specific features of this funding opportunity To support the goal of expanding the generalizability and acceptability of the repertoire of measures available to describe language development and/or development, and predictors thereof, and the goal to support strengths-focused, culturally and linguistically responsive tools, specific research features are needed to be responsive to this funding opportunity, namely community engagement and input.

Community Engagement: Community-engaged research involves community members in the research process and enhances the relevance of the research to the community as they are helping guide it. Applications to this funding opportunity must provide a community engagement plan that outlines how communities will be engaged throughout the research process.

The plan should identify relevant invested parties as collaborators at a level of involvement that is meaningful and feasible for the community partner(s) and appropriate for the project to enhance the impact of the research.

No specific community engaged research approach is required, but please see the National Academy of Medicine’s Advancing Health Equity and Systems Transformation through Community Engagement strategy for assessing meaningful community engagement as a reference and to identify core principles to follow.

Applications are required to include a Community Engagement (CE) plan submitted as Other Project Information as an attachment (see Section IV). The CE plan will be assessed as part of the scientific and technical peer review evaluation, as well as considered among programmatic matters with respect to funding decisions. This NOFO explicitly emphasizes the NIH application instructions related to rigor and transparency ( https://grants.

nih. gov/policy/reproducibility/guidance. htm ).

For example, the rationale for the proposed experiments must be based on rigorous and robust supporting data, which means that data should be collected via methods that minimize the risk of bias and be reported in a transparent manner. If previously published or preliminary studies do not meet these standards, applicants should address how the current study design addresses the deficiencies in rigor and transparency.

Proposed experiments should likewise be designed in a manner that minimizes the risk of bias and ensures validity of experimental results.

Expectations and Requirements for Resource and Data Sharing The NIH Policy for Data Management and Sharing (Policy) expects researchers to maximize the sharing of scientific data and data be 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.

NIH requires all applications submitted in response to this NOFO to include a Data Management and Sharing Plan (DMS Plan). The DMS Plan is expected to address the Elements as described in Supplemental Information to the NIH Policy for Data Management and Sharing: Elements of an NIH Data Management and Sharing Plan ( NOT-OD-21-014) . The DMS 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. Awardees are expected to share data and/or biospecimens through broad-sharing data and/or biospecimen repositories. For applications that aim to analyze existing data, DMS plans should describe where and how other researchers can access that data to enable reproducibility and reuse.

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

The following types of applications will not be considered responsive to this NOFO and will be withdrawn prior to review: Development or implementation of interventions; Development of measures of concepts with no theoretical or evidential link with children’s language development; Applications that do not include a CE plan; Institute/Center-Specific Interests NINDS is particularly interested in applications that focus on the assessment of language acquisition or communication difficulties in the context of neurological conditions, including (but not limited to) pediatric stroke, epilepsy, perinatal or other early brain injury, neurodevelopmental disorders, and genetic conditions that may impact neurodevelopment.

Therefore, proposals that include activities described above and are focused on these populations are welcomed. Research activities outside the NINDS mission, or traditionally supported by another NIH Institute or Center, will not be considered through this program.

Applicants are highly encouraged to reach out to the Scientific Contact(s) to discuss fit to the Institute and responsiveness to this NOFO prior to submission of an application. 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. 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 not limited but 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 five years. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO. Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized).

Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Organizations) Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are allowed. Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award.

All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.

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

System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM. gov registration process.

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

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants. gov – Applicants must have an active SAM registration in order to complete the Grants.

gov registration. Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.

If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply-Application Guide. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1. 2 Definition of Terms .

3. Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.

3. 7. 4 Submission of Resubmission Application .

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

An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2. 3. 9.

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

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

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

Content and Form of Application Submission It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for review. All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed. Instructions for Application Submission The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

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

Other Attachments: The following attachments are required and must be provided or the application will be incomplete and will not be reviewed. 1. Community Engagement (CE) plan (required): In an Other Attachment entitled “Community Engagement Plan.

pdf”, all applicants must include a summary that describes how community engagement strategies, community input, and community-engaged research will be incorporated throughout the study (from conceptualization of the study idea to dissemination of results). The attachment should describe the community partners (e.

g, who they consist of – community advisory boards, community organization, families from appropriate linguistic and cultural backgrounds), their role, and how they will be collaboratively engaged in the research project (e.g., activities, frequency and duration of involvement). Serving as a research participant is not considered a collaboration, nor is solely informing recruitment and retention strategies.

The community engagement plan should justify how the planned partners and level of involvement will enhance the research project and relevance of the project to the communities the research is meant to impact. The plan also should demonstrate the feasibility of engaging the community partners in the research at the planned level of involvement.

Demonstration of feasibility should include (but is not limited to) letters of support and/or formal roles on the application (e.g., co-investigator, consultant). The CE plan may be no more than 2 pages in length and should include a timeline and milestones for relevant components that will be considered as part of the review.

Examples of meaningful community-engaged research elements to detail as part of the CE plan include but are not limited to : Ensuring that the community partners represent interests relevant to community of interest described within the study (e.g., cultural and linguistic expertise).

Defined expectations of academic partners and community partners, including the composition and expertise of the community partners and invested parties, the phase(s) (i.e., design, conduction, analysis, interpretation, and/or dissemination) of research the community partner will be engaged in, the program infrastructure and management of partnerships (e.g., memorandum of understanding) co-created with or approved by the community partner, if applicable.

Obtaining and incorporating community partner input regarding utilization of appropriate linguistic and cultural competence strategies within the study design and ensuring representation of participants who have significant social, economic and/or linguistic disadvantage anticipated to participate in study.

Describing how community partners will be engaged at specific phases of the research study and a plan for how their input and feedback will be incorporated. Ensuring appropriate and useful resources are provided to community partners based on their time and effort spent contributing to the study, as well as mutual benefit and recognition (i.e., publication authorship, conference presentation, work group representation, etc.).

Outlining methods and metrics to monitor community engagement efforts, including a description of how data will be collected within the framework of the grant activities. The anticipated or planned personal benefits including dissemination of information during and following the study, knowledge and empowerment of community partners.

SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply- Application Guide must be followed. CE plan implementation costs Applicants may include allowable costs associated with CE plan implementation (as outlined in the Grants Policy Statement section 7: https://grants.

nih. gov/grants/policy/nihgps/html5/section_7/7. 1_general.

htm ). 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: Investigators are urged to follow the NIH guidance for rigor and transparency in grant applications ( https://grants. nih. gov/policy/reproducibility/guidance.

htm ) and the research practices described at https://www. ninds. nih.

gov/Funding/grant_policy . This will ensure that robust experiments are designed, potential experimenter biases are minimized, results and analyses are transparently reported, and results are interpreted carefully.

These recommended research practices include, where applicable, expressing clear rationale for the chosen model(s) and primary/secondary endpoint(s), describing tools and parameters clearly, blinding, randomizing, ensuring adequate sample size, pre-specifying inclusion/exclusion criteria, appropriately handling missing data and outliers, implementing appropriate controls, pre-planning analyses, and using appropriate quantitative techniques.

It is also strongly recommended to indicate clearly the exploratory vs. confirmatory components of the study, consider study limitations, and plan for transparent reporting of all methods, analyses, and results so that other investigators can evaluate the quality of the work and potentially perform replications.

Investigators should indicate whether data presented or cited in the application as key support for the proposed work were collected, analyzed, and reported in a rigorous and transparent manner as indicated above. A plan to address any ambiguity, weaknesses, or limitations in the prior research should be included in the application. Proposed experiments should similarly adhere to these high standards of rigor and transparency.

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