Research on Autism Spectrum Disorders (R03-Clinical Trial Optional)

Research on Autism Spectrum Disorders (R03-Clinical Trial Optional) is sponsored by National Institute of Mental Health (NIMH). This grant funds small-scale research projects designed to elucidate the characterization, pathophysiology, treatment, and outcomes of autism spectrum disorders. It is supported by NIMH along with NICHD, NIDCD, NIEHS, and other NIH institutes.

Expired PA-21-199: Research on Autism Spectrum Disorders (R03 Clinical Trial Optional) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute of Mental Health ( NIMH ) Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD ) National Institute on Deafness and Other Communication Disorders ( NIDCD ) National Institute of Environmental Health Sciences ( NIEHS ) Funding Opportunity Title Research on Autism Spectrum Disorders (R03 Clinical Trial Optional) Notices of Special Interest associated with this funding opportunity February 14, 2024 - Notice of Extension to PA-21-199 Research on Autism Spectrum Disorders (R03 Clinical Trial Optional) and PA-21-200 Research on Autism Spectrum Disorders (R21 Clinical Trial Optional).

See Notice NOT-MH-24-175 NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022 October 28, 2021 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available.

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

August 5, 2021 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements. See Notice NOT-OD-21-170 April 20, 2021 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel. See Notice NOT-OD-21-109 Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity Exploratory/Developmental Grants See Section III.

3. Additional Information on Eligibility . Assistance Listing Number(s) 93.

242, 93. 113, 93. 865, 93.

173 Funding Opportunity Purpose The purpose of this Funding Opportunity Announcement (FOA) is to encourage research grant applications to support research designed to elucidate the etiology, epidemiology, diagnosis, and optimal means of service delivery in relation to Autism Spectrum Disorders (ASD). An R03 grant supports small, discrete, well-defined projects that can be completed in two years and that require limited resources.

R03 applications may include development of new research methodologies or technology, secondary analysis of existing data, and pilot or feasibility studies. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies. Applicants pursuing exploratory/developmental research to support early and conceptual stages of project development should consider the companion R21 FOA, PA-21-200 .

Applicants pursuing larger studies in established scientific areas where preliminary data are expected should consider the companion R01 FOA, PA-21-201 . Open Date (Earliest Submission Date) Letter of Intent Due Date(s) The following table includes NIH standard due dates marked with an asterisk. Renewal / Resubmission / Revision (as allowed) All applications are due by 5:00 PM local time of applicant organization.

All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s). Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

New Date November 17, 2024 (Original Date: March 17, 2024) per issuance of NOT-MH-24-175 Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide ,except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review. Part 1. Overview Information Part 2.

Full Text of Announcement Section I. Funding Opportunity Description Section II. Award Information Section III.

Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Part 2.

Full Text of Announcement Section I. Funding Opportunity Description The purpose of this Funding Opportunity Announcement (FOA) is to encourage research grant applications to support research designed to elucidate the etiology, epidemiology, diagnosis, and optimal means of service delivery in relation to Autism Spectrum Disorders (ASD).

An R03 grant supports small, discrete, well-defined projects that can be completed in two years and that require limited resources. An R03 grant application may not contain extensive detail or discussion. R03 applications may include development of new research methodologies or technology, secondary analysis of existing data, and pilot or feasibility studies.

Preliminary data are not required, particularly in applications proposing pilot or feasibility studies. Autism Spectrum Disorders share a cluster of impairments in social communication, as well as the presence of restricted/stereotyped behavior, interests, or activities.

These complex disorders are usually of lifelong duration and affect multiple aspects of development, learning, and adaptation at home and in the community, thus representing a pressing public health need. The etiologies of these disorders are not yet understood, but may include a combination of genetic and environmental influences.

Basic research into the pathophysiology of ASD, including research on brain mechanisms, is of special interest. Also of high priority are clinical and applied investigations that may lead to the development of new treatments and interventions.

Areas of interest include, but are not limited to, those described below: Epidemiology: Studies of the genetic and environmental epidemiology of ASD to determine risk and protective processes in the etiology of the disorder, including environmental exposures during pregnancy and early childhood; longitudinal studies of high-risk populations; epidemiologic research on the interplay of genetic and non-genetic (e.g., environmental and other modifiable exposures); studies of the developmental course of ASD across the life-span; studies that characterize the range of phenotypic expression within families; and research that characterizes and quantifies risk and protective processes associated with co-occurring/co-morbid features.

Screening, Early Identification, and Diagnosis: Studies of key features of ASD associated with various stages of development, including those focused on adults; development of new screening tools for use in a variety of settings; assessment of comorbid features including epilepsy; and the creation of new measures to be used in longitudinal studies, as well as measures that further differentiate subtypes of ASD.

Genomic Studies: Unbiased and well-powered family-based or population-based genetic analyses that aim to: identify genomic factors influencing risk, symptom severity, phenotypic trajectories, and the spectrum of co-morbidities; identify specific susceptibility genes using whole genome/exome approaches; investigate epigenetic mechanisms and long range control of gene expression; use systems approaches that incorporate multiple types of -omics data; and detect locus heterogeneity.

Brain Mechanisms: Studies of brain mechanisms underlying the development, regulation, and modulation of behaviors characterizing ASD, particularly those mechanisms involving social communication and sensory processing; studies of brain mechanisms involved in the development of abnormal electroencephalograms and epilepsy, and studies to clarify the subtypes of seizures and seizure disorders in ASD; studies using model systems to examine brain mechanisms related to ASD; and studies using novel reagents and tools to identify molecular, cellular, or developmental mechanisms relevant to ASD.

Shared Neurobiology of ASD with Fragile X Syndrome, and Other Related Disorders: Studies of developmental and functional processes, pathways, and brain mechanisms that will lead to an understanding of shared etiology or pathophysiology among these disorders; analysis of autism-related neurobiological and behavioral phenotypes in related monogenic disorders; and analyses that would identify useful and specific clinical endpoints that would register measurable improvements in response to treatment interventions in clinical populations.

Cognitive Science: Developmental studies of relevant behaviors during infancy including attention to social and nonsocial stimuli, affective behavior, gaze, imitation, reciprocity and play, and their emergence in infants with, or at-risk for, ASD; research on social behavior and social cognition across the life-span; studies leading to more sophisticated measures of higher cognitive functioning, especially in social communication; and studies of sensorimotor factors and multisensory integration.

Communication Skills: Longitudinal developmental studies of behaviors that are precursors to later communication, and their emergence in children with ASD; research on sensory, motor, and social-cognitive impairments that impact interaction and communication; and studies of predictors of atypical onset patterns in expressive language abilities.

Services Research: Research on the organization, delivery, coordination, implementation, and financing of services for persons with ASD and their families, within or across service settings; studies aimed at better identifying and addressing changes in service and rehabilitative needs across the life-span, including during transitions from childhood to adolescence, and adolescence to adulthood; studies of ways to coordinate, implement or integrate services across settings including specialty mental health, general health, and other settings such as educational, vocational, and housing services, in order to maximize receipt of appropriate services; and research on assessing the value and improving the efficiency of the delivery, scale-up and sustainability of needed services.

This FOA will support mechanistic clinical trials, as defined by the NIH to include studies designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention.

The proposed human clinical studies will meet the NIH definition of a clinical trial (see NOT-OD-15-015 ), but will not include studies whose purpose is to evaluate safety; clinical efficacy, effectiveness, and management; and/or implementation. Such trials will not be supported by this FOA. Applicants proposing clinical trials that are not supported by this FOA should refer to the relevant IC's clinical trial policies and FOAs.

Applicants are also strongly encouraged to review the information provided on the Support for Clinical Trials at NIMH webpage and NOT-MH-21-105 , "Consolidated Notice on NIMH Clinical Trials Policies". The NIMH has published updated policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring ( NOT-MH-19-027 ).

The application’s Protection of Human Subjects and Clinical Trials Information and data and safety monitoring plans should reflect the policies and guidance in this notice. Plans for the protection of research subjects and data and safety monitoring will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations. See Section VIII.

Other Information for award authorities and regulations. Section II. Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed Resubmission from PA-18-399 and PA-21-199 Revision from PA-18-399 and PA-21-199 The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA. 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 two-year project period may not exceed $100,000.

No more than $50,000 in 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 FOA.

Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) Non-domestic (non-U.S.) Entities (Foreign Institutions) 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 SF 424 (R&R) Application Guide to be eligible to apply for or receive an award.

All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.

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

NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.

gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants.

gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants. gov registration. Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account.

PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement. 3. Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.

A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application. An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101 ) Section IV. Application and Submission Information 1.

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

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

Content and Form of Application Submission It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for review. All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

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

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

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

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

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

All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide. The following modifications also apply: All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Sharing Human Data via the National Database for Autism Research: In order to advance autism research as broadly and effectively as possible, investigators funded under this FOA who are collecting data from humans are expected to share those data among ASD researchers through a broadly accessible repository addressing the needs of the autism research community, e.g., via the National Database for Autism Research, now housed under the umbrella of the NIMH Data Archives (NDA; http://nda.

nih. gov ). Fulfilling this expectation by the awardee will be among the terms and conditions of the award.

Established by the NIMH, and supported by other NIH Institutes, the NDA is a secure informatics platform for scientific collaboration and data-sharing that enables the effective communication of detailed research data, results, tools, and supporting documentation. All human subjects data collected and/or derived for a project funded under this FOA are expected to be submitted to the NDA.

Data resulting from existing samples, cells, or sequences previously collected are also expected to be submitted to the NDA. Products such as tools, pipelines, and algorithms that will not result in a commercial product are expected to be shared via the NDA Study.

Investigators funded under this FOA are expected to use NDA technologies to submit data in accordance with the NDA Data Sharing Terms and Conditions, incorporated by reference, which can be found at https://nda. nih. gov/contribute/sharing-regimen.

html . A resource sharing plan, formulated in accordance with these NDA Data Sharing Terms and Conditions, should be included in the grant application. The NDA links data across research projects through its Global Unique Identifier (GUID) and Data Dictionary technologies.

Investigators funded under this FOA are expected to use these technologies to submit and share their research data and results at the appropriate times. To accomplish this objective, it will be important to formulate a) an enrollment and consent strategy that will obtain the information necessary to generate a GUID for each research participant; and, b) a budget strategy that will cover the costs of data sharing.

The NDA Cost Estimation Tool is a customizable Excel worksheet that can be used to calculate an estimate of the resources needed to submit and share data with the NDA. This resource estimate should be submitted as part of the application budget ( http://nda. nih.

gov/contribute_cost_estimation. html ). Only limited Appendix materials are allowed.

Follow all instructions for the Appendix as described in the SF424 (R&R) 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 SF424 (R&R) Application Guide, with the following additional instructions: If you answered “Yes” to the question “Are Human Subjects Involved?

” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the SF424 (R&R) Application Guide must be followed.

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed. PHS Assignment Request Form All instructions in the SF424 (R&R) Application Guide must be followed.

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement , and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide. 3. Unique Entity Identifier and System for Award Management (SAM) See Part 1.

Section III. 1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants. gov 4.

Submission Dates and Times Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day. Organizations must submit applications to Grants. gov (the online portal to find and apply for grants across all Federal agencies).

Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , NIH’s electronic system for grants administration. NIH and Grants. gov systems check the application against many of the application instructions upon submission.

Errors must be corrected and a changed/corrected application must be submitted to Grants. gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission. Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission. Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E. O.

12372) This initiative is not subject to intergovernmental review. All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement . Pre-award costs are allowable only as described in the NIH Grants Policy Statement .

7. Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide . If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII .

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide. See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed. Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described in the policy .

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

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system. 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. In addition, for applications involving clinical trials: 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 review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?

How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

In addition, for applications involving clinical trials Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms?

For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?

If the project is collaborative or multi-PD/PI,