Support for Research Excellence (SuRE) Award (R16 Clinical Trial Not Allowed) is sponsored by NIGMS. Enhances research capacity at institutions that serve underrepresented groups.

PAR-25-414: Support for Research Excellence (SuRE) Award (R16 Clinical Trial Not Allowed) 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 General Medical Sciences ( NIGMS ) National Eye Institute ( NEI ) National Human Genome Research Institute ( NHGRI ) National Institute on Alcohol Abuse and Alcoholism ( NIAAA ) National Institute of Allergy and Infectious Diseases ( NIAID ) National Institute of Arthritis and Musculoskeletal and Skin Diseases ( NIAMS ) National Institute of Biomedical Imaging and Bioengineering ( NIBIB ) Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD ) National Institute on Deafness and Other Communication Disorders ( NIDCD ) National Institute of Dental and Craniofacial Research ( NIDCR ) National Institute of Diabetes and Digestive and Kidney Diseases ( NIDDK ) National Institute on Drug Abuse ( NIDA ) National Institute of Environmental Health Sciences ( NIEHS ) National Institute of Mental Health ( NIMH ) National Institute of Neurological Disorders and National Institute of Nursing Research ( NINR ) National Institute on Minority Health and Health Disparities ( NIMHD ) National Library of Medicine ( NLM ) National Cancer Institute ( NCI ) Funding Opportunity Title Support for Research Excellence (SuRE) Award (R16 Clinical Trial Not Allowed) R16 Research Excellence Award Notices of Special Interest associated with this funding opportunity January 28, 2026 - NIH Removing AIDS Application Due Dates from NOFOs.

See Notice NOT-OD-26-029 . 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 Research Excellence Award See Section III. 3.

Additional Information on Eligibility. Assistance Listing Number(s) 93. 859, 93.

853, 93. 121, 93. 273, 93.

172, 93. 865, 93. 113, 93.

279, 93. 361, 93. 846, 93.

867, 93. 398, 93. 173, 93.

286, 93. 307, 93. 847, 93.

855, 93. 879, 93. 242, 93.

866 Funding Opportunity Purpose The SuRE program supports research capacity building at eligible higher education institutions by funding investigator-initiated biomedical research in basic, social, clinical, behavioral, or translational science that falls in the mission areas of the NIH.

The purpose of SuRE awards is to provide support for investigator-initiated research at resource-limited institutions by full-time faculty who are not currently funded by any NIH Research Project Grants (RPGs ) with the exception of SuRE or SuRE-First awards, to furnish students with high-quality undergraduate and/or graduate research experiences, and to enhance the institutional scientific research culture.

Funding Opportunity Goal(s) To ensure the vitality and continued productivity of the research enterprise, NIGMS provides leadership in supporting the training of future scientists and developing research capacity throughout the country. 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 There is a pressing need to enhance biomedical research capacity and opportunities for research at resource-limited institutions, many of which disproportionately serve regions of the U.S. that have not historically participated in substantial NIH research, including rural areas.

Support for these institutions will allow different research questions and ideas to be studied and ensure that students from all communities and regions of the country have the opportunity to participate in high quality scientific inquiries and explore careers in biomedical research.

The Support for Research Excellence (SuRE) program aims to develop and sustain research excellence at such institutions by supporting investigator-initiated research with strong student participation. SuRE investigator-initiated research projects must fall within the scope of the NIH mission, or they will be withdrawn prior to review.

More complete information about the mission of each NIH Institute/Center (IC) can be found at https://www. nih. gov/institutes-nih/list-institutes-centers .

Applicants are encouraged to contact the NIH IC Scientific/Research contact listed in Section VII. Agency Contacts that best aligns with their proposed research. For ICs not listed and for all general programmatic questions, inquiries should be directed to the NIGMS Scientific/Research contact.

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 number of meritorious applications received.

Applications may request up to $100,000 in direct costs per year, excluding consortium facilities and administrative (F&A) costs. The scope of the proposed project should determine the project period. The maximum period of support is 4 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO. Section III.

Eligibility Information Higher Education Institutions - Includes all types Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education This funding opportunity announcement is limited to institutions of higher education that: 1) award undergraduate (B. S. or B.

A.)

and/or graduate degrees in biomedical sciences; and 2) have received no more than $6 million dollars per year (total costs) from NIH Research Project Grants (RPGs) in each of the preceding two fiscal years, calculated using NIH RePORTER , at the time of the application; and 3) enroll at least 25% of undergraduate students supported by Pell grants based on the most recent two years of data available from the Integrated Postsecondary Education Data System (IPEDS) database maintained by the National Center for Education Statistics.

IPEDS reports the percentage of students supported by Pell grants in two ways: (1) the percentage of all undergraduates enrolled and (2) the percentage of full-time, first-time, degree/certificate-seeking undergraduate students. Institutions may use either option for determining their eligibility.

Irrespective of which category of IPEDS data is used, the institution’s Pell enrollment in that category must be at least 25% for the two most recent years of reported data. The application must be submitted by an eligible organization with a Unique Entity Identifier (UEI) and a unique NIH eRA Institutional Profile File (IPF) number.

For institutions with multiple campuses, eligibility can be considered for an individual campus (e.g., main, satellite, etc.) as the applicant organization only if a UEI and a unique NIH eRA IPF number are established for the individual campus . For institutions that use one UEI or NIH IPF number for multiple campuses, eligibility as the applicant organization is determined for the campuses together.

An institution with a combined total of 20 or more active SuRE, SCORE SC1, and SCORE SC3 awards is only eligible to submit renewal applications. For this eligibility criterion, active awards include those in no-cost extension. Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are not 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. Since the SuRE award is structured to best support a single PD/PI, multiple PD(s)/PI(s) (MPI) are not allowed.

Institutions can apply for separate awards for PDs/PIs with similar or complementary research interests . The PD/PI must have a full-time appointment, defined here as a tenure-track or other type of independent faculty position, at the applicant institution and must be leading their own independent research program. An individual holding a postdoctoral, trainee, or similar non-independent position is not eligible to apply.

The PD/PI of an active SCORE, SuRE or SuRE-First grant may apply in the last year of funding or during a no-cost extension. A PD/PI holding other active NIH Research Project Grants (RPGs) at the time of application, most commonly R01s, R35s, U01s, P01s, R21s, R03s, R00s, and R15s, is not eligible to apply for a SuRE award. A complete list of NIH RPG grants can be found in the NIH Glossary .

For this eligibility criterion, grants in no-cost extension are considered active grants. NIH RPGs that name the SuRE PD/PI as a co-investigator, collaborator, consultant, or to a position other than PD/PI do not disqualify an investigator from applying for SuRE support. The SuRE award is renewable.

A PD/PI may hold only one SuRE, SuRE-First, or SCORE award at any time. Concurrent or duplicate applications to the SuRE and SuRE-First NOFOs are not allowed. 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 and is led by a different PD/PI.

Concurrent applications by the same PD/PI to this NOFO and its companion, PAR-25-415 are prohibited. 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.

Facilities & Other Resources: All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: It is expected that the research will be directed by the PD/PI and the majority of experiments will be conducted at the applicant institution. Limited use of special facilities or equipment at another institution is permitted but should be well-justified.

For any proposed research facilities or equipment at a site(s) other than the applicant institution, provide a description of the resources and describe the PD/PI’s access to these resources. 2) Institutional Letter - Support for the PD/PI’s Research Career Development: A letter from the Department Chair or Dean is required and should confirm that the time and effort requested by the PD/PI for the proposed project will be provided.

Additional institutional support to the PD/PI, including mentoring and teaching release time, should also be described. The file should be named “Institutional Letter – PD/PI Support”. SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply- Application Guide must be followed.

Biographical Sketch: The Personal Statement of the PD/PI’s biosketch should include a summary of prior and current experience supervising students in research. Publications should indicate with an asterisk the names of any student authors who were directly supervised by the PD/PI. 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: The application should include a detailed strategy that describes experimental approach(es) and expected/alternative outcomes for the proposed studies. The scientific foundation for the proposed research should be established using preliminary data and/or published data.

Although preliminary data are not required for a SuRE application, they may be included if available. The approach should be made compelling primarily by the logic of the arguments presented and reference to the published literature.

The Research Strategy must include a separate section entitled "Student Involvement Plan" that describes how students will be involved and supervised in conducting hands-on, rigorous research, including their participation in the execution, analysis, and reporting of the research.

Formal training plans (e.g., non-research activities, didactic training, seminars) should not be provided, although such programs available at the institution can be described in the Facilities and Resources section. Progress Report for Renewal Applications : Include a report of student participation in the previous SuRE project, their time spent in the lab, degree(s) obtained, and last known occupations and employing organizations.

Progress Report Publication List: Use an asterisk to indicate the names of student co-authors on each relevant publication. 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.

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. A permanent change of PD/PI is not allowed. A temporary change of PD/PI may be allowed with NIH prior approval under circumstances such as sabbatical, medical leave, disability, or personal or family situations.

In the event of a change in employment of the PD/PI (e.g., leaving the grantee institution, inability to direct the project for a prolonged time period, loss of full-time appointment as defined in Section III), a temporary change may be permitted with prior NIGMS approval to allow for orderly termination of grant activities.

SuRE awards may only be transferred to another SuRE-eligible institution with the consent of the recipient institution and NIH prior approval. This is expected to be a rare occurrence. 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 NIGMS. Applications that are incomplete and/or non-compliant will not be reviewed. Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award.

See Mandatory Disclosures, 2 CFR 200. 113 and NIH Grants Policy Statement Section 4. 1.

35 . Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected] . Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described in the policy Section V.

Application Review Information Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following: This NOFO has three objectives: (1) provide support for meritorious research conducted by eligible full-time faculty investigators who are at institutions with limited NIH Research Project Grant funding; (2) strengthen the research capacity of these institutions; and (3) provide students with opportunities to participate in high-quality biomedical research.

The scientific foundation for the proposed research should be established using preliminary data and/or published data. Although preliminary data are not required for a SuRE application, they may be included if available. The approach should be made compelling primarily by the logic of the arguments presented and reference to the published literature.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to make important scientific contributions to the research field(s) involved, while providing research opportunities to students, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

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 project will yield rigorous data that can be disseminated and will be important to the field.

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 effect of this award on strengthening the institutional research environment and involving students in research.

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 important for the field.

Evaluate whether the proposed work applies novel concepts, methods or technologies or uses existing concepts, methods, technologies in novel ways, to enhance the overall impact of the project. Factor 2. Rigor and Feasibility (Approach) Evaluate the scientific quality of the proposed work.

Evaluate the likelihood that compelling, reproducible findings will result (rigor) and assess whether the proposed studies can be done well and within the timeframes proposed (feasibility). Evaluate the proposed plans for engaging undergraduate students in meaningful aspects of the research. Evaluate the potential to produce unbiased, reproducible, robust data.

Evaluate the rigor of experimental design and whether appropriate controls are in place. Evaluate whether the sample size is sufficient and well-justified. Assess the quality of the plans for analysis, interpretation, and reporting of results.

Evaluate whether the investigators presented adequate plans to address relevant biological variables, such as sex or age, in the design, analysis, and reporting. For applications involving human subjects or vertebrate animals, also evaluate: the rigor of the intervention or study manipulation (if applicable to the study design). whether outcome variables are justified.

whether the results will be generalizable or, in the case of a rare disease/special group, relevant to the particular subgroup. whether the study population appropriately models the target population. For applications involving human subjects, including clinical trials, assess the adequacy of inclusion plans as appropriate for the scientific goals of the research.

Considerations of appropriateness may include disease/condition/behavior incidence, prevalence, or population burden, population representation, and/or current state of the science. Evaluate whether the proposed approach is sound and achievable, including plans to address problems or new challenges that emerge in the work.

For proposed studies in which feasibility may be less certain, evaluate whether the uncertainty is balanced by the potential for major advances. For applications involving human subjects, including clinical trials, evaluate the adequacy and feasibility of the plan to recruit and retain a study population that appropriately models the target population.

Additionally, evaluate the likelihood of successfully achieving the proposed enrollment based on age, race, ethnicity, and sex. For clinical trial applications, evaluate whether the study timeline and milestones are feasible. Factor 3.

Expertise and Resources (Investigator(s) and Environment) Evaluate whether the investigator(s) have demonstrated background, training, and expertise, as appropriate for their career stage, to conduct the proposed work and in supervising and engaging students in research, including dissemination of research results.

Evaluate whether the institutional resources, both applicant and other leveraged organization(s), are appropriate to ensure the successful execution of the proposed work. Assess the likely availability of students to participate in the research project. Evaluate plans for informing students of opportunities to participate in the research project.

Additional Review Criteria As applicable for the project proposed, reviewers will consider the following additional items while determining scientific and technical merit, but will not give criterion scores for these items, and should consider them in providing an overall impact score.

Protections for Human Subjects For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46,