PAR-28-042-Full-Announcement.html

Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)

Note: Not all NIH Institutes, Centers, and Offices (ICOs) participate in Announcements. Applicants should carefully note which ICOs participate in this announcement and view their respective areas of research interest at the ICO-Specific Scientific Interests website. ICOs that do not participate in this announcement will not consider applications for funding.

Funding Opportunity Title

Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH2/UH3 Clinical Trial Not Allowed)

Activity Code

UH2/UH3 Phase Innovation Awards Cooperative Agreement

Announcement Type

Reissue of

PAR-25-074

Reissue of

PAR-25-075

Related Notices

Check for any recent Notices of NIH Policy Changes that may impact application requirements.

Funding Opportunity Number (FON)

PAR-28-042

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.CA1

Funding Opportunity Purpose

The purpose of the Notice of Funding Opportunity (NOFO) is to support the analytical and clinical validation of molecular, cellular, and imaging biomarkers and assays for cancer detection, diagnosis, prognosis, monitoring, prediction of response or resistance to treatment, cancer prevention and control, as well as pharmacodynamic markers and markers of toxicity. Utilizing either a phased UH2/UH3 or a standalone UH3 mechanism, funding will facilitate laboratory optimization and clinical validation of assays that work on human samples and address a clearly defined cancer-related clinical need within a well-specified intended use.

Funding Opportunity Goal(s)

To support and advance research that improves the prevention, screening, detection, diagnosis, treatment, and understanding of cancer, with the overarching goal of improving public health.

Key Dates

Posted Date

November 03, 2026

Open Date (Earliest Submission Date)

January 16, 2027

The following table includes NIH standard due dates marked with an asterisk.

February 16, 2027 *

March 16, 2027 *

Not Applicable

December 2027

June 16, 2027 *

July 16, 2027 *

Not Applicable

April 2028

October 16, 2027 *

November 16, 2027 *

Not Applicable

July 2028

February 16, 2028 *

March 16, 2028 *

Not Applicable

December 2028

June 16, 2028 *

July 16, 2028 *

Not Applicable

April 2029

October 16, 2028 *

November 16, 2028 *

Not Applicable

July 2029

February 16, 2029 *

March 16, 2029 *

Not Applicable

December 2029

June 16, 2029 *

July 16, 2029 *

Not Applicable

April 2030

October 16, 2029 *

November 16, 2029 *

Not Applicable

July 2030

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.

Due Dates for E.O. 12372

Not Applicable

Expiration Date

November 17, 2029

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.

Table of Contents

Part 1. Overview Information Key Dates 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

Background Clinical trials increasingly rely on biomarker assays to determine patient eligibility, track disease, and measure treatment response. While academic and small biotech investigators excel at discovering these markers, they often lack the expertise to validate them for clinical use or navigate complex regulatory requirements, leading to trial delays and higher costs. This Notice of Funding Opportunity (NOFO) uses a cooperative agreement that allows NCI staff to actively help investigators analytically validate their assays and prepare them for clinical trials.

Application Options Applicants can choose a 5-year two-phase UH2/UH3 grant to support analytical followed by clinical assay validation, or a 3-year single-phase UH3 grant for clinical validation of established assays.

Research Objectives This NOFO seeks to optimize an existing assay(s) using human specimens in a clinical laboratory into assays that can be used in a clinical trial/study for the treatment, prevention or control of cancer. However, efforts to harmonize clinical laboratory tests, including investigation into the performance and reproducibility of assays across multiple clinical laboratories, are also appropriate for this funding opportunity. In the context of this NOFO, "imaging" refers to in vitro imaging modalities such as microscopy, but not clinical radiology.

The primary elements for achieving the research objectives are as follows:

Existing assay: an assay that has been reduced to practice in human tissues. The status of the existing assays and the plan for optimization in the clinical laboratory are critically important. Awards will be based on how well the applicant justifies the use of their proposed assay(s) and marker(s) in clinical studies and the team's ability to validate these.

Specific Areas of Research Interest

Applications Not Responsive to this NOFO The following types of requests are not responsive to this NOFO:

Applications proposing such requests will be considered non-responsive and will not be reviewed or considered for funding.

Note: Applicants uncertain whether their intended project meets the requirements of this NOFO are encouraged to contact the Scientific/Research Contact listed in Section VII.

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

Section II. Award Information

Funding Instrument

Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this NOFO.

Application Types Allowed

New

Resubmission

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.

Clinical Trial?

Not Allowed: This NOFO only accepts applications that do not propose clinical trials. Note: Applications may propose activities involving human subjects that are not deemed 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.

Award Budget

Applicants may request up to $275,000 direct costs for the entire UH2 phase with no more than $200,000 requested in any one year and up to $250,000 direct costs per year for the UH3 phase. For stand-alone UH3, up to $250,000 direct costs per year.

Award Project Period

The proposed project period for the initial development phase (UH2) must not exceed 2 years (but may be shorter). The proposed project period for the second validation phase (UH3) must not exceed 3 years.

The maximum project period for the stand-alone UH3 for clinical validation of assays is 3 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

1. Eligible Applicants

Eligible Organizations

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Local Governments

Federal Governments

Eligible Agencies of the Federal Government

U.S. Territory or Possession

Other

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

Regional Organizations

Foreign Organizations/International Collaborations

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 allowed.

NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16.8 Collaborative International Research Awards.

Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

Required Registrations

Applicant Organizations 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. Foreign organizations must obtain a NATO Commercial and Government Entity (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.

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.

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

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.

2. Cost Sharing 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 Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.

A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts). Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations 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.

SF424(R&R) Cover All instructions in the How to Apply - Application Guide must be followed.

Requirements for Bi-phasic UH2/UH3 Applications The UH2/UH3 mechanism has two phases. Investigators applying for UH2/UH3 must address both UH2 and UH3 phases, and propose milestones to be accomplished in the UH2 phase for transition to the UH3 phase. The initial UH2 phase will provide up to 2 years of support for analytical validation of the assays in the UH2 phase. If the project meets the metrics described for the UH2 phase, then the project will proceed to the UH3 phase pending review and availability of funds as described below.

Assay Pre-requisites and Preliminary Data The applicant must have a working assay(s) using human specimens. The assays may be derived from marker discovery research or result from previous hypothesis-driven clinical studies. The assay(s) may be a multiplex assay or a classifier but must, after conversion to a clinical assay, be suitable for performing in a clinical trial/study. Preliminary data should define the current status of the assays as well as justify support for optimization and usability in a clinical trial/study.

UH2 Phase Objectives for the UH2 phase (analytical validation phase) During the UH2 phase, the investigators must complete the analytical validation of their assays. Since this is not likely to require large numbers of samples, the investigators are expected to have access to samples that are appropriate for the clinical context of the intended use of the assays. Attention needs to be paid to pre-analytic variables and their effect on marker stability within biospecimens appropriate for the clinical context of use.

The UH2 Analytical Validation phase should determine the following (but not be limited to) performance characteristics of the assay required for the successful conduct of the study proposed for the UH3 award:

Investigators with assays that have already met the above criteria for analytical validation may apply directly for the stand-alone UH3 to study clinical validation of assays.

Minimum criteria for transition from UH2 to UH3 After administrative review by NCI program staff, successful UH2 projects will be prioritized for selection and transition to the UH3 phase. Criteria will include consideration of access to the clinical specimens which would be used for the clinical validation.

UH3 Phase Objectives for the UH3 phase (clinical validation phase): The UH3 phase will support the clinical validation of the markers/assays and prepare them for use in a clinical trial/study. If the markers/assays are already established in practice, investigators should propose to develop the markers/assays for a novel clinical context of use. Including a description of whether the team will be able to manage the further development of the assay(s) should it be successful so that it can be distributed and ultimately available to the healthcare community.

Expected outcomes of the UH3 phase that should be met by each project: The UH3 project should demonstrate the association of the result of the assays with a clinical endpoint (e.g., survival, response, disease presence or absence) in samples from patients that have been treated or exposed to a uniform intervention or observation in treatment, prevention or cancer control studies, for example:

Requirements for Stand-Alone UH3 Applications Assay Pre-requisites and Preliminary Data for stand-alone UH3 (clinical validation):

The applicant for the stand-alone UH3 must have an assay(s) that has been analytically validated within its intended clinical context of use. The assay(s) may be a multiplex assay or a classifier but must, after conversion to a clinical assay, be suitable for performing in a clinical trial/study. Preliminary data should define the current status of the assays as well as justify support for optimization and usability in a clinical trial/study. Analytical performance must meet standard criteria including accuracy; precision; analytical sensitivity; analytical specificity, including in the presence of interfering substances; reportable range of test results for the test system; reference intervals (normal values) with controls and calibrators; standardization of methods if the assays are to be performed in multiple laboratories; establishment of appropriate quality control/assurance measures and improvement procedures; and any other performance characteristic required for assay/test performance with determination of calibration and quality control procedures. Applicants should demonstrate access to the clinical specimens (e.g. letter from the collaborator or NCI approved document stating tissue access) which would be used for the clinical validation.

Objectives for the UH3 (Clinical Validation Phase): This NOFO will support stand-alone UH3 projects for clinical validation of the markers/assays and prepare them for use in a clinical trial/study. If the markers/assays are already established in practice, investigators should propose to develop the markers/assays for a novel clinical context of use.

Expected outcomes of UH3 that should be met by each project: A stand-alone UH3 project should demonstrate the association of the result of the assays with a clinical endpoint (e.g., survival, response, disease presence or absence) in samples from patients that have been treated or exposed to a uniform intervention or observation in treatment, prevention or cancer control studies. Examples may include determining the sensitivity and specificity of the assay results with respect to the defined clinical endpoint; Estimation of the prevalence of the markers within subjects or patients for the intended clinical context; and Establishment of an appropriate cut-off or threshold for the assays using appropriate statistical analysis.

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

SF424(R&R) Senior/Key Person Profile

R&R Budget

R&R Subaward Budget

PHS 398 Cover Page Supplement

PHS 398 Research Plan All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Specific Aims Provide the overall goals for the entire application and if applicable, indicate separately Specific Aims to be accomplished in the UH2 phase and in the UH3 phase.

Research Strategy Applicants should organize the Research Strategy into the sub-sections identified below. Applicants may include other sections as needed but must include the information requested below.

Sub-Section A. Importance of Research (Background and Significance) Define the specific cancer-related problem to be addressed, including the markers and assays and how they fit the intended clinical context in which they will be used;

Provide the biologic or discovery research rationale for the marker(s) and its importance;

Outline the proposed marker(s) and assay(s), and their potential for affecting the intended clinical context in treatment trials, prevention studies or cancer control studies;

Include the type of specimen to be used for the assays and how the assay results will be used.

Sub-Section B. Preliminary Data

Sub-Section C. Rigor and Feasibility (Approach - may be divided into two parts corresponding to the UH2 and UH3 phases applicable for UH2/UH3 applications and only one UH3 phase for the standalone UH3 clinical validation applications) UH2 Analytical Validation Phase should address each of the items listed below:

UH3 Clinical Validation Phase should describe the plan for clinical validation of the assays within the intended clinical context of use and should address each of the items below:

Sub-Section D. Milestones and Timeline A timeline (Gantt chart) including milestones is required. Milestones are goals that create go/no-go decision points in the project and must include clear and quantitative objective criteria for success. Milestones must consist of appropriate objective performance targets such as a required limit of detection and coefficient of variation, or sensitivity and specificity. Yearly quantitative milestones are required to provide clear indicators of a project's continued progress or emergent difficulties and will be used to evaluate the application not only in peer review but also in consideration of the awarded project for funding of non-competing award years. The application must include well-defined milestones and timelines for assessing progress in both the UH2 and UH3 phases, including specific milestones for progressing from the UH2 phase to the UH3 phase.

Milestones and timelines for each UH2 and/or UH3 phase must be provided in a separate heading at the end of the Approach section and should:

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.

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed.

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

Delayed Onset Study 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

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.

6. Funding Restrictions All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply – Application Guide. Paper applications will not be accepted.

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

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

Important reminders:

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

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization's profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply – Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Mandatory Disclosure

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.

Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria 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 is focused on the validation of assays that will be used in clinical trials or studies on cancer treatment, prevention or cancer control. Therefore, the potential of the proposed project to validate or harmonize such assays and markers for a specific cancer-related clinical context is essential and will be a main factor in assessing the overall merit of the applications.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Scored Review Criteria

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)

Innovation

Factor 2. Rigor and Feasibility (Approach)

Rigor:

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.

Feasibility:

Factor 3. Expertise and Resources (Investigator(s) and Environment)

Investigator(s) Evaluate whether the investigator(s) have demonstrated background, training, and expertise, as appropriate for their career stage, to conduct the proposed work. For Multiple Principal Investigator (MPI) applications, assess the quality of the leadership plan to facilitate coordination and collaboration.

Environment Evaluate whether the institutional resources are appropriate to ensure the successful execution of the proposed work.

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, evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects; 2) adequacy of protection against risks; 3) potential benefits to the subjects and others; 4) importance of the knowledge to be gained; and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, evaluate: 1) the justification for the…