RFA-RM-27-002-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 INSTITUTES OF HEALTH (NIH)

This Notice of Funding Opportunity (NOFO) is developed as a Common Fund initiative through the Office of the NIH Director, Office of Strategic Coordination. All NIH Institutes and Centers participate in Common Fund initiatives.

Funding Opportunity Title

NIH Director's New Innovator Award (DP2 Clinical Trial Optional)

Activity Code

DP2 NIH Director's New Innovator Awards

Announcement Type

Reissue of

RFA-RM-25-002

Related Notices

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

Funding Opportunity Number (FON)

RFA-RM-27-002

Companion Funding Opportunity

None

Number of Applications

There is no limit to the number of applications an institution may submit. Individuals may submit only one application as PD/PI in response to this NOFO.

Assistance Listing Number(s)

93.310

Funding Opportunity Purpose

The NIH Director's New Innovator Award supports early-stage investigators of exceptional creativity who propose bold and highly innovative research projects with the potential to produce a major impact on broad, important areas relevant to the mission of NIH. Applications in any area within the biomedical sciences are welcome; topics may involve basic, translational, or clinical research. The NIH Director's New Innovator Award complements other ongoing efforts by NIH and its Institutes and Centers to fund early-stage investigators. The NIH Director's New Innovator Award is a component of the High-Risk, High-Reward Research (HRHR) program of the NIH Common Fund.

Funding Opportunity Goal(s)

This listing covers the Common Fund, administered by the Office of Strategic Coordination (OSC) in the NIH Office of the Director which offers assistance awards or supplements to assistance awards.

Key Dates

Posted Date

June 26, 2026

Open Date (Earliest Submission Date)

July 17, 2026

August 17, 2026

Not Applicable

Not Applicable

July 2027

All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

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

Expiration Date

August 18, 2026

Due Dates for E.O. 12372

Not Applicable

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 How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - 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

The NIH Director's New Innovator Award addresses two important goals: stimulating bold and highly innovative research and supporting promising Early Stage Investigators, as defined by NIH policy. Early Stage Investigators may have exceptionally innovative research ideas but not the preliminary data required to fare well in the traditional NIH peer review system. As part of NIH's commitment to increasing opportunities for Early Stage Investigators, it has designed the NIH Director's New Innovator Award to support exceptionally creative Early Stage Investigators who propose bold and highly innovative research projects with the potential for unusually high impact. This award complements ongoing efforts by the NIH and its Institutes and Centers to fund Early Stage Investigators through R01 grants and other mechanisms.

The NIH Director's New Innovator Award is different from traditional NIH grants in several aspects. It is specifically designed to support unusually creative investigators with bold and highly innovative research ideas at an early stage of their career when they may lack the preliminary data required for a conventional R01 grant application. The emphasis is on innovation and creativity; preliminary data are not required but may be included. The review process emphasizes the individual's creativity, the innovativeness of the research approaches, and the potential of the project, if successful, to have a significant impact on an important biomedical research problem. Given the highly innovative nature of the research, New Innovator Award recipients are given unusual flexibility to pivot research directions as they see fit to maximize research impact.

Applications are welcome in all research areas broadly relevant to the mission of NIH. Research may be basic, translational, or clinical. The primary requirements are that the research be highly innovative and have the potential for unusually broad impact.

Investigators who were not selected for an award in prior years may submit applications for this competition as long as they meet eligibility requirements (including Early Stage Investigator status) described in this NOFO; however, all applications must be submitted as "new" applications, regardless of any previous submission to the initiative. No reference to any prior application may be included. Any reference to a prior application may be grounds for administrative withdrawal.

NIH program staff will hold a pre-application webinar to explain the program and answer questions about the application and review process. Check the NIH Calendar of Events for more information. Questions should be sent to NewInnovatorAwards@mail.nih.gov. More information, FAQs, application guide, contacts for clinical trials, and webinar recording are on the Common Fund website.

The NIH Director's New Innovator Award is part of the High-Risk, High-Reward Research (HRHR) program funded through the NIH Common Fund, which supports cross-cutting programs that are expected to have exceptionally high impact. All Common Fund initiatives invite investigators to develop bold, innovative, and often risky approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

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

Section II. Award Information

Funding Instrument

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

New

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?

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

NIH intends to commit approximately $23 million for approximately 30 awards in FY 2027. The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Awards will be for up to $475,000 in Direct Costs per year, plus applicable indirect costs.

Award Project Period

Project periods will be for five years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Local Governments

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/Foreign 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 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.

Only single PD/PI applications are allowed. Applications with multiple PD(s)/PI(s) will not be accepted. There is no limit to the number of applications an institution may submit, but individuals may submit only one application as PD/PI in response to this NOFO.

Applicants must meet the definition of an Early Stage Investigator (ESI) at the time of application submission. An ESI is a PD/PI who has completed their terminal research degree or end of post-graduate clinical training, whichever date is later, within the past 10 years and who has not previously competed successfully as PD/PI for a substantial NIH independent research award. See the Office of Extramural Research website for a complete list of NIH awards that do not disqualify a PD/PI as a new investigator and for frequently asked questions about the NIH ESI Policy.

An extension to the 10-year period may be granted under certain circumstances (e.g., childbirth, family care responsibilities, clinical loan repayment requirements, disability or illness, natural or other disaster, etc.). It may take several weeks for the review process for the request, so applicants should plan accordingly. Note: If an applicant is not identified as an ESI in the eRA Commons, it may result in the application not being reviewed. Applicants are responsible for reviewing and/or updating their degree information in their eRA Commons account in a timely fashion.

Applicants must hold an independent research position at a domestic (U.S.) institution by September 1, 2027. For this NOFO, an "independent research position" is a position that automatically confers eligibility to the investigator (based on institutional policy) to apply for R01 grants with appropriate institutional commitment of facilities for the conduct of the proposed research. Investigators still in training or mentored status (such as postdoctoral fellows) are not eligible to apply unless they have a written commitment from the institution stating they will be in an independent faculty position by September 1, 2027. The commitment is certified by the institution's submission of the application.

Applicants may submit or have an NIH R01 or other grant application (including an ESI MIRA R35 application) pending concurrently with their NIH Director's New Innovator Award application, but scientific overlap is not allowed per NIH policy. If a pending grant becomes active prior to the New Innovator Award, and the grant mechanism is not on the list of smaller NIH grants and awards that maintain ESI status, then the applicant is no longer eligible to receive the New Innovator Award.

Award recipients are required to commit at least three person-months (25%) of their research effort each year to activities supported by the New Innovator Award.

2. Cost Sharing This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement 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:

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 How to Apply - 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.

Agency Routing Identifier (Field 4b): Enter science area designations.

Using the list below, designate the two most appropriate scientific areas (a primary and secondary) of the proposal. For each area, enter the one-digit code and abbreviation (e.g., 1 CB).

1 CB - Chemical Biology 2 CTR - Clinical and Translational Research 3 IDI - Infectious Diseases and Immunology 4 IE - Instrumentation and Engineering 5 MCB - Molecular and Cellular Biology 6 NS - Neuroscience 7 HIB - High-Throughput and Integrative Biology 8 BCB - Bioinformatics and Computational Biology

For each area, enter the primary area first, followed by a semicolon, then add the secondary area (e.g., 1 CB; 7 NS).

The areas of science listed above are very broad and frequently overlap. Choose the two science areas most appropriate for your proposed project. The scientific areas are used solely as an aid to assign panel reviewers, who are chosen for their breadth of knowledge and expertise and will be able to review a broad range of applications. Science area designations do not affect an application's funding potential, and application requirements and instructions are identical for all science areas. All applications are reviewed in the same time period, with the same review criteria, and compete for a single source of dedicated funds.

Note: The science area designations (two one-digit codes with abbreviation) must also be included at the beginning of the Research Strategy essay.

Type of Application (Field 8): New Proposed Project (Field 12): Start Date is September 1, 2027, and Ending Date is August 31, 2032 Estimated Project Funding (Field 15):

Note: The total direct costs for the 5-year project period of the award is $2,375,000 and is entered in the "Total Federal Funds Requested" and "Total Federal & Non-Federal Funds" fields (as described above). Applicable indirect costs will be determined at the time of award and should not be included in the budget request. A detailed budget and other budget forms are not required and will not be accepted. Funds may be used for personnel (including collaborators), supplies, equipment, subcontracts, data management and sharing costs, and other allowable costs.

SF424(R&R) Project/Performance Site Locations

SF424(R&R) Other Project Information

Bibliography & References Cited: DO NOT USE. Provide essential reference citations in the essay.

Facilities & Other Resources: Upload a brief statement (1-page maximum) of the facilities to be used for the conduct of the research.

Equipment: DO NOT USE.

Other Attachments: Only attach Foreign Justification, if applicable.

SF424(R&R) Senior/Key Person Profile

Profile – Project Director/Principal Investigator Field – Current and Pending Support: Attach a list of Current and Pending Support from all sources and effort devoted to each project in person months.

Profile – Senior Key Person 1: DO NOT USE. Submit information only for PD/PI. Information on collaborators or other key personnel is not required but may be included in the Essay.

Research and Related Senior/Key Person Profile (Expanded) - Additional Senior/Key Person Profiles(s): DO NOT USE. Only the PD/PI may serve as senior/key personnel.

Research and Related Senior/Key Person Profile (Expanded) - Additional Biographical Sketch(es): DO NOT USE. Only the PD/PI may submit a Biographical Sketch.

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: DO NOT USE

Research Strategy: The Research Strategy section should be structured as an essay that focuses on the goals of the New Innovator Award. The essay should consider (1) the significance and potential impact of the project, (2) what makes the approaches exceptionally innovative, (3) how will risks and challenges be addressed, and (4) the applicant's qualifications for this award (without duplicating information in the biosketch). Presenting the proposed research as a series of specific aims is discouraged, and a detailed experimental plan should not be included. Preliminary data are allowed but not required. The description of the scientific plan should be written at a level appropriate for reviewers who are broadly knowledgeable but may not be experts in the research area. The essay should include the following sections in order with headings and within the page limit:

Project science areas: Provide 1-digit code and abbreviation for primary and secondary science areas at the beginning of essay. See "Agency Routing Identifier" information above for codes and format.

Project Description: Describe the scientific challenge or opportunity that you propose to address, its importance, and how addressing this would have a major impact on a broad area of research relevant to NIH. Provide the scientific context by summarizing the current landscape of the field and how your research, if successful, would extend substantially beyond current boundaries. Describe the overall approach to be taken. State prominently that to comply with the NOFO, a detailed experimental plan and extensive preliminary data are not being provided. However, the essay must be written so that reviewers have a clear sense of what is being proposed to be done and why and are convinced that the research will be performed in a robust and rigorous manner.

Innovativeness: State clearly and concisely what makes your project bold and unusually innovative in the context of what is currently state-of-the-art in the field. Since the approaches may be highly innovative, and hence risky, what will you do if these approaches are not successful?

Investigator qualifications: Provide evidence to support your claim of innovativeness and creativity in your prior research. For example, what personal qualities and experiences demonstrate your inclination to question paradigms and work with intellectual uncertainties, develop unique collaborations, integrate diverse sources of information, or develop novel approaches when new challenges or opportunities arise?

Suitability for the New Innovator Award: Explain why the planned research is uniquely suited to the New Innovator Award rather than a more "traditional" grant mechanism.

Statement of research effort commitment: A statement must be included that, if chosen to receive an award, the applicant will commit a minimum of three person-months (25%) of their research effort to the project supported by the New Innovator Award.

Note: Any bibliographic citations provided must fit within the ten-page limit. To aid in the assessment of scientific rigor, inclusion of the most critical citations is encouraged. Figures and illustrations may be included but must also fit within the ten-page limit. Letters of collaboration will not be accepted. Information on collaborators may be included in the Essay and their names and affiliations should be listed in the PHS Assignment Request Form in the section for individuals who should not review the application.

Applicants considering clinical trial research are strongly advised to discuss their research with the scientifically most relevant NIH Institutes or Centers (ICs) to ensure that such research would conform to the clinical trial research policies of those ICs. Funding of applications involving clinical trials is contingent upon conformance to the policies of the IC administering the award. For a list of IC staff contacts, see links through the NIH Common Fund website.

Progress Report Publication List: DO NOT USE.

Multiple PD/PI Leadership Plan: DO NOT USE.

Consortium/Contractual Arrangements: DO NOT USE.

Letters of Support: DO NOT USE. Letters of Support are not allowed.

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.

For this NOFO, the Resource Sharing Plan will be expected as Just in Time information if an award is being considered.

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.

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

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

Since all applications are received as "Office of the Director" applications and are reviewed by Special Emphasis Panels, applicants should not request assignment to a particular review panel (integrated review group) or awarding component (NIH Institute/Center). Since letters of collaboration and biosketches of collaborators are not allowed, provide the names of collaborators and their institutional affiliations in the section for individuals who should not review the application. Also, if you wish to request that certain individuals not review your application, list their names, institutional affiliations, and the reasons why they should not serve as reviewers. NIH will consider this request but is not obligated to accept it.

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

Only documents to inform of unforeseen events, such as natural disasters, that substantially affect the ability to execute the proposed research will be accepted. No publication updates will be allowed as post-submission material.

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 NOFO, note the following:

The NIH Director's New Innovator Award supports innovative research that has the potential to produce a major impact on a broad area of biomedical research. A New Innovator Award grant application does not have extensive experimental details, and the essay focuses on the goals of the New Innovator Award. Preliminary data are not required but may be included. Accordingly, reviewers will provide comments emphasizing the following: 1) the importance of the scientific problem and the potential impact of the research, 2) the novelty and innovativeness of the approach, and 3) evidence of the applicant's potential for creative and innovative research as an early-stage investigator.

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.

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 review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

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.

Significance

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, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

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, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

In addition, for applications involving clinical trials With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Specific to this NOFO: Does the PD/PI have a track record of unusual innovation or creativity and of overcoming substantial technical or conceptual hurdles?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

In addition, for applications involving clinical trials Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice? For example, innovative designs such as platform trials, adaptive, including real-time adaptive methods, seamless Phase I/II designs, and Bayesian designs are encouraged as applicable.

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

In addition, for applications involving clinical trials Does the application adequately address the following, if applicable Study Design Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, sex, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

In addition, for applications involving clinical trials If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Study Timeline

Specific to applications involving clinical trials Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

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, the committee will 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, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Human Subjects Policies

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for inclusion. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions (as applicable), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals (as applicable), the committee will consider the progress made in the last funding period.

Revisions

For Revisions (as applicable), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee,…