PAR-27-064-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 Institute of Allergy and Infectious Diseases (NIAID)

Funding Opportunity Title

NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

Reissue of

PAR-24-100

Related Notices

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

Funding Opportunity Number (FON)

PAR-27-064

Companion Funding Opportunity

None

Number of Applications

See Part 2, Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.855

Funding Opportunity Purpose

This notice of funding opportunity (NOFO) encourages applications for implementation of investigator-initiated, milestone driven clinical trials that need enhanced oversight, and as applicable, include mechanistic studies. Mechanistic work in clinical trials may be of great value because it promotes the understanding of human diseases and the development of future therapeutic modalities. Support is available for clinical trials up to 5 years, as well as for extended clinical trials of 6- or 7-years.

Investigators are encouraged to visit this NIH website for additional information about the overall mission and research areas of NIAID.

Only one clinical trial may be proposed in each NIAID Clinical Trial Implementation Cooperative Agreement (U01) application. In accordance with NIH standard peer-review processes, the applications will be peer-reviewed, and only meritorious applications will be considered.

Funding Opportunity Goal(s)

To assist public and private nonprofit institutions and individuals to establish, expand and improve biomedical research and research training in infectious diseases and related areas; to conduct developmental research, to produce and test research materials. To assist public, private and commercial institutions to conduct developmental research, to produce and test research materials, to provide research services as required by the agency for programs in infectious diseases, and controlling disease caused by infectious or parasitic agents, allergic and immunologic diseases and related areas. Projects range from studies of microbial physiology and antigenic structure to collaborative trials of experimental drugs and vaccines, mechanisms of resistance to antibiotics as well as research dealing with epidemiological observations in hospitalized patients or community populations and progress in allergic and immunologic diseases. Because of this dual focus, the program encompasses both basic research and clinical research.

Key Dates

Posted Date

June 16, 2026

Open Date (Earliest Submission Date)

September 05, 2026

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

October 05, 2026 *

November 05, 2026 *

Not Applicable

July 2027

February 05, 2027 *

March 05, 2027 *

Not Applicable

December 2027

June 05, 2027 *

July 05, 2027 *

Not Applicable

April 2028

October 05, 2027 *

November 05, 2027 *

Not Applicable

July 2028

February 05, 2028 *

March 05, 2028 *

Not Applicable

December 2028

June 05, 2028 *

July 05, 2028 *

Not Applicable

April 2029

October 05, 2028 *

November 05, 2028 *

Not Applicable

July 2029

February 05, 2029 *

March 05, 2029 *

Not Applicable

December 2029

June 05, 2029 *

July 05, 2029 *

Not Applicable

April 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

July 06, 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 are one strategy NIAID uses to improve prevention, diagnosis, and treatment of infectious, immunologic, and allergic diseases in addition to understanding the mechanisms of these diseases. For additional information about the mission, strategic plan, and research interests of NIAID, applicants are encouraged to consult this NIH website.

Historically, NIAID has supported both the infrastructure and clinical trial networks through a variety of funding mechanisms. NIAID recognizes that additional models of clinical research are important to advance its research mission; therefore, NIAID has established this investigator-initiated clinical trial funding opportunity for clinical trials that cannot or will not be conducted through existing NIAID-supported clinical trial networks or infrastructure. The proposed clinical trial must be ready for implementation, and appropriate documentation must support readiness.

Scope The NIAID Clinical Trial Implementation Cooperative Agreement supports implementation of clinical trials that address research areas supporting the mission and goals of NIAID and require enhanced oversight.

NIH defines a clinical trial as: "A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes." For additional details, see NOT-OD-15-015.

A clinical trial that requires enhanced oversight has one or more of the following attributes:

Any clinical trial that will require a regulatory oversight (such as Investigational New Drug [IND] or Investigational Device Exemption [IDE]) would be considered to require enhanced oversight.

NIAID expects all activities and communications regarding all clinical laboratory testing for study participants to comply with U.S. Code of Federal Regulations (see 42 CFR part 493.2 and 493.3(b)(2)).

The NIAID Clinical Trial Implementation Cooperative Agreement will support the conduct, completion, and analysis of the clinical trial, and related activities, for example:

NIAID reserves the right to specify: 1) whether an IND/IDE application should be submitted to the appropriate regulatory agency; 2) the entity (NIAID, primary recipient, etc.) who will hold the IND/IDE; 3) the requirements for the establishment of a Data Safety Monitoring Board (DSMB)/Safety Monitoring Committee (SMC) or the use of an NIAID-sponsored DSMB/SMC; and 4) the use of other NIAID clinical resources such as a Statistical and Clinical Coordinating Center. Applicants are encouraged to discuss those decisions and requirements with NIAID prior to submission of the application.

Extended Performance Period Rationale The scope of the proposed clinical trial and related research activities should determine the project period with the expectation that most trials can be completed within 5 years. Examples of factors that may require a project period of 6- or 7-years include:

Applications Not Responsive to This NOFO The following types of applications are not responsive to this NOFO and will not be reviewed:

For studies that do not require enhanced oversight, NIAID encourages submission of applications to either NIH Research Project Grant (Parent R01 Clinical Trials Required) PA-25-305 or NIH Research Project Grant (Parent R21 Clinical Trial Required) PA-25-306. Applicants are strongly encouraged to contact the Scientific/Research Contact(s) listed in Section VII. Agency Contacts for questions concerning the classification of the proposed clinical trial.

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

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

Renewal

Resubmission

Revision

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?

Required: Only accepting applications that propose clinical trial(s).

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets are not limited but need to reflect the actual needs of the proposed project.

Award Project Period

The scope of the proposed project should determine the project period. The expectation is that most trials will be completed within 5 years, however, the maximum project period is 7 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

Non-domestic (non-U.S.) Entities (Foreign Organizations)

Foreign Organizations/International Collaborations

Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

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.

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

If mechanistic studies are proposed, describe the appropriate expertise within the biosketch of the individual who will have the general responsibility for the scientific and the technical/laboratory aspects of the proposed work. This person may be the application's PD/PI or a single PD/PI in a multi-PD/PI application.

If a platform trial is proposed, describe the appropriate expertise in statistical design and analysis within the biosketch of the individual that will be responsible for the design of the platform trial.

R&R or Modular Budget

All applications must request funding needs for the entire trial and data analysis period. In addition to funds required to support clinical trial conduct, the budget should reflect sufficient funds to support independent study monitoring, medical and data monitoring, clinical site monitoring, regulatory submissions, quality management, safety oversight activities. Costs of study agent and/or product, labeling, distribution should also be delineated, if applicable. If parts of the costs of the trial are to be borne by sources other than NIH, these contributions must be presented in detail along with supporting letters signed by individuals who have the authority to make fiduciary commitments on behalf of the institution. These outsource costs do not constitute cost sharing as defined in the current NIH Grants Policy Statement and should not be presented either as part of the requested budget or as Estimated Project Funding. NIAID reserves the right to independently procure drug for the study if that offers cost or other advantages to the clinical trial.

Further information concerning budget preparation may be obtained from the Financial/Grants Management Contact(s) listed in Section VII. Agency Contacts.

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:

Each application may propose a single clinical trial that may include more than one intervention. A single platform trial that allows for simultaneous comparison of multiple intervention groups against a single control group or a trial that includes more than one sequential stage is permitted.

All clinical trial planning activities must be completed prior to the time of application submission and investigators must be ready to implement the proposed trial at the time of award.

As applicable, mechanistic studies will be supported as part of the proposed clinical trial. DAIT-focused clinical trials on allergic, autoimmune, and immune-mediated diseases or transplantation must include mechanistic studies.

Prior to initiation, protocols and consent forms may be subject to review by NIAID. Investigators are strongly encouraged to contact the Scientific/Research Contact(s) listed in Section VII. Agency Contacts for more information regarding division-specific clinical protocol templates.

Specific Aims: Specify the primary and major secondary outcomes and endpoints to be measured. Provide a clear explanation of the importance of various outcome measures and endpoints and their relevance to the hypothesis being tested.

Research Strategy: Within the Research Strategy describe the following:

Letters of Support: Provide letters of support to document access to or commitment of critical resources, including consortium and/or site participants, cores, laboratories, pharmacies, data management resources, or other collaborators, including sharing of NIH resources, in the case of intramural collaborators. Intramural scientist collaborators are referred to their intramural division contacts for additional guidance on Intramural Scientist Collaboration on Extramural Funded Grants. If co-funding or in-kind support is planned from any source (non-NIH sources or NIH sources), letter(s) of commitment (e.g., type, amount, and source of support), signed by a business official, on organization letterhead, must be included in the Letters of Support section.

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.

The following modifications apply:

Include the informed consent form(s) and, if applicable, assent form(s).

Complete Clinical Protocol: include a complete protocol as part of the Appendix. Investigators should contact the relevant Scientific/Research Contact(s) listed in Section VII. Agency Contacts to obtain the NIAID Division-specific protocol template for their application. Investigators are urged to address all protocol template elements in a succinct manner.

Applications that lack the Complete Clinical Protocol are incomplete and will not be reviewed.

Provide the informed consent forms, assent forms and the Complete Clinical Trial Protocol combined in a single PDF file 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

Section 2 - Study Population Characteristics

2.7 Study Timeline

Include the following:

Section 3 - Protection and Monitoring Plans

3.3 Data and Safety Monitoring Plan

The Data and Safety Monitoring (DSM) Plan must address the following areas:

Applications that lack the DSM Plan are incomplete and will not be peer reviewed.

3.5 Overall Structure of the Study Team

This section must include:

A description of the study organization and administration, including, but not limited to: a description of committee structures needed to manage the complexity of the trial; the role of any internal or external advisory committees; the oversight, responsibilities, and coordination of any sites or cores proposed; and the role of any subawards or service providers for personnel or facilities. Note: If proposing an external advisory committee, then please do not contact potential members prior to award nor propose their names in the application.

Section 4 - Protocol Synopsis

4.5 Will the study use an FDA-regulated intervention?

4.5.a If yes, describe the availability of Investigational Product (IP) and Investigational New Drug (IND)/Investigational Device Exemption (IDE) status If FDA staff have determined that IND/IDE approval is not required, include a copy of the FDA letter/email stating no IND/IDE is required and the date of the decision.

Section 5 - Other Clinical Trial-related Attachments

5.1 Other Clinical Trial-related Attachments

The following additional documents should be included as attachments:

If any of these documents requested in Section 5 are not available at the time of submission, substitute a justification for their omission. The Study Timeline included as part of the application should address when these materials will be available, if applicable.

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

Foreign Organizations Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the How to Apply- Application Guide.

3. Unique Entity Identifier and System for Award Management (SAM) See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times Part I. contains information about Key Dates and times. Applicants are encouraged to 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.

Prior Consultation with NIAID Consultation with NIAID staff is strongly encouraged. If requested, NIAID staff will consider whether the proposed clinical trial meets the goals and mission of the Institute and is appropriate to conduct as an investigator-initiated clinical trial. Additionally, NIAID staff will consider the appropriateness of the proposed project period and the readiness of the proposed clinical trial. Consultation with NIAID staff is recommended a minimum of 10 weeks prior to submitting the application.

NIAID staff will not evaluate the technical and scientific merit of the proposed trial; technical and scientific merit will be determined during peer review using the review criteria indicated in Section V of this NOFO. NIAID staff members are also available to work with potential applicants to determine the level of oversight needed for the proposed trial and delineate all documentation that will be needed at the time of application submission. During the consultation phase, if the proposed trial does not meet NIAID's programmatic needs or is not appropriate as an investigator-initiated clinical trial, applicants will be strongly encouraged to consider other NOFOs.

For further information on prior consultation with NIAID program staff, and required documents, applicants are strongly encouraged to contact the Scientific/Research Contact(s) listed in Section VII.

NIAID reserves the right to provide support for clinical trials through other available mechanisms supported by NIAID. If NIAID ascertains that enhanced oversight of this clinical trial is not necessary, then the applicant will be encouraged to consider funding under the Parent R01 Clinical Trial Required (PA-25-305) or Parent R21 Clinical Trial Required (PA-25-306).

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.

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 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 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.

Vertebrate Animals

When the proposed research includes Vertebrate Animals, evaluate the involvement of live vertebrate animals according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the…