RFA-DE-27-001-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 Dental and Craniofacial Research (NIDCR)

Office of AIDS Research (OAR)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)

Office of Behavioral and Social Sciences Research (OBSSR)

Office of Research on Women's Health (ORWH)

Funding Opportunity Title

Community Engagement Evaluation and Data Coordination (CEED) Hub to Advance Data and Practice Transformation for Optimizing Oral Health for All (U01, Clinical Trial Not Allowed)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices

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

Funding Opportunity Number (FON)

RFA-DE-27-001

Companion Funding Opportunity

PAR-27-015

UG3/

UH3

Phase 1 Exploratory/Developmental Cooperative Agreement/Exploratory/Developmental Cooperative Agreement Phase II

Number of Applications

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

Assistance Listing Number(s)

93.121, 93.310, 93.313

Funding Opportunity Purpose

The purpose of this Notice of Funding Opportunity (NOFO) is to seek applications for a Community Engagement Evaluation and Data coordination hub (CEED) for the Community-Based Participatory Research (CBPR) consortium: Advancing Data and Practice Transformation (ADAPT) for Optimizing Oral Health for All. In addition to CEED, the ADAPT consortium will include separately funded CBPR projects, which will receive consultative services from the NIH Community Engagement Alliance Consultative Resource (CEACR) and join in the Science Collaborative for Health and Artificial Intelligence Reduction of Errors (SCHARE) platform for the overarching goal of promoting data use and transformational community engagement to optimize oral health for all people. The CEED hub will coordinate communications and various activities in support of CBPR projects and consortium functions in three domains:1) Data Planning, Consultation, and Technical Assistance for Research Methodology and Analytics; 2) Community Engagement Evaluation; and 3) ADAPT Infrastructure and Operational Support.

Funding Opportunity Goal(s)

The mission of the National Institute of Dental and Craniofacial Research (NIDCR) is to advance fundamental knowledge about dental, oral, and craniofacial (DOC) health and disease and translate these findings into prevention, early detection, and treatment strategies that improve overall health for all individuals and communities across the lifespan.

Key Dates

Posted Date

April 27, 2026

Open Date (Earliest Submission Date)

September 19, 2026

October 19, 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.

Due Dates for E.O. 12372

Not Applicable

Expiration Date

October 20, 2026

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

This Notice of Funding Opportunity (NOFO) seeks applications for a Community Engagement Evaluation and Data coordination hub (CEED) for the Community-Based Participatory Research (CBPR) consortium: Advancing Data and Practice Transformation (ADAPT) for Optimizing Oral Health for All. In addition to CEED, the ADAPT consortium will include separately funded CBPR projects, which will receive consultative services from the NIH Community Engagement Alliance Consultative Resource (CEACR) and join in the Science Collaborative for Health and Artificial Intelligence Reduction of Errors (SCHARE) platform for the overarching goal of promoting data use and transformational community engagement to optimize oral health for all people across the lifespan. CEED will coordinate communications and various activities for the consortium in three domains: 1) Data Planning, Consultation, and Technical Assistance for Research Methodology and Analytics; 2) Community Engagement Evaluation; and 3) ADAPT Consortium Infrastructure and Operational Support.

Key Definitions for this NOFO:

Community: A social group of any size whose members reside in a specific locality, share government, and often have a common cultural and historical heritage. Community may be self-defined or defined by the catchment areas of local government or service providers (e.g. residents served by a county school district or community clinic). Examples of communities include but not limited to neighborhoods, towns, cities, counties, school districts, reservations or Tribal communities, military bases, and college campuses. Virtual or other communities that do not reside in the same geographic location are not the focus of this initiative.

Community-Based Participatory Research (CBPR): A highly-evolved collaborative approach in research that expects researchers and groups of people affiliated by, for example, geographic proximity or other defining characteristics to identify and address issues affecting the well-being of those people as equivalent partners in all aspects of the research process. Community engagement in research can be viewed in the context of a continuum, ranging from consultation with community partners to community-driven research. Moving along the continuum, as the relationships between community partners and researchers grow, the meaningfulness to community partners and the impact of research to community health increase.

Cross-Sector Partnerships: A collaborative partnership between two or more community-based service sectors with the goal of leveraging the resources and expertise of the partners to achieve a mutually beneficial outcome. In ADAPT, cross-sector partnerships must include healthcare-related (e.g. businesses that provide dental and medical services, equipment/supplies, insurance) and non-healthcare-related organizations and individuals from these service sectors.

Levels of Influence: The socio-ecological levels, such as individual, interpersonal, organizational, community, or societal levels, at which specific domains of factors (e.g. biological, behavioral, physical/built environment, sociocultural environment, healthcare system) operate to influence risks and resilience for subsequent health outcomes. In ADAPT, the intervention(s) of interest must directly address factors at the community and/or societal levels of influence, not merely be implemented at these levels.

Background: Despite considerable advances in science and the practice of preventing and controlling oral diseases over the last 20 years, oral diseases such as dental caries and periodontal disease remain among the most common chronic diseases across the lifespan. In the United States, approximately one in four preschool children reportedly have experienced caries in their primary teeth, and nine in ten adults ages 20-64 years have either treated or untreated caries in their permanent teeth. Periodontal disease is more common as people age, and more than 40% of US adults 30 years or older have some form of periodontitis. Chronic oral diseases such as dental caries and periodontal diseases progress silently over the lifespan, influenced by various individual and contextual factors, resulting in pain and loss of teeth, supporting tissues, and basic functions of the mouth such as eating and speaking thus impairing a person’s health and psychosocial and economic well-being. Among US adults 65 years and older, approximately 25% have lost eight or fewer teeth, and the prevalence of complete tooth loss is more than 15%. Poor oral health and untreated oral diseases are particularly common among populations with low socioeconomic status.

The mouth is a portal to chronic disease risk, with tobacco use and an unhealthy diet also contributing to poor oral health outcomes and America's chronic disease crisis. The mouth, which is home to over 700 microbial species, often shows early signs of physiological challenges such as altered immunity and inflammation while untreated oral diseases and sustained localized inflammation in the mouth can trigger the initiation of systemic inflammatory responses and multimorbidity.

The conditions in which people are born, grow, learn, work, play, live, and age, and the wider set of upstream factors shaping the conditions of daily life (e.g. systems and policies that impact social, economic, educational, and neighborhood conditions as well as health care access and quality) can improve, maintain, or hinder health through multiple direct, indirect, and interacting mechanistic pathways. They may also interact with downstream factors to influence disease risks and resilience to further promote or compromise health across the life-course. Enhanced access to high-quality, affordable, and evidence-based oral health services is an important step towards improving oral health in communities. Nevertheless, multi-level common risk factors giving rise to oral and systemic multimorbidity must be considered to increase the efficiency and value of oral health care delivery for optimizing oral and overall health for all people.

CBPR utilizes a collaborative approach that engages community members as equivalent partners with scientists throughout the research process. The NIH has supported research using CBPR strategies for several decades to accelerate the translation of scientific discovery into communities. Despite progress, gaps remain in the level of community engagement within NIH-funded research, presenting opportunities to deepen community-researcher partnerships and enhance the impact of research in improving community health.

The ADAPT Consortium Structure: The ADAPT consortium comprises the Community Engagement Evaluation and Data Coordination hub (CEED) awarded through this NOFO and separately funded UG3/UH3 research projects. The consortium will receive consultative services from the NIH Community Engagement Alliance Consultative Resource (CEACR) and join in the Science Collaborative for Health and Artificial Intelligence Reduction of Errors (SCHARE) platform. CEACR, which was established within NIH Community Engagement Alliance (CEAL), provides curated expert consultations tailored to the needs of each consultee by using a panel of community and academic experts in community engagement. In this initiative, CEACR will be available to provide up to three episodic, expert panel consultations for each project, as proposed and budgeted in the application. CEACR will also provide longitudinal consultative services (e.g. targeted consultations, office hours and webinars etc.) that are aligned with CEACR objectives and scope of work supported by NIDCR-co-funding to promote adherence to the principles of community-partnered research approaches and enhancing participant representation in CBPR projects. SCHARE, a cloud-based platform developed by a collaboration of several NIH Institutes, includes datasets relevant to population health science to enable researchers to link, analyze, and export data within a secure and collaborative workspace that is equipped with advanced computational tools. In this consortium, CEED will manage the ADAPT workspace provided by SCHARE, and each CBPR project will have its own SCHARE workspace. CEED will coordinate communications and various activities in support of CBPR projects and consortium functions in three domains: 1) Data Planning, Consultation, and Technical Assistance for Research Methodology and Analytics; 2) Community Engagement Evaluation; and 3) ADAPT Consortium Infrastructure and Operational Support. CEED will chair the ADAPT Steering Committee (SC) which will serve as the primary governing body of the consortium and will include at least two representatives from each research project (e.g. one from research institutions and the other from partner community organizations) and non-voting members such as NIDCR Program staff and representatives from SCHARE and CEACR. The ADAPT SC will meet quarterly and engage in a range of planning and evaluation activities for the consortium including data harmonization, assessing needs and priorities for community engagement capacity building, and reviewing and planning of manuscripts or other resources/products. In addition to the SC, an external expert committee may be convened by NIDCR. Applicants are encouraged to review the companion CBPR research project UG3/UH3 NOFO (PAR-27-015) to fully understand the consortium objectives and activities.

Scope of Work for the CEED hub:

CEED’s scope of work will be in the three domains, and activities may include but are not limited to:

1. Data Planning, Consultation, and Technical Assistance on Research Methodology and Analytics

2. Community Engagement Evaluation

3. ADAPT Consortium Infrastructure and Operational Support

Applications Not Responsive to the NOFO

Non-responsive applications will not be reviewed. Applicants are strongly encouraged to reach out to this NOFO's Scientific Contact to discuss whether their planned applications are responsive.

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

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

NIDCR intends to commit $1M in FY2027 to fund one (1) award.

Award Budget

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

Award Project Period

The maximum project period is 5 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 not 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

R&R or Modular 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:

Research Strategy:

The Research Strategy must include a description of the proposed CEED structure, as well as activities, strategies, timeline, platforms and available resources for accomplishing the three domains of coordination hub responsibilities. Applications should include a plan that demonstrates infrastructure and personnel readily available to accomplish CEED activities and processes, including relevant support services, data harmonization, management and analytic support, and real-time analytic capacity. In addition, the following information should be provided if not included in above descriptions:

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:

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

A community engagement evaluation study should be included to describe the human subjects research associated with collecting quantitative and qualitative data from CBPR investigators and community partners.

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

Any instructions provided here are in addition to the instructions 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.

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.

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.

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 appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Biohazards

When the proposed research includes Biohazards, evaluate whether specific materials or procedures that will be used are significantly hazardous to research personnel and/or the environment, and whether adequate protection is proposed.

Resubmissions

As applicable, evaluate the full application as now presented.

Renewals

As applicable, evaluate the progress made in the last funding period.

Revisions

As applicable, evaluate the appropriateness of the proposed expansion of the scope of the project.

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Authentication of Key Biological and/or Chemical Resources

For projects involving key biological and/or chemical resources, evaluate the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Evaluate whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by an appropriate Scientific Review Group convened by the Center for Scientific Review, in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Requests for reconsideration of initial peer review will not be accepted for applications submitted in response to this NOFO.