IR-ORI-26-003 Program Development and Evaluation Program.pdf

U.S. Department of Health and Human Services

Office of Research Integrity

Notice of Funding Opportunity Ensuring Research Integrity – Program Development and Evaluation Program (PDE)

Opportunity Number

IR-ORI-26-003

Application Due Date 7/27/2026 at 6:00 PM Eastern

Technical Assistance Webinar Date 7/13/2026 at 1:00 PM Eastern

Table of Contents

SUMMARY _________________________________________________________________ 1

A. ELIGIBILITY INFORMATION _______________________________________________ 1

1. Eligible Applicants ________________________________________________________ 1

B. PROGRAM DESCRIPTION _________________________________________________ 4

1. Expectations for Recipients ________________________________________________ 5

2. Federal Involvement in the Project ____________________________________________ 7

3. Eligibility criteria for project participants _______________________________________ 7

C. AWARD INFORMATION ___________________________________________________ 7

D. APPLICATION CONTENTS AND FORMAT ___________________________________ 8

1.Format of the Application ___________________________________________________ 8

2. Content ________________________________________________________________ 11

E. SUBMISSION REQUIREMENTS AND DATES ________________________________ 21

1. Obtaining an Application Package ___________________________________________ 21

2. Required Registrations ____________________________________________________ 21

3. Submission Instructions ___________________________________________________ 24

4. Other Submission Requirements _____________________________________________ 27

F. APPLICATION REVIEW INFORMATION ____________________________________ 28

1. Responsiveness Review ___________________________________________________ 29

2. Merit Review Criteria _____________________________________________________ 30

3. Merit Review and Selection Process __________________________________________ 32

4. Review of Risk Posed by Applicant __________________________________________ 33

G. AWARD NOTICES ________________________________________________________ 34

H. AWARD REQUIREMENTS AND ADMINISTRATION __________________________ 35

1. Administrative and National Policy Requirements ______________________________ 35

2. Program Specific Terms and Conditions ______________________________________ 37

3. Award Closeout __________________________________________________________ 37

4. Lobbying Prohibitions _____________________________________________________ 37

5. Non-Discrimination Requirements __________________________________________ 38

6. Smoke- and Tobacco-free Workplace _________________________________________ 38

7. Acknowledgement of Funding ______________________________________________ 38

8. HHS Rights to Materials and Data ___________________________________________ 39

9. Trafficking in Persons _____________________________________________________ 39

10. Efficient Spending _______________________________________________________ 39

11. Whistleblower Protection _________________________________________________ 39

12. Health Information Technology (IT) Interoperability ___________________________ 39

13. Certain telecommunications and video surveillance services or equipment ___________ 40

14. Human Subjects Protection ________________________________________________ 41

15. Research Integrity _______________________________________________________ 41

16. Reporting ______________________________________________________________ 41

I. CONTACTS ______________________________________________________________ 44

J. OTHER INFORMATION ____________________________________________________ 45

1. Application Checklist _____________________________________________________ 45

2. Acronyms ______________________________________________________________ 46

3. Glossary ________________________________________________________________ 47

4. Object Class Descriptions and Required Justifications ____________________________ 47

5. Considerations in Recipient Plans for Oversight of Federal Funds __________________ 53

6. Financial Assistance General Certifications and Representations ___________________ 54

BASIC INFORMATION

Opportunity Title Ensuring Research Integrity – Program Development and Evaluation Program (PDE)

Program Office Office of Research Integrity Application Submission and Format

Electronic application submitted via Grants.gov ONLY. Opportunity Number

IR-ORI-26-003

Award Type Grant

Application Deadline 7/27/2026 06:00 PM Eastern

Announcement Type Initial

Technical Assistance Webinar Date 7/13/2026 01:00 PM Eastern

Assistance Listing 93.085

Technical Assistance Webinar Details https://www.ori.hhs.gov

Eligible Applicants (see Section A.1 for full details) Executive Order 12372 does apply to this NOFO (see section E.3.D)

Estimated Total Funding Available $200,000

Estimated Period of Performance (months)

Estimated Number of Awards

Anticipated Award Date 09/30/2026

Anticipated Award Funding Range $75,000 to $100,000 per budget period

Anticipated Project Start Date 09/30/2026

QUESTIONS?

Additional contact information in Section G

SUMMARY

The Office of Research Integrity announces the anticipated availability of funds for Fiscal Year (FY) 2026 grants under the authority of 42 U.S.C. § 241 (Section 301 of the Public Health Service Act).

This notice solicits applications for projects to advance Administration priorities that strength scientific integrity and research integrity, adhering to principles of gold standard science – including transparency, data reproducibility, and scientific rigor. The Program Evaluation and Development Program was started by ORI in 2020. The purpose of the grant program is to support projects for the development and implementation of innovative approaches and tools to promote research integrity and prevent misconduct. This includes creating interventions based on empirical evidence, including findings from ORI-funded research, and tools to identify at-risk individuals or laboratories.

We seek applications for projects that create and/or evaluate interventions and assessment tools aimed at promoting research integrity. These efforts are intended to support the development of evidence-based practices, tools, and resources that enhance the credibility, transparency, and reliability of research across institutions and the broader research community. We anticipate two awards of between $75,000 and $100,000 in total costs

The Office of Research Integrity encourages applicants to review all program requirements, eligibility information, application format and submission information, evaluation criteria, and other information in this funding announcement to ensure that their application complies with all requirements and instructions.

The Office of the Assistant Secretary for Health (OASH) Grants and Acquisitions Management Division (GAM) will administer this competition.

We encourage you to review all program requirements, eligibility information, application format and submission instructions, and other content of this notice to ensure your application complies with all requirements.

A. ELIGIBILITY INFORMATION

1. Eligible Applicants You must meet all of the eligibility requirements in order for us to review your application.

a. Eligible Entities

Public or nonprofit universities, hospitals, laboratories, and other institutions are eligible to apply for an award under this announcement.

Faith-based organizations and community-based organizations are eligible to apply.

American Indian, Alaska Native, Native Hawaiian, and Pacific Islander organizations are eligible to apply.

Additional examples of eligible entities include:

• State governments

• County governments

• City or township governments

• Special district governments

• Independent school districts

• Public and State controlled institutions of higher education

• Native American tribal governments (Federally recognized)

• Public housing authorities/Indian housing authorities

• Native American tribal organizations (other than Federally recognized tribal governments)

• Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education

• Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education

• Private institutions of higher education

• For profit organizations other than small businesses

• Small businesses

b. PD/PI Eligibility

There is no restriction on an individual’s eligibility to be Project Director (PD)/Principal Investigator (PI) on an application. However, we will not make an award with a PD/PI who has an active government-wide exclusion, suspension, or debarment recorded in SAM.gov.

We expect that throughout the period of performance the PD/PI will be involved in, and have substantial knowledge about, all aspects of the project. Although your organization may recognize co-PD/PIs on team-managed projects, we recognize only a single PD/PI who will be responsible for the programmatic aspects of the project.

c. Other Considerations Submitting Multiple Applications

You may submit more than one application, but each application must be for a distinctly different project.

If you submit multiple applications for the same project, we will accept only the last application submitted a Grants.gov timestamp that is before the due date and time. We will disqualify all other versions of the application. See Section F.1.b for all disqualification factors.

Submitting an Application as a Group or Consortium

For any given project, we will only make an award to a single eligible entity. More than one entity may choose to work together on a project under this opportunity, but only one entity may submit the application. If awarded, that entity will be the award recipient and will be responsible for conducting the project.

The other entities may participate in the project, if awarded, and would be responsible to the recipient for their respective roles, typically as subrecipients.

Groups may form a consortium, partnership, or other legally recognized entity for the purpose of applying for this opportunity and carrying out any awarded project. The resulting entity must exist and be legally recognized when it applies and must have an active registration in SAM.gov.

We will conduct a risk assessment on the applying entity (Section F.4) prior to making any award.

Eligibility Documentation

We do not require you to submit documentation of your eligibility (e.g., proof of 501(c)(3) status as determined by the Internal Revenue Service or an authorizing tribal resolution) when you submit your application. It is important that your organization is correctly classified in your SAM registration (Section E.2.a).

During our review of your application, we might request additional documentation to support your eligibility. This request means only that your application is under review and not that you will receive an award.

More specific information on the type of documentation that we might request specific to this opportunity appears in Section E.4.b.

Application Disqualification

We will disqualify applications that fail to meet the eligibility, responsiveness, formatting, and submission requirements (Sections F.1.b) prior to conducting merit review. Disqualified applications will not undergo further review.

We will notify disqualified applicants at the end of the competition when we announce the award recipients.

2. Application Responsiveness Criteria

We will review your application to determine whether it meets the responsiveness criteria below.

If your application does not meet the responsiveness criteria, we will disqualify it from the competition; we will not review it beyond the initial screening.

The responsiveness criteria are as follows:

A. Specify which focus area(s) of research integrity the project addresses outlined in section B.1.

B. Describe how the proposed project advances Administration priorities by strengthening scientific integrity and research integrity, reduces administrative burden, and adheres to principles of gold standard science – including transparency, data reproducibility, and scientific rigor.

3. Cost Sharing or Matching

You are not required to provide cost sharing or matching in your proposed budget.

B. PROGRAM DESCRIPTION

The Office of the Assistant Secretary for Health (OASH), The Office of Research Integrity announces the anticipated availability of funds for Fiscal Year (FY) 2026 grants under the authority of 42 U.S.C. § 241 (Section 301 of the Public Health Service Act).

The primary focus of OASH is to lead Americans toward healthier lives by promoting health and well-being across the lifespan. Grants funded through this NOFO will advance Administration priorities through strengthening scientific integrity and research integrity, ensuring adherence to principles of gold standard science – including transparency, data reproducibility, and scientific rigor. Through this program, federal funding will be directed towards projects that support the development, implementation, and evaluation of innovative programs, tools, and educational interventions that promote research integrity and prevent research misconduct.

Funded projects are expected to convene interdisciplinary experts, incorporate robust methodologies, and engage researchers, administrators, and other stakeholders in creating practical solutions to identify, mitigate, and prevent misconduct. Projects should produce measurable outcomes, assess the effectiveness of interventions or tools, disseminate best practices, and provide resources that enhance the reliability, integrity, and overall excellence of the scientific enterprise.

Institutions applying for or receiving Public Health Service (PHS) support for biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or research training are required to “[f]oster a research environment that promotes research integrity and the responsible conduct of research, discourages research misconduct, and deals promptly with allegations or evidence of possible research misconduct.” 42 C.F.R.

§ 93.300(c). Core to ORI’s mission is the support of education and outreach activities that aid PHS-funded research institutions in their efforts “to teach the responsible conduct of research, promote research integrity, prevent research misconduct, and… respond effectively to allegations of research misconduct.” (65 Fed. Reg. 30,600, 30,601 (May 12, 2000)).

Background

The purpose of this initiative is to promote the development and implementation of innovative programs and tools for (a) fostering research integrity; (b) preventing or detecting research misconduct; (c) protecting whistleblowers, respondents, and other vulnerable researchers; (d) modernizing research integrity and reducing unnecessary administrative burden; and (e) enabling the proper handling of research misconduct allegations. For the purposes of this announcement, research integrity is defined as the use of honest and verifiable methods in proposing, performing, and evaluating research and reporting research results with particular attention to adherence to rules, regulations, guidelines, and commonly accepted professional codes or norms of the research community.

ORI has funded grant projects over the years with the goal of providing evidence based empirical research to aid researchers in creating programs and tools that promote research integrity and prevent research misconduct. With this development, there is a growing need for programs to evaluate the effectiveness of existing programs and a need to develop new, innovative programs or tools that meets today’s challenges. This funding opportunity specifically aims to support the development and evaluation of programs and research tools that promote research integrity and cultivate norms, values, and cultures that promote the appropriate practice of science, prevent and detect research misconduct, protect whistleblowers, respondents and other vulnerable populations, and enable the proper handling of research misconduct allegations.

ORI encourages proposed projects to include collaboration or consultation with institutional research misconduct officials, professional organizations, and/or others who have direct experience with 42 C.F.R. Part 93, including institutional attorneys experienced with institutional research misconduct proceedings. ORI also encourages proposed projects take place in research settings and/or include individuals actively engaged in or training for careers in research.

1. Expectations for Recipients

Required Alignment with OASH Mission and Agency Priorities The recipients of this award must implement any funds awarded under this NOFO to effectuate program goals and agency priorities in accordance with the Priorities of the Office of the Assistant Secretary for Health (available online at: https://health.gov/priorities), and when authorized by law according to the Office of Research Integrity statute, regulations, legislative mandates, and additional program guidance. Funded activities must advance and support OASH’s mission to improve the health and well-being of Americans.

In addition, the recipient is required to administer any project that is awarded under this NOFO in accordance with the following objectives in the Program Development and Evaluation Program that are authorized to advance them:

A. Development of Educational Resources

• Creation of novel online training modules incorporating interactive scenarios to teach principles of research integrity.

• Development of engaging, in-person or classroom educational programs that promote the responsible conduct of research, prevent research misconduct, or encourages the reporting of suspected research misconduct.

B. Creation of Risk Assessment Tools

• Design, develop, and test assessment tools for principal investigators, department chairs, or other research administrators to evaluate the risk for individuals, laboratories, or research programs to engage in misconduct or detrimental research practices.

https://health.gov/priorities

• Design, develop, and test assessment tool that examines institutional research culture or practices that impact or lead to potential research misconduct.

• Design, develop, and test AI-enabled tools that leverage machine learning or natural language processing to identify early indicators of research misconduct or risky research practices at the individual, team, or institutional level, while ensuring ethical use and transparency of AI systems

• Design, test/pilot technology-enabled solutions that demonstrably reduces staff hours required for routine integrity tasks without compromising oversight. These findings should be disseminated, enabling broader adoption of streamlined practices.

C. Implementation and Testing of Intervention Programs

• Pilot interventions designed to improve data management and record-keeping in labs, with pre- and post-assessment of research integrity.

• Implementation of mentorship and leadership training programs in research settings to foster a culture of ethical and responsible research.

The recipients must demonstrate ongoing compliance with these priorities, in all programs that are authorized to advance them, through program design, implementation, reporting, and evaluation. Failure to meaningfully align funded activities with the applicable requirements may result in corrective action, additional reporting requirements, or other actions consistent with federal grant regulations found at 2 C.F.R. Part 200 and the terms and conditions of this award (including termination pursuant to 2 C.F.R. 200.340(a)(4) for no longer effectuating program goals or agency priorities).

Goals and Objectives for this Opportunity

• Design and test interventions aimed at enhancing research integrity.

• Develop assessments to identify the risk of misconduct or detrimental research practices.

• Evaluate the effectiveness of these programs or tools in various research environments.

Overall project objectives should be designed to advance Administration priorities by strengthening scientific integrity and research integrity and upholding the gold standard of science, including transparency, data reproducibility, and scientific rigor. Projects should aim to generate actionable, evidence-based tools, interventions, or approaches that can be applied to improve research practices, institutional policies, or systems that support research integrity.

The intended effect will be measured by the publication of relevant research findings and/ or the development of novel practical approaches, resources, training materials, or tools that can be used by researchers, research administrators, and research institutions to promote research integrity.

Expected Performance Goals and Outcomes for Funded Projects Award recipients under this announcement should meet the below expectations in the execution of their funded project:

A. Design and test interventions aimed at enhancing research integrity.

We expect that the recipient will conduct research focused on developing and implementing innovative programs and tools to promote research integrity and prevent misconduct. We expect the recipients will consider efforts to reduce administrative burden and modernize research integrity.

B. Demonstrate the impact and/or effectiveness of the policies and training:

We expect the recipient to evaluate existing policies and training materials to assess their impact. We expect that recipients will revise the materials as necessary to address issues, identified during the evaluation process, that may prevent effective implementation by the relevant stakeholders.

C. Creation of Risk Assessment Tools:

We expect the recipient to design, develop, and test assessment tools for principal investigators, department chairs, or other research administrators to evaluate the risk for individuals, laboratories, or research programs to engage in misconduct or detrimental research practices as well as design, test/pilot technology-enabled solutions that demonstrably reduces staff hours required for routine integrity tasks without compromising oversight. These findings should be disseminated, enabling broader adoption of streamlined practices.

2. Federal Involvement in the Project If you receive an award, we will encourage you to seek the advice and opinion of federal staff when problems arise. However, you would be responsible for making sound programmatic and administrative judgments. The responsibility for operating decisions will be yours and does not shift to HHS, OASH, or The Office of Research Integrity.

Under a grant, the program office’s involvement may include routine monitoring and technical assistance such as monthly conference calls, occasional site visits, ongoing review of plans and progress, participation in relevant meetings, provision of training and technical assistance.

3. Eligibility criteria for project participants You must not restrict participation in the project on the basis of race, color, national origin, religion, sex, disability, age, or another protected characteristic (See Section H.5).

C. AWARD INFORMATION

Budget period(s)

We expect to fund awards in 12-month budget periods for a total period of performance up to 12 month. However, we may approve shorter periods of performance. Budget periods may vary from the estimated 12 months because of the timing of award issuance or other administrative factors.

For multi-year projects, recipients must submit a non-competing continuation (NCC) application for each budget period after the first. We will provide guidance generally 3 months prior to the end of the active budget period. Continuation funding is contingent upon the availability of funds, satisfactory progress of the project, appropriate stewardship of federal funds, and the best interests of the government. Funding for all approved budget periods after the first is generally the same as the initial award amount and may be subject to any offset with funds unused in a previous budget period.

D. APPLICATION CONTENTS AND FORMAT

1.Format of the Application You must prepare your application using the forms and information described in this NOFO.

The official online application package on Grants.gov contains all necessary forms and guidance for preparing an application. This package includes but is not limited to:

• Full Text of the NOFO

• Standard forms (required) and their instructions o SF-424 Application for Federal Assistance o SF-424A Budget Information for Non-Construction Programs o SF-LLL Disclosure of Lobbying Activities o Project Abstract Summary

• Sample templates, if available.

In addition to the four standard forms in the application package, your application will consist of 3 sections of materials you prepare:

1. Project Narrative

2. Appendices to the Project Narrative

3. Budget Package.

We strongly encourage you to read all instructions for the application format and content to avoid disqualification of your application. An application checklist is available in Section J.1.

a. Project Narrative – Formatting Following the formatting instructions below will help ensure that your application is readable for review process. Acceptable electronic file formats are in Section E.3.a.

Names of Individuals

We encourage you to use individuals’ full names (first, middle, last) on the standard forms and any other documents such as résumés/curricula vitae/biographical sketches to distinguish them for verification in the SAM exclusion records. Delays may result in award processing if full names are not provided.

You should avoid submitting personally identifiable information such as personal contact information (e.g., home address and telephone number) on résumés/curricula vitae/biographical sketches. Do not submit social security numbers.

If you receive an award, only one Project Director/Principal Investigator (PD/PI) will be named on the award documents. (Section A.1.b) Avoid using a placeholder or honorary PD/PI. If you have not hired an individual to be the PD/PI, you should name an interim PD/PI, and your application should clearly identify that person as such.

We typically expect the PD/PI to be named on the SF-424 in box 8.f. Avoid naming grant writers in box 8.f unless they have the expertise to respond to technical questions about the proposed project in a timely manner.

Identify other personnel who are essential or key to the execution of the proposed project clearly in your project narrative.

If you receive an award, a request for a change in PD/PI or key personnel under any circumstance requires prior approval of the grants management officer before becoming effective. We may disallow any costs incurred as a result of that change prior to our approval. See Section H.1.c.

Page Formatting

If you submit documents that do not conform to the following instructions, GAM will disqualify your application during the review process (SectionF.1.b).

Use an easily readable typeface, such as Times New Roman or Arial.

Use a 12-point font.

Use an 8.5” X 11” page size. Any other size page (e.g., A4, legal) will disqualify your application.

Use 1” margins on all sides (top, bottom, left and right).

You must double-space the Project Narrative pages or we will disqualify your application. You may single-space tables or use alternate fonts, but you must ensure the tables are easy to read.

Do not number pages or include a table of contents. Our grants management system will generate page numbers once your application is complete.

You must submit your application in the English language and in terms of U.S. dollars (2 C.F.R. § 200.111(a)).

Page Limits https://www.ecfr.gov/current/title-2/subtitle-A/chapter-II/part-200/subpart-B/section-200.111#p-200.111(a) https://www.ecfr.gov/current/title-2/subtitle-A/chapter-II/part-200/subpart-B/section-200.111#p-200.111(a)

Your project narrative and appendices must adhere to these page limits.

The page limits do not include the budget package (Section D.2.c)

The page limits do not include the required forms (SF-424, SF-424A, SF-LLL, and the Project Abstract Summary)

If your application exceeds the specified page limits when printed on 8.5” X 11” page, we will not review your application further.

We encourage you to print out your application before submitting it to ensure that it is within the page limits and is easy to read. Do not reduce pages to fit multiple pages on a single sheet to avoid exceeding the page limitation.

Do not hyperlink to documents or sites outside of your application to augment your application. Reviewers will not be permitted to follow links to external content during their assessment of your application. The one exception to this is a link to your internal controls as part of your budget package (Section D.2.c.3).

Page Limit

Project Narrative 25

Project Narrative plus Appendices 75

Labeling Proprietary Information

Proprietary information includes patentable ideas, trade secrets, privileged or confidential commercial or financial information, the disclosure of which may harm the applicant.

You should include proprietary information in your application only to the extent that it is essential to the reviewers’ understanding of the project. Proprietary information should not appear in your Project Abstract Summary.

If your application contains proprietary information, you should clearly label the top of the first page of the project narrative. For example, Contains proprietary or confidential information that [Your Organization Name] requests not be released to persons outside the government, except for purposes of review and evaluation.

Awarded applications are subject to release under the Freedom of Information Act (FOIA) with redactions as the FOIA statute permits.

b. Appendices to the Project Narrative – Formatting Your appendices should include any specific items outlined in Section D.2.b. Your documents should be easy to read.

You should use the same formatting specified for the Project Narrative. However, documents such as résumés/curricula vitae/biographical sketches, organizational charts, tables, Memoranda of Agreement (MOAs) or Letters of Commitment (LOCs) may have formatting common to those documents, so long as the pages are easy to read. For example, resumes, MOAs and LOCs may be single-spaced.

You must upload all of your appendices as a single, consolidated file in the Attachments section of your Grants.gov application. You must use an acceptable file format (Section E.3.a). We strongly encourage you to convert your file(s) to PDF format before uploading and review them to ensure accurate conversion.

Your Project Narrative plus the Appendices may not exceed the total number of pages for the application (Section D.1.a).

c. Budget Package - Formatting The budget narrative should use the formatting required of the project narrative for the explanatory text. Budget tables may be single-spaced but should be laid out in an easily readable format and within the printable margins of an 8.5” x 11” page. You must use an acceptable file format (Section E.3.a). We do not accept Excel or other similar spreadsheet formats.

The application page limit does not include the SF-424A or the budget narrative (including budget tables).

We recommend you present budget amounts and computations in a columnar format: first column, object class categories; second column, federal funds requested; third column, non-federal resources; and last column, total budget.

Object Class Federal Funds Requested

Non-Federal Resources Total Budget

Personnel $100,000 $25,000 $125,000

2. Content

a. Project Narrative - Content

The Project Narrative is the most important part of your application. We will use it as the primary basis to determine whether your project merits an award. The project narrative should provide a clear and concise description of your project. We recommend that your project narrative include the following components with the requested information. Labeling the sections accordingly will help the reviewers find information quickly.

Successful proposals should include the following:

1.Project Description You should:

• Describe the proposed project and how it will address the Expectations of this announcement. You should:

o Identify the focus area(s) being addressed by the proposed project.

o Explain the rationale for the proposed project.

o Describe the scope and breadth of the issue and critical barrier(s) to progress on the selected research integrity topic/focus area. Describe potential impacts on affected groups or populations (e.g., researchers, research administrators, Research Integrity Officers).

o Describe in detail how the project will potentially affect the populations served, specific subgroups within those populations, and other interested stakeholders as identified.

State concisely the goals of the proposed project and summarize the expected outcome(s), including the impact that the results of the proposed project will exert on the selected topic/focus area (e.g., solve a specific problem, provision of a new resource).

o Describe the overall strategy, activities (e.g., research, material development, implementation, and evaluation efforts), and methods that you will use to accomplish the goals of the project. Include how the data will be collected, analyzed, and interpreted.

o Describe why the specific activities were selected. Explain how the proposed activities will help to achieve the overall project goals and outcomes. Indicate why the overall approach as described is appropriate.

Present a clear connection between selected research integrity topic/focus area and the proposed activities. Explain how the proposed activities contribute to strengthening research practices that are transparent, reproducible, and methodologically sound.

o Describe any novel approaches or methods you intend to employ to achieve the project goals. If utilizing approaches or methods that do not diverge substantially from existing practices, describe the novelty in the application of those methods to the topic. Reference, where applicable, existing approaches for the purpose of contrasting the novel approaches or methods you propose.

o List succinctly the specific and time-framed objectives of the proposed project as they relate to the project goals.

o Provide detailed descriptions of specific materials proposed for development or modification.

o List succinctly the anticipated, specific, and measurable outcomes of the proposed project as they relate to the project goals.

o Discuss potential problems, alternative strategies, and benchmarks for success with respect to project goals. Note any major barriers you expect to encounter as well as how your project will be able to overcome those barriers.

• Describe how technology will be incorporated to advance programs and services, provide training and/or technical assistance, and disseminate information and products. Where applicable, describe how technologies (including artificial intelligence) will be used in ways that support research integrity, transparency, and responsible and ethical research practices.

• Describe the role and makeup of potential individuals or entities intended to be involved in completing specific tasks. Identify the level of effort each is anticipated to provide in completing programmatic activities. Describe how each will engage in the project.

• If the project is in the early stages of development, describe any strategies that you will use to establish feasibility, and address the management of any high-risk aspects of the proposed work.

• If applicable, describe and justify the proposed involvement of human subjects (45 C.F.R. Part 46) in the proposed work by describing the following:

o Characteristics of the subject population, including their anticipated number, age range, etc.

o The sampling plan and justification for proposed plan as well as the recruitment and retention strategies and the criteria for inclusion or exclusion of any subpopulation.

o Data that will be collected from human subjects for the project(s) described in the application.

o Who will have access to individually identifiable private information about human subjects.

o How the records and/or data will be collected, managed, and protected as well as whether material or data that include individually identifiable private information will be collected specifically for the proposed research project.

o Plans for the recruitment of subjects (where appropriate) and the process for obtaining informed consent. If the proposed studies will include children, describe the process for meeting requirements for parental permission and child assent.

o Identify the Institutional Review Board (IRB) you will use during the study, including the Federal-wide Assurance number and IRB registration number. Include a proposed timeline for acquiring the approval of the IRB for the proposed activities. Any award based on your application does not supersede the need for IRB review, approval, or determination of an exemption. Do not include in your application the package prepared for your IRB review.

2. Outcomes You should:

• Keep the focus of this section on describing what outcome(s) will be produced by the project. In many cases, it is very appropriate for a project to have only ONE outcome that it is trying to achieve through the intervention reflected in the project’s design. You should use the Evaluation section noted below to describe how you will assess the project outcome(s).

• Specify the tangible/measurable outcome(s) that will result from your project.

HHS/OASH will not fund any project that does not include measurable outcomes. A tangible/measurable outcome is an observable end-result that describes how an activity, event, resource, or approach helps the intended audience; it is large enough to be noticed. It demonstrates the “impact” of the activity, event, resource, or approach. For example, a tangible/measurable outcome may be a change in knowledge, skill, attitude, awareness, or behavior about the subject matter because of the project. This may include new knowledge or a tangible/measurable increase in institutional awareness. A tangible/measurable outcome is not a measurable/quantifiable “output,” such as the number of materials produced, the number of stakeholders using these materials, or the number of lectures/training sessions provided. These numbers in combination with other measures may contribute to the overall evaluation of the activity or project.

• In addition to any discussion in the Project Description, describe how you envision the project will benefit the field at large and advance Administration priorities by strengthening scientific integrity and research integrity, and adhere to principles of gold standard science – including transparency, data reproducibility, and scientific rigor.

• Describe how the proposed outcomes will contribute to improving research practices, institutional policies, or systems, and how these outcomes may be applied or adapted beyond the immediate project setting.

• Describe how the proposed outcomes will reduce administrative burden and modernize research integrity.

• In addition to any discussion in the Dissemination section below, describe how you will report on the outcomes of the project.

3. Evaluation You should:

• Describe the quantitative and/or qualitative tools and techniques that you will employ to assess and evaluate the ease with which the materials developed as part of this project can be directly used by the relevant stakeholder(s), their effectiveness in facilitating improved practices, and their impact on research integrity and/or compliance with 42 C.F.R. Part 93.

• Describe the quantitative and/or qualitative tools and techniques that you will employ to assess and evaluate outcome(s) and how you will identify and document the “lessons learned.”

• Describe how you will collect and report evaluation data. Describe how you will ensure the validity and reliability of these data. Evaluation approaches should reflect principles of scientific rigor and support transparency and reproducibility in study design, measurement, and analysis. Applicants should describe how evaluation methods, analytic approaches, and findings will be documented with sufficient detail to support transparency, verification, and, where appropriate, replication or adaptation by other researchers or institutions.

4. Dissemination You should:

• Describe a comprehensive, time-framed dissemination plan to communicate key findings to stakeholders, the public, and/or others who might be interested in the results of the proposed project. HHS/OASH expects that nationwide dissemination of products and knowledge will be facilitated.

• Describe the method you will use to disseminate the project’s results and findings in a timely manner and in easily understandable formats to the PHS-funded research community, the public, and/or others who might be interested in using the results of the project to inform practice, service delivery, program development, and/or policymaking, in a manner that promotes transparency, accessibility, and broader use of materials and knowledge generated through the project.

5. Project Management You should:

• Identify the Principal Investigator, collaborators, and other researchers, including subrecipients, consultants, or contractors, proposed for the project. Include a clear delineation of the roles and responsibilities of each, their relevant expertise, and how they will contribute to achieving the project goals and outcomes.

• Identify the individual who will serve as the Principal Investigator/Project Director and that individual’s qualifications. HHS/OASH expects that, throughout the award period, the Principal Investigator/Project Director will be involved in, and have substantial knowledge about, all aspects of the project.

• Specify who would have day-to-day responsibility for key tasks such as:

leadership of project; monitoring the project’s on-going progress; preparation of reports; and communications with collaborators and HHS/OASH.

• Describe the approach that you will use to monitor and track progress on the project’s tasks and objectives.

6. Environment and Organizational Capability You should:

• Describe your organization’s capability to successfully implement the proposed project.

• Describe the research/scientific environment in which the work will be done and how it will contribute to the probability of success. This should include a description of the institutional support, equipment, and other physical resources available to the investigators.

• Describe how your organization (or the division of a larger organization which will have responsibility for this project) is organized, the nature and scope of its work, and the capabilities it possesses.

• Describe the organizational investment in the success of the investigator and proposed project. Examples of such investment include provision of resources such as office space sufficient for project needs, logistical support such as administrative management and oversight, and financial support such as protected time for research with salary support.

• Describe the activities the organization undertakes to “[f]oster a research environment that promotes research integrity and the responsible conduct of research, discourages research misconduct, and deals promptly with allegations or evidence of possible research misconduct” (42 C.F.R. § 93.300(c)).

• Describe the way in which the proposed project will contribute to and enhance the recipient’s (institution’s) activities related to research integrity and/or compliance with 42 C.F.R. part 93.

• Describe the capabilities of your organization not included elsewhere in the program narrative, such as any current or previous relevant experience and/or the record of the project team in preparing cogent and useful reports, publications, and other products. If appropriate, include an organization chart in your Appendices showing the relationship of the project to the current organization.

• Include information about any contractual and/or supportive staff/organization(s) that will have a secondary role(s) in implementing the project and achieving project goals. Describe collaborations in the application and accompanying letters of commitment.

b. Appendices to the Project Narrative – Content All items described in this section will count toward the total page limit of your application. You must submit them as a single electronic file uploaded to the Attachments section of your Grants.gov application.

Samples and optional forms/templates for some of these items are located under the Related Documents tab for this NOFO on Grants.gov.

Your application should include the following appendices:

Work Plan

Include a detailed work plan that is consistent with your project narrative and budget narrative. Your work plan should reflect the estimated one-year period of performance.

A work plan should include a statement of the project’s overall goal(s), key SMART objectives (specific, measurable, achievable, relevant, and time-bound), milestone activities, and anticipated measurable outcome(s)/impact(s). Your objectives should align with the expectations of this opportunity, and the major tasks, action steps, or activities to achieve the goal and outcome(s). For each major task, action step, or activity, the work plan should identify the person(s) responsible, the timeline for completing activities (including start- and end-dates), and measures of success.

A suggested Work Plan Template is included under Related Documents in Grants.gov (the instruction pages will not count toward your page limit) or you may create your own work plan. Regardless of the option you choose, the work plan you submit must address all of the content requested.

Curricula Vitae, Résumés, Biographical sketches for Key Project Personnel

Submit curricula vitae, résumés, or biographical sketches (biosketches) for all key project personnel including the Project Director/Principal Investigator (PD/PI).

Key personnel includes those individuals who will oversee the technical, professional, managerial, and support functions and/or assume responsibility for assuring the validity and quality of the project. Do not include curricula vitae, résumés, or biosketches for individuals who provide routine administrative support to the project as part of their broader support of the organization. For key personnel positions that are currently vacant, please provide a copy of the position description or a list of duties for the position.

You should use full names (first, middle, last) on these documents to distinguish them for verification in the System for Award Management exclusion records. Use the formatting common to those documents. (See https://grants.nih.gov/grants/forms/biosketch.htm for templates and sample biographical sketches.)

References Cited

Include your references cited in your project narrative. You may use any standard format that you choose as long as it clearly leads the reader to your source of the information or data.

c. Budget Package - Content A complete budget package consists of the following required components:

• SF-424A “Budget Information Non-Construction Programs”

• Budget narrative with detailed justification by cost category/object class, and

• Plan for oversight of federal funds.

You should include supporting documentation for your budget (e.g., a copy of your approved indirect cost rate) as part of the budget package, not as part of your appendices to the project narrative. There is no page limit for the budget package contents. If you are recommended for an award, you may be asked to provide additional information about your budget package.

Throughout your budget package, “Federal resources” refers only to the funds you are requesting from the program office for this project. “Non-federal resources” are all other non-HHS/OASH federal and non-federal resources. Funds from federal grant programs typically are not eligible as cost share for other federal grants. It is your responsibility to confirm with other federal agencies whether funds you receive from them are eligible resources to apply to your proposed project.

1. Standard Form SF-424A

You must enter the project budget according to the directions provided with the standard form.

You must provide costs by object class category for the first 12 months (i.e., first budget period) of the proposed project using Section B, box 6 of SF-424A. If the estimated period of performance is 12 months or less, this will be your total budget request for the entire project.

"Federal resources" refers only to the funds for which you are applying under this NOFO. "Non-federal resources" are all other resources (federal and non-federal).

https://grants.nih.gov/grants/forms/biosketch.htm

Do not include costs beyond the first budget period in the object class budget in box 6 of SF- 424A or box 18 of SF-424. The amounts entered in these sections should only reflect the first budget period.

If there is a discrepancy between your SF-424A and budget narrative and justification, we will rely on the narrative and justification to determine the final amounts.

2. Budget Narrative with Justification

Your budget narrative must include a detailed line-item budget and must include calculations for all costs and activities by the “object class categories” identified on SF-424A. You must provide a detailed justification for the costs by object class. The object class budget organizes your proposed costs into a set of defined categories.

Use the guidelines in Section J.4 for preparing the detailed object class budget.

Budget Periods

Your budget narrative must describe the first budget period in detail. For each proposed cost for the first budget period, provide a justification that includes explanatory text and line-item detail.

You should describe how you derived your categorical costs. Your justification should show the necessity and reasonableness of the proposed costs for the project.

For subsequent budget years in an anticipated multi-year period of…