PKG00291216.pdf

U.S. Department of Health and Human Services

Office of Research Integrity

Notice of Funding Opportunity Ensuring Research Integrity - Research on Research Integrity (RRI)

Opportunity Number

IR-ORI-25-001

Application Due Date 07/30/2025 at 6:00 PM Eastern

Technical Assistance Webinar Date 07/15/2025 at 1:00 PM Eastern

BASIC INFORMATION

Opportunity Title Ensuring Research Integrity - Research on Research Integrity (RRI)

Program Office Office of Research Integrity

Application Submission and Format Electronic application submitted via Grants.gov ONLY.

Opportunity Number

IR-ORI-25-001

Award Type G (Grant)

Application Deadline 07/30/2025 06:00 PM Eastern

Announcement Type Initial

Technical Assistance Webinar Date 07/15/2025 at 01:00 PM Eastern

Assistance Listing 93.085

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

Eligible Applicants (see Section A.1 for full details)

Executive Order 12372 does not apply to this NOFO (see section E.3.D)

Estimated Total Funding Available $500,000

Estimated Period of Performance (months)

Estimated Number of Awards

Anticipated Award Date

09/15/2025 Anticipated Award Funding Range $150,000 to $250,000 per budget period

Anticipated Project Start Date 09/30/2025

QUESTIONS?

OASH_Grants@hhs.gov

Additional contact information in Section G mailto:OASH_Grants@hhs.gov

SUMMARY

The Office of Research Integrity announces the opportunity to apply for Fiscal Year (FY) 2025 awards under the authority of 42 U.S.C. § 241 (Section 301 of the Public Health Service Act).

The Office of Research Integrity (ORI) seeks to promote the integrity and reliability of Public Health Service (PHS)-funded biomedical and behavioral research through the support of projects aimed at understanding the factors that affect research integrity. We seek applications to conduct empirical research on societal, organizational, behavioral, group, and individual factors that affect integrity in research, focusing on the identification of the root causes of research misconduct and driving factors for research integrity in compliance with 42 C.F.R. Part 93. The projects funded under this opportunity must aim to research any combination of the following focus areas: 1) Explore the financial, cultural, institutional, and individual factors; 2) Assess the effectiveness of policies and training; 3) Investigate reporting and response mechanisms.

We expect to fund awards in 12-month budget periods for a total period of performance up to 24 months. Recipients must submit a non-competing continuation (NCC) application for each budget period after the first. 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 subject to any offset with funds unused in the previous budget period. We anticipate two awards of between $150,000 and $250,000 in total costs (direct plus indirect) for year 1 and $375,000 for year 2, for a total project period not to exceed two years (two 12-month project periods and budget periods).

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.

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

a. Eligible Entities

Universities, hospitals, laboratories, other public or private institutions, and individuals 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

• Individuals

• 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

1. Eligible Applicants

A. ELIGIBILITY INFORMATION

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.

Direct and Indirect Costs

Direct and indirect costs proposed and, if successful, must meet the cost requirements of 45 C.F.R. part 75 Subpart E—Cost Principles (“Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards” or UAR). These requirements apply to you and any subrecipients. You should thoroughly review these regulations before developing your proposed budget. We have provided an excerpt of the more commonly used cost categories in Section J; however, you should review the full Cost Principles.

Restrictions on Costs

Restrictions on costs appear in Section D.2.c.2. Such costs are unallowable for awards made under this NOFO.

We may not disqualify your application from merit review if it contains a request for restricted costs. In some cases where those costs are not essential to the success of the project, we may negotiate with you for modifications to the project implementation or budget prior to making an award. However, if your application relies substantially on restricted costs, we may decide to not fund your application because any negotiated changes would fundamentally change the project as proposed.

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).

https://www.ecfr.gov/current/title-45/part-75/subpart-E https://www.ecfr.gov/current/title-45/part-75/subpart-E

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 in Section F.1. 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.

3. Cost Sharing or Matching You are not required to provide cost sharing or matching in your proposed budget.

If you voluntarily include cost sharing in your application, you must include in your budget narrative a non-federal sources justification as described in Section J.4 or we will disqualify your application (Section F.1.b). Voluntary cost sharing is not expected for research applications.

During merit review (Section F.3), reviewers will only consider cost sharing in the overall assessment of the adequacy of the total proposed budget (i.e., Federal share plus cost share) to support your proposed project. You will not receive any preference, priority, or special consideration for voluntarily including cost sharing or matching in your proposed budget.

If you propose any voluntary cost sharing or matching in your budget package, we will include that voluntary cost sharing or matching as a commitment on the notice of award at the level you proposed (Section D.2.c). Any later change in the cost sharing or matching commitment will require prior approval of the grants management officer.

Cost- sharing or matching may include any in-kind contributions necessary for the implementation of the proposed project (45 C.F.R. § 75.306).

https://www.ecfr.gov/current/title-45/section-75.306

B. PROGRAM DESCRIPTION

The Office of Research Integrity anticipates making award(s) for Fiscal Year (FY) 2025 under the authority of 42 U.S.C. § 241 (Section 301 of the Public Health Service Act).

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)).

Our Research on Research Integrity Grant Program contributes to this mission by supporting projects that foster empirical research on societal, organizational, behavioral, group, and individual factors that affect, both positively and negatively, integrity in research with a focus on the identification of the root causes of research misconduct and driving factors for research integrity in compliance with 42 C.F.R. Part 93.

1. Purpose of this Opportunity

a. Background

The purpose of this initiative is to provide assistance to recipients to promote the integrity and reliability of PHS-funded research through empirical research on societal, organizational, behavioral, group, and individual factors that affect, both positively and negatively, integrity in research with a focus on the identification of the root causes of research misconduct and driving factors for research integrity in compliance with 42 C.F.R Part 93.

We have selected the following three focus areas for Fiscal Year 2025:

1) Explore the financial, cultural, institutional, and individual factors

2) Assess the effectiveness of policies and training

3) Investigate reporting and response mechanisms

The project should contain feasible ideas with tangible/measurable outcomes supported by an appropriate budget request and work plan to meet the Expectations of this announcement and project goals. The proposed project period must not exceed two years (i.e., two 12-month budget periods). You may propose a shorter project period of one year if the project goals and outcomes are achievable within that period. Funding after the first budget period will require submission of a non-competing continuation application for a second budget period for any project period exceeding 12 months. Funding for the second budget period will be contingent upon availability of funds, satisfactory progress of the project (including recipient progress towards meeting stated project milestones and goals, timely submission of required reports, and compliance with all grant terms and conditions), appropriate stewardship of federal funds, and the best interests of the government. This funding opportunity does not support projects with the primary purpose of holding meetings, conferences, or workshops. See opportunity number IR-ORI-25-002 for those purposes. We encourage proposed projects to include collaboration or consultation with individuals and/or organizations with experience in handling issues or providing guidance related to research integrity, research climate/culture, the responsible conduct of research, and/or compliance with 42 C.F.R Part 93. This may include, but is not limited to, institutional research integrity officers; professional organizations; others who have direct experience with 42 C.F.R. Part 93; and institutional attorneys experienced with these matters. We also encourage proposed projects to include individuals actively engaged in, or training for, careers in research, and whenever practical, to take place in research settings.

b. Opportunity Details

Priorities for this Opportunity

The projects funded under this opportunity must aim to research any combination of the focus areas below:

1) Explore the financial, cultural, institutional, and individual factors:

• Studying the impact of institutional culture on research practices and misconduct

• Studying the day-to-day policies and procedures, such as record keeping, experimental design, bias reducing techniques, and data sharing in research institutions and their impact on research misconduct

• Examining the influence of team dynamics and leadership styles in fostering research integrity

• Examining the influence of team dynamics, mentor/mentee relationship, and leadership styles that lead to detrimental research practices and/or research misconduct

• Examining how time constraints and funding needs influence research misconduct

2) Assess the effectiveness of policies and training:

• Conducting randomized controlled trials to test the impact of training programs on researchers' understanding and application of ethical standards as well as social responsibility

• Analyzing longitudinal data to evaluate the long-term effects of policy changes on research integrity

3) Investigate reporting and response mechanisms

• Studying the psychological barriers to reporting misconduct and develop strategies to overcome them

• Researching the effectiveness of different institutional responses to allegations of misconduct and their impact on deterring future issues.

Goals and Objectives for this Opportunity The goal of this initiative is to provide assistance to recipients to promote the integrity and reliability of PHS-funded research through empirical research on societal, organizational, behavioral, group, and individual factors that affect, both positively and negatively, integrity in research with a focus on the identification of the root causes of research misconduct and driving factors for research integrity in compliance with 42 C.F.R Part 93. The intended effect will be measured by the publication of relevant research findings and/or the development of novel practical approaches, resources, or training materials that can be used by researchers, research administrators, and research institutions to identify the root causes of research misconduct and driving factors for research integrity.

Expected Performance Goals and Outcomes for Funded Projects

Award recipients under this announcement must aim to research any combination of the focus areas below:

A. Conduct research related to ensuring research integrity

We expect that the recipient will conduct empirical research focused on identifying the root cause of societal, organizational, behavioral, group, and individual factors that affect, both positively and negatively, integrity in research.

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

We expect the recipient to implement and evaluate the materials developed above to determine the ease with which they can be directly used by the relevant stakeholder(s) (i.e., individual researcher/research group, research administrator, or research institution), their effectiveness in facilitating improved practices, and their impact on research integrity and/or compliance with 42 C.F.R. Part 93. 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. Investigate reporting and response mechanisms:

We anticipate that the funded recipient will engage in a comprehensive examination of the psychological factors that may prevent individuals from reporting instances of research misconduct.

This includes identifying internal and external barriers—such as fear of retaliation, stigma, or lack of confidence in reporting mechanisms—and exploring ways to mitigate or eliminate these obstacles.

In addition, we expect the recipient to investigate and evaluate a range of institutional responses to allegations of misconduct. This component of the project should assess how different approaches— such as transparency, disciplinary actions, support for whistleblowers, or restorative practices— affect not only the resolution of individual cases but also the broader goal of preventing similar incidents in the future by promoting a culture of accountability and integrity.

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.

C. AWARD INFORMATION

We intend to make funds available for competing G (Grant) awards.

Budget period(s)

We expect to fund awards in 12-month budget periods for a total period of performance up to 24 month(s). 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.

Transition to Post-Award Sustainability of Successful Projects For this opportunity, we anticipate offering a competitive additional budget period for the purpose of funding selected recipients in transitioning successful projects to sustainability once the period of performance ends. Funding for this additional budget period is not guaranteed nor do we expect it to be at the same level of any previous budget periods. Therefore, this potential for an additional year is not reflected in the estimated performance period.

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; and

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.

Format of the Application

D. APPLICATION CONTENTS AND FORMAT

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.

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 (45 C.F.R. § 75.111(a)).

Page Limits

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 https://www.ecfr.gov/current/title-45/section-75.111 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 30

Project Narrative plus Appendices

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 applications will contain 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.

o 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.

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.

• 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. 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.

3. 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.

4. 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.

5. 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 cover all years of the estimated 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.

Documentation of Level of Commitment

Submit documentation to support the level of commitment of any partners or collaborators you have described as having essential or important roles in the project’s success.

Documentation of commitment is typically a Memorandum of Agreement (MOA) or a Letter of Commitment (LOC). A signed MOA generally demonstrates a higher level of commitment between the partners or collaborators. LOCs are typically a precursor to an MOA that the partners or collaborators sign before a project begins.

Data Sharing Agreements (DSAs) are a type of documentation of commitment that establish the parameters and responsibilities related to data collection, storage, and sharing. See Section F.6 for information about the federal government’s interests in any data produced under an award under this NOFO.

Do not provide copies of contracts.

Regardless of what you call your document, it should include specific roles, responsibilities (including specific activities), resources, and contributions of the partner(s) or collaborator(s) to the project. The document should also describe each partner’s or collaborator’s specific expertise, experience, and access to the targeted population(s) or community(ies). It is your responsibility to ensure that all partners and collaborators have the necessary understanding of their roles to participate in the project.

If signed documentation for one or more partners or collaborators are not available when you submit your application, submit an unsigned draft of the document and the anticipated date of having all signatures.

If not provided as an appendix, fully-executed DSAs and MOAs identified for essential roles in the project will be required within the first 30 days of the period of performance for any award made under this NOFO. Special conditions may be applied to an award that does not meet this deadline.

Do not provide letters of support. Letters of support are not the same as MOAs and LOCs. Letters of support are general in nature and speak to the writer’s belief in the capability of an applicant to accomplish a goal/task. Letters of support also may indicate an intent or interest to work together in the future, but they lack specificity. We will not consider letters of support during the review.

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).

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.

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

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 performance, provide a summary narrative and line-item budget for each year beyond the first. For categories or items that differ significantly from the first budget period, provide a detailed justification explaining these changes.

Funding levels for all approved budget periods after the first are generally the same as the initial award amount and are subject to an offset with funds unused in the previous budget period.

Carryover of unobligated funds from one budget period to the next requires prior approval.

Determining Proposed Costs

Your budget narrative should justify the overall cost of the project as well as the proposed cost per activity, service delivered, and/or product. For example, the budget narrative should define the amount of work you have planned and expect to perform, what it will cost, and an explanation of how the result is cost effective. If you are proposing to provide services to clients, you should describe how many clients you expect to serve, the unit cost of serving each client, and how this is cost effective.

Proposed costs must adhere to the cost principles described in 45 C.F.R. §§75.400-75.477. We have provided additional information on the most common cost categories for applications for OASH awards in Section J.4.

Budget calculations must include estimation methods, quantities, unit costs, and other similar quantitative detail sufficient to verify the calculations. Carefully review Funding Restrictions (below) for specific information regarding allowable, unallowable, and restricted costs.

Describing Federal and Non-federal Share https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-75/subpart-E

Both federal and non-federal resources (if applicable) must be detailed and justified in the budget narrative. “Federal resources” refers only to the HHS/OASH funds for which you are applying under this NOFO. “Non-federal resources” are all other non-HHS/OASH federal and non-federal resources.

If matching or cost sharing is required or offered voluntarily, you must include a detailed listing of any funding sources identified in box 18 of SF-424 (Application…