Part 1. Overview Information

Key Dates

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

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

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

This is a Notice of Funding Opportunity (NOFO) for a limited competition that invites applications from eligible organizations to apply. Please see Section III. Eligibility for additional information. In accordance with NIH standard peer-review processes, the applications will be peer-reviewed, and only meritorious applications will be considered.

Authorized by the U.S. Congress in 1993, the National Institutes of Health (NIH) established the Institutional Development Award (IDeA) program to build biomedical research capacity in 23 U.S. states and Puerto Rico, which had historically low NIH grant funding success rates. IDeA programs support biomedical research in basic, clinical, behavioral, and translational science in IDeA-eligible states by developing faculty investigators, providing research opportunities to students, and enhancing research infrastructure.

One of the components of IDeA is the Clinical & Translational Research (IDeA-CTR) program. This program builds or expands clinical and translational (C&T) research capacity to enable research on diseases and health conditions which are prevalent in IDeA states and in alignment with the mission and priorities of the NIH. The program has two tracks:

• IDeA Clinical and Translational Research Development (CTR-D) supports health research organizations with limited C&T research infrastructure to build and enhance their C&T research capacity and develop the necessary workforce to support C&T research.
• IDeA Clinical and Translational Research Networks (CTR-N) expands existing C&T research infrastructure of statewide or multi-state networks of health research organizations, community clinics or Practice-Based Research Network (PBRN). The CTR-N will enable the networks to conduct complex observational studies and clinical trials (CTs) while continuing to develop the necessary workforce.  

To ensure that organizations apply to the track that best fits their current level of development, applicants should clearly justify their choice of track.

Organizations that already receive IDeA-CTR, CTR-N, or CTR-D funding and choose to apply for the CTR-D track must explain:

• Why a developmental-level award (CTR-D) is appropriate for their program, and
• How a CTR-D will help them successfully apply for a network-level (CTR-N) award in the future

Current CTR-D award recipients who have made progress in building clinical and translational research capacity are encouraged to consider applying to the CTR-N track, if they meet eligibility requirements.

Program Overview

Health research organizations located in an IDeA state and committed to the goals of building, developing or expanding C&T research capacity are encouraged to apply. Lead organization(s) should have a well-established research administration infrastructure to manage C&T research projects and identify the population health needs and the C&T research workforce gaps of the state(s). The proposed research areas should be sufficiently broad to address relevant diseases and health conditions in the state(s). 

IDeA-CTR programs provide a vision for building or enhancing C&T research capacity in the state(s), and a coordinated plan to integrate activities of all the components and partner organizations as necessary, including community clinics and Practice Based Research Networks (PBRNs). CTR-N applications must include a nexus of community clinics and PBRNs to demonstrate active PBRN engagement as a required element of research capacity.

Developing a strong C&T research capacity often requires tailored strategies and realistic timelines.

• CTR-Ds are to phase-in core activities to build research capacity.  The Administrative, Professional Development, Community Engagement and Outreach, and Research Design, Compliance and Data Management cores are the foundational infrastructure that must be built first to enable the HR core to support rigorous science.
•  All CTR-N core activities may begin at the start of the award, provided the existing capacity is justified. 

An IDeA-CTR consists of the following two committees and five required cores.

Committees:

• Internal Advisory Committee (IAC) consists of PD(s)/PI(s) and senior organizational leaders from each partner organization. The IAC oversees all major program components and activities, including health research compliance, regulatory monitoring, and sustained organizational support for workforce participation in IDeA-CTR activities.
• External Advisory Committee (EAC) consists of experts from outside the state or network and provides scientific and administrative guidance while overseeing integration of activities between the required cores.

Cores:

• Administrative Core (AC) manages operations and ensures compliance with CTR award requirements. The AC will handle reporting and evaluation, administer the IDeA-CTR award, and work with the other cores to achieve the center's goals.
• Professional Development (PD) Core oversees workforce training activities for the center. It organizes and sponsors the organization and/or network-wide professional and research development activities to meet the needs of the C&T workforce.
• Community Engagement and Outreach (CEO) Core leads the center's engagement with community groups and state organizations. This engagement is necessary to identify health research needs, promote community participation in clinical research, and ensure the center's research priorities are guided by community health priorities. 
• Research Design, Compliance and Data Management (RDCD) Core supports center investigators across all stages of C&T research by providing methodological, biostatistical, and CT expertise. The RDCD core enhances the center's data infrastructure related to electronic health records or clinical datasets and improves C&T research efficiency.
• Health Research (HR) Core advances all stages of investigator-initiated C&T research to address the IDeA state's health priorities through Health Research Projects (HRPs). HRPs are a central part of the IDeA-CTR award and serve as the main way the program supports and advances C&T research. 
  • Through the Health Research (HR) Core, projects move through a structured pathway: 
    • This pathway starts with the Research Preparation Phase (RPP), which provides short-term (6–12 months) support to help investigators develop strong, implementation-ready studies. 
    • Promising projects then progress to HRPs, which support rigorous observational studies and early- to mid-phase clinical trials that address important health needs in IDeA states and position investigators for future NIH funding.
  • HRPs include two-year Developmental Projects for clinician fellows and early-career or independent investigators, with required mentoring and opportunities for exploratory or ancillary studies.
  • In the CTR-N track, the program may also support Multi-Site Collaborative Projects (MCPs)–larger, phased studies led by experienced investigators that involve multiple sites and focus on high-priority health conditions.

Together, these project types create a continuum that builds investigator capacity, produces publishable results, and strengthens the overall research enterprise in IDeA states. 

Key Terms and Definitions in this NOFO

• IDeA-eligible state, commonwealth, or jurisdiction (referred to as 'IDeA state' throughout this document): Alaska, Arkansas, Delaware, Hawaii, Idaho, Kansas, Kentucky, Louisiana, Maine, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Mexico, North Dakota, Oklahoma, Puerto Rico, Rhode Island, South Carolina, South Dakota, Vermont, West Virginia, and Wyoming
• Lead Organization: Applicant health research organization that is responsible for administering the award.
• Partner Organization: An organization that significantly contributes to the center's goals and activities, such as community clinics, PBRNs, hospitals, medical centers and state public health entities.
• Multi-State Network/Multi-State Region: Formed when multiple IDeA states are linked as part of a single CTR.

Applications Not Responsive to this NOFO

Applications with a narrow disease or population focus are not responsive to this NOFO and will not be accepted for review.

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

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions - Includes all types

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

 Eligibility Criteria for Lead and Partner Organizations

• Every organization in the application must be either a Lead or a Partner–no organization can be both.
• Every organization in the application must be in an IDeA-eligible state.
• There are strict limits to avoid overlap:
  • Each IDeA-eligible state can only have one active IDeA-CTR-type (IDeA-CTR, CTR-N, or CTR-D) award at a time.
  • An organization can only be involved in one IDeA-CTR-type award at a time.
  • Organizations may not serve as a lead, partner or otherwise participate with an active Clinical and Translational Science Award (CTSA). 
• Organizations must meet all eligibility rules at the time of application submission and award.

Additional Eligibility Criteria for Lead Organizations

To apply as the lead, the organization must:

• Already have externally-funded clinical and translational (C&T) research.

Additional Eligibility Criteria for Partner Organizations

To participate as a partner, the organization must

• Be in the same state or multi-state region as the lead organization.

Note:

• Active awards include awards in no-cost extension (NCE).
• An organization that currently leads an active IDeA-CTR-type award may submit a new application if substantial changes to the CTR are proposed. 
  • If the new application is funded, the current award will be administratively ended before the new award begins.

Foreign Organizations/International Collaborations

Non-domestic (non-U.S.) Entities (Foreign Organization) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed. 

• Unfunded foreign components are allowed with prior approval.
  • An unfunded foreign component would be a collaboration with investigators at a foreign site anticipated to result in co-authorship but with no IDeA funds transferred to the institution(s) or investigator(s) in a foreign country. Please also see NOT-OD-26-084.
• Foreign PIs or organizations may use center resources as a fee-for-service.
  • In such cases, resulting publications cannot cite or acknowledge NIH grant support.

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. Obtaining an eRA Commons account can take up to 2 weeks.

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help. 

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. 

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide.

At the time of submission, the primary appointment of the contact PD/PI must be at the applicant organization. An IDeA-CTR PD/PI (including any MPIs) may not simultaneously lead an IDeA COBRE or INBRE award. Only PDs/PIs associated with the eligible applicant organizations as outlined above may apply.

NIGMS strongly encourages multiple PD/PI (MPI) applications, particularly given the complexities of C&T research and CTs. An established clinician scientist with a track record of leading externally funded C&T/CT research projects or programs is expected to lead the IDeA-CTR as the contact PD/PI. The PD/PI should have:

• a demonstrated history of leadership experience.
• mentoring experience in fostering the development of a C&T/CT research and workforce.
• demonstrated success in working across organizational boundaries.

This expertise is important to unite the participating organizations into a cohesive network and to properly integrate the IDeA-CTR's components to maximize efficiency and effectiveness.

The MPI team should also include a PD/PI with relevant scientific expertise to guide the center.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2- Definitions of Terms.

3. Additional Information on Eligibility

Number of Applications

Only one application per institution (normally identified by having a unique entity identifier (UEI) or NIH IPF number) is allowed.

The NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts) and where instructions in the How to Apply - Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations

All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application.

Overall Component

When preparing the application, use Component Type 'Overall'.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions, as noted.

SF424(R&R) Cover (Overall)

Complete entire form.

The title of the application should indicate the CTR track in the format of "CTR-D: [Title]" or "CTR-N: [Title]"

PHS 398 Cover Page Supplement (Overall)

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Locations (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research and Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application.

Biographical Sketch: Each PD/PI should describe their leadership and administrative experience, as well as any prior and relevant experience for the IDeA-CTR track they are applying for in the Personal Statement of the NIH Biographical Sketch Supplement. The Biographical Sketch Common Form and NIH Biographical Sketch Supplement should provide evidence of the PD/PI's:

• experience directing research centers and leading an efficient and effective C&T research program
• history of clinical research involvement
• administrative experience working across departments and with external collaborators
• mentoring experience

Current & Pending Support: Attach a copy of the PD/PI's Current and Pending (Other) Support Common Form, which is critical information for determining the PD/PI's eligibility and suitability to lead the Center:

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Research Strategy: The IDeA-CTR aims to build or expand C&T research capacity. All cores must work together to provide shared, non-duplicative resources that strengthen infrastructure, expertise, and workforce development. Applicants should describe the major health challenges of the population in the state(s) served and how the center will build or expand C&T research capacity to address them. 

Provide the Overall Plan for the IDeA-CTR, which must include the following sections:

A. Goals of the IDeA-CTR: Describe the goals of the IDeA-CTR and the roles of the lead organization and any partner organizations in meeting those objectives. Key elements to include are:

• The overall vision of the IDeA-CTR, including how the center's goals align with the lead organization's strategic priorities, and how each organization will contribute to these overarching center goals.
• Plans to address the state(s)' major health concerns through support for research, infrastructure, and workforce development.
• Innovative approaches to overcome barriers and improve/strengthen C&T research at the involved organizations, including plans to:
  • Increase interest among investigators in conducting C&T research on health concerns or health challenges that impact the population in the state(s).
  • Develop and/or strengthen collaborations across the partnering organizations to ensure the center performs effectively across organizational boundaries (applicable to the CTR-N track).
  • Develop novel C&T methodologies such as pragmatic or adaptive trials.
  • Enhance the use of innovative technologies/tools (for example, real-world data platforms or a mobile clinical trial unit).
  • Use C&T technologies and resources such as Fast Healthcare Interoperability Resources (FHIR) standard, EHR or other real-world data platforms, if applicable.
  • Connect researchers across disciplines to drive health research in support  of precision and evidence-based medicine, if applicable.
• Plans to leverage resources and infrastructure supported by other IDeA awards (such as INBRE, COBRE, and IDeA Clinical Research Resource Center) or those supported by other NIH-funded C&T programs.

B. Organizational Structure and Governance Model: The applicant should provide a clear organizational structure that illustrates the relationships among the lead organization, partner organizations, committees, and cores within the IDeA-CTR. Key elements to include are:

• The available research administration infrastructure, including its:
  • Capacity for administering the IDeA-CTR award
  • Ability to manage subcontracts
  • Experience in managing research involving human subjects, clinical trials, and vertebrate animals.
  • Clinical trial infrastructure, and centralized Institutional Review Board (IRB)
  • IRB approval processes that provide timely support to investigators conducting human subjects research and clinical trials
• A list identifying the externally funded C&T research base (including participation in clinical trials), for the lead and partner organizations.
• Areas of C&T research expertise among investigators and how their expertise will contribute to the goals of the IDeA-CTR.
• A management plan for the IDeA-CTR, including a description of:
  • How the IAC and EAC and the IDeA-CTR components will work together.
  • Interactions between the PD(s)/PI(s) and Core Leads, who will direct core operations by coordinating PIs and both advisory committees to standardize procedures, support investigators, and advance technology capabilities across all components.
  • How Core Leads will:
    • Develop or improve standard operating procedures governing the utilization and management of core expertise and resources;
    • Disseminate information;
    • Ensure state-of-the-art technologies and knowledge capabilities will be gained and attained;
    • Recommend necessary technology and equipment to the IDeA-CTR PD(s)/PI(s).
  • How each organization or component will have input and participate in decision-making.
  • How ongoing communication channels will be maintained among components.
  • A succession plan in the event there is a change of PD(s)/PI(s).
• A description of the required committees,their responsibilities, and how these commitees will assist the PD(s)/PI(s) in administering the award:
  • Internal Advisory Committee (IAC):
    • Committee composition:
      • PD(s)/PI(s)
        • The contact PD/PI serves as the chair
      • One senior organizational leader (President, Vice President, Provost, Dean or equivalent) from each lead and partner organization. 
      • Ad hoc committee members as needed.
    • How the IAC will:
      • Ensure the program stays aligned with IDeA-CTR goals.
      • Oversee all major program components and activities.
      • Give input on major program or network decisions. 
      • Provide annual updates to the EAC through a progress report.
      • Organize the Health Research Compliance (HRC) sub-committee which is responsible for all aspects of research compliance including Federal, NIH and organizational research regulations, and requires the following experts:
        • Clinical Research Program Coordinator.
        • Members of the CTR leadership team.
        • Regulatory Specialist/Research Navigators.
        • Research Compliance Officers.
      • Ensure the HRC will:
        • Establish a plan for oversight during the entire duration of HRPs, and for making HRP funding recommendations and monitoring progress of the projects.
        • Ensure HRP applications submitted to the EAC include:
          • IAC assessment.
          • The project's Individualized Action Plan.
          • Career development and mentoring plan for the investigator.
          • Report of Consultations and Outcomes (RCO).
          • Quarterly post-award monitoring plan.
        • Ensure that each Individualized Action Plan should cover the following topics:
          • Quality assurance monitoring.
          • Expectations for the project investigator during the project period.
          • The investigator's experience.
          • Mentor's oversight of human subjects research.
          • Coordinator/Navigator involvement.
  • External Advisory Committee (EAC) 
    • Committee composition: 
      • PD(s)/PI(s) 
      • At least 3 – 5 experts in C&T research from outside the state/network. 
      • EAC chair appointed by the PD(s)/PI(s) in consultation with the IAC. 
      • Additional members appointed by the PD(s)/PI(s) 
    • Operating Plan:  
      • Process of filling EAC vacancies 
      • Description of the qualities and scientific expertise desired for EAC members, without naming specific individuals or contacting them prior to receiving the Notice of Award for the application.
    • How the EAC will: 
      • Evaluate the program's annual progress report prepared by the IAC.
      • Give recommendations to help the PDs/PIs improve the center.
      • Assess all proposed HRPs before they are submitted to NIH for approval.
• If a Multiple PD/PI application is submitted, a "Multiple PD/PI Leadership Plan" is required as a separate attachment and the information in that plan should not be duplicated here. This section should address:
  • How the entire group will function to accomplish program objectives and vision
  • Strategies for building and maintaining group participation
  • Succession planning in the event of a change in PD(s)/PI(s).

C. Capacity for C&T Research:

To properly assess the baseline level of C&T research capacity in the organization or network, describe the current C&T research capacity of lead and partner organizations (use tables where appropriate). Key elements to include are:

• Investigator research support and productivity:
  • The current number and annual total dollar amount of C&T research grants held by investigators at the organizations or network organizations.
  • A summary of C&T related publications authored by investigators at the organization(s) or network organizations over the past five years.
  • A summary of the health conditions that are currently being studied.
  • If applicable, information on the progress and accomplishments from the current IDeA-CTR funding period including:
    • The annual number of:
      • C&T research projects supported.
      • Publications, research grant applications and awards resulting from research project support.
    • The annual number of research projects that were:
      • Collaborative
      • Multidisciplinary
      • Multi-site or
      • CTs
  • A summary of non-research project C&T research supported by supplement awards and/or current IDeA-CTR cores.
• Organization or Network Strength:
  • Summarize the existing research collaborations among participating organizations and network investigators and other IDeA-supported programs.
  • Generate a synopsis of existing connections with community clinics/PBRN sites in the state(s).
• Professional Development:
  • Summarize the programs, seminars, workshops, mentoring activities provided to participating organizations or network investigators.
  • Indicate the activities that were developed during the current IDeA-CTR funding period, if applicable.

Letters of Support: The application must include a letter of support from a senior official from the lead (applicant) organization and each partner organization that demonstrates organizational commitment to the IDeA-CTR program. The letter must:

• Commit the organization to the IDeA-CTR's goals and describe:
  • How these goals align with the organization's strategic priorities.
  • Each partner organization's specific and actionable goals, not just formal endorsements.
• Describe the commitment of specific resources, such as:
  • Support for hiring new staff.
  • Investment in necessary infrastructure.
  • Specific commitments to cores or other components should be summarized in a table.

Optional Letters of Support (10-page maximum): The application may include additional letters 

• From the PD(s)/PI(s) of other NIH IDeA awards describing how their programs will significantly support the IDeA-CTR and its goals.
• That address important and specific needs of the IDeA-CTR may also be included, as applicable, but must not exceed the 10-page maximum.

Letters of support that repeat material or do not add new content should not be included in the application. 

Resource Sharing Plan:
Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

Other Plan(s): 

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

• A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply - Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.

PHS Assignment Request Form (Overall)

All instructions in the How to Apply- Application Guide must be followed.

Administrative Core 

The Administrative Core administers the IDeA-CTR award. The contact PD/PI is expected to lead the AC. The AC administers the IDeA-CTR award and works closely with the other cores and organizational leadership to develop and implement plans that will meet the strategic goals of the organization(s) to support C&T research and synergize existing strengths and resources. The AC assesses the C&T/CT research capacity building needs of the organization(s) and develops and executes plans needed to meet those needs. 

When preparing your application, use Component Type 'Admin Core.'

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant's Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administrative Core)

Follow standard instructions. 

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.

Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Core Lead' and provide a valid eRA Commons ID in the Credential field.
  • The Core Lead should be the PD/PI or contact PD/PI for multi-PI applications. 
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch Common Form and NIH Biographical Sketch Supplement for for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package. 

• A maximum annual level-of-effort of 6.0 person-months may be requested for all PDs/PIs, collectively. 
  • For multi-PI applications, no more than 2 PD(s)/PI(s) are allowed and the minimum level of effort for each PD/PI is 3.0 person-months. 
• A PD/PI may not use IDeA-CTR funds to supplement research activities for his or her own research projects or research team.
• A PD/PI is not eligible to serve as a project lead on another IDeA-CTR award.  
• Funds may be requested:
  • To support staff to manage the budget and conduct annual IDeA-CTR program evaluations.
  • For the EAC and IAC, including travel costs and compensation to members as consultants via a fee-for-service arrangement, if applicable.
  • For consulting services that assist in strategic planning. 
  • To assist with the recruitment of additional faculty or staff to provide C&T research expertise. These funds are limited to $200,000 in annual direct costs and may be used for salary, supplies, and/or equipment costs.
  • To help defray the costs for the PD(s)/PI(s) and other key personnel funded through this NOFO to attend the National Symposium of Biomedical Research Excellence (NISBRE) biennial meetings.
• Funds cannot be used by or for collaborators at organizations in non-IDeA states or at foreign sites. However, funds may be used in IDeA and non-IDeA states for fee-for-service activities such as learning new techniques (for example, biostatistics or clinical research design courses), sample and data analysis, attending workshops, or obtaining scientific, methodological or biostatistical advising/consulting/mentoring.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administrative Core)

 Research Strategy: 

This section should describe how the Core will:

• Manage and oversee the entire IDeA-CTR program, including coordinating and integrating all activities. 
• Ensure clear and timely communication among relevant staff.
• Coordinate and support the activities of the two required committees – IAC and EAC.
• Coordinate activities across center components.
• Manage finances.
• Provide accurate and timely progress reports to the NIH.
• Annually monitor and evaluate performance of each core component. 
• Track usage of core components and adapt cores to the needs of investigators.
• Provide the annual evaluation report to the EAC. 

Letters of Support: Not allowed. Organizational Letters of Support, including support for the Administrative Core, should be included in the Overall Component.

PHS Human Subjects and Clinical Trials Information (Admin Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed. 

Professional Development (PD) Core

The PD Core oversees workforce development for the IDeA-CTR and organizes professional development activities. These activities should be tailored to the needs of the IDeA-CTR's C&T research workforce, including investigators eligible for HR Core funding and members of their research teams. The PD Core is expected to collaborate with other IDeA-CTR cores to identify needs for additional expertise and to ensure training in research regulations, mentoring, and the ability to provide scientific and technical review of post-award applications.

When preparing your application, use Component Type 'Core.'

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (PD Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant's Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (PD Core)

Follow standard instructions. 

Research & Related Other Project Information (PD Core)

Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.

Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (PD Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (PD Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Core Lead' and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch Common Form and NIH Biographical Sketch Supplement for for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (PD Core)

Budget forms appropriate for the specific component will be included in the application package.

• Each Core Lead must devote a minimum of 1 person-months annually to direct the core.
• Funds to cover the salaries of the PD Core staff to provide services to the IDeA-CTR's investigators are allowed.
• The acquisition and/or modernization of new equipment may be proposed.
• Funds to support scientific and professional development activities such as, but not limited to:
  • seminar series
  • workshops
  • training for biostatistician/methodologists in biostatistics and/or clinical trials related courses
  • training for mentors and reviewers
  • retreats.
• Funds to hire consultants for professional development activities are allowed.
• Funds to provide access to training resources and materials for the program's clinical research workforce are allowed.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (PD Core)

Research Strategy: 

This section should include the following elements:

• Leadership and staffing
  • The roles and responsibilities of the Core Lead and staff.
  • Plans to assess current expertise and identify gaps.
  • Plans to recruit additional personnel, if needed.
• A description of core services and operating procedures.
• Plans for coordination with other IDeA-CTR cores to offer professional development activities.
• A description of professional development workshops, training, and educational opportunities that address the specific needs of the C&T research workforce. This includes all investigators, clinicians, core and research staff, and relevant staff from community clinics and PBRNs. For each planned activity, identify the intended audience. Relevant topics include but are not limited to:
  • Mandatory training for all investigators to ensure regulatory compliance with Federal and organizational policies, rules, and guidelines for research involving human subjects, CTs, vertebrate animals, and biohazards.
  • Mandatory training for all investigators and biostatisticians/methodologists on biostatistics, methodology and CT research design to remain up-to-date with current and advanced techniques.
  • Education on research protocol design to minimize bias, ensure scientific rigor and robustness, and manage risk to participants.
  • Research seminar series, grant-writing workshops, and pre-application seminars that cover topics such as:
    • Review of SF424 forms and instructions 
    • Biostatistics and research design
    • Regulatory processes required to obtain IRB/IACUC approvals
    • How to translate C&T research into real-world viable research protocols.
  • Strategies that foster study participant engagement that are respectful of the IDeA-CTR community's values and perspectives in research.
  • The creation of a mentor-mentee match from a faculty mentor pool list.
  • Training for mentors in evidence-informed practices for providing scientific advice and career development guidance.
  • Training for reviewers in conducting unbiased reviews and providing meaningful feedback on HRP applications.

Letters of Support: Only letters of support specific to the PD Core are allowed (e.g., a Chief Institutional Review Board supports training on how to formulate research protocols). Do not include letters from lead or partner organizations that describe support for the PD Core - this support should be described in the organizational Letters of Support included in the Overall Component.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: 

Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within the Overall Component.

PHS Human Subjects and Clinical Trials Information (PD Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

Community Engagement and Outreach (CEO) Core 

The CEO Core oversees engagement with community groups and state organizations to identify statewide health research needs and challenges. This information should be used to inform center leadership and cores in designing and expanding capacity-building and research activities. The CEO Core partners with community members and PBRNs to promote community participation in clinical research. The Core engages community clinic staff and patients to increase research familiarity and fosters bidirectional engagement so community health priorities guide IDeA-CTR research. It also supports C&T researchers and staff with needs assessments, measurement, study design, and strategies to enhance participant recruitment and retention.

When preparing your application, use Component Type 'Core.'

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (CEO Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant's Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (CEO Core)

Follow standard instructions. .

Research & Related Other Project Information (CEO Core)

Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.

Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (CEO Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (CEO Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Core Lead' and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch Common Form and NIH Biographical Sketch Supplement for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (CEO Core)

Budget forms appropriate for the specific component will be included in the application package.

• Each Core Lead must devote a minimum of 1 person-month annually to direct the core.
• Funds may be used to cover the salaries of CEO Core staff.
• The acquisition and/or modernization of new equipment may be proposed.
• Funds may be used to establish or strengthen the IDeA CTR's dissemination efforts.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (CEO Core)

Research Strategy: 

This section should include the following elements:

• Leadership and staffing
  • The roles and responsibilities of the Core Lead and staff.
  • Plans to assess current expertise and identify gaps.
  • Plans to recruit additional personnel, if needed.
• Plans to determine C&T research needs in the community and among PBRNs.
• Plans to assess available expertise and additional needs of the CEO Core.
• Plans for engaging clinics in PBRNs.
  • If a PBRN is not currently in place in the states(s), the applicant must provide plans to engage community clinics for research.
• Plans to help integrate community engagement into the center's strategic plan
  • These plans should include establishing or enhancing community advisory boards (CABs).
  • CABs should assist in identifying and prioritizing health issues and concerns of communities and the population served by the program.
  • CABs should consist of community representatives, patients, community-based clinicians, health systems representatives, experts in informatics, or relevant industry representatives.
• Supporting research participation
  • Assisting investigators with recruiting and retaining research participants.
  • Engaging clinics involved in PBRNs. 
  • If the state does not currently have a PBRN, plans to engage community clinics for research.
• Plans to attract providers in clinics and PBRNs to propose HRPs or participating in research
• Strategies for helping investigators with the recruitment and retention of research participants.

Letters of Support: Only letters of support specific to the CEO Core are allowed (for example, a CAB member supports advising researchers on engaging community clinics in research activities). Do not include letters from lead or partner organizations that describe support for the CEO Core. This support should be described in the organizational Letters of Support included in the Overall Component. 

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: 

Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within the Overall Component.

PHS Human Subjects and Clinical Trials Information (CEO Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed. 

Research Design, Compliance, and Data Management (RDCD) Core

The RDCD Core supports IDeA-CTR investigators across all stages of C&T research by providing essential resources and services. The Core Lead is responsible for mentoring staff and helping investigators and C&T teams conduct human subjects and CT research. This support includes guidance on risk assessment, safety and ethics, intervention design, and federal regulatory and reporting requirements. IDeA-CTRs are expected to ensure that C&T research follows current human subjects research standards and Good Clinical Practice (GCP) principles.

When preparing your application, use Component Type 'Additional Core.'

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (RDCD Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant's Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (RDCD Core)

Follow standard instructions.

Research & Related Other Project Information (RDCD Core)

Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.

Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (RDCD Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (RDCD Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Core Lead' and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch Common Form and NIH Biographical Sketch Supplement for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

The Core Lead should have strong methodological expertise, and the staff should include experienced biostatisticians, methodologists, bioinformaticians, and CT specialists. 

Budget (RDCD Core)

Budget forms appropriate for the specific component will be included in the application package.

• The RDCD Core Lead must devote a minimum of 1 person-month annually to direct the core.
• Funds may be used:
  • To cover the salaries of the RDCD Core staff to provide services to the IDeA-CTR's investigators.
  • To recruit biostatisticians, methodological experts, or bioinformaticians.
  • For software and/or modernization of new equipment/software to improve research compliance, such as SMART IRB or clinical trials management system.  
  • To prepare and maintain large clinical datasets and real-world data platforms for research use.
  • To hire consultants.
  • To provide access to training activities and resources to develop investigator competence in areas related to the RDCD Core's mission. Individuals to be trained include, but are not limited to:
    • Individuals with biostatistical, methodological and clinical trial expertise.
    • Staff responsible for planning, conducting, monitoring, and reporting the CT results.
    • Clinical research coordinators.
    • Quality control/quality insurance clinical research associates.
    • Regulatory or ethics personnel (including an independent medical monitor) to work with IRB, Ethics Committee or Data Safety Monitoring Board.
    • Personnel to ensure data integrity, protocol compliance, and protection of participant rights and safety.
• Funds may not be used to procure access to commercially available EHR data.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (RDCD Core)

Research Strategy: This section should include plans for the following:

• Leadership and staffing
  • The roles and responsibilities of the Core Lead and staff.
  • Plans to recruit additional personnel, if needed.
  • How the RDCD Core will work with the PD Core to:
    • Assess current expertise.
    • Identify gaps and additional needs.
• Training and resources to develop investigator competence in conducting C&T research, related to the following topics:
  • Clinical research management.
  • Knowledge of federal and organizational policies, rules and guidelines for research involving human subjects, CTs, vertebrate animals, and biohazards.
  • Protocol design that avoids bias, ensures scientific rigor, and manages risk to participants.
  • Biostatistics, CT management, and FHIR-compliant EHR training.
  • The curation and use of large clinical datasets, bioinformatics, computing, and digital health and research tools.
  • Investigational new drug submission consultations and other relevant regulatory matters.
• Support for investigators in:
  • Research design.
  • Clinical protocols and risk assessment.
  • Safety protocols and ethics.
  • Intervention models and biostatistical analyses, and
  • Federal and organizational regulatory requirements.
• Data management 
  • Data quality 
    • Validate research results. 
    • Identify and remove biases in the datasets.
  • Data curation and management, including:
    • Software and tools. 
    • Data cleaning and harmonization methods.
    • Common Data Models used across the program or network.
  • EHR-based research infrastructure, including:
    • Upgrading data platforms and equipment.
    • Engaging PBRN sites in research.
  • How EHR data are:
    • Obtained, managed, and accessed, including:
      • Patient consent process.
      • Data de-identification.
      • IRB approvals.
  • Improvement of workflows, such as making access to clinical data more efficient.
  • Data security and compliance to safeguard access to protected health information for all clinical datasets.
• Advanced data and research capabilities
  • Building and leveraging real-world data platforms and advanced analytics to support innovative CTs and complex observational studies.
  • The use real-world data platforms to expand research access across the IDeA state(s).
  • Developing new participant recruitment methods including digital marketing, Patient Portals, and cross-study recruitment. 

Letters of Support: Only letters of support specific to the RDCD Core are allowed (for example, a Chief Informatics Officer supports EHR data use in a partner hospital). Do not include letters from lead or partner organizations that describe support for the RDCD Core. This support should be described in the organizational Letters of Support included in the Overall Component.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: 

Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within the Overall Component.

PHS Human Subjects and Clinical Trials Information (RDCD Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

Health Research (HR) Core 

The HR Core manages and supports all research projects in the center, from research preparation through implementation. Its primary role is to build C&T research capacity by developing investigators, strengthening study design and execution, and ensuring projects meet high scientific and regulatory standards. The core supports the following: 

• Research Preparation Phase (RPP):The RPPs help investigators advance concepts into competitive and implementation-ready studies. As the first step in the HR Core Pathway, an RPP:
  • Provides protected time for independent investigators and clinician scientists to work with the AC, PD, CEO and RDCD Cores.
  • Supports Investigators while they:
    • engage IDeA-CTR cores for biostatistics, regulatory guidance and clinical operations expertise
    • receive targeted training for C&T and clinical trials research.
    • refine study design, feasibility, implementation and regulatory compliance strategies.
    • Note:
      • RPPs do not require prior approval
      • The number of RPPs is limited by the HR Core budget cap.
      • An RPP must be completed in order to be competitive for a Health Research Project.
      • Completion of an RPP does not guarantee approval of a Health Research project. 
• Health Research Projects (HRPs): There are two types of HRPs supported by the core. 
  • Two-year Developmental Projects led by:
    • Clinician fellows, who will follow a structured mentoring plan with experienced research mentors.
      • Early-stage interventional or exploratory studies are permitted when supported by strong clinical and scientific rationale.
      • Ancillary studies leveraging ongoing patient cohorts are encouraged.
      • A formal career development mentoring plan is required.
    • Independent investigators (such as Assistant Professors, Assistant Scientists, Research Assistant Professors, or equivalent) and clinician scientists with appropriate expertise.
      • Investigators conducting CTs must partner with experienced clinician scientist mentors to ensure trial integrity and regulatory compliance.
  • Multi-Site Collaborative Projects (MCP) (CTR-N Track Only) support complex, multi-site CTs addressing high-priority health conditions within and across IDeA states. Each MCP must be led by an established investigator with demonstrated scientific and administrative leadership, directing clinical or population-based research.
    • MCPs should use a phased approach. For example, year 1 can focus on preparation and planning, and later years can focus on implementation. To move to the next phase, they must meet proposed science milestones and performance benchmarks.
    • Investigators must be capable of managing multidisciplinary teams and overseeing regulatory and operational requirements.
    • Investigators must maintain timelines and budgets.

When preparing your application, use Component Type 'Additional Core.'

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (HR Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant's Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (HR Core)

Follow standard instructions.

Research & Related Other Project Information (HR Core)

Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.

Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (HR Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (HR Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Core Lead' and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch Common Form and NIH Biographical Sketch Supplement for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

The contact PD/PI of the IDeA-CTR is expected to lead both the HR Core and collaborations with IDeA Clinical Research Resource Center (I-CRRC) for participating in large-scale clinical studies and training the IDeA-CTR's clinical researchers. 

Budget (HR Core)

Budget forms appropriate for the specific component will be included in the application package.

• Each Core Lead must devote a minimum of 1 person-month of effort per year to direct the core.
• HRP independent investigators (Assistant Professors, Assistant Scientists, Research Assistant Professors, or equivalent) must commit at least 6 person-months of effort per year towards the HR project.
• HRP clinical investigators (such as clinicians, clinician scientists, and clinician fellows) must commit up to 3 person-months of effort per year towards the HR project.
• Funds may be used to:
  • Cover the salaries of the HR Core staff to provide services to the IDeA-CTR's investigators.
  • Recruit CT experts or other relevant clinical workforce personnel.
  • Compensate mentors for up to 1 person-month of effort that provides protected time for scientific advising and career development guidance.
    • Mentors from non-IDeA states can be compensated as consultants or via a fee-for-service arrangement.
  • Support community clinics and PBRNs by providing protected time for providers to participate in research or to conduct research. 
• CTR-D: Direct costs of up to $750,000 annually in years 2-5 may be requested to support the HR Core's activities. 
  • The HR Core's research projects will require prior approval; see Section VI. Post-Award Program Requirements.
  • The year 1 budget should not include a request for Research Preparation Phase or Developmental Project funds.
  • The Research Preparation Phase (RPP) budget is up to $150,000 in annual direct costs per RPP with a duration of 6-12 months.
  • The budget for a Developmental Project is $150,000 in annual direct costs with a duration of 2 years. 
• CTR-N: Direct costs of up to $1,250,000 annually in years 2-5 may be requested to support the HR Core's activities.
  • The HR Core's research projects will require prior approval; see Section VI. Post-Award Program Requirements.
  • The budget for year 1 may be up to $750,000 to support RPP and/or DP if sufficiently justified.
  • The Research Preparation Phase (RPP) budget is up to $150,000 in annual direct costs per RPP, with a duration of 6 to 12 months.
  • The budget for an individual Developmental Project (DP) is $150,000 in annual direct costs with a duration of 2 years.
  • A budget of up to $500,000 may be requested to support one or more Multi-site Collaborative Projects(MCPs).
    • Sites outside the network, but located in IDeA states, may be supported via subcontracts from the IDeA-CTR award or from other sources of funding.
    • MCPs require completion of the Research Preparation Phase before the project can begin.
    • The budget should specify how early funding will be used in Year 1 to meet benchmarks, such as arranging data use and data transfer agreements, obtaining protocol and informed consent, and related activities.; see Section VI. Post-Award Program Requirements. 
• Restrictions:
  • Funds must support only the approved HRPs as part of this award.
  • Funds cannot be used for graduate student or postdoctoral stipends. However, students and postdoctoral scholars may receive salary support as research staff from an awarded project.
  • Postdoctoral scholars and others holding non-independent positions are not eligible to lead an HRP.
    • Exception: Clinician Fellows working with a research mentor(s), may lead a DP.
  • HRPs may not overlap with ongoing funded projects of the project investigators or mentors.
  • HRP leads may not receive simultaneous research support as project leads from this or another IDeA parent award.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (HR Core)

Research Strategy: 

HR Core components:

The Research Strategy section should include the following elements:

• Roles and responsibilities of CL and staff, and any plans for the recruitment of appropriate personnel.
• Include details on how the HR Core will manage all research supported by the program including:
  • How the HR Core supports HRPs with the goal of building C&T capacity and developing a C&T research workforce
  • Plans to strengthen investigator-initiated C&T research.
  • A description of the impact of CTs and observational studies conducted at organizations or network organizations.
• The approximate numbers of RPPs and HRPs that will be supported each year.
  • The estimates should include a justification for how this distribution will be selected.
  • Identify both the existing and planned expansion of C&T research infrastructure in terms of personnel and resources within the context of the planned annual post-award projects.
• A description of:
  • How the RPPs and HRPs are integrated into the center's or network's clinical research workforce.
  • How applications for the RPP and HRPs will be solicited, reviewed, and recommended for funding from the organization(s).
    • Considerations include how to maximally engage investigators at different career stages from a variety of disciplines and clinical specialties from across the organizations(s).
  • Timelines and plans to ensure appropriate use of the RPP for enhancing the scientific rigor of proposed HRPs and the applicant's C&T research expertise.
  • A plan for how investigators will use the RPP time to:
    • Engage IDeA-CTR cores for biostatistics, regulatory guidance, clinical operations, and other C&T expertise.
    • Receive C&T training relevant to their needs.
    • Refine study design, feasibility, and implementation plans.
    • Develop regulatory and compliance strategies appropriate to the proposed research.
• Plans to pair up experienced clinician scientists and the leads of CT HRPs to promote CT-specific mentorship. 
• A plan for how HR Core staff collaborating along with the health research compliance sub-committee, will monitor post-award projects to ensure study participant safety and that all federal, state, local and organizational regulatory requirements are met.
• Before submission of an HRP as a post-award project to NIH for approval, it must include a Report of Consolutations and Outcomes (RCO) for the RPP. See Section VI. Post-Award Program Requirements.

Notes:

• The completion of an RPP does not guarantee the approval of a subsequent HRP proposal.
• The RPP is not intended for:
  • data collection of any kind, including clinical or pre-clinical data as a part of the future trial;
  • CT planning activities for more than one study or trial per HRP applicant;
  • any investigational new drug or device development activities; or
  • implementation of a CT.
• CTR-D applications must provide a timeline for a phased approach of their cores. AC, PD, CEO and RDCD cores must be functioning before HR core activities may begin.
• CTR-N applications do not require a phased approach. 
  • However, if a phased approach is not chosen, applicants must justify how existing resources already cover required AC, PD, CEO and RDCD core  activities before HR core activities may begin.

Letters of Support: Only letters of support specific to the HR Core are allowed (for example, a Medical Director of a hospital supports by providing access for research activities). Do not include letters from lead or partner organizations that describe support for the HR Core. This support should be described in the Organizational Letters of Support included in the Overall Component. 

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: 

Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within the Overall Component.

PHS Human Subjects and Clinical Trials Information (HR Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.  

3. Unique Entity Identifier and System for Award Management (SAM)

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

4. Submission Dates and Times

Part I. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH's electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in How to Apply- Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

For information on how applications will be automatically assembled for review and funding consideration after submission, refer to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply - Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization's profile in the eRA Commons and for the System for Award Management. Additional information may be found in How to Apply - Application Guide. 

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed. 

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.36.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the center to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Specific to this NOFO:

• What important problems or barriers to conducting Clinical and Translational (C&T) research have been identified? How will the plans to address these barriers strengthen C&T research at the organization(s) or across the network?
• How will the organization(s) or each network organization contribute to the center's goals?
• How likely is the IDeA-CTR to advance research on important health concerns for the population of the state(s)?
• If the application has an active IDeA-CTR, CTR-N, or CTR-D award, to what extent did the current CTR awards strengthen the capacity of the organization or network organizations to conduct C&T research? 
• IDeA CTR-N only: Does the proposed network have existing C&T research capacity and evidence of collaborations among participating organizations at the level expected for a CTR-N? 

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the IDeA-CTR?

Specific to this NOFO:

• How well does scientific and administrative leadership experience prepare the PD(s)/PI(s) to lead and integrate the components that comprise the center?
• How robust is the evidence that the leadership is capable of working across departments and organizational boundaries, and as applicable, with other organizations?
• How strong is their prior mentoring experience as preparation for fostering the development of a clinical research workforce, including independent investigators?
• For MPI applications, to what extent are the leadership approach and arrangements for sharing responsibility appropriate for the center? Is the team management plan complementary to the multiple PD/PI leadership plan? Does the team management plan provide for effective team leadership and management with distributed responsibility and decision-making processes?

Innovation

Specific to this NOFO:

• How innovative are the plans to build or enhance C&T research capacity within the IDeA-CTR organizations or networks?
• How innovative are the approaches for engaging more investigators in conducting C&T research at the organization(s) or the participating organizations?
• In what ways are the proposed plans innovative to enhance communication, coordination, and/or collaboration among investigators and staff within and across the health research organizations, cores, community clinics, and other community groups or state populations?

Approach

Specific to this NOFO:

• How effective is the Overall Plan for the program to significantly strengthen C&T research activities at the organization(s) or at the participating organizations?
• To what extent do the center's plans for networking, sharing of resources, and cross-collaborations leverage the resources of other NIH-supported programs such as COBREs, INBREs and I-CRRC?
• Are the plans to collaborate with other organizations feasible for IDeA-CTR, and to what extent will they strengthen the ability of the center investigators to conduct collaborative C&T research studies?
• Are the roles of the IAC and EAC, clearly described and appropriate? How appropriate is the expertise of the proposed members of the IAC and EAC for their respective functions?
• To what extent will the organizational structure, governance model and governance plan enable synergistic collaboration and coordination across organizations to maximize the center's success?
• How does the organizational structure and governance plan enable effective communications with and among the IAC and EAC, between the proposed cores and, as applicable, the succession plan?
• How well will community input and engagement be incorporated into the development of C&T research capacity of a CTR-D or into the enhancement of C&T research capacity for a CTR-N?
• How strong are the plans to adopt innovative/pragmatic/adaptive CT approaches and to pursue complex observational studies? How strong are the plans to leverage resources from the I-CRRC, other external sources, partners with PBRNs, and/or collaborate with other IDeA programs?

Environment

Specific to this NOFO:  

• To what extent is the lead organization's research administration infrastructure appropriate for leading the center?
• How adequate are the organizational commitments of the applicant, any partner organizations, or the network organizations for supporting the goals of the center?
• To what extent does the organization(s) have adequate C&T research investigators and/or a workforce who can benefit from the center's resources?
• How suitable are the research and clinical infrastructures of the lead and, if applicable, partner organizations to effectively make use of the IDeA-CTR?
• How effective is the IRB infrastructure for obtaining timely review and approval of research protocols?
• How available are the support, equipment, technical expertise and other physical resources to investigators to meet the needs of the anticipated research activities?
• If the application has an active IDeA-CTR, CTR-N, or CTR-D award, how successful was that program's environment, and does it create a strong foundation on which to build additional C&T research capacity?
• IDeA CTR-N only: How strong is the C&T research base of the lead organization? How broad is the C&T research expertise of its faculty investigators? To what extent will the network organizations be able to contribute to and benefit from the overall C&T infrastructure of the network? 

Additional Review Criteria - Overall

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

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Human Subjects Policies

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Renewals

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

Revisions

For Revisions (as applicable), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations - Overall

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

Review Criteria for Cores

Each of the following components of the application will be assessed and given a score; the component scores will also be considered in assigning an Overall Impact score to the overall application.

Administrative Core

• How well developed are plans for managing, coordinating, integrating and overseeing the cores and committees of the center, over the entire range of its activities? How well integrated are the cores?
• To what extent are effective strategies proposed for facilitating communication at the lead organization, with any partner organizations, organizational leaders, core leads, investigators, and program staff?
• How suitable are the proposed strategies to assess, prioritize and address the health needs of the state's population?
• How appropriate are plans to manage the center's budget, and prepare and submit accurate and timely financial reports?
• How strong are the proposed evaluation strategies that will measure the effectiveness of each component and the success of investigators supported by the center? How suitable are the proposed benchmarks for success and methods for tracking the use of each core? How strong are the plans for implementing the EAC's recommendations?
• How suitable are plans to work with the IDeA-CTR cores to identify needed expertise and to recruit faculty, staff, and/or clinician fellows to the organization(s)? 

PD Core

• How appropriate are the plans to interface with other IDeA-CTR Cores to select topics for workshops, seminars, and training, to enhance the knowledge base and competency of investigators, research and clinical staff, biostatistician, methodology experts, clinical trial experts, and community members:
  • For conducting C&T research?
  • For ensuring statistical rigor and robust research design and biostatistical methodology?
  • To prepare them to carry out community-engaged research?
  • To prepare them to carry out human subjects and clinical trial research?
  • To prepare mentors to provide suitable scientific and career development advice to investigators and clinician fellows and, as applicable, to project leads of clinical trials?
  • To prepare reviewers to conduct unbiased reviews of HRP applications?
• To what extent will the PD Core provide staff from other cores with opportunities to maintain and enhance their expertise? 

CEO Core

• To what extent will the proposed communication strategies engage and connect communities, community clinics or clinics of PBRNs, investigators, leadership and staff for their mutual benefit?
• How strong are the plans to engage community advisory boards to identify and prioritize the health issues and concerns of the organization's or the network's communities and populations?
• To what extent will the CEO Core assist investigators in developing culturally appropriate community-engaged research projects and facilitate the recruitment and retention of research participants?

RDCD Core

• Is the Core appropriately designed to assist investigators in developing suitable research protocols, and how well-suited is the RDCD Core for providing advice on the assessment and mitigation of risk to human subjects, safety protocols, regulatory compliance, and the selection of appropriate intervention models?
• How well-suited is the RDCD Core to leverage the use of biostatisticians, methodologists, and clinical trial experts to provide sound methodological feedback on research designs, power analysis, and statistical analysis plans?
• How strong are the proposed processes for accessing, curating and using clinical database(s) or EHRs or RWDs for research, their management and use, and the protection of personal health information? How robust are the proposed processes for developing real-world data research and the supporting infrastructure for cutting-edge tools use, or for maintaining or establishing necessary technology research infrastructure, if applicable?

HR Core

• How strong are the communication strategies to engage investigators at different career stages from a variety of disciplines or across the center?
• How well designed are the plans for ensuring adequate and effective RPP and HRP research investigators? Will completion of the RPP lead to improved rigor of the HRPs and enhanced C&T research capacity at the organization?
• How well-developed are the plans to solicit, review and select:
  • Investigators who will complete the RPP?
  • Developmental Projects?
  • Multi-Site Collaborative Projects (CTR-N only) that lead to more extensive collaborations and address important health concerns?
• How suitable is the plan for distributing support between the RPP, DP and (if applicable) MCP, to meet the needs of the organization(s)? How likely is it that the plan will lead to an increase in external funding for C&T research or establish a pipeline of future investigators?
• How strong are the plans to pair Developmental Project investigators proposing clinical trials with mentors who are experienced clinician scientists?
• How well-designed are the plans to ensure the safety of study participants and compliance with applicable federal, state, local and organizational laws, regulations and policies?
• In the CTR-D track: How adequate is the planned timeline for developing the capacity-building cores (AC, PD, CEO, RDCD)?
• In the CTR-N track: If the applicant proposes not to phase-in the establishment and activities of the cores AC, PD, CEO, RDCD, how adequate are the rationale and justification for the approach?

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by CSR, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Relevance of the proposed project to programmatic priorities.
• Potential to serve the population of the state(s) and address their most urgent health concerns.  
• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Geographical distribution among IDeA-eligible states.
• Availability of funds.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant's federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant's integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 "Federal awarding agency review of risk posed by applicants."  This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access their Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient's business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain "applicable clinical trials" on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient organizations must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

Post-Award Program Requirements

Prior Approval of HR Core Projects

• All HRPs require prior approval by NIH prior to initiation. Submission of the prior approval request is due to NIGMS between October 15 and January 15. Post-award applications submitted before the designated window will not be reviewed until that window opens, and those submitted after the window will not be reviewed or approved.
• The recipient organization must comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval.
• The recipient organization must provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies
• NIGMS strongly encourages the use of the Smart IRB platform for collaborative projects involving human subjects.
• Per NOT-OD-26-026, all prior approval requests must be submitted using the eRA Prior Approval Module. 

Using SF424 forms and instructions, only the following sections need to be submitted:

• Face page (signed by organizational signing official)
• Biographical Sketch Common Form for the HRP lead and
• Biographical Sketch Common Form for the mentor, if applicable
• Updated Other Support for the project lead
• Updated Other Support for the mentor, if applicable
• Project Summary
• Detailed budget and budget justification
  • For MCPs, the budget should indicate where early funding is used to meet specific year 1 benchmarks in preparation for research – such as data use agreements, protocol development, informed consent and assent, IRB approval, and IND/IDE approval – with more substantial funding release once those benchmarks have been met.
  • Identify the early benchmarks and provide an anticipated timeline for their completion.
• Specific Aims
• Research Strategy (up to 6 pages): The following three sections comprise the Research Strategy: Significance, Innovation, and Approach. The Research Strategy must include:
  • The significance of the problem being studied in the state or network, the need for the study, and the potential impact of the results of the study, as well as how the study will test the hypothesis or hypotheses being proposed.
  • A concise description of the overall strategy, methodology and analyses to be used to accomplish the goals and specific aims of the study.
  • Sufficient details of the study, such as study design, primary objective, inclusion and exclusion criteria, proposed study population, proposed study agent(s).
    • For CTs, include preliminary sample size, clinical end points, duration of recruitment and follow-up to allow assessment of the likelihood that a feasible CT will be developed.
  • A description of the potential problems and alternative strategies.
  • Plan for a subsequent submission of peer-reviewed grant proposals and publications.
• Letters of Support:
  • Letter of Support from a senior organizational official demonstrating a clear commitment to support an independent (faculty) investigator.
  • Letter of Support from a department chair to support protected research time for clinicians, clinician scientists, and clinician fellows.
  • Report of Consultations and Outcomes (RCO) (3 page maximum): A letter of support from the EAC chair that:
    • indicates that the EAC concurs with the HRPs being recommended, along with the proposed career development and mentoring plan.
    • identifies the usage of capacity-building core(s) in the development of this HRP must be included. For example, specifying how the PD Core was accessed for regulatory or biostatistics training, or how the RDCD Core consultation improved research methodology. 
    • states that the research to be performed does not involve dangerous Gain of Function research (per NOT-OD-25-127).  
    • The RCO should identify how the RPP:
      • served to increase the scientific rigor, scientific knowledge and technical capacity to increase the chances of timely scientific progression.
      • aided in the development of required IRB protocol(s), or any other required assurances.
      • helped to identify a research mentor (if applicable), research team members, collaborators and other individuals needed to increase the success of the research project.
• Resource Sharing Plan (if applicable)
• Data Management and Sharing Plan (if applicable)
• Authentication of Key Biological and/or Chemical Resources (if applicable). See Notice NOT-OD-16-011 for details.
• Checklist Format Page with F&A cost breakdown.

If the proposed project involves human biospecimens or data, the application must include:

• Current PHS Human Subjects and Clinical Trials Information Form

If the proposed project involves Human Subjects, the application must include:

• Current PHS Human Subjects and Clinical Trials Information Form
• Institutional Review Board (IRB) approval
• Human Subjects Education Certification (required even when research is exempt)

If the proposed project involves Clinical Trials, the application must include:

• Current PHS Human Subjects and Clinical Trials Information Form
• IRB approval
• Documentation of Investigational New Drug/Investigational Device Exemption status for studies that are subject to FDA regulation
• Human Subjects Education Certification and GCP Training Certification
• Biosketches for the individual(s) responsible for the data and safety monitoring.
• For all CTs, in addition to the information requested in Section 3.3 of the PHS Human Subjects and Clinical Trials Information form, the awardee organization will provide NIGMS with:
  • a statement detailing the risks to study participants
  • the frequency of monitoring of clinical trial data and participant safety monitoring
  • the name(s) of the responsible party/parties for regulatory and legal compliance, adverse event reporting, and adherence to the HSCT form and NIH Data and Safety Monitoring Plan policies.
• At a minimum, an Independent Medical Monitor is required for all clinical trials. A Data and Safety Monitoring Board (DSMB) may also be used for oversight of Phase I or Phase II trials that: 
  • Have multiple sites of patient enrollment.
  • Test high-risk interventions.
  • Have more than 100 participants.
  • Involve special populations (for example, persons with impaired ability to consent).
• Valid analyses and a DSMB are required for NIH-defined Phase III Clinical Trials. Use NIH resources to assist in determining whether a CT is Phase II or Phase III, as defined by the NIH.

Note: For Human Subjects or CTs, the grant recipient must enter study data in the Human Subjects System (HSS) before requesting NIGMS approval. The HSS study record must exist at the time of post-award application submission to NIGMS.

If the proposed project involves Vertebrate Animals for a preclinical study, include:

• IACUC approval
• Vertebrate Animal Section
•  If a preclinical study uses animal models, the proposed study must explain:
  • why these studies are necessary,
  • why the study cannot be conducted using clinical research methods,
  • how the outcomes of the preclinical study will inform and lead to clinical research.

Research using animals models must be accompanied by a research plan which translates the preclinical research into a human subjects study.

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.

Applicants and recipients are strongly encouraged to refer to the NIH Director's Statement of Priorities, entitled "Advancing NIH's Mission Through a Unified Strategy." 

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

• ongoing and consistent access to HHS owned or operated information or operational technology systems; and
• receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Cybersecurity plans and procedures must at minimum include the following:

• Develop cybersecurity plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data:
  • Identify:
    • Develop an inventory of all assets and accounts with access to HHS owned and operated information or operational technology systems or which obtain PII or PHI for the purposes of the award.
  • Protect:
    • Limit access to HHS owned and operated systems to only those in need of access to complete reward activities.
    • Require all staff to complete annual cybersecurity and privacy awareness training. Visit 405(d): Knowledge on Demand (hhs.gov) to obtain free trainings, if needed.
    • Enable multifactor authentication for all employees, subrecipients, and third-party entities to access HHS owned and operated information or operational technology systems.
    • Regularly backup sensitive data and test backups.
  • Detect:
    • Install anti-virus or anti-malware software on all devices, servers, and accounts used to connect to HHS owned and operated systems.
  • Respond:
    • Develop an incident response plan. See Incident-Response-Plan-Basics_508c.pdf (cisa.gov) to learn about developing incident response plans.
    • Have cybersecurity incident reporting procedures that ensure the relevant HHS awarding agencies are notified of a cybersecurity incident within 48 hours of discovery. A cybersecurity incident is defined as an unplanned interruption to a technology service or reduction in the quality of a technology service, or an occurrence that actually or potentially jeopardizes the confidentiality, integrity, or availability of an information system or the information the system processes, stores, or transmits.
  • Recover:
    • Investigate incidents and plug any security gaps identified. 

All activities proposed in your application and budget narrative must align with applicable law, including but not limited to statutes, executive orders, federal regulations and applicable judicial holdings.  Accordingly, discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate; racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation; denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic; illegal immigration; or any other initiatives that compromise public safety.  If an application does not align, the application will not receive funding to the extent permitted by law and applicable court orders.

For applications involving substance abuse, the application must not support harm reduction. Please see Updated Funding Guidance for Recipients on Supplies and Services.

For applications involving funding Medication-Assisted Treatment (MAT) or medications for opioid use disorder (MOUD), this funding should be used to provide comprehensive treatment and recovery support services rather than medication-only models for opioid use disorder. Services should include medications, where clinically indicated, in conjunction with psychosocial and other treatment and recovery support services. Funding can also be used to support individualized tapering and discontinuation of medications when clinically indicated. Please see Updated Funding Guidance for Recipients on  MAT/MOUD.

As of October 1, 2025, HHS has adopted 2 CFR Part 200, with some modifications included in 2 CFR Part 300. These regulations replace those in 45 CFR Part 75. However, for NIH, under the Consolidated Appropriations Act for FY 2026, (P.L. 119-75, Division B, Title II, Sec. 224), the provisions relating to indirect costs in 45 CFR 75 continue to apply to NIH awards. Consistent with the statute, NIH will not apply updated thresholds outlined within 2 CFR Part 200, at this time.

In administering programs under this and all funding announcements, NIH prioritizes: 

• Research involving rigorous scientific methods, including for studies related to children and adolescents, where NIH is committed to approaches that reflect the highest standards of clinical care and child safety. 
• Biological and physiological integrity: Recognizing the relevance of biological sex to health outcomes, NIH encourages applicants to account for sex-based health factors in program design, data collection, and service delivery where scientifically appropriate.
• NIH will implement these priorities consistent with applicable laws, regulations, court orders, and all required administrative procedures. Applicants are encouraged to describe how their proposed programs align with these priorities in their project narratives. Funded activities must advance NIH's vision of protecting and improving the health and well-being of Americans. The particular focus is on those who are medically vulnerable, or live in areas with limited access to care. NIH's duty is to serve wisely, effectively, and with measurable results that justify every taxpayer dollar invested. 

Not Applicable

3. Data Management and Sharing

A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format.. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

• When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

5. Evaluation

In carrying out the stewardship of grant programs, NIGMS will periodically evaluate the IDeA-CTR program employing the representative measures identified below. In assessing the effectiveness of research capacity building investments, NIGMS may use information from progress reports and public databases, PDs/PIs, and from participants themselves. Where necessary, PDs/PIs and participants may be appropriately contacted after the completion of the grant period for updates on participants' subsequent outcomes. The overall evaluation of the program will be based on metrics that may include, but are not limited to, the following:

•  Indicators of network, organizational and investigator capacity building, such as
  • Development of investigators and clinician fellows 
  • Improved access to scientific research infrastructure 
  • Subsequent submission of HRPs after completing the RPP'
  • Subsequent submission of peer-reviewed grant proposals (for example, K-awards, RPGs) 
  • Subsequent external independent funding obtained by participants in the program 
  • Subsequent implementation of research findings across the organization, partners, or the state to inform evidence-based practices and policy.
• Characteristics of the applicant and awardee pool for the program, such as: 
  • Geographic distribution 
  • Organization types 
• Indicators of scientific productivity and impact among program or network organizations, such as: 
  • Peer-reviewed research publications and citations 
  • Conference presentations 
  • A number of clinical trials and complex observational studies conducted 
  • Utilization of the I-CRRC: 
    • Tracking the number of Clinical Trial participation and the number of participants in the Clinical Research Coordinator Certificate(s) 
    • Real-World Data-enabled activities attributable to IDeA Clinical Research Resource Center (I-CRRC) engagement, such as relevant grant submissions, funded awards, and dissemination efforts
• Indicators of research or research network development and collaboration, such as: 
  • Number and characteristics of partner organizations 
  • Resources shared among partner organizations 
  • Research collaborations established across lead organizations and with other IDeA organizations (CTR-D) or network organizations and with non-network IDeA organizations (CTR-N) 
  • Engagement with PBRNs or community clinics to expand resources, expertise, and funding opportunities
  • Number of HRP submissions by PBRN or community clinic investigators

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk - Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues.

Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).

NIGMS IDeA CTR
National Institute of General Medical Sciences (NIGMS) 
Email:  NIGMS_IDeA-CTR@mail.nih.gov

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

National Institute of General Medical Sciences (NIGMS)
Email:  NIGMSRCBGABNOFO@nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.