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 Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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.
   
   



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

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 the 23 U.S. states and Puerto Rico that had historically low NIH grant funding success rates. IDeA funding programs collectively 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.

The IDeA Clinical & Translational Research programs build clinical and translational (C&T) research capacity to enable research on diseases and health challenges prevalent in IDeA states. This Notice of Funding Opportunity (NOFO) supports IDeA Clinical and Translational Research Development (CTR-D) awards that focus on C&T research workforce development and infrastructure enhancement at health research organizations in IDeA-eligible states that have limited clinical research capacity. Parallel to this NOFO, PAR-23-241 supports IDeA Clinical & Translational Research Network (CTR-N, P50) awards that support statewide or multi-state networks of health research organizations to expand existing infrastructure, develop the research workforce to enhance the network organizations ability to design and implement competitive C&T research programs, and coordinate clinical research activities state-wide and/or across IDeA states. In addition, an IDeA-Clinical Research Resource Center (I-CRRC) has been funded to develop clinical research coordinators in IDeA states and to improve clinical research and clinical trials in IDeA states, including those affiliated with CTR-Ns and CTR-Ds.

To maximize the impact of the capacity building investment, an organization may participate in only one CTR-D, CTR-N, or IDeA-CTR award at a time; see Section III. Eligibility Information for details. Additionally, an organization may only receive funding from one CTR-D. In keeping with the goals of the CTR-D program, applications with a narrow disease or population focus will not be accepted for review.

Program Description and Requirements

Applicant Organizations and Program Leadership

Applicants to this NOFO are expected to be health research organizations committed to CTR-D's goal of developing C&T research capacity. Applicant organizations are encouraged to partner with other eligible health research organizations or healthcare delivery organizations that desire to engage in clinical research. Applicant organizations should have a well-established research administration infrastructure that can effectively manage C&T research projects and potentially administer sub-awards made to other organizations. CTR-D partner organizations must substantively participate in CTR-D activities and contribute to the program’s mission. CTR-D programs are encouraged to work with community clinics, such as those of the Practice-Based Research Network (PBRN), with the goal of engaging their clinical staff and patients in research.

An established investigator, or investigators for multiple PD/PI (multi-PI) applications, with a track record of external funding in C&T research is expected to lead the CTR-D program as the Program Director/Principal Investigator (PD/PI). The PD(s)/PI(s) should also have the leadership experience to work across organizational boundaries and to have mentoring experience in fostering the development of a C&T research workforce

Three committees are required to assist the PD/PI’s leadership:

1. Steering Committee (SC): The SC is composed of the PD(s)/PI(s) and one senior institutional leader (President, Vice President, Provost, Dean or equivalent) from each lead and partner organization. The SC is charged with ensuring the CTR-D program’s adherence to its mission in building C&T research capacity and maintaining each organization’s support for participation of their workforce in CTR-D activities.
2. Executive Committee (EC): The EC is composed of the PD(s)/PI(s), a representative from each partner organization if applicable, and other key personnel appointed by the PD(s)/PI(s) to assist in administering the award.
3. External Advisory Committee (EAC): The EAC is composed of 3-5 experts outside the state who provide advice on critical scientific activities and administrative decisions.

See Section IV for Composition and Responsibilities of each Committee.

CTR-D Program Components

Each CTR-D application must include an Overall Plan and the following 5 cores:

• Administrative Core (AC)
• Professional Development (PD) Core
• Community Engagement and Outreach (CEO) Core
• Research Design, Compliance, and Data Management (RDCD) Core
• Health Research (HR) Core

The primary goal of a CTR-D is to build C&T research capacity. All Cores must contribute to this goal through consistent efforts to develop infrastructure, expertise, and workforce in their respective responsibility areas. Core services should be made available to all investigators of the CTR-D organization(s) and provide facilities and/or services that are not duplicative of existing services or facilities in the organization(s). Upgrading existing research facilities, including those supported by other IDeA programs (e.g. INBRE, COBRE) is encouraged. All components are expected to interact with each other and leverage relevant existing resources of the applicant organization and any partner organizations to support the development of a well-integrated research environment.

Overall Plan: The applicant should describe the major health challenges of the populations the CTR-D will serve and how the program will build C&T research capacity with a goal of addressing those challenges. The primary focus of the CTR-D should be on building the needed workforce, expertise and infrastructure at the participating organization(s) to conduct well-designed and impactful C&T research. The plan should demonstrate that the applicant organization’s strategic priorities for growing its C&T research capacity align with the goals of the CTR-D, and that all cores will work together cohesively to develop workforce and infrastructure for C&T research. Because CTR-D awards are primarily intended to support organizations with limited existing C&T research capacity, the activities of the cores can be phased in such that the AC, PD, and CEO cores first lay the groundwork that allows the RDCD and HR cores to follow and ramp up as capacity is developed.

Administrative (AC) Core: The AC administers the CTR-D 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 with existing strengths and resources. The AC core assesses the C&T research capacity building needs of the organization(s) and develops and executes plans needed to meet those needs, including the recruitment of additional faculty, staff, and/or clinical fellows and the establishment of necessary infrastructure. Additionally, the AC core coordinates the activities of all organizations, participating departmental units, cores, and committees, manages the CTR-D budget, prepares accurate and timely program and financial reports, conducts annual performance evaluations of the program, and carries out other functions required to implement the CTR-D’s overall plan. The PD/PI (or the contact PD/PI for a multi-PI application) is expected to lead the AC.

Professional Development (PD) Core: The PD Core oversees workforce development for the CTR-D. The PD Core collaborates with other CTR-D cores to assess needs for additional expertise in their respective functional areas and ensures that training and mentoring activities in these areas are provided. For example, the PD Core is expected to work with the RDCD Core to offer training on federal and institutional policies for research involving human subjects, vertebrate animals, and/or biohazards. The PD Core also organizes and sponsors professional development activities such as research seminar series, grant-writing workshops, skills training, and mentoring guidance. These activities should be tailored to meet the specific needs of the CTR-D's C&T research workforce, which includes investigators who are eligible for funding through the CTR-D's Health Research Core and members of their research teams.

Community Engagement and Outreach (CEO) Core: The CEO Core leads the engagement with community groups and state organizations to understand the health research needs and challenges of the population across the state and/or in local regions. This information is used by the CTR-D leadership and cores in designing its capacity building and research programs. The CEO Core Lead works together with the PD Core to develop the relevant expertise of CEO staff and mentors the CEO staff to develop their skills and prepare them for community outreach. The CEO Core also engages with the clinical staff and patients from community clinics to familiarize them with research. The CEO Core promotes multi-directional engagement among researchers and community groups to build trust and ensure that health concerns of the community are among the top research priorities for investigators supported by the CTR-D program. The CEO Core assists CTR-D researchers and staff in developing cultural respect and knowledge regarding assessment, measurement and research design, and offers strategies to increase the recruitment and retention of diverse populations in clinical research.

Research Design, Compliance and Data Management (RDCD) Core: The RDCD Core provides CTR-D investigators with expertise needed to design research protocols with sufficient statistical power to ensure rigor and avoid methodological bias. The RDCD Core Lead works with the PD Core to develop the expertise of core staff and provides guidance and mentoring that prepares staff for assisting CTR-D investigators and professional staff on conducting human subjects research, including risk assessment, safety, intervention models, and federal regulatory and reporting requirements. Through providing guidance and service, the RDCD Core is responsible for ensuring compliance with NIH and institutional data management policies to safeguard protected health information. In addition, the RDCD Core is expected to establish or enhance procedures to facilitate the use of Electronic Health Records (EHR) for research. It is responsible for dataset curation and for providing data analytic and biostatistical assistance to investigators in developing database queries, validating research results and preventing methodological bias, and for recommending related equipment and data platform purchases or upgrades.

Health Research (HR) Core: The HR Core manages all research supported by the CTR-D. It supports two types of projects with the goal of developing a C&T workforce and strengthening investigator-initiated C&T research.

• Pilot Projects: These are one-year feasibility pilots to allow investigators to test ideas suitable for development into independent applications such as NIH career development (K-series) or small/developmental research project grant (RPG) awards. A feasibility pilot may be led either by an independent investigator or by a clinician fellow working with a research mentor. The budget for an individual Pilot Project is $50,000-$100,000 in annual direct costs.
• Developmental Projects: These are 2-year projects suitable for developing into investigator-initiated applications such as NIH R01-equivalent RPGs with additional data. A Developmental Project should be led by an independent investigator with the background and scientific expertise necessary to lead the proposed research. The maximum budget for a Developmental Project is $100,000 in annual direct costs.

The HR Core is responsible for establishing appropriate mechanisms to administer these projects, including soliciting applications, arranging for their review, and selecting meritorious applications for funding; with priority given to investigations of diseases that affect CTR-D populations or involve collaborations of basic, clinical, and translational researchers. The HR Core is expected to be led by an experienced clinical researcher, who will provide mentoring to investigators funded by the HR Core and, where feasible, coordinate large-scale clinical studies. The HR Core Lead will also work with the PD Core to identify relevant topics and deliver training that prepare investigators to conduct C&T research.

See Section VI. Award Administration Information for details on submitting HR Research Projects for NIH approval.

Plan for Enhancing Diverse Perspectives (PEDP) (required):

NIGMS recognizes that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. There are many benefits that flow from a diverse scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from research, and enhancing public trust.

To support the best science, NIGMS encourages inclusivity in research. Examples of structures that promote diverse perspectives include but are not limited to:

• Transdisciplinary research projects and collaborations among program institutions in all biomedical research areas, including fields such as computational biology, physics, engineering, mathematics, computer and data sciences, as well as bioethics.
• Engagement from different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Individual applications and partnerships that enhance geographic and regional heterogeneity.
• Investigators and teams composed of researchers at different career stages.
• Participation of individuals from diverse backgrounds, including groups historically underrepresented in the biomedical, behavioral, and clinical research workforce (see NOT-OD-20-031), such as underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women.

This NOFO requires a PEDP as part of the application (see Section IV.2 SF424(R&R) Other Project Information. Other Attachments). Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material .

The examples listed above may be included if they are appropriate for the goals and requirements of the CTR-D program.

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

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

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

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

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

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

Additional Eligibility Criteria for Lead Organizations

To be eligible to submit a CTR-D application as the lead/applicant organization, an organization must meet each of the following criteria:

• Is located in an IDeA-eligible state, commonwealth, or jurisdiction, which are 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; and
• Holds externally funded C&T research grants; and
• At the time of submission:
  • Is not a lead or partner organization of an active CTR-D, CTR-N, IDeA-CTR or Clinical and Translational Science Award (CTSA) Hub award; and
  • Is not located in a state with an active CTR-D, CTR-N, or IDeA-CTR award.

Additional Eligibility Criteria for Partner Organizations

To be eligible to participate in a CTR-D as a partner organization, the organization must meet each of the following criteria:

• Is located in an IDeA-eligible state, commonwealth, or jurisdiction, which are 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; and
• Is not a lead or partner organization of an active CTR-N, IDeA-CTR, or CTSA Hub award.

Active awards include those in no-cost extension.

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

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) 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. The NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• 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.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an 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. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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 SF424 (R&R) Application Guide.

At the time of submission, the primary appointment of the contact PD/PI must be at the applicant institution. A CTR-D PD/PI may not simultaneously lead an IDeA COBRE or INBRE award.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

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

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 and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations

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

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Facilities and Other Resources: Resources including equipment and instrumentation at the applicant/lead and as applicable, partner organizations that support C&T research activities should be described.

Other Attachments: The application must include the following attachment:

Plan for Enhancing Diverse Perspectives (PEDP) (1-page maximum): In an Other Attachment entitled Plan for Enhancing Diverse Perspectives , all applications must include a summary of strategies to advance the scientific and technical merit of the proposed program through expanded inclusivity. The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicants should align their description with these required elements within the Research Strategy section. The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the program aims are structured. The PEDP should include a timeline and milestones for relevant components that will be considered as part of the review. Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:

• Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Description of any planned partnerships that may enhance geographic and regional diversity.
• Plan to enhance recruiting of women and individuals from groups historically underrepresented in the biomedical, behavioral, and clinical research workforce.
• Proposed monitoring activities to identify and measure PEDP progress benchmarks.
• Plan to utilize the program infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers.
• Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers, and co-investigators from diverse backgrounds.
• Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research questions.
• Publication plan that enumerates planned manuscripts and proposed lead authorship.
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse backgrounds, including those from underrepresented groups in research.

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.

In the Personal Statement of the Biographical sketch, each PD/PI should describe their experience in leading a C&T research program, including involvement with clinical research, their administrative experience in working across departments and/or other types of organizational units and as applicable, with other organizations, and prior mentoring experience in fostering the development of a clinical research workforce including independent investigators.

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.

Specific Aims: Provide Specific Aims for the CTR-D program.

Research Strategy: Provide the Overall Plan for the CTR-D program, which must include the following sections, as applicable:

A. Goals of the CTR-D Program: Describe the goals of the CTR-D program and the roles of the applicant and, as applicable, any partner organizations in meeting those goals. Key elements to include are:

• The overall goals of the CTR-D.
• A description for the applicant organization and, as applicable, any partner organizations, of how the CTR-D goals align with their strategic priorities, the barriers each organization faces to conducting C&T research, and how each organization will contribute to accomplishing the CTR-D's goals.
• Innovative approaches to overcome barriers and strengthen C&T research at the applicant organization and as applicable, partner organizations, including:
  • Plans to increase interest among faculty in conducting C&T research on health challenges that impact the population served by the CTR-D.
  • Plans for developing and/or strengthening collaborations within and as applicable across the participating CTR-D organizations and with community clinics.
• Plans to collaborate with and leverage resources and infrastructure of other awards supported by the IDeA program at the CTR-D participating organization(s) (e.g., INBRE and COBRE) and/or with other organizations in IDeA states, including other NIH-funded C&T programs (e.g., other CTR-N, CTR-D, CTSA or I-CRRC).

B. Organizational Structure and Governance Model: The applicant should provide a clear organizational structure of the CTR-D that illustrates the relationships among the applicant and, as applicable, partner organizations, participating departmental/organizational units, cores, and committees. Key elements to include are:

• The applicant organization's research administration infrastructure, its suitability for administering the CTR-D award and any needed subcontracts, and its experience in managing research involving human subjects and vertebrate animals.
• The externally funded C&T research base, including any participation in clinical trials, for the applicant and any partner organizations. Describe areas of C&T research expertise of faculty-level investigators and how their expertise will contribute to the goals of the CTR-D program.
• A description of the required CTR-D committees that will assist the PD(s)/PI(s) in administering the award:
  • Steering Committee (SC): The SC is composed of the PD(s)/PI(s) and one senior institutional leader (President, Vice President, Provost, Dean or equivalent) from each lead and partner organization. The PD/PI (or the contact PD/PI) of the CTR-D award serves as the Chair. The SC should be consulted for decisions with program-wide impact, such as changes to organizational membership, appointment of the EAC Chair, and alterations of program priorities and key policies, to ensure the program’s adherence to the CTR-D’s mission in building C&T research capacity. As senior leaders of their respective organizations, the SC members also assure their organizations' commitments to supporting their workforces' participation in CTR-D activities and developing/sharing C&T research resources. An operating plan for the SC, including the names and positions of its members, should be provided.
  • Executive Committee (EC): The EC is composed of the PD(s)/PI(s), a representative from each partner organization, if applicable, and other key personnel appointed by the PD(s)/PI(s) who have critical roles in administering the award. The PD/PI (the contact PD/PI in cases of multi-PI applications) should serve as Chair of the EC. The EC assists the PD(s)/PI(s) in establishing policies, developing initiatives, overseeing components of the CTR-D, making funding recommendations, and coordinating program-wide activities, and must submit annual progress reports to the EAC. An operating plan for the EC, including the names and positions of its members, should be provided.
  • External Advisory Committee (EAC): The EAC is composed of 3-5 experts in C&T research from outside the state. The EAC chair is appointed by the PD(s)/PI(s) in consultation with the SC. Other EAC members are appointed by the PD(s)/PI(s). The EAC reviews the annual CTR-D progress report provided by EC and provides feedback for improvement to the PD(s)/PI(s) and the SC through its annual assessment report. The EAC also assesses all research projects of the HR Core prior to their submission to the NIH for approval. An operating plan for the EAC should be provided that includes a description of the process for filling EAC vacancies and a 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.
• A management plan for the CTR-D, which should include a description of:
  • How each organization and/or organizational component (as applicable) will have input and participate in decision-making and how ongoing communication will be maintained.
  • How the committees will work with each other and with the CTR-D components to accomplish the goals of the program.
• If the establishment and activities of the cores will be phased, with the RDCD and HR cores starting after the other cores, a clear rationale and plan should be provided.
• Interactions between and among the PD(s)/PI(s) and Core Leads, who must be experienced personnel with the requisite stature, knowledge, authority, leadership, administrative skills and capabilities to direct the resources, which includes leading a team that provides services to investigators and being responsible for:
  • Developing or improving standard operating procedures governing the utilization and management of core expertise and resources;
  • Developing or improving plans for disseminating information, training, and serving as subject-matter-experts to investigators;
  • Maintaining state-of-the-art technologies and knowledge capabilities; and
  • Recommending to the CTR-D PD(s)/PI(s) and the EC any technology updates and/or replacement of equipment.

Letters of Support: A letter of support from a senior official of the applicant organization and, as applicable, each partner organization is expected to demonstrate institutional commitment for the CTR-D program. Each letter should:

• Commit the organization to the CTR-D's goals and describe how the CTR-D's goals align with the organization's strategic priorities.
• Describe the commitment of specific resources, which may include support for hiring new investigators, clinical and core support staff, and/or investment in the infrastructure needed to conduct C&T research. Specific commitments to cores or other components should be summarized in a table.

Letters from the PD(s)/PI(s) of other NIH IDeA awards describing how their programs will support the CTR-D program and its goals may be included. Additional letters addressing substantive and specific needs of the CTR-D program may also be included.

Resource Sharing Plan:
Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) 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 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, 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 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.

PHS Assignment Request Form (Overall)

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

Administrative Core

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)

Enter Human Embryonic Stem Cells in each relevant component.

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 Administrative 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 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 Profiles Format Page 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 the PD/PI. 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; the allowable support for all PD(s)/PI(s) remains at 6.0 person-months effort collectively.
• A PD/PI may not use CTR-D funds to supplement research activities for their own research projects or research team and is not eligible to serve as a project lead on the CTR-D award nor other IDeA awards including COBRE, INBRE, CTR-N, CTR-D, or IDeA-CTR awards.
• Funds may be requested to support staff to lead or implement critical functions of the core such as managing the budget and conducting annual program evaluations.
• Funds may be used to assist with the recruitment of additional faculty, staff or clinical fellows 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.
• Funds may be requested for the EAC, including travel costs and compensation to EAC members as consultants via a fee-for-service arrangement.
• Funds may be requested to compensate EC members for their service to the CTR-D program.
• Funds cannot be used by or for collaborators at organizations in non-IDeA states or at foreign sites. However, funds may be used in other IDeA and non-IDeA states and at foreign sites for fee-for-service activities such as learning new techniques, sample and data analysis, workshops, etc.
• Funds should be requested for the PD(s)/PI(s) and other key personnel funded through this NOFO to attend the National IDeA Symposium of Biomedical Research Excellence (NISBRE) biennial meetings.
• PEDP implementation costs: Budget request may include allowable costs associated with PEDP implementation, as outlined in the Grants Policy Statement.

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)

Introduction to Application: For Resubmission applications, an Introduction to Application attachment is allowed for each component.

Specific Aims: Provide the Specific Aims for the Administrative Core (AC).

Research Strategy: The Administrative Core administers the CTR-D award. This section should describe:

• Plans for managing, coordinating, integrating and overseeing the entire range of CTR-D activities, and for implementing effective and timely communication among the lead organization, any partner organizations, core leads/directors, investigators, and program staff.
• Plans to assess the needs of CTR-D Cores and build relevant capacities so that expertise, training and suitable mentorship is available to support C&T research.
• The plan for coordinating and supporting the activities of the SC, EC and EAC committees.
• The plan for coordinating activities supported by the AC and other components, especially the PD Core and those that involve more than one Core.
• A financial management plan that provides scientific and fiscal flexibility to enhance C&T research, establish or strengthen relations with the community clinics, and respond to emerging health research needs of its population.
• A plan to provide accurate and timely progress reports to the NIH.
• An overall Evaluation Plan including metrics, milestones, benchmarks, and timelines to annually monitor and evaluate the individual performance of each CTR-D component and assess the overall impact of the award. The Evaluation Plan should propose methods to track the utilization of core resources and for adapting to the needs of investigators.
• A process for providing the annual evaluation to the EAC and implementing its recommendations should be included.

Letters of Support: Not allowed. Institutional Letters of Support, including support for the Administrative Core, should be 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 SF424 (R&R) Application Guide.

Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Professional Development (PD) Core

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)

Enter Human Embryonic Stem Cells in each relevant component.

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 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 may be requested to cover the salaries of the core's staff to provide services to the program's investigators.
• Funds may be requested to hire consultants and provide access to training resources and materials for CTR-D participants.
• In addition to personnel and supply costs, the acquisition and/or modernization of new equipment may be proposed.
• Funds to support scientific and professional development activities such as seminar series, workshops, training, and retreats may be requested.

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)

Introduction to Application: For Resubmission applications, an Introduction to Application attachment is allowed for each component.

Specific Aims: Provide the specific aims for the PD Core.

Research Strategy: This section should include the following elements:

• Roles and responsibilities of Core Lead and staff and plans for the recruitment of appropriate personnel.
• Core description, services, and operating procedures that reach investigators at all CTR-D organizations.
• Plans for the coordination with other CTR-D Cores to offer professional development activities affiliated with those Cores.
• A description of professional development workshops, training, and educational opportunities that address the specific needs of the C&T research workforce. This includes investigators and their research staff, mentors, CTR-D Core staff, clinical fellows, and community clinic staff. For each planned activity, identify the intended audience. Relevant topics include but are not limited to:
  • Federal and institutional policies, rules, and guidelines for research involving human subjects, clinical trials, vertebrate animals, and biohazards.
  • Protocol design that avoids bias, ensures rigor, and manages risk to participants.
  • The curation and use of large clinical datasets for research.
  • Management of protected health information.
  • Development of cultural respect and other strategies that foster the respectful engagement of the program's communities in research.
  • Training for mentors in best practices for providing scientific advice and career development guidance to clinician fellows, and as applicable to project leads of clinical trials.

Letters of Support: Only letters of support specific to the PD Core are allowed. Do not include letters from lead or partner organizations that describe support for the PD Core this support should be described in the Institutional 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 SF424 (R&R) Application Guide.

Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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

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)

Enter Human Embryonic Stem Cells in each relevant component.

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 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-months annually to direct the core.
• Funds may be requested to cover the salaries of the core's staff to provide services to the program's investigators.
• In addition to personnel and supply costs, the acquisition and/or modernization of new equipment may be proposed.
• Funds may be requested to establish or strengthen connections to community clinics (e.g., a PBRN) and to develop communication mechanisms among CTR-D investigators and the clinical staff and patients of community clinics and PBRNs, to define research capacity building goals and further research related to the needs of the state's population.

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)

Introduction to Application: For Resubmission applications, an Introduction to Application attachment is allowed for each component.

Specific Aims: Provide the specific aims for the CEO Core.

Research Strategy: This section should include the following elements:

• Roles and responsibilities of Core Lead and staff, and any plans for the recruitment of additional personnel.
• In conjunction with the PD Core, plans to assess the available expertise and additional needs of the CEO Core, and to offer training and resources to develop investigator competence in conducting community-engaged research, which might include:
  • Strategies for communicating with and promoting research participation of diverse populations and community groups.
  • Cultural respect training for CTR-D investigators and research staff.
• Plans for engaging community clinics.
• Plans to help integrate community engagement into the CTR-D's leadership, planning, capacity building, and research, including establishing or enhancing community advisory boards for identifying and prioritizing health issues and concerns of communities and the population served by the CTR-D.
• Strategies for providing assistance to investigators with the recruitment and retention of research participants.

Letters of Support: Only letters of support specific to the CEO Core are allowed. Do not include letters from lead or partner organizations that describe support for the CEO Core - this support should be described in the Institutional 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 SF424 (R&R) Application Guide.

Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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

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 (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)

Enter Human Embryonic Stem Cells in each relevant component.

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 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 (RDCD 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 may be requested to cover the salaries of the core's staff to provide services to the program's investigators.
• Funds may be requested to hire consultants and provide access to training activities and resources to develop the skills and knowledge of CTR-D participants in areas related to the RDCD core's mission, in conjunction with the PD core.
• In addition to personnel costs, the acquisition and/or modernization of new equipment may be proposed.
• Funds may be used to prepare and maintain large clinical datasets (EHR, medical images, biospecimens from biorepositories, etc) for research use, including data curation and integration across datasets. 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)

Introduction to Application: For Resubmission applications, an Introduction to Application attachment is allowed for each component.

Specific Aims: Provide the specific aims of the RDCD Core.

Research Strategy: This section should include the following elements:

• Roles and responsibilities of the Core Lead and staff, and any plans for the recruitment of additional personnel.
• If the activities of the RDCD Core will be ramped up over time, provide a rationale and explain how the phased approach is beneficial to accomplishing the goals of the CTR-D.
• In conjunction with the PD Core, plans to assess the available expertise and additional needs of the RDCD Core, and to offer training and resources to develop investigator competence in conducting C&T research, especially:
  • Management of clinical research, knowledge of federal and institutional policies, rules, and guidelines for research involving human subjects, clinical trials, vertebrate animals, and biohazards.
  • Protocol design that avoids bias, ensures rigor, and manages risk to participants.
  • The curation and use of large clinical datasets for research.

• Plans to provide investigators with assistance on research design, clinical protocols and risk assessment, intervention models and biostatistical analyses, and federal and institutional regulatory requirements.

• Plans for establishing or enhancing procedures to facilitate the use of Electronic Health Records (EHR) for research, including the purchase or upgrading of data platforms and related equipment.
• Plans for dataset curation and management, including:
  • Descriptions of software, approaches to data cleaning and harmonization, and Common Data Model(s) that are or will be used by the CTR-D organization(s).
• A summary of how EHR is currently or will be obtained, managed, and accessed, including the processes for managing patient consent, de-identification, and IRB approval, and any plans for improving the workflow.
• Plans for working with researchers to provide expertise for querying databases, validating research results, and identifying and removing existing biases in the datasets.
• Plans to safeguard personal protected health information.

Letters of Support: Only letters of support specific to the RDCD Core are allowed. Do not include letters from lead or partner organizations that describe support for the RDCD Core. This support should be described in the Institutional 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 SF424 (R&R) Application Guide.

Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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

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 (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)

Enter Human Embryonic Stem Cells in each relevant component.

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 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 (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 annually to direct the core.
• Funds may be requested to cover the salaries of the core's staff to provide services to the program's investigators.
• In addition to personnel and supply costs, the acquisition and/or modernization of new equipment may be proposed.
• Direct costs of up to $500,000 annually may be requested to support the HR Core's research projects. The budget should only include a placeholder for the HR Core's research projects as prior approval is required before a project can begin; see Section VI. Post-Award Program Requirements.
  • The budget for an individual Pilot Project is $50,000-$100,000 in annual direct costs.
  • Up to $100,000 in annual direct costs may be requested to support an individual Developmental Project with a duration of up to 2 years.
• Restrictions:
  • Funds cannot be used for graduate student or postdoctoral stipends, but students and postdocs may receive salary support as research staff from an awarded project.
  • Postdoctoral scholars and others holding non-independent positions are not eligible to lead any HR Core projects, except clinician fellows, who may lead Pilot Projects.
  • Projects may not overlap with ongoing funded projects of the project leads.
  • HR project leads may not receive simultaneous research support as project leads from this and another IDeA parent award (e.g., COBRE, INBRE, IDeA-CTR, CTR-N, or CTR-D), but may be eligible to serve as a project lead of a supplement to an IDeA 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)

Introduction to Application: For Resubmission applications, an Introduction to Application attachment is allowed for each component.

Specific Aims: Provide the specific aims for the HR Core.

Research Strategy: This section should include the following elements:

• Roles and responsibilities of Core Lead and staff, and any plans for the recruitment of appropriate personnel.
• In conjunction with the PD Core, plans to assess the available expertise and additional needs of the HR Core, and to offer training and resources to develop investigator competence in conducting C&T research, which may include:
  • Training on the development of a C&T research concept into a successful HR Pilot or Developmental Project, and subsequent application for independent external funding.
  • Training for mentors in best practices for providing scientific advice and career development guidance.
  • Management and reporting requirements for HR projects funded by the CTR-D.
  • Training in the development of proposal solicitations and their unbiased review.
  • Plans for the HR Core to interface with other CTR-D cores to ensure that all project leads receive guidance on applicable federal and institutional policies and rules for research involving human subjects, vertebrate animals, and biohazards, as appropriate for the research.
• A description of how applications for each type of project will be solicited, reviewed, and selected for funding from the CTR-D organization(s) and investigators at different career stages from a variety of disciplines will be engaged.
• The approximate numbers of Pilot and Developmental Projects that will be supported each year, and a justification for how this distribution was selected .
• A description of how the two types of projects will be integrated to develop the participating organizations' clinical workforce.
• Plans to pair project leads of HR Core projects that involve clinical trials with experienced clinician scientists who serve as mentors.
• A plan for how HR Core staff will monitor projects to ensure study participant safety and that all federal, state, local and organizational regulatory requirements are met.

Note: Research plans for HR research projects should not be included in the application.

Letters of Support: Only letters of support specific to the HR Core are allowed. Do not include letters from lead or partner organizations that describe support for the HR Core - this support should be described in the Institutional Letters of Support included in the Overall Component.

Resource Sharing Plan: Applicants are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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 1. 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. Overview Information 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 the SF424 (R&R) 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.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) 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 the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and NIGMS. Applications that are incomplete or non-compliant will not be reviewed.

Applications must include a PEDP submitted as an Other Attachment on the SF424(R&R) Other Project Information form. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn without review.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the program 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 program 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 program that by its nature is not innovative may be essential to advance a field.

Significance

• What important problems or barriers to conducting C&T research have been identified? How will the plans to address these strengthen C&T research at the CTR-D organization(s)?
• How will the organization(s) contribute to the goals of the CTR-D program?
• To what extent do the efforts described in the Plan for Enhancing Diverse Perspectives further enhance the significance of the program?

Investigator(s)

• Are the PD(s)/PI(s) well suited to lead the CTR-D program? How does their prior scientific and administrative leadership experience prepare them to lead and integrate the components that comprise the CTR-D and to work across departments and organizational units, 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 multi-PI applications, to what extent are the leadership approach and arrangements for sharing responsibility appropriate for the CTR-D program?
• To what extent will the efforts described in the PEDP strengthen and enhance the expertise required for the program?

Innovation

• How innovative are the plans to build C&T research capacity within the CTR-D organization(s)?
• How innovative are the approaches for engaging more investigators in conducting C&T research?
• In what ways are the proposed plans to enhance communication, coordination, and/or collaboration among investigators and staff within and across the CTR-D's organizations, community clinics and other community groups innovative?
• To what extent will the efforts described in the PEDP meaningfully contribute to innovation?

Approach

• How effectively will the Overall Plan for the CTR-D program strengthen C&T research activities at the organization(s)?
• How well will community input and engagement be incorporated into the development of C&T research capacity?
• To what extent does the CTR-D's plans for sharing of resources and cross-collaborations leverage the resources of other NIH-supported programs such as COBREs and INBREs?
• Are plans to collaborate with other IDeA state organizations feasible, and to what extent will they strengthen the ability of CTR-D investigators to conduct collaborative C&T research studies?
• Are the roles of the SC, EC and EAC, clearly described and appropriate? How appropriate is the expertise of the members of the SC, EC, and EAC for their respective functions?
• To what extent will the CTR-D's organizational structure, governance model and governance plan, including communications with and among the SC, EC and EAC, and among CTR-D cores, enable synergistic collaboration and coordination to maximize the program’s success?
• If the applicant proposes to phase in the establishment and activities of the cores, how sound are the rationale and plans for doing this?
• Are the timeline and milestones associated with the PEDP well-developed and feasible?

Environment

• How suitable are the research and clinical infrastructures of the lead and, if applicable, partner organizations to effectively make use of the CTR-D?
• To what extent is the lead organization's research administration infrastructure appropriate for leading the CTR-D program?
• How adequate are the institutional commitments of the applicant and, as applicable, partner organizations for supporting the CTR-D's goals?
• To what extent do the CTR-D organization(s) have C&T research investigators and/or workforce who can benefit from the program's resources?
• To what extent will features of the environment described in the PEDP (e.g., collaborative arrangements, geographic diversity, institutional support) contribute to the success of the program?

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. .

Administrative Core

• How well-developed are plans for managing, coordinating and overseeing the cores and committees of the CTR-D program, 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, and with core leads, investigators, and program staff?
• How appropriate are plans to manage the CTR-D program's budget, and prepare and submit accurate and timely financial reports?
• How suitable are plans to work with CTR-D cores to identify needed expertise and to recruit faculty, staff, and/or clinical fellows to the CTR-D organization(s)?
• How appropriate are evaluation strategies to measure the effectiveness of each component and the success of investigators supported by the CTR-D program? How suitable are benchmarks for success and tracking the use of each core? How suitable are plans for implementing recommendations of the EAC?
• How suitable are the proposed strategies to assess, prioritize and address the health needs of the population served by the CTR-D?

Professional Development Core

• How appropriate are the plans to interface with other CTR-D Cores to select topics for workshops, seminars, and training, to enhance the knowledge base and competency of investigators, research and clinical staff, and community members:
  • For conducting C&T research?
  • To prepare them to carry out community-engaged research?
  • To prepare them to carry out human subjects research?
  • To access and use EHRs for research?
  • To prepare mentors to provide suitable scientific and career development advice to clinician fellows, and as applicable to project leads of clinical trials?
• To what extent will the PD Core provide staff from other cores with opportunities to maintain and enhance their expertise?

Community Engagement and Outreach Core

• To what extent will the proposed communication strategies engage and connect communities, community clinics, investigators, and CTR-D 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 CTR-D’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?

Research Design, Compliance and Data Management 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 of risk to human subjects, safety protocols, regulatory compliance, and the selection of appropriate intervention models?
• How strong are the plans to develop processes for the curation of an EHR database for research, its management and use, and the protection of private health information?

Health Research Core

• How strong are the communication strategies to engage investigators at different career stages from a variety of disciplines?
• How well-developed are the plans in place to solicit, review and select:
  • Pilot Projects that support feasibility studies?
  • Developmental Projects that support data collection for the future submission of R01- equivalent RPGs or similar grants?
• How suitable is the plan for distributing support between the two types of projects to meet the needs of the CTR-D organization(s)? How likely is it that the plan will lead to an increase in externally supported C&T research?
• To what extent do the plans for the HR Core interface with other CTR-D Cores and ensure that all HR project leads will receive the guidance needed for conducting their research? How strong are the plans to pair project leads involved in clinical trials with mentors who are experienced clinician scientists?
• To what extent are the support, equipment, technical expertise and other physical resources being made available to investigators adequate for the anticipated research activities?
• 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?

Additional Review Criteria - Overall Application and Components, as applicable

As applicable for the component 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 Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. 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 criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. 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, 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

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the proposed program, 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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute of General Medical Sciences (NIGMS), 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 may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

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 submitted in response to this NOFO. 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:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Geographic distribution of awards.
• Potential to serve the CTR-D population and address their most urgent health concerns.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her 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

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.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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: Grantee institutions 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 https://grants.nih.gov/policy/humansubjects/policies-and-regulations/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).

Prior Approval of HR Core Projects

All recipient-selected projects require prior approval by NIH prior to initiation.

• The recipient organization will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval.
• The recipient organization will 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.

Using PHS398 forms and instructions, the following sections need to be provided when submitting a HR Core project for approval:

• Face page (signed by institutional signing official)
• Biosketch for the project lead and
• Biosketch for the mentor, if applicable
• Updated Other Support for the project lead, and
• Updated Other Support for the mentor, if applicable
• Project Summary
• Detailed budget and budget justification (Developmental Projects only)
• Specific Aims
• Research Strategy (up to 3 pages for Pilot Projects, up to 6 pages for Developmental Projects)
  • Provide a description of the scientific premise for the proposed project, including consideration of the strengths and weaknesses of published research or preliminary data crucial to the support of project, and a description of the experimental design and methods proposed and how the investigator will achieve robust and unbiased results.
• If applicable, a brief description of the methods to ensure the identity and validity of key biological and/or chemical resources used in the proposed project (see Notice NOT-OD-16-011 for details).
• External Advisory Committee (EAC) Approval
  • Communication from the EAC chair (at a minimum) indicating that the EAC concurs with supporting the project.
• Checklist Format Page with F&A cost breakdown.

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

• Current PHS Human Subjects and Clinical Trials Information Form

If the proposed project involves Human Subjects, 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, include:

• Current PHS Human Subjects and Clinical Trials Information Form
• Institutional Review Board (IRB) approval
• Documentation of Investigational New Drug (IND)/Investigational Device Exemption (IDE) status for studies that are subject to FDA regulation
• Human Subjects Education Certification and Good Clinical Practice (GCP) Training Certification
• For all clinical trials, 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, and the name(s) of the responsible party/parties for regulatory and legal compliance, adverse event reporting, and clinicaltrials.gov registration and results reporting.

Note: For Human Subjects or Clinical Trials, the grantee must enter study data in the Human Subjects System (HSS) before requesting NIGMS approval. For recipient-selected projects that involve clinical trials or studies involving greater than minimal risk to human subjects:

• The recipient organization will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval.
• The recipient organization will 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.

If the proposed project involves Vertebrate Animals, include:

• IACUC approval
• Vertebrate Animal Section

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. 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, including of note, but not limited to:

• Federal-wide Standard Terms and Conditions for Research Grants
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, 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.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS Assurance of Compliance form (HHS 690)) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.htmlandhttps://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 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.

Not Applicable

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described. If additional Data Management and Sharing requirements need to be added, please insert what requirements are desired.

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.

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. 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 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

5. Evaluation

In carrying out the stewardship of grant programs, NIGMS will periodically evaluate the CTR-D 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 institutional and investigator capacity building, such as
  • Development of investigators and clinical fellows
  • Improved access to scientific research infrastructure
  • Subsequent submission of peer-reviewed grant proposals
  • Subsequent external independent funding obtained by participants in the program
• Characteristics of the applicant and awardee pool for the program, such as:
  • Geographic distribution
  • Investigator demographics
  • Institution types
• Indicators of scientific productivity and impact among program institutions, such as:
  • Peer-reviewed research publications and citations
  • Conference presentations
• Indicators of research development and collaboration, such as:
  • Number and characteristics of any partner organizations
  • Resources shared among any partner organizations
  • Research collaborations established across lead institutions and with other IDeA institutions.

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)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Michele McGuirl, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: michele.mcguirl@nih.gov

Email: NIGMSReview@mail.nih.gov

Christy Leake
National Institute of General Medical Sciences (NIGMS)
Email: christy.leake@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 45 CFR Part 75 and 2 CFR Part 200.