It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) 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.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. 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

NIH established the Institutional Development Award (IDeA) Program in 1993 to enhance biomedical research activities in states that have had historically low NIH grant funding success rates. The program currently supports competitive research in 23 states and Puerto Rico. Strengthening clinical and translational research in IDeA-eligible states/jurisdictions is a pressing need, since health conditions such as obesity, diabetes, cardiovascular diseases, cancer, infectious diseases, chronic obstructive pulmonary diseases, maternal health, and substance overuse disorders are disproportionally prevalent in these mostly rural and often economically disadvantaged states/jurisdictions. NIH is committed to supporting health and health research professionals with first-hand knowledge about these challenges to lead the charge in improving the health of residents in IDeA states/jurisdictions. This funding opportunity announcement (FOA) supports the development and/or enhancement of statewide and/or interstate regional networks for clinical and translational research in IDeA-eligible states/jurisdictions.

The objectives of the IDeA-CTR initiative are the following:

• To support the development and/or enhancement of infrastructure and human resources required to address clinical and translational research needs in IDeA-eligible states.
• To strengthen clinical and translational research that addresses the broad spectrum of health challenges faced by populations in IDeA-eligible states/jurisdictions.
• To foster and coordinate collaboration in clinical and translational research within an IDeA-CTR network and with other institutions.

For the purposes of this initiative, the following definitions apply:

• "Clinical research" comprises studies and trials in human subjects as defined by NIH Regulations and Policies (https://grants.nih.gov/grants/glossary.htm#ClinicalResearch).
• "Translational research" includes research that aims to convert basic research advances to practical applications in humans, and research aimed at the adoption of best practices in community healthcare.

This FOA provides funding through the U54 cooperative agreement mechanism. As a cooperative agreement, implementation involves the participation of NIGMS IDeA Program staff in the planning and execution of the proposed activities.

An IDeA-CTR is expected to be a statewide or interstate regional network that supports the development and/or enhancement of infrastructure and human resources required for clinical and translational research, organizes and leads clinical and translational research activities that help address the broad spectrum of health challenges faced by the population in the state(s), and fosters and coordinates collaboration in clinical and translational research. Only one IDeA-CTR award can be made per eligible IDeA state. In keeping with the objective that these awards address broad health concerns, applications with narrow disease or population focus will not be funded.

The network must be led by an academic medical center (the lead institution) that organizes and administers the award. The network must include one or more partner institutions that are also committed to the IDeA-CTR's goals and objectives. The lead and partner institutions, referred to as network participating institutions, together provide the human and infrastructure resources for the conduct of the clinical and translational research supported by the IDeA-CTR award. Inclusion of minority-serving institutions in the IDeA-CTR is encouraged. In order to maximize the capacity-building effect of the IDeA funding, an institution may participate in only one IDeA-CTR network at any given time, either as the lead institution or a partner institution. Institutions in states that already have a CTSA must include compelling justification for a new clinical and translational research network in the state. CTSA institutions may be included as partners in an IDeA-CTR network only when there is compelling justification for the additional research capacity investment by the IDeA Program in that institution.

IDeA-CTR networks are expected to leverage resources and facilities supported by other IDeA funding initiatives and other NIH programs, such as the IDeA Networks of Biomedical Research Excellence (INBREs), the Centers of Biomedical Research Excellence (COBREs), the Native American Research Centers for Health (NARCH), the Science Education Partnership Awards (SEPA), the Clinical and Translational Science Awards (CTSAs), the Research Centers in Minority Institutions (RCMI), and the IDeA States Pediatric Clinical Trials Network (ISPCTN). IDeA-CTR networks are expected to facilitate collaboration within each network among participating institutions, and with institutions outside of the network in their research pursuits.

• To meet the objectives of the IDeA-CTR, each network is required to have the following key components:
• Administrative Core
• Professional Development Core
• Biostatistics, Epidemiology, and Research Design (BERD) Core
• Community Engagement and Outreach (CEO) Core
• Pilot Projects Program
• Tracking and Evaluation Core

The aims of the components and the services provided are expected to address the needs of clinical and translational investigators at the participating institutions and to include the full range of biomedical and biobehavioral sciences funded at these institutions. In addition to the required components described below, an IDeA-CTR application may propose other components such as Clinical Research Resources Core and Alterations and Renovations to achieve the specific objectives of the network. The application must provide strong justification for these optional components. In establishing required and optional components, IDeA-CTRs are expected to synergize with other IDeA-funded programs in the participating states and not duplicate or substantially overlap with cores/resources/activities of these programs. Required and optional components must be led/directed by either the lead or partner institutions of the IDeA-CTR network. If included as partners, CTSA institutions may not lead components/cores.

The Administrative Core, directed by the Program Director(s)/Principal Investigator(s) [PD(s)/PI(s)], is tasked with the management of the administrative, fiscal, and scientific aspects of the IDeA-CTR, including the oversight and coordination of the different components of the award and the implementation of the network's overall goals and objectives. Responsibilities of the Administrative Core include, but are not limited to, ensuring all network activities comply with federal regulations and programmatic requirements, managing the network's budget, organizing network-wide scientific and professional development activities, and preparing accurate and timely programmatic and financial reports.

Program Director(s)/Principal Investigator(s) (PDs/PIs) and Program Coordinator(s) (PC) of the IDeA-CTR.

The PD(s)/PI(s) are ultimately responsible for the implementation of IDeA-CTR activities as proposed. The PD(s)/PI(s) are expected to be established clinical scientist(s) with clinical and/or translational research experience and an on-going research program supported by extramural funding. Additionally, the PD(s)/PI(s) are expected to have sufficient leadership experience and skills to direct and work across institutional boundaries to integrate all components of this multi-faceted program. As the director of the IDeA-CTR, the PD(s)/PI(s) are tasked with establishing the appropriate administrative structure that will ensure efficient management of the facilities and resources across the institutions and organizations that participate in the IDeA-CTR program. The PD(s)/PI(s) are responsible for management, staffing and resource allocation, and for administering the award in accordance with NIH policies. The PD(s)/PI(s), in consultation with the Steering Committee, are responsible for selecting replacement Core directors, resolving disputes, and for final budget decisions.

The PD(s)/PI(s) may be assisted by a PC who is tasked with the day-to-day operational and administrative oversight of assigned area(s) of responsibilities, and as appropriate, help core directors set work priorities and coordinate recommendations for major purchases of supplies, equipment upgrades, technical support staff, and assist in the resolution of other budget issues with the core directors and the PD(s)/PI(s).

Steering Committee

Each IDeA-CTR Network will be directed by a Steering Committee chaired by the PD/PI of the award. The Steering Committee is tasked with establishing the strategic and operational plans for the network, formulating the guidelines for determining the most appropriate methods for providing access to the core facilities and services, and ensuring that the impact of the network on clinical and translational research among the participating institutions/organizations is maximized. The PD(s)/PI(s), PC(s), a senior institutional official from the lead institution, a representative from each partner institution, and an NIGMS-appointed Project Coordinator are required members of the Steering Committee. Other members with institutional and network responsibilities relevant to meeting the network's goals and objectives may be included in the Steering Committee.

Advisory Committees

Each IDeA-CTR must establish an External Advisory Committee (EAC). The EAC members are expected to be well-recognized scientific leaders with proven track-records in leading complex, multi-component clinical or translational networks. The PD(s)/PI(s), with the concurrence of the Steering Committee, appoints the members of the EAC. The EAC provides scientific, technical, and management advice to the network leadership, including the review and recommendation of pilot projects. The EAC will meet at least annually to review progress of the IDeA-CTR and offer recommendations to the PD(s)/PI(s).

Each IDeA-CTR is also required to establish an Internal Advisory Committee (IAC), consisting of senior officials of the lead and partner institutions, to advise the PD(s)/PI(s) on the institutions' strategic priorities, policies, and resources that are critical for the IDeA-CTR network to meet its stated goals and objectives. The IAC should be consulted prior to the submission of the application and through the course of the award.

IDeA-CTR Networks are required to establish a dedicated core for facilitating mentored clinical and translational research and for overseeing professional development activities for investigators from a variety of disciplines and clinical specialties (e.g., medicine, nursing, dentistry, pharmacy, public health, biostatistics, epidemiology, and/or bioengineering). IDeA-CTR Networks are encouraged to innovate in professional development methods and structures and may include non-degree opportunities tailored to the specific needs of the clinical and translational research workforce at the participating institutions. Programs and activities provided by the core are expected to increase the competitiveness of investigators to obtain additional funding for clinical and translational research.

The BERD Core is tasked with providing IDeA-CTR investigators with expertise and assistance on, but not limited to, the following: developing, validating and integrating research designs and biostatistical methodologies essential to clinical and translational studies; preventing bias in research methodology; developing innovative methods of enhancing the power of studies; capturing appropriate data; developing design and analysis plans for studies of unique or vulnerable populations or very small numbers of subjects.

An IDeA-CTR must establish a Community Engagement and Outreach Core for identifying priority health issues and concerns of communities/populations within the participating state(s) and to develop plans for building the capacity to respond to these issues/concerns. The CEO Core must engage primary care physicians affiliated with Practice-Based Research Networks (PBRN) within the participating state(s). The core provides support for investigators in conducting community engagement and outreach activities. This may include planning, implementing, evaluating, and disseminating effective prevention and intervention strategies. Other appropriate activities of the CEO Core could include cultural sensitivity training for institutional clinical and translational researchers, community and health care provider education and outreach, establishing community advisory boards, software development for facilitating collaboration with community practitioners, and developing/evaluating strategies for communicating with and promoting participation of diverse populations and community groups.

The IDeA-CTR is required to have a Pilot Projects Program for soliciting and awarding clinical and translational pilot projects. Expected activities related to the program include the solicitation of applications, their review and funding prioritization, oversight and evaluation procedures, and assurance of full compliance with all applicable federal policies, rules, and guidelines for research involving human subjects, vertebrate animals, and/or biohazards. The majority of pilot projects funded each year by the network are required to be 'clinical' as defined above. Projects involving collaborative research between basic, clinical, and translational researchers from different disciplines, departments and/or programs within or across institutions are encouraged. Pilot investigations on diseases that affect the medically underserved and diseases that disproportionately affect populations in the participating states are expected to be prioritized.

An IDeA-CTR is required to have a well-defined internal evaluation plan for monitoring and documenting progress towards achieving the target goals and timelines. Functions of the core are expected to be performed by a team that is independent/autonomous from network leadership. Objective criteria and concrete outcome measures must be formulated that will allow the IDeA-CTR leadership and NIH program staff to evaluate the progress and trajectory of the network. Annual summative evaluations and more frequent formative evaluations are expected. Annual evaluation reports that include plans for any corrective actions must be provided to the advisory committees, core directors, other key personnel, institutional stakeholders, and NIH program staff.

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

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

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:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o 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)

The states/jurisdictions that are eligible for IDeA Program funding are currently restricted to the following: 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, Wyoming.

The applicant institution for an IDeA-CTR award must be an Academic Health Center in an IDeA-eligible state. The applicant institution, which serves as the lead institution of the IDeA-CTR network, must have extramurally funded multidisciplinary clinical and translational research and demonstrate a strong commitment to lead the statewide or interstate regional network.

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 Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• 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.
• o 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.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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 DUNS number and 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 underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

The PD(s)/PI(s) must hold a senior-level faculty appointment at the applicant institution at the time of application. The PD(s)/PI(s) must be an established clinical scientist with on-going research program supported by extramural funding. The PD(s)/PI(s) of COBRE and INBRE awards are not eligible.

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

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. 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 NOT-OD-11-101).

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 FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement 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.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Ming Lei, Ph.D
Email:leim@mail.nih.gov

Available Component Types	Research Strategy/Program Plan Page Limits
Overall	12
Admin Core (use for Administrative Core)	12
Core (use for the following components/cores: - Professional Development Core - Biostatistics, Epidemiology, and Research Design Core - Community Engagement and Outreach Core - Pilot Projects Program - Tracking and Evaluation Core - Optional scientific/technical cores)	12
Project (use for Alterations and Renovations)	6

Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall: required
• Administrative Core: required
• Professional Development Core: required
• Biostatistics, Epidemiology, and Research Design Core: required
• Community Engagement and Outreach Core: required
• Pilot Projects Program: required
• Tracking and Evaluation Core: required
• Optional scientific/technical cores: optional
• Alterations and Renovations: optional

When preparing your application, use Component Type Overall .

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

Complete entire form.

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

Follow standard instructions.

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.

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

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.

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.

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

Specific Aims: Provide the Specific Aims for the overall IDeA-CTR.

Research Strategy: Each IDeA-CTR must have a well-delineated organizational structure and the requisite administrative mechanisms that foster interactions among investigators, accelerate the pace of clinical and translational research, and ensure a productive research effort that help address diseases and health conditions prevalent in the states/jurisdictions the IDeA-CTR network serves. The applicant must demonstrate that all planned activities that comprise the IDeA-CTR are well integrated into a cohesive and coherent program and clearly indicate the roles of the participating institutions. The scientific and administrative management/organizational structure of the program must include individuals from diverse fields and backgrounds. The application must provide details of the overall network organization that includes the following items:

Background and Goal of the proposed IDeA-CTR

• An overview of the current clinical and translational research resources available in the lead and partner institutions and areas of clinical and translational research in which additional support may have the maximal impact.
• An overview of the major health concerns of residents in the participating state(s), the efforts that have been made to address these concerns, and the scientific and structural challenges that have been encountered.
• The overall goal of the proposed IDeA-CTR in the next five years, and how the goal is aligned with the lead institution's mission and strategic priorities.

Organizational Structure and Strategy

• Descriptions of the organizational structure and governance plan of the IDeA-CTR. A justification for including each partner institution is required.
• Justification(s) for each proposed optional component.
• Overall strategies for achieving the goal and specific aims of the proposed IDeA- CTR.
• Innovative approaches to increase interest among investigators in conducting clinical and translational research on health concerns that disproportionately affect populations in the state(s).
• Administrative and scientific relationships between the lead and partner institutions.
• Plans for developing and/or strengthening collaborations within the network among participating institutions, and with institutions and other networks outside of the network. The application must provide evidence and/or assurances that adequate cooperative arrangements are in place between participating institutions to ensure that the network performs effectively as one cohesive and coherent program across institutional boundaries. Budgetary and administrative arrangements are to be negotiated between the participating institutions.
• Plans for facilitating multi- or inter-disciplinary collaborations among basic, clinical, and translational investigators
• Plans for collaboration with other IDeA-CTRs and other IDeA-funded programs within and/or outside the state as appropriate. Collaborations with recipients of other IDeA-supported initiatives (i.e., INBRE and COBRE) and/or other NIH-funded clinical/translational programs (e.g., CTSAs, RCMIs, ISPCTN) are strongly encouraged. When practical, the IDeA-CTR should seek to utilize existing resources and facilities supported by other programs of the NIH, other Federal, and/or non-Federal organizations.
• Plans to address cross-institutional, geographical, cross-disciplinary, regulatory, and other hurdles related to partnerships and collaborations.

Progress and Accomplishments

For renewal applications, details on performance during the prior project period must be provided on the following:

• Impact of the IDeA-CTR award in developing the infrastructure for clinical and translational research at the participating institution(s). Describe the improvements to the clinical and translational research infrastructure relative to institutional baseline infrastructure in place at the onset of the prior project period.
• Impact of the IDeA-CTR award in addressing the major health concerns in the state(s).
• Evidence of progress in conducting clinical and translational research enabled by the IDeA-CTR infrastructure including, but not limited to:

- increase in the number of pre-clinical, clinical, and translational research projects initiated, ongoing, and/or completed utilizing IDeA-CTR activities and/or infrastructure

- examples of multi-disciplinary research projects initiated as a result of IDeA-CTR activities and/or infrastructure

- an increase in the number of multi-site or other collaborative research projects initiated, on-going or completed

- examples of basic biomedical science projects that, as a result of IDeA-CTR activities, have pre-clinical applications, and examples of clinical projects that now have practice or community relevance

• Challenges encountered and solutions that were successfully implemented as well as improvements in institutional commitments to providing support for clinical and translational research.
• Evidence of overall research productivity attributed to and/or impacted by the IDeA-CTR award (other than lists submitted in the Progress Report Publication List) including, but not limited to:

- presentations at major scientific meetings

- workshops, seminars, community activities, technical assistance webinars and other capacity-building activities

- numbers and types of research grant applications submitted, and grants/contracts awarded (including funding source)

• Other metrics as defined by the applicant that demonstrate accomplishments during the prior project period.

Progress Report Publication List: All publications produced in the prior project period must be listed here. Also, to be listed in this section are patents and inventions, videos, and other materials attributable to the IDeA-CTR components.

Letters of Support: Applicants must provide letters from the appropriate senior institutional officials from the lead institution and partner institutions that:

• Commit the institutions to the IDeA-CTR goals, indicating that the program will be integral to their broad vision of clinical and translational research.
• Define the position, authority, and reporting responsibility (on the institution's organizational chart) for the IDeA-CTR PD(s)/PI(s).
• Define the financial and other resource support for the IDeA-CTR that will be provided by the applicant institution(s). There are no dollar requirements, but specific commitment is required. Some examples include financial support, adequate space, release time agreements, tenured or tenure-track positions for clinical/translational faculty, FTEs for clinical support or ancillary personnel, core consolidation, and maintenance. Specific commitments to components/cores can be summarized in a table. Co-funding or matching funds from other sources (including industry) are encouraged, as long as these funds do not limit faculty research, communications, and implementation at any point and there are methods in place to ensure transparency, prevent misuse of federal funds, and ensure that NIH policies with respect to sharing of data and resources, academic freedom, and publication rights are not violated.
• Define the authority or influence that the IDeA-CTR PD(s)/PI(s) has, and/or will have over the different components of the network, facilities and space, as well as decision-making authority for hiring and/or approving new faculty and support personnel.
• Commit to notify NIGMS of adverse events in all clinical studies supported by the IDeA-CTR that are serious, unexpected, and related to participation in research. A reiteration to notify NIGMS of all unanticipated problems as outlined in OHRP guidance (http://www.hhs.gov/ohrp/policy/advevntguid.html) on studies supported by IDeA-CTR resources would satisfy this requirement. These notifications include all adverse events as noted above as well as other reportable unanticipated problems.

As appropriate, letters from the PD(s)/PI(s) of other NIH-funded centers (e.g. INBREs, COBREs, CTSAs, RCMIs, ISPCTN sites) must be included indicating their program’s role in supporting the IDeA-CTR’s goals for clinical and translational activities.

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 (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

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

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.

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

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.

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.

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

Each IDeA-CTR PD/PI must devote a minimum time commitment of 3.6 person months for the administrative oversight of the network, serving as the Administrative Core Lead. A maximum of 6.0 person months effort may be supported. Each individual named as a Program Coordinator (PC) may devote 3.6 to 6.0 person months. The levels of effort specified for the PD(s)/PI(s) and the PC(s) are required whether or not salary support is requested.

The Administrative Core Lead(s) [PD(s)/PI(s)] of the IDeA-CTR are not eligible for research support from the IDeA-CTR award, nor can he/she use IDeA-CTR funds to supplement research activities within his/her laboratory. Scientific and/or career advisors may be compensated for up to 1-person month of effort.

Funds can be requested for activities related to the External Advisory Committee (EAC), including travel and consultant fees.

Funds cannot be used at institutions in non-IDeA states. However, funds may be used in other IDeA and non-IDeA states for fee-for-service activities such as learning new techniques, sample and data analysis, workshops, etc.

If items are requested as direct costs that are normally treated as F&A costs (e.g., general office supplies), the applicant must provide a strong justification for those items and demonstrate that the cost is commensurate with the benefit that those items of cost will have on the associated activity. Failure to adequately justify such costs will likely result in their deletion from the requested budget.

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.

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

Specific Aims: Provide the Specific Aims for the Administrative Core.

Research Strategy: Crucial to the effective operation of the IDeA-CTR is an Administrative Core that oversees the coordination and facilitation of all research and investigator development activities supported by the different components/cores. When completing the research strategy section for the Administrative Core, the following elements must be addressed:

Overall Plans

• Plans for managing, coordinating, and supervising the entire range of IDeA-CTR activities; realignment of institutional resources among the different components and partners as needed; and monitoring progress and ensuring that the IDeA-CTR milestones are being met and are being implemented effectively within the proposed timelines.
• Plans for ensuring scientific and fiscal flexibility. The leadership is responsible for the use of IDeA-CTR resources to meet the needs of partners and collaborators, including the authority to change allocation of resources according to the guidelines of the network’s operating policies and procedures. An explicit discussion of how fiscal and other resources will be prioritized, allocated, and managed must be provided.
• Discussion of the structure and roles of administrative staff and the functions to be performed and a discussion on how the IDeA-CTR will ensure effective and timely communications between the lead institution and partners/collaborators, core leads/directors, investigators, and IDeA Program staff. The Administrative Core must provide both an organizational and administrative structure that is conducive for ensuring collaborative efforts and interaction among the participating institutions/organizations, components/cores and network investigators. The application must include a description of operational plans that will govern the leadership's interactions and functional relationships with the proposed components/cores, steering and advisory committees, and aligned investigators.
• Description of personnel, resources, and other infrastructure needed for overseeing the IDeA-CTR and ensuring management of the components/cores and other related activities. If warranted, applicants should describe plans for recruiting and hiring additional research personnel that may be required to accomplish the goals of IDeA-CTR. This may include hiring of senior magnet clinical and translational investigators who have independent research support and will serve as mentors and role models to junior investigators. As appropriate, applicants must include a proposed timetable specifying the expected hiring date for each new faculty and/or staff member.

Policies and Procedures

• Clear and explicit discussion of the policies and procedures that will govern the management of the IDeA-CTR. Policies should be considered as a set of guiding principles of operation. Procedures should be considered to be a set of specific actions used to conduct the affairs of the IDeA-CTR. Procedures should specify how various tasks will be accomplished within the policy guidelines of the IDeA-CTR.
• Proposed roles of the IDeA-CTR Director, Core Leads, IDeA-CTR investigators, advisory committees, and institutional officials in the decision-making process.
• The annual strategic planning process. Examples of issues that should be considered include:

- how funds will be allocated to all components/cores and activities and procedures for changes in support of any components/cores

- how network-sponsored conferences, seminars, workshops, and other activities will be identified

- how priorities for communication, outreach, and additional IDeA-CTR activities will be established

- how components/cores, Core Leads, leaders of additional IDeA-CTR activities, internal and external advisory committees will be selected and evaluated the plans for leadership succession

- the membership, authority, and responsibilities of advisory committees

- how components/cores are selected, and reports are developed, including the annual strategic plan and the noncompeting continuation application

- the plans for conflict resolution

- process for informing IDeA Program staff of major changes in the IDeA-CTR

• Policies and procedures for identifying new components/cores or network activities and eliminating components/cores or network activities after they either have achieved independent sustainability or have been deemed unproductive.
• Other mechanisms used to determine research core needs at the participating institution(s), assigning priorities to potential components/cores, and selecting the basic and clinical Cores to be included in the application.
• Plans for ensuring compliance with all regulatory guidelines pertaining to the protection of human subjects, and the care and welfare of vertebrate animals involved in research.

Leadership and Governance

When describing the leadership of the Administrative Core, the application must consider and explicitly address the following elements:

• Demonstration/evidence that the PD(s)/PI(s) have sufficient authority and credibility to work across institutional boundaries. The responsibilities of the PD(s)/PI(s) must be defined in establishing the appropriate administrative structure that will ensure efficient management of the facilities and resources across the institutions and organizations that participate in the IDeA-CTR program (e.g., overall management, staffing and resource allocation, and administration of the award in accordance with NIH policies).
• Description of responsibilities of the PC(s) in day-to-day operational and administrative oversight of assigned area(s) of responsibilities, and as appropriate, helping Core Leads set work priorities, and coordinating recommendations for major purchases of supplies, equipment upgrades, technical support staff, and assisting in the resolution of other budget issues with the Core Leads and the PD(s)/PI(s).

Steering Committee

Functions and responsibilities of the Steering Committee should be clearly defined. The application should provide details of how the Steering Committee will establish guidelines to determine the most appropriate methods for providing access to the component/core facilities and services and other strategic and operational plans, to maximize the impact of the IDeA-CTR on clinical and translational research within the network.

Internal and External Advisory Committees

• Composition and justification for the IAC membership. The IAC may consist of six to eight members depending on the scope and complexity of the proposed IDeA-CTR. The application must provide functional and operational details of the duties and responsibilities of the group.
• The areas of expertise and requisite qualifications of new members who will be recruited for the EAC and their terms of service. In order to maintain the largest possible reviewer pool for this FOA, new applicants should not contact potential EAC members or provide the names of potential EAC members during the preparation or review of the application. Renewal applications should name members of the EAC who will continue in that capacity, but not new members.
• Plans for ensuring that the efforts and recommendations of the IAC and EAC are secured, considered, and implemented by the IDeA-CTR leadership as appropriate.

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 (Administrative 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

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 (Professional Development 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 (Professional Development Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Professional Development 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) (Professional Deve lopment 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 (Professional Development 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 (Professional Development Core)

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

Each Core Lead must devote a minimum of 2.4 person months annually to direct the core.

Scientific and/or career advisors may be compensated for up to 1-person month of effort. Advisors from non-IDeA states can be compensated as a consultant or on a fee-for-service basis. Funds cannot be used for graduate student or postdoctoral stipends. Funds cannot be used to compensate individuals for the use of professional development activities developed by the core.

If items are requested as direct costs that are normally treated as F&A costs (e.g., general office supplies), the applicant must provide a strong justification for those items and demonstrate that the cost is commensurate with the benefit that those items of cost will have on the associated activity. Failure to adequately justify such costs will likely result in their deletion from the requested budget.

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 (Professional Development Core)

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

Specific Aims: Provide the specific aims for the Professional Development Core

Research Strategy: The Research Strategy for this core must provide descriptions of the following elements:

• Core description, services, and operating procedures including plans for the integration and coordination of professional development activities within and across all participating institutions that form the network and plans for enhancing the competitiveness of investigators to obtain additional funding for clinical and translational research.
• Activities or programs to support research mentoring and professional development that specifically targets junior faculty from a variety of disciplines and clinical specialties (MD, DDS, PhD, Pharm D, RN); these can include short-term courses, curricula, seminars, workshops, sabbaticals, and visiting scholarships. The activities or programs proposed must address scientific/education areas (e.g. grant-writing, science communication, lab safety) and/or topics important to clinical and translational science in a variety of research areas.
• As applicable, plans for collaborating with existing IDeA awards, CTSAs, RCMIs, or ISPCTN to leverage the educational and training opportunities already in place at these sites.
• Plans for the development and retention of investigators interested in pursuing clinical and translational science careers in IDeA states
• Operational plans for publicizing resources, assisting users, and prioritizing projects.
• For renewal applications, a description of major progress and accomplishments that includes:

- impact of professional development activities on clinical and translational investigators supported in the prior project period and their current status

- challenges encountered and solutions that were successfully implemented in facilitating the professional development of clinical and translational faculty

- other metrics as defined by the applicant that demonstrate accomplishments during the prior project period.

Letters of Support: Applicants can provide letters from the appropriate high-ranking institutional official(s) that details financial and other resources that will be provided by the institution specifically for the Professional Development Core. Examples may include funds for development of curriculum or other educational/mentoring activities, release time for participating faculty and other individuals targeted for development, and commitment to providing didactic and mentoring experiences.

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 (Professional Development 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

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 (BERD 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 (BERD Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (BERD 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) (BERD 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 (BERD 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 (BERD Core)

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

Each Core Lead must devote a minimum of 2.4 person months annually to direct the core. Staff members must be in sufficient numbers and have adequate training and effort to support the inter- and intra-institutional needs of the IDeA-CTR.

If items are requested as direct costs that are normally treated as F&A costs (e.g., general office supplies), the applicant must provide a strong justification for those items and demonstrate that the cost is commensurate with the benefit that those items of cost will have on the associated activity. Failure to adequately justify such costs will likely result in their deletion from the requested budget.

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 (BERD Core)

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

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

Research Strategy: The Research Strategy for the BERD Core must provide descriptions of the following elements:

• Services and resources that will be provided for the design and analysis of clinical and translational studies. The core is expected to provide expertise and assistance on, but not limited to, the following:

- developing, validating, and integrating research designs and biostatistics methodologies essential to clinical and translational studies

- preventing bias in research methodology

- developing innovative methods of enhancing the power of studies

- capturing appropriate data

- developing design and analysis plans for studies of unique or vulnerable populations, and/or very small numbers of subjects.

• Plans for developing tools or methods in these areas that will maximize the quality and productivity of research projects.
• Educational and mentoring activities that will be available to investigators.
• Operational plans for marketing resources, assisting users, and reviewing and prioritizing projects.
• Existing Biostatistics, Epidemiology, and Research Design resources supported by other programs that are leveraged and utilized.
• Expertise, roles, and responsibilities of Core Lead and staff and plans for the recruitment of appropriate personnel.
• For renewal applications, a description of major progress and accomplishments that includes:

- summary of investigators and projects that were impacted by the resources provided by the core

- challenges encountered and solutions that were successfully implemented

- evidence of overall research productivity attributed to and/or were impacted by the core, other than lists submitted in the Progress Report Publication List

- other metrics as defined by the applicant that demonstrate accomplishments during the prior project period

Progress Report Publication List (for renewal applications only). All publications attributable to this core produced in the prior project period must be listed here. Also, to be listed in this section are patents and inventions, videos, and other materials.

Letters of Support: Only letters of support specific to the BERD Core should be attached to this section. If provided, the letter(s) from appropriate high-ranking institutional official(s) must detail financial and other support that will be provided by the institution specifically for the BERD Core.

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 (BERD 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.

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 (Community Engagement and Outreach 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 (Community Engagement and Outreach Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Community Engagement and Outreach 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) (Community Engagement and Outreach 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 (Community Engagement and Outreach 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 (Community Engagement and Outreach Core)

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

Each Core Lead must devote a minimum of 2.4 person months annually to direct the core. Staff members must be in sufficient number and have adequate training and effort to support the inter- and intra-institutional needs of the IDeA-CTR

If items are requested as direct costs that are normally treated as F&A costs (e.g., general office supplies), the applicant must provide a strong justification for those items and demonstrate that the cost is commensurate with the benefit that those items of cost will have on the associated activity. Failure to adequately justify such costs will likely result in their deletion from the requested budget.

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 (Community Engagement and Outreach Core)

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

Specific Aims: Provide the specific aims for the Community Engagement and Outreach Core.

Research Strategy: The Research Strategy for the Community Engagement and Outreach Core must provide descriptions of the following elements:

• Clear and detailed plans for identifying priority health issues and concerns of communities/populations within the participating state(s). It is equally important to outline plans for developing the capacity to respond to these issues/concerns. The applicant must describe how the institution will involve the community in setting research priorities that directly affect targeted communities/populations.
• Services and resources that will be provided to support investigators in conducting community engagement and outreach activities. The core is expected to provide expertise and assistance on, but not limited to, the following:

- planning, implementing, evaluating, and disseminating effective preventions and interventions

- cultural sensitivity training for institutional clinical and translational researchers

community and health care provider education and outreach

- establishing community advisory boards

- software development for facilitating collaboration with community practitioners

- strategies for communicating with and promoting participation of diverse populations and community groups

- recruitment and retention of research participants in clinical and translational research

- developing two-way communication with relevant community groups

- development of best practices for engaging various community members

• Plans for integrating community engagement into leadership, research, and communication strategies of the CTR that includes clinicians, advocacy groups, and other community stakeholders. Plans for community engagement and participation must be made clear and significant beyond the mere inclusion of human subjects in research.
• Plans for engaging existing Practice-Based Research Networks (PBRNs) in the participating states. If PBRNs are not currently in place, the applicant must provide plans for initiating the establishment of such a network.
• Educational and mentoring activities that will be available to investigators.
• Operational plans for assisting users and reviewing and prioritizing projects.
• Roles and responsibilities of Core Lead and staff and plans for the recruitment of appropriate personnel.
• For renewal applications, a description of major progress and accomplishments that includes:

- evidence of fostering relationships between the CTR and the community for their mutual benefit

- summary of investigators and projects that were impacted by the resources provided by the core

- challenges encountered and solutions that were successfully implemented

- other metrics as defined by the applicant that demonstrate accomplishments during the prior project period

Letters of Support: Only letters of support specific to the Community Engagement and Outreach Core should be attached to this section. If provided, the letter(s) from appropriate high-ranking institutional official(s) must detail financial and other support that will be provided by the institution specifically for the CEO Core.

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 (Community Engagement and Outreach 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.

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 (Pilot Projects Program)

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 (Pilot Projects Program)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Pilot Projects Program)

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) (Pilot Projects Program)

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 (Pilot Projects Program)

• 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 (Pilot Projects Program)

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

Funds cannot be used for graduate student or postdoctoral stipends. The PD(s)/PI(s) of the IDeA-CTR are not eligible for pilot project funding.

If items are requested as direct costs that are normally treated as F&A costs (e.g., general office supplies), the applicant must provide a strong justification for those items and demonstrate that the cost is commensurate with the benefit that those items of cost will have on the associated activity. Failure to adequately justify such costs will likely result in their deletion from the requested budget.

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 (Pilot Projects Program)

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

Specific Aims: Provide the specific aims for the Pilot Projects Program

Research Strategy: The Research Strategy section for the Pilot Projects Program should include the following elements:

• A plan for the solicitation of proposals, prioritization of the projects, and the review of their methodology and research performance. Proposals that propose to conduct an NIH-defined clinical trial, must be evaluated using the NIH clinical trial-specific review criteria.
• Plans for constituting the review panel, their qualifications and expertise.
• The plans for defining the scope of the projects, eligibility requirements, the limit on the dollars available, and the number of years of support per project. Other important elements include:

- majority of pilot projects that are funded per year must be "clinical research as defined above

- pilot investigations on diseases that affect the medically underserved and diseases that disproportionately affect populations in the participating states should be prioritized

- projects involving collaborative research between basic, clinical, and translational researchers from different disciplines, departments, and/or programs within or across institutions should be encouraged

• Governance and oversight procedures that include the EAC.
• The potential pool of qualified investigators from whom to solicit proposals.
• Institutional plans and procedures for assuring compliance with applicable federal regulations and NIH policies for the protection of human research participants, including the evaluation of risks and protections in project proposals, appropriate ethical oversight of funded projects, and plans for monitoring data and safety in clinical research projects.
• For renewal applications, data on the effectiveness of the program including the dissemination and review process, the number of applicants and awardees per cycle, outside grant applications submitted by pilot investigators and were funded, any significant scientific/technical breakthroughs, and other metrics as defined by the applicant demonstrating impact.
• Research plans for individual pilot projects should not be included in the application.
• Restrictions:

- leaders of pilot projects must hold a faculty appointment or equivalent at the time the pilot award commences. For the purposes of this FOA, these are individuals who can independently apply for Federal or non-Federal investigator-initiated peer-reviewed Research Project Grants (RPG). Individuals holding postdoctoral fellowships or other positions that lack independent status are not eligible to lead pilot projects

- the Project lead for Pilot projects may not concurrently have research funding from - other IDeA Program award mechanisms (e.g., INBRE, COBRE)

- pilot projects may not overlap with ongoing funded projects

Letters of Support: Only letters of support specific to the Pilot Projects Program should be attached to this section. If provided, the letter(s) from appropriate high-ranking institutional official(s) must detail financial and other support that will be provided by the institution specifically for the Pilot Projects Program.

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 (Pilot Projects Program)

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

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 (Tracking and Evaluation 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 (Tracking and Evaluation Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Tracking and Evaluation 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) (Tracking and Evaluation 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 (Tracking and Evaluation Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project 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 (Tracking and Evaluation Core)

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

Each Core Lead must devote a minimum of 2.4 person months annually to direct the core. Staff members must be in sufficient numbers and have adequate training and effort to support the inter- and intra-institutional needs of the IDeA-CTR.

If items are requested as direct costs that are normally treated as F&A costs (e.g., general office supplies), the applicant must provide a strong justification for those items and demonstrate that the cost is commensurate with the benefit that those items of cost will have on the associated activity. Failure to adequately justify such costs will likely result in their deletion from the requested budget.

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 (Tracking and Evaluation Core)

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

Specific Aims: Provide the specific aims for the Tracking and Evaluation Core.

Research Strategy: The application must include a Tracking and Evaluation Core that is tasked with overseeing an internal evaluation plan for assessing implementation of the short-term and long-term goals of the IDeA-CTR, including implementation of specific program activities. The applicant must describe how they will track the use, quality, and cost of the programs and resources and services provided by the IDeA-CTR and components/cores and how the data will be assessed, and programs, resources, and services modified to better meet researcher needs, increase efficiency and quality, and lower cost. Tracking and assessment of innovative new methods and practices in structuring, bundling, and delivery of programs, resources, and services are encouraged.

The Research Strategy section for the Tracking and Evaluation Core should include the following:

• Plans for assessing progress in implementation of the short-term and long-term IDeA-CTR goals, including implementation of specific program activities (process), and plans for documenting the accomplishments anticipated for each budget period and within the total award period (outcomes). For each proposed activity or core, the plan should include the objectives of the evaluation or tracking activities, the principal measures or indicators, and potential data sources.
• Performance milestones for each component/core, and the schedules and timelines that will be used to measure progress in each budget period towards the achievement of performance goals (e.g., logic models and GANTT charts).
• Plans for assessing demand, function, utilization, and effectiveness of the component/core in providing the resources and expertise including, but not limited to, the following:

- assessment of budget implementation, allocation of resources, and leveraging of additional resources to achieve component/core objectives

- assessment of effectiveness of resource sharing

- assessment of outreach, user training, and dissemination plans

• Anticipated impediments that could require revision of the milestones with a discussion of possible solutions.
• Roles and responsibilities of Core Lead and staff and plans for the recruitment of appropriate personnel.
• For renewal applications, provide data on the effectiveness of the core including:

- examples where challenges or impediments were identified that required revision of milestones

- examples of data collection and analysis that aided IDeA-CTR leadership in formulating policy or programmatic decision(s) that significantly impacted the network or components of the network

- other metrics as defined by the applicant demonstrating effectiveness

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 (Tracking and Evaluation 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.

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 (Optional Scientific/Technical Cores)

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 (Optional Scientific/Technical Cores)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Optional Scientific/Technical Cores)

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) (Optional Scientific/Technical Cores)

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 (Optional Scientific/Technical Cores)

• 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 (Optional Scientific/Technical Cores)

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

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 (Optional Scientific/Technical Cores)

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

Specific Aims: Provide the specific aims of the Optional Core

Research Strategy: The Research Strategy section for each proposed core must provide details of the following:

• Core description and justification
• Roles and responsibilities of Core Lead and staff and, as needed, plans for the recruitment of appropriate personnel.
• Operating procedures of the core:

- maintenance of state-of-the-art techniques and quality controls

- mentoring and training of investigators in the capabilities of the core

- allocation of core budgets

- process for reviewing, prioritizing, and supporting projects. Resolution of disputes relating to core usage

- fee-for-service arrangements and procedures for waiver

• Plans for tracking utilization of core resources and for adapting to the needs of investigators.
• For renewal applications that include continuation of a core, a description of major progress and accomplishments that includes:

- summary of investigators and projects that were impacted by the resources provided by the core

- challenges encountered and solutions that were successfully implemented

- evidence of overall research productivity attributed to and/or were impacted by the core, other than lists submitted in the Progress Report Publication List

- other metrics as defined by the applicant that demonstrate accomplishments during the prior project period

When completing the Research Strategy section, the following elements must be considered for each proposed core:

Resources and services: Each proposed component/core must be well justified with the expectation that each will foster, facilitate, and enhance clinical and translational research capabilities of partners and collaborators. The aims of the component/core and the services it provides should address the needs of clinical and translational investigators at the participating institutions and be inclusive of the full range of biomedical and biobehavioral sciences funded at these institutions. The application must show that the resources and services offered by each proposed core are adequate to achieve the stated goals and objectives of the IDeA-CTR program, including capabilities to support intra- and inter-institutional operations and multi-disciplinary activities. Essential services for each core will include dissemination of core capabilities and mentoring in core technology and instrumentation and providing scientific guidance in the design of research applications and experiments. Other core functions that must be defined include: (1) standard operating procedures governing the utilization and management of core expertise and resources, (2) maintenance of state-of-the-art technologies and knowledge capabilities as applicable, (3) recommending to the PD(s)/PI(s) and PC(s) any updates and/or replacement of equipment or personnel.

Leveraging: Acknowledging that existing resources vary among applicant institutions, the support requested for each of the proposed components is expected to vary, reflecting current and projected needs. Where applicable, applicants are encouraged to develop creative collaborations to improve utilization of existing resources. Applicants must demonstrate cooperation between the IDeA-CTR and other IDeA- or NIH-funded programs in the participating states, and not duplicate or substantially overlap with activities of these programs. Applicants should seek to utilize existing equipment and instrumentation supported by other COBRE or INBRE awards. Applicants should describe how cores with partial IDeA-CTR funding will be used to enhance ongoing and planned research. For example, a proposed IDeA-CTR core supported by other funding (e.g., COBRE Bioinformatics Core, INBRE Community Outreach Core, or a CTSA Mentoring Core) may become more accessible to prospective clinical and translational investigators through leveraging of these existing resources. Requests that appear to be duplicative of existing equipment or instrumentation, including computational facilities and related bioinformatics resources, must be appropriately justified.

Descriptions of Potential Optional Cores

1. Clinical Research Resources and Facilities

Applicants may propose a core that will oversee the recruitment and retention of research participants and the provision of necessary resources for cost-effective research participant interactions. Some examples of resources that may be requested include out-patient or community-based examination rooms, satellite research participant recruitment/enrollment sites at smaller institutions, research nurses, research coordinators and other support personnel, scheduling services, and services for research specimen collection and shipping. It is important that applicants describe a plan to familiarize investigators at all partner institutions/organizations and medical catchment areas of the available IDeA-CTR resources to support clinical translational research studies.

If proposed, applicants should describe:

• resources that will be offered, with plans for their prioritization, availability, and management, and tracking of usage
• methods to ensure that all studies utilizing these resources will meet the highest standards for quality of science, statistical rigor, ethical evaluation, robust design, participant safety, and strict implementation, analysis, and reporting
• how Good Clinical Practices (GCP) will be implemented
• how the institution(s) will anticipate and be responsive to changing needs of the clinical and translational research communities
• evaluation processes for justifying an investigator’s continued access to resources
• integration with similar resources at the partner institutions if these are currently available
• plans for cost recovery from funded investigators, where appropriate
• plans for obtaining required Office of Human Research Protections (OHRP) assurances, if not already in place
• plans for supporting clinical trial activities, if applicable

2. Biomedical Informatics, Bioinformatics, and Cyberinfrastructure Enhancement Core

Applicants may propose a core for the organization and analysis of biological and related information, involving the use of computers to develop databases, retrieval mechanisms, and data analysis tools. Comprehensive supporting infrastructure may be proposed that integrates data-gathering facilities, computing hardware, data analysis and informatics tools, software and middleware, high-bandwidth network connectivity, and technical support. Resources that provide cyber access to rural areas and other hard to reach populations are strongly encouraged. Equally important are resources to enhance communications within the state(s) and with the rest of the world, including but not limited to library access to research journals and video-teleconferencing services. Applicants should consider both inter- and intra-institution communication platform(s) and external interoperability to allow for communication among the IDeA-CTR partners of clinical and translational investigators and other entities (e.g., government, clinical research networks, pharmaceutical companies, commercial vendors, laboratories, and equipment manufacturers). Whenever available, bioinformatics resources already provided through other NIH-funded programs should be leveraged by the IDeA-CTR as it develops its own biomedical informatics infrastructure for clinical and translational activities. Biomedical informatics research activities should show innovation in the development of new tools, methods, and algorithms.

If proposed, applicants should describe:

• informatics resources for supporting operations, administration, and clinical/translational research activities of the IDeA-CTR
• plans to establish communication with relevant external organizations
• processes by which standards and other mechanisms will be developed and used to maximize interoperability among internal systems and systems in external organizations
• plans for inter- and intra-organizational sharing of data, technology, and best practices
• plans for increasing cyber access for and to rural areas and other hard to reach populations (e.g. access to research journals, video-teleconferencing services)
• plans for ensuring privacy and confidentiality of all human subjects' data

3. Ethics and Regulatory Knowledge Core

Regulatory knowledge and support activities of the IDeA-CTR should promote the protection of human subjects and facilitate regulatory compliance. Best practices can be formulated that will reduce or remove institutional impediments to clinical and translational research. This core will develop the regulatory support interactions with the Institutional Review Board (IRB) and compliance office to facilitate research without loss of participant protections. A group that is independent of the institutional IRB or compliance office should be identified and will act as a sounding board for potential research participants, serve as their research subject advocate (RSA), and work with investigators to ensure that research involving human subjects places the highest priority for human subjects protections. Regulatory support provided through an IDeA-CTR may not take the place of an institutional compliance or enforcement office nor shall it be responsible for IRB activities. Instead, it should assist investigators in their documentation requirements for these offices. Other regulatory support activities can include the provision of integrated training, services, or tools for protocol and informed consent authoring and translation, adverse event reporting, and safety and regulatory management and compliance.

If proposed, applicants should describe:

• services to be provided, their selection, and implementation
• interaction with IRBs, IACUCs, and regulatory entities (e.g., FDA)
• operation of the human research subject advocacy resources
• plans for providing formal and informal instruction in scientific research integrity and the responsible conduct of research
• plans for mitigating or removing institutional impediments to clinical and translational research

4. Technologies and Resources for Research Core Laboratories

If research resources core(s) are requested, these must be for multiple users and include infrastructure applicable to various disciplines (e.g., medicine, nursing, dentistry, pharmacy, public health, biostatistics, epidemiology, and/or bioengineering) and for the benefit of researchers and research projects across disease areas. The level of support requested must be justified by the projected use by clinical and translational researchers from among the partner institutions/organizations. The applicant should describe the standard operating procedures of the core, how state-of-the-art techniques will be maintained, how quality control will be managed, how disputes concerning core usage will be resolved, and how research investigators will be trained in the capabilities of the core and the techniques required. Where applicable, participation in national or international quality control and standardization efforts should be outlined. Examples of core resources that can be developed include those for biorepositories, 'omics' technologies (e.g., genomics, proteomics, metabolomics), and technologies for patient monitoring or examination. Activities aimed at reducing redundancy and using, enhancing, or improving existing core facilities rather than creating new cores are strongly encouraged. If applicants propose to acquire new technologies, the plans must be fully justified within the context of the overall proposed program goals. Core facilities supported through this FOA must not duplicate existing facilities within the participating states made available through other NIH funding mechanisms (e.g. INBREs, COBREs, CTSAs). Cost recovery for core support should be sought from funded investigators.

If proposed, applicants should describe:

• resources that will be offered, plans for their prioritization, availability, applicability to various disciplines, management, user training, and tracking
• integration of requested resources with similar resources at the institution and any affiliates
• how the institution(s) will anticipate and be responsive to changing needs of the clinical and translational research communities
• plans for participation in national or international quality control and standardization efforts
• plans for cost recovery from funded investigators, where appropriate

Letters of Support: Only letters of support specific to the core should be attached to this section. If provided, the letter(s) from appropriate high-ranking institutional official(s) must detail financial and other support that will be provided by the institution specifically for the component/core. Co-funding by the applicant organization or by outside sources is encouraged.

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 (Optional Scientific/Technical Cores)

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

When preparing your application, use Component Type Project.

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

SF424 (R&R) Cover (Alterations and Renovations)

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 (Alterations and Renovations)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Alterations and Renovations)

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.

Other Attachments:

1. Line drawings (if applicable): Instructions for preparing line drawings are as follows:

• Submit line drawings on 8-1/2" x 11" paper only. (DO NOT SUBMIT BLUEPRINTS). All floor plans must be legible, with the scale clearly indicated.
• The line drawings of the proposed renovation must be at a scale adequate to explain the project. The drawings should indicate size (dimensions), function, and net and gross square feet of space for each room. The total net and gross square feet of space to be renovated should also be given.
• The floor plan should indicate the location of the proposed renovation area in the building.
• Include the as-built drawings of the proposed renovation area and indicate any areas that will be demolished.
• Changes or additions to existing mechanical and electrical systems should be clearly described in notes made directly on the plan or attached to the plan.
• Indicate the type(s) of new finishes to be applied to room surfaces.

2. Cost estimates including vendor quotes if available.

Project /Performance Site Location(s) (Alterations and Renovations)

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 (Alterations and Renovations)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project 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 (Alterations and Renovations)

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

This FOA will provide up to $300,000 in direct costs in year one of the award as a one-time cost expenditure. Direct costs requested for A&R will not be subject to facilities and administrative costs (F&A) and will be in addition to the total costs requested for the applicant IDeA-CTR program.

Sufficient detail must be provided to estimate the cost and the suitability of the project. Failure to adequately justify an A&R request may result in its deletion from the requested budget.

Proposed A&R should not include new construction, including completion of shell space, or the purchase of movable research or clinical equipment/instrumentation or equipment intended for teaching or other non-research related purposes. A list of allowable fixed equipment can be found at https://www.nigms.nih.gov/Research/CRCB/IDeA/Documents/List_of_AME.pdf.

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 (Alterations and Renovations)

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

Specific Aims: The SF424 Application Guide must be followed.

Research Strategy: A&R projects must be relevant to the scope of the proposed activities at the institution involved in the network.

A narrative summary must:

• Relate the proposed renovations to planned activities by the IDeA-CTR. If renovations to animal facilities are proposed, they should be related to the projected animal populations (by species) in anticipated projects. If renovations to animal facilities are proposed, include the lines of authority and responsibility for administering the institution's animal care and use program. The role and composition of the Institutional Animal Care and Use Committee (IACUC) and how compliance with relevant laws, policies, and guidelines are achieved should also be included.
• List the functional modules, including the size (dimensions) and square footage of each module (room, alcove, or cubicle) that will be directly affected by the renovation project.
• List engineering criteria applicable to each module (mechanical, electrical, and utilities). Include information such as the number of air changes per hour, electrical power, light levels, hot and cold water, and steam.
• List appropriate architectural criteria (such as width of corridors and doors, surface finishes).
• List and justify all fixed equipment items requested for the renovated area.

Letters of Support: Only letters of support specific to the Alterations and Renovations project should be attached to this section. If provided, the letter(s) from appropriate high-ranking institutional official(s) must detail financial and other support that will be provided by the institution specifically for the Alterations and Renovations project.

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 (Alterations and Renovations)

Not applicable

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.

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 Policy on Late Application Submission.

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.

This initiative is not subject to intergovernmental review.

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.

In keeping with the broad objectives of the IDeA-CTR in building research capacity and fostering collaborations in resource-limited IDeA states/jurisdictions and addressing the broad spectrum of diseases and conditions that impact the health of populations in these states, the following additional restrictions and considerations apply for IDeA-CTR funding:

• No more than one IDeA-CTR award will be issued in each eligible IDeA state.
• An individual institution may not receive IDeA-CTR support as a lead or partner from more than one IDeA-CTR award.
• No IDeA-CTR award will be issued to institutions that lead active CTSA awards. If an IDeA-CTR lead receives a CTSA award, the IDeA-CTR award must be relinquished.
• Applications proposing to support a CTSA institution as an IDeA-CTR partner must provide compelling justification for the IDeA-CTR's research capacity building investment in a CTSA institution in order to be considered for funding.
• Applications from institutions in states with CTSA(s) must include compelling justifications for a new clinical and translational research network in the state in order to be considered for funding.
• IDeA-CTR award will not be made for applications that are primarily focused on one disease/disorder or on a single population.

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 your application will be automatically assembled for review and funding consideration after submission go 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 Component of the SF424(R&R) Application Package. 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 DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

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

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 IDeA-CTR 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 IDeA-CTR 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 n IDeA-CTR that by its nature is not innovative may be essential to advance a field.

Does the IDeA-CTR address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed network rigorous? If the aims of the IDeA-CTR are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this FOA: Does the IDeA-CTR maximize the research capacity-building effect of the IDeA program in the context of existing infrastructure ? Do the clinical and translational research activities proposed address the broad spectrum of health challenges faced by populations in the state(s)/jurisdictions the IDeA-CTR serves? Are the overall program vision and strategy adequate to facilitate and sustain clinical and translational research on health concerns prevalent in the target area(s)? Has the application provided a vision and strategy that are conducive for enhancing and facilitating clinical and translational research efforts in the participating institutions? Will the proposed IDeA-CTR have potential to enhance the competitiveness of the investigators to obtain additional funding for clinical and translational research? Does the application provide strong evidence that the addition of the IDeA-CTR will provide resources that would not otherwise be possible?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the IDeA-CTR? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the IDeA-CTR is collaborative or multi-PD/PI , do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the IDeA-CTR?

Specific to this FOA: Do the PD(s)/PI(s) have the experience and qualifications to provide scientific and administrative leadership and direction for the IDeA-CTR? Do the PD(s)/PI(s) and PC(s) have the experience and skills, and committed time to administer the proposed IDeA-CTR award? Will the PD(s)/PI(s) have sufficient leadership seniority in the institution to work across institutional boundaries? Has/Have the PD(s)/PI(s) shown effective leadership and judgment in the selection of optional components in terms of these components/cores being related to and consistent with the overall goals of the center? Do the program leadership and management team bring complementary and integrated expertise to the network? Do the PC(s) have the requisite background and knowledge that complement those of the PD(s)/PI(s) with respect to managing proposed resources and overall operations of the network? Has PC(s) demonstrated an ability to oversee and coordinate research activities?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Specific to this FOA: Is the IDeA-CTR positioned to develop new approaches to increasing the ease and efficiency of conducting clinical and translational research in the participating institutions that involve and engage investigators from different disciplines? Is there a well-designed and innovative plan for enhancing communication, coordination, and collaboration among investigators, the required and proposed components/cores, and targeted populations?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the IDeA-CTR? To what extent will the proposed plans support the development and/or enhancement of infrastructure and human resources required to address clinical and translational research needs in the network institutions? Are the plans adequately justified? Has the application provided robust and appropriate plans for fostering and coordinating collaboration in clinical and translational research among the institutions and investigators within the proposed IDeA-CTR network? To what extent do the proposed plans of the IDeA-CTR foster the development and increase the number of junior investigators interested in clinical and translational research? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed IDeA-CTR? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the IDeA-CTR is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the IDeA-CTR involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and

2) 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), justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA: Will the proposed IDeA-CTR have the organizational structure that is conducive for and will significantly strengthen clinical and translational research activities at the participating institutions? How well will the components of the IDeA-CTR be integrated with each other? Has the applicant demonstrated the need for all proposed optional components and the effectiveness of these activities to enhance clinical and translational efforts in the participating institutions? Does the application identify key impediments to the performance of translational and clinical research and then propose plans or means to overcome these? Does the applicant indicate how the organization will be adapted to respond flexibly to changes in plans and priorities? Does the IDeA-CTR facilitate intra-institutional, inter-institutional, and multi- or interdisciplinary collaborations? Are plans included to address cross-institutional, geographical, cross-disciplinary, regulatory, and other hurdles? Is the governance plan appropriate for coordinating all proposed programmatic activities, fiscal administration, and personnel and property management? Will the resources be available to researchers in different disciplines? Are the operations and maintenance of resources and facilities appropriate and necessary for the functioning of the IDeA-CTR?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the IDeA-CTR proposed? Will the network benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Specific to this FOA: Is the institutional environment supportive and conducive for achieving the objectives of the IDeA-CTR? Will the PD(s)/PI(s) and PC(s) have adequate support for managing the resources committed by the institution(s) for the IDeA-CTR? Are there adequate cooperative arrangements between participating institutions to ensure that the IDeA-CTR performs effectively as one activity across institutional boundaries? Are there effective lines of communication and cooperation among the IDeA-CTR leadership, Core Leads and staff, targeted investigators, and the Leadership at the applicant and partner institutions?

In addition to the above criteria, the following components of the IDeA-CTR application will be scored independently AND will be considered in the determination of the overall impact score for the whole application.

Administrative Core

Reviewers will consider the following criteria in the determination of an impact score for the Administrative Core, although scores for the individual criteria will not be provided.

Governance. Is the governance structure designed to ensure the optimal operations and accountability of all components that comprise the IDeA-CTR? Are the organization and administration lines appropriately structured for promoting the discipline of clinical and translational research? Are the lines of administrative responsibilities within the IDeA-CTR and the relationships between the PD(s)/PI(s), PC(s), and the Core Leads clearly delineated? Are appropriate and well-defined responsibilities described for the PD(s)/PI(s), PC(s), Advisory Committees, Core Leads, and other involved parties?

Communications. Are the proposed dissemination and communication plans adequate for reaching a wide range of investigators and promoting expansion of clinical and translational research efforts in the state(s)? Are there adequate plans for establishing communication lines between the IDeA-CTR leadership and the External Advisory Committee and Institutional Leaders?

Advisory Committees. Is the IDeA-CTR guided by an appropriately constituted Internal Advisory Committee? Does the Internal Advisory Committee include representation from various participating institutions? Has the applicant provided sufficient details of the areas of expertise and requisite qualifications of prospective members who will constitute the External Advisory Committee, and are these qualifications appropriately aligned with the objectives of the IDeA-CTR? Has the applicant provided details of the functional and operational duties and responsibilities of the IAC and EAC? Has the applicant provided appropriate plans for ensuring that the recommendations of the Steering and Advisory Committees will be integrated into the effective fiscal, personnel and scientific management of the IDeA-CTR over the course of the award?

Components/Cores

Reviewers will consider the following criteria in the determination of an impact score for each component/core, although scores for the individual criteria will not be provided.

Operations and Programs. Are the resources and expertise provided by the core adequate and appropriate for accomplishing the overall objectives of the IDeA-CTR and its other component activities? Will this resource be sufficient for intra- and inter-institutional operations? Does the core provide appropriate programs, services, and plans for addressing scientific and educational areas important to clinical and translational science that specifically target postdoctoral level professionals and junior faculty from a variety of disciplines and clinical specialties (e.g., MD, DDS, Clinical PhD, Pharm D, RN)? Are there appropriate plans for marketing resources of the core to target audiences, assisting projected users, and prioritizing projects? Will resource utilization be tracked and are mechanisms proposed to adapt resources to the needs of investigators? Additional criteria:

• For the Professional Development Core only: Has the applicant provided clear plans for the development of investigators interested in pursuing clinical and translational science careers and enhancing their ability to obtain additional funding for clinical and translational research?
• For the Community Engagement and Outreach Core: Will the resource(s) foster long-term bidirectional relationships between the IDeA-CTR institution(s) and the community for their mutual benefit? To what extent does the application describe a practical means to engage the variety of local communities with an interest in clinical and translational research, such as patients, clinicians, advocacy groups, PBRNs, and others? To what extent does the application include a description of approaches or strategies to engage communities? To what extent does the application describe how CEO Core resources will be utilized to develop best practices, informational materials, and consultations on how to engage communities as strong, well prepared and active partners around CTR projects?
• For Optional scientific/technical cores: Is the proposed core well justified?
• If an Ethics and Regulatory Knowledge Core is proposed: Are plans for establishing a group that will serve as a research subject advocate sound and appropriate?
• If a Biomedical Informatics and Cyberinfrastructure Enhancement Core is proposed: Are plans for ensuring data security and privacy sound and appropriate?

Personnel. Are the qualifications, experience, and commitment of the Core Lead and other core personnel appropriate for the functions of the core? Has the core leadership demonstrated appropriate expertise and experience in core capabilities? Are staff members of sufficient numbers and adequate training to support the needs of the projected pool of junior investigators?

• For the Professional Development Core only: Is there a sufficient pool of senior clinical investigators who can serve as advisors to junior faculty?

Environment. Is there institutional commitment for this core? Will resources, expertise, and support services already provided by existing programs funded by other Federal or non-Federal support be leveraged and utilized in standing up the core?

Pilot Projects Program

Reviewers will consider the following criteria in the determination of an impact score for the Pilot Projects Program, although scores for the individual criteria below will not be provided.

Significance: Is the Pilot Projects Program well integrated into the overall goals and objectives of the IDeA-CTR? Is the Pilot Projects Program configured to promote increased research interest and efforts in clinical and translational sciences? Is the Pilot Projects Program designed such that diseases that affect the medically underserved and/or diseases that disproportionately affect populations in the state(s) are prioritized?

Innovation: Is the program structured to allow the development of novel concepts, approaches, and methodologies? Does the program encourage new collaborative research efforts between basic, clinical, and translational researchers from different disciplines and/or programs within and across institutions?

Operations: Is there an adequate plan to solicit proposals, to prioritize the projects, and to review research performance? Are the plans for constituting the review panel, their qualifications and expertise, appropriate to evaluate pilot project applications? Has the applicant provided plans for governance, oversight, and evaluation of the program and supported pilot projects that involve the EAC? Is the program structured such that the required and optional components are utilized and/or leveraged in the conduct of the pilot projects? Are there adequate institutional plans and procedures to assure compliance with applicable federal regulations and NIH policies for the protection of human research participants, including the evaluation of risks and protections in project proposals, appropriate ethical oversight of funded projects, and plans for monitoring data and safety in clinical research projects?

Environment: Does the institution have a sufficient pool of qualified investigators from whom to solicit applications? Is there institutional commitment for the program?

Tracking and Evaluation Core

Reviewers will consider the following criteria in the determination of an impact score for the Tracking and Evaluation Core, although scores for the individual criteria will not be provided.

Approaches and Plans. Is there an evaluation plan that includes key milestones for the overall program and for each key component? To what extent are the proposed plans adequate in evaluating the short-term and long-term goals for each of the proposed key activities? Do the milestones and timelines provide feasible objectives, and detailed quantitative and/or concrete criteria by which milestone achievement will be assessed? To what extent are the measures valid for assessing the program s goals and how accessible and practical are the available data sources? Are appropriate diagnostic, formative, and summative assessments provided for all key components?

Personnel. Are the qualifications, experience, and commitment of the Core Lead and other core personnel appropriate for the functions of the core? Has the core leadership demonstrated appropriate expertise and experience in tracking and evaluation? Are staff members of sufficient numbers and adequate training to support the tracking and evaluation needs for all the components of the IDeA-CTR?

Alterations and Renovations

Reviewers will consider the following criteria in the determination of an impact score for the Alterations and Renovations, although scores for the individual criteria will not be provided.

Scientific Need. Are requested alteration and renovation projects relevant to the scope of the proposed activities of the IDeA-CTR? Are the costs and suitability of the project justified? If renovations to animal facilities are proposed, do the proposed renovations relate to the projected animal populations (by species)? If renovations to animal facilities are proposed, are the lines of authority and responsibility for administering the institution's animal care and use program indicated?

Architectural Plans. Are the projected costs commensurate with the architectural plans for the proposed A&R? Are the functional components described in the plans, including the size (dimensions) and square footage of each component (room, alcove, cubicle) that will be directly affected by the renovation project, appropriately described for the project? Are the descriptions of the engineering criteria applicable to each component (mechanical, electrical, and utilities) including information such as the number of air changes per hour, electrical power, light levels, hot and cold water, and steam, as well as the appropriate architectural criteria (such as width of corridors and doors, surface finishes), adequately explained for the proposed work? Is the justification provided for all fixed equipment items requested for the renovated area appropriate? Are the line drawings and plans provided for all of the proposed renovations sufficiently well described and appropriate for the proposed A&R, with regards dimensions, function, location(s), demolition(s), mechanical and/or electrical systems, and type(s) of finishes?

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.

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.

When the proposed component 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.

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 Animal Section.

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.

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.

For Renewals, the committee will consider the progress made in the last funding period.

Not Applicable

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

Not Applicable

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).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan .

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.

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by 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:

• 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.
• Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. 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.

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.

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 grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. 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 FOA 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 awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

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

Awardee-selected projects that involve clinical trials or studies involving greater than minimal risk to human subjects require prior approval by NIH prior to initiation.

The awardee institution will provide NIH with written study protocols that address risks and protections for human subjects in accordance with NIH’s Instructions for Preparing the Human Subjects Section of the Research Plan.

The awardee institution 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.

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

• Face page (signed by institutional signing official)
• Project Summary (page 2)
• Research Strategy section
• Research proposal
• Rigor and transparency: As appropriate, 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 approval communication from the EAC chair (at a minimum) indicating that the EAC concurs with supporting the pilot project.
• If proposed study involves human subjects, the following documents must be submitted to NIH:
• Current PHS Human Subjects and Clinical Trials Information Form https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general/g.500-phs-human-subjects-and-clinical-trials-information.htm
• Institutional Review Board (IRB) approval
• Human Subjects Education Certification (required even when research is exempt)
• Submission of new enrollment report in the Human Subjects System (HSS)
• If the proposed project involves clinical trials, the following documents must be submitted to NIH:
• Current PHS Human Subjects and Clinical Trials Information Form https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general/g.500-phs-human-subjects-and-clinical-trials-information.htm
• 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 institution 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.
• If the proposal involves Vertebrate Animals, the following documents must be submitted to NIH:
• IACUC approval
• Vertebrate Animal Section (see https://grants.nih.gov/grants/olaw/vertebrate_animal_section.htm).

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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/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 FOA.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
• Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. 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.
• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please 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 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

External Advisory Committee (EAC) Reports

Official minutes of EAC meetings must be kept on file with particular attention to documenting problems and special concerns, along with any recommendations for their mitigation or resolution. A summary of the issues discussed at each EAC meetings, recommendations made, and actions taken will have to be provided in yearly progress reports submitted to NIH. The EAC report must not be submitted directly by the EAC to NIH Program staff.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

Program Director(s)/Principal Investigator(s) and Program Coordinator(s) will have the primary responsibility for:

• Oversight and management of all the Components.
• Working towards developing, adopting and implementing the agreed-on policies, procedures, best practices, or other measures for developing clinical and translational capabilities among the collaborating and partnering institutions.
• Providing the NIH Program Officer(s) annual written progress reports, and periodic supplementary reports upon request.
• Participating in the overall coordination of IDeA Program-wide efforts in clinical and translational research. This participation may include collaboration and consultation with other IDeA program awardees and/or other clinical and translational research awardees and the sharing of information, data, and research materials.
• In consultation with the Steering Committee, selecting the Core Leads, resolving disputes arising in the priority of usage of the core resources and facilities, and for final budget decisions.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH Program staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

NIGMS will assign a Program Official, a Project Coordinator, and a Grants Management Specialist to each IDeA-CTR.

An NIH Program Official will be responsible for the normal programmatic and scientific stewardship of the award and will be named in the award notice. The program official(s) will:

• Enforce general statutory, regulatory, or administrative assistance policy requirements;
• Evaluate progress by reviews of technical and fiscal reports or by staff visits, to determine that performance is consistent with objectives, terms, and conditions of the award;
• Ensure that activities proposed for development or implementation do not overlap or duplicate activities supported by other NIH programs;
• Coordinate the interactions of the IDeA-CTR network with other IDeA-CTR Networks and other NIH programs (e.g., COBREs, INBREs, and CTSAs) to maximize the usage of resources, and recommends adjustments of projects, programs, or approaches as warranted;
• Assist and review major transitional changes of individual IDeA-CTR activities prior to implementation to ensure consistency with the goals of this FOA;
• Monitor institutional commitments and resources to ensure that partner institutions of the IDeA-CTR Network receives the maximum chance of support;
• Recommend the termination or curtailment of an investigator or KCA/Core in the event the proposed activities fail to evolve within the intent and purpose of this initiative
• Assist with the NIGMS’s monitoring of financial oversight of the Program.

An NIH Project Coordinator will have substantial programmatic involvement that is above and beyond the normal stewardship role in the award. The Project Coordinator will:

• Participate on the steering committee of the IDeA-CTR Network as a voting member as needed to provide NIH inputs on decisions pertaining to Network membership, advisory committee membership, and starting/terminating of major projects or activities.
• Provide assistance in obtaining access to resources from, and facilitating collaboration with, other IDeA-CTR Networks and other NIH programs (e.g., INBREs, COBREs, CTSAs).

Areas of Joint Responsibility Include:

Awardees agree to governance, through voting and decision making, of the IDeA-CTR through a Steering Committee. Steering Committee voting membership shall consist of the PD(s)/PI(s), Program Coordinator(s), a senior institutional official from the lead institution, and the NIH Project Coordinator. The IDeA-CTR PD/PI will serve as chairperson of the steering committee. Quarterly meetings of the Steering Committee will ordinarily be held by telephone conference call in the first year of the award. Frequency of meetings in succeeding years will be decided by the Steering Committee at the beginning of each budget period. Each member of the Steering Committee will have one vote. The IDeA-CTR Network PD/PI will be required to accept and implement policies approved by the Steering Committee.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

In the RPPR, include progress towards objectives of the IDeA-CTR outlined in this Funding Opportunity Announcement to assist in evaluating the program. Progress reports should describe status of Pilot Projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.

In addition to submitting annual progress reports, IDeA-CTR awardees are also required to provide Supplemental Programmatic Data in the NIGMS Scientific Information Reporting System (SIRS). The SIRS system can be accessed at: https://sirs.nigms.nih.gov. Similar to the RPPR submission, SIRS submissions are due 60 days before the end of the active budget period. Approved Pilot Projects should be reported as separate components in the RPPR.

A summary of the issues discussed at each EAC meeting, recommendations made, and actions taken must be included in the yearly progress reports submitted to the NIGMS.

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.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees 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 $25,000. 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 Appendix XII to 45 CFR Part 75, 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 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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: http://grants.nih.gov/support/ (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: 301-637-3015

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

Ming Lei, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: leim@mail.nih.gov

Stephanie Constant, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: Stephanie.Constant@nih.gov

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

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.