NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

It is critical that applicants follow the 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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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

The purpose of this funding opportunity announcement (FOA) is to invite applications to participate in the Clinical and Translational Science Award (CTSA) program which supports high quality translational and clinical research locally, and nationally, and fosters innovation in methods, training, and career development.

Translating biomedical discoveries into clinical applications to improve human health is a complex process with high costs and substantial failure rates. These often lead to a delay of years or decades before improved outcomes result from discoveries in biomedical research that benefit patients and communities. Recognizing the need to improve translation, the National Institutes of Health (NIH) established the CTSA program in 2006. In 2011, the CTSA Program became part of the National Center for Advancing Translational Sciences (NCATS). NCATS does not focus on a particular subgroup of diseases, but supports research efforts to identify and test promising innovations and to develop, demonstrate, and disseminate advances in translational science.

At the suggestion of Congress, the Institute of Medicine (IOM) was invited to assess the CTSA Program and its contributions to the acceleration and dissemination of advances in the prevention, diagnosis and treatment of human illness. Unless indicated otherwise, quotes in this FOA are from the IOM report which can be found at "The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research - Institute of Medicine".

In June 2013, the IOM Committee concluded that the CTSA Program had been successful in creating academic focal points for clinical and translational research at many medical research centers. The Committee noted that this program, currently composed of 62 largely independent units, could greatly increase the impact of their work in translation were they to evolve into a national network to enhance the transit of therapeutic, diagnostic, and preventive interventions along the developmental pipeline .

The following are the main recommendations from the IOM Committee on the NIH CTSA Program:

1. Strengthen NCATS leadership of the CTSA Program.

2. Reconfigure and streamline the CTSA Consortium.

3. Build on the strengths of individual CTSAs across the spectrum of clinical and translational research.

4. Formalize and standardize evaluation processes for individual CTSAs and the CTSA Network.

5. Advance innovation in education and training programs.

6. Ensure community engagement in all phases of research.

7. Strengthen clinical and translational research relevant to child health.

The IOM report was reviewed by an NCATS Advisory Council Working Group that in turn issued a draft report in May 2014 that will serve as a reference for developing strategies to strengthen the CTSA Program and as a guide for measuring and reporting progress . The Working Group report which can be found at http://www.ncats.nih.gov/files/CTSA-IOM-WG-Draft-Report.pdf lists the following strategic goals (page 3):

1. Workforce Development - The translational science workforce has the skills and knowledge necessary to advance translation of discoveries.

2. Collaboration and Engagement - Stakeholders are engaged in collaborations to advance translation.

3. Integration - Translational science is integrated across its multiple phases and disciplines within complex populations and across the individual lifespan.

4. Methods and Processes - The scientific study of the process of conducting translational science itself enables significant advances in translation.

With the goal of catalyzing the translation of biomedical discoveries into better health, the NCATS CTSA program is charged with creating an integrated research and training environment for clinical and translational sciences and support for research resources needed by local and national research communities to improve quality and efficiency across the translational research continuum. CTSAs also promote the development of a recognized, skillful translational workforce to conduct multi-disciplinary team science, the engagement of a broad range of stakeholders, the integration of translational research across the lifespan and across special populations, and the commitment to innovate and improve processes and methods.

To meet the current education and training needs in translational research, the IOM report encourages innovative curricula with team-based education and training, and preparation for working in multidisciplinary research groups. CTSA programs should foster training in rigorous research methodology that would help promote best practices among the next generation of researchers for minimizing bias in experimental design and reporting. Non-traditional experiences such as "mini-sabbaticals" in industry, other CTSA hubs or research organizations should be considered. With an increased focus on core competencies in translational research rather than on formal degrees, the CTSA education and training programs should provide flexibility to adapt to individual training needs. CTSA hubs are encouraged to collaborate in education and training initiatives. Taking advantage of modern information technology, CTSA hubs should seek opportunities to share methods or online resources, and to disseminate tools.

This FOA is one of several sequential steps in NCATS effort to improve the CTSA program and to augment its ability to enhance the transit of therapeutics, diagnostics, and preventive interventions along the developmental pipeline . In keeping with the IOM report recommendation of Identifying and disseminating a set of clearly defined, measurable strategic goals as a starting point for shaping the program’s future , this FOA defines a set overarching strategic goals for the CTSA program to which each member of the CTSA network should contribute. The FOA also defines a set of standards and resources that should be available at each member site to strengthen the capacity of the CTSAs as a research network. The institutions that make up the CTSA network will hereafter be referred to as hubs to indicate the central role they play in their local clinical and translational research environment, and in collaborating with their communities. An important operational principle of all NCATS programs, including the CTSAs, is to maximize impact via a catalytic approach: developing, demonstrating utility of, and then disseminating improvements in translational science and operations.

The NCATS CTSA program as a whole actively supports the full spectrum of clinical and translational research while encouraging flexibility for each hub to build on its own unique strengths. To reach and maintain this goal, defined sets of capacities and resources should be present at each hub so that it can act as a qualified partner in the CTSA program, promoting an environment of quality, safety and efficiency for translational and clinical research. CTSA hubs should be agents of continuous improvement as they identify gaps and opportunities in the research process and develop innovative solutions. CTSA hubs should promote team science, and the development of a well-trained and skilled translational workforce.

An additional important objective for each CTSA hub is the support of collaboration among CTSA hubs towards building a national CTSA network. This national network will allow for the efficient planning and implementation of high-quality multi-center research, will harmonize standards and best practices, and will enhance translational research training through shared innovative curricula, mentorship programs, online courses, or externships to take advantage of unique learning opportunities outside of the CTSA hub. In response to the IOM report, an enhanced CTSA program will have an increased focus on the network as a whole, and its goal to realize the promise of translational science. Synergy within the CTSA program is likely to yield greater impact than any sum of unique, individual efforts. Strengthening synergy will add to the justification of the nation’s investment into the CTSA program.

Enhancing the CTSA program’s capacity as a network will require changes at the local hubs. It is, however, expected that these changes will in the long run improve the local hubs ability to compete nationally and internationally, and will increase scientific and economic opportunities. As the rising tide lifts all boats, it is anticipated that the evolution of the CTSA program into a synergistic network will benefit all participants, and most importantly result in improved health with the community enjoying more effective prevention, diagnosis and treatment of diseases sooner.

In the future, NCATS plans to strengthen the CTSA program’s capacity as a network by creating new centers that will focus on supporting multi-site clinical studies through centralized infrastructure (such as IRB and contracting) and through centralized recruitment efforts. These new centers will work with all CTSA hubs that elect to participate in a given study.

This FOA calls for applications from medical research institutions to participate as hubs in the CTSA program. This program includes three parts which are linked at the time of application, but will be separated at the time of award:

• UL1 award for a translational science hub that provides an Administrative Core and four additional components: (1) Translational Science Base; (2) Research Expertise and Methods; (3) Research Implementation and Participation; and (4) Network Resources and Optional Modules;

• KL2 award for mentored career development programs;

• TL1 award (optional) to support research training for pre- and post-doctorates.

The K and T components will be reviewed by training experts and will receive separate scores. The overall impact score for the U54 will include all components. When NCATS issues the separate yet linked K and/or T awards, it will formally designate as PD/PIs those individuals identified with the Project Role of Other-Project Lead for those programs in the application. Meritorious K and T awards will only be made when the associated UL1 is funded. The U, K, and T awards each will maintain their own, separate budgets.

The CTSA hubs are charged with the continuing education of translational and clinical research personnel so that they have mastered core competencies in their own discipline, and the capacity to effectively communicate and collaborate as members of multidisciplinary teams. CTSA hubs should foster innovation in research education. This research education may include non-degree opportunities tailored to the specific needs of the workforce at the CTSA hub, and for those involved with human subjects, lead to Good Clinical Practice (GCP) certification as a minimum standard. CTSA hubs should foster team science and develop academic promotion criteria that help create a viable career path for translational scientists. The CTSA T and K programs are complementary and focus on the education of pre- and postdoctoral trainees, and on the career development of early-career translational researchers, respectively.

Translational science is a team-based endeavor. CTSA hubs are expected to support active partnerships throughout the translational process. To accelerate health discovery, these partnerships should be formed not only between academic collaborators, but also by involving, where and when appropriate, other stakeholders and communities, such as patients, their caregivers and families (local and online communities), non-profits, governmental agencies, community-based clinicians (hospitals, practices and clinics), health care delivery systems, industry, and other entities. CTSA hubs should develop a methodological framework for discovering, demonstrating and disseminating successful collaboration models.

Translational research must be integrated within complex populations, including the young and old to uncover the interrelationships of disease phenotype with genomics, environmental exposures, health-related behaviors, and social factors across the lifespan. CTSA hubs should have plans to enhance the participation in research of pediatric, geriatric, and other special or underserved populations, and in some instances make them the focus of study. Approaches could include designating a point person at the hub for research in these special populations, as appropriate for the individual and program capacities. CTSA hubs should seek to implement methodological innovations to integrate special populations into translational research.

CTSA hubs are expected to address bottlenecks impeding the conduct of clinical and translational research. Specifically, in response to this FOA, the application should include plans for the adoption and institution-wide implementation of pilot interventions shown to improve the translational process, including useful informatics environments (policies and infrastructure) that facilitate the integration of research and clinical care while at the same time protecting the privacy of research participants. Plans to promote a research-friendly environment where patients, clinicians and other stakeholders are given easily accessible opportunities to contribute to research should also be included. In addition, the application should include plans for adoption and implementation of innovative policies and infrastructure that improve the quality of human subject protections and promote a culture of responsibility, while streamlining institutional bureaucracy, and minimizing burden and delays, across all participating institutions and organizations.

Disease and condition-specific research supported by NIH Institutes and Centers is enhanced by the resources and services available through CTSAs, which in themselves are disease-agnostic and structured to provide innovation and support for all scientific/medical communities engaged in clinical and translational research.

NCATS will conduct a technical assistance webinar regarding RFA-TR-14-009: Clinical and Translational Science Award (U54) on Wednesday, September 17, 2014, from 12:00 to 1:30 pm EDT.

The webinar will review the purpose and objectives of the FOA and address questions from the community concerning the FOA. All prospective applicants are invited to participate. Submit questions in advance to CTSAFOAQuestions@mail.nih.gov.

Webinar Details

Date: Wednesday, September 17, 2014

Time: 12:00 to 1:00 pm EDT

URL: https://ncatsevents.webex.com/ncatsevents/onstage/g.php?t=a&d=663362661

Frequently Asked Questions

NCATS will post answers to frequently asked question on its website at www.ncats.nih.gov/ctsa-funding-faq.html

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to 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:

• Hispanic-serving Institutions

• Historically Black Colleges and Universities (HBCUs)

• Tribally Controlled Colleges and Universities (TCCUs)

• Alaska Native and Native Hawaiian Serving Institutions

• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)

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

The CTSA application may include domestic institutions of higher education, universities, academic health centers, or non-profit research organizations other than institutions of higher education that conduct clinical and translational research; however, a graduate school accredited to award higher degrees in clinical or translational science must be included (e.g., M.S. or Ph.D. in topics such as Clinical Research, Public Health, Pharmacology, Nursing, Informatics, Health Economics, or Epidemiology. Partnerships are encouraged among various disciplines including medicine, dentistry, nursing, pharmacy, osteopathy, public health, engineering and others).

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 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) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.

• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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.

It is expected that the UL1 Award PD(s)/PI(s) will be an established clinician/scientist who reports directly to an official with broad trans-institutional authority, and who personally has the authority and influence necessary to successfully promote translational and clinical research locally, partnering with internal and external stakeholders, supporting CTSA network activities as described below, fully integrating the hub into the CTSA network nationally. This may include authority, perhaps shared with other high level institutional officials, over requisite space, clinical and translational research resources, data and privacy resources, faculty appointments, protected time, promotions, institutional review boards, contracting, budgeting for clinical research, staff qualification and certification. In loosely coupled organizations that consist of university and hospital units, the CTSA PD(s)/PI(s) should have the authority or influence, personally or on their leadership team, to integrate these interdependent parts of the organization toward the CTSA program goals. The CTSA PD(s)/PI(s) are each expected to commit at least two months and preferably three to six months effort to the grant regardless of whether salary is requested. Those with designated responsibility for defined programmatic areas of the CTSA program should, in general, possess the knowledge, leadership, and administrative skills and capabilities necessary to direct those programs and to speak for the CTSA institution in national forums.

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).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;

• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or

• Of an application with a changed grant activity code.

Currently awarded CTSAs with project period end dates in 2016, 2017, or 2018 are not eligible to apply to this FOA.

Scholar Candidates

Scholars supported under the K component must be postdoctoral candidates with a research or health-professional doctoral degree or its equivalent.

Scholar Appointments

Candidates must have a full-time appointment at the applicant institution. Support is provided for a minimum of two years and a maximum of five years of consecutive funding for each scholar, consisting of consecutive 12-month appointments.

Selection Restrictions

Scholars may not simultaneously submit or have pending an application for any other PHS mentored career development award (e.g., K07, K08, K22, K23) that duplicates any of the provisions of the K component. Former or current PDs/PIs on any NIH research project grant (this does not include NIH Small Grants (R03), Exploratory/ Developmental (R21) or SBIR, STTR (R43, R44 grants)) or equivalent non-PHS peer reviewed research grants that are over $100,000 direct costs per year, or project leaders on sub-projects of program project (P01) or center grants (P50) are NOT eligible to participate as scholars. Appointed scholars are encouraged to apply for individual mentored K awards (e.g., K07, K08, K22, K23) and independent awards (R01, R03, R21); if successful, the KL2 appointment would be terminated and funding received from the new individual K or R award.

Scholars in the last two years of their appointment period may reduce effort on the mentored career award to a minimum of 6 person-months and hold concurrent support from their mentored career award and a competing PHS research grant on which they are the PD/PI or component lead.

Trainee Candidates
Trainees supported under the T component may be predoctoral or postdoctoral candidates seeking a research or health-professional doctoral degree or its equivalent. All trainees are required to pursue their research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies. Details on citizenship requirements and the full description of eligible degree options are available in NRSA Policy Statement for Institutional T32 Awards.

Predoctoral Trainees

Pre-doctoral trainees must have received a baccalaureate degree by the beginning date of their NRSA trainee appointment. Individuals currently supported by other Federal funds are not eligible for trainee support from the T32 component.

Postdoctoral Trainees

Postdoctoral trainees must have received, as of the beginning date of the NRSA appointment, a PhD, MD, DDS, or comparable doctoral degree from an accredited domestic or foreign institution. Eligible doctoral degrees include, but are not limited to, the following: DMD, DC, DO, DVM, OD, DPM, ScD, EngD, AuD, DPT, DPH, DNSc, PharmD, ND (Doctor of Naturopathy), DSW, PsyD as well as a doctoral degree in nursing research or practice. Documentation by an authorized official of the degree-granting institution certifying all degree requirements have been met prior to the beginning date of the training appointment is acceptable.

Trainee Appointments

Appointments are normally made in 12-month increments, and no trainee may be appointed for less than 9 months during the initial period of appointment, except with prior approval of the NIH awarding unit, or when trainees are appointed to approved, short-term (2 -3 months) training positions.

No individual trainee may receive more than 5 years of aggregate NRSA support at the predoctoral level or 3 years of support at the postdoctoral level, including any combination of support from institutional training and individual fellowship awards.

Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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:

Petra Kaufmann, M.D. M.Sc.
National Center for Advancing Translational Sciences (NCATS)
6701 Democracy Boulevard, Room 934
Bethesda, MD 20892
Telephone: 301-435-0178
Fax: 301-480-3661
Email: CTSAFOAQuestions@mail.nih.gov

Component types available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12 pages
Admin Core (use for Administrative Core)	12 pages
Transl Science (use for Translational Science Base)	12 pages
REM (use for Research Expertise and Methods)	12 pages
RIP (use for Research Implementation and Participation)	12 pages
NRO (use for Network Resources and Optional Modules)	12 pages
Inst Career Dev (use for Mentored Career Development)	25 pages*
NRSA Training (use for NRSA Training Core)	25 pages**

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

* The 'Inst Career Dev' component type will follow the page limits for the Institutional Career Development (KL2) activity code as defined in the Table of Page Limits. Note that the limit of 25 pages refers to the combination of Background, Program Plan, and Recruitment and Retention Plan to Enhance Diversity (attachments 2-4 of Research Training Program Plan form).

** The 'NRSA Training' component type will follow the page limits for the Institutional Training activity code as defined in the Table of Page Limits. Note that the limit of 25 pages refers to the combination of Background, Program Plan, and Recruitment and Retention Plan to Enhance Diversity (attachments 2-4 of Research Training Program Plan form).

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

Translational Science Base: Required

Administrative Core: Required

Translational Science Base: Required

Research Expertise and Methods: Required

Research Implementation and Participation: Required

Network Resources and Optional Modules: Required

Mentored Career Development: Required

NRSA Training Core: Optional

When preparing your application in ASSIST, use Component Type Overall .

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

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

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

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Location(s) (Overall)

Enter primary site only.

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

Research & Related Senior/Key Person Profile (Overall)

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.

Budget (Overall).

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

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

PHS 398 Research Plan (Overall)

Specific Aims: Describe the specific aims for the CTSA hub as a catalyst for high-quality clinical and translational research, locally and nationally.

Research Strategy: This section describes the overall vision, the track record in clinical and translational research, the integration of healthcare and research and the development of a diverse workforce.

Vision and Strategic Goals

The applicant should describe at a high level their strategic goals and vision for workforce development to ensure that translational researchers and their teams have the skills and knowledge necessary to advance translation of discoveries. This includes developing innovative curricula, and promoting greater participation of underrepresented groups in clinical and translational research careers, as well as a vision for collaborating with other CTSA hubs in advancing training goals. This also includes ensuring high research quality through training of research staff at all levels in appropriate, rigorous research methodology and implementation, ethics, and for all those involved with human subjects this includes training in good clinical practice as a minimum standard.

The applicant should describe their vision for creating a shared environment within their own CTSA hub, and within the CTSA network. This includes strategic goals to increase incentives for teamwork, to facilitate the assembly of multi-disciplinary translational teams, to promote collaborations, and to increase knowledge and awareness of what works best in team science. This also includes coordination with any local partner institutions and with other CTSA hubs to improve translational research, and to jointly evaluate, demonstrate and disseminate new research tools or methods. Applicants should describe the opportunities and challenges in improving clinical and translational research and training, along with innovative solutions.

The applicant should describe their vision for engagement of local and national communities in all phases of translational research, as well as increased engagement of interdependent stakeholders (patients, clinicians, healthcare delivery systems, categorical NIH Institutes and Centers, other federal agencies, and industry).

The applicant should describe at a high level their vision to incorporate where possible translational research across the lifespan, with particular focus on pediatric research. Further, the applicant should describe their vision on integrating special populations in translational research, in particular those affected by health disparities.

The applicant should describe at a high level their strategic goals for improving and streamlining methods and processes with focus on quality. This includes understanding and minimizing roadblocks, recognizing and filling gaps, enhancing the use of parallel processes, focusing on quality control and assurance, monitoring outcomes, and obtaining feedback from stakeholders. The vision should describe the CTSA hub commitment to innovation in processes and methods locally, as well as in the context of a national CTSA network. The applicants should describe their interest in participating in a network of CTSA hubs to study important clinical questions to be funded by NIH Institutes/Centers and other sponsors.

Track Record in Translational and Clinical Research

Briefly describe the institution’s notable contributions to translational and clinical research over the past 5 years with emphasis on high impact achievements that have advanced research towards better health. This section should address the four thematic areas highlighted in the IOM and NCATS Advisory Council Working Group: (1) Workforce development; (2) Collaboration/Engagement; (3) Integration; and (4) Methods/Processes. This section should discuss prior accomplishments and progress in translational research efforts

Integration of Health Care and Research

Specific focus should be placed on the coordination between the health care delivery system and the translational research enterprise to ensure synergy and early engagement to avoid downstream roadblocks, implement advances in the research domain seamlessly into clinical care settings, and prioritize translational research problems identified in the health care delivery context. With the concept of a learning healthcare system in mind, the applicant should describe system-wide approaches on how patients receiving care at the hub will be made aware of ongoing research, and invited to partake in research opportunities.

This section should also explain how clinicians at health care facilities and in the community are integrated in the research enterprise, how they can provide input into the questions asked, how they can be incentivized to refer or enroll research participants, how they can be engaged in research, how they can receive feedback on research results, and how they can help promote the implementation of research findings. The CTSA hubs are encouraged to coordinate and collaborate with other CTSA hubs, and to adopt and utilize tools developed by others to avoid duplication and redundancy.

This section may also describe a research-friendly environment where patients seeking clinical care at the CTSA hub could be routinely offered opportunities to contribute to translational research (opt-out, or opt-in). Other approaches could include finding innovative ways to provide information and education on clinical research in general to patients who use a CTSA hub for clinical care.

Workforce Diversity

The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation’s capacity to address and eliminate health disparities.

Accordingly the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, behavioral, clinical and social sciences such as: individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. In addition, NIH seeks to address the underrepresentation of women at the faculty and above level in academic research (www.nsf.gov/statistics/wmpd ).

To promote diversity within the NIH-funded scientific workforce applicants should describe their plans to recruit and retain a diverse workforce in their translational research program. Applicants should describe the current demographic distribution of their translational research workforce (faculty and trainee composition for departments considered part of the clinical/translational research enterprise), as baseline as data, and should describe their plans to track subsequent activity for 10 years.

Applicants should describe how they will identify and address barriers that may impede the participation of underrepresented racial and ethnic minorities, persons with disabilities and women in the program. Applications should address barriers for all these underrepresented groups, and how they will be addressed. For example, if an institution identifies barriers to the participation of women or caregivers, institutions could describe how they plan to address this issue in the application. This might include providing opportunities to remotely participate in training and work interactions.

Letters of Support: Letters of Support should state the institutional support for being part of the CTSA network. The CTSA program is moving towards centralized, streamlined network infrastructure. State how the applicant institution and any partner institutions anticipate participation in NIH programs with full reliance on a centralized IRB, the use of pre-negotiated master subcontracts, and providing transparent fee for service cost listings for research items.

These letters should commit the institutions to the CTSA program's goals and should indicate their willingness to work with a central IRB.

There is no cost sharing requirement under this FOA; however, indication of institutional support will be considered positively in the programmatic evaluation of applications.

The application is expected to include letters from the officials responsible for intellectual property issues at the applicant institutions (including sub-contractor institutions) stating that the institution supports and agrees to abide by the Resources and Data Sharing Plan and the Software Sharing Plan put forth in the application. These letters should be clear expressions of commitment consistent with achieving the goals of the program.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide

The CTSA program encourages sharing of resources with broad availability of policies, practices, materials, and tools to facilitate collaboration, reuse, and replication. In addition, the CTSA program encourages sharing of research data in a timely manner with appropriate privacy and confidentiality protections to facilitate further research, reuse of data, and replication. Thus the CTSA program expects grantees to implement a Resources and Data Sharing Plan consistent with achieving these program goals.

The CTSA program encourages sharing of software and code that are developed or modified to accomplish aims of this program. This may include, but is not limited to, software, tools, or code sets for: extraction and use of data for research from clinical systems; implementation of new efficient workflows for research studies; innovative networking to connect scientists, patient communities, industry, resources, data, and ideas; novel analytic and analysis programs; and educational tools. While software development is not the primary goal of this program, it is expected that software or sets of code may be developed under this program. Thus, grantees and their sub-contractors are expected to implement a Software Sharing Plan consistent with achieving the goals of this program.

A Resources and Data Sharing Plan is expected to be included in the application, and should include a plan for the sharing of software. There is no particular software dissemination license required for this program. However, NIH does have goals for software sharing and reviewers will be instructed to evaluate the sharing plan relative to the following goals:

• The software should be freely available to biomedical researchers, health care systems, and research institutions or organizations.

• The terms should also permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or components of it into other software packages.

• The terms of software availability should include the ability of individuals outside the applicant institution and its collaborating organizations to modify the source code and to share modifications with other colleagues.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Admin Core.

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

• Applicant Information

• Type of Applicant (optional)

• Descriptive Title of Applicant’s Project

• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

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

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

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

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

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Administrative Core

ASSIST will default to Project Lead . If you would like to use a different category, then replace Project Lead below with a different Category (e.g., Core Lead).

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 (Administrative Core)

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

The budget should cover travel expenses for appropriate personnel (up to 5 people) to attend two annual in-person CTSA investigator meetings. The expectation is that administrative operations be streamlined so that the overall cost for administration does not exceed 10% of the total direct costs.

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

PHS 398 Research Plan (Administrative Core)

Specific Aims: Describe the specific aims to address describethe organization, governance, collaboration, communication, as well as evaluation and continuous improvement.

Research Strategy:

Organization, Governance, Collaboration and Communication

Describe the organizational and governance structure and provide an organizational chart. This section should also describe the proposed relationship of the applicant institution and any participating partner institutions if applicable, integration (what each partner will contribute, how each partner will have input and participate in decision making, and how the partners will maintain ongoing communication). It is critical that the inclusion of any partners be well justified, that they each contribute essential elements or unique strengths to the overall program, and that there is a strong plan on how the partners work closely and directly together. Describe a leadership plan and succession plan.

Plans for managing competing institutional perspectives, disparities in institutional culture and resources and sharing of institutional expertise and resources should be provided. Plans for collaborative leadership and communication should consider the inclusion of a diverse range of internal and external partners and stakeholders. To promote synergy between the UL1 Lead, the K Award lead, and if applicable, the T Award lead, a collaborative leadership and communication plan between research, career development, and training should be described that integrates the educational programs of degree-granting institutions in clinical and translational science with the other partners at the CTSA hub.

Evaluation and Continuous Improvement

NCATS is committed to transparency and accountability in the CTSA program. The most meaningful measures of success pertain to impact and quality, and often do not lend themselves to simple, quantitative tracking. However, NCATS aims to implement Recommendation 4 of the IOM report to Formalize and standardize evaluation processes for individual CTSAs and the CTSA program , and has taken a two-pronged approach of standardization combined with metrics: First, NCATS has defined in this FOA essential modules in the REM, RIP, and NRO component that align tasks with the program’s mission and the IOM recommendations. These modules will be consistent across CTSA hubs, clearly named, associated with defined tasks, and a budget framework. This will set the stage for a standardized evaluation process for individual hubs and the CTSA program. Second, NCATS will work with the successful applicants to develop specific operational plans to implement a set of common metrics across the hubs, building on existing efforts in the CTSA program. Examples of metrics have been included with the research modules described below. When no meaningful quantitative metrics could be identified, then qualitative approaches were taken with focus on impact. NCATS will evaluate the feasibility, burden and usefulness of these metrics and make adjustments as needed.

Applicants should describe how they plan to collect metrics and how leadership will monitor progress. Applicants should describe milestone goals for their CTSA hub. Common metrics will be developed across the CTSA program and applicants should indicate how they will prepare for collecting data towards common metrics.

Applicants should also describe how they will consult the External Advisory Committee (EAC), a group that each CTSA hub must have. This EAC should meet annually to review progress and offer recommendations to the CTSA PD(s)/PI(s). Applicants with an existing EAC should name the members of their EAC and should describe changes they have made in response to EAC recommendations. Applicants without an existing EAC should describe their plans for constituting an EAC; the types of expertise to be represented in the EAC should be broad and include stakeholders that can bring a range of important perspectives such as patients, community-based clinicians, health systems representatives, informaticians, and industry. Applicants should describe their plan for EAC membership accordingly, but should not specify names and should not contact potential EAC members in advance of review of the application. In this section, applicants must also describe how they will collect and monitor metrics under the different modules, as well as how leadership internally and the external advisory board will be presented with the information so that they can take corrective action if needed, or identify particularly winning strategies for further dissemination.

Whenever possible, applicants should consider an experimental approach to evaluating innovations in training or research implementation. Different units of one CTSA hub, or several collaborating CTSAs could for example be randomized to the innovative intervention in training or research, and then prospectively compared to those randomized to standard practice. This will allow for subsequent data-driven decisions.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Administrative Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Administrative Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Transl Science.

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

SF424 (R&R) Cover (Translational Science Base)

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 (Translational Science Base)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Translational Science Base)

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) (Translational Science Base)

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 (Translational Science Base)

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.

• Because translational research is a collaborative endeavor, leadership roles should be considered for team members from different disciplines, departments, and schools. Further, team members critical to the success in translational research may be external to the applicant institution itself, such as patients, community-based physicians, health delivery systems, research institutes, and others.

Budget (Translational Science Base)

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

CTSA applications in response to this FOA shall consist of a single applicant institution, plus the possibility of one or more participating partner institutions that are effectively integrated into the proposed activities. The maximum total amount that can be requested per year for the U and K awards is 2.5% of the total FY13 institutional NIH funding and is listed at http://www.ncats.nih.gov/files/fy13-nih-funding-table.xlsx. If the applicant institution is currently funded by the CTSA program at a higher level (>25% total cost of the FY14 U and K awards excluding supplement and carryover actions), then the amount requested may be phased in over 3 years if needed to meet the award budget expectations described in this FOA by the beginning of year 4. It is expected that at least 25% of the reduction is proposed for year 1 funding, 50% for year 2, and 75% for year 3. A well justified plan that takes into account any changes in partners will be considered when NCATS funds the awards.

Budget Justification: Applicants should in the first paragraph summarize how they determined the maximum amount they could request and the phase-in plan if applicable. As a general principle, the amount actually requested should be well justified and depend on the work proposed.

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 (Translational Science Base)

Specific Aims: Describe the specific aims to address informatics, team science, community engagement and quality and efficiency goals..

Research Strategy:

Describe approaches to overarching topics in translational research, to identify and address roadblocks through innovative methods, with particular focus on the areas listed below.

Informatics

Per the IOM report, The challenge for the next phase of the CTSA Program will be to establish a more integrated and collaborative national network that will further catalyze the development of new diagnostics, therapeutics, and preventive interventions while driving innovation in clinical and translational research methods, processes, tools, and resources and leveraging the ever-expanding capabilities of health informatics tools and other research technologies .

Biomedical informatics is a critical CTSA focus for enabling and advancing translational research, which is increasingly data intensive, and requires collaboration across many communities, including healthcare, research, and public health. Additionally, the increasing amounts and types of data (e.g., genetic, imaging, clinical, economic, environmental, behavioral, patient reported) need to be integrated to generate knowledge. Cooperation and coordination among the data stewards in various organizations and institutions on policy issues, and among the managers of those data systems on technical issues are critical. This section should describe how the applicant will facilitate exchange of data among various sources required by translational researchers. Organizational, policy, and technical issues should be addressed. This section should explain how electronic or other medical records interface with clinical research data systems.

CTSA hubs should offer researchers a user-friendly data management system along with training on its use and some basic support. CTSA applicants should encourage compatibility of their research systems with broadly accepted content and technical standards including those adopted by the Department of Health and Human Services for use in U.S. health care and public health operations. In addition, as NIH Institutes and Centers adopt common data elements in their domain areas, CTSA hubs should ensure their research tools are compatible (see http://www.nlm.nih.gov/cde/Home for more information).

Maintaining the security of study data, particularly in studies involving human subjects, is critical. Many clinical and translational researchers manage such data in systems, processes, and formats that lack appropriate security. Academic institutions vary in the availability of low cost and user friendly infrastructure to assist investigators in ensuring the security of their data or in their requirements for its use by faculty, staff, and students. Applicants must describe their plan for ensuring the security of research data on all studies involving human subjects at all participating institutions. This plan should address policy, workflow, technical, and enforcement issues. The plan should outline challenges and possible alternative approaches for surmounting them.

CTSA hubs should work towards a flexible, sustainable digital enterprise where digital assets are interoperable so that, for example, data from the electronic health record (EHR) can be used for research purposes. This will require informatics solutions that are embedded in HIPAA regulations and other measures to safeguard patient privacy and autonomy. CTSA hubs should support a research-friendly integrated IT environment where information on applicable research opportunities is presented to clinicians and patients via EHR at the time of the clinical encounter. Other useful services might include noting a patient’s participation in a research study in the clinical EHR for the benefit of the treating clinician, and efficient routing of laboratory results. Applicants should describe any solutions they currently have locally to integrate health care and research data, as well as plans for the future. Applicants should indicate if they are currently participating in initiatives that make use of EHR data for research or surveillance (such as for example Mini-Sentinel, PopMedNet/PCORNet, i2b2, or SHRINE), and how they integrate participation with these initiatives into their local digital enterprise and network activities.

To accelerate translation, CTSA hubs should work towards data sharing and enabling data access, integration and processing. Applicants should indicate whether they have initiatives at their hub that support data sharing, how they promote broad use of data, and how they encourage investigators to submit data to repositories (see for example NIH Data Sharing Repositories). In this context, applications should also describe how they train researchers to prepare for downstream data sharing, such as by providing training and sample language for research-friendly consent forms that support broad data use (not limited to time, place or purpose), and that avoid complex nested formats to the extent possible. This is based on the observation that patients consenting to research participation are often information altruists who welcome the secondary use of research data so long as appropriate measures have been taken to protect their privacy. Applicants should also describe how they might collaborate with other CTSA hubs on using common data standards in multi-site projects.

NCATS attaches importance to assessments of informatics performance and goal setting across the entire CTSA community. Therefore informatics leadership from each CTSA is expected to participate in national CTSA network informatics activities, and the application should indicate an informatics point person that can serve as liaison to the network. The CTSA hubs are encouraged to share their informatics tools, and to adopt and utilize tools developed by others to avoid duplication and redundancy. The CTSA hub must be committed to working toward adoption and implementation of standards and practices endorsed by the CTSA program.

Collaboration and Multi-Disciplinary Team Science

The IOM Report stressed the importance of collaborations to accelerate translational research. These may include collaborations among multi-disciplinary teams of scientists at a CTSA hub, collaborations across CTSA hubs, and shared efforts with external public and private entities.

In this context, applicants should describe how they will foster collaborations by providing education in team science to teach the development and implementation of multi-disciplinary teams. Applicants should plan for ways to identify best practices in team science, and to disseminate successful models. This should include consideration on how team scientists will be considered in the academic promotion context, as well as consideration of enhancing the professional experience for all members of a translational team, not only the lead discovery or clinical researcher. Applicants may describe for example how pharmacologists or statisticians, often critical to success in translation, will be professionally recognized and thus incentivized to engage in collaborations. This may also include using innovative measures (other than the sole use of publications or grant support) when evaluating researchers. These measures could focus for example on contributions to therapeutics development (such as patents, or the impact of projects advanced). Further, applicants should describe how they envision working with other CTSA hubs and the national network, for example through shared online courses or best practices. The CTSA hubs are encouraged to adopt and utilize courses or tools developed by others to avoid duplication and redundancy. Applicants may describe innovative models on how to promote collaborations, such as for example conferences for multi-disciplinary researchers centered on a specific disease, agreements that facilitate collaboration/team science, or work on a translational roadblock or unmet need to spark collaborations and innovative solutions. Another approach is to offer consultations to researchers by a multi-disciplinary team of experienced translational experts so that researchers can better understand next steps, timelines, and plan to assemble the appropriate collaborators.

Community Engagement

This section should describe how the CTSA hub will engage communities, defined broadly, in the translational research enterprise. Communities may include but are not limited to non-profit or industry entities engaged in translational research, disease advocacy groups, local health providers, community-based organizations, culturally defined groups, and other national or local communities.

The IOM report recommended that Community engagement must be cross-cutting and embedded in leadership, implementation, research, and communication strategies across all levels of the CTSA program . The benefits of engaging patients and communities not only as consumers of healthcare, but as active partners in the full spectrum of translational research include, but are not limited to: identifying community health needs and priorities, providing input on relevant research questions, contributing to appropriate research design and methods, developing culturally sensitive and ethical proposals, enhancing the recruitment and retention of research participants, and implementing and disseminating research findings more effectively. Most community engaged research has taken place in the later phases of translational research, so that there is less experience on how to identify and involve communities from the beginning research stages throughout the translational continuum. In addition, since the optimal ways to involve relevant communities in each stage of the translational process have not been defined, there is a need for community engagement to be addressed as a scientific problem, in order to identify best practices and most effective approaches in an experimental, data-driven fashion.

Applicants should describe how patient and community engagement will be integrated into the translational science spectrum. CTSA hubs may engage communities based on a geographically defined area, a defined population or a disease entity. Communities to be engaged may be physical or virtual, online communities. Each institution is encouraged to build on their existing capacity and expertise in community engaged research and to evaluate which approaches or programs most contribute to advancing the process of turning observations in the laboratory and clinic into interventions that improve the health of individuals and the public. The guiding principle should be to not create community engagement infrastructure for the sake of it being there, but to engage communities around specific projects and translational research goals. Applicants should therefore describe how they will use the CTSA resources provided to develop best practices, information material and consultations on how to engage communities around specific projects. Applicants should also describe in this section how they will achieve inclusion of community engaged research into academic policies (such as promotion and tenure), how they will develop culturally competent training, how they will provide training for staff and communities (e.g. training for patients participating in translational research), how they will foster innovation, and how they will participate in the dissemination of best practice. The CTSA hubs are encouraged to coordinate and collaborate with other CTSA hubs, and to adopt and utilize tools developed by others to avoid duplication and redundancy.

If successful, community engagement would help ensure that communities have the capacity to participate as full partners; that communities are consulted for their research priorities; that all stakeholders are respected, valued and rewarded for their time and expertise, that more effective implementation and dissemination strategies are developed, and that there is increased public support for research, and ultimately improvements in the health and well-being of communities.

Quality and Efficiency

This section should describe the CTSA hub s overall commitment to quality, and plans to ensure safe and ethical human subjects research, including the appropriateness of study design, recruitment, feasibility, timely closure of futile studies, research study workflow, analysis, and dissemination of results. Applicants should also describe how they will provide high quality study drug management.

Applicants should describe how quality will be encouraged, monitored, and how interventions will be implemented when needed. Applicants should also describe how they will foster innovative methods and operational principles, how they will demonstrate the effectiveness of the innovation, and if found so, how they plan to disseminate their findings.

Applicants also should also describe a system-wide approach to increasing efficiency that includes plans for parallel processing, monitoring research timelines, reviewing processes to identify opportunities for increased efficiency, and systematic approaches to streamlining administrative processes through innovation.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Translational Science Base)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Translational Science Base

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type REM.

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

SF424 (R&R) Cover (Research Expertise and Methods)

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 (Research Expertise and Methods)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Expertise and Methods)

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) (Research Expertise and Methods)

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 (Research Expertise and Methods)

ASSIST will default to Project Lead . If you would like to use a different category, then replace Project Lead below with a different Category (e.g., Core Lead).

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 (Research Expertise and Methods)

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

The budget will depend on the development needs for each hub to reach the strategic goals. For the required modules, tasks are defined, and associated with budget suggestions adjusted for the anticipated award size to clarify expectations of scope. The tasks are listed below showing in parentheses the recommended budget amount in $1000s for small (total anticipated CTSA award <$6M), medium (total anticipated CTSA award $6-8M), and large awards (total anticipated CTSA award >$8-10M).

1. Translational Workforce Development (TWD) (200, 300, 400)

2. Biostatistics, Epidemiology and Research Design (BERD) (200, 300, 400)

3. Regulatory Knowledge and Support (RKS) (150, 300, 400)

1. Translational Workforce Development (TWD) (200, 300, 400)

Applicants should budget for workforce development for hubs with small, medium and large awards (defined above). Education administration or project management expenses and support for the TWD-liaison to network-wide activities may be included. Further, the budget may as needed be used for: 1) curriculum and degree program expenses to develop lectures, courses, seminar series; 2) education programs for non-degree seeking undergraduates, allied health personnel, study coordinators, project managers; and 3) development of innovative, online tools or training collaborations with other CTSA hubs, the CTSA network, and other entities.

2. Biostatistics, Epidemiology and Research Design (BERD) (200, 300, 400)

Appropriate budget items would include for example the support of expert time for consultations, for project management time to coordinate course and training opportunities, and to connect methodology researchers with others who have identified a gap in translation that could be filled through methodological innovation.

3. Regulatory Knowledge and Support (RKS) (150, 300, 400)

Appropriate budget items would include for example the support of regulatory experts and protocol writers to provide consultations and assistance to investigators who submit IND applications, or in other regulatory matters including innovative strategies such as remote monitoring or risk-based monitoring. Other appropriate expenditures might include provision of information and access to coursework in regulatory sciences.

It is evident that not all research conducted at an academic medical center could receive support from finite CTSA resources. Because the mission of NCATS and the CTSA program is disease-agnostic, CTSA funds can therefore not be used to offset the cost for a necessarily select set of disease-oriented research studies. As a general principle, therefore, the CTSA funding should be used to facilitate and catalyze research supported by other funders (with the exception of those pilot and collaborative studies that are funded by the CTSA itself). An important operational principle of all NCATS programs, including the CTSAs, is to maximize impact via a catalytic approach: developing, demonstrating utility of, and then disseminating improvements in translational science and operations. The CTSA support should thus focus on providing a foundation that promotes quality, efficiency, collaboration, and ultimately success as defined by impact. This support should also be used to identify roadblocks and to foster innovation to overcome them. Administrative costs should be carefully considered and justified. Examples of appropriate funding requests may include a limited number of experienced research professionals who can provide oversight, consultations, education, serve as liaison between different partners, help with quality control and assurance, and promote innovation, but who cannot provide the actual research procedures (except those included under the voucher program described in detail below and accounted for separately).

Budget Justification: For all tasks described in the modules above, the amount requested must be well justified. The budget justification should list each module identified above and a corresponding justification for the associated costs.

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 (Research Expertise and Methods)

Specific Aims: Describe the specific aims to lay the foundation for high quality research. Specifically, how the clinical and translational workforce will be trained in clinical research methodology and how high quality biostatistics and regulatory support will be provided.

Research Strategy: For each of the required modules below, applicants should describe how CTSA funding will be used to enhance innovation, access and quality in a measurable way.

• Translational Workforce Development (TWD)

For this module, applicants should describe a comprehensive approach to the continuous development of the translational workforce at the CTSA hub. This needs to be well integrated with the K- and T- components of the overall U54 program, the CTSA hub. The workforce development should be directed not only at physician scientists, but also at members of translational and clinical research teams, such as pre-clinical translational scientists, research coordinators, and other allied health professionals involved in human subjects research. At a minimum, all staff involved in human subjects research should receive Good Clinical Practice (GCP) training. The training programs should be adapted to the trainees needs to insure, to the extent possible, high level performance by all levels of the research team. The training programs may include on-site and on-line opportunities, and should be tailored, practical and interactive. They may be designed around relevant, real-world scenarios to be solved individually or by teams. The training experience should emphasize that translational and clinical research is a collaborative endeavor. Translational researchers should be offered experiential learning opportunities, and should be encouraged for example to pursue externships at organizations such as the Food and Drug Administration (FDA), patient advocacy groups, biotech or pharmaceutical industry, venture capital groups or other health research related organizations. In addition to continuing education opportunities to be offered to faculty and professional staff, applicants should consider efforts to provide training for community partners such as for example patients, their families members, social workers or others who are participating in the translational or clinical research enterprise.

Applicants should describe how existing training programs will be offered to the CTSA staff or adapted to their specific needs, and how they will streamline resources and avoid redundancy by collaborating with other CTSA hubs or related training efforts. To that effect, applicants should appoint a liaison to interact with the emerging network-wide training and staff qualification initiatives.

Metrics: TWD metrics might track the number of currently GCP trained individuals relative to the number of individuals listed on an IRB protocol as research staff. TWD may list the titles of courses, whether they were on-site or remote, how many people participate, confidential participant feedback, and any innovative course features (e.g., interactive, real-world, relevant problem to be solved).

• Biostatistics, Epidemiology and Research Design (BERD)

The BERD module must include a service and training elements to provide investigator support for clinical research design and analyses, and provide educational topics and courses for research staff. BERD also should include an academic research section capable of developing novel tools and methods intended to solve problems and address barriers to the conduct of clinical and translational research projects. The BERD module maps to Recommendations 3 and 5 in the IOM report which emphasize inter-disciplinary team-based approaches, driving innovation/collaboration in methodologies, and flexible/personalized training experiences.

BERD will provide easily-accessible consultations in biostatistics, epidemiology, research design, and analysis. BERD cannot furnish comprehensive statistical support for all translational research projects. For each project, adequate methodological support must be planned for and included in any funding request to a sponsor. The BERD consultations should be limited in scope and intended to help researchers understand the underlying methodological aspects of their research so that they can adequately plan their projects. In addition, BERD consultations are intended to help connect researchers with expert collaborators for additional or ongoing support.

BERD will include user-friendly courses for research staff at all levels, which are integrated and stimulated by the work environment so that everyone in the research enterprise is continually exposed to these foundational methods. BERD cannot provide the entire range of possible coursework, but can facilitate access, can raise awareness of learning opportunities, and collaborate with entities such as the department of biostatistics, or with other CTSA hubs or external groups to be able to connect learners with cost-effective training opportunities. BERD may also help develop a degree or certificate in clinical and translational biostatistics open to trainees with a range of primary degrees. Applicants should describe their plans to include innovative approaches such as online classes or interactive programs.

BERD will promote innovations in tools and methods intended to address barriers to translational and clinical research. This will be done in collaboration with internal groups, groups at other CTSAs or external groups. BERD cannot support all innovations itself, but helps identify the gap and opportunity, and to connect the collaborators needed to solve the problem.

Applicants should describe how they might collaborate with other CTSA hubs to leverage resources, or to demonstrate the value of innovation.

Metrics: For BERD consultations, metrics may include for example novel methodological approaches, demonstration of impact of consultations on translational effectiveness, number of consultations, turnaround time, confidential investigator feedback on quality, and on successful connection with experts in statistics or research design as collaborators. For BERD courses, metrics might include a list of the courses facilitated by BERD along with the number or participants and confidential participant feedback on the usefulness of the course. For methodological innovations initiated by BERD, metrics may include a list of projects stating the gap they intend to address, the innovation, and the outcome.

• Regulatory Knowledge and Support (RKS)

RKS couples efficient planning and execution of trial start-up with the protection of human subjects by facilitating regulatory knowledge and compliance related to clinical and translational research in conformance with IRB policies, State laws, and Federal regulations. Applicants are encouraged to innovate at all levels of clinical and translational research including, for example, the provision of integrated research education, guidance, services, or tools for protocol and informed consent formulation, adverse event reporting, safety and regulatory management and compliance. Educational resources might be available remotely, and could be harmonized or shared with other CTSA hubs or external entities. The CTSA hubs are encouraged to coordinate and collaborate with other CTSA hubs, and to adopt and utilize tools developed by others to avoid duplication and redundancy. Regulatory support provided through the CTSA should neither take the place of an institutional compliance office nor be responsible for Institutional Review Board (IRB) activities, but should assist investigators, coordinators and others as needed. The institution should demonstrate innovation in providing regulatory support to facilitate clinical and translational science research without loss of participant protections, promoting regulatory competency, regulatory science, and new regulatory-compliant strategies for emergent technologies. Examples include improvements to the informed consent process which may include innovative approaches to limiting the total number of pages to 5-8, or to making the informed consent form more user-friendly and informative, by separating legal and contractual language from the information that is of importance to research participants, and/or by providing supplemental video or other visual material. Applicants should describe how they might collaborate with other CTSA hubs to leverage resources, or to demonstrate the value of RKS innovation.

Metrics: For RKS consultations, the number of consultations, turnaround time, demonstration of impact on projects, and confidential investigator feedback on quality would be useful. For RKS protocol writing support, metrics may include the number of projects that have received assistance, and the time from submission to IRB to IRB approval compared with those without such assistance to test the assumption that high quality protocols can expedite the time to IRB approval. For the informed consent process, metrics may include the length of consent forms, the provision of visual material, and confidential research participant feedback on the consent process. For RKS courses, metrics may include the number of participants, confidential feedback, and the use of innovative methods such as online or interactive courses, and collaborations across the CTSA network. For methodological innovations initiated by RKS, the impact of the innovation should be measured and reported, and published when appropriate.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Research Expertise and Methods)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Research Expertise and Methods)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type RIP.

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

SF424 (R&R) Cover (Research Implementation and Participation)

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 (Research Implementation and Participation)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Implementation and Participation)

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) (Research Implementation and Participation)

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 (Research Implementation and Participation)

ASSIST will default to Project Lead . If you would like to use a different category, then replace Project Lead below with a different Category (e.g., Core Lead).

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 (Research Implementation and Participation)

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

The budget will depend on the development needs for each hub to reach the strategic goals. For the required modules, tasks are defined, and associated with budget suggestions adjusted for the anticipated award size to clarify expectations of scope. The tasks are listed below showing in parentheses the recommended budget amount in $1000s for small (total anticipated CTSA award <$6M), medium (total anticipated CTSA award $6-8M), and large awards (total anticipated CTSA award >$8-10M).

1. Pilot Translational and Clinical Studies (PTC) (200, 300, 400)

2. Integrating Special Populations (ISP) (200, 300, 400)

3. Participant and Clinical Interactions (PCI)* (400, 750, 1000)

* Space, beds, or patient evaluations are not allowable costs outside of a voucher program which may be used for pilot studies that do not have sufficient dedicated funding. Through such a voucher program only, and after rigorous and standardized internal review, qualified pilot studies may receive a defined amount towards costs related to patient evaluations (e.g. blood drawing, beds).

1. Pilot Translational and Clinical Studies (PTC) (200, 300, 400)

Most of the PTC funding should be allocated to pilot projects, with a small amount for review and administration of the program. The PTC must not support any clinical trials beyond phase IIA. As noted in Section IV. (Funding Restrictions), NCATS can develop and provide infrastructure and resources for all phases of clinical trials, but it can directly support clinical trials only through the end of phase IIA.

2. Integrating Special Populations (ISP) (200, 300, 400)

Appropriate budget items might include identifying point persons for pediatrics research, for geriatrics research, or for other special populations. Such a person could identify opportunities, establish best practices for including an increased range of the study population, longitudinally and cross-sectionally, provide consultations, foster collaborations, and effect policy changes to enhance opportunities for ISP.

3. Participant and Clinical Interactions (PCI)* (400, 750, 1000)

CTSA funding can be used to support clinical research staff only for oversight and quality assurance, but not to support actual research activities that are part of studies and trials conducted at the CTSA hub. For example, the CTSA funding may be used to support a limited number of experienced clinical research professionals such as research nurses or coordinators who can facilitate access to resources, can assist study-specific staff, and can provide oversight and help with quality control and assurance. Support for the study-specific staff conducting the actual research participant evaluations must be included in the per patient fee or other funding provided by the NIH ICs or the private sector supporter of that study or trial. If a pool of coordinators or research nurses is available to conduct participant evaluations and implement protocols at a CTSA hub, their activities must be charged to the study budget itself.

Space to conduct research cannot be charged to the CTSA grant. If research space is provided by the institution for inpatient and or outpatient participant evaluations, the application should describe the space, potential availability and if applicable hourly or overnight rates charged for NIH-funded or other research. Inpatient and outpatient care costs cannot be charged to the CTSA grant.

The cost of evaluations such as laboratory testing or imaging should be included in the budget for each specific study and included in the funding for that study. The cost for these tests cannot be charged to the CTSA grant. The only exception is the option of including a "voucher" program. Such a voucher program can provide small amounts of support for research evaluations, for instance laboratory testing in pilot studies (e.g. those funded by the CTSA or those that are part of the NCATS K-award program). The total amount for a voucher program cannot exceed $100,000 for small; $200,000 for medium; and $300,000 for large academic medical centers (tiers as defined above). The vouchers have to be approved by a committee with members from different departments or schools as applicable, can go to IRB approved studies only, and should generally range between $ 1000 and $5000 each.

It is evident that not all research conducted at an academic medical center could receive support from finite CTSA resources. Because the mission of NCATS and the CTSA program is disease-agnostic, CTSA funds can therefore not be used to offset the cost for a necessarily select set of disease-oriented research studies. As a general principle, therefore, the CTSA funding should be used to facilitate and catalyze research supported by other funders (with the exception of those pilot and collaborative studies that are funded by the CTSA itself). An important operational principle of all NCATS programs, including the CTSAs, is to maximize impact via a catalytic approach: developing, demonstrating utility of, and then disseminating improvements in translational science and operations. The CTSA support should thus focus on providing a foundation that promotes quality, efficiency, collaboration, and ultimately success as defined by impact. This support should also be used to identify roadblocks and to foster innovation to overcome them. Administrative costs should be carefully considered and justified. Examples of appropriate funding requests may include a limited number of experienced research professionals who can provide oversight, consultations, education, serve as liaison between different partners, help with quality control and assurance, and promote innovation, but who cannot provide the actual research procedures (except those included under the voucher program described in detail below and accounted for separately).

Budget Justification: For all tasks described in the modules above, the amount requested must be well justified. The budget justification should list each module identified above and a corresponding justification for the associated costs.

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 (Research Implementation and Participation)

Specific Aims: Describe the specific aims for the pilot study program, the integration of special populations (such as pediatric and geriatric) into research and the aims for participant and clinical interactions.

Research Strategy: For each of the required modules below, applicants should describe how CTSA funding will be used to enhance innovation, access and quality in a measurable way.

• Pilot Translational and Clinical Studies Program (PTC)

The intent of the CTSA Translational Pilot Program is to develop novel technologies and methodologies, to test the feasibility of novel approaches, and to stimulate inter-disciplinary collaborations that test generalizable solutions to translational research problems. Each CTSA hub has the flexibility to focus and design their translational pilot program to address their particular priorities; however, the program should not exclusively focus on a select disease category, a few diseases or specialties, or on a limited number of investigators. Applicants should not include detailed and specific pilot projects to be reviewed as part of their U54 application.

Applicants should describe their translational pilot program guidelines: addressing solicitation, review, prioritization, business and cost management, progress tracking, and program evaluation. The review must be rigorous and include an in-person meeting of a multi-disciplinary committee patterned after an NIH study section peer review process to ensure that pilot projects are of high methodological quality, and can answer important scientific question proposed. Pilot studies should have a clear path forward along with criteria for go/no go decisions, next steps if the pilot is successful, and plan for reporting of negative results if not successful. Applicants also should discuss their experience or interest in adopting any emerging CTSA review standards, or participate in reciprocal review support to exchange expertise. The CTSA hubs are encouraged to coordinate and collaborate with other CTSA hubs, and to adopt and utilize tools developed by others to avoid duplication and redundancy. Appropriate policies must be included to ensure translational pilot program project compliance with all federal regulations and NIH policies, including, but not limited to, studies involving human subjects, genetic material, stem cells, or model organisms.

Metrics: PTC metrics may include the generalizable translational solutions developed, demonstration of feasibility accomplished, enumeration of pilot projects funded along with a rating of methodological quality of trial design when applicable and performance as measured for instance by power calculations; measures to minimize bias; measurement of impact, not only or even principally in publications or further funding obtained, but most importantly impact on one or more extant translational roadblocks, and critically, plans for implementation/dissemination.

• Integrating Special Populations (ISP)

Translational Research is needed to ensure that breakthroughs are quickly translated to the benefit of society and all subpopulations within. Significant evidence gaps remain in our understanding of childhood diseases, and of the effect of treatments on children. As a result, clinicians must often take action based on data from adults. Applicants should describe efforts to include children as a focus of translational research.

With the graying of the US population, investigators must recognize and adapt to population longevity and the questions so driven. Applicants should describe efforts on how older patients will be included in research, for example how they might increase or drop the upper age limit for trial participation and how such a change would improve translational efficiency and effectiveness, and be scientifically or medically justified. This section should also indicate how research will be promoted that focuses on older populations, including the relationships of diseases to environmental exposures or behaviors. Another special group includes those who are the survivors of formerly lethal childhood diseases. Research is needed to better understand the impact on and approach to adults with chronic health conditions that originated in childhood, both as a consequence of the disease or its treatment.

In addition to considering longitudinal differences across the lifespan, translational research must also consider cross-sectional differences across populations, such as underserved or health disparity populations, which includes racial, ethnic or gender differences as well as differences in socio-economic status or in a rural vs. urban environment. This may also include other populations such as pregnant women, people with particular disabilities, and hard-to-reach groups that are often impacted by health disparities. Applicants should describe how they might collaborate with other CTSA hubs to leverage resources. Applicants are encouraged to adopt and utilize tools developed by others to avoid duplication and redundancy.

Metrics: ISP metrics may include the proportion of clinical and translational research projects that incorporate individuals across the lifespan, at either end of the lifespan, or in minority and health disparity populations. Further, ISP metrics could for example include the number of projects that specifically focus on or include a realistic, declared stretch goal percentage of health disparities populations. The following populations have been designated as health disparity populations: Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, socioeconomically disadvantaged populations, and rural populations. Finally, ISP metrics should report the policy changes or other methodological innovations that were made to promote translational research across the lifespan and across underserved or health disparity populations.

• Participant and Clinical Interactions (PCI)

CTSA applicants must describe detailed plans to ensure that high quality human subjects research is conducted at their institutions and that scientifically or ethically flawed studies are identified, not approved or conducted, and learned from at an individual and institutional level. The application should address the appropriateness of specific study designs, development of realistic recruitment goals, tracking of enrollment, follow-up, submission of high quality data, careful data monitoring, steps to ensure the timely assessment of feasibility and closure of studies that do not meet goals or suggest toxicity or breach boundaries established to identify efficacy, and orderly closeout and publication of results. There should be efficient institutional workflows for planning and conduct of studies, the evaluation of patients by trained personnel, expectation of prompt analysis, and dissemination of results.

CTSA program funding is at the moment fixed, but clinical and translational research opportunities are likely to continue to increase, given the rapid pace of advances in fundamental research. Funding for specific clinical and translational research projects must therefore come from a variety of sources in addition to the CTSA program itself, such as the disease-specific NIH Institutes and Centers (ICs), or the private sector. The CTSA program must ensure quality and efficiency so that these sources come to value the CTSA Network because of dependable and efficient processes, leading to timely completion of trials with lower overall cost as a result of more efficient implementation.

Additionally, the registration of all clinical studies and trials in clinicaltrials.gov is encouraged; registration of all applicable trials is required, as is the posting of results per Food and Drug Administration Amendments Act (FDAAA). Applicants should describe any education or support they provide to clinical investigators for registering or reporting on the clinicaltrials.gov website.

Metrics: PCI metrics may include for example measures of quality such as the number of major protocol violations reported to the IRB, the proportion of clinical research studies approved by the IRB that successfully completed projected enrollment for a given calendar year, and the compliance with the FDAAA-required clinicaltrials.gov registration and reporting.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Research Implementation and Participation)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Research Implementation and Participation)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type NRO.

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

SF424 (R&R) Cover (Network Resources and Optional Modules)

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 (Network Resources and Optional Modules)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Network Resources and Optional Modules)

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) (Network Resources and Optional Modules)

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 (Network Resources and Optional Modules)

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 (Network Resources and Optional Modules)

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

The budget will depend on the development needs for each hub to reach the strategic goals. For the required modules, tasks are defined, and associated with budget suggestions adjusted for the anticipated award size to clarify expectations of scope. The tasks are listed below showing in parentheses the recommended budget amount in $1000s for small (total anticipated CTSA award <$6M), medium (total anticipated CTSA award $6-8M), and large awards (total anticipated CTSA award >$8-10M).

1. Multi-Site Study Support (200, 350, 400)

2. Recruitment of Research Participants (200, 300, 400)

3. Optional Modules as appropriate, similar range as above is recommended

1. Multi-Site Study Support (200, 350, 400)

Based on the research volume at the hub (small, medium, or large awards), the applicant may include costs for staff with legal, IRB, budgeting, or project management expertise to work on planned CT-SCs activities.

2. Recruitment of Research Participants (200, 300, 400)

Based on the research volume at the hub (small, medium, or large awards), the applicant may include costs for staff with data, informatics, analysis, privacy protection, study recruitment, communications or project management expertise to work in the recruitment unit.

3. Optional Modules

The amount applicants may request is variable and depends on the scope of work.

It is evident that not all research conducted at an academic medical center could receive support from finite CTSA resources. Because the mission of NCATS and the CTSA program is disease-agnostic, CTSA funds can therefore not be used to offset the cost for a necessarily select set of disease-oriented research studies. As a general principle, therefore, the CTSA funding should be used to facilitate and catalyze research supported by other funders (with the exception of those pilot and collaborative studies that are funded by the CTSA itself). An important operational principle of all NCATS programs, including the CTSAs, is to maximize impact via a catalytic approach: developing, demonstrating utility of, and then disseminating improvements in translational science and operations. The CTSA support should thus focus on providing a foundation that promotes quality, efficiency, collaboration, and ultimately success as defined by impact. This support should also be used to identify roadblocks and to foster innovation to overcome them. Administrative costs should be carefully considered and justified. Examples of appropriate funding requests may include a limited number of experienced research professionals who can provide oversight, consultations, education, serve as liaison between different partners, help with quality control and assurance, and promote innovation, but who cannot provide the actual research procedures (except those included under the voucher program described in detail below and accounted for separately).

Budget Justification: For all tasks described in the modules above, the amount requested must be well justified. The budget justification should list each module identified above and a corresponding justification for the associated costs.

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 (Network Resources and Optional Modules)

Specific Aims: Describe the specific aims to address the support of network wide studies and aims for optional activities in areas of unique strength or opportunity.

Research Strategy: Applicants should describe how the CTSA hub will connect with the CTSA network resources and how it will support multi-center studies. This component also allows applicants to propose optional modules for particular strengths and interests. For each of the modules below, applicants should describe how CTSA funding will be used to enhance innovation, access and quality in a measurable way.

• Multi-site Study Support

To facilitate multi-site research, applicants should develop a local unit to facilitate start-up and implementation. The unit might include staff experienced in IRB, contracting and budget matters, as well as coordination and/or project management, and will serve as liaison to the planned CTSA-support centers (CT-SC). The local study support units will facilitate the implementation of multi-site research using tools such as reliance on a common IRB and standardized contracting resources. It is anticipated that these centralized activities will commence in late 2015. Until the CT-SCs have been established, the local study support units will work on accelerating IRB and contracting using the existing mechanisms, will set up a tracking system for study metrics as described below, and will prepare for working with the planned CT-SCs. Once the planned CT-SCs are operational, they will establish IRB reliance agreements and master subcontract agreements/trial agreements with the local study support units.

Also, the study support unit will streamline budget preparation by establishing, updating, and posting for CTSA internal use the price of clinical research items (such as for example a chest X-ray, or a complete blood count). Applicants should describe one price per item, and as needed, a transparent price adjustment in the form of a discount for NIH studies, or a surcharge for industry studies to account for F & A differentials. This price inventory will facilitate and expedite the planning of clinical research.

The subsequent task of the study unit will be to support application for IRB approval of specific protocols and the execution of trial-specific amendments to the master contract agreements to be established between the CTSA hubs and the planned CT-SCs. Examples of IRB reliance agreements and master contracting templates used by the NIH can be found at NEURONEXT Central IRB. Applicants and authorized institutional officials are strongly encouraged to review these documents carefully, and to anticipate a comparable framework for CT-SCs.

The objective of the planned CT-SCs and the network they will create is to streamline the implementation of clinical research. While NIH has historically often funded trials to test drugs already approved for other indications, the network is intended to assure the broadest access to any new therapies for patients by carrying out trials derived from partnerships between NIH and industry, foundations, or academia. These trials will utilize a variety of the NIH agreement mechanisms (e.g., Cooperative Research and Development Agreements [CRADAs]) that facilitate industry participation and support. (See for example, NEURONEXT CRADA.)

The applicant should describe how the study unit will coordinate between reliance on a central IRB and the other research oversight tasks carried out at the institution, such as radiation safety approval, or conflict of interest reporting and management. CTSA applicants and participating elements should anticipate and agree, in principle, to work collaboratively with other institutions and funding agencies to facilitate participation by their research teams in multi-site studies including their willingness to adopt centralized IRB arrangements. Applicants should describe institutional processes for clinical trial agreements and contracts and likely timelines for completion. Applicants are also encouraged to engage their authorized institutional official(s) in addressing this section of the FOA.

Specifics on interactions between the local study units and the future CT-SCs are expected to be defined in the form of joint standard operating procedures once the planned CT-SCs are established. Therefore, applicants should describe in detail how they will work locally to aid efficient trial implementation, and should describe in general terms only their capacity and willingness to engage with the planned CT-SCs.

Metrics: Applicants should include a table with the application that contains a brief description of all clinical trials with site activation in the first half of 2013, showing time from contract received to execution, time from protocol received by the trial principal investigator (or time protocol finalized if local trial) to IRB approval, time from subcontract executed to first patient first visit, and time from IRB approval to first patient first visit.

• Recruitment of Research Participants

Delays in recruiting participants to clinical studies are a major barrier to progress in clinical research. In this section, the applicants should describe how they will develop a unit dedicated to supporting the recruitment of trial participants. This unit will need to combine data expertise so that resources like the electronic health record (EHR) can be accessed to identify potential research participants, with expertise in clinical research, patient engagement, and ethics so that potential participants can be notified of research opportunities in an ethical and effective way. The local recruitment unit will interact with the planned CTSA Network Recruitment Centers (CT-RCs). These CT-RCs will provide trial sponsors (initially primarily anticipated to be the categorical NIH institutes and centers) with accurate data on potential research participants that meet the study entry criteria. The data can be used for site selection, recruitment planning and outreach to potential participants. To that effect, the local recruitment unit must enable information extraction from electronic health record (EHR) on potential trial participants that can be shared in a de-identified, aggregate format with the planned CT-RCs. The applicants should describe how this will be done at all clinical spokes affiliated with the CTSA hub, how patient privacy will be safeguarded and how the process complies with regulations pertaining to privacy and human subject protection. In addition, the local recruitment unit will be involved in informing potential research participants of research opportunities. The applicant will describe how the local recruitment unit will help connect participants to active trials in accordance with the Health Insurance Portability and Accountability Act (HIPAA) and consistent with any consent documents used. Potential clinical trial candidates are often informed of research opportunities by their health care provider only. However, applicants may describe more streamlined models that they will implement at their institution. Until the CT-RCs are operational, the CTSA hubs will support the identification of potential research participants and their recruitment into studies locally. Specifics on interactions between the local recruitment units and the future CT-RC efforts are expected to be defined in the form of joint standard operating procedures once the planned CT-RC centers are established. Therefore, applicants should at this time describe in general terms only their capacity to interact with the planned CT-RC centers. However, as noted above, applicants should describe in detail whether and how they can access the EHR locally to aid the identification of patients who might quality for trial participation and if so, how they might be informed and recruited. They should describe how they will assist researchers in contacting patients, and how they will consider whether any policy changes are needed at their hub.

Metrics: The applicant should show a second table for the same trials listed above under Multi-site Study Support of planned monthly enrollment in a given trial versus the number of patients actually enrolled at the hub.

Optional Modules

Applicants may include up to two additional modules based on specific strengths and needs of the particular proposed CTSA hub. Applicants may include additional modules including for example Phase 1 trial units, genomics, drug discovery, preclinical development, imaging, or collaboration with Veterinary Medicine School, rural health/telemedicine and others. Optional modules need to be feasible based upon unique opportunity and substantial prior experience.

These are areas which applicants propose to develop in addition to the required modules described above. These optional modules should be limited in number to one or two, and based on a well justified need or opportunity at the hub, such as access to a particular population or expertise. These optional modules may also focus on collaborations with other CTSA hubs, for example to evaluate the effect of a new or existing tool or method on clinical and translational research at multiple hubs. Whenever possible, applicants should consider an experimental approach to evaluating innovations. Different components of one CTSA hub, or several collaborating CTSAs could for example be randomized or cluster-randomized to the innovative approach, and then prospectively compared to those randomized to standard practice. This will allow for subsequent data-driven decision making.

Letters of Support: The application must include a letter of support from an authorized institutional official stating that the institution is willing to work under a central IRB, is willing to use master subcontract agreements/trial agreements (NEURONEXT Master Clinical Trial Agreement), and is willing to work under a transparent cost structure for per patient cost.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Network Resources and Optional Modules)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Network Resources and Optional Modules)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Inst Career Dev .

Relevant table shells can be found at the following link: http://grants.nih.gov/grants/funding/424/index.htm#data.

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) applications except where indicated below:

Substitute the term scholars for all references to trainees in the SF424 (R&R) Application Guide, and substitute the term career development for all references to training in the SF424 (R&R) Application Guide.

SF424 (R&R) Cover (Mentored Career Development)

Complete only the following fields:

• Applicant Information

• Type of Applicant (optional)

• Descriptive Title of Applicant’s Project

• Proposed Project Start/Ending Dates

Project/Performance Site Location(s) (Mentored Career Development)

Follow "Special Instructions for 4.3 Research & Related Project/Performance Site Locations" provided in the SF424 (R&R) Supplemental Instructions for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application.

Research & Related Other Project Information (Mentored Career Development)

Follow "Special Instructions for 4.4 Research & Related Other Project Information Form" provided in the SF424 (R&R) Supplemental Instructions for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application, with the following additional modifications:

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 Summary/Abstract: Provide an abstract of the component, including the long-term goals and objectives of the program.

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. Therefore, applications will not receive an error if omitted in K12 component.

Research & Related Senior/Key Person Profile (Mentored Career Development)

Follow "Special Instructions for 4.5 Senior/Key Person Profile (Expanded) Form" provided in the SF424 (R&R) Supplemental Instructions for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application, with the following additional modifications:

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.

• Include the Project Lead, and any other individuals whose contributions are critical to the development, management and execution of the "Mentored Career Development Core" in a substantive, measurable way (whether or not salaries are reimbursed). These would include co-Leader(s), if applicable, and other Core staff.

• Do not include individuals who will only serve as proposed mentors and faculty members in this section.

• The Project Lead of the Mentored Career Development program may not be the PD/PI of the CTSA application but should work closely with the CTSA leadership to leverage training opportunities and share faculty expertise. The Project Lead will assume the PD/PI role on the KL2 award following a successful review and funding of the U54 application; absent U funding, K awards will not be made.

PHS 398 Cover Page (Mentored Career Development)

Follow "Special Instructions for 4.6 PHS 398 Cover Page Supplement" provided in the SF424 (R&R) Supplemental Instructions for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application.

Budget (Mentored Career Development)

Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

Include all personnel other than the Core Lead(s) in the Other Personnel section, including clerical and administrative staff. Also include proposed salary costs for planned scholars.

Do not complete the section on Participant/Trainee Support Costs.

The CTSA Mentored Career Development Program for translational researchers will be programmatically linked, but will have a separate PD/PI when awarded, and a budget based on the number of scholars projected. The recommended number of scholars to budget for in the application is 3 for small hubs (total anticipated CTSA award <$6M), 5 for medium hubs (total anticipated CTSA award $6-8M), and 8 for large hubs (total anticipated CTSA award >8-10M).

For each scholar, the following should be budgeted: Salary support (for 75% effort for career development and research activities associated with the program for a minimum of 2 years) will be provided up to $100,000. In addition support may be requested for research and career development activities as detailed below. The average total amount budgeted per scholar must not exceed $ 200,000 in direct costs.

The CTSA institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale. In no case may additional PHS funds be used for salary supplementation. Institutional supplementation must not require extra duties or responsibilities that would interfere with the K training experience, or the requirement of having 75% of time protected (or 9 person months) for research and career development.

Other Direct Costs. Mentor support may include up to $10,000 per year for associated laboratory or other research-related expenses. Salary support for mentors excluding laboratory- or research-related expenses is not an allowable budget item.

The K budget may include funds to support K scholar research projects and career development activities. This support will range from $25,000 to $50,000 per project per year to cover the following expenses: (a) tuition and fees related to career development; (b) research expenses, such as supplies, equipment and technical personnel; (c) up to $2,500 for scholar travel to scientific meetings and research training workshops, and (d) statistical services.

Budget Justification. Provide details on the level of effort and salary of the leadership including the Component lead, administrative staff, faculty, and mentors in the justification section.

PHS 398 Research Training Program Plan (Mentored Career Development)

Follow "8.7. Research Training Program Plan Form" provided in the SF424 (R&R) Supplemental Instructions for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application, with the following additional modifications:

Background: Provide the rationale for the proposed program, relevant background history, and the need for the research career development proposed. Indicate how the proposed program relates to current career development activities at the applicant institution.

Program Plan: The Program Plan should be saved as a single pdf file and should consist of the following elements:

Program Administration (Leadership)

Describe the acknowledged strengths, leadership and administrative skills, training experience, scientific expertise, and active research of the Project Lead. Relate these strengths to the proposed management of the career development core. Describe the planned strategy and administrative structure to be used to oversee and monitor the core.

Program Faculty (Mentors)

The application must include information about the Center faculty who will be available to serve as preceptors/mentors and provide guidance and expertise appropriate to the level of scholars proposed in the application. Describe the complementary expertise and experiences of the proposed Center Faculty, including active research and other scholarly activities in which the faculty are engaged, as well as experience mentoring individuals at the proposed career stage(s). For any proposed Center Faculty lacking research training experience, describe a plan to ensure successful scholar guidance. Describe the criteria used to appoint and remove faculty and to evaluate their participation.

A diverse faculty/mentor pool that includes persons from underrepresented backgrounds, including women, underrepresented racial and ethnic groups, and individuals with disabilities, is important and strongly encouraged.

Proposed Career Development Program

Provide an overview of the proposed program. Outline the objectives of the program and the program activities that will be used to meet these objectives. Describe for whom the career development program is intended, including the training level(s) of the scholars, the academic and research background needed to pursue the proposed career development, and, as appropriate, plans to accommodate differences in preparation among scholars. Include information about planned courses, mentored research experiences, and any activities designed to develop specific technical skills or other skills essential for the proposed career development. Describe how scholars will be educated in the human health- and disease-related aspects of their research career development.

Instruction in grant writing, the peer review process, and novel training opportunities (e.g., optional experiences in industry, community health centers, other CTSA hubs or research institutions, non-governmental organizations) is also encouraged, so that scholars obtain a working knowledge of career options and the steps required to transition successfully to the next stage of their chosen career. Describe how knowledge will be fostered in rigorous research methodology that would help promote best practices among the next generation of researchers for minimizing bias in experimental design and reporting. Describe how flexibility to adapt to individual education needs will be provided.

Applicants should present a broad vision of the workforce needed to drive future innovation and implement effective clinical and translational research. Describe ideas for integrating a team science approach into career development, and for offering a research curriculum aligned to core competencies in translational research. Early exposure to collaboration leveraging disparate areas of expertise may enhance efforts to cultivate a team approach to tackle current challenges facing clinical research. The Mentored Career Development component will provide formal coursework, research experiences, and career guidance to postdoctoral scholars. The CTSA career development environment should serve as a hub for fostering high-impact research careers in translational research.

Harmonizing career development across a CTSA hub requires integrating clinical and translational science across multiple departments, schools, and clinical research institutes in a team science approach to research collaboration. Support for a range of disciplines (including medicine, dentistry, nursing, pharmacy, public health, epidemiology, or bioengineering) as well as background knowledge/training in informatics and biostatistics should be offered. The program should describe ideas for developing unique and transformative training experiences that cross traditional boundaries such as optional externships (with industry, community health centers, non-governmental agencies, CTSA hub partners, or with other organizations).

Distance training, sharing resources, and reciprocal exchanges of scholars/mentors are encouraged but not required. They can address the research and career guidance needs of scholars and introduce interactive and innovative programs that include real-world exposure to different areas of translational research.

Describe any plans to collaborate with other CTSA hubs are encouraged to collaborate in education and training initiatives. Taking advantage of modern information technology, CTSA hubs should seek opportunities to share methods or online resources, and to disseminate tools.

Program Evaluation

Describe the evaluation plan to review and determine the effectiveness of the K component. This should include plans to engage faculty, professional staff, and scholars in educational efforts and obtain feedback from them to help identify weaknesses and to provide suggestions for program improvements (i.e., retention, diversity, and outcomes).

Describe plans for tracking career progress among scholars. Identify tools to assess program performance including evaluation of the curriculum, mentors, career development opportunities, and scholars. Specified evaluation metrics should be tied to the goals of the program.

Candidates/Scholars

Describe, in general terms, the size and qualifications of the pool of candidates including information about the types of prior clinical and research training and career level required for the program. Describe new areas of recruitment leveraging expertise from faculty, for example, health disparities, pediatrics, or ethics. Describe specific plans to recruit candidates and explain how these plans will be implemented (see also section on Recruitment and Retention Plan to Enhance Diversity). Describe the individual development plan process for prospective candidates and how plans will be designed to meet their research training needs.

Recognizing the scope of career opportunities, NCATS strongly encourages the use of Individual Development Plans for all scholars supported by the K program, including for example areas such as problem solving, communication, team science, time management, and leadership skills, as well as career guidance. See notice http://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-113.html.

Institutional Environment and Commitment to the Program

Describe the environment for career development, emphasizing institutional strengths; broadly indicate which disciplines/departments candidates may apply from, quoting any historical data from the previous 5 years (as applicable).

The sponsoring institution must ensure support for the career development component including assurance that sufficient time will be allowed for the Project Lead and other faculty to contribute to the proposed training and that there will be protected time for scholars (9 persons month, equivalent 75%) selected for the program. Institutions with ongoing research training, student development, or career development programs that receive external funding should explain what distinguishes the proposed career development component from existing training programs targeting the same candidates. Additionally, explain how the programs will synergize (if applicable), whether scholars are expected to transition from one support program to another, and how the training faculty, pool of potential scholars, and resources are sufficiently robust to support the proposed training in addition to existing ones.

Recruitment and Retention Plan to Enhance Diversity: Individuals are required to follow the instructions for Recruitment and Retention Plan to Enhance Diversity as provided in Chapter 8 of the SF424 (R&R) Application Guide. Applications must include a description of plans to recruit a diverse scholar pool and may wish to include data in support of past accomplishments. Information should be included on both successful and unsuccessful recruitment strategies.

Plan for Instruction in the Responsible Conduct of Research: Individuals are required to comply with the instructions for Plan for Instruction in the Responsible Conduct of Research as provided in Chapter 8 of the SF424 (R&R) Application Guide.

Participating Faculty Biosketches: Faculty Biosketches for participating faculty (excluding Senior/Key Personnel) should follow the Additional NIH and other PHS Agencies Instructions for a Biographical Sketch, except that a personal statement is not required for participating faculty. These should be attached as a single pdf document.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. Do not place any required information in an Appendix.

Planned Enrollment Report (Mentored Career Development)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Mentored Career Development)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type NRSA Training.

Relevant table shells can be found at the following link: http://grants.nih.gov/grants/funding/424/index.htm#data

The Training component will offer predoctoral students an orientation to translational science and postdoctoral appointees advanced research training aligned with the CTSA goals of advancing therapeutics (drugs, devices, and preventatives), clinical interventions, and behavioral modifications to improve health. The training component should serve as a pipeline introducing trainees of various disciplines to translational research. Types of training that may be offered are optional and should be flexibly adapted to the individual trainee's needs and may include short-term training, combined training, year-off training, and for postdoctoral trainees advanced research training

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) except where indicated below:

SF424 (R&R) Cover (NRSA Training Core)

Complete only the following fields:

• Applicant Information

• Type of Applicant (optional)

• Descriptive Title of Applicant’s Project

• Proposed Project Start/Ending Dates

Project/Performance Site Location (NRSA Training Core)

Follow Special Instructions for 4.3 Research & Related Project/Performance Site Locations provided in the SF424 (R&R) Supplemental Instructions for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application.

Research & Related Other Project Information (NRSA Training Core)

Follow Special Instructions for 4.4 Research & Related Project/Performance Site Locations provided in the SF424 (R&R) Supplemental Instructions for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application, with the following additional modifications:

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 Summary/Abstract: Summarize the objectives of the Training Core. Applicants should present a broad vision of the workforce needed to drive future innovation and implement effective clinical and translational research. Include a brief description of the level(s) (i.e., predoctoral, postdoctoral) and duration of the proposed training, the projected number of participating trainees and their anticipated levels of experience.

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. Therefore, applications will not receive an error if omitted in this component.

Research & Related Project Senior/Key Person Profile (NRSA Training Core)

Follow "Special Instructions for 4.5 Senior/Key Person Profile (Expanded) Form" provided in the SF424 (R&R) Supplemental Instructions for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application, with the following additional modifications:

The Training Core Leader and any other individuals whose contributions are critical to the development, management and execution of the Training Core in a substantive, measurable way (whether or not salaries are reimbursed) should be identified as senior/key persons. These would include co-Leader(s), if applicable, and other Training Core staff. Do not include individuals who are serving only as proposed mentors and training faculty members in this section.

• 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.

Biographical Sketches: Do not include proposed mentors and training faculty members (other than senior/key persons) in this section. Biographical Sketches for mentors and participating faculty will be included in the PHS 398 Research Training Program Plan Form, Participating Faculty Biosketches attachment. If more than 100 Senior/Key Persons are included in a component, the Additional Senior Key Person attachments should be used.

PHS 398 Cover Supplement (NRSA Training Core)

Follow "Special Instructions for 4.6 PHS 398 Cover Page Supplement" provided in the SF424 (R&R) Supplemental Instructions for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application.

PHS 398 Training Budget (NRSA Training Core)

For the Training Core, follow 8.5. PHS 398 Training Budget provided in the SF424 (R&R) Supplemental Instructions for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application, with the following additional modifications:

The NRSA Training Core is an optional part of the CTSA U54 application and will be funded only if the U application is successful. The training component provides stipends as a subsistence allowance to help defray living expenses during the research and clinical training experiences. The recommended number of trainees to budget for in the application is 10 for small hubs (total anticipated CTSA award <$6M), 15 for medium hubs (total anticipated CTSA award $6-8M), and 20 for large hubs (total anticipated CTSA award >8-10M). The amount budgeted per pre-doctoral and post-doctoral trainee must comply with the NRSA stipend levels and allowable costs specified below.

Part A: The application should request stipends for trainees. The most recent stipend, tuition, and fee levels are described on the Ruth L. Kirschstein National Research Service Award (NRSA) site. Visit NIH Grants Policy Statement: Ruth L. Kirschstein National Research Service Awards for more information.

Part B: Enter the total costs for Trainee Travel. Include expenses associated with the training core (such as salary support for Training Core Leader and other staff, consultant costs, equipment, research supplies, staff travel, etc.) in the "Training Related Expenses." Provide details on level of effort and salary of core leader/staff, description other expenses, etc. in the justification section.

Other expenses may include:

• Up to $1500 may be allotted for trainee travel, including attendance at a scientific meeting that the institution determines to be necessary to the individual's research training.

• Institutional costs of $4,200 a year per predoctoral trainee and $7,850 a year per postdoctoral trainee may be requested to help defray the costs of other research training related expenses, such as health insurance (self-only or family, as appropriate), staff salaries, consultant costs, equipment, research supplies, and travel expenses for the training faculty. Under exceptional circumstances, which can include providing accommodations for a trainee with disabilities, it is possible to request institutional costs above the standard rate. Requests for additional trainee costs must be explained in detail and carefully justified in the application. Training related expenses will be adjusted in future fiscal years.

Although the maximum request is explained under Budget information the awarded funds will depend upon the scientific and technical merit of the proposed program as determined by scientific peer review and the relevance of the proposed program to programmatic priorities. Further consideration will address program goals and resources, educational resource sharing, and the availability of funds. Applicants should expect that final budgets may be adjusted post-review depending on these factors.

Part F. Budget Justification. Provide in the budget justification attachment details on the level of effort and salary of the leadership including the component lead, administrative staff, faculty, and mentors in addition to the budget justification.

PHS 398 Research Training Program Plan (NRSA Training Core)

Follow 8.7. Research Training Program Plan Form provided in the SF424 (R&R) Supplemental Instructions for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application with the following additional modifications:

Background: Provide the rationale for the Training Core. Indicate how the Training Core will relate to current training activities at the applicant institution.

Program Plan: The Program Plan should be saved as a single pdf file and should consist of the following elements:

Program Administration:

Describe the acknowledged strengths, leadership and administrative skills, training experience, scientific expertise, and active research of the Project Lead. Relate these strengths to the proposed management of the training core. Describe the planned strategy and administrative structure to be used to oversee and monitor the core.

Program Faculty

Identify a core group of faculty and mentors. Mentors must be recognized as accomplished investigators in clinical and translational research. Mentors should either have a track record of success in training students and/or investigators and fostering their transition to independence, or documented expertise, national recognition, and training sufficient to show that they are appropriately prepared to serve in this role. Mentors should have sufficient independent research support to cover the costs of their proposed research project in excess of the allowable costs of the training component.

A diverse faculty/mentor pool comprised of including persons from underrepresented backgrounds, including women, individuals from underrepresented racial and ethnic groups, and individuals with disabilities, is important and strongly encouraged.

Describe the complementary expertise and experiences of the proposed Center Faculty, including active research and other scholarly activities in which the faculty are engaged, as well as experience mentoring and training individuals at the proposed career stage(s). For any proposed Center Faculty lacking research training experience, describe a plan to ensure successful trainee guidance by these individuals. Describe the criteria used to appoint and remove faculty and to evaluate their participation.

Proposed Training

Provide an overview of the proposed program. Outline the objectives of the program and the program activities that will be used to meet these objectives. Describe for whom the training program is intended, including the training level(s) of the trainees, the academic and research background needed to pursue the proposed training, and, as appropriate, plans to accommodate differences in preparation among trainees. Include information about planned courses, mentored research experiences, and any activities designed to develop specific technical skills or other skills essential for the proposed research training. Describe how trainees will be educated in the human health- and disease-related aspects of their research training. Describe how training will be fostered in rigorous research methodology that would help promote best practices among the next generation of researchers for minimizing bias in experimental design and reporting.

Recognizing the scope of career opportunities, NCATS strongly encourages the use of Individual Development Plans for trainees, including for example areas such as problem solving, communication, team science, time management, and leadership skills, as well as career guidance. See notice http://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-113.html .

Describe ideas for implementing training in team science, and for offering training options that are flexibly adapted to the individual trainee's needs and may include short-term training, dual-degree training, year-off training, and for postdoctoral trainees master's level training. Curricula should be aligned to translational research core competencies, and career guidance should be provided to trainees. Describe how flexibility to adapt to individual training needs will be provided.

Harmonizing research training across Clinical and Translational Science Award (CTSA) program sites requires integrating clinical and translational science across multiple departments, schools, and clinical research institutes in a team science approach to research collaboration. Support for a range of disciplines (including medicine, dentistry, nursing, pharmacy, public health, epidemiology, or bioengineering) as well as background knowledge/training in informatics and biostatistics should be offered. The program should emphasize the importance of developing unique and transformative training experiences such as optional externships (with industry, community health centers, non-governmental agencies, CTSA hub partners, or with other organizations) to provide students with exposure to training opportunities that would otherwise be inaccessible.

Describe any plans to collaborate with other CTSA hubs are encouraged to collaborate in training initiatives. Taking advantage of modern information technology, CTSA hubs should seek opportunities to share methods or online resources, and to disseminate tools.

The training component may offer health-professional predoctoral level students practical experience in clinical research ranging from 2 to 3 months through summer or special rotations each year. The curricula of the rotations should have clearly outlined goals. Ideally, student trainees should have a research project that will serve as the core of the rotation, and be exposed to many aspects of clinical research (design, implementation, data analysis, and publication).

Training Program Evaluation

Describe the evaluation plan to review and determine the effectiveness of the training component. This should include plans to engage faculty, professional staff, and trainees in educational efforts and obtain feedback from them to help identify weaknesses and to provide suggestions for program improvements (i.e., retention, diversity, and outcomes). Describe plans for tracking career progress among trainees. Identify tools to assess program performance including evaluation of the curriculum, mentors, research training opportunities, and trainees. Evidence should be provided that the CTSA supported activities are synergistic (not duplicative) with other funded NIH T32 programs (as applicable).

Trainee Candidates

Describe, in general terms, the size and qualifications of the pool of trainee candidates including information about the types of prior clinical and research training and career level required for the program. Do not name prospective Trainees. Describe the nomination and selection process to be used to select candidates who would be offered admission to the program and criteria for trainees reappointment to the program.

Institutional Environment and Commitment to Training

Describe the training environment emphasizing institutional strengths; broadly indicate which disciplines/departments candidates may apply from quoting any historical data from the past 5 years (as applicable). Describe new areas of recruitment leveraging expertise from faculty. Describe specific plans to recruit candidates and explain how these plans will be implemented (see also section on Recruitment and Retention Plan to Enhance Diversity).

The sponsoring institution must ensure support for the proposed component including assurance that sufficient time will be allowed for the Project Lead and other faculty to contribute to training. Institutions with ongoing research training, programs that receive external funding should explain what distinguishes the proposed training component from existing training programs at the same trainee level. Additionally, explain how the programs will synergize, if applicable, whether trainees are expected to transition from one support program to another, and how the training faculty, pool of potential trainees, and resources are sufficiently robust to support the proposed training in addition to existing ones.

Recruitment and Retention Plan to Enhance Diversity:

Individuals are required to follow the instructions for Recruitment and Retention Plan to Enhance Diversity as provided in Chapter 8 of the SF424 (R&R) Application Guide. Applications must include a description of plans to recruit a diverse trainee pool and may wish to include data in support of past accomplishments. Information should be included on both successful and unsuccessful recruitment strategies.

Plan for Instruction in the Responsible Conduct of Research:

Individuals are required to comply with the instructions for Plan for Instruction in the Responsible Conduct of Research as provided in Chapter 8 of the SF424 (R&R) Application Guide.

Participating Faculty Biosketches:

Faculty Biosketches for participating faculty (excluding Senior/Key Personnel) should follow the Additional NIH and other PHS Agencies Instructions for a Biographical Sketch, except that a personal statement is not required for participating faculty. These should be attached as a single pdf document.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. 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.

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.

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.

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 Applying Electronically.

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 by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NCATS Referral Office by email at ncatsreferal@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact - Overall

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the CTSA hub 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 hub proposed).

Scored Review Criteria - Overall

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project 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?

Does the CTSA application clearly describe and justify their strategic vision and goals? Are the goals realistic and coupled with timelines and metrics for successful completion?

Is the role of partner institution(s), if proposed, clearly defined? Are partner institution(s) complementary? Are partner institution(s) well integrated and is there strong evidence to support this?

Do the proposed vision and declared strategic goals for the CTSA hub position it as a successful catalyst and innovator for collaborating, multi-disciplinary translational and clinical research and training?

Is there a catalytic approach to translational science: developing, demonstrating utility of, and then disseminating improvements?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or 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 project 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 project?

Will the CTSA PD(s)/PI(s), based upon prior experience, enjoy sufficient authority to work through local institutional boundaries and barriers such as institutional policies, personalities and organization structure? Are plans in place to facilitate change and/or succession should it be required?

Based upon prior experiences, is the overall staffing, including the PD(s)/PI (or multi-/PIs) and other staff, including partnering institutions commensurate with declared goals?

Innovation

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? Does this application reveal a willingness to embrace innovation/creativity in the planning and evaluation of clinical and translational research in the local environment?

Are novel changes and approaches proposed to increase the quality, safety, efficiency, and speed of clinical and translational research in the local environment and culture, such as, the use of randomized experimental designs to assess training or research interventions?

Is innovation evident at the interface of the hub and the local training program’s supporting staff development, including CTSA and other K- and T- programs?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project 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 children, justified in terms of the scientific goals and research strategy proposed? Does the CTSA hub support a broad spectrum of local clinical and translational research, including institutions listed as partners? Are obstacles identified and plans for mitigation implemented?

Is the governance and organizational plan collaborative? Does it include partners from different areas across the organization, as well as representation of external stakeholders?

Is the role of each partner institution clearly described, including how each will significantly benefit from and contribute to clinical and translational research and training at the hub? Is the inclusion of each sub-contracted partner well justified?

Is the evaluation plan sound? Are there declared metrics that permit identification of opportunities for improvement? Are there plans to review evaluations and to find innovative solutions?

Are there unique features and best practices at this hub that offer innovative means to advance translational research that might be used by other hubs and other institutions engaged in translational research and training?

Are the applicants planning to adopt and utilize existing tools and approaches rather than creating new, very specific solutions that may be redundant or not generalizable?

Is the governance structure, including the External Advisory Committee, strong and responsive?

Environment

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 project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Does the application describe unique institutional strengths including institutional commitments, infrastructure, human capital, and skillful proposed partner institutions, to support clinical and translational research?

Is the clinical research environment adequate to enable high quality implementation in terms of space, research pharmacy, imaging, and laboratory resources?

Does the proposed CTSA application exhibit a scientific culture that is likely to promote translational research in accordance with the CTSA program objectives described?

Do the institutional commitment and support of the PD(s)/PI (s) and staff enable them to significantly impact the local conduct of clinical translational research?

Is the institutional commitment commensurate with achieving the specific aims of the proposed CTSA?

Additional Review Criteria - Overall

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

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six 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 six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the 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) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the component 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 component proposed).

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

Does the CTSA application include realistic plans to participate as a member of an integrated CTSA network, capable of implementing multi-site clinical trials??

Does the application propose realistic plans to participate, as a member of an integrated CTSA network, in the use of informatics for data discovery from the electronic medical record? Does the application propose realistic plans to improve the recruitment of research participants to studies?

Are plans for engaging local stakeholder communities well developed based upon successful prior efforts, and compatible with local translational research in the young, old and other, underserved populations?

Are investigators at this hub well suited to participate in transformational activities that will lead to the creation of a collaborative and integrative CTSA network?

Is there evidence that investigators at this CTSA hub possess the skills, expertise and leadership abilities to implement a trial unit that can successfully participate in multi-site trials conducted in the CTSA network?

Are innovative methods evident, such as experimental approaches to identifying best practices in translational research? Does the application identify barriers to translational research across the CTSA network? Are creative approaches to mitigation proposed?

Does the CTSA application show a strong track record in clinical and translational research over the past five years with regards to innovation and impact?

Will the local site efforts regarding the solicitation, review, prioritization, tracking, and evaluation of the translational pilot program ensure accountability and innovation?

Does the application describe a focus on one or two unique areas of strength and need?

Will the proposed approaches to the overarching issues and the specific modules contribute to efficient, high quality clinical and translational research and training?

Will the proposed CTSA program support the development of a strong translational science workforce? Is there institutional commitment to adjust the academic award system towards greater incentives for translational researchers and team scientists?

For the required modules (Translational Workforce Development; Biostatistics, Epidemiology and Research Design; Regulatory Knowledge and Support; Pilot Translational and Clinical Studies; Integrating Special Populations; Participant and Clinical Interactions; Multi-Site Study Support; and Recruitment of Research Participants), assess the following. Are each of the required modules organized, funded, and staffed in a constructive manner? For each, will the hub enhance research and training, and promote innovation? Are resources available for each module well justified in the application? Does the application indicate the capability and willingness to propose and collect the uniform metrics described?

Does the plan for informatics coordination include relevant partners? Are there plans to integrate clinical and research data? Will the plan for management of research data ensure the security of researchers data at participating institutions? Is the timeline feasible and well-managed? Are there plans to harmonize with other hubs or initiatives?

Does the application identify key obstacles to the performance of CTSA network translational and clinical research and propose plans and/or demonstrate a means to overcome them? Does the application plan to use an experimental approach to evaluate new approaches?

Are the applicants planning to adopt and utilize existing tools and approaches rather than creating new, very specific solutions that may be redundant and not generalizable?

Does the application describe a plan to expand translational research to encompass the young and older persons, other special populations, and propose network approaches?

Does the application describe a means to promote collaboration and the engagement of a broad range of stakeholders at the local and network level?

Will processes and methods be tracked so that opportunities for improvement can be identified and addressed with innovative solutions?

Are there appropriate plans to support collaboration between and among CTSA hubs toward an efficient and effective national CTSA network?

Is the applicant likely to actively participate in creating a clinical translational research network attractive to entities that support large clinical trials (NIH ICs and private sector companies in devices, medications, diagnostics and others)?

Environment

Are plans in place for the CTSA institution(s) to act on advice from the EAC? Are the types of members described appropriate?

Is the plan to improve the environment for clinical and translational research presented in sufficient detail and explained in a thoughtful manner? Is there institutional willingness to participate in the use of a central IRB and pre-negotiated subcontracts as participant hub in the CTSA network?

Is the CTSA hub a strong and committed member of the overall CTSA network? Is there commitment to engage with national initiatives for research and education?

Is the inclusion of all partner institutions listed on the page immediately preceding the budget section of the application well justified in this CTSA application? Is the collaboration established and likely to be vigorous?

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 six 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 six 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 Human Subjects Protection and Inclusion Guidelines.

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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.

Not Applicable

Not Applicable

Not Applicable

Reviewers will provide an overall impact score to reflect their assessment that the proposed career development component will prepare individuals for successful, productive scientific research careers and thereby impart a sustained influence on the research field(s) involved. The environment, leadership and mentors, and the evaluation plan will all factor into the overall impact score for each training component. The career development component will receive an overall impact score in addition to separate scores for the listed categories.

Scored Review Criteria - Mentored Career Development

Reviewers will consider each of the review criteria below in the determination of the merit of the career development program, and give a separate score for each. When applicable, the reviewers will consider relevant questions in the context of proposed short-term career development. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Career Development Program and Environment

Does the proposed program clearly outline a plan to recruit and develop well-qualified junior investigators for successful careers as biomedical or clinical researchers?

Is there evidence of an adequate pool of potential scholars who could benefit from receiving career development support?

Are the content and duration of any proposed didactic, training-related, and research-related activities of the program appropriate?

Are appropriate timelines indicated for career progression and transition to independence?

Does the institutional environment (e.g., research facilities and other relevant resources) in which the program will be conducted contribute to the probability of success?

Does the proposed career development program benefit from unique features of the scientific environment, subject populations, or employ useful collaborative arrangements?

Is the institutional commitment to the proposed program appropriate?

If multiple sites are participating, is this adequately justified in terms of the career development and research experiences provided?

Is there sufficient assurance that the required effort of the PD/PI, mentors and scholars will be devoted directly to the research training, career development, and related activities?

When applicable, is there adequate documentation describing the responsibilities of the advisory committee with regard to the provision of input, guidance and oversight of the program?

Is the proposed research education curriculum aligned with core competencies in translational research?

Are there innovative or non-traditional methods or educational opportunities?

Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))

Do the PD/PI and Research Administrator (if applicable) have the experience to develop, direct and administer the proposed program?

Does the leadership team bring complementary and integrated expertise to the program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure program objectives?

Are the research qualifications, scientific stature, previous leadership and mentoring experience, and track record(s) appropriate for the proposed career development program?

Are the PD(s)/PI(s) currently engaged in research relevant to the scientific area of the proposed program?

For applications designating multiple PDs/PIs:

Is a strong justification provided that the multiple PD/PI leadership approach will benefit the career development program and the scholars?

Is a strong and compelling leadership approach evident, including the designated roles and responsibilities, governance, and organizational structure consistent with and justified by the aims of the career development program and the complementary expertise of the PDs/PIs?

Mentors

Do the mentors have appropriate expertise and experience, as well as track records of past mentoring and training?

Are the quality and extent of the mentors roles in providing guidance and scientific advice to the scholars acceptable? Are the mentors currently engaged in relevant research?

Is there a formal or informal mentor training program?

Candidates/Scholars

Is a recruitment plan proposed likely to attract high quality, diverse scholar candidates?

Are there well-defined and well-justified recruitment and selection strategies? Is there evidence of a sufficiently large, competitive scholar pool to warrant the proposed size of the career development program?

Are the content, phasing, and proposed duration of the career development plan appropriate for achieving scientific independence of the scholar candidates?

What is the likelihood that the career development plan will contribute significantly to the scientific development of the scholars?

Does the plan for selection of the scholars include all of the eligibility criteria stated in the FOA?

Is there a description of the Individual Development Plan process? Are the content, training track, and proposed duration of the individual (career) development plan appropriate for achieving scientific independence? What is the likelihood that the personalized plan will contribute significantly to the scientific development of the scholars?

Program Evaluation and Training Record

Is there evidence of a successful past training record of similar K12/KL2 programs? Does the detailed evaluation plan explain plans to engage faculty, professional staff, and community partners in educational efforts and obtain feedback from them?

Have tools been identified to assess program performance including evaluation of the curriculum, diversity, mentors, research training opportunities, and scholars? Does the program have a rigorous evaluation plan to assess the quality and effectiveness of the program objectives?

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

Protections for Human Subjects

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Inclusion of Women, Minorities, and Children

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Vertebrate Animals

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Biohazards

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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

Recruitment & Retention Plan to Enhance Diversity

Peer reviewers will separately evaluate the recruitment and retention plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented groups. The plan will be rated as ACCEPTABLE or UNACCEPTABLE, and the consensus of the review committee will be included in an administrative note in the summary statement.

Training in the Responsible Conduct of Research

All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the specific characteristics of the career development program, the level of trainee experience, and the particular circumstances of the scholars, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - Does the plan satisfactorily address the format of instruction, e.g. lectures, coursework and/or real-time discussion groups, including face-to-face interaction? (A plan involving only on-line instruction is not acceptable.); 2) Subject Matter Does the plan include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics? 3) Faculty Participation - Does the plan adequately describe how faculty will participate in the instruction? For renewal applications, are all career development faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period named in the application? 4) Duration of Instruction - Does the plan meet the minimum requirements for RCR, i.e., at least eight contact hours of instruction? 5) Frequency of Instruction Does the plan meet the minimum requirements for RCR, i.e., at least once during each career stage (undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels) and at a frequency of no less than once every four years?

Select Agent Research

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

Budget and Period of Support

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

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment that the proposed training component will prepare individuals for successful and productive scientific research careers. The environment, leadership and mentors, and the evaluation plan will all factor into the overall impact score.

Scored Review Criteria - NRSA Training

Reviewers will consider each of the review criteria below in the determination of the merit of the training program, and give a separate score for each. When applicable, the reviewers will consider relevant questions in the context of proposed program plan. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Training Program and Environment

Are the research facilities and research environment conducive to preparing trainees for successful careers as biomedical research scientists?

Are the objectives, design and direction of the proposed research training program likely to ensure effective training?

Do the courses, where relevant, and research experiences provide opportunities for trainees to acquire state-of-the-art scientific knowledge, methods, and tools that are relevant to the goals of the training program?

Does the program provide appropriate inter- or multidisciplinary research training opportunities?

Is the proposed training program likely to ensure trainees will be well prepared for research-intensive and research-related careers?

Is the level of institutional commitment to the training program, including administrative and research training support, sufficient to ensure the success of the program?

Is it clear how the proposed training program is distinguished from other externally funded training programs at the institution?

Specific to this FOA

Are the objectives of the program clearly explained and reflective of the institutional strengths?

Is CTSA hub including the research environment conducive to preparing trainees for successful careers as translational scientists? Is the NRSA Training component sufficiently integrated with the CTSA scientific vision?

Is the institutional commitment to the proposed program appropriate? If multiple sites are participating, are the trainee appointments equitable across the sites and if not, is the distribution justified in terms of the research training experiences provided? Is the NRSA Training component integrated with other institutional training (NRSA) programs at the institution? Is the NRSA Training component sufficiently integrated with the CTSA scientific vision? Does the applicant indicate appropriate institutional and departmental commitment to the program reflected in recruitment efforts, educational resources and equipment, and faculty? Is there sufficient assurance that the required effort of the Program Lead, mentors, and trainees will be devoted directly to the research training and related activities?

Does the applicant have strong plans to work with other CTSA sites on shared training opportunities and on harmonization in education and training?

Are conceptual elements of team-based research included in the scope of program activities?

Are appropriate advanced degree granting programs offered? Does the proposed program clearly outline a plan to recruit candidates across multiple disciplines ranging from basic science to social science including medicine and allied health fields?

Does the curriculum offer novel learning models to meet the needs of trainees? Will the curricula provide appropriate training in clinical and translational research relevant to a broad range of specialties and with appropriate emphasis on the needs of team science?

Does the curriculum offer innovative methods or access to non-traditional learning experiences?

Training Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))

Does the PD/PI have the scientific background, expertise, and administrative and training experience to provide strong leadership, direction, management, and administration of the proposed research training program?

Does the PD/PI plan to commit sufficient effort to ensure the program’s success?

For applications designating multiple PDs/PIs:

Is a strong justification provided that the multiple PD/PI leadership approach will benefit the training program and the trainees?

Is a strong and compelling leadership approach evident, including the designated roles and responsibilities, governance, and organizational structure consistent with and justified by the aims of the training program and the complementary expertise of the PDs/PIs?

Preceptors/Mentors

Are sufficient numbers of experienced preceptors/mentors with appropriate expertise and funding available to support the number and level of trainees (including short-term trainees, if applicable) proposed in the application?

Do the preceptors/mentors have strong records as researchers, including recent publications and successful competition for research support in areas directly related to the proposed research training program?

Do the preceptors/mentors have strong records of training individuals at the level of trainees (including short-term trainees, if applicable) proposed in the program? Are appropriate plans in place to ensure that preceptors lacking sufficient research training experience are likely to provide strong and successful mentoring?

Is there a formal/informal mentor training program to offer mentors an opportunity to improve their mentoring skills?

Trainees

Is a recruitment plan proposed with strategies likely to attract well-qualified candidates for the training program?

Is there a competitive applicant pool of sufficient size and quality, at each of the proposed levels (predoctoral, postdoctoral and/or short-term), to ensure a successful training program?

Are there well-defined and justified selection and re-appointment criteria as well as retention strategies?

Training Record

How successful are the trainees (or, for new applications, other past students/postdoctorates in similar training) in completing the program?

Has the training program ensured that trainees are productive (or, for new applications, other past students/postdoctorates in similar training) in terms of research accomplishments, publication of research conducted during the training period, and subsequent training appointments and fellowship or career development awards?

How successful are the trainees (or, for new applications, other past students/postdoctorates in similar training) in achieving productive scientific careers as evidenced by successful competition for research science positions in industry, academia, government or other research venues; grants; receipt of honors, awards, or patents; high-impact publications; promotion to scientific leadership positions; and/or other such measures of success?

To what extent do trainees subsequent positions in industrial, academic, government, non-profit, or other sectors benefit from their NRSA-supported research training and directly benefit the broader biomedical research enterprise?

Does the program propose a rigorous evaluation plan to assess the quality and effectiveness of the training? Are effective mechanisms in place for obtaining feedback from current and former trainees?

For applications that request short-term research training positions, is there a record of retaining health professional trainees in research training or other research activities for at least two years?

Does the evaluation plan describe strategies to engage current and former trainees to assess the quality and effectiveness of the program objectives?

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

Protections for Human Subjects

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Inclusion of Women, Minorities, and Children

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Vertebrate Animals

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Biohazards

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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

Recruitment & Retention Plan to Enhance Diversity

Peer reviewers will separately evaluate the recruitment and retention plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented groups. The plan will be rated as ACCEPTABLE or UNACCEPTABLE, and the consensus of the review committee will be included in an administrative note in the summary statement.

Training in the Responsible Conduct of Research

All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the specific characteristics of the career development program, the level of trainee experience, and the particular circumstances of the scholars, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - Does the plan satisfactorily address the format of instruction, e.g. lectures, coursework and/or real-time discussion groups, including face-to-face interaction? (A plan involving only on-line instruction is not acceptable.); 2) Subject Matter Does the plan include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics? 3) Faculty Participation - Does the plan adequately describe how faculty will participate in the instruction? For renewal applications, are all career development faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period named in the application? 4) Duration of Instruction - Does the plan meet the minimum requirements for RCR, i.e., at least eight contact hours of instruction? 5) Frequency of Instruction Does the plan meet the minimum requirements for RCR, i.e., at least once during each career stage (undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels) and at a frequency of no less than once every four years?

Budget and Period of Support

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

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

As part of the scientific peer review, all applications:

• Will be discussed and assigned an overall impact score.

• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

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.

• Policies consistent with goals for resource, data sharing and sharing of software.

• Programmatic priorities, including but not limited to geographic distribution of CTSA hubs and access to special populations

• NCATS may fund a UL1 only or a UL1 & KL2 or a UL1 & TL1 or a UL1 & KL2 & TL1 depending on the scientific and technical merit of the application components.

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.

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.

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.

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 Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), 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.

The PD(s)/PI(s) will have the primary responsibility for:

• Determining approaches, designing, implementing, and setting milestones for advancing translational and clinical research and training

• Ensuring all participating institutions are fully integrated into the CTSA hub

• PD(s)/PI(s) has ultimate responsibility for implementing the activities at the CTSA hub

• Management, implementation, and tracking of the pilot project program

• Ensuring informatics coordination and data exchange to facilitate translational research, compatibility of research systems with broadly accepted content and technical standards including those adopted by the Department of Health and Human Services for health care and public health operations, and compatibility with NIH Institute and Center endorsed common data elements

• Implementation of a data security plan at all participating institutions that ensures the security of research data on all studies involving human subjects

• Maintaining visibility of scientists and resources of CTSA institutions to facilitate collaboration

• Implementation of a plan to create and maintain a broad culture of responsibility for safe and ethical conduct of human subjects research at all participating institutions, which ensures scientifically and ethically flawed studies are not conducted, enrollment is tracked and futile studies are closed in a timely manner, workflow for conduct of clinical and translational research is efficient, prompt analysis of results, and dissemination of those results

• Implementation of tracking processes, metrics, and milestones including some metric common to the hubs participating in the CTSA program

• Provision of disease-agnostic support to translational and clinical researchers. The support must facilitate the participation of local investigators in national networks and multi-site studies, particularly those supported by NIH

• Establishment of career development opportunities that encourage new investigators to work in clinical and translational science

• Implementation of the proposed educational programs in collaboration with other hubs of the CTSA program, and innovative curriculum activities and assessment of their effectiveness

• Effecting steps toward implementation of the agreed on policies, procedures, best practices, or other measures established by NCATS

• Provision of information to the NIH Program Officer and the NIH Project Coordinator concerning progress

• Support of CTSA network activities

• Principal investigators and key personnel as appropriate are expected to participate in annual meetings

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

The NIH Project Coordinators (PC) will:

• Provide substantial programmatic involvement that is above and beyond the normal stewardship role in awards.

• Cooperation or coordination with, or assistance to, awardees in performing project activities, e.g., coordination of research networks; coordinating access to NIH supported research resources; identifying other researchers/resources for the projects

• Participation on steering and operations committees as a voting member or in other functions responsible for helping to guide the course of long-term projects or activities; e.g., annual meetings

• No involvement in normal program stewardship

• Not attending peer review meetings of renewal or revision applications unless an NCATS waiver is obtained per NCATS procedures for management of concern about bias

• Provision of a broad overview of the value provided by the awardee as measured by its achievement of its stated aims, the significance of its innovations and deliverables, and its metrics for application of its strengths to the transformation of clinical and translational research within its hub

• Assessment of the awardee’s overall participation in and contributions to the CTSA Network and its support for development and implementation of best practices, policies, and procedures

• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Additionally, an NIH Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The NIH Program Official stewardship includes:

• Enforcement of general statutory, regulatory, or policy requirements

• Approval of awardee plans prior to award and review of performance after completion

• Evaluation of progress by reviews of technical or fiscal reports, by program visits, or with external consultants, to determine that performance is consistent with objectives, terms and conditions of the award

• Technical assistance requested by awardees, or correcting programmatic or financial deficiencies in awardee performance

• Scientific and technical discussions with awardees, or actions to facilitate or expedite interactions between awardees; e.g., organizing and holding meetings of investigators

Areas of Joint Responsibility include:

• None; all responsibilities are divided between awardees and NIH staff as described above.

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 Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

Other Reporting Requirements

• The institution must submit a completed Statement of Appointment (PHS Form 2271) for each scholar or trainee appointed or reappointed to the training grant or career development award. Grantees must submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at xTrain (eRA Commons). An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year.

• A notarized statement verifying possession of permanent residency documentation must be submitted with the Statement of Appointment (Form PHS 2271). Individuals with a Conditional Permanent Resident status must first meet full (non-conditional) Permanent Residency requirements before receiving support.

• Termination Notice: Within 30 days of the end of the total support period, the institution must submit a Termination Notice (PHS Form 416-7) via xTrain for each scholar or trainee appointed for eight weeks or more.

For awards involving postdoctoral NRSA training through a TL1, a completed Payback Agreement Form (PHS 6031) must be submitted for each postdoctoral trainee in his or her first 12 months of support.

Trainees with service payback requirements must notify the NIH of any change in address and submit Annual Payback Activities Certification Forms (PHS 6031-1) until the payback service obligation is satisfied.

Additionally, details on the support provided to clinical trials with NCATS grant funds must be recorded and available if NIH requests this information related to the NCATS Clinical Trial Funding Restrictions.

A final progress report, 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.

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
Email: GrantsInfo@nih.gov

Bernard Talbot, M.D., Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0793
Email: CTSAFOAQuestions@mail.nih.gov

Mohan Viswanathan, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-312-3745
Email: CTSAFOAQuestions@mail.nih.gov

Gabriel Hidalgo
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0839
Email: CTSAFOAQuestions@mail.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 Parts 74 and 92.