Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Center for Advancing Translational Sciences (NCATS)

Funding Opportunity Title

Institutional Clinical and Translational Science Award (U54)

Activity Code


U54 Specialized Center- Cooperative Agreements

Successful applicants will receive support through the Linked Specialized Center Cooperative agreement mechanism that includes a primary UL1 award and a linked KL2 award with an optional TL1 linked award.

Announcement Type

New

Related Notices
  • August 17, 2012 - Notice of Clarification for RFA-TR-12-006. See Notice NOT-TR-12-009.
Funding Opportunity Announcement (FOA) Number

RFA-TR-12-006

Companion Funding Opportunity

None

Number of Applications

Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.350

Funding Opportunity Purpose

The purpose of the Institutional Clinical and Translational Science Awards (CTSA) is to strengthen the entire spectrum of NIH supported translational research.  Through integrated homes that build upon and support institutional scientific strengths, they provide research resources and workforce training that improve the quality, validity, generalizability, and efficiency of clinical and translational research.  These awards are the centerpiece of the NCATS CTSA program.

Key Dates
Posted Date

July 6, 2012

Letter of Intent Due Date

December 10, 2012

Application Due Date(s)

January 8, 2013

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review

February-March 2013

Advisory Council Review

May 2013

Earliest Start Date(s)

July 1, 2013

Expiration Date

January 9, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, 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.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of 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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

Advances in basic biological research continue to provide new opportunities for medical benefits in real-world settings. Translating biomedical research findings into clinical applications that improve human health, however, is a slow and complex process with high costs and high failure rates. The average time required to design, approve, and open a cancer clinical trial is two years, prompting a 2010 Institute of Medicine report to note the urgent need for improving speed and efficiency of the design, launch, and conduct of clinical trials. Such a slow pace warrants action.

To bring the benefits of science more quickly into patient care, NCATS was formed with the mission to catalyze the generation of innovative methods and technologies that will enhance the development, testing, and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. The mission of NCATS includes strengthening the entire spectrum of translational research. NCATS defines translational research broadly to include the early steps necessary to develop new therapeutics, devices and diagnostics from basic discoveries, the steps necessary to establish real world efficacy, and the research needed to improve the practical implementation and dissemination of improved approaches to care. This breadth is sometimes described as T1 through T4.

The NCATS CTSA program is central to achieving the mission of the new center (see http://www.ncats.nih.gov/research/cts/ctsa/about/about.html). The CTSA program was initiated by the NIH in 2006 to transform the local, regional, and national environment for clinical and translational research. Under NCATS, the goal of the CTSA program remains focused on integrated academic homes for the clinical and translational sciences that increase the quality, safety, efficiency and speed of clinical and translational research, particularly for NIH supported research. The Institutional CTSA awardees are supported by cooperative agreements that also emphasize improving the national and regional environment for clinical and translational research through broad sharing and adoption of policies and practices within and beyond the CTSA Consortium.

The mission of the NCATS CTSA program addresses these needs by creating an integrated academic home for the clinical and translational science, by working to improve the efficiency and quality of all clinical research, and by engaging local communities in the research process. The NCATS CTSA program supports disease- and condition-specific networks funded by other NIH Institutes and Centers, but is disease agnostic in its resources and approach. The NCATS CTSA program will include Institutional CTSA Awards, which are the subject of this FOA, and Consortial Awards and Demonstration Projects which will be the subject of future solicitations. CTSA Consortial Awards will concentrate on Consortia collaborations to more broadly address the quality, efficiency, and cost of clinical and translational research and issues that cannot be addressed locally. The Consortial Awards are expected to build on the experience, best practices, and tools of Institutional CTSAs to facilitate clinical and translational research more broadly. CTSA Demonstration Projects will support scientific projects utilizing novel processes, methods, and models for design, conduct, analysis, or dissemination of translational research initiated in the CTSA program. These projects are expected to be supported in partnership with other NIH institutes and centers and provide real world projects to test novel approaches, methods, and technologies for improving translational research.

The CTSA program has evolved continually with each FOA since 2005.  The NIH also undertook major efforts to solicit feedback on the CTSA’s initial years and suggestions for improvement to the program. The NIH CTSA Working Group recommended that under NCATS, the CTSA program should continue to provide infrastructure to support the full spectrum of translational research and recommended a number of steps to build upon the existing strengths of the CTSA program and ensure its further development in implementation of NCATS mission. The full report is available at http://www.ncats.nih.gov/files/recommendations.pdf. NCATS also issued a Request for Information for broad public input into further refining the CTSA program (see report at www.ncats.nih.gov/files/report-ctsa-rfi.pdf). While the current FOA incorporates many of the suggestions for achieving the goals of the CTSA program from the RFI, the NIH CTSA Working Group, and recommendations from the CTSA principal investigators (Clin Trans Sci 2012), NCATS looks forward to the findings of an IOM evaluation of the CTSA program, expected by June 2013 for guidance on the continued evaluation of the CTSA program.

Specific Objectives of the Institutional CTSA Awards

Institutional CTSAs are made to degree granting institutions or groups of institutions that receive significant funding from the NIH. CTSAs require institutional commitment, the status of a major scientific and administrative entity within and across an applicant and partner institution(s), and a CTSA PD(s)/PI(s) with the authority and influence necessary to successfully create an institutional home for clinical and translational research. This may include authority, perhaps shared with other high level institutional officials, over requisite space, resources, faculty appointments, protected time, and promotions.

Institutional CTSAs support an academic home that creates an integrated research and training environment across an applicant institution and its partner institutions in order to:

Institutional CTSAs are encouraged to develop programs tailored to meet the needs of their own investigative and public communities and to develop and build upon unique institutional and community strengths. All sites are expected to provide core resources for the entire spectrum of translational research; however, focused programs may be developed to meet the needs of local investigators and build on unique institutional strengths. Possible examples of such programs include, but are not limited to, the following:

The CTSAs are expected to promote innovation in translational research methods and in the effective incorporation of new technologies into clinical and translational research, with the goal of enhancing the application of knowledge from basic laboratories, particularly NIH-supported laboratories, into development, testing, and adoption of novel therapeutics and diagnostics in appropriately defined populations.

The Institutional CTSA Program focuses on interdisciplinary translational research needs by integrating clinical and translational science across multiple departments, schools, and clinical research institutes representing a team science approach to research collaboration among institutional partners. Resources and training available through the CTSA should support a range of disciplines (including medicine, dentistry, nursing, pharmacy, public health, epidemiology, or bioengineering) and offer critical background knowledge/training in informatics and biostatistics needed to conduct multidisciplinary research projects.

CTSAs are charged with facilitating the efficient implementation of clinical studies, including multisite studies, locally, regionally, and nationally.

Institutional CTSAs are expected to address major impediments or risks for the conduct of clinical and translational research. Specifically, in response to this FOA, this includes plans for the adoption and institution-wide implementation of informatics environments (policies and infrastructure) that ensure the security of all data from clinical and translational research involving human subjects at all participating institutions and organizations. Additionally, this includes plans for adoption and implementation of policies and infrastructure that improve quality of human subjects protection and promote a culture of responsibility, while minimizing burden and delays, across all participating institutions and organizations.

CTSAs are charged with all aspects of the development of the workforce for translational research, including identification of work force needs, curriculum development aligned to core competencies, support of trainees and scholars, and career guidance.

Applications that focus CTSA research or training resources on a few diseases or specialties or on a limited number of investigators will be considered unresponsive to this solicitation. Disease and condition-specific research supported by other NIH Institutes and Centers frequently builds upon resources and services available through CTSAs, but the focus and core CTSA services should, in general, be ‘disease-agnostic’ and structured to provide broad support for all scientific communities engaged in clinical and translational research.

CTSA Application Structure

This FOA utilizes the U54 cooperative agreement mechanism for the application. Successful applicants will receive support through the Linked Specialized Center Cooperative agreement mechanism that includes a primary UL1 award and a linked KL2 award with an optional TL1 linked award. Organizations may not apply for Linked Specialized Center Cooperative Agreement awards; these awards may only be disaggregated from a U54 application.

The application should be organized as outlined below and as detailed in Section IV:

Overall Review criteria and Review Criteria for each of the three Sections can be found in the FOA Section V. Application Review Criteria.

Applicants have substantial programmatic, administrative and fiscal flexibility to form an integrated institutional home for clinical and translational research and training that optimizes the utilization of resources to support and address the needs of translational research within the participating institutions and nationally. It is anticipated that sites will continue to address areas that were highlighted in previous CTSA solicitations, such as informatics, biostatistical support, education, and community engagement. Please note, however, that all applications should be organized and structured as specified in this FOA.

Budget Information

Past budget policy for the CTSA program was based upon previous support from predecessor programs. As the program mission evolves, the budget policy needs to evolve accordingly. The NCATS vision of the CTSA program includes support of integrated homes for translational science forming efficient, high quality, and cost-effective national translational research infrastructure. A subsequent FOA will support the evolution of the institutional CTSAs into an infrastructure network. This FOA for Institutional CTSAs will support only the infrastructure—the integrated home—for translational science based on the magnitude of NIH funded research at each institution. Institutions vary greatly in the scope and scale of their funded research. CTSA budgets will be scaled accordingly. While the overall budget for the CTSA program will not change, individual center budgets may increase or decrease depending on (a) NIH institutional research to be supported and (b) involvement in the national network. Importantly, this FOA, which deals only with the integration of local research, is designed to free up funds for the support of the CTSAs in the national network for translational research. Subsequent solicitations will describe the funding of these consortial activities.

Institutional CTSAs are designed to improve the quality and efficiency of clinical research at institutions that receive significant funding from the NIH. The needs for the resources, services and programs supported by a CTSA are expected to vary depending upon the extent of NIH support to the institutions participating in the CTSA. While previous CTSA awards were based in part upon the budget for predecessor programs, for this FOA, CTSA awards are expected to be based on the applicant and partner institutions’ total support from NIH and upon programmatic priorities.

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 NIH Funding Base, which will be used to calculate the expected allowable budget request for this FOA, is defined as the sum of the FY 11 NIH funding to the applicant and partner institutions.  The FY 11 NIH Funding Table (www.ncats.nih.gov/files/fy11-nih-funding-table.xls) should be used for this calculation. For the purpose of the maximum budget request, each institution listed on FY 11 NIH Funding Table can only be an applicant or partner institution on one application in response to this FOA. 

For applicants who do not have an existing CTSA award, the maximum total costs per year (direct costs plus facilities and administrative costs) that may be requested in response to this FOA is 3.0% of the NIH Funding Base. For example, if the NIH Funding Base is $500 million, then the maximum total costs that can be requested are 3.0% percent of that sum (i.e., $15.0 million).  If the NIH Funding Base is less than $133 million the applicant may request a total cost budget of $4.0 million.

If the applicant institution was previously awarded a CTSA, the application can request in the initial budget period an amount equal to the Approved Budget in Section 1 of the Notice of Award (i.e., does not include any carryovers or supplemental actions) from any one of the last three awarded budget periods (i.e., the award in FY2010, FY2011, FY2012) of the previous grant or 3.0% of the NIH Funding Base, whichever is greater.  If the initial budget is based on a prior award, the budget in years two through five should be phased to meet the budgetary expectations described in this FOA.  The proposed phasing plan requires written prior approval from the NCATS Program Officer.

The budget maximum calculation has the following considerations and exceptions:

Although the maximum request is explained here, the awarded costs will depend on the scientific and technical merit of the proposed program as determined by scientific peer review, the relevance of the proposed program and resources and services to programmatic priorities, policies consistent with the goals for resource, data sharing and sharing of software, and the availability of funds.  Applicants should expect that final budgets may be adjusted post-review depending on these factors.

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH staff will assist, guide, coordinate, or participate in project activities.

This funding opportunity solicits U54 applications. Successful applicants will receive support through the Linked Specialized Center Cooperative agreement mechanism which includes a primary UL1 award and a linked KL2 award with an optional TL1 linked award.

Application Types Allowed

New.

All applications, including those from institutions that currently have a CTSA award, will be considered as new applications.

The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NCATS intends to commit approximately $110 million in FY 2013 to fund up to 18 awards in response to this FOA.

Awards issued in response to this FOA are contingent upon funds availability, the quality of applications received, and programmatic priorities.

Award Budget

The dollar amount an applicant may request is dependent on base institutional NIH funding as described above. Application budgets need to reflect actual needs of the proposed project.

Award Project Period

Applicants may request up to 5 years of support.

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.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

As noted above, “Institutional Clinical and Translational Science Awards are made to institutions that receive significant funding from the NIH.” Eligibility to apply and the total costs that may be requested are described above in Section II. Only one application as applicant or participating institution (normally identified by having a unique DUNS number or NIH IPE number) is allowed per institution.

The CTSA application may include domestic institutions, universities, academic health centers, or other research organizations conducting clinical and translational research; however, a graduate school accredited to award higher degrees (e.g., Masters or Ph. D.) in clinical or translational science must be included. Examples of acceptable higher degrees include M.S. and Ph. D. in topics such as Clinical Research, Public Health, Pharmacology, Nursing, Informatics, Health Economics, or Epidemiology. Partnerships among schools of medicine, dentistry, nursing, pharmacy, osteopathy, public health, engineering and other clinically-related institutions are strongly encouraged.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Director(s)/Principal Investigator(s) [(PD(s)/PI(s)] must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.

It is expected that the PD(s)/PI(s) will be an established clinician/scientist who reports directly to an official with broad trans-institutional authority. 

The CTSA PD(s)/PI(s) is expected to have the authority and influence necessary to successfully create an institutional home for clinical and translational research. This may include authority, perhaps shared with other high level institutional officials, over requisite space, resources, faculty appointments, protected time, and promotions.

The CTSA PD(s)/PI(s) is expected to commit at least two months and preferably six months effort to the grant regardless of whether salary is requested.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Only one application as applicant or participating institution (normally identified by having a unique DUNS number or NIH IPE number) is allowed. Currently awarded CTSAs with project period end dates in 2014, 2015, or 2016 are not eligible to apply in response to this FOA.  

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. 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.

Letter of Intent

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:

The letter of intent should be sent to:

Mohan Viswanathan, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Office of Grants Management and Scientific Review
6701 Democracy Boulevard, Room 1084
Bethesda, MD 20817
Telephone: 301-312-3745
Email: CTSAFOAQuestions@mail.nih.gov

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application must be sent to:

Mohan Viswanathan, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Office of Grants Management and Scientific Review
6701 Democracy Boulevard, Room 1084
Bethesda, MD 20817
Telephone: 301-312-3745
Email: CTSAFOAQuestions@mail.nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide must be followed, with the following exceptions or additional requirements:

Specific Instructions for This FOA

Detailed Budget for Initial Budget Period and Entire Proposed Period of Support

Prior to the inclusion of the usual budget pages that are part of every NIH grant application, this application must include a page which lists: 1) the applicant institution; 2) the partner institution(s) (if any); 3) the NIH funding dollar amounts for each institution from FY 11 NIH Funding Table; 4) total of all items in 3; and 5) calculation (i.e., multiplying Total by 3.0%) of allowable total costs for this application.

Four sets (three sets, if optional T is not requested) of budget pages (Form pages 4 & 5) are required that together incorporate all the proposed activities and costs of the CTSA:

1. U Program budget – contains the majority of the items in the program.

This budget includes justification for equipment, personnel and supplies, including administrative expenses anticipated for the Education program of the application.

2. Career Development (K) program budget

This budget provides information for the number of scholars being proposed in the Career Development (K) program. The budget should reflect the costs associated with the K scholars, such as planned salaries, fringe benefits, and research or pilot project expenses (see further information below). 

3. Optional T Training program component

This budget includes costs for trainee stipends, travel, and training-related expenses per NRSA guidelines. This budget should be submitted on the Kirschstein-NRSA Substitute Form Pages.

4. Composite budget – includes all above costs

This budget reflects all costs from the first three sets of budget pages (if a T component is requested).  T Training stipends should be included in the personnel category, and all other training costs in the other expenses category. Budget items should be requested for 12 months. Should an award be made, NCATS may prorate these items as necessary.

When multiple institutions are involved, one institution must be designated as the applicant institution and funding for the other participating institution(s) must be requested via a subcontract to be administered by the applicant institution. When submitting a detailed budget, the applicant institution should submit its budget using the PHS 398 forms. All other participating components requiring separate budgets (e.g., pediatric PIs, partner institutions) should also submit separate individual budgets on PHS 398 forms.

Education and Training specific budget information:

Education administration expenses should be included in the U budget.  These could include, but are not limited to: 1) curriculum and degree program expenses to develop and provide lectures, courses, seminar series; 2) education programs for undergraduates, allied health personnel, study coordinators, project managers; and 3) mentor support and training. Mentor support may include up to $3,000 per year for hosting T trainees and up to $10,000 per year for hosting K scholars to help defray mentor-associated laboratory or other research-related expenses. Salary support for mentors excluding laboratory- or research-related expenses is not an allowable budget item. Training stipends and K scholar salaries are not allowed on the U budget.  The K budget may include funds to support K scholar pilot 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 $2500 for scholar travel to scientific meetings and research training workshops,  and (d) statistical services including personnel and computer time.

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

The application should be organized as outlined below. Overall Review criteria and Review Criteria for each of the three Sections can be found in the FOA Section V. Application Review Criteria.

Overall Strategy and Vision Introduction (Page limits: up to 12 pages, plus up to 1 page for Specific Aims)

This section should describe the overall vision and strategic plan for an integrated home for clinical and translational science in which the entire range of translational research is supported; translational research in all science domains can access disease- and specialty-agnostic resources and services; and the workforce for translational research is trained and their career development is nurtured and promoted. This section should define the unique institutional strengths, institutional commitments, and the proposed role of applicant and partner institutions in creation of the integrated home. Specific proposed programs that build upon institutional strengths should be described. Steps to promote innovation and creativity in the methods, policies, and practices for supporting and conducting translational research should be defined with clear metrics to judge success. Strategies to ensure effective and efficient functioning of the integrated institutions locally and their participation in supporting national research networks, particularly those supported by NIH, should be outlined. Proposed or implemented mechanisms to improve the efficiency and quality of clinical and translational research as well as reducing costs should be highlighted.

The applicant should describe the diversity of investigative communities that will be supported by the CTSA, the range of resources and services to be supported, strategies to address challenges in advancing translational research, and the approach to evaluating success and identifying new local and national needs. The applicants should also use this section to describe the opportunities and challenges in improving the environment for clinical and translational research and training, and experience in addressing these challenges 

Each CTSA should have an External Advisory Committee (EAC) that meets at least annually to review structure and progress and offer recommendations to the CTSA PD(s)/PI(s). Applicants with an existing EAC 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 described, but the applicant should not specify the proposed membership.

Integrated Home Leadership Section (Page limits: up to 30 pages, plus up to 1 page for Specific Aims)

This section should describe the detailed plan for realizing the proposed vision for the integrated home. This should describe the organizational structure, governance, and the implementation plan for the integrated home; an innovative translational pilot program; informatics coordination and research data security; the plan for enhanced clinical and translational research environment; and tracking, assessment, and evaluation of programs, resources, and services provided to researchers.

Organization and Governance

The Organization and Governance should describe the proposed relationship of the applicant institution and the participating partner institutions in creating the integrated home and proposed steps to ensure effective integration. Plans for managing competing institutional perspectives, disparities in institutional culture and resources, sharing of institutional expertise and resources, and competing research needs should be described. The integration of the degree-granting institution (s) and its (their) educational programs in clinical and translational science with all participating institutions should be provided.

It is expected that the CTSA PD(s)/PI(s) will be an established clinician scientist who reports directly to an official with broad trans-institutional authority. A commitment of at least two months and preferably six months effort to the grant regardless of whether salary is requested is needed for effective leadership. The CTSA PD(s)/PI(s) must have ultimate responsibility for the implementation and function of the entire CTSA program and daily involvement with the activities of the CTSA. The CTSA PD(s)/PI(s) is also expected to have the authority and influence necessary to successfully create an institutional home for clinical and translational research. This may include authority, perhaps shared with other high level institutional officials, over requisite space, resources, faculty appointments, protected time, and promotions. This section should detail the proposed responsibilities and qualifications of the PD(s)/PI(s). If multiple PD(s)/PI(s) are designated, a leadership plan must be included describing how the CTSA PD/PI responsibilities will be fulfilled by the designated multi-PD(s)/PI(s). When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PD/PI," who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PI and the commitment of each of the multi-PD(s)/PI(s) is expected to be significant.

This section should describe the administrative structure, including designated staff, their responsibilities and qualifications. Those with designated responsibility for defined programmatic areas of the CTSA program should, in general, be senior faculty members who possess the stature, knowledge, authority, leadership, and administrative skills and capabilities necessary to direct those programs and to speak for the CTSA institution in national forums. A pediatric principal investigator may be appointed within a single Clinical and Translational Science Award with a separate budget and infrastructure for child health clinical research.

Additional areas that could be addressed, include, but are not limited to:

Translational Pilot Program

The intent of the CTSA Translational Pilot Program is to develop novel methodologies for cost-effective execution of research projects, stimulate interdisciplinary team collaboration on innovative or high risk translational research questions, and test feasibility of novel approaches to translational research. Each CTSA has flexibility to focus and design their translational pilot program to address particular priorities of their integrated home; however, the program cannot focus on a select disease category, a few diseases or specialties, or on a limited number of investigators. No more than 10% of the total NIH CTSA award funds may be allocated for the Translational Pilot Program. Funds requested for scholar pilot projects as part of the training program are excluded from this allocation limit. Additionally, the Translational Pilot Program must not support any clinical trials beyond phase IIA as noted in Section IV. Funding Restrictions.

Applicants should describe their translational pilot program guidelines: addressing solicitation, review, prioritization, business and cost management, progress tracking, and program evaluation. 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, GWAS, stem cells, model organisms.

Informatics Coordination and Research Data Security

Biomedical informatics is a critical CTSA focus for enabling and advancing translational research, which is increasingly data intensive. The data required for translating basic discoveries into clinical therapeutics and diagnostics and their testing and use in appropriate patients requires collaboration across many communities, including healthcare, research, and public health. Additionally, the amount and types of data (i.e., genetic, imaging, sensor, clinical, economic, environmental, behavioral, patient reported) that need to be integrated to generate knowledge is growing. Cooperation and coordination among the data stewards in various organizations and institutions on policy issues and 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.

A key area of risk for translational research is the security of study data, particularly in studies involving human subjects. Many clinical and translational researchers manage such data in systems, processes, and formats that lack appropriate security. Academic institutions are mixed 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. While a phased approach is expected, the plan should include a timeline that clearly indicates the expected number and percentage of studies whose data are securely managed at each phase. The plan should outline challenges and possible alternative approaches for surmounting them.

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 should ensure their research tools are compatible.

Providing visibility of CTSA participating institution scientists and resources to facilitate communication and collaboration between CTSAs and with non-CTSA communities is encouraged.

NIH 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 consortial informatics activities. The CTSA institution must be committed to working toward adoption and implementation of standards and practices endorsed by the CTSA Consortium Steering Committee.

Clinical and Translational Research Environment

CTSA applicants should describe how they will ensure a broad culture of responsibility for safe and ethical conduct of human subjects research throughout the institutions participating in the CTSA. Clinical research cannot be totally risk free, but meticulous attention to ethical standards, procedural safeguards and regulatory requirements is essential to minimize risk to patients and prevent any erosion in the trust of the public in the research enterprise.

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 not approved or conducted. The appropriateness of specific study designs, development of realistic recruitment goals, tracking of enrollment, steps to ensure the timely assessment of feasibility and closure of studies that do not meet goals, efficient institutional workflows for conduct of translational studies, expectation of prompt analysis of results, and dissemination of those results should each be addressed. The entire range of translational research studies should be addressed including all clinical research studies, all phases of clinical trials, behavioral studies, and those with vulnerable and special populations. Although regulatory compliance and review are required, the intent of this plan is to focus CTSA institutions on conducting only high quality translational research, ensure that clinical and translational researchers and research teams work in an environment that understands and facilitates their research, and increases efficiency and decreases cost through institution-wide accountability and transparency.

Tracking of all clinical studies at the participating institutions from inception through review, activation, conduct, closure, analysis, and dissemination of results should be addressed to facilitate identification of inefficiencies, troubled studies, and bottlenecks so they can be addressed. Additionally, the registration of all clinical studies and trials in clinicaltrials.gov is encouraged; registration of all “applicable trials” is required. 

Multi-site studies, including clinical trials, are necessary to address many important questions, but are particularly difficult to conduct in a timely manner. Clinical study oversight, timely recruitment, effective enrollment, and follow up, retention of participants, data quality and security, availability of highly trained study staff and ancillary services, and timely submission of adverse events are expected in all studies at participating CTSA institutions. Applicants should describe how all participating institutions in their CTSA anticipate working 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 similar to those utilized in many NIH networks. Applicants should describe institutional processes for clinical trial agreements and contracts and timelines for completion.

Tracking, Assessment, and Evaluation

The NIH is committed to transparency in the CTSA program to ensure the program is delivering on its mission of increased quality, efficiency, and decreased cost of all translational research within academic institutions and nationally. Success of the program will be defined by increased efficiency and decreased costs for other NIH institutes and centers completing clinical and translational research.

The applicant must describe how they will track the use, quality, and cost of the programs and resources and services provided by the CTSA; how the data will be assessed and programs, resources, and services modified to better meet researcher needs, increase efficiency and quality, and lower cost. Tracking and assessment of innovative new methods and practices in structuring, bundling, and delivery of programs, resources and services are also encouraged. 

The applicant must describe how they will track, assess, and evaluate the effectiveness of their plan for ensuring high quality and efficient human subjects research, including the appropriateness of study design, recruitment, feasibility and timely closure of futile studies, research study workflow, analysis, and dissemination of results.

It is expected that the programs, resources and services provided by each CTSA will vary as will the costs. The NIH also expects that this information will be important to the CTSA PD(s)/PI(s) and staff for assessing their activities, adjusting programs to be most efficient and cost effective while effectively providing high quality.

Applicants should provide a full description of tracking processes, metrics, and milestones proposed to ensure ongoing assessment and timely adjustment of activities of the CTSA.

Clinical and Translational Resources and Services Section (Page Limits: up to 30 pages, plus up to 1 page for Specific Aims)

The Institutional Clinical and Translational Science Award must provide disease-agnostic resources and services that address the needs of translational investigators at the participating institutions. These resources and services should address the many stages of translational research, including planning, conduct, analysis, and dissemination.

Research Resources and Services should be provided to researchers at all participating institutions, should be configured to promote broad access and reliable quality, and should provide clear cost expectations. CTSA infrastructure should leverage and complement other NIH infrastructure investments at the applicant institutions, and not duplicate those investments.

The definition of what constitutes a Resource or Service is sufficiently broad to address the needs of the entire range of translational research. The structure, organization, and specifics of resources and services are expected to vary among CTSA applicants. The choice and configuration of the resources and services should address the needs of local translational teams; however, their structure should also facilitate participation of local investigators in national networks and multi-site studies, particularly those supported by NIH. While examples of possible resources and services are noted below, the particular resources and services selected for inclusion by the applicant should be well justified to meet the needs and offer significant value to the translational investigators at the participating institutions. Examples could include but are not limited to: biostatistics, informatics, regulatory, clinical research design, recruitment services, specimen collection, nursing services, coordinator services, laboratory assays, clinic space (i.e., in-patient bed, day hospital, clinic room), and computing or data resources. It is expected that the provision of resources and services will constitute a significant portion of the requested budget.

An applicant's initial choice of Resources and Services is an important measure of the strategy and vision for supporting clinical and translational research. Applicants should describe each Resource and Service to be supported at the time that the CTSA grant is awarded, how the choice of resources and services was made, other potential resources and services that were evaluated but not selected, mechanisms for evaluating the utilization of each proposed resource and service, criteria for increasing or decreasing funding from the CTSA grant for a resource or service, and process for adding or deleting resources and services during the course of the award. The applicant must clearly describe the cost allocation from the CTSA budget for each Resource and Service and how costs for Resources and Service are allocable to specific research teams or projects.

Each CTSA is expected to phase-in a Program Income System, i.e., a method of allocating usage of Resources and Services and the cost for their provision from the CTSA budget. This should include equipment, time, supplies (such as reagents) and personnel providing the service. The development of a Program Income System will permit program income costs, as appropriate, to be budgeted within the user’s research grant. The funds freed from the CTSA budget, originally allocated for the establishment of the Resource or Service, could consequently be rebudgeted (may require prior NIH approval) to establish new Resources and Services or expand existing Resources and Services. Users of Resources and Services should be aware that CTSA Resources and Services may generate program income. Each applicant must include a plan for a phased Program Income System that will be implemented by the end of the first year.

Clinical research units and other dedicated research facilities or subsidy of patient care costs are not required components of a CTSA application. If they are included in the CTSA budget, they must be structured as a Resource or Service and clearly described as noted above for any Resource or Service. Special attention to their appropriateness for diverse research communities and their usage is expected. Inclusion in the Program Income System is expected.

Education, Training, and Career Development Section (Page Limits: Education - up to 12 pages, K program – up to12 pages, optional T program – up to 12 pages; plus up to 1 page for Specific Aims for entire section)

A. Overview

In this portion of the application, the applicant should present a broad vision of the workforce needed to drive future innovation and implement effective clinical and translational research. Objectives of the CTSA training program include addressing future workforce needs, implementing a team science approach for research training, offering research curriculum aligned to core competencies, and providing support and career guidance to trainees and scholars. Early exposure to collaboration and career guidance may serve to enhance the team approach necessary to meet the multidisciplinary challenges of clinical research. The CTSA training programs should serve as a pipeline introducing postgraduate students to translational science, and promoting scientific curiosity and discovery among postdoctoral clinician scientists.

The applicant institution should provide a comprehensive description of the existing or proposed higher degree-granting programs such as Masters or PhD in Clinical and Translational Research. Institutional approaches to ensure appropriate recognition and incentive for team-based research should be described.  Steps to guarantee sufficient protected time for clinical investigators to balance research demands with patient care responsibilities should be outlined.  Strategies to create effective and synergistic interactions with trans-NIH funded training programs should be defined. Individuals supported by other NIH training and career development mechanisms (K, T, or F awards) may receive, and indeed are encouraged to receive, educational experiences supported by the UL1 research education component, as participants, but may not receive salary or stipend supplementation from the CTSA research education component.

Program Evaluation

Describe an evaluation plan to review and determine the effectiveness of the program. This should include plans to obtain feedback from current and former trainees and scholars to help identify weaknesses and to provide suggestions for program improvements (i.e, retention, diversity, and outcomes). Describe plans for assessing career progression among scholars and trainees, including defined metrics such as publications, career choice, and subsequent positions. Identify tools to assess program performance including evaluation of the curriculum, mentors, scholars/trainees, and opportunities for collaborative research. Specified evaluation metrics should be aligned to the goals of the program. In addition, evidence should be included that the CTSA supported activities will be synergistic with other NIH clinical and translational research programs.  Evaluation results should be included in non-competing continuation  applications and in the Final Progress Report.

Leadership and mentoring: The application should provide a comprehensive description of the faculty, mentors, and trainee/scholar pools including any recognized areas of strength. The KL2 and optional TL1 programs are components of the educational and training mission of the CTSA. The directors of these programs should be established investigators with the scientific and administrative skills and established leadership in career development of translational researchers. The individuals should be senior faculty members with extensive expertise in recruiting, mentoring, and sustaining junior investigators in research careers, and executing research training programs.

Identify a core group of primary sponsor/mentors for the training programs. Each mentor together with the mentee will be responsible for the planning, direction, and execution of each career development plan and research project. Mentors must be recognized as accomplished investigators in clinical and translational research and have a track record of success in training new investigators and fostering their transition to independence. Mentors without a track record in mentoring should have documentation of sufficient expertise, national recognition, and adequate training 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 TL1 and KL2 awards. The use of co-mentors to achieve the goals of the program is encouraged. Mentors are expected to provide career guidance to both scholars and trainees to improve the recruitment and retention of clinical and translational investigators. A diverse mentor pool including women, minority individuals, and individuals with disabilities is important. Describe existing or future plans to create a formal or informal mentor training program, and approaches to develop metrics for assessment of mentoring quality and time commitments.

Applicants have the option, within the pages limits, of including a tabular listing up to 30 potential mentors including a) faculty appointment, b) clinical/basic science discipline; c) area of research experience; d) number of former mentees; and e) former mentee research projects.

Biographical sketches for the education and training leadership including KL2 Program Director and the TL1 Program Director (if included), and up to 30 potential mentors may be included in the application.

B.  Mentored Career Development Program (KL2)

 A Mentored Career Development program is a required component of a CTSA. The objectives should be clearly defined and justified based on institutional strengths, the pool of potential scholar candidates and faculty mentors, and synergy (avoiding redundancy) with other NIH funded translational research programs namely the NIH K12 grant mechanism. Justify the proposed number of scholars and explain the criteria used to select, accept, and evaluate candidates. Describe the career development plans for prospective candidates and how plans will be designed to meet the needs of the scholars. Global health research training is one possible area of emphasis, and if selected, a detailed foreign component description should be provided including a mentoring plan tailored to the needs of the scholar and the research environment. All foreign activities must be cleared through the NIH foreign component tracking system https://fts.nhlbi.nih.gov/nihfts/login. Scholars supported through the KL2 mechanism are expected to be engaged in translational research.

Mentored Career Development Program (KL2) Scholar Eligibility:

Only U.S. citizens or non-citizen nationals, or an individual lawfully admitted for permanent residence who possesses an Alien Registration Receipt Card (I-151 or I-551), or some other verification of legal admission as a permanent resident prior to appointment, are eligible to accept a KL2 appointment. Individuals on temporary or student visas are not eligible. Plans for recruiting scholars should include accessing under-served and under-represented minority and ethnic populations.

Scholar Appointments:  KL2 scholars must have a research or health-professional doctoral degree or its equivalent. Candidates must be able to commit a minimum of 9 calendar months of full-time professional effort for career development and research activities associated with the program. The remaining 3 calendar months’ effort can be divided among other research, clinical and teaching activities only if these activities are consistent with the proposed goals of the KL2 program. The eligibility of potential candidates holding VA appointments should be confirmed with NCATS Office of Grants Management and Program staff prior to the individual being appointed to the program. The KL2 program provides support for a minimum of two years and a maximum of five years of consecutive funding for each scholar, consisting of consecutive 12-month appointments.

Applicants for KL2 appointments 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 KL2 program. Former or current principal investigators on any NIH research project grant (this does not include NIH Small Grants (R03) or Exploratory/ Developmental (R21) grants or their equivalents) 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 KL2 scholars. Appointed KL2 scholars may apply for individual mentored K awards (e.g., K07, K08, K22, K23); if successful, the KL2 appointment would be terminated and funding received from the new individual K award.

C.  Predoctoral and Postdoctoral Research Training Program (TL1):

The inclusion of a TL1 institutional research training program is optional, and if selected, should be justified by the institutional vision and programmatic strengths. The program needs to fit within the general guidelines of National Research Service Award (NRSA) institutional training programs. Additional NRSA information and instructions are available at: http://grants.nih.gov/grants/funding/phs398/phs398.html.

The objectives, leadership, institutional commitments, and proposed trainee pool should be described as well as the role of the Program Director and faculty serving as mentors to the trainees. Justify the proposed number of trainees and explain how they will be engaged on translational research projects and the relationship of such activities to the overall educational goals.

Predoctoral and Postdoctoral Research Training Program (TL1) Trainee Eligibility:

At the time of appointment to the training program, individuals selected to participate in the training program must be citizens or non-citizen nationals of the United States, or have been lawfully admitted to the United States for permanent residence and have in their possession an Alien Registration Receipt Card (I-151 or I-551) or other legal verification of admission for permanent residence. Non-citizen nationals are persons born in lands that are not States but are under U.S. sovereignty, jurisdiction, or administration (e.g., American Samoa). Individuals on temporary or student visas are not eligible for NRSA support. In addition, trainees must be able to commit full-time effort in the program at the time of appointment.

Predoctoral Trainees: Pre-doctoral trainees must have received a baccalaureate degree by the beginning date of their NRSA trainee appointment and must be training at a post-baccalaureate level and enrolled in a program leading to a PhD in a clinical research-related doctoral degree program, or a combined doctoral level professional degree plus a clinical research-related advanced degree, such as a MD, DDS, DO, DNP, PharmD/MS or MD, DDS, DO, DNP, PharmD/PhD. Students who are officially enrolled in a qualifying health-professional doctoral program and wish to postpone their professional studies for one year to gain research experience, may be appointed to the TL1 research training grant for that period, provided that NRSA eligibility requirements are met. NRSA support is not provided for study leading to a MD, DO, DDS, DNP, PharmD or other similar professional clinical degrees, or a master's degree that is not pursued in a combined program with a professional level doctorate. Individuals currently supported by other Federal funds are not eligible for trainee support from the TL1 program at the same time.

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: 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. 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 month) training positions.

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

Training in the Responsible Conduct of Research: For both the Career Development and the optional Institutional Training programs, applications must include a description of plans to provide formal and informal instruction in scientific integrity and the responsible conduct of research. Every scholar and trainee supported by this CTSA grant must receive this instruction. All applications must include a plan to provide such instruction, and applications lacking these plans will be returned without review. More detail about instruction in the responsible conduct of research can be found in NOT-OD-10-019. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-019.html  See SF424, Section 8.7. Research Training Program Plan Components, Item 5, Plan for Instruction in the Responsible Conduct of Research. As specified, plans must address five components: format; subject matter; faculty participation; duration of instruction; and frequency of instruction.

Recruitment and Retention Plan to Enhance Diversity: The NIH recognizes the need to promote diversity in the biomedical, behavioral, clinical and social sciences workforce leading to the recruitment of the most talented researchers from all groups; improving the quality of the educational and training environment; broadening research priorities; diversifying the backgrounds of clinical research subjects; and improving the Nation’s capacity to address and eliminate health disparities.

The NIH encourages institutions to diversify their trainee and faculty populations to include individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis. The NIH is particularly interested in encouraging the recruitment and retention of the following:

A.   Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27 and the most recent report on Women, Minorities, and Persons with Disabilities in Science and Engineering). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: African Americans, Hispanic Americans, American Indians, Alaska Natives, Native Hawaiians, and other Pacific Islanders. In addition, it is recognized that under-representation can vary from setting to setting and individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program.

B.   Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.

C.   Individuals from disadvantaged backgrounds who are defined as:

1.    Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at HHS - Poverty Guidelines, Research, and Measurement. For individuals from low income backgrounds, the institution must be able to demonstrate that such candidates have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professional Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.

2.    Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.

Recruitment and retention plans related to a disadvantaged background (C1 and C2) are most applicable to high school and perhaps undergraduate candidates, but would be more difficult to justify for individuals beyond that level of achievement.  Under extraordinary circumstances the PHS may, at its discretion, consider an individual beyond the undergraduate level to be from a disadvantaged background.  Such decisions will be made on a case-by-case basis, based on appropriate documentation.

Sharing Plans

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 PHS398 Application Guide.

NIH considers the sharing of unique research resources and data developed through NIH-sponsored research an important means to enhance the value of, and advance research. Inclusion of a Resources and Data Sharing Plan and a Software Sharing Plan is expected in response to this FOA. If the final data/resources are not amenable to sharing, this should be explained in the proposed Sharing Plans.

Resources and Data Sharing Plan

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.

A Resources and Data Sharing Plan is expected to be included in the application. The initial review group will comment on the appropriateness and adequacy of the proposed Resources and Data Sharing Plan. Program staff and advisors will also consider the adequacy of the proposed plan as one criterion for award. The proposed Resources and Data Sharing Plan, after negotiation with the applicant when necessary, will be made a condition of award. Evaluation of the annual non-competing progress reports will include assessment of the responsiveness to the Resources and Data Sharing Plan included in the Notice of Award.

Software Sharing Plan

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 Software Sharing Plan, with appropriate timelines, is expected to be included in the application. 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:

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

2. 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.

3. 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.

The review group will comment on the appropriateness and adequacy of the proposed Software Sharing Plan to meet the goals of the NIH in this program. Program staff and advisors will also consider the adequacy of the proposed plan as one of the criteria for award. The proposed Software Sharing Plan, after negotiation with the applicant when necessary, will be made a condition of the award. Evaluation of the annual non-competing progress reports will include assessment of the responsiveness to the Software Sharing Plan included in Notice of Award.

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.

Required Institutional Letters

Applicants must provide letters from the appropriate high-ranking institutional official(s) from the parent institution(s) and all partner institutions that:

Appendix

 Appendices are not allowed.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates.               

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Section 479(b) of the Public Health Service Act (as amended by the Consolidated Appropriations Act, 2012, Public Law 112-74), states that NCATS may provide infrastructure and resources for all phases of clinical trials, but that NCATS can only support clinical trials through Phase IIA. Therefore, unless specifically authorized via Revised Notice of Award, with attendant specific Terms of Award, NO clinical trial activity beyond phase IIA may be supported with NCATS funds through the pilot project, K or T program. However, all phases of clinical trials may utilize infrastructure and resources provided by the CTSA.

6. Other Submission Requirements and Information

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

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.  

Technical Assistance Webinar

NCATS will conduct a technical assistance webinar regarding RFA-TR-006: Institutional Clinical and Translational Science Award (U54) on Monday, July 23, 2012 from 2:00 to 3:30 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: Monday, July 23, 2012

Time: 2:00-3:30 PM EDT

URL: https://ncatsevents.webex.com/ncatsevents/onstage/g.php?t=a&d=660437516

Questions: CTSAFOAQuestions@mail.nih.gov

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

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.

For this particular announcement, note the following:

The CTSA program supports academic homes that are charged with creating an integrated research and training environment across the applicant institution and partner institutions in order to: promote institutional change that enhances quality, safety, efficiency, and cost effectiveness of clinical and translational research for all conditions; provide resources and services to support and speed the planning and implementation of clinical and translational research across the entire range of research and communities; and facilitate the training and career development of a robust translational research workforce.

Overall Impact - Overall

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the clinical and translational sciences, in consideration of the following review criteria and additional review criteria (as applicable for the project 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

Do the proposed vision and strategy identify important problems or critical barriers to progress in advancing translational research?

Will the CTSA create a strong integrated home for the translational science research and training?

If the aims of the proposed CTSA are achieved, will the environment for clinical and translational research and training be improved across the spectrum of specialties and domains?

If the aims of the proposed CTSA are met, will translational research and training improve in quality and efficiency at the participating institutions? Will the highest level of oversight and protection of human subjects be ensured?  

Investigator(s)

Is the overall staffing, including the PD/PI (or multi-PD/PIs) and other staff, well suited to make significant impact in the conduct of translational research inclusive of all participating institutions?

Do the leadership and staff demonstrate commitment to making any necessary changes in institutional policies, organization, and/or practice to achieve the goals of the CTSA program?  

Innovation

Are innovation and creativity in the methods, approaches, technologies, resources, services, and policies for translational research encouraged across the translational spectrum?

Are novel approaches proposed to increase the quality, safety, efficiency, and speed of clinical and translational research?

Is innovation evident in the delivery of support for translational research? Across the participating institutions and across the spectrum of clinical research, is innovation in the access to clinical translational research resources proposed or evident?  

Approach

Will the proposed CTSA program support a broad spectrum of clinical and translational research at all participating institutions? Will clinical and translational researchers at all participating institutions benefit from the integrated home? 

Does the application identify key obstacles to the performance of translational and clinical research and then propose plans and/or demonstrate means to overcome these?

Will the unique features of this CTSA provide innovative opportunities to advance translational science? 

Is the organization of the External Advisory Committee (EAC) conducive to providing constructive, stimulating, and thoughtful advice for the overall CTSA performance? Are plans in place for the CTSA institution(s) to act on advice from the EAC? Are the types of members described appropriate?  

Environment

Will the scientific environment at the applicant and participating institutions bring strengths to the translational sciences?

Does the proposed CTSA demonstrate value-added to already existing infrastructure and/or realize efficiencies in access to clinical and translational research resources and training that will enhance cost and process efficiencies while maintaining a quality research environment?

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

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/priority 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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

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.

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. All applications in response to this FOA will be considered new applications.

Revisions

Not Applicable.

Additional Review Considerations - Overall

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

Resources and Data Sharing Plan

The reviewers will comment on the appropriateness and adequacy of the proposed Resources and Data Sharing Plan to meet the goals of the Institutional Clinical and Translational Award program.

Software Sharing Plan

Reviewers will evaluate and comment on the Software Sharing Plan relative to the following goals:

1. The software should be freely available to biomedical researchers, health care delivery systems, research institutions, and government health care systems and researchers.

2. 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.

3. 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.

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).

Other 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) Sharing Model Organisms; and 2) 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.

Scored Review Criteria - Integrated Home Leadership

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

Will the proposed organizational structure, governance, informatics coordination plan, clinical and translational research environment plan, translational pilot program, and tracking, assessment, and evaluation plan contribute to making clinical and translational research higher quality and more efficient?

Is the governance designed to ensure accountability and that appropriate authority is structured such that the PD/PI or multiple PD(s)/PI(s) can significantly impact the efficient conduct of clinical and translational research across participating institutions?

Are the plans for managing and addressing competing issues and challenges in the integrated home appropriate? Are effective plans proposed to manage/prioritize/improve in areas of competing institutional perspectives, disparities in institutional culture and resources, sharing of institutional expertise and resources, and competing research needs?

Are there appropriate plans to integrate CTSA activities across relevant departments, schools, and clinical research institutes at the participating institutions?

Investigator(s)

Do the CTSA PD(s)/PI(s) have the authority and committed time to administer the proposed CTSA, including at least 2 calendar months by the CTSA PD(s)/PI(s)?

Will the CTSA PD(s)/PI(s) have sufficient authority to work across institutional boundaries?

Are plans in place to facilitate change, if needed?

Is the leadership structure inclusive of all participating institutions?

Innovation

Do the proposed plans demonstrate innovation in governance, in oversight of the translational pilot program, in oversight of clinical and translational research environment, in informatics coordination, and in tracking, assessment, and evaluation?

Is there innovation in how institutions will work collaboratively together and with others?

Approach

Are the roles of each participating institution and identified strengths and challenges, potential problems, and their alternative strategies consistent with achieving efficiency and quality and decreasing the overall cost of clinical and translational research while ensuring the highest level of oversight and protection of human subjects?

Is the role of each partner institution in the integrated home clearly described, including how each will significantly benefit from and contribute to its creation and function?

Does the applicant demonstrate a commitment to establishing and plans for following through on measurable metrics for success?

Does the evaluation plan for tracking, assessment, and adjustment ensure accountability for use, quality, and cost of the proposed activities, resources, services, and educational programs? Are adequate processes, metrics, and milestones identified to ensure and evaluate ongoing improvement of CTSA activities?

Is the plan to improve the environment for clinical and translational research well thought out? Is there institutional openness to innovative approaches to oversight of human subjects research, such as participation in NIH networks with centralized IRBs?

Does the plan for informatics coordination include all relevant partners? Will the plan for management of research data ensure the security of all researchers’ data at participating institutions? Is the timeline feasible and well-managed?

Will the guidelines for the solicitation, review, prioritization, and tracking and evaluation of the translational pilot program provide accountability and ensure innovation?

Environment

Does the application describe unique institutional strengths, institutional commitments, and the proposed role of applicant and partner institutions in creation of the integrated home for clinical and translational research? 

Are the institutional support, availability and type of equipment and other physical resources appropriate for ensuring a nurturing environment for clinical and translational research and education and the career development of translational researchers?

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

Additional Review Criteria - Integrated Home Leadership

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/priority 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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

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.

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.

Scored Review Criteria – Clinical and Translational Resources and Services

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

Do the proposed Resources and Services address important needs or critical barriers for translational researchers and research teams locally?

Will the proposed Resources and Services assist investigators participating in national networks, particularly NIH disease-specific networks?

If the Resources and Services are provided as described, will the full spectrum of translational research capability at all participating institutions be improved?

Do the Resources and Services address the various stages of translational research, including planning, conduct, analysis, and dissemination?

Investigator(s)

Does the proposed staffing for each Resource or Service bring the stature, knowledge, administrative skills, and technical skill necessary? Are the administrative and professional staff and any named collaborators appropriately trained and well suited to carry out this work? 

Does the Resources and Services staff have sufficient breadth and depth of technical and/or scientific knowledge to cover a wide range of clinical and translational research and investigators or teams that vary in knowledge and sophistication, e.g., trainees to senior researchers?

Is sufficient effort committed to each Resource and Service?

Do the Resources and Services staffing plans address potential variability in usage from the research community?

Innovation

Do the proposed Resources and Services employ novel concepts, approaches, methodologies, tools, or technologies?

Is there innovation in the approach to delivery, allocation, or leveraging of Resources and Services?

Do the Resources and Services create innovative and unique opportunities to foster synergy and increase coordination among clinical and translational researchers across participating institutions?

Approach

Do the choice and configuration of the Resources and Services to be offered adequately address the needs of a broad array of local clinical and translational researchers and research teams across all participating institutions?

Is the process for selection, review, modification, and discontinuation of specific Resources and Services or the mix of Resources and Services well described?

If the Resource or Service is in the early stage of development, are plans proposed to establish feasibility and is consideration given to how particularly risky aspects will be managed?

Are adequate plans proposed for issues related to prioritization of workload for the Resources and Services?

Is there an adequate plan to develop a phased Program income System and to track the use, quality, reliability, and cost of the Resources or Service?

Are potential problems, alternative strategies, and benchmarks for success presented for Resources and Services?

Are disease-agnostic Resources and Services provided to assist a broad array of researchers in the conduct of novel clinical translational research?

Do the proposed Resources and Services leverage and complement other NIH infrastructure investments at participating institutions and not duplicate those investments?

Will the applicant’s plan for quantification and allocation of the use of each resource and service by specific research projects or teams allow timely tracking, assessment, and review of utilization?

Environment

Is the institutional support of the Resources and Services and available equipment and other physical resources appropriate for ensuring responsiveness to the needs of a broad array of clinical and translational researchers?

Do the proposed Resources and Services build upon the unique features of the scientific environment, subject populations, or collaborative arrangements? 

Additional Review Criteria - Clinical and Translational Resources and Services

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/priority 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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

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.

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.

Scored Review Criteria- Education, Training, and Career Development Section

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. These review criteria apply to the Educational Overview program and the K Career Development program.  The optional T Training Program Review Criteria are found in the Additional Review Criteria.

Program and Environment

Research Education: Are the quality, innovation and content of courses and the curriculum adequate? Is the curriculum aligned with core competencies for clinical and translational research? Will the curriculum 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? Is the scope of the curriculum flexible enough to include learning models that meet the needs of the institution and participants?

Career Development (KL2): Does the vision of the CTSA career development program reflect the anticipated workforce needs for clinical and translational research? Is there appropriate clarity and justification for the specific goals of the proposed career development program?

Does the overall clinical research and training environment reflect an adequate record of the institution(s) conducting multidisciplinary, collaborative, clinical and translational research? Is there broad representation of clinical and scientific disciplines among the leadership, faculty, and trainees?

Does the institution have a sufficient pool of academically strong scholars and well-qualified mentors to justify the proposed KL2 program? Are there higher degree-granting programs in place for formal clinical research training? Do the research education, training and career development components strengthen the training and career pathways for all clinical and translational research professionals and team members? Is the KL2 program integrated with other institutional K programs at the institution? Is there sufficient evidence that the education and training plans of the CTSA are fully integrated with all other institutional and individual training and career development programs at the participating institutions?

In the design of the career development program, is adequate attention paid to the benefits and challenges of conducting collaborative research in a multidisciplinary setting?  Does the proposed training program provide appropriate courses for clinical and translational science research? Are appropriate programmatic research activities incorporated into the training program?

Is the institutional commitment to the proposed KL2 program appropriate?  If multiple sites are participating, is this adequately justified in terms of the career development and research experiences provided?  What higher-degree granting programs are affiliated with the CTSA and are these programs representative of top-tier environments for clinical and translational research training? Is there sufficient assurance that the required effort of the PD(s)/PI(s), mentors and scholars will be devoted directly to the research training, career development, and related activities?

Training Program Director(s) (PDs)

Does the PD(s) and Training Administrator (if applicable), have the experience to develop, direct and administer the proposed KL2 program?  Does the recruitment, retention and career path of individuals trained at these institution(s) support a successful program in career development of translational researchers? Does the leadership team bring complementary and integrated expertise to the program? Are the research qualifications, scientific stature, leadership experience, and research training record(s) appropriate for the proposed career development program? Are the PD(s) currently engaged in translational research?

Mentors

Does the applicant name high caliber, productive, researchers as mentors? Do the proposed mentors have the experience, skills, and strong training record necessary to provide the scholars with appropriate research training and career guidance? Do the proposed mentors reflect the scientific focus of the CTSA and/or the specific needs of clinical and translational research, as described in the CTSA vision statement? Is there a formal/informal mentor training program to offer mentors an opportunity to improve their mentoring skills?

Candidates/Scholars

Is there a functional plan for the selection of individuals for appointment to the career development program? What are the quality and size of the applicant pool? Are the recruiting procedures, scholar selection criteria, and retention strategies appropriate and well-defined? What are the recruitment and retention rates for the program? Does the plan for selection of the scholars include all of the eligibility criteria stated in the FOA? Is there support for scholars to conduct pilot research projects?

Training Record

Is there a rigorous evaluation plan to assess the quality and effectiveness of the career development program? Are there tracking tools in place to assess program performance including the curriculum, mentors, scholars, and opportunities for collaborative research? What options are available to make changes to improve program performance (i.e, retention, diversity, and outcomes)? Is there evidence that the institution is successful in developing research skills and providing career guidance to clinician scientists? Has the institution obtained feedback from current and former scholars concerning subsequent career choices/outcomes? 

Additional Review Criteria

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/priority score, but will not give separate scores for these items.

(Optional) National Research Service Award (NRSA) Predoctoral and Postdoctoral Research Training (TL1) Program

Training Program and Environment

Is there a high quality institutional training environment for trainees? Does the curriculum offer novel learning models to meet the needs of the institution and 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?

Is the institutional commitment to the proposed program appropriate?  If multiple sites are participating, is this adequately justified in terms of the research training experiences provided? Is the TL1 program integrated with other institutional training (NRSA) programs at the institution? Is the TL1 program 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 PD(s), mentors, and trainees will be devoted directly to the research training and related activities?

Program Director

Does the applicant have experience in administering predoctoral and postdoctoral training programs? Is sufficient administrative and research training support provided for the program?  Has the Program Director(s) committed adequate time to program administration? If there are multiple program directors, 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 with the complementary expertise of each of the PD(s)?

Preceptors/Mentors

Are sufficient numbers of experienced preceptors/mentors with appropriate expertise and funding available to support the number and level of trainees proposed in the application?

Do the preceptors/mentors have strong records as researchers, including successful competition for research support in areas directly related to the proposed research training program? Do the preceptors/mentors have strong records of training pre- and/or post-doctoral students? 

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

Candidates/Trainees

Is there a functional plan for the selection of candidates for appointment to the research training program? What are the quality and size of the applicant pool? Is there evidence of a competitive applicant pool in sufficient numbers to warrant the proposed size and levels (predoctoral, postdoctoral and/or short-term) of the training program? Are the recruiting procedures, trainee selection criteria, and retention strategies well defined? What are the recruitment and retention rates for the program? Does the plan for selection of the trainees include all of the eligibility criteria stated in the FOA? 

Training Record

Is there a rigorous evaluation plan to assess the quality and effectiveness of the trainingprogram? Are there tracking tools in place to assess program performance including the curriculum, mentors, trainees, and opportunities for collaborative research? What options are available to make changes to improve program performance (i.e, retention, diversity, and outcomes)?  Is there evidence that the institution is successful in developing research skills and providing career guidance to trainees ? Has the institution obtained feedback from current and former trainees concerning subsequent career choices/outcomes? 

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.

Additional Review Considerations

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/priority 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 review panel’s evaluation will be included in an administrative note in the summary statement. Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Training in the Responsible Conduct of Research

For Career Development (K) component: Taking into account the specific characteristics of the career development program, level of scholar experience, and the particular circumstances of the scholars, the reviewers will address the following questions.  Does the plan satisfactorily address the format of instruction, e.g., lectures, coursework and/or real-time discussion groups?  Do plans include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety?  Do the plans adequately describe how faculty will participate in the instruction?  Does the plan meet the minimum requirements for RCR, i.e., eight contact hours of instruction every four years? 

For Optional T component: Taking into account the specific characteristics of the training program, level of trainee experience, and the particular circumstances of the trainees, the reviewers will address the following questions.  Does the plan satisfactorily address the format of instruction, e.g., lectures, coursework and/or real-time discussion groups?  Do plans include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, and laboratory safety?  Do the plans adequately describe how faculty will participate in the instruction?  Does the plan meet the minimum requirements for RCR, i.e., eight contact hours of instruction every four years? 

Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

2. Review and Selection Process

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. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and 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:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD(s)/PI(s) 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.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the 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 the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

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:

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

The Program Official stewardship includes:

The NIH Project Coordinators (PC) will:

Areas of Joint Responsibility include:

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.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

Other Reporting Requirements

Reporting that ensures transparency of the types and cost of resources and services provided by the NCATS CTSA grant to support clinical and translational research projects at funded applicant and participating institutions will be required.  It is expected that the proposed plan of successful applicants will be a Term of the Award. 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. 

Section VII. Agency Contacts

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

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

G. Iris Obrams, M.D., M.P.H., Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Division of Clinical Innovation
6701 Democracy Boulevard, Room 914
Bethesda, MD 20817
Telephone: 301-435-0790
Email: CTSAFOAQuestions@mail.nih.gov

Peer Review Contact(s)

Mohan Viswanathan, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Office of Grants Management and Scientific Review
6701 Democracy Boulevard, Room 1084
Bethesda, MD 20817
Telephone: 301-312-3745
Email: CTSAFOAQuestions@mail.nih.gov

Financial/Grants Management Contact(s)

Gavin T. Wilkom
National Center for Advancing Translational Sciences (NCATS)
Office of Grants Management and Scientific Review
6701 Democracy Blvd, Room 1046
Bethesda, MD 20817
Telephone: 301-435-0964
Email: CTSAFOAQuestions@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

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.


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