Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
This RFA is developed as a Roadmap initiative. All NIH Institutes and Centers participate in Roadmap initiatives. This RFA will be administered by the National Center for Research Resources on behalf of the NIH. http://www.ncrr.nih.gov/.

Title: Institutional Clinical and Translational Science Award

Announcement Type
New

Update: The following updates relating to this announcement have been issued:

Request For Applications (RFA) Number: RFA-RM-06-002

Catalog of Federal Domestic Assistance Number(s)
93.389

Key Dates
Release Date: October 12, 2005
Letters of Intent Receipt Date(s): February 27, 2006
Application Receipt Dates(s): March 27, 2006
Peer Review Date(s): Summer 2006
Council Review Date(s): September 2006
Earliest Anticipated Start Date: September 2006
Additional Information To Be Available Date (URL Activation Date): October 2005
Expiration Date: March 28, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

  Section I. Funding Opportunity Description
   1. Research Objectives

  Section II. Award Information
   1. Mechanism(s) of Support
   2. Funds Available

  Section III. Eligibility Information
   1. Eligible Applicants
     A. Eligible Institutions
     B. Eligible Individuals
   2.Cost Sharing or Matching
   3. Other - Special Eligibility Criteria

  Section IV. Application and Submission Information
   1. Address to Request Application Information
   2. Content and Form of Application Submission
   3. Submission Dates and Times
     A. Receipt and Review and Anticipated Start Dates
       1. Letter of Intent
     B. Sending an Application to the NIH
     C. Application Processing
   4. Intergovernmental Review
   5. Funding Restrictions
   6. Other Submission Requirements

  Section V. Application Review Information
   1. Criteria
   2. Review and Selection Process
     A. Additional Review Criteria
     B. Additional Review Considerations
     C. Sharing Research Data
     D. Sharing Research Resources
   3. Anticipated Announcement and Award Dates

  Section VI. Award Administration Information
   1. Award Notices
   2. Administrative and National Policy Requirements
     A. Cooperative Agreement Terms and Conditions of Award
       1. Principal Investigator Rights and Responsibilities
       2. NIH Responsibilities
       3. Collaborative Responsibilities
       4. Arbitration Process
   3. Reporting

  Section VII. Agency Contact(s)
   1. Scientific/Research Contact(s)
   2. Peer Review Contact(s)
   3. Financial/ Grants Management Contact(s)

  Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement
Section I. Funding Opportunity Description

1. Research Objectives

2. Key Functions of an Institutional CTSA

The CTSA should support the discipline of clinical and translational science and the needs of its researchers. Applicants are encouraged to propose novel concepts, methodologies, and approaches that are integrated into a comprehensive, effective, and efficient researcher-, trainee-, and participant-centered program. Applicants are free to develop their own list of key functions of the C/D/I and to use the following topics relevant to clinical research as a guide:

The C/D/I should provide resources for researchers, trainees, and research projects across multiple health conditions studied by a wide range of NIH Institutes and Centers. Focusing CTSA resources on only a few diseases, specialties, or for limited number of investigators is strongly discouraged. Applicants are encouraged to partner with foundations and industry and community organizations as appropriate. In such cases, these partners must agree to follow NIH policies with respect to (1) listing clinical trials at ClinicalTrials.gov; (2) sharing of resources; (3) datasharing and public access and (4) establishing policies in support of investigator academic independence, reporting of patents or patentable concepts, and publication rights. Acknowledging that existing resources vary among applicant institutions, the support requested for each of these components is expected to vary, reflecting current and projected needs. Integration of existing resources and grants into the CTSA activities will be viewed as a strength.

3. Direction of an Institutional CTSA

4. National CTSA Consortium

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the U54 award mechanism that includes linked K and T components. Applicants will submit a single unified U54 grant application containing up to four separate sets of budget pages (the parent U54 activity, K12 and T32 components, as applicable, and a summary budget). If a CTSA application is selected for funding, the U54, K12 and T32 components will be funded as separate, yet administratively linked, grants. Applicants may request up to 5 years of support.

The NIH U54 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

Research Education Component

The Research Education component of the CTSA application will be funded as part of the U54 application and is subject to the consideration in the paragraph above.

Predoctoral Research Training Component-T32

The Predoctoral Research Training -T32 component will be supported under the auspices of the National Research Service Awards (NRSA) program. All regulations and policies governing NRSA awards must be followed. Detailed information regarding NRSA policies and procedures can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/policy.htm.

The T32 component will support research training experiences for at least 4 predoctoral trainees who are interested in pursuing research careers in multi-disciplinary clinical and translational science. Only predoctoral NRSA positions may be requested and supported through the T32 part of this initiative. Trainees are selected by a Program Director normally for 12-month appointment periods with support for additional years based on satisfactory progress and the continued availability of funds.

See Section IV.5. Funding Restrictions, for a description of Allowable Costs.

Mentored Career Development Component-K12

The mentored career development component-K12 will provide for a minimum of two years and a maximum of five years of consecutive funding for each CR Scholar, consisting of consecutive 12-month appointments. In general, 75 percent of the CR Scholars' full-time professional effort must be devoted to the K12 Program. However, certain clinical specialties can have less than 75 percent, but no less than 50 percent, protected time for this Program if sufficiently justified and programmatically approved (for example, surgical specialties requiring 50 percent direct patient care time to keep up surgical skills). The remaining effort must be devoted to activities related to the development of a successful clinical and translational research career. The salary must be consistent both with the established salary structure at the institution and salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities. The award will support the salary, fringe benefits, and research costs for scholars planning research careers in multi-disciplinary clinical and translational science. Individual scholars are eligible for up to $160,000 salary plus fringe benefits based on the sponsoring institution's rate per year. If full-time, 12-month salaries are not currently paid to comparable staff members, the proposed salary must be appropriately related to the existing salary structure.

The sponsoring institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale; however, supplementation may not be from other Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case may PHS funds be used for salary supplementation. Institutional supplementation must not require extra duties or responsibilities that would interfere with the purpose of the K12 component.

Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. The total salary, however, may not exceed the legislated maximum.

Effective for all competing research project grant applications submitted for the February 1, 2004, deadlines and beyond, mentored career award recipients, including K12 scholars) in the last 2 years of career award support may reduce effort on the career award to a minimum of 50% and hold concurrent support from their career award and a competing NIH research grant when recognized as a Principal Investigator or subproject Director. This new policy can be found at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html.

Pilot and Feasibility Project Support

K12 Scholars may receive funds to support 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) travel to research meeting, workshops, or training; (d) statistical services including personnel and computer time.

Ancillary Personnel Support

Salary for mentors, secretarial and administrative assistance, etc., is not an allowed cost as part of the K12 or T32 components. Administrative support could be included as part of the U54 component if sufficiently justified.

Facilities and Administrative Costs

These costs, which were formerly called indirect costs, will be reimbursed at eight percent of modified total direct costs, or the actual indirect cost rate, whichever is less.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

NOTE: Refer to the concurrently issued RFA-RM-06-001, which is for a separate set of planning grants for a CTSA program using the P20 mechanism. Institutions may submit applications for either solicitation, but not both. The NIH intends to issue solicitations for additional CTSAs in future years, for which amended applications will be accepted, but may not issue additional solicitations for planning grants.

2. Funds Available

3. Special Consideration

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

1.B. Eligible Individuals

1.B.1. Eligible Principal Investigators

The Principal Investigator is expected to have the institutional authority to direct the C/D/I or other entity that comprises the proposed institutional home for clinical and translational science. The PI should have direct knowledge and hands-on involvement in the daily activities of the C/D/I. It is expected this individual would be an established clinician scientist who reports directly to an official with broad trans-institutional authority. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

1.B.2. Eligible Key Function Directors

All Directors of Key Functions and any co-Program Directors should have the necessary recent clinical and translational research background and administrative qualifications and experience to provide scientific leadership, management, and coordination of their respective programs or components. The Principal Investigator of the CTSA will coordinate the activities of all the Directors of Key Functions.

The T32 Program Director must be an established researcher with acknowledged accomplishments in clinical and translational science research, and should be capable of providing both administrative and scientific leadership to the proposed multi-disciplinary training program. The training Program Director will be responsible for planning, directing, and executing the research training program and the selection, appropriate supervision/mentorship, and evaluation of the trainees progress.

The Program Director for the K12 component must be an established investigator with the scientific and administrative skills, knowledge and leadership to coordinate and supervise the mentored career development program. The individual must be a senior faculty member or director of research with extensive expertise recruiting, advancing, and retaining individuals in clinical and translational science careers.

1.B.3. Eligible Research Education, Training and Career Development trainees, scholars and mentors

Research Education Component

Clinical research is multidisciplinary so participants in this program should represent diverse academic backgrounds with the potential for benefit from a core curriculum for clinical research. Interactions during the early years of career development may serve to enhance the team approach necessary to meet the multidisciplinary challenges of clinical research. Individuals supported by NIH training and career development mechanisms (K, T, or F awards) may receive, and indeed are encouraged to receive, educational experiences supported by the research education component, as participants, but may not receive salary or stipend supplementation from the CTSA research education component.

Predoctoral Research Training Component-T32 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 must have received a baccalaureate degree by the beginning date of their NRSA appointment, and must be training at a post-baccalaureate level and enrolled in a program leading to a Ph.D. in a research doctoral degree program, or a combined clinical degree and Ph.D., such as M.D./Ph.D. NRSA traineeships are not provided for study leading to a M.D., D.O., D.D.S., or other similar professional clinical degree, or master's clinical degree. Individuals currently supported by other Federal funds are not eligible for trainee support from the T32 program at the same time.

Trainees are customarily appointed for full-time, 12-month continuous periods. No trainee may be appointed for less than nine months during the initial period of appointment except with prior approval of the NIH program staff. All trainees are required to pursue their research training on a full-time basis, at a minimum of 40 hours per week.

An individual trainee may receive no more than five years of NRSA support in the aggregate at the predoctoral level, including any combination of support from institutional training grants and individual fellowship awards. Exceptions to this limitation require a waiver from the director of the funding Institute based on a review of the justification provided by the awardee, and must be submitted for prior written approval.

Mentored Career Development Component-K12 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 become K12 scholars. Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible.

K12 scholars must have a research or health-professional doctoral degree or its equivalent. Candidates must be able to commit a minimum of 75 percent of full-time professional effort conducting research career development and research activities associated with the program. The remaining 25 percent effort can be divided among other research, clinical and teaching activities only if these activities are consistent with the proposed goals of the K12 program. The eligibility of potential candidates holding VA appointments should be confirmed with NIH staff responsible for the fiscal management of the award prior to the individual being appointed to the program.

K12 scholar 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 K12 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 K12 scholars.

K12 Mentor Eligibility

The K12 component of the application must identify a core group of primary sponsor/mentors for the career development program. Each mentor together with the scholar 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 should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of the K12 and CTSA. The use of co-mentors to achieve the goals of the program is encouraged. Where feasible, women, minority individuals and individuals with disabilities should be involved as mentors to serve as role models.

2. Cost Sharing or Matching

Significant institutional commitment is required by the applicant institution(s). This may take the form of office, laboratory, or clinical space; personnel; equipment; integration of other clinical grants or centers; other resources; or dollars. There is no requirement for cost sharing or matching for institutional eligibility.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria
Not applicable

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-0088.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

Special Program Requirements

The NIH recognizes that individual institutions will be able to respond in different ways to the opportunities presented by this RFA. Applicants are strongly encouraged to contact NIH program staff early in the application process and they should have a thorough understanding of the intent and expectations of this RFA before developing an application. There will be a Frequently Asked Questions website (http://www.ncrr.nih.gov/clinicaldiscipline.asp) and a pre-submission meeting will be conducted at the Sheraton Crystal City Hotel, 1800 Jefferson Davis Highway , Arlington , Virginia on Monday, October 17, 2005 from 12:30pm to 3:30pm. At the meeting, NCRR and other NIH staff will explain the goals and objectives of the CTSA program and answer questions. All prospective applicants are invited to attend the meeting or view the meeting through videocast (webcast). Registration for the meeting is through the webpage at http://www.ncrr.nih.gov/clinicaldiscipline/CTSA101705meeting.asp. Attendance at the meeting is limited to 230 people, so registration is first-come, first-served. Institutions are asked to send no more than two representatives. Additional information on videocasting is also available at the meeting webpage. The meeting videocast will be archived at videocast.nih.gov.

Applicants should address the key functions proposed for their CTSA using the FORMAT OF THE APPLICATION following this section. All information must be contained within the body of the application; appendices are not allowed.

1. Overall approach.

Applicants should describe how the CTSA will transform clinical and translational research at their institutions. They should describe the components and functions of a C/D/I with reference to:

Progress toward projects' goals will be considered when renewal applications are re-competed. Applicants are requested to relate the goals described above to the Key Functions in their application and, where appropriate, to the examples of CTSA activities listed below.

2. Governance.

Applicants should describe:

The rationale for these approaches should be described. Applicants describing an External Advisory Committee should not contact potential members until after an award has been made. Names of potential members must not be listed in the application.

Applicants should indicate the level of authority that the institution(s) will delegate to CTSA personnel when they participate on the institution(s)'s behalf in developing trans-CTSA policies, procedures, or best practices. They should also indicate the institution's willingness to adopt and implement these practices.

3. Development of Novel Clinical and Translational Methodologies and Pilot and Collaborative Translational and Clinical Studies.

Applicants should describe the means for selecting Novel Clinical and Translational Methodologies that will receive core support, together with a plan for their governance, operation and evaluation. The description of Pilot and Collaborative Project support should include the scope; eligibility requirements; the limit on the dollars available and the number of years of support per project; the submission, review, and selection criteria and process; oversight and evaluation procedures; and assurances that all projects supported from this grant will comply fully with all applicable Federal policies, rules, and guidelines for research involving human subjects.

4. Biomedical Informatics.

Applicants should describe:

Biomedical Informatics is expected to be the subject of an overall NIH CSTA Informatics Steering Committee that ensures interoperability between the CTSA institutions and with their external partners. National issues impacting clinical and translational science research will be addressed jointly by the NIH CTSA Informatics Steering Committee, working with national leaders in healthcare informatics technology, national standards organizations, and the government.

5. Design, Biostatistics and Clinical Research Ethics.

Applicants should describe:

6. Regulatory Knowledge and Support.

Applicants should describe:

7. Participant and Clinical Interactions Resources (PCIR).

Applicants should describe and justify:

8. Community Engagement

Descriptions of Community Engagement could include how the institution will involve the community in setting research priorities that directly affect patients, innovative ways to engage community members in mentoring processes, partnerships in clinical and translational research, and collaborations to enhance research perspectives (e.g., health disparity research), public trust, and recruitment for clinical and translational research. Additional topics include outreach plans for community practitioners including means of engagement, possible incentives, application of research results (dissemination), and plans for training CTSA researchers, trainees and scholars in community outreach, cultural sensitivity, and population and community-based research methods.

9. Translational Technologies and Resources.

Applicants should describe:

10. Research Education, Training and Career Development.

Applicants should describe:

Evaluation and Tracking

The application should describe a strong evaluation and tracking plan for all Research education, training and career development activities. The plan should include the review of the effectiveness of all aspects of the program (including curriculum development, training faculty, Program Directors). Program Directors are encouraged to develop plans to obtain feedback from current and former trainees to help identify weaknesses in the training program and to provide suggestions for program improvements. The application should describe plans for a research education, training and career development program advisory committee.

The NIH may, in the future, request information about trainees for program evaluation purposes. In addition, institution(s) with other clinical or translational training and career programs must provide strong evidence that this CTSA Program will improve existing clinical and translational research career development and mentoring programs (including but not limited to individuals supported via NIH T32, K12, K23, K24 and K30 grants) and how they will interact with the CTSA program.

Training in the Responsible Conduct of Research

Applications must include a description of programs designed to provide formal and informal instruction in scientific integrity or the responsible conduct of research relevant to all CTSA activities. Applications without plans for instruction in the responsible conduct of research for each component will be considered incomplete and may be returned to the applicant without review.

Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, data management, data sharing, and policies regarding the use of human and animal subjects. Within the context of training in scientific integrity, it is also beneficial to discuss the relationship and the specific responsibilities of the institution and the predoctoral trainees appointed to the program. Plans must address the subject matter of the instruction, the format of the instruction, the degree of training faculty participation, trainee attendance, and the frequency of instruction. The rationale for the proposed plan of instruction must be provided.

Program reports on the type of instruction provided, topics covered, and other relevant information, such as attendance by trainees and faculty participation, must be included in progress reports and future competing continuations. The NIH encourages institutions to provide instruction in the responsible conduct of research to all graduate students, postdoctorates and research staff regardless of their source of support.

Please see http://www.nih.gov/sigs/bioethics/researchethics.html for additional guidance.

Minority Recruitment and Retention Plan

The NIH remains strongly committed to increasing the participation of individuals from underrepresented minority groups and individuals with disabilities in biomedical and behavioral research. Institutions are encouraged to identify participants who will increase diversity on a national or institutional basis. The following groups have been identified as underrepresented in biomedical and behavioral research nationally: African Americans, Hispanic Americans, Native Americans, Alaska Natives, and Pacific Islanders. Applicants must describe their program plans and efforts to recruit such individuals, as well as their success in the retention, and graduation of these individuals. All applications must contain plans to demonstrate commitment and proactive recruitment efforts. The review panel's evaluation will be included in an administrative note in the summary statement. If the plan or the record of minority recruitment and retention is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received. NIH Staff will determine whether amended plans and reports submitted after the initial review are acceptable.

Research Education Component

Applicants should describe the content of the proposed courses, their potential benefits to the participants and how continuation and/or expansion of an existing program or development of a new program will benefit clinical and translational science training at the institution. The commitment of the applicant institution and the faculty to providing didactic and mentoring experiences should be described, together with the pool of potential participants and information about the types of prior clinical and research training.

Predoctoral Research Training Component-T32

1. Proposed Training Program
The training program must be described in detail, including the objectives, design and courses planned for the trainees. Within the 40 hours per week training period, provide the plan for the proposed research training and the role of the Program Director and faculty serving as mentors to the trainees. Explain how the trainees will be engaged on research projects and the relationship of such activities to the overall goals of the education and career development program of the cooperative agreement and the career goals of the trainees.

2. Institutional Commitment
The administration of the applicant institution as well as all participating units and departments should indicate, in the application, their support for the goals of the training program. Describe support (financial or otherwise) that the institution will provide for the proposed predoctoral training program. This could include, for example, space, shared laboratory facilities and equipment, funds for curriculum development, release time for the Program Director or participating faculty, support for additional trainees in the program, or any other creative mechanisms to improve the climate for the establishment and growth of the training program.

3. Faculty and Mentors
Describe the plans for mentoring of the trainees selected for the program. Include information about past mentoring experiences and active research programs being conducted by the proposed mentors and faculty involved in the proposed training program. Describe collaborative arrangements with mentors and students which will enhance the training program and broaden the training experiences involved in the clinical and translations science program.

Additional NRSA information and instructions are available at: http://grants.nih.gov/grants/funding/phs398/phs398.html.

Mentored Career Development Component-K12

This application section should begin with an overview of the proposed program and describe:

11. Tracking and Evaluation Plan.

Evaluation Plan. The proposal should first include a detailed self-evaluation plan to assess implementation of the short-term and long-term CTSA goals, including implementing program activities and tracking trainees and scholars and their mentors, their pilot projects, and their involvement with multidisciplinary team research. For each proposed key function, the plan should include the objectives of the evaluation or tracking activities, the principal measures or indicators, and potential data sources. Applicants should describe procedures to obtain IRB approval to consent trainees, scholars, and mentors in evaluation data collection efforts, Listed below are examples of evaluation objectives for illustrative key functions:

CTSA Key Functions:

Assess the demand for, and effectiveness of, any Novel Clinical and Translational Methodologies, Pilot and Collaborative Translational and Clinical Studies, Community engagement and Translational Technologies and Resources

Biomedical Informatics

Design, Biostatistics and Clinical Research Ethics

Regulatory Knowledge and Support

Participant and Clinical Interactions Resources

Research Education, Training and Career Development

Overall Operational Functions

The evaluation plan should also describe how the applicant will participate in the national CTSA program evaluation. The NIH plans to conduct a national evaluation of the CTSA, as an important part of its stewardship of new major programs affecting all NIH Institutes and Centers. The goals of the national evaluation are to:

To support this effort, the NIH will request that grantees participate in the planning, design, and conduct of the national evaluation and that grantees plan local evaluation activities that will provide data necessary for both their own evaluation and the national evaluation.

12. Implementation Plan.

The applicant should describe the process by which the CTSA will be implemented and integrated into the strategic plan of the institution. A time-line for this process should be provided, reflecting specific goals, target dates and alternatives should those goals not be reached. It is anticipated that resources other than those provided by the CTSA will also be employed during the implementation phase. These should be described and will be considered as further indicators of institutional commitment.

13. Required Institutional Letters.

Applicants should provide letters from the appropriate high-ranking institutional official(s) from the parent institution(s) and its affiliates that:

Separate letter(s) co-signed by the CTSA Principal Investigator and the Principal Investigator of each of the NIH-funded NCRR, Roadmap, and Trans-NIH awards listed above to acknowledge that each of these grants will be relinquished in the event this application is funded. These letters must be also co-signed by the appropriate business officials of each specific award and of this CTSA application. Applications with unacceptable letters will not be reviewed or awarded.

Separate letter(s) co-signed by the PI and all the appropriate technology transfer offices that they will abide by the data and resource sharing plans specified in the application. Applications with unacceptable letters will not be reviewed or awarded.

Format of the Application

The instructions in the Form PHS 398 do not fully apply to the special needs of this grant application. Therefore, follow the modified instructions below in preparing an application for an Institutional Clinical and Translational Science Award. The application should be organized as follows (when following this format, applicants should refer regularly to those sections of this announcement that delineate “Special Programmatic Requirements” and “Review Criteria”):

A. Face Page: Use Form Page 1 of the PHS 398. On Line 1, include the title that best represents the nature of the Institutional CTSA Program. On Line 2, provide the number of this Request for Applications, RFA-RM-06-002, and the RFA title "Institutional Clinical and Translational Science Awards." The budget figures on this page should be taken from the consolidated program budget (see below).

B. Description, Performance Sites, and Key Personnel. Key Personnel include the Principal Investigator, co- Program Director(s), Directors(s) and co- Directors(s) of key resources, and other key professional and administrative members of this Program. Do not include trainees, mentors, or external advisory committee members. Only include named individuals for whom salary support is requested in the application.

C. Table of Contents

D. Detailed Budget Page for Initial Budget Period: Four sets of budget pages (Form pages 4 & 5) are required that together incorporate all the proposed activities of the CTSA. The first set is for the U54 budget that contains the majority of the items in the program. The second set for a Career Development (K12) component should use Form Page 4, provide information reflecting the administrative expenses anticipated for the K12 component, which includes: Personnel, supplies, travel expenses for the Program Director to attend relevant scientific meetings for the initial year. Include under Other Expenses: scholar costs, which includes planned salaries, fringe benefits, and research expenses for the number of scholars being proposed in the program. Form Page 5 should propose a complete budget for each year of the proposed period of support, followed by a narrative budget justification. The third set of Form pages 4 & 5 is for a pre-doctoral (T32) component that pays for pre-doctoral trainee stipends, travel, and training-related expenses per NRSA guidelines; the fourth set is a consolidated summary budget that includes all program expenses. Budget items should be requested for 12 months; NCRR will prorate these items accordingly at the time of award. An optional spreadsheet useful for displaying resource allocations across cores will be provided on the CTSA program website (URL).

E. Budget for Entire Proposed Period of Support. Four sets of budget pages are required (U54, that includes the research education component, K12, T32, and consolidated summary components). An optional spreadsheet useful for displaying resource allocations across cores will be provided on the CTSA program website (URL).

F. Biographical Sketches and other support in standard NIH format for Program Director, co-director(s), other listed key professional and administrative members of this Program, and internal steering committee members. Do not include biographical sketches for trainees or external advisory committee members.

G. Institutional Clinical and Translational Science Award Program: The application must present all the proposed activities of the CTSA within the page limits shown below. Note that these are upper limits: applicants are urged to be concise and to present information as tables where possible. Applicants are strongly discouraged from giving programmatic URL's in their applications, and reviewers are not obligated to view applicant's web sites to review existing public information. No appendices are allowed. The information should be arranged as follows:

(1) Overall Integrated Approach/Governance (25 pages)
* Approach/Meeting the Intent of this Initiative
* Participating Institution(s)
* Innovation
* Institutional Commitment
* Governance
* National Collaboration, Sharing, and Dissemination Plan

(2) Program functions (15 pages each unless noted)
* Development of Novel Clinical and Translational Methodologies
* Pilot and Collaborative Translational and Clinical Studies
* Biomedical Informatics
* Design, Biostatistics, and Clinical Research Ethics
* Regulatory Knowledge and Support
* Participant and Clinical Interaction Resources
* Community Engagement
* Translational Technologies and Resources
* Research Education, Training and Career Development (25 pages)

* Other program functions (no more than 15 pages per function; 50 pages total)

(3) Tracking and Evaluation (20 pages)

(4) Implementation Phase and Milestones (10 pages)

(5) Tables (50 pages maximum). The organization and content of the tables is left up to the applicant; however, summary and graphical displays are encouraged. Programs may wish to comment on:
* Past and current funded clinical and translational research support and productivity.
* Past and current clinical and translational research infrastructure support and productivity. This table should include all shared clinical and translational research services and facilities within the institution(s) (e.g., GCRCs, technology cores, centers, etc.).
* Past and current funded training and career development programs relevant to clinical and translational research (e.g., K30s, T32s, R25s, K12s, GCRCs, School of Public Health , Degree Programs, etc.) support and productivity.
* Past and current expertise and training record of program members and potential members.
* Past and current Biomedical Informatics resources, including critical information systems and current efforts at providing an interoperable environment.

H. Required Institutional Letters (see Special Program Requirements above)

I. Human Subjects

J. Patient Care Rate Agreement (if applicable)

K. Vertebrate Animals

L. Checklist

3. Submission Dates and Times
Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: February 27, 2006
Application Receipt Date(s): March 27, 2006
Peer Review Date: Summer 2006
Council Review Date: September 2006
Earliest Anticipated Start Date: September 2006

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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.

The letter of intent is to be mailed by the date listed above to:

Anthony Hayward M.D., Ph.D.
Division for Clinical Research Resources. NCRR
6701 Democracy Blvd
Democracy 1, Room Number 906
Bethesda , MD 20892
Telephone: (301) 435 0790
FAX: 301 480 3661
Email: haywarda@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 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)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Office of Review
National Center for Research Resources
National Institutes of Health
6701 Democracy Blvd., Room 1001
Bethesda, MD 20892-4874 (Regular mail)
Bethesda, MD 20817 (FedEx or courier)
Phone: (301) 435-0811

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NCRR. Incomplete and non-responsive applications will not be reviewed.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

4. Intergovernmental Review
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. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

With the exception of a T32 component, Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

The Program budget should be constructed using the following general guidelines. Note that the TOTAL cost budget may not exceed the maximum allowed ($6M) in addition to the combined current total costs of certain NIH awards (NCRR K12, K30, M01 and Roadmap T32 and K12) held by the applicant institution and its affiliates. Most items in the program will be listed in the U54 budget including:

Salary and fringe benefits for the CTSA PI, CTSA co-PI (if any), component directors(s) or co-director(s), professional and administrative staff, etc.
Research education component (excluding K12 and T32 components).
Consultant costs, Equipment, Supplies, Travel, Patient care costs, Alternations, Other expenses, Consortium/contractual costs.
Applicants may request funds to support pilot research projects. These funds can be used for research expenses, such as supplies, equipment, and technical personnel.
Funds requested for payment to a hospital for Participant and Clinical Interaction resources shall be requested on PHS 398-Form Page 4, as “Patient Care Costs.” If there is a negotiated Research Patient Care Rate Agreement established between the hospital and DHHS, include a copy of that agreement with the application.

Awards will be made on the basis of Total Cost Commitment. Awardees can request the transfer of awarded funds between the U54 and K12 components. No component of a CTSA award will have automatic carryover authority. Approved fund transfers and carryovers will be provided in award notices.

5.1 Specific Instructions and Limitations Related to the Research Education, Training and Career Development Components

5.1.1 Research Education Component

Research Education, but not T32 or K12, education costs should be placed on the U54 budget pages. These might include, but are not limited to: 1) curriculum and degree granting elements including costs to develop and provide lectures, courses, seminar series, etc.; 2) programs to provide research educational experiences to undergraduate students, and allied health professions such as study coordinators, project managers, non-doctoral master's students (such as Masters in Clinical Research obtained after a MD or DDS degree, etc.); 3) a faculty core to provide mentor support and training in mentoring, leadership, research and laboratory management, and research team building skills. Mentors may receive up to $3,000 per year per pre-doctoral trainee and $10,000 per year per career development scholar to help defray laboratory or other research related expenses associated with hosting a trainee or scholar.

5.1.2 Mentored Career Development Component-K12

The NIH will also help defray the costs for the following expenses: (1) tuition and fees related to career development; (2) travel for scholars to the annual NIH meeting; (3) travel to one additional training or scientific meeting per year; (4) recruitment costs (up to $3,000 per year) to attract participants who can excel in, and potentially become leaders in, clinical research.

5.1.3. Predoctoral Research Training Component-T32

Allowable costs for each Predoctoral trainee for a 12-month appointment period include:

Stipend

A stipend is provided as a subsistence allowance to help trainees defray living expenses during the research training experience. It is not provided as a condition of employment with either the Federal Government or the awardee institution. Stipends must be paid to all trainees at the levels approved by the Secretary of the Department of Health and Human Services. The NIH will provide stipends for each predoctoral trainee position selected for the predoctoral research training component according to the appropriate fiscal year predoctoral NRSA stipend schedule. Stipend levels are adjusted periodically. The current NRSA stipend schedule can be found on the NIH Web site at: http://grants.nih.gov/training/nrsa.htm. The total stipend must be based on a 12-month appointment. No departure from the established stipend schedule may be negotiated by the institution with the trainee. The grantee institution is allowed to provide funds to an individual in addition to the stipends paid. Such funds may be provided either in the form of stipend supplementation from non-federal funds, or in the form of compensation such as salary or tuition remission for services provided by the trainee such as teaching or serving as a laboratory assistant. Under no circumstances may the conditions of stipend supplementation or the services provided for compensation interfere with, detract from, or prolong the trainee's approved NRSA training program.

Tuition, Fees, and Health Insurance

The NIH will offset the combined cost of tuition, fees, and health insurance (either self-only or family as appropriate) at the current rates as published at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part10.htm#_Toc5460018.

Trainee Travel

Trainee travel, including attendance at scientific meetings that the institution determines to be necessary to the individual's research training, is an allowable trainee expense.

Training-Related Expenses

Institutional costs of $2,200 a year per predoctoral trainee may be requested to help defray the costs of other research training related expenses, such as staff salaries, consultant costs, equipment, research supplies, and travel expenses for the training faculty. Under exceptional circumstances, which can include providing accommodations for a trainee with disabilities, it is possible to request institutional costs above the standard rate. Requests for additional trainee costs must be explained in detail and carefully justified in the application. Training related expenses may be adjusted in future fiscal years.

Facilities and Administrative Costs

A facilities and administrative allowance (indirect cost allowance) based on 8 percent of total allowable direct costs (this excludes amounts for tuition, fees, health insurance, and equipment) may be requested. See NRSA Policy Guidelines on the NIH Web site at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part11.htm.

Concurrent Awards: An NRSA may not be held concurrently with another federally sponsored fellowship or similar Federal award that provides a stipend or otherwise duplicates provisions of the NRSA.

Taxability of Stipends: Internal Revenue Code Section 117 applies to the tax treatment of all scholarships and fellowships. The Tax Reform Act of 1986, Public Law 99-514, impacts on the tax liability of all individuals supported under the NRSA program. Under that section, non-degree candidates are now required to report as gross income all stipends and any monies paid on their behalf for course tuition and fees required for attendance. Degree candidates may exclude from gross income (for tax purposes) any amount used for tuition and related expenses such as fees, books, supplies, and equipment required for courses of instruction at a qualified educational organization.

The IRS and Treasury Department released regulations in January 2005 (Revenue Procedure 2005-11) clarifying the student exception to the FICA (Social Security and Medicare) taxes for students employed by a school, college, or university where the student is pursuing a course of study. Our understanding is that these final regulations do not apply to or impact Kirschstein-NRSA programs or awards. An NRSA stipend is provided by the NIH as a subsistence allowance for Kirschstein-NRSA fellows and trainees to help defray living expenses during the research training experience. NRSA recipients are not considered employees of the Federal government or the grantee institution for purposes of the award. We must note that NIH takes no position on the status of a particular taxpayer, nor does it have the authority to dispense tax advice. The interpretation and implementation of the tax laws are the domain of the IRS.

Individuals should consult their local IRS office about the applicability of the tax laws to their situation and for information on their tax obligation.

5.2. Plans for support beyond 5 years:

NIH is planning for an additional 5 year competitive renewal of these awards. NIH support beyond the initial five-year project period is not guaranteed and is dependent upon the availability of appropriated funds, and success in any competition for renewed support. In the event that there is no further support, no phase-out funds will be provided. Thus, the applicant institution(s) must have plans in place to provide continued support to remaining trainees in the event that funding from the NIH is not available.

6. Other Submission Requirements

This Program is not subject to the streamlined non-competing application process (SNAP). In general, this means that all reporting of budgetary information and Program progress is provided in greater detail in an annual progress report.

Plan for Sharing Research Data

Data sharing is a requirement of this RFA and the data sharing plan should be included in the description of the CTSA Governance. The precise content of the data-sharing plan will vary, depending on the data being collected. The applicant may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing. References to data sharing may also be appropriate in other sections of the application.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers and will be factored into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131. Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff when making recommendations about funding applications will consider the adequacy of the resources-sharing plan and the related data-sharing plan. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report. (PHS 2590). See Section VI.3. Reporting. Plans for the development of research resources for use by the biomedical community should have appropriate timelines and mileposts.

The application must include clear written commitments from the officials responsible for intellectual property issues at all of the applicant institutions and their sub-contractors, to the effect that the institution(s) supports and agrees to abide by the research resource dissemination plans put forth in the application. A separate letter should be sent by each participating organization including each subcontractor. Lack of such letters will result in withdrawing the application as non-responsive. Additionally, peer reviewers, program staff, and advisors will evaluate the adequacy of dissemination plans prior to award (see below). Please note that institutional sign-off on the grant application signifies that all relevant components of the institution(s), including the technology transfer office(s), have reviewed and approved the document.

The initial review group will comment on the appropriateness of the proposed plan for data and resources dissemination. Program staff and advisors will also consider the adequacy of the dissemination plan as one of the criteria for award. The proposed sharing plan, after negotiation with the applicant when necessary, will be made a condition of the award. Evaluation of competing renewal application and annual non-competing progress reports will include assessment of the responsiveness to NIH guidelines of data, materials, methods, and software dissemination practice by the grantee.

Plan for Sharing Software

An additional software dissemination plan, with appropriate timelines, must be included in the description of the CTSA Governance. There is no prescribed single license for software produced in this project. However, NIH does have goals for software dissemination, and reviewers will be instructed to evaluate the dissemination plan relative to these goals:

  1. The software should be freely available to biomedical researchers, educators, and institutions in the non-profit sector, such as institutions of education, research institutions, and government laboratories.
  2. The terms of software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
  3. The terms of software availability should include the ability of research institutions outside the CTSA to modify the source code and to share modifications with other colleagues as well as with the CTSA.
Section V. Application Review Information

1. Criteria

The following will be considered in making funding decisions:

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NCRR in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposal will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Overall Evaluation: All components of the unified CTSA application, i.e., all related sections of the single overall application that are received as a unit, will be awarded a single overall priority score determined after evaluation of all components. Reviewers will ask whether the proposed CTSA will significantly impact the overal