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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) 710-0267, Email: [email protected].

Telecommunications for the hearing impaired: TTY 301-451-5936.

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: [email protected]

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 overall quality of clinical and translational science at the proposed C/D/I. Does the program make only modest incremental improvements to an already strong program, or will significant value be added to existing resources? Are the key components adequately described? Will the proposed program provide adequate support for clinical and translational investigators as well as for the development of new knowledge that drives the discipline of clinical and translational research? Will the proposed program significantly enhance/improve patient interaction resources, career development and training, informatics, research design, ethics, and interactions with human subjects? Will the resources be equitably distributed among different disciplines (e.g., medicine, pediatrics, pre-clinical research)? Does the applicant acknowledge potential problem areas and consider alternative tactics? Is the institutional commitment appropriate?

Significance: Will the proposed CTSA significantly impact the overall quality of clinical and translational science at the applicant institution? Is the overall program vision and strategy adequate to satisfy the intent of this initiative to facilitate and sustain a home for clinical and translational science that incorporates a wide range of clinical disciplines, specialties, and sub-specialties? Will there be value added by the proposed C/D/I to the multidisciplinary translational research of its members? Will the proposed CTSA have potential to make significant contributions to a national consortium of CTSAs?

Approach: Will the CTSA program enhance, complement, or extend the applicant's current resources for clinical and translational science research? Does the application identify key obstacles to the performance of translational and clinical research and then propose plans or means to overcome these? Will the proposed C/D/I include relevant scientific disciplines to maximize productivity? Does the application make efficient use of potentially unique resources, such as access to certain human subject populations or the provision of pre-clinical resources? Does the applicant indicate how the organization will be adapted to respond to changes in translational focus? Will new opportunities for careers in clinical research arise across the spectrum of clinical and translational science?

CTSA Governance: Have the applicants described an effective administration and governance structure that will promote the discipline of clinical and translational science? Will an Advisory Committee be constituted to provide critical, stimulating, and thoughtful advice for the overall CTSA performance and CTSA Key functions? Are there plans to implement recommendations?

Implementation Plans: Is an implementation phase well described? Is the timeline for implementation feasible and are specific goals and target dates set? Are alternatives proposed should the goals and targets not be reached in a timely manner? Is there a feasible time line for integrating CTSA resources with other complementary resources available to the institution?

Integration: How well will the components of the CTSA be integrated with each other? Are there plans to integrate CTSA activities into all the relevant schools that participate in clinical and translational science in the applicant institution? Is there a commitment to integrate the CTSA into the institution and into a national network of CTSAs and also to reach out to the local community? Will this integration be reflected in the senior leadership and decision-making processes of the CTSA? Is the CTSA program integrated, cohesive, synergistic, adaptable, and potentially more effective than what currently exists?

Local and National Collaboration, Data Sharing, and Dissemination: How adequately will the institution and its researchers collaborate, share and disseminate resource tools and resources at institutional, community, and national levels? Are plans included to address regulatory hurdles locally? Is there a commitment to and plans for adopting and implementing national standards?

Innovation: Is the CTSA program original and innovative? Are new approaches proposed that would integrate clinical, basic and other relevant (e.g. public health, bioinformatics) disciplines? Does the program develop or employ novel concepts, approaches, methodologies, tools, or technologies that will improve the discipline? Is the program likely to develop novel approaches to increasing the ease and efficiency of clinical and translational research, allowing research results to move from patient observations and laboratory discoveries to the bedside and to clinical practice?

Investigators: Does the PI have the experience and authority and committed time to administer the proposed institutional home for clinical and translational research? Will the PI have sufficient authority and credibility in the institution to work across institutional boundaries? Will the PI have the environment and institutional support necessary to be responsible for the resources committed by the institution(s) for the C/D/I? Does the program leadership and management team bring complementary and integrated expertise to the project?

Will the proposed C/D/I have the professional staffing to impact significantly the overall quality of clinical and translational science at the institution? If part of the proposal, do other resource Directors have the appropriate training, experience and resources to assume leadership roles of their respective units (such as Training; Biomedical Informatics; Design, Biostatistics, and Clinical Research Ethics; Regulatory Support; or Participant and Clinical Interactions)? Have the Program Director, co-Program Director(s), and Director(s) and co-Director(s) of the key resources committed sufficient time to devote to this Program? Will the Directors have the authority to implement best practices identified at Steering Committees at their Institution? Are the administrative and professional staff appropriately trained and well suited to carry out this work?

Environment: Does the applicant adequately demonstrate that a program for awarding higher degrees in clinical research is in place? Do the academic and scientific environments contribute to the probability of success in establishing a home for clinical and translational science? Is there a strong training record at both institutional and faculty levels? Does the proposal provide strong evidence that the addition of the CTSA will provide resources that would not otherwise be possible? If applicable, are there adequate cooperative arrangements between affiliated institutions to ensure that the CTSA program performs effectively as one activity across institutional boundaries? Are there unique features of the scientific environment or in the available human subject populations or collaborative arrangements?

2.A. Additional Review Criteria:

In addition to the above criteria, the following components of the CTSA application will be considered in the determination of the overall priority score for the entire U54 application.

Institutional Commitment: Is there institutional commitment to establishing the CTSA program as an integral part of its overall clinical research environment? Will the institution align or adjust incentives and rewards to promote the academic mission and new modes of team-based research? Is there substantial commitment from the institutional leadership to protect the time of the investigators to pursue clinical and translational research and mitigate the demands of providing patient care? Will clinical researchers/trainees career development be supported in terms of a specific tenure process for clinical researchers at the institution? Is the institutional leadership committed to this program and its goals in terms of providing specific assets specifically for the program, such as financial support, faculty support, specific equipment, dedicated space, or tuition rebates, as a few examples?

Development of Novel Clinical and Translational Methodologies: Is there an active program of research in novel methodologies? Is the outcome likely to benefit the C/D/I? Is there a plan to involve new investigators? Will these activities be integrated with the CTSA as a whole?

Pilot and Collaborative Translational and Clinical Studies: Is there an adequate plan to prioritize the projects and to review their methodology and research performance? Will the expected benefits to the CTSA and to the wider research community be measured and tracked? Will lessons learned be shared?

Biomedical Informatics: Will the biomedical informatics resources offered be commensurate with the breadth of the CTSA program? Will data security and privacy be safeguarded? Are assessments of performance of this resource included? Will the Biomedical Informatics Director have the necessary authority to the ensure implementation of best practices as adopted by the Biomedical Informatics Steering Committee? As applicable, will this resource be sufficient for intra- and inter-institutional operations? Will the institution be willing to work toward interoperability of the informatics systems and adopting national data standards?

Design, Biostatistics, and Clinical Research Ethics: What types of support and resources will be in place to ensure all clinical and translational research designs are sound and that statistical analyses are appropriate and rigorous? Will this training include conflict of interest, federal codes requirements, guaranteeing privacy and safety of research participants, especially as pertaining to vulnerable populations? Are there plans for creation and innovation in developing the application of these topics to clinical research? As applicable, will this resource be sufficient for intra- and inter-institutional operations?

Regulatory Knowledge and Support: Will this resource provide researcher-focused support for regulatory compliance and management? Is the resource well integrated with biomedical informatics and participant and clinical interactions? Is there duplication of IRB responsibilities? Does the institution have experience in working with multi-site trials and with the FDA with respect to studies involving investigational new drug application procedures? Will CTSA staff members be available with the necessary experience in working with the FDA and in ensuring that standards for reporting adverse events are met? Are criteria for identifying a research participant advocate sound?

Participant and Clinical Interactions: Will human subject participation in clinical research protocols be encouraged? Will the institution work with underserved populations in clinical research? Has the applicant adequately described and justified the resources to be provided? Will PCI resources meet the highest standards for subject safety, quality of science and statistical and ethical design? Is the application of Good Clinical Practice guidelines appropriate? Will resource utilization be tracked and are mechanisms proposed to adapt resources to the needs of investigators? Will the resources provided serve small as well as large studies or trials?

Community engagement: Will this effectively involve the community in which the CTSA institution resides, both the public and practitioners, in clinical and translational research priority setting, participation, and follow-up? Are there adequate plans to train researchers, trainees, and scholars in the methodology of community/population-based research and outreach? Will the resource foster long-term relationships between the CTSA institution and the community for their mutual benefit? Will the research interests of CDI faculty contribute to an intellectually stimulating environment? Will faculty members be encouraged to pursue research in areas that develop translational methodologies?

Translational Technologies and Resources : Is the plan to identify technologies to be offered appropriate? Will resource utilization and evaluation be adequate? Is their flexibility in types of resources to be offered?

Research Education and Career Development: 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? Can increased efficiency shorten the period of training? Does the institution have a sufficient pool of academically strong trainees and commensurate experienced and well-qualified mentors to justify the career development pathways that are proposed? Will the curricula and courses proposed provide appropriate training in clinical and translational research relevant to a broad range of specialties? How will trainee registration for higher degrees in clinical research be encouraged? Does the Research Education Co-Program Director(s) have the scientific background, expertise, and experience or potential to coordinate and supervise the proposed research education, training and/or career development program? Has the Program Director committed adequate time to program administration?

Research Education Component: Review considerations include the quality, innovation and content of courses and adequacy of the syllabus; the scientific qualifications and experience of the faculty; the criteria for selecting participants; efforts to publicize the availability of the program to potential participants.

Pre-doctoral Research Training Component (T32): The quality of the proposed training program will be considered as well as whether the requested number of trainee positions is appropriate for the planned research training program. Does the proposed training program provide appropriate courses available to provide a curriculum for clinical and translational science research? Are appropriate programmatic activities incorporated into the training program?

Research Training Record: This criterion evaluates the past research training record of both the program and the designated mentors. How successful are former trainees in seeking further career development and in establishing productive scientific careers? Evidence of further career development can include successful completion of the Ph.D., receipt of fellowships, career development awards, additional training appointments, and similar accomplishments. Evidence of a productive scientific career can include a record of successful competition for research grants, receipt of special honors or awards, a record of publications, receipt of patents, promotion to scientific positions, and any other measure of success consistent with the nature and duration of the training received. What is the track record of the mentors in directing pre-doctoral training or the potential of those mentors lacking a track record?

Mentored Career Development (K12) and Research Program Design: This criterion will assess the likelihood that the proposed career development and research plans will contribute significantly to the scientific development of the candidate scholars to successfully pursue clinical and translational research careers. Reviewers will evaluate whether the proposed plans include appropriate course work and/or activities to achieve program goals. The scientific quality, technical merit and degree of relevance of the proposed research projects the scholars will be pursuing will be evaluated.

Training (T32) and Career Development (K12): In addition to the above criteria, reviewers will be asked to comment on the following criteria for both the pre-doctoral (T32) and the career development (K12) programs.

Preceptors/Mentors: This criterion assesses the caliber of mentors as researchers, including successful competition for research support in areas directly related to the proposed research training or career development program. What is the overall quality of mentors' research, their publication record, and their successful competition for research support in areas directly related to the proposed training program? How strong is their record as mentors?

Institutional Training Environment and Commitment to the Program: For the training program, this criterion assesses the quality of the institutional training environment for NRSA supported trainees and the relationship of the NRSA program to the broader training program (if appropriate). What is the level of institutional commitment, quality of the facilities, availability of appropriate courses, and the availability of research and research training support? Does the environment in which the training program will be conducted, i.e. the quality of the participating departments and the extent of their participation, contribute to the probability of success? Is there evidence of adequate institutional commitment?

For the career development program, this criterion will assess the applicant institution's commitment to the program, such as recruitment efforts, necessary educational resources and equipment, and available established investigators who will serve as mentors, evidence that scholars will have sufficient protected time to devote to the program.

Trainee Recruitment, Selection and Retention: This criterion evaluates the quality of the applicant pool and the plan for selection of individuals for appointment to the training or career development program. Specifically, what is the quality and size of the applicant pool? Are the recruiting procedures, trainee selection criteria, and retention strategies appropriate and well defined?

Evaluation and Tracking of Research Education, Training & Career Development: Is the plan adequate to determine progress and outcome measures for each of the research education, training and career development components? Does it include a system for tracking participants following program completion to determine success or failure of the program? The tracking would include information on program publications; grant proposals and awards, and career trajectory of the trainees that were supported in the program. If an Advisory Committee is proposed, are plans adequate and appropriate to ensure proper monitoring of the research education, training and career development components? Are there means to modify the research education, training and career development components based on appropriate recommendations from the Advisory Committee?

Training in the Responsible Conduct of Research: Peer reviewers will assess the applicant's plans for training in the responsible conduct of research on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction for the research education, training and career development components.

Plans will be discussed after the overall determination of merit, and the review panel's evaluation of the plan will not be a factor in the determination of the priority score. Plans will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note on the summary statement. Regardless of the priority score, applications with unacceptable plans will not be funded until the applicant provides a revised, acceptable plan. Program staff will judge the acceptability of the revised plan.

Minority Recruitment and Retention Plan: Peer reviewers will separately evaluate the minority recruitment plans for the research education, training and career development components after the overall score has been determined. The review panel's evaluation will be included in an administrative note in the summary statement. If the plan for minority recruitment and retention is judged to be unacceptable, funding will be withheld until a revised plan that addresses the deficiencies is received. Staff within the NIH awarding component, with guidance from the appropriate national advisory committee or council, will determine whether amended plans and reports submitted after the initial review are acceptable.

Evaluation Plan: Is the plan adequate to evaluate the short and long-term goals for each of the key proposed functions? Are the measures valid for the programs' goals to be assessed and how accessible and practical are the available data sources? Does the plan make sufficient resources available for participation in the national CTSA programs? Is the plan to obtain IRB consent adequate for self-evaluation activities and the national program evaluation?

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans will be assessed as appropriate for the scientific goals of the research on the inclusion of subjects according to gender, all racial and ethnic groups (and subgroups), and children. Plans for the recruitment and retention of subjects also will be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used, the five points described under Section F of the PHS Form 398 research grant application instructions must be included.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protections are adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. Is the range of support to be provided appropriate to the institution's environment, track record, and current and projected needs? Is the proposed budget and requested period of support reasonable in relation to the proposed research and size of the clinical research base, trainee pool, and faculty expertise? The priority score will not be affected by the budget evaluation.

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data-sharing plan will be assessed by the reviewers and factored into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing. The presence of a data-sharing plan will be part of the terms and conditions of the award.

2.D. 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 and http://www.ott.nih.gov/policy/rt_guide_final.html. Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible. The reasonableness of the resources sharing plan or the rationale for not sharing research resources will be assessed by the reviewers and factored into the determination of scientific merit or the priority score.

The adequacy of the data and the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the Principal Investigator before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. 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

3. Anticipated Announcement and Award Dates
Not applicable

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. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

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. See Also Section IV.5. Funding Restrictions.

At the time of an award decision, the U54 application will be disaggregated into up to three separate yet administratively linked awards: the U54 and the K12 and T32 (as applicable) awards. The U54 award will reflect full F&A rate reimbursement based upon the negotiated rate in effect at the time of award. The K12 and T32 awards will be subject to the 8 percent F&A rate reimbursement standard for these mechanisms.

The budgetary recommendations of the peer review committee and programmatic considerations will be taken into account in developing a funding plan for successful applicants.

Research Education, Training and Career Development

Evaluation

In carrying out its stewardship of human resource-related programs, the NIH may begin requesting information essential to an assessment of the effectiveness of CTSA components. Accordingly, recipients are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of the Trainees' employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

Predoctoral Research Training Component-T32

Leave: Trainees supported by academic institutions should refer to the NIH NRSA guidelines at: http://grants.nih.gov/grants/guide/pa-files/PA-02-109.html for guidance regarding vacations and requested leave.

Carryover of un-obligated balances: The carryover of funds from one budget period to the next requires prior written approval of the NIH awarding component.

Change of Program Director: If change of a Program Director is necessary, support of the award is not automatic, but may be continued with NIH funding component prior approval, provided:

Changes of Program: Awards are made to a specific institution for a specific program under the guidance of a particular Program Director. Changes in any of these parameters require prior approval by NIH Program Staff. A rationale must be provided for any proposed changes in the aims of the original peer-reviewed program. Programmatic changes will be evaluated to ensure that the program remains within the scope of the original peer-reviewed application. If the new program does not satisfy this requirement, the T32 component of the cooperative agreement award will be terminated.

Transfer of Program: The research training component may not be transferred to another institution. If there are plans to alter or terminate the approved program, the NIH must be notified immediately to take appropriate actions.

Mentored Career Development Component-K12

Other Income: Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, honoraria from other institutions for lectures or seminars, fees resulting from clinical practice, professional consultation or other comparable activities, provided these activities remain incidental, are not required by the research and research-related activities of this award, and provided that the retention of such pay is consistent with the policies and practices of the grantee institution.

Usually, funds budgeted in an NIH supported research or research training grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be rebudgeted. The awarding component will give consideration to approval for the use of released funds only under unusual circumstances. Any proposed retention of funds released as a result of a career award must receive prior written approval of the NIH awarding component.

Special Leave: Under unusual and pressing circumstances, a scholar may submit a written request to the awarding component requesting a reduction in professional effort below 75 %. Such requests will be considered on a case-by-case basis during the award period. In no case will it be permissible to work at less than 50% effort. The nature of the circumstances requiring reduced effort might include medical conditions, disability, or pressing personal or family situations such as child or elder care. Permission to reduce the level of effort will not be approved to accommodate job opportunities, clinical practice, or clinical training. In each situation, the grantee institution must submit documentation supporting the need for reduced effort along with assurance of a continuing commitment to the scientific development of the scholar. In addition, the scholar must submit assurance of his/her intention to return to at least 75% effort as soon as possible. During the period of reduced effort, the salary and other costs supported by the award will be reduced accordingly.

Termination: When a grantee institution plans to terminate an award, the Grants Management Specialist listed on the Notice of Grant Award must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. The Director of the NIH may terminate an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, NIH shall notify the grantee institution in writing of this determination, the reasons therefore, the effective date, and the right to appeal the decision.

Transfer of Program: The K12 component may not be transferred to another institution, and scholars who wish to move to another institution must terminate their support under the K12 program.

Changes in Research Education and Career Development: Program Consultation with NIH staff should occur if a significant change in the approved career development program and/or research plan is being considered.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the Notice of Award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS 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 (U54), 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 above.

2.A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility to define objectives and approaches of the CTSA. The primary responsibilities of the awardees are to:

Awardees will retain custody of and primary rights to their data and intellectual property developed under the award subject to current government policies regarding rights of access as consistent with current HHS, PHS, and NIH policies and subject to the terms and conditions of this RFA.

Principal investigators and key personnel as appropriate are expected to participate in annual Steering Committee meetings.

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

2.A.2. NIH Responsibilities

NIH Science Officers will have substantial scientific involvement during the conduct of this activity, through technical assistance, advice, and coordination above and beyond normal program stewardship for grants. One or more Science Officers will be assigned by the NIH CTSA Program Director to each CTSA Steering Committee, including those constituted to address key functions. A given individual may serve on more than one CTSA Steering Committee. NIH Science Officer(s) will:

To help carry out these duties, Science Officers may consult with non-NIH experts in the field.

NCRR Program Officers will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The Program Officer will:

Additionally, the NCRR CTSA Program Officer will be responsible for normal stewardship of the award and may recommend the termination or curtailment of an investigator or project/program (or an individual award) in the event the partnerships fail to evolve within the intent and purpose of this initiative.

2.A.3. Collaborative Responsibilities

A National CTSA Consortium Steering Committee shall be established and composed of the PIs of each CTSA and appropriate NIH Science Officers. A Chair will be selected by the Steering Committee at an early meeting of the group from among the non-Federal members. The Consortium Steering Committee will enlarge to accommodate new PIs of CTSAs that are funded in future years and to accommodate the NIH Science Officers of key-function-specific Steering sub-committees, as they are established. Each PI will have one vote while the fraction of NIH Staff votes will be adjusted so it does not exceed 33% of the Steering Committee.

The National CTSA Consortium Steering Committee shall be a forum for sharing policies, practices, and resources and for discussion of opportunities, impediments, joint agreement on broad issues impeding clinical research, government policies and practices, and other appropriate topics. The Committee will identify and approve best practices and policies that will advance clinical and translational research as a discipline and facilitate collaboration and sharing among CTSA institutions and with partners in clinical and translational research, e.g., industry, laboratories, hospitals.

Each CTSA institution must agree to work toward adopting and implementing the policies and best practices that are approved by the National CTSA Consortium Steering Committee.

CTSA Steering sub-committees will be established for common themes identified by NIH (e.g., Research Education, Biomedical Informatics, Regulatory Affairs) and additional sub-committees for key resources will be established as required. Membership of these sub-committees will comprise the Directors of the corresponding key functions at each CTSA, one member of the National CTSA Consortium Steering Committee and one or more NIH Science Officers appointed by the NCRR CTSA Program Director. A Chair will be selected by the Steering Committee at an early meeting of the group from among the non-Federal members. Each full member will have one vote with the fraction of NIH Staff votes will be adjusted so it does not exceed 33% of the Steering sub-committee. The Chair will report sub-committee recommendations regarding policies and best practices to the National CTSA Consortium Steering Committee for approval.

2.A.4. Arbitration Process

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 arbitration. An Arbitration 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 arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

The NIH will convene an independent CTSA Evaluation Working Group to perform an evaluation of the overall program. The awardees are expected to provide information that is requested by the NIH for the evaluation process. The submission of this material is expected to be electronic but may require submission of some paper.

1. Progress Reports

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement. Progress reports are submitted using the Form PHS 2590, which can be obtained at the following website address: http://grants.nih.gov/grants/funding/2590/2590.htm. Forms are also available at most institutional offices of sponsored research. The report should provide information about changes in the Program and a summary report of any evaluations by External Advisors. These Annual Progress Reports will be closely monitored by NIH staff to ensure that the grant is achieving the goals of the Program. Since the Form PHS 2590 does not apply easily to the this grant, adapt the application for continuation to contain the following information:

Predoctoral Research Training Component-T32: The NRSA instructions for the Non-Competing Grant Progress Report (Form 2590, starting on page 19) should be followed. The names and levels of those trainees who are continuing in the research-training program should be listed on Additional Form Page 5. Information on each trainee should also be included in the narrative portion of the progress report as described in the PHS Form 2590 instructions. An evaluation and tracking report as described in Section IV.6. of this announcement should be included annually as part of the Progress Report. Additional information that should be reported in concert with the PHS 2590 Progress Report instructions:

Financial Status Report (FSR): An annual FSR is required and must be submitted within 90 days of the end of each budget period for the T32 component of the U54 award. Continuation support will not be provided for this component until the required information is submitted and reviewed.

Trainee Reporting Requirements: The institution must submit a completed Statement of Appointment (PHS Form 2271) for each trainee appointed or reappointed to the training grant. This Form must be completed at the beginning of the initial appointment and annually thereafter. No funds may be provided until this document is submitted and accepted by the funding Institute.

Within 30 days of the end of the total support period for each trainee, the institution must submit a Termination Notice (PHS 416-7) to the NIH. Failure to submit the required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award. Forms may be found on the NIH Website at http://grants.nih.gov/grants/forms.htm.

There is no service payback obligation for current predoctoral trainees.

Mentored Career Development Component-K12 progress reports should include the following:

Provide Biographical sketches of new CTSA faculty and new mentors

Report Biomedical Informatics status, progress, problems, and solutions

Report Design, Biostatistics and Clinical Research ethics status, progress, problems, and solutions

Report Regulatory Support status, progress, problems, and solutions. Specific procedures or organizational components that lessen time or effort required to perform clinical research, or enhance the quality of clinical research

Report Participant and Clinical Interactions status, problems and solutions

Report any other resources added, describing status, progress, problems, and solutions

List of studies completed, ongoing, and planned, with brief descriptions, estimated cost, NIH Institute and Center focus, and progress.

Report status of the ongoing evaluation. Report information regarding self-evaluation activities and activities related to the national evaluation. Include:

a. Evaluation objectives to be addressed
b. Logic Model being used as a conceptual framework for the self-evaluation activities
c. Variables being measured
d. Data collection methods being employed (include instruments that were used)
e. Confidentiality and Human Subjects' Protection activities (include IRB protocols)
f. Interim findings
g. Timeline for future activities
h. Issues or barriers encountered
i. Roles and responsibilities in fulfilling the national evaluation requirements

List of publications from studies benefiting from CTSA resources, including trainees.

Report collaborative efforts among CTSA faculty, between CTSA faculty and other university faculty; between CTSA faculty and outside scientists

Additional information will be required regarding Institutional support, Industry involvement and support for HIV/AIDS-related studies, that will be announced through a program website.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Dr. Anthony Hayward
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: [email protected]

2. Peer Review Contacts:

Dr. Sheryl Brining
Office of Review, NCRR
6701 Democracy Blvd
Democracy 1, Room Number 1072
Bethesda , MD 20892
Telephone: (301) 435-0811
FAX: (301) 480-3660
Email: [email protected]\

3. Financial or Grants Management Contacts:

Ms. Holly Atherton
Office for Grants Management, NCRR
6701 Democracy Blvd
Democracy 1, Room Number 1040
Bethesda , MD 20892
Telephone: (301) 435-0844
FAX: (301) 480-3777
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://www.nih.gov/about/publicaccess/ and view the Policy or other Resources and Tools including the Authors' Manual (http://www.nih.gov/about/publicaccess/publicaccess_Manual.htm).

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 52 and 45 CFR Parts 74 and 92. The National Research Service Award (T32) component is supported under the authorization of Section 487 of the Public Health Service Act as amended (42 USC 288) and under Federal Regulations 42 CFR 66. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.

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