Research Career Development Programs in Vascular Medicine

RFA Number: RFA-HL-05-002

Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (

Components of Participating Organizations
National Heart, Lung, and Blood Institute (NHLBI), (

Announcement Type

Update: The following update relating to this announcement has been issued:

Catalog of Federal Domestic Assistance Number(s)
93.837, 93.839

Key Dates

Release Date: November 17, 2004
Letters Of Intent Receipt Dates: April 13, 2005 and April 12, 2006
Application Receipt Dates: May 11, 2005 and May 12, 2006
Peer Review Date(s): September-October, 2005 and September-October, 2006
Council Review Date(s): February, 2006 and February, 2007
Earliest Anticipated Start Date: April 1, 2006 and April 1, 2007
Expiration Date: May 13, 2006

Due Dates for E.O. 12372
Not Applicable

Executive Summary

This document invites applications for NHLBI Research Career Development Programs in Vascular Medicine. The goal of this initiative is to prepare clinicians for academic leadership roles in the rapidly evolving field of vascular medicine. Programs will provide comprehensive training in research methodology, risk assessment, diagnosis, treatment and prevention of all vascular diseases (arterial, venous and lymphatic). The NHLBI intends to commit $3.1 million in FY 06 to fund seven awards using the NIH Mentored Clinical Scientist Development Program (K12) mechanism. The NHLBI intends to have a second competition to support four more new Programs in FY2007. Eligible organizations include domestic, for profit and non-profit, public and private, institutions such as universities, colleges and hospitals. Foreign institutions are not eligible to apply. However, collaboration with foreign institutions may be allowable with proper justification. Eligible Principal Investigators are physicians who are established clinical investigators in vascular medicine with strong leadership capabilities and substantial mentoring experience. An eligible institution may submit only one application in response to this RFA. Applications must be prepared using the PHS 398 application form which can be downloaded at ( Modified instructions for this particular type of grant application (K12) must be followed and are found in Section IV.2., Content and Form of Application Submission, of this announcement. Telecommunications for the hearing impaired are available at: TTY 301-451-5936.

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
    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
      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
    3. Merit Review Criteria
      A. Additional Review Criteria
      B. Additional Review Considerations
      C. Sharing Research Data
      D. Sharing Research Resources

  Section VI. Award Administration Information
    1. Award Notices
    2. Administrative 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. Award Criteria
    4. 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 Training Objectives

Purpose of this RFA

The primary goal of this RFA is to promote comprehensive clinical research training for physicians wanting to specialize in vascular medicine. Through this initiative, the National Heart, Lung, and Blood Institute (NHLBI) will support several multidisciplinary, postgraduate career development programs to prepare clinicians for academic leadership roles in mentoring and clinical research in vascular medicine.

For the purposes of this initiative, vascular medicine is defined as a discipline devoted to clinical evaluation and management of individuals with arterial, venous, and lymphatic diseases. Clinical research is broadly defined to include epidemiologic and natural history studies, translational research, patient-oriented research, clinical trials, and outcomes research.

Research Training Objectives

The research training objectives of this initiative, focused specifically on the area of vascular medicine, are to:

These objectives stem from the fact that despite scientific progress on several fronts, systematic and comprehensive training for physicians in risk assessment, diagnosis, treatment, and preventive approaches for all vascular diseases (coronary and peripheral) has not been widely available in academic medical institutions.

It is important to note that the proposed programs are distinct from traditional clinical fellowships. The NHLBI programs require a one-year, multidisciplinary clinical core curriculum, and emphasize two years of mentored research and formal didactics to foster careers in vascular medicine research and teaching.


Traditionally, care of patients with vascular disorders has been administered by vascular surgeons and physicians in multiple other specialties (such as internal medicine, cardiology, hematology, nephrology, neurology, endocrinology, interventional radiology, pulmonary medicine, and rehabilitative medicine), depending on the anatomy or organ involved, the particular concurrent diseases (e.g., diabetes, hypertension), and the patterns of practice at the specific institution. Coordinated care, based on recognition of the multiplicity of risk factors requiring attention in patients with vascular diseases, has not been the norm.

Identifying a training need, NHLBI released an RFA in 1990 for Academic Awards in Systemic and Pulmonary Vascular Disease to improve quality of clinical, educational and research programs in vascular disease and promote professional development of the awardees. Although the initiative was successful, it was not sufficiently far-reaching. Training of vascular medicine specialists has lagged behind expanding public health needs. Today there are too few senior-level physician-investigators who can conduct translational research and mentor junior faculty in the many areas germane to vascular medicine. The nation also lacks practicing physicians who can bridge the disciplines to deliver coordinated, state-of-the-art care to patients with vascular disease.

Public Health Focus

Atherosclerosis, stroke, venous thromboembolism, aneurysm, varicose veins, vasospasm, and lymphedema are examples of the broad spectrum of vascular disorders, both common and rare, that account for substantial morbidity and mortality.

In recent years, advances in relevant pharmacology and technology have paralleled progress in defining the epidemiology and pathophysiology of vascular disorders. More options are now available to patients earlier in the course of many vascular diseases. Evidence is rapidly accumulating to support preventive and therapeutic approaches for specific atherosclerotic and venous thromboembolic disorders.

For example, some recent findings that will significantly affect future management of patients with venous thromboembolism include the following:

Program Description

Through the Research Career Development Programs in Vascular Medicine, NHLBI will provide awards to educational institutions to develop curricula in vascular medicine and train clinicians to become independent investigators capable of assuming leadership roles. These Programs will address historical barriers that have hindered development of vascular medicine as a unique specialty, including lack of (1) faculty, (2) a clear career pathway, (3) a comprehensive curriculum for training (4) recognized criteria of excellence, and (5) potential for board certification.

The Program Director (PD) will draw on the strengths of his/her institution to tailor a specialized clinical research curriculum in vascular medicine. The Program Director will be the scientific and administrative leader of the Program and obtain guidance from a multi-disciplinary advisory committee focused on program oversight and evaluation.

The curriculum for the first year will include required core clinical training and, if schedules allow, some didactics in clinical research methodology. The clinical core will expose physicians to the inpatient vascular medicine consultation service, outpatient clinic, vascular diagnostic laboratory, peripheral angiography and other imaging approaches for vascular diseases, catheter-based endovascular intervention, vascular surgery, vascular pathology and specific aspects of other areas, such as hematology (coagulation), dermatology (wound care), neurology (stroke management) and nephrology (ischemic renal disease). Options will then exist for two years of further didactics and mentored research training in areas of the trainee's choice such as imaging, endovascular intervention, pharmacology, prevention, rehabilitation, and clinical trials. During this time, trainees will be expected to participate substantively in a research project.

Faculty representing multiple specialties will closely mentor trainees and supervise their research projects.

Eligible clinician trainees may come from a wide range of disciplines including, but not limited to, internal medicine, vascular surgery, primary care medicine, cardiology, hematology, neurology, radiology, and rehabilitative medicine. Junior faculty wanting to further specialize may apply.

Examples of research topics that trainees might pursue after completing the core clinical requirements include, but are not limited to, the following:

It is anticipated that clinicians who complete the Program will be prepared to apply for another NIH career development award (e.g., K23 or K08) or investigator-initiated research award (e.g., R01 or R21). They may receive a certificate of completion from the Program or an advanced degree, if applicable.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the NIH Mentored Clinical Scientist Development Program (K12) grant award mechanism(s). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. An applicant who is unsuccessful in receiving an award in the first competition of this RFA may revise and resubmit on the second receipt date .

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. The K12 is subject to Expanded Authorities, including carry-over of funds.

2. Funds Available

The participating IC, NHLBI, intends to commit approximately $3.1 million dollars in FY 2006 to fund seven new grants in response to this RFA. NHLBI plans to fund an additional three to four new grants in FY 2007 from applications submitted on the second receipt date. An applicant should request a project period of five years and a budget for direct costs up to $400,000 dollars in the first year and up to an aggregate of 3.6 million dollars in direct costs for the subsequent four years (i.e., the direct cost cap for five years is 4.0 million dollars). The earliest anticipated start date is April 1, 2006. Because the nature and scope of the proposed research training will vary from application to application, it is anticipated that the size of each award will also vary. Although the financial plans of the NHLBI provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. Fiscal and administrative costs are not included in the direct cost limitation, see NOT-OD-04-040 .

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:

Although foreign institutions are not eligible to apply, foreign collaborators may participate in this program through subcontract(s) with domestic applications.

Applicant institutions must have strong clinical research faculty representing the broad spectrum of clinical disciplines relevant to vascular medicine. Applicants proposing revamping or supplementing an existing training program are eligible to compete if all required elements are addressed (see Section III.1.3., Other–Special Eligibility Criteria).

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

The Program Director (i.e., the Principal Investigator) must be a practicing physician as well as an established investigator in patient-oriented research with the ability to provide the necessary scientific and administrative leadership to coordinate and supervise a vascular medicine research and career development program. Patient-oriented research is defined as research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator directly interacts with human subjects. This area of research includes 1) mechanisms of human disease; 2) therapeutic interventions; 3) clinical trials, and; 4) the development of new technologies. Studies falling under Exemption 4 for human subjects research are not included in this definition.

Training candidates, hereafter referred to as “Candidates,” must currently be physicians with an M.D. or D.O. degree and must have completed their residency training. Candidates will vary in their level of training (e.g., still in fellowship or at junior faculty level) and their specialty (i.e., internal medicine, vascular surgery, cardiology, radiology, hematology, etc.).

Candidates must be citizens or noncitizen nationals of the United States, or must be lawfully admitted to the United States for permanent residence (i.e., in possession of a currently valid Alien Registration Receipt Card I-155 or other legal verification of such status). Noncitizen nationals are generally persons born in outlying possessions of the United States (i.e., American Samoa and Swains Island). Individuals on temporary visas are not eligible.

At least 75% of the Candidate's full-time professional effort must be devoted to the Program and the remainder devoted to clinical and teaching pursuits consonant with the objectives of the award. The Candidate must not be or have been a Principal Investigator on an R01 or R21 award or on a component project of a Program Project (P01), Center grant (P50, P60, or U54), mentored career development (K-series) grant, or other equivalent research grant award. Candidates may have had support on a NRSA grant (F or T) or NIH small grant (R03).

2. Cost Sharing

Cost sharing is not required under this program.

3. Other-Special Eligibility Criteria

An eligible institution (e.g., a school of medicine) may submit only a single application in response to this RFA. Multiple applications from different divisions, faculties, centers, etc. at the same institution will be returned without further consideration by the NIH.

To be considered responsive, applicants must address all of the following specific Program elements:

1. Program Director : The proposed Program Director must be a senior faculty member or director of a research center or multidisciplinary institute who possesses scientific expertise in vascular medicine, experience in patient-oriented research, and the leadership and administrative capabilities required to coordinate and supervise an interdisciplinary research and career development program of this scope. The Program Director should be able to demonstrate a superior record of preparation of clinicians for independent research. Effort devoted to Program leadership and administration must be at least 25%. Start-up effort of up to 40% may be requested in the first six months.

2. Institutional Commitment : Applicant institutions should demonstrate their commitment to the Program's goals. For example, applicants should include letters in their application from appropriate institute officials addressing the following issues:

3. Clinical Research Capability and Infrastructure : The institution must demonstrate that it has a well-funded clinical research base, the infrastructure to support clinical research (for example, GCRC, clinical coordinator(s), biostatistics expertise, etc.), and the facilities (e.g., inpatient and outpatient facilities, affiliate hospitals, etc.) and patient resources to expose the Candidates to the full range of vascular medicine. If other institutions are involved, each must provide written commitments of resources to be provided to the Program.

4. Advisory Committee : A multidisciplinary Advisory Committee of three to four members appointed by the Program Director will be responsible for general oversight and evaluation of the Program. The chair of the Advisory Committee will be appointed by the Program Director. Members of the Advisory Committee may be faculty from within and outside the institution. Advisory Committee members will be compensated for their Program-related activities (see 14.c. below). Proposed external Advisory Committee members should not be specifically identified in the application because doing so limits availability of qualified peer reviewers not in conflict. However, the types of expertise expected for the Advisory Committee should be described. Additional duties that may be assigned to the Advisory Committee, at the discretion of the Program Director, include: establishing selection criteria for Candidates; reviewing the core clinical and research curricula; approving education and career development plans (e.g., formal coursework, mentors, research experience); providing interim monitoring and evaluation of each Candidate's progress with recommendations for modifications in the plan, if necessary, or termination of a Candidate who is not making adequate progress; and establishing criteria for awarding a certificate of completion of the Program. The Advisory Committee should meet regularly and keep written minutes, which may be reviewed in an NHLBI site visit, and/or as part of competing or non-competing continuation applications. The Advisory Committee will provide the Program Director with a summary annual progress report of the Program's development, including an evaluation of its strengths and weaknesses.

5. Mentors : Each Candidate appointed under the K12 award must be supervised by a mentoring team of at least two mentors, one primary and one or more secondary, from different disciplines relevant to the research project. For example, a mentoring team might consist of one clinical trials specialist and one clinical cardiologist, or one interventional radiologist and one vascular surgeon. The primary mentor should be recognized as an independent investigator who is actively involved in clinical research and has a successful track record of mentoring. The mentors must be committed to continue their involvement with the Candidate for the duration of his/her appointment on this Career Development Program. Each Program should have a minimum of four mentors, each devoting 5-10% effort. Mentors should be specifically identified in the application. In general, to facilitate access and communication with Candidates, mentors should be members of the faculty of the grantee institution. Proposed exceptions should be well justified.

6. Candidate positions : The final selection of Candidates will be made by the Program Director, with input from the Advisory Committee. Candidates must commit to three years of training. To ensure that all Candidates receive their full three years of training, no new Candidates should begin the Program after Year 3 unless arrangements have been made for “bridging funds” through the grantee institution or some other source. The applicant can request support for five to six trainees over the five years of the award. One way, but not the only way, to fully train 5 individuals would be to support one new Candidate in Year 1, two new Candidates in Year 2, and two new Candidates in Year 3. Applicants should describe their anticipated schedule for appointment of Candidates to their Program. This timeline should allow up to six months for initial Program development. The number of mentors supported during any year should meet the needs of the expected number of Candidates in training.

7. Clinical Core Curriculum : The initial, one-year, clinical core curriculum will expose physicians to the following: the inpatient vascular medicine consultation service, the outpatient clinic, the vascular diagnostic laboratory, peripheral angiography and other imaging approaches for vascular diseases, catheter-based endovascular intervention, vascular surgery, vascular pathology and specific aspects of other areas, such as hematology (coagulation), dermatology (wound care), neurology (stroke management), and nephrology (ischemic renal disease).

8. Didactic Clinical Research Curriculum : While participating in the Program, preferably in the first and second years, each Candidate must receive didactics in epidemiology, clinical study and trial design, statistics, regulatory compliance, bioethics, responsible conduct of research, good clinical practices, manuscript and grant writing, mentoring, leadership, and team building skills. The curriculum can be individualized, depending upon the level of experience of the Candidate. For example, Candidates who can demonstrate mastery in a specific area (e.g., statistics) may be exempted from that aspect of the clinical research curriculum. Course work may be obtained through affiliated schools of public health or other educational institutions or sources. If a master's degree in clinical research of other applicable area is available at the institution, Candidates may choose to pursue a master's degree as part of their career development plan.

Programs, in addition, should propose regularly scheduled career development opportunities such as journal clubs, seminars, grand rounds, and other forums designed specifically for Candidates. Candidates should be encouraged and funded to attend national scientific meetings and present their research.

9. Mentored Research Experience : The mentored research experience must last a minimum of two years. It is anticipated that the Candidate may first participate in an ongoing clinical research project, working alongside the mentor lead. Subsequently, the Candidate will be expected to develop and pursue a new research project by first writing, under the guidance of mentors, a mock K23 or R01 application that will be reviewed by the Program Director and Advisory Committee. This project should provide a suitable experience for the Candidate to gain independence as a clinical researcher.

10. Recruitment Plan : Applicants must submit a recruitment plan that includes a scheme for: (1) recruiting Candidates from both outside and inside their institution(s), and (2) recruiting Candidates from under-served and under-represented minority and ethnic populations. Programs are encouraged to collaborate with minority-serving institutions.

11. Evaluation and Tracking Plan : The applicant should describe a strong evaluation and tracking plan that will review the effectiveness of all aspects of the Program (including courses, Mentors, Advisory Committee members, Program Director), and a system for tracking graduates throughout their career to determine the success rate of applying for and obtaining federal and nonfederal research grant support. Tracking should include Candidate appointment information (diversity of backgrounds, disciplines and specialties) and outcome measures (academic placement, clinical vs. basic science research), etc.

12. Participation in the NHLBI Program : Programs will be expected to interact with the other NHLBI Research Career Development Programs in Vascular Medicine. NHLBI will host a grantees' meeting in Bethesda, MD, within the first few months after awards are made and annually thereafter. Program Directors, Candidates, and Faculty will be invited to attend for the purposes of sharing information and making midcourse corrections that will improve Programs. Travel for these meetings should be budgeted. NHLBI Program Staff may conduct periodic site visits to review each site's progress in meeting its overall goals.

13. Programmatic Overlap : When there is an existing institutional National Research Service Award (T32) in the area of vascular medicine, the applicant should address overlap with the K12 program.

14. Allowable Costs :

a. Direct cost cap: Direct costs for a single application may not exceed four million dollars over five years.

b. Candidates' Salaries: Candidates will receive salary support of up to $75,000 each year, plus fringe benefits commensurate with the applicant institution's salary structure for persons of equivalent qualifications, experience, and rank. The K12 award will provide for three years of funding for each Candidate, consisting of three consecutive 12-month appointments. The institution may supplement the NHLBI contribution; however, supplementation may not be from 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 of salary may not require extra duties or responsibilities that would interfere with the purpose of this award. The total salary requested must be based on a full-time, 12-month staff appointment.

c. Personnel Costs for Program Director, Mentors, and Advisory Committee members: Up to 40% of the Program Director's salary and fringes may be requested for the first six-month start-up phase, and up to 25% per year thereafter. Mentors may be paid 5-10% of their salary and fringes per year (maximum of three Mentors per Candidate). The Advisory Committee chair and members may be paid a maximum of $10,000 per year. Travel for the Program Director and active Mentors to the annual grantees' meeting in Bethesda, MD, should be budgeted.

d. Research and Development Support: Up to $30,000 per Candidate per year can be provided for the following types of expenses: (1) research expenses, such as supplies, equipment and technical personnel; (2) tuition, fees and books related to career development; (3) travel to research meetings, training, and NHLBI-sponsored annual grantees' meetings; and (4) statistical services including personnel and computer time. These costs must be specifically documented for each individual candidate and must be specifically and directly related to the Candidate's research activities. These costs may not be used for Program advertising or recruiting.

e. Ancillary Personnel Support: Up to 75% effort may be budgeted for an administrative assistant.

f. Facilities and Administrative Costs: These costs, which were formerly called indirect costs, will be reimbursed at 8% of modified total direct costs.

g. Other Income: Fees resulting from clinical practice, professional consultation, or other comparable activities required by the research and research-related activities of this award may not be retained by the career award recipient. Such fees must be assigned to the grantee institution for disposition by any of the following methods:

Candidates may retain royalties and fees for activities such as scholarly writing, service on advisory groups, or honoraria from other institutions for lectures or seminars, provided these activities remain incidental and provided that the retention of such pay is consistent with the policies and practices of the grantee institution.

h. Funds budgeted in an NHLBI-supported research or research training grant for the salaries or fringe benefits of individuals, but freed as a result of a K12 award, may not be re-budgeted without prior approval.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email:

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

2. Content and Form of Application Submission

Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 11/2004). Applications must have a Dun and Bradstreet (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 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.

The instructions in the Form PHS 398 do not fully apply to the special needs of this grant application. Therefore, please follow the modified instructions below in preparing an application for a Research Career Development Program (K12) in Vascular Medicine.

1. Face Page: Use Form Page 1 of the PHS 398. On Line 1, include the title that best represents the nature of the Career Development Program. On Line 2, provide the number of this Request for Applications, RFA-HL-05-002, the RFA title, "Research Career Development Programs in Vascular Medicine," and check the YES box. The Program Director will be the Principal Investigator (PI) of the grant application.

2. Description/Performance Site(s)/Key personnel (Form Page 2 of PHS 398): Complete as directed in the PHS 398 instructions. Information should be provided for the Program Director, Mentors, and other faculty participating in the Program.

3. The application should be organized as follows (if questions arise when following this format, applicants should refer regularly to those sections of this announcement that delineate “Other-Special Eligibility Criteria” and “Merit Review Criteria”):

A. Face Page

B. Description, Performance Sites, and Key Personnel

C. Table of Contents

D. Detailed Budget Page for Initial Budget Period: This should include any budget needed for curriculum development in the first six months and costs to support at least one Candidate.

E. Budget for Entire Proposed Period of Support that escalates the number of Candidates in the remaining years to fully train five to six Candidates over five years.

F. Biographical Sketches in the standard NIH format for the Program Director, Mentors, and other Faculty of, and Consultants to, this Program.

G. Other Support for the Program Director, Mentors, other Faculty of, and Consultants to, this Program. Any changes in Other Support will be requested just prior to award.

H. Clinical Research Career Development Program (not to exceed 40 pages):

(1) Overall Aims

(2) Institutional Commitment

(3) Major Program Elements

(4) Candidate Pool and Recruitment Plans

(5) Evaluation and Tracking

(6) Participation in NHLBI Activities for Grantees

I. Human Subjects

J. Vertebrate Animals

K. Checklist

L. Appendices and Tables: Suggested tabular formats for this information will be made available from the Program office (see Section VII.1., Scientific/Research Contacts). The following information should be included:

1. Funded Training and Career Development Programs Relevant to Clinical Research. This should include all programs within the institution that are relevant to the purpose and objectives of the Program (e.g., K30s, T32s, R25s, Ts, Ks, GCRCs, Schools of Public Health, Degree Programs, etc.). The table should be organized using the following headings: Principal Investigator, Source of Support (e.g., institutional, NIH, other federal, non-federal, industry), Title, Vascular Health Focus if applicable (e.g., peripheral arterial disease, venous thromboembolism), number of trainees, and Description (no more than two sentences).

2. Clinical Research Infrastructure. This should include all shared clinical research facilities within the institution(s) (e.g., GCRCs, statistical expertise, clinical databases, etc.).

3. Expertise and Training Track Records of Program Director, Mentors, and Other Faculty. This should include name, rank, department/division, area of expertise, and other relevant information. For each person, please include a list of recent mentored trainees (name, degree, research project, current position, and current research area).

4. Clinical Facilities, Patients, and Specialized Populations. This should include all hospitals and inpatient and outpatient clinics; the estimated numerical distribution of patients with specific vascular diseases and/or related health issues cared for in these facilities; and specialized populations that are served by the institutions in this Program. Letters of collaboration from each institution other than the applicant institution should be included.

3. Submission Dates

Applications must be mailed on or before the receipt date described below (Section IV.3.A).

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Dates: April 13, 2005 and April 12, 2006
Application Receipt Date(s): May 11, 2005 and May 12, 2006
Peer Review Date: September-October, 2005 and September-October, 2006
Council Review Date: February, 2006 and February, 2007
Earliest Anticipated Start Date: April 1, 2006 and April 1, 2007

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 NHLBI staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Valerie Prenger, Ph.D.
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924
Telephone: (301) 435-0270
FAX: (301) 480-0730

3.B. Sending an Application to the NIH

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

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

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

Valerie Prenger, Ph.D.
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service, non-USPS service)
Telephone: (301) 435-0270
FAX: (301) 480-0730

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: .

3.C. Application Processing

Applications must be received on or before the application receipt date listed in the heading of this funding opportunity. If an application is received after that date, it will be returned to the applicant without review. Applications will be evaluated for completeness by CSR.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application previously submitted in response to this funding opportunity and reviewed, but such application must include an Introduction addressing the previous critique.

Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NHLBI . Incomplete and/or nonresponsive 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 of the receipt date.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All 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 (See also Section VI.3., Award Criteria).

6. Other Submission Requirements

Other special programmatic, performance and reporting requirements not stated elsewhere in the announcement include the following:

1. Special Leave: Leave of a Candidate to another institution, including a foreign laboratory, may be permitted if directly related to the purpose of the award. Only local, institutional approval is required if such leave does not exceed three months. For longer periods, prior, written approval of NHLBI staff is required. A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the award will continue during such leave.

Leave without award support may not exceed 12 months. Such leave requires the prior written approval of the NHLBI and will be granted only in unusual situations. Support from other sources is permissible during the period of leave. Parental leave will be granted consistent with the policies of the NHLBI and the grantee institution.

2. Termination: When a grantee institution plans to terminate an appointment of a Candidate, the NHLBI must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination.

3. Change of Institution: The Research Career Development Program in Vascular Medicine (K12) cannot be transferred from one institution to another.

4. Change of Program Director: If the Program Director moves to another institution or resigns from the position, support of the award may be continued with NHLBI prior approval provided the current Program Director or the grantee institution has submitted a written request for change of Program Director, countersigned by the appropriate institutional business official, to the NHLBI Program Director describing the reasons for the change. The biosketch of the proposed new Program Director, including a complete listing of active research grant support, must be provided. The information in the request should establish that the specific aims of the original peer reviewed program will remain unchanged, and that the new Program Director has the appropriate research and administrative expertise to lead the Program. The request should be submitted far enough in advance of the requested effective date to allow the necessary time for review.

5. Changes of Program: Awards are made to a specific institution for a specific program with a specific research training scope under the guidance of a particular Program Director. Changes in any of these parameters require prior approval by NHLBI Program staff.

6. Progress Reports: An Annual Progress Report for the grant is required. See Section VI.4., Reporting.

7. Evaluation: In carrying out its stewardship of human resource related programs, the NHLBI may request information essential to an assessment of the effectiveness of this Program. Accordingly, recipients are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their 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.

Plan for Sharing Research Data
Not applicable

Sharing Research Resources
Not applicable.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

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 NHLBI in accordance with the review criteria stated below.

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

3. Merit Review Criteria

The goal of this Career Development Program is to prepare clinicians for academic leadership roles in the field of vascular medicine . In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed Program will have a substantial impact on the pursuit of this goal . The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application.

The application does not need to be strong in all categories to be judged likely to have major impact and thus deserve a high priority score.

Approach: Is the overall Program strategy adequate to satisfy the intent of this initiative to develop and sustain a high quality career development program in vascular medicine? Does the Program provide comprehensive training in the design and conduct of clinical research? Will Candidates acquire the appropriate clinical skills? Does the Program take maximum advantage of existing didactic capabilities, clinical infrastructure, and faculty strengths? Does this Program integrate all vascular medicine resources (faculty, clinical departments, laboratories, educational opportunities and infrastructure) to enhance Candidates' training?

Institutional Commitment: Is the institutional leadership committed to this Program and its goals? Does the institution provide assurances that clinical research facilities and training opportunities will be available to the Program? Are there adequate cooperative arrangements between consortium institutions, if applicable, to ensure that the Program performs effectively as one activity across institutional boundaries? Have institutional barriers for clinical research and clinical researchers been adequately addressed? Is there adequate commitment from the institution(s) to protect 75% professional effort of each Candidate, to actively promote each Candidate's clinical research career, and to support the career and tenure process for clinical researchers at the institution? Will there be ample protected time for the Program Director and Mentors?

Clinical Research Capability and Infrastructure : Is the overall clinical research and training environment adequate for conducting multidisciplinary, peer-reviewed clinical research (e.g., translational research, Phase I, II, and III therapeutic trials, epidemiological studies, etc.) in vascular medicine and related fields? Are the existing infrastructure of the institution(s) (e.g., imaging facilities, vascular ultrasound, research nurses, data managers biostatistics expertise, informatics), and infrastructure supported by NIH (e.g., GCRCs) and other sources adequate? Are there sufficient plans to improve and complement the existing infrastructure, e.g., by collaborations with other institutions?

Program Leadership : Does the Program Director have the necessary, recent clinical research background and administrative qualifications and experience to provide scientific leadership, manage, and coordinate a clinical research career development program of this size and complexity? Has the Program Director committed sufficient time to devote to this Program? Will the Program Director have sufficient authority and credibility in the institution to work across institutional boundaries?

Advisory Committee : Will the Advisory Committee have sufficient and appropriate expertise to oversee this multidisciplinary career development program? Will the Advisory Committee operational procedures provide adequate monitoring and evaluation of the Candidates and the overall Program? Will the process and review criteria for evaluating the Candidate's clinical research projects meet the high scientific standards of an NIH review? Will the projects comply with all applicable federal rules and regulations?

Program Mentors : Are the Mentors who will participate in this Program identified? Do they have the experience, skills, and track records in mentoring necessary to provide Candidates with high-quality research training, and do they broadly represent the disciplines, specialties, and subspecialties necessary to make this Program work effectively? Will the Mentors commit sufficient time to ensure the success of the Program? Are the proposed plans for mentoring likely to nurture development of good research skills and independence on the part of the Candidates?

Curriculum : Does the one-year clinical core curriculum cover essential topics/skills needed for specialization in vascular medicine? Are the didactic requirements sufficient to train Candidates to lead, design, and conduct clinical research and work effectively in collaborative teams? Are these elements timed properly to maximize opportunities for Candidates to apply new skills in their own research? Does the Program have adequate flexibility to accommodate Candidates from different disciplines with different levels of experience?

Candidate Pool and Recruitment Plans : Does the application adequately describe recruitment procedures, potential sources and numbers of high-quality Candidates, Candidate selection criteria, and retention strategies? Does the Program seek to recruit Candidates from outside the institution? Are there substantive plans to recruit women and members of under-represented racial/ethnic minorities?

Evaluation and Tracking : Are plans adequate for the Advisory Committee and/or other procedures to evaluate the performance of the Program as a whole (e.g., quality of the didactic training, adequacy of the performance of mentors, adequacy of faculty participation), to set benchmarks, and to make changes that improve performance and outcomes? Are plans adequate to track career outcomes of Candidates, including positions held, papers published, grants and awards submitted/obtained, and other relevant information?

3.A. Additional Review Criteria:

In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score:

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 to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also 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 in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

3.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

3.C. Sharing Research Data
Not applicable

3.D. Sharing Research Resources
Not applicable.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

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 (

A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

An award notice will be sent via e-mail to the Institution's business official.

2. Administrative Requirements

All NIH Grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities

3. Award Criteria

The following will be considered in making funding decisions:

4. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually: and financial statements as required in the NIH Grants Policy Statement. Forms are also available at most institutional offices of sponsored research.

The K12 grant, as administered by the NHLBI, is not subject to the Streamlined Noncompeting Application Process (SNAP). In general, this means that all reporting of budgetary information and program progress are provided in greater detail in an annual progress report. This report should provide information about changes in the Program, the evaluation summary of the Advisory Committee, and a description of the research and career progress of each Candidate. These Annual Reports will be closely monitored by NHLBI staff to ensure that the grant is achieving the goals of this Research Career Development Program in Vascular Medicine.

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:

Diane Reid, M.D.
Division of Heart and Vascular Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 9182
Bethesda, MD 20892-7940
Telephone: (301) 402-3824
FAX: (301) 480-1336

2. Peer Review Contacts:

Valerie Prenger, Ph.D.
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924
Telephone: (301) 435-0270
FAX: (301) 480-0730

3. Financial or Grants Management Contacts:

David Reiter
Grants Management Branch
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7172
Bethesda, MD 20892-7926
Telephone: (301) 435-0153
FAX: (301) 480-3310

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 (, as mandated by the Health Research Extension Act of 1985 (, and the USDA Animal Welfare Regulations (, 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.

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, June 12, 1998:

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,

Investigators should seek guidance from their institutions, on issues related to institutional policies, 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.

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 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 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:
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (; a complete copy of the updated Guidelines is available at 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 that is available at

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

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at and at Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for federal funding (see 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.

Public 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 public 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 Applicants may wish to place data collected under this PA 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.

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 ( 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

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

Authority and Regulations:

This program is described in the Catalog of Federal Domestic Assistance at 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. 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

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:

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

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