ACADEMIC AWARD IN VASCULAR DISEASE

NIH GUIDE, Volume 21, Number 37, October 16, 1992



PAR NUMBER:  PAR-93-008



P.T. 34



Keywords:

  Cardiovascular Diseases 

  Biomedical Research, Multidiscipl 



National Heart, Lung, and Blood Institute



Application Receipt Date:  January 7, 1993



PURPOSE



The National Heart, Lung, and Blood Institute (NHLBI) of the National

Institutes of Health (NIH) announces the third national competition

for Academic Awards in Vascular Disease.  These awards have the dual

purpose of encouraging the development and/or improving the quality

of clinical, educational, and research programs in vascular disease

and of encouraging the professional development of the Awardee so

that he or she can serve as the focal point for multidisciplinary

interactions in the field of vascular medicine.



HEALTHY PEOPLE 2000



The Public Health Service is committed to achieving the health

promotion and disease prevention objectives of "Healthy People 2000,"

a PHS-led national activity for setting priority areas.  This Program

Announcement, Academic Award in Vascular Disease, is related to the

priority area of heart disease and stroke. Potential applicants may

obtain a copy of "Healthy People 2000" (Full Report:  Stock No.

017-001-00474-0 or Summary Report:  Stock No. 017-001-00473-1)

through the Superintendent of Documents, Government Printing Office,

Washington DC 20402-9325 (telephone 202-783-3238).



ELIGIBILITY REQUIREMENTS



Each school of medicine or osteopathy in the United States and its

possessions and territories is eligible to compete for a nonrenewable

Academic Award in Vascular Disease for a project period that does not

exceed five years.  Awards will not be made to foreign institutions

nor to domestic applicants with international components.   The

Principal Investigator must hold the M.D. or D.O. degree or the

equivalent. Applications from minority individuals and women are

encouraged.  An individual institution may submit an application for

a systemic vascular program and an application for a pulmonary

vascular program for a given receipt date.  However, an individual

institution applying for a comprehensive systemic and pulmonary

vascular program in a single application may submit only one

application for a given receipt date.  The number of new awards made

each year will depend on the availability of funds.



MECHANISM OF SUPPORT



The mechanism of support for this program is the Academic/Teacher

Award (K07).



RESEARCH OBJECTIVES



This Academic Award is initiated to address problems that prevent

rapid and effective application of new developments in medical

diagnosis and care of the individual patient.  Major reasons for

inefficient transfer of new technology to patients with vascular

disease relate to the rapid advance of basic and clinical research as

well as to the absence of a specific specialty dedicated to such

patients.  Thus, the purpose of this Academic Award is to provide

financial support for individuals applying, in conjunction with their

institutions, to develop and implement approaches to the coordinated

care of patients with vascular disease in need of a variety of

specialty and subspecialty expert consultation.  In conjunction with

this program, it is also expected that complementary educational and

research programs will be developed or are already in place.



For the purposes of this Award, vascular medicine is defined as the

clinical discipline that has as its objectives:  (1) clinical

characterization, (2) pathogenesis, (3) diagnosis, (4) treatment, and

(5) prevention of systemic and/or pulmonary vascular disease.  To be

responsive to this announcement, an application must provide for a

program in systemic or pulmonary vascular disease or a comprehensive

program in both.  A systemic vascular program should include

cerebral, coronary, aortic, renal, peripheral and lymphatic

circulations and address such disorders as atherosclerosis, lipid

metabolic disorders, hypertension, lymphedema, thrombosis, vasculitis

and vasospastic disorders.  A pulmonary vascular disease program

should include primary and secondary pulmonary hypertension,

pulmonary vasculitis and pulmonary thromboembolism.



STUDY POPULATIONS



SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH

POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL

RESEARCH STUDY POPULATIONS



NIH policy is that applicants for NIH clinical research grants and

cooperative agreements are required to include minorities and women

in study populations so that research findings can be of benefit to

all persons at risk of the disease, disorder or condition under

study; special emphasis must be placed on the need for inclusion of

minorities and women in studies of diseases, disorders or conditions

which disproportionately affect them.  This policy is intended to

apply to males and females of all ages.  If women or minorities are

excluded or inadequately represented in clinical research,

particularly in proposed population-based studies, a clear compelling

rationale must be provided.



The composition of the proposed study population must be described in

terms of gender and racial/ethnic group.  In addition, gender and

racial/ethnic issues should be addressed in developing a research

design and sample size appropriate for the scientific objectives of

the study. This information must be included in the form PHS 398 in

Sections 1-4 of the Research Plan AND summarized in Section 5, Human

Subjects.  Applicants are urged to assess carefully the feasibility

of including the broadest possible representation of minority groups.

However, NIH recognizes that it may not be feasible or appropriate in

all research projects to include representation of the full array of

United States racial/ethnic minority populations (i.e., Native

Americans (including American Indians or Alaskan Natives),

Asian/Pacific Islanders, Blacks, Hispanics).  The rationale for

studies on single minority population groups must be provided.



For the purpose of this policy, clinical research is defined as human

biomedical and behavioral studies of etiology epidemiology,

prevention (and preventive strategies), diagnosis, or treatment of

diseases, disorders or conditions, including but not limited to

clinical trials.



The usual NIH policies concerning research on human subjects also

apply.  Basic research or clinical studies in which human tissues

cannot be identified or linked to individuals are excluded.  However,

every effort should be made to include human tissues from women and

racial/ethnic minorities when it is important to apply the results of

the study broadly, and this should be addressed by applicants.



For foreign awards, the policy on inclusion of women applies fully.

Since the definition of minority differs in other countries, the

applicant must discuss the relevance of research involving foreign

population groups to the United States populations, including

minorities.



If the required information is not contained within the application,

the review will be deferred until the information is provided.



Peer review will address specifically whether the research plan in

the application conforms to these policies.  If the representation of

women or minorities in a study design is inadequate to answer the

scientific question(s) addressed AND the justification for the

selected study population is inadequate, it will be considered a

scientific weakness or deficiency in the study design and will be

reflected in the priority score assigned to the application.



All applications for clinical research submitted to NIH are required

to address these policies.  NIH funding components will not award

grants or cooperative agreements that do not comply with these

policies.



APPLICATION PROCEDURES



Prospective applicants are asked to submit, by November 20, 1992, a

letter of intent, countersigned by the applicant's Department

Chairman, Dean of the School of Medicine or Osteopathy, and Director

of the hospital(s).  This letter of intent should include a

descriptive title of the proposed research, the name, address, and

telephone number of the Principal Investigator, the identities of

other key personnel and participating institutions, and the number

and title of the program announcement in response to which an

application may be submitted.  Although a letter of intent is not

required, is not binding, and does not enter into the review of

subsequent applications, the information that it contains allows

NHLBI staff to estimate the potential review workload and to avoid

possible conflict of interest in the review.



The letter of intent is to be sent to --



C. James Scheirer, Ph.D.

Chief, Contracts, Clinical Trials, and Training Review Section

Review Branch, Division of Extramural Affairs

National Heart, Lung, and Blood Institute

Westwood Building, Room 548

Bethesda, MD  20892

Telephone:  (301) 496-7363



Applications for the Academic Award in Vascular Disease must be

received no later than January 7, 1993, by the NIH for review by the

National Heart, Lung, and Blood Advisory Council in May 1993.  The

requested start date for funding should be July 1, 1993.



Applications are to be submitted on the traditional research grant

application form PHS 398 (rev. 9/91).  The form is available in an

applicant institution's office of sponsored research or business

office and from the Office of Grants Inquiries, Division of Research

Grants, National Institutes of Health, 5333 Westbard Avenue, Room

449, Bethesda, MD 20892, telephone 301/496-7447.  Use the

conventional format for research grant applications and ensure that

the points identified in the section "INSTRUCTIONS FOR PREPARING

APPLICATIONS" are fulfilled.  Applicants are expected to conform to

the 25-page limit as directed in the application kit (PHS 398).

Appendices containing supporting materials may be submitted with the

application, but may not be used to circumvent this requirement.



Send or deliver an original completed application and three signed,

exact photocopies to --



Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892**



At the same time, applicants must also send two additional copies of

the application to Dr. James Scheirer at the address listed above.



Applications must be received by January 7, 1993, for review at the

May 1993 meeting of the National Heart, Lung, and Blood Advisory

Council.  Awards will be made with a beginning date of July 1, 1993.



REVIEW PROCEDURES



The primary technical review of applications will be by a special

review group managed by the Division of Extramural Affairs, NHLBI,

predominantly composed of non-federal scientists with expertise in

various areas of systemic and pulmonary vascular disease.  The review

will include an initial assessment of the written application based

on the Objectives and Criteria for the Award in the Guidelines.

Guidelines may be requested from individuals named below under

INQUIRIES.



Prospective Awardees whose applications are determined to be

competitive will be invited for an interview in Bethesda, Maryland.

Travel expenses for this interview must be paid by the applicant

institution.  When necessary, a site visit may be made to the

institution to determine the institutional environment, the

commitment of the sponsoring division or department head and director

of the hospital, and evidence of cooperation that may be needed to

implement the candidate's proposed program.  Following scientific-

technical review, the applications will receive a second level review

by the National Heart, Lung, and Blood Advisory Council.



AWARD CRITERIA



Criteria for the award include the ability of both the sponsoring

institution and the candidate to implement a program based on the

objectives of the Academic Award. Awards will also be dependent on

the availability of funds.



INQUIRIES



To receive the full set of Guidelines and to clarify questions

related to applicant eligibility and appropriate areas of emphasis,

contact any of the following:



Carol H. Letendre, Ph.D.

Associate Director for Scientific Programs

Division of Blood Diseases and Resources

National Heart, Lung, and Blood Institute

Federal Building, Room 516

Bethesda, MD  20892

Telephone:  (301) 496-8966



David M. Robinson, Ph.D.

Associate Director for Scientific Programs

Division of Heart and Vascular Diseases

National Heart, Lung, and Blood Institute

Federal Building, Room 416B

Bethesda, MD  20892

Telephone:  (301) 496-5656



Carol Vreim, Ph.D.

Associate Director for Scientific Program Operation

Division of Lung Diseases

National Heart, Lung, and Blood Institute

Westwood Building, Room 6A16C

Bethesda, MD  20892

Telephone:  (301) 496-7208



Direct inquiries regarding fiscal matters to --



Mrs. Marie A. Willett

Deputy Chief, Grants Operations Branch

Division of Extramural Affairs

National Heart, Lung and Blood Institute

Westwood Building, Room 4A12

Bethesda, MD  20892

Telephone:  (301) 496-7255



AUTHORITY AND REGULATIONS



This program is described in the Catalog of Federal Domestic

Assistance No. 93.837, 93,838, and 93.839. Awards are made under

authorization of the Public health Service Act, Title IV, Part A

(Public Law 78-410, as amended by Public Law 99-158. 42 USC 241 and

285) and administered under PHS grants policies and Federal

Regulations 42 CFR 52 and 45 CFR Part 74.  This program is not

subject to the intergovernmental review requirements of Executive

Order 12372 or Health Systems Agency review.



.

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