Full Text PA-95-085

RESEARCH ON ATHEROSCLEROSIS LESIONS USING HUMAN TISSUES COLLECTED IN PDAY/RFEHA

NIH GUIDE, Volume 24, Number 31, August 25, 1995

PA NUMBER:  PA-95-085

P.T. 34

Keywords: 
  Cardiovascular Diseases 
  Tissue Culture 


National Heart, Lung, and Blood Institute

PURPOSE

The Division of Heart and Vascular Diseases, National Heart, Lung,
and Blood Institute (NHLBI) announces a program to support research
on atherosclerosis lesions utilizing human tissues collected in the
Pathobiological Determinants of Atherosclerosis in Youth/Risk Factors
in Early Human Atherogenesis (PDAY/RFEHA) program.  These specimens
are suitable for use to investigate cellular and molecular factors
that may be implicated in the initiation and progression of
atherosclerotic lesions.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) 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 PA,
Research on Atherosclerosis Lesions Using Human Tissues Collected in
PDAY/RFEHA, 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
202-512-1800).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by foreign and domestic, for-profit and
non-profit organizations, public and private, such as universities,
colleges, laboratories, units of State and local governments, and
eligible agencies of the Federal government.  Racial/ethnic minority
individuals, women, and persons with disabilities are encouraged to
apply as principal investigators.  Foreign institutions are not
eligible for First Independent Research Support and Transition
(FIRST) (R29) awards.

MECHANISM OF SUPPORT

Research support mechanisms include traditional research project
grants (R01) and FIRST (R29) awards.  Traditional research project
grants (R01) provide support for up to five years.  Applications for
FIRST (R29) awards must request support for five years and are
limited to $350,000 in direct costs over the entire project period.

RESEARCH OBJECTIVES

The NHLBI sponsored a multi-center study (PDAY/RFEHA) to document the
natural history of atherosclerosis, its relationship to risk factors,
and the pathobiology of lesion development in humans.  From over
3,000 autopsy cases, there are samples collected from the thoracic
and abdominal aortas, right and left anterior descending, and left
circumflex coronary arteries in addition to samples of serum, liver,
spleen, kidney, heart and adipose tissue.  The samples collected are
all from individuals who suffered sudden traumatic deaths ages 15 to
34, who had no indication of chronic disease.  They are approximately
75 percent male, almost equally divided between black and white
races, and are fairly evenly distributed among the four age cells of
five years each from 15 to 34.

Samples were collected by standardized techniques and the tissues
have been prepared and stored in a variety of manners (i.e., frozen
at -80x, OCT and glutaraldehyde-fixed).  Most of these cases have
demographic data on age, race, and sex.  There are also risk factor
data on smoking, hyperlipidemia, hypertension, diabetes, and obesity.
Arteries have been evaluated for lesions (extent and stage of
complexity) and correlated with available risk factors and
demographic data.  In addition, a number of genotypes related to
apoproteins have been determined and correlated with the risk
factors.  More statistical analyses and correlations are currently
under way to confirm that atherosclerosis starts at an early age, and
that the recognized risk factors for coronary heart disease are
associated with lesion development in the arteries of young subjects.
However, because of the vast potential wealth of information that
could be obtained, these tissues should provide a special opportunity
to initiate studies on the origin and progression of the
atherosclerotic lesion in humans.  This program announcement provides
the opportunity to perform state-of-the-art cellular and molecular
biological research on PDAY/RFEHA specimens.  Investigators are
expected to utilize selected material from the PDAY/RFEHA samples for
their proposed basic research projects.  Thus, the type and quantity
of tissue needed to perform the proposed research should be
specified.  The tissues are centrally housed at Louisiana State
University Medical Center in New Orleans and will be provided to
investigators (Jack Strong, M.D., Phone 504/568-6033).  A Scientific
Advisory Committee with representation from NHLBI, non-PDAY and PDAY
Steering Committee will be convened to ensure that specimens will be
provided according to Study Section recommendations.  For other
interested investigators, who already have non-NIH independent
support, this committee will also assess the scientific merits and
feasibility of their requests, which will not be reviewed by the NIH
peer review system.  In the event that an investigator requires extra
samples, the Committee will be responsible for approving the request.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS

It is the policy of the NIH that women and members of minority groups
and their subpopulations must be included in all NIH-supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This new policy results
from the NIH revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations), which
have been in effect since 1990.  The new policy contains some
provisions that are substantially different from the 1990 policies.

All investigators proposing research involving human subjects should
read the "NIH Guidelines For Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted
in the NIH Guide for Grants and Contracts, Volume 23, Number 11,
March 18, 1994.

Investigators also may obtain copies of the policy from the program
staff listed under INQUIRIES.  Program staff may also provide
additional relevant information concerning the policy.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS
398 (rev. 5/95) and will be accepted at the standard application
deadlines as indicated in the application kit.  Application kits are
available at most institutional offices of sponsored research and may
be obtained from the Office of Grants Information, Division of
Research Grants, National Institutes of Health, 6701 Rockledge Drive,
Room 3032, MSC 7762, Bethesda, MD 20892, telephone 301/435-0714.  The
title and number of the program announcement must be typed in Section
2 on the face page of the application.

Applications for the FIRST award (R29) must include at least three
sealed letters of reference attached to the face page of the original
application.  FIRST award (R29) applications submitted without the
required number of reference letters will be considered incomplete
and returned without review.

The completed original application and five legible copies must be
sent or delivered to:

DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established Public
Health Service referral guidelines.  Applications will be reviewed
for scientific and technical merit by study sections of the Division
of Research Grants, NIH, in accordance with the standard NIH peer
review procedures.  Following scientific and technical review, the
applications will receive a second-level review by the appropriate
national advisory council.

As part of the initial merit review, all applications will receive a
written critique and undergo a process in which only those
applications deemed to have the highest scientific merit, generally
the top half of applications under review, will be discussed,
assigned a priority score, and receive a second level review by the
appropriate national advisory council or board.

Review Criteria

o  scientific, technical or medical significance and originality of
proposed research,

o  appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research;

o  qualifications and research experience of the Principal
Investigator and staff, particularly, but not exclusively, in the
area of the proposed research;

o  availability of the resources necessary to perform the research;

o  appropriateness of the proposed budget and duration in relation to
the proposed research;

o  adequacy of plans to include both genders and minorities and their
subgroups as appropriate for the scientific goals of the research.
Plans for the recruitment and retention of subjects will also be
evaluated.

The initial review group will also examine the provisions for the
protection of human and animal subjects and the safety of the
research environment.

AWARD CRITERIA

Applications will compete for available funds with all other approved
applications.  The following will be considered in making funding
decisions:  quality of the proposed project as determined by peer
review, availability of funds, and program priority.

INQUIRIES

Inquiries are encouraged.  The opportunity to clarify any issue or
questions from potential applicants is welcome.

Direct inquiries regarding programmatic issue to:

Momtaz Wassef, Ph.D
Division of Heart and Vascular Diseases
National Heart, Lung, and Blood Institute
Two Rockledge Center, Suite 10193
6701 Rockledge Drive
Bethesda, MD  20892-7956
Telephone:  (301)435-0550
FAX:  (301) 480-2858
Email:  MOMTAZ_WASSEF@NIH.GOV

Direct inquiries regarding fiscal matters to:

William W. Darby
Grants Operations Branch
National Heart, Lung, and Blood Institute
Two Rockledge Center Suite 7128
6701 Rockledge Drive
Bethesda, MD  20892-7128
Telephone:  (301)435-0177
FAX:  (301)480-3310
Email:  WILLIAM_DARBY@NIH.GOV

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.837.  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.

The PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the non-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.

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