Full Text DK-95-003

CYSTIC FIBROSIS CORE CENTER

NIH GUIDE, Volume 23, Number 41, November 25, 1994

RFA:  DK-95-003

P.T.


Keywords: 


National Institute of Diabetes and Digestive and Kidney Diseases

Letter of Intent Receipt Date:  June 22, 1995
Application Receipt Date:  July 20, 1995

PURPOSE

Cystic Fibrosis (CF) Core Centers provide shared resources to enhance
research ranging from elucidation of the molecular pathogenesis of CF
to development of new therapies for this disorder.  Biomedical
research cores are intended to enhance the efficiency of research and
foster collaborations at institutions with strong existing bases of
research relevant to CF.  In addition to biomedical research cores,
Centers provide support for pilot and feasibility studies and an
enhanced environment for research training.

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 Request
for Applications (RFA), Cystic Fibrosis Core Center, is related to
the priority area of chronic diseases.  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

Applications may be submitted by domestic, for-profit and non-profit
organizations, public and private, such as universities, colleges,
hospitals, 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.  An outstanding interdisciplinary
program of CF research must be in existence at the applicant
organization.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) core center
grant (P30).  Responsibility for the planning, direction, and
execution of the proposed project will be solely that of the
applicant.  The total project period for an application submitted in
response to this RFA may not exceed five years.  The maximum budget
request is limited to $750,000 in direct costs in any annual budget
period.  The anticipated award date is April 1, 1996.  This RFA is a
one-time solicitation.

FUNDS AVAILABLE

The National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) anticipates funding one core center grant application
submitted in response to this RFA, and will commit up to $1.1 million
total costs in FY 1996 for this purpose.  The receipt of one
competing continuation application is anticipated, which will be in
competition together with other applications received in response to
this RFA.  Although this program is provided for in the financial
plans of the NIDDK, the award of a grant pursuant to this RFA is
contingent upon the availability of funds for this purpose and upon
the receipt of at least one application of high scientific merit.

RESEARCH OBJECTIVES

CF is the most common fatal genetic disease in caucasians, affecting
approximately one in 2500 newborns.  Since the cloning of the CF gene
and identification of its protein product as a cAMP-regulated
chloride channel, there has been impressive progress in the molecular
understanding of this disorder.  CF Core Centers are part of an
integrated program of CF-related research support within the NIDDK
directed at further defining the molecular mechanisms underlying CF
and translating information about the molecular basis of the disease
into new treatments.  Continued progress will depend on
multidisciplinary collaborations among clinical and basic scientists.
Core centers provide a focus for enhancing such collaborations.
Centers promote efficient management of resources, interaction and
collaboration among scientists in multiple disciplines, and a
multifaceted approach to a common goal.  The objective of the core
center is facilitation of progress in research on CF with the
ultimate goal of developing new therapies for this disorder.

CF Core Centers are designed to enhance the efficiency and
effectiveness of an established, ongoing program of research through
provision of core resources, support of pilot and feasibility
studies, and support of program enrichment activities.  Thus, an
outstanding existing program of biomedical research in the area of CF
is an essential prerequisite for a CF Core Center.  This research
should be in the form of NIH-funded research projects (R01 or R29),
program projects (P01), Specialized Centers of Research (P50), or
other peer-reviewed research such as that supported by the Cystic
Fibrosis Foundation.  This established research program must be in
existence at the time of submission of a CF Core Center application.

A CF Core Center is composed of shared resources (cores) that enhance
productivity or in other ways benefit a group of investigators
pursuing a multifaceted approach to significant problems related to
the pathogenesis and treatment of CF.  The CF Core Center is intended
to improve the quality and efficiency of research on CF by providing
shared access to specialized technical resources and expertise.
Examples of cores that would be considered responsive to this RFA
include the following:  electrophysiology, cell morphology,
microscopy, imaging, assay, tissue culture, protein expression,
mutagenesis, transgenic, animal models, structural biology, vector,
and clinical resources.  Specific cores should be proposed based on
the requirements of the investigators at the applicant institution.

Two other types of activities may also be supported with center
funding:  a pilot and feasibility program and an enrichment program.
The pilot and feasibility program provides modest support for
initiatives by new investigators, established investigators entering
CF research, or established CF investigators exploring a new research
direction related to CF.  The Center grant may also include limited
funds for program enrichment such as, but not limited to, seminars,
visiting scientists, consultants, and workshops.

Applicants from institutions that have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research
Resources may wish to identify the GCRC as a resource for conducting
the proposed research.  If so, a letter of agreement from either the
GCRC program director or principal investigator should be included
with the application.

SPECIAL REQUIREMENTS

Applicants must be willing to participate in an annual centers
directors meeting and are advised to include such travel in their
budget 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.

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