Full Text AR-93-03

SKIN DISEASES RESEARCH CORE CENTERS

NIH GUIDE, Volume 21, Number 44, December 11, 1992

RFA:  AR-93-03

P.T. 04

Keywords: 
  Skin Diseases 
  Biochemistry 
  Immunology 
  Biomedical Research, Multidiscipl 


National Institute of Arthritis and Musculoskeletal and Skin Diseases

Letter of Intent Receipt Date:  May 10, 1993
Application Receipt Date:  June 18, 1993

PURPOSE

The National Institute of Arthritis and Musculoskeletal and Skin
Diseases (NIAMS) invites applications for research core centers (P30s)
in skin diseases.  The Skin Diseases Research Centers (SDRCs) will
provide the resources for a number of established, currently funded
investigators, often from different disciplines, to adopt a
multidisciplinary approach to common research problems in skin diseases
and to ensure greater productivity than from each of the separate
projects.

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), Skin Diseases Research Core Centers, is related
to the priority area of chronic disabling conditions.  Potential
applicants may obtain a copy of "Healthy People 2000" (Full Report:
Stock No. 017-001-00474-0) or "Healthy People 2000" (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.  An established clinical
and research program in skin diseases should be present.  Foreign
organizations are not eligible.  Applications from minority individuals
and women are encouraged.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) core research
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 applications submitted in response to the
present RFA is five years.  The direct costs requested cannot exceed
$400,000 each year.  The anticipated award date is March 1, 1994.

FUNDS AVAILABLE

The NIAMS intends to fund three SDRCs from this RFA in FY 1994, subject
to the availability of resources and receipt of sufficiently
meritorious applications.  The estimated funds (total costs) available
for the first year of support of these centers are $1.0 million.

RESEARCH OBJECTIVES

Research in skin diseases is at a stage where a number of areas are
making broad advances that can be effectively fostered by research core
centers.  Examples of these areas include, but are not limited to:

o  stratum corneum: biochemistry, structure, function
o  epidermis: differentiation, keratinization, cellular constituents
o  dermal-epidermal junction: structure, functions, diseases
o  skin as an immunological organ
o  autoimmune skin diseases
o  dermis: structural components, diseases

The choice of research problem upon which the SDRC would focus is made
by the principal and collaborating currently funded investigators.

The SDRCs will provide support for:

1.  Core resources and facilities to be used by investigators of
individually supported research projects in order to enhance and
coordinate their activities.  This support may include personnel,
equipment, supplies, services, and facilities.

2.  Limited funds for pilot and feasibility studies.

3.  Program enrichment activities.

An SDRC should be an identifiable organizational unit within a
university-affiliated medical center.  An Administrative Core should be
proposed to coordinate the Center and administer the program enrichment
activities.  One or more research cores may be proposed.  A research
core is a facility shared by two or more Center investigators that
enables them to conduct their independently funded individual research
projects more efficiently and/or more effectively.  Cores generally
fall into one of four categories:  (1) provision of a technology that
lends itself to automation or preparation in large batches (e.g.,
histology and tissue culture); (2) complex instrumentation (e.g.,
electron microscopy); (3) animal preparation and care; and (4) service
and training (e.g., molecular biology, biostatistics).

A pilot and feasibility study program provides modest research support
for a limited time (three years or less) to enable eligible
investigators to explore the feasibility of a skin diseases-related
concept and amass sufficient data to pursue it through other funding
mechanisms.  Eligible investigators include:

1.  an established investigator in skin diseases or related areas with
a proposal for testing the feasibility of a new or innovative idea that
is skin diseases-related but represents a clear and distinct departure
from the investigator's ongoing research interest;

2.  an established, supported investigator with no previous work in
skin diseases or related areas who is willing to test the applicability
of his/her expertise on a skin diseases-related problem; and

3.  a new investigator who has not been a principal investigator in a
past or current NIH research project grant (R01, R29, P01).  New
investigators should be clearly independent and have a faculty
appointment higher than that of postdoctoral fellow or research
associate.

SPECIAL REQUIREMENTS

Specific guidelines have been developed for the SDRC application and
program.  These guidelines may be obtained from the contact person
listed under INQUIRIES.

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.  Details of the interactions of the SDRC staff with the GCRC
staff and research personnel may be provided in a statement describing
the collaborative linkages being developed.  A letter of agreement from
the GCRC Program Director must be included with the application.

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 and 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 must 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 (rev. 9/91) 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 should
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 application will be returned.

Peer reviewers 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 reflected in assigning
the priority score 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.

LETTER OF INTENT

Prospective applicants are asked to submit, by May 10, 1993, a letter
of intent that includes 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 RFA in response to which the
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 NIAMS staff to estimate the potential review
workload and to avoid conflict of interest in the review.

The letter of intent is to be sent to:

Dr. Julia B. Freeman
Centers Program, EP
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Westwood Building, Room 403
Bethesda, MD  20892
Telephone:  (301) 402-3348
FAX:  (301) 480-7881

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these grants.  These forms are available at most
institutional offices of sponsored research and from the Office of
Grants Inquiries, Division of Research Grants, National Institutes of
Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone
301/496-7441.

Special guidelines have been developed for the SDRC program in the
NIAMS.  These guidelines must be used in assembling the application.
The guidelines may be obtained by contacting the Centers Program
Director listed under INQUIRIES.

The RFA label available in the application form must be affixed to the
bottom of the face page of the application.  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 2a of the face page of the
application form and the YES box must be marked.

Submit a signed, typewritten original of the application, including the
Checklist, and three signed, photocopies, in one package to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

At the time of submission, two additional copies of the application
must also be sent to:

Dr. Tommy L. Broadwater
Chief, Review Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Westwood Building, Room 405
Bethesda, MD  20892

Applications must be received by June 18, 1993.  If an application is
received after that date, it will be returned to the applicant without
review.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the
Division of Research Grants (DRG) and responsiveness by the NIAMS.
Incomplete applications will be returned to the applicant without
further consideration.

Applications that are received after the June 18, 1993, receipt date,
that exceed the budget limit of $400,000 in direct costs, or that are
otherwise unresponsive to the major criteria of the RFA will be
returned to the applicant.

Applications may be triaged by an NIAMS peer review group on the basis
of relative competitiveness.  The NIH will withdraw from further
competition those applications judged to be non-competitive for award
and notify the applicant Principal Investigator and institutional
official.  Those applications judged to be competitive will undergo
further scientific merit review. It is unlikely that a site visit will
be conducted.  Each proposal should therefore be complete in itself and
be prepared as if no site visit is expected.

Those applications that are complete and responsive will be evaluated
in accordance with the criteria stated below for scientific/technical
merit by an appropriate peer review group convened by the NIAMS.  The
second level of review will be provided by the National Arthritis and
Musculoskeletal and Skin Diseases Advisory Council.

Review criteria for RFAs are generally the same as those for
unsolicited research grant applications.

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.

Factors to be considered in evaluation of the scientific merit of each
application will include an evaluation of the independently funded
biomedical research base, the appropriateness of the proposed cores,
the quality of the proposed pilot and feasibility studies, and their
proposed management.  The evaluation of the biomedical research base
will encompass the record of research training and the institution's
commitment to the Center program.

AWARD CRITERIA

The anticipated date of award is March 1, 1994.

The primary factors determining the award will be the priority score
and the availability of funds.  Since the NIAMS is interested in
funding only the best research, individual research projects of lesser
quality may not be funded, even if approved, under the "umbrella" of
the SDRC mechanism.

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcome.

Direct inquiries regarding programmatic issues to:

Dr. Julia B. Freeman
Centers Program, EP
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Westwood Building, Room 403
Bethesda, MD  20892
Telephone:  (301) 402-3348
FAX:  (301) 480-7881

Direct inquiries regarding fiscal matters to:

Mary L. Graham
Grants Management Officer
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Westwood Building, Room 722A
Bethesda, MD  20892
Telephone:  (301) 402-3361

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance
No. 93.846, Arthritis, Musculoskeletal and Skin Diseases Research.
Awards will be made under the authority of the Public Health Service
Act, Title III, Section 301 (Public Law 410, 78th Congress, as amended,
42 USC 241) and administered under PHS grants policies and Federal
regulations 42 CFR Part 52 and 45 CFR Part 74.  This program is not
subject to intergovernmental review requirements of Executive Order
12372 or Health Systems Agency review.

.

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