Full Text AR-96-001

SKIN DISEASES RESEARCH CORE CENTERS

NIH GUIDE, Volume 24, Number 39, November 3, 1995

RFA:  AR-96-001

P.T. 04

Keywords: 
  Skin Diseases 


National Institute of Arthritis and Musculoskeletal and Skin Diseases

Letter of Intent Receipt Date:  May 10, 1996
Application Receipt Date:  June 19, 1996

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 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 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.  At the time
of award, the applicant institution cannot have another Skin Diseases
Research Core Center funded by NIAMS.  Foreign organizations are not
eligible.  Applications from racial/ethnic minority individuals and
women and persons with disabilities are encouraged.

MECHANISM OF SUPPORT

This RFA will use the NIH Core Center Grant (P30).  Responsibility
for the planning, direction, and execution of the proposed project
will be solely that of the applicant.  Investigators may request five
years of support.  The direct costs requested cannot exceed $400,000
each year.  The anticipated award date is March 1, 1997.

FUNDS AVAILABLE

The direct costs requested may not exceed $400,000 each year.  The
NIAMS intends to fund two SDRCs from this RFA in FY 1997, 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 $1.2 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 (3 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.

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.

SPECIAL REQUIREMENTS

The director and co-director should budget for an annual one-day
meeting in Bethesda, MD with NIAMS staff.

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.

LETTER OF INTENT

Prospective applicants are asked to submit, by May 10, 1996, 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 selection of reviewers.  The letter of
intent is to be sent to Dr. Julia B. Freeman at the address listed
under INQUIRIES.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 5/95) is to be used
in applying for these grants.  These forms 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 3034, MSC
7762, Bethesda, MD 20892-7762, telephone 301/435-0714, email:
girg@drgpo.drg.nih.gov.

Special guidelines have been developed for the SDRC program in NIAMS.
These guidelines should be used in assembling the application.  See
INQUIRIES for obtaining a copy of these guidelines.

The RFA label available in the PHS 398 (rev. 5/95) 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, "Skin Diseases Research Core
Center", and number, "AR-96-001" must be typed on line 2 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 of the application in one
package 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)

At the time of submission, send two additional copies of the
application to:

Review Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Natcher Building, Room 5AS.25U - MSC 6500
Bethesda, MD  20892-6500
Bethesda, MD  20814 (for express/courier service)

Applications must be received by June 19, 1996.  If an application is
received after that date, it will be returned to the applicant
without review.  The Division of Research Grants (DRG) will not
accept any application in response to this RFA that is essentially
the same as one currently pending initial review, unless the
applicant withdraws the pending application.  The DRG will not accept
any application that is essentially the same as one already reviewed.
This does not preclude the submission of substantial revisions of
applications already reviewed, but such applications must include an
introduction addressing the previous critique.

REVIEW CONSIDERATIONS

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 the NIAMS in accordance with NIH peer review
procedures.  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.

The factors to be considered in the evaluation of the merit of each
application will be those used in the review of the cores in standard
multi-project research grant applications.  Applicants should clearly
demonstrate the ways in which the SDRC will build the local research
program, will support on-going projects and will attract both senior
and new investigators to skin diseases research.  Each application
must be thorough and complete enough to stand on its own and should
be prepared as if no site visit will occur.  Additional materials or
revisions will not be accepted after the receipt date.  It is
strongly recommended that, if appropriate,  Institutional Review
Board (IRB) and Institutional Animal Care and Use committee (IACUC)
approval be secured before the application is submitted.  Otherwise,
it is the applicant's responsibility to ensure these certifications
are sent to the NIAMS Review Branch within 60 days of the receipt
date.  Applications failing to comply with this requirement will be
returned without review.

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, the safety of the
research environment, and conformance with the NIH Guidelines for the
Inclusion of Women and Minorities as Subjects in Clinical Research.

Additional factors to be considered in evaluation of the scientific
merit of each SDRC 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.

Research

o  The overall purpose of a SDRC is to increase the quantity and
quality of research in skin diseases within an applicant institution.
The expected effect of the SDRC on the capacity of the institution to
conduct skin diseases research and to secure extramural funding will
be a factor in review.

o  A base of ongoing high quality research dependent on core
resources and the potential to launch additional appropriate research
activities is a prerequisite for the establishment or continuation of
a SDRC and is an important component of the review.

o  The merit of the pilot and feasibility grant program proposed in
the new application and the quality of pilots funded in the previous
award period for competing continuations will be an important
criterion for evaluating pilot programs.

Administration

o  The scientific and administrative leadership ability of the SDRC
director and his/her staff, and their commitment and ability to
devote adequate time to the management of the SDRC program.

o  The proposed administrative organization.

o  Coordination of ongoing research and its use of the SDRC.  This
includes various mechanisms of internal monitoring.

Cores

o  How does each proposed core fit into the overall research program?
Will it enhance collaborative and/or interdisciplinary research?

o  Would the proposed core(s) duplicate existing resources or
services?  If so, are the requested new resources justified?  Do
other grant funds already provide any of the requested capabilities?

AWARD CRITERIA

The anticipated date of award is March 1, 1997.  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 pilot and feasibility projects or cores of
lesser quality will not be funded, even if recommended for approval,
under the "umbrella" of the SDRC mechanism.

INQUIRIES

Inquiries are encouraged.  The opportunity to clarify any issues or
questions from potential applicants is welcome.  Inquiries regarding
programmatic issues and letters of intent may be directed to:

Dr. Julia B. Freeman
Centers Program, EP
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Natcher Building, Room 5AS.19F -  MSC 6500
Bethesda, MD  20892-6500
Telephone:  (301) 594-5052
FAX:  (301) 480-4543
Email:  freemanj@ep.niams.nih.gov

Copies of the guidelines for the SDRC program may be obtained from:

NIAMS Clearinghouse
1 AMS Circle
Bethesda, MD  20892-3675
Telephone: (301) 495-4484
FAX: (301) 587-4352

Direct inquiries regarding fiscal matters to:

Sally A. Nichols
Grants Management Officer
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Natcher Building Room 5AS.49F - MSC 6500
Bethesda, MD  20892-6500
Telephone:  (301) 594-3535
FAX:  (301) 480-5450
Email:  nicholss@ep.niams.nih.gov

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 grant
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.

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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