Subject: NIH GUIDE - RFA AR-92-01 - V20(43) 11/15/91
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Fri, 15 Nov 91 08:51 EST

Hi Paul,
    Please post this to the NIH Listserver as:
        RFAAR-92-01.911115
                          Dottie
 ---------------------------- Text of forwarded message -----------------------
 
$$XID RFA AR9201 AR-92-01 P1O1 *****************************************
 
SKIN DISEASES RESEARCH CORE CENTERS
 
RFA:  AR-92-01
 
P.T. 04; K.W. 0715185, 0710030
 
National Institute of Arthritis and Musculoskeletal and Skin Diseases
 
Letter of Intent Receipt Date:  February 17, 1992
Application Receipt Date:  April 22, 1992
 
BACKGROUND
 
The National Institute of Arthritis and Musculoskeletal and Skin
Diseases (NIAMS) invites applications for research core centers 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.
 
RESEARCH GOALS AND SCOPE
 
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 problems upon which the SDRC would focus is made
by the Principal Investigator and collaborating currently funded
investigators.
 
The SDRCs will provide support for:
 
o  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.
 
o  Limited funds for pilot and feasibility studies.
 
o  Program enrichment activities.
 
An SDRC must be an identifiable organizational unit within a
university- affiliated medical center.  An Administrative Core must 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 project 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) as a Principal
Investigator.  New investigators must be clearly independent and have
a faculty appointment higher than that of postdoctoral fellow or
research associate.
 
ELIGIBILITY
 
Applications may be submitted by domestic, nonprofit, public and
private organizations, such as universities, colleges, hospitals,
laboratories,units of State or local governments, and eligible agencies
of the Federal government.  Applications from minority individuals and
women are encouraged.
 
MECHANISM OF SUPPORT
The Center Core Grants designation (P30) will be used for the SDRCs.
The P30 grant is a mechanism for integrating, coordinating, and
fostering the interdisciplinary cooperation of a group of established
investigators conducting programs of active, high-quality research that
relate to a common theme and for stimulating new research.
Applications for noncompeting renewal will have specific, additional
reporting requirements to document progress in the larger aims of the
Center.
 
Applicants from institutions having 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.  In such a case, a letter of agreement from either the GCRC
program director or Principal Investigator must be included with the
application.
 
The NIAMS intends to fund two SDRCs in FY 92, subject to the
availability of resources and receipt of sufficiently meritorious
applications, each with a yearly direct cost budget of no more than
$400,000.  To fund these awards, one million dollars has been set aside
for total costs in the first year.  The award of grants pursuant to
this RFA is contingent upon the receipt of appropriate funds for this
purpose.  The funding period is five years and may be renewable on a
competitive basis.  There have been no funds specifically reserved for
renewals at this time.
 
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS
 
NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical
research grants and cooperative agreements will be 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 should be placed on the need
for inclusion of minorities and women in studies of diseases,
disorders, and conditions that disproportionately affect them.  This
policy is intended to apply to men and women 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 should 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 should be included in the Form PHS 398 in
Section 2, A-D of the Research Plan, and summarized in Section 2, E,
Human Subjects.  Applicants/offerors 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 includes 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;
because the definition of minority differs in other countries, the
applicant must discuss the relevance of research involving foreign
population groups to U.S. 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 will be 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.
 
REVIEW PROCEDURES AND CRITERIA
 
All applications submitted in response to the RFA will first be
reviewed by NIAMS staff to ensure that they are responsive to the RFA.
Applications that are received after the April 22, 1992, 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.  Accepted applications will be reviewed for
scientific and technical merit by an initial review group within the
NIAMS that will be convened solely to review these applications.  It is
unlikely that a site visit will be conducted.  Each application must,
therefore, be complete in itself and be prepared as if no site visit is
expected.
 
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.
 
Following assessment by the initial review group, applications will be
evaluated by the National Arthritis and Musculoskeletal and Skin
Diseases Advisory Council.  The NIAMS Review Branch will review the
applications during June or July 1992.  Secondary review will occur at
the September 1992 meeting of the National Arthritis and
Musculoskeletal and Skin Diseases Advisory Council.  Earliest possible
funding will be September 1992.
 
METHOD OF APPLYING
 
Applications must follow the SDRC guidelines to be accepted for review.
Prospective applicants are asked to submit a letter of intent that
includes identification of any other participating investigators and
institutions and a descriptive title.  NIAMS requests such letters only
for the purpose of providing an indication of the number and scope of
applications to be received and, therefore, usually does not
acknowledge their receipt.  A letter of intent is not binding, and it
will not enter into the review of any applications subsequently
submitted, nor is it a necessary requirement for application.  The
letter of intent is requested by February 17, 1992, and is to be sent
to:
 
Julia B. Freeman, Ph.D.
Director, Centers Programs
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Westwood Building, Room 403
Bethesda, MD  20892
Telephone:  (301) 496-7495
 
Applications must be submitted on form PHS 398 (rev. 10/88) that is
available in the institution's collaborative research or business
office and 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.  The phrase "RFA AR-92-01,
Skin Diseases Research Core Center" must be typed on line 2 of the
first page of the application.  The RFA label available in the 10/88
revision of application form PHS 398 must be affixed to the bottom of
the face page.  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.
 
The receipt date for an original and four copies of the complete
application is on or before April 22, 1992.  Applications must be sent
to:
 
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD   20892**
 
In addition, two informational copies must be sent under separate cover
to:
 
Dr. Tommy Broadwater
Chief, Scientific Review Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Extramural Programs
Westwood Building, Room 403
Bethesda, MD  20892
 
INQUIRIES
 
Applicants must request the detailed guidelines for the SDRC grant
application from:
 
Julia B. Freeman, Ph.D.
Director, Centers Programs
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Westwood Building, Room 403
Bethesda, MD  20892
Telephone:  (301) 496-7495
 
For fiscal and administrative matters, contact:
 
Mary Graham
Grants Management Specialist
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Westwood Building, Room 417E
Bethesda, MD  20892
Telephone:  (301) 496-2665
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic Assistance
No. 93.846.  Grants are awarded under the authority of the Public
Health Service Act, Section 301 (42 USC 241) and administered under PHS
grants policies and Federal Regulations, most specifically at 42 CFR
Part 52 and 45 CFR Part 74. This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or
review by a Health Systems Agency.