Subject: (Copy) RFA AR-91-01
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Thu, 27 Dec 90 13:45 EST

Hi Paul,
   This is one of two left from the l2/28/90 NIH Guide.  Please post
to the listserver as:
     RFAAR-91-01.901228
   Thanks.
          Dottie
 ---------------------------- Text of forwarded message -----------------------
 
SPECIALIZED CENTERS OF RESEARCH IN RHEUMATOID ARTHRITIS (RA)
SPECIALIZED CENTERS OF RESEARCH IN OSTEOPOROSIS (OP)
SPECIALIZED CENTERS OF RESEARCH IN OSTEOARTHRITIS (OA)
 
RFA AVAILABLE:  AR-91-01
 
P.T. 04; K.W. 0715010, 0705050, 0710030
 
National Institute of Arthritis and Musculoskeletal and Skin Diseases
 
Letter of Intent Receipt Date:  July 15, 1991 (RA and OP)
                                November 14, 1991 (OA)
 
Application Receipt Date:       October 15, 1991 (RA and OP)
                                February 14, 1992 (OA)
 
The National Institute of Arthritis and Musculoskeletal and
Skin Diseases (NIAMS) established 9 Specialized Centers of
Research (SCORs) in Fiscal Year 87, three each in
osteoarthritis, osteoporosis, and rheumatoid arthritis.  The
purpose of this Request for Applications (RFA) is to recompete these
centers in an open
competition.  The specific areas will remain osteoarthritis,
osteoporosis, and rheumatoid arthritis.  Applications for
SCORs in rheumatoid arthritis and osteoporosis will be
accepted on October 15, 1991.  Applications for SCORs in
osteoarthritis will be accepted on February 14, 1992.  The
direct cost budget requested may not exceed $1 million each
year.  The applications should present five years of work.
 
BACKGROUND
 
A SCOR consists of a cluster of individual, but
interrelated, basic and clinical research projects, each
with high scientific merit and clear research objectives
and, in the aggregate, devoted to a specific major health
area.  Ongoing projects may be absorbed into the SCOR if
their original funding source is relinquished.
 
In addition, funding may also be requested for one or more
core resources devoted to performing specialized support
activities, such as biochemical analysis, electron
microscopy, or data management.  A core is defined as a
resource shared by several investigators that should
enhance research productivity and increase the functional
capacity of the SCOR.  The core is designed to provide an
added dimension generating a new accomplishment greater than
that obtained by the performance of the sum of the
individual projects alone.  Developmental research (for
example, development of new assays or procedures) needed to
further research efforts of the SCOR investigators will be
permitted in a core.
 
NIAMS currently supports
SCORs in three areas of special importance to the
Institute:  rheumatoid arthritis, osteoporosis, and
osteoarthritis.  Each SCOR is envisioned as a national
resource associated with a major medical complex and
dedicated to working with the NIAMS in furthering the
research effort related to a given arthritis and
musculoskeletal disease area.  The SCOR program complements
other programs in research and training supported by the
Institute.  SCORs should foster a concerted research effort
that strongly emphasizes basic disciplines, but also
involves significant interaction between
basic research and clinical investigations of diseases
within the purview of the Institute.
 
OBJECTIVES AND SCOPE
 
SCOR programs must include both basic and clinical research.
Each program will provide for a mutually supportive
interaction between scientists conducting basic research and
those performing clinical investigation.  The individual
projects and cores should be correlative or complementary in
the area selected for the SCOR.
 
The objective of this SCOR program is to expedite
development and application of new knowledge of specific
importance to arthritis and musculoskeletal diseases, to
learn more about the etiology of these diseases, and to
foster improved approaches to treatment and/or prevention.
Each SCOR should provide a multidisciplinary approach
utilizing both laboratory and clinical research to focus on
a particular health problem and provide for a mutually
supportive interaction between basic scientists and clinical
investigators.  Although research programs will vary at each
institution according to local expertise, interests, and
resources, each SCOR should have a central theme related to
osteoarthritis, rheumatoid arthritis, or osteoporosis to
which individual projects relate and that serves as an
integrating force.  Emphasis in proposed projects should be
on development of innovative approaches, elaboration of new
and significant hypotheses, and generation of improved
strategies for approaching current issues relating to
arthritis and musculoskeletal diseases.
 
Support for large clinical trials or for applications that
contain exclusively clinical or exclusively basic studies
will not be provided within this SCOR program.
Applicants from institutions which 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.  In such a
case, a letter of agreement from either the GCRC program
director or Principal Investigator is requested with
the application.
 
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 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 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; 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 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.
 
PROGRAM ADMINISTRATION/INTERACTION
 
The NIAMS Centers Program Director will facilitate program
development, disseminate new findings, and increase
interaction among SCOR's.  The program director will
coordinate plans for any special activities of mutual
interest to the Institute and the SCOR or, perhaps, to
several SCORs.  The NIAMS program director may make periodic
visits to various Centers and will be responsible for
evaluating progress.
 
To foster cooperation among Centers, SCOR personnel may be
asked to meet periodically to review progress and plans for
future work.  Applicants, therefore, should include a
request for travel funds for the Center Director and other
key staff members to travel to the Washington, D.C. area in
each year of their budget.
 
MECHANISM OF SUPPORT
 
The support mechanism will be the research grant-in-aid (P50).
The Direct Costs requested cannot exceed $1 million each
year.  The number and size of any resultant awards will be
based upon the merit of the applications received and the
funds available.  If sufficient applications are judged by
peer review to be of excellent to outstanding merit, NIAMS
anticipates funding 9 SCORs for 5 years, three for each of
the diseases listed.  The grants may be renewable on a competitive
basis.
 
Applicants are expected to furnish estimates of the time
required to achieve specific objectives of the proposed work
and a schedule for completion of the work.  The SCOR will
plan, direct, and implement its own research program.  However, any
substantial modifications in the scope or objectives must be
agreed upon mutually by the SCOR institution and the NIAMS.
 
REVIEW PROCEDURES AND CRITERIA
 
Applications for Arthritis and Musculoskeletal Diseases SCORs
will be first screened for completeness, responsiveness, and
scientific merit.  Applications that are incomplete for review or
nonresponsive to this RFA will be screened out by the Division of
Research Grants and NIAMS staff upon receipt.  Applications that
are complete and responsive may be subjected to a preliminary
evaluation by a peer review group to determine their scientific
merit relative to the other applications received in response to
this RFA (triage); the NIH will withdraw from further
consideration applications judged to be noncompetitive and
promptly notify the Principal Investigators and the official
signing for the applicant organization.  Those applications
judged to be competitive will be further evaluated for scientific
merit by an ad hoc review group.  This phase of peer review will
be conducted by a group of expert consultants convened by the
Review Branch of the NIAMS.  Each proposal should be complete in
itself.  Site visits are not anticipated.  A second level of
review will be performed by the National Arthritis and
Musculoskeletal and Skin Diseases Advisory Council.
 
Major factors to be considered in evaluation of applications
will include the:
 
1.   Scientific merit of each proposed project, including
the originality and feasibility of the project and the
adequacy of the experimental design;
 
2.   Scientific merit of combining the component parts into
a SCOR;
 
3.   Technical merit and justification of each core unit;
 
4.   Competence and commitment of the investigators to accomplish the
proposed research goals, and the time they
will devote to the research program;
 
5.   Adequacy of facilities to perform the proposed
research, including laboratory and clinical facilities,
instrumentation, and data management systems, when needed;
 
6.   Adequacy of plans for interaction among investigators,
and the integration of the various projects and core units;
 
7.   Qualifications, experience, and commitment of the SCOR
Director and his/her ability to devote time and effort to
provide effective leadership;
 
8.   Scientific and administrative structure, including
internal and external procedures for monitoring and
evaluating the proposed research and for providing ongoing
quality control and scientific review;
 
9.   Institutional commitment to the program, and the
appropriateness of resources and policies for the
administration of a SCOR;
 
10.  Appropriateness of the budget for the proposed program
and its individual components.
 
METHOD OF APPLICATION
 
Program Guidelines and Letter of Intent
 
Program guidelines, developed by NIAMS for its SCOR Program,
are available by contacting the Centers Program Director
below.  It is especially important that applicants obtain
and follow these supplemental NIAMS guidelines that
require certain information in addition to the usual
instructions.
 
To facilitate Institute planning, applicants are requested
to submit a letter of intent by July 15, 1991 for the RA and
OP SCOR and by November 14, 1991 for the OA SCOR.
The letter
should include a descriptive title, the name
and address of the Principal Investigator and other key
investigations, and the names and address of any other
participating institutions.
 
The letter of
intent, and any inquiries about the program, should be
directed to:
 
Julia B. Freeman, Ph.D.
Centers Program Director, EP, NIAMS
Westwood Building, Room 403
5333 Westbard Avenue
Bethesda, MD  20892
Telephone:  (301) 496-7495
FAX:  (301) 480-7881
 
The Institute requests such letters for the purpose of
obtaining an indication of the number and scope of
applications to be received.  A letter of intent is not
binding, will not enter into the review of any proposal
subsequently submitted, and is not a requirement for
application.
 
The letter of intent, however, may be useful as a basis for
consultation prior to submission of an application.
Applicants should make arrangements for such consultation
early in the application preparation process.  Applicants
should not construe advice given by Institute staff as
assurance of a favorable review or funding.  The program
staff will not evaluate or discuss the merit of the
proposal.
 
Application Procedure
 
Type in the RFA number and title of this announcement on line 2
of the application face page.
 
The RFA label (found in the 10/88 revision of application form
PHS 398) must be affixed to the bottom of the face page of the
original copy of the application.  Failure to use this label
could result in delayed processing of your application such that
it will not reach the review committee in time for review.
 
The signed, completed, original application and four (4)
signed, exact photocopies, should be sent or delivered to:
 
Application Receipt Office
National Institute of Health
Division of Research Grants
Westwood Building, Room 240
Bethesda, MD  20892**
 
Applications must be received by the dates listed in this
announcement for each specific competition.  An application
not received by this date will be considered ineligible.
 
In addition to mailing the application to the Division of
Research Grants, send two (2) copies of the application to:
 
Tommy Broadwater, Ph.D.
Chief, Review Branch, EP, NIAMS
Room 5A-07 Westwood Building
5333 Westbard Avenue
Bethesda, MD  20892
FAX:  (301) 480-7881
 
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 grant policies and
Federal Regulations, most specifically at 42 CFR Part 52 and
45 CFR Part 74.  This program is not subject to review by a
Health Systems Agency.