Full Text AR-93-02

SPECIALIZED CENTER OF RESEARCH IN SYSTEMIC LUPUS ERYTHEMATOSUS

NIH GUIDE, Volume 21, Number 43, November 27, 1992

RFA:  AR-93-02

P.T. 04

Keywords: 
  Autoimmunity 
  Biomedical Research, Multidiscipl 
  Disease Prevention+ 
  Treatment, Medical+ 


National Institute of Arthritis and Musculoskeletal and Skin Diseases

Letter of Intent Receipt Date:  March 1, 1993
Application Receipt Date:  April 20, 1993

PURPOSE

The National Institute of Arthritis and Musculoskeletal and Skin
Diseases (NIAMS) invites applications for Specialized Centers of
Research (SCORs) in systemic lupus erythematosus.  A SCOR is
envisioned as a national resource associated with a major medical
complex and dedicated to furthering the research effort related to
systemic lupus erythematosus.  A SCOR should foster a concerted
research effort that strongly emphasizes basic disciplines, but also
involves significant interaction between basic research and clinical
investigations of systemic lupus erythematosus.

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), Specialized Center of Research in Systemic
Lupus Erythematosus, 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 that have established
clinical programs in rheumatology and research in systemic lupus
erythematosus.  Foreign organization are ineligible.  International
collaborations in domestic applications will only be accepted if the
resources are clearly shown to be unavailable in the United States.
Applications from minority individuals and women are encouraged.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) specialized
center grant (P50).  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 should be five years.  The anticipated
award date is September 30, 1993.  The direct costs requested cannot
exceed $500,000 each year.  Future SCOR awards or renewals will be by
RFA only.

FUNDS AVAILABLE

The estimated funds (total costs) available for the first year of
support for new SCORs is $1.5 million.  Two awards are anticipated.
However, funding will be contingent on receiving applications judged
by peer review to be highly meritorious.

RESEARCH OBJECTIVES

A SCOR consists of at least three 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.  Funding
may also be requested for one or more core resources.  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 objective of this SCOR program is to expedite development and
applications of new knowledge of specific importance to systemic
lupus erythematosus, to learn more about the etiology of this
disease, and to foster improved approaches to treatment and/or
preventions.  A SCOR should provide a multidisciplinary approach and
utilize both laboratory and clinical research to focus on systemic
lupus erythematosus.  The proposed SCOR should provide for a mutually
supportive interaction between basic scientists and clinical
investigators.  Research programs may vary at each institution
according to local expertise, interests, and resources.  Emphasis in
the proposed projects should be on the elaboration of new and
significant hypotheses, development of innovative approaches, and
generation of improved strategies for approaching current issues
relating to systemic lupus erythematosus.

Specific research issues were identified in the workshop, "Future
Research Agenda:  Systemic Lupus Erythematosus," sponsored by the
NIAMS and held January 13 and 14, 1992, in Bethesda, Maryland.  These
topics, although not necessarily all of them, are expected to be
targeted in a successful SCOR.  Special emphasis should be placed on
systemic lupus erythematosus as a disease more common in women, and
especially in black women.

Potential areas of inquiry include, but are not limited to:

o  mechanisms of immunologic tolerance;

o  immunoregulatory defects characteristic of systemic lupus
erythematosus;

o  mechanisms of tissue injury;

o  induction and perpetuation of autoantibody functional effects of
autoantibody on cell biology;

o  genetic controls of disease onset and persistence;

o  consequences of gender (why are females predominantly affected),
including the effects of oral contraceptives and estrogen replacement
therapy;

o  biologic differences among ethnic groups, including cross-cultural
studies and studies of migrants;

o  treatment:  novel treatment trial strategies; measurement
criteria; strategies to diminish toxicity; strategies to accelerate
the development of new agents; and treatment during pregnancy.

A copy of the notes from this workshop will be included in the
guidelines obtained from the contact person listed below.

Institutions With General Clinical Research Centers

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 SCOR 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.

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 March 1, 1993, a
letter of intent that includes a descriptive title of the proposed
research projects, 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, Extramural Programs
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 SCOR 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 above.

The RFA label available in the PHS 398 (rev. 9/91) 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 April 20, 1993.  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 announcement 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

Upon receipt, applications will be reviewed for completeness by the
DRG and responsiveness by the NIAMS.  Incomplete applications will be
returned to the applicant without further consideration.

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.  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 NIAMS.  The second level of
review will be provided by the National Arthritis and Musculoskeletal
and Skin Diseases Advisory Council.

Review criteria for this RFA 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;

Additional scientific/technical merit criteria specific to the
objectives of the SCOR program include:

o  scientific merit of combining the component parts into a SCOR;

o  technical merit and justification of each core unit;

o  adequacy of plans for interaction among investigators, and the
integration of the various projects and core units;

o  qualifications, experience and commitment of the SCOR Director and
his/her ability to devote time and effort to provide effective
leadership;

o  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.

Each project will be assigned a separate priority score, taking into
consideration only its merit as an individual research project.

AWARD CRITERIA

The anticipated date of award is September 30, 1993.

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 SCOR mechanism.  In addition, it is obviously
important that each project fit in with, and contribute to, the theme
of the overall SCOR.

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, Extramural Programs
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:

Mara H. DeKemper
Grants Management Officer
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Westwood Building, Room 732
Bethesda, MD  20892
Telephone:  (301) 496-0552

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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