Full Text AR-93-01

JUVENILE RHEUMATIC DISEASES RESEARCH CENTER PLANNING GRANT

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

RFA:  AR-93-01

P.T. 34

Keywords: 
  Rheumatic Diseases 
  Arthritis 
  Biomedical Research, Multidiscipl 


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 a planning grant for a
juvenile rheumatic diseases research center.

The goal of the planning grant is to establish a Juvenile Rheumatic
Diseases Research Center (JRDRC).  The JRDRC planning grant will allow
the applicant to develop key multidisciplinary research areas needed to
establish a JRDRC.  A JRDRC is envisioned to be a resource center for
research in juvenile arthritis and musculoskeletal diseases.  This
center will be associated with a major medical complex or consortium
and dedicated to furthering the research effort related to juvenile
arthritis and musculoskeletal diseases.

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), Juvenile Rheumatic Diseases Research Center
Planning Grant, 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 an established
program for pediatric rheumatology and a relevant research base.
Foreign research organizations 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) planning
grant (P20).  Responsibility for the planning, direction, and execution
of the proposed program will be solely that of the applicant.  The
total project period for applications submitted in response to the
present RFA should be three years.  The anticipated award date is
September 30, 1993.  The direct costs requested cannot exceed $200,000
each year.  The award will not be renewed, but may be converted to
another funding mechanism.

FUNDS AVAILABLE

The estimated funds (total costs) available for the first year of
support for a JRDRC planning grant is $300,000.  One award is
anticipated.  Funding will depend on receiving applications judged
highly meritorious by peer review.

RESEARCH OBJECTIVES

Chronic rheumatic diseases represent an important entity among chronic
conditions affecting children.  Among the rheumatic diseases seen in
juvenile populations are rheumatoid arthritis, chronic arthritis
(systemic, polyarthritic, and pauciarticular), spondyloarthropathy,
systemic lupus erythematosus, dermatomyositis, scleroderma and other
vasculopathies and connective tissue disorders.  Many childhood
rheumatic diseases have orthopaedic aspects.  A research agenda for the
genetic, infectious, and immunologic aspects of juvenile rheumatic
diseases will benefit from a multidisciplinary approach.  Because the
research issues for juvenile arthritis and musculoskeletal diseases are
complex, the NIAMS seeks to use a planning grant to explore the
potential for establishing a JRDRC through a planning grant.

Applications for a JRDRC planning grant should propose a program of
multidisciplinary research development as a resource for research in
arthritis and musculoskeletal diseases in children and for research to
develop effective education programs for children, their families, and
the public.

The goal of the planning grant will be to develop those areas needed at
the applicant institution or consortium.  The applicant should outline
the areas that may be part of a future JRDRC and the research projects
presented in the planning grant should relate to the development of key
areas in that center.  A major goal of a JRDRC is to promote bench to
bedside application of research.  Clinical projects are required.

The planning grant will provide funds for an Administrative and
Planning Core and for Pilot Studies to develop and expand the research
base.

An Administrative and Planning Core will manage the overall activities
related to developing the JRDRC.  There must be a Director (Principal
Investigator of the planning grant), a discrete administrative
structure, and an Advisory Committee.  The Core may also include the
administration of shared resources, such as data sets or community or
clinical research facilities, or provide research design and data
analysis/statistical service.

The Director will be the key figure in the scientific administration
and management of the planning grant.  The Director must be an
experienced researcher with demonstrated leadership appropriate to the
coordination and development of a Center.

Although the final administrative structure of a Center will be left to
the discretion of the applicant institution, experience demonstrates
that effective development of Center programs requires interaction
among the Director, the Principal Investigators of the pilot studies,
appropriate institutional administrative personnel, and the staff of
the NIAMS.  Like other interdisciplinary grant programs, the success of
a Center is dependent upon the involvement of scientific and
professional personnel representing a variety of disciplines who must
be willing to relate to and collaborate with each other in order to
facilitate the development of new knowledge.

The Advisory Committee assists the Director in making the scientific
and administrative decisions relating to a Center.  With the Director,
the Advisory Committee will have the responsibility of evaluating the
pilot studies proposed in the initial application and to be developed
during subsequent years.  (This does not preclude the applicant
institution from developing a separate external review process to
evaluate the scientific merit of the individual pilot studies developed
during subsequent years.  The final evaluation of the pilot studies,
however, will rest with the Advisory Committee and the Director).  The
Advisory Committee may perform other duties as deemed appropriate by
the applicant institution.  The Advisory Committee must be composed of
scientists and administrators with expertise and experience relevant to
the Center's scientific program.  Members may be employees of the
applicant institution or of other institutions.  However, at least two
members of this committee must be from outside the Director's
supervision (i.e., either at the applicant institution or another
institution).

The program areas of a JRDRC are to be related to arthritis and
musculoskeletal diseases in children and may include treatment
strategies.  In the planning grant, pilot studies are to be proposed to
expand the research base at the applicant institution.  The P20 funding
mechanism is intended to furnish modest support that will allow the
investigators the opportunity to develop preliminary data sufficient to
provide the basis for applications for independent research through
conventional granting mechanisms.  Pilot studies are typically limited
to a nonrenewable period of one to two years.

Applications submitted in response to this RFA must propose a minimum
of three pilot studies to be supported during at least the first year
of the award.  Subsequent preliminary research projects may be
developed during the course of the award.  The Advisory Committee will
have final approval for future pilot studies after a local peer review
of the proposals.

Appropriate research areas may include, but are not limited to:

o  Basic and clinical research leading to understanding the cause(s),
diagnoses, improved treatment, and ultimate prevention of arthritis and
musculoskeletal diseases in children is a critical aspect of the JRDRC.
Clinical studies may address such research areas as: providing critical
data for the design of larger clinical trials, testing the feasibility
of new pharmacologic interventions, and devising improved diagnostic
strategies.  Studies integrating physical therapy and/or orthopaedic
research with functional outcome may be included, as may epidemiologic
studies that offer new insights.

o  Research development and evaluation of new programs, techniques or
methodologies for the education of health professionals, patients,
families of patients, and the public are appropriate.  Evaluation and
validation of patient assessment tools for the pediatric population may
be proposed.  Psychosocial research leading to improved intervention
strategies, counseling, and enhancing the coping skills of children and
their families are appropriate.

SPECIAL REQUIREMENTS

Investigators will be asked to meet periodically with NIAMS staff in
Bethesda to review progress and plans for future work.

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 interaction of the planning center staff and
pilot study members 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; 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; and from the NIAMS program administrator listed under
INQUIRIES.

Special guidelines have been developed for the JRDRC planning grant.
These guidelines must be used in writing and 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 April 20, 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 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 the NIAMS.  The second level of review will be
provided by the National Arthritis and Musculoskeletal and Skin
Diseases 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 Director (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; and

o  appropriateness of the proposed budget and duration in relation to
the proposed research.

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

o  qualifications, experience and commitment of the Director (Principal
Investigator) 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;

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

o  potential for developing a JRDRC from the resources and projects
described; and

o  commitment to developing a JRDRC as a national resource.

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 planning grant (P20) 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:

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 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.

.

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