SPECIALIZED CENTERS OF RESEARCH (SCORs) IN RHEUMATOID ARTHRITIS AND 
IN OSTEOPOROSIS

Release Date:  December 5, 2001

RFA:  RFA-AR-02-005

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Letter of Intent Receipt Date:  September 16, 2002
Application Receipt Date:       October 16, 2002

PURPOSE
												
The National Institute of Arthritis and Musculoskeletal and Skin Diseases 
(NIAMS) invites applications for Specialized Centers of Research (SCORs) in 
osteoporosis or in rheumatoid arthritis.  A SCOR should foster a coordinated 
research effort that strongly emphasizes basic disciplines, but also involves 
significant interaction between basic research and clinical investigations in 
one of these two disease areas.  A SCOR is envisioned as a national resource 
associated with one or more major medical complexes and dedicated to working 
with the NIAMS in furthering the research effort to translate basic research 
to clinical application.

HEALTHY PEOPLE 2010

The Public Health Service (PHS) is committed to achieving the health 
promotion and disease prevention objectives of "Healthy People 2010," a PHS-
led national activity for setting priority areas.  This Request for 
Applications (RFA), Specialized Centers of Research, is related to one or 
more of the priority areas.  Potential applicants may obtain a copy of 
"Healthy People 2010" at http://www.health.gov/healthypeople/.

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 the 
disease area should be present.  Foreign organizations are not eligible. 
International collaborations in domestic applications will only be accepted 
if the resources are clearly shown to be unavailable in the United States. 
Applications from racial/ethnic minority individuals and women and persons 
with disabilities are encouraged.

MECHANISM OF SUPPORT

Support of this program will be through the NIH specialized center (P50) 
award.  Responsibility for the planning, direction, and execution of the 
proposed project will be solely that of the applicant.  Investigators are to 
request five years of support.  The anticipated award date is July 1, 2003.

FUNDS AVAILABLE

The direct costs requested cannot exceed $750,000 each year (exclusive 
of facilities and administrative costs of subcontracts with 
collaborating organizations).  The NIAMS intends to fund up to 2 new 
and/or competing continuation applications responding to this RFA in FY 
2003 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 
$2.2 million.

RESEARCH OBJECTIVES

The objective of the SCOR program is to expedite development and 
application of new knowledge to human diseases, to learn more about the 
etiology of these diseases, and to foster improved approaches to 
treatment and/or prevention.  A SCOR consists of at least three 
individual, but interrelated, research projects, each with high 
scientific merit and clear research objectives and, in the aggregate, 
devoted to a specific major health area.  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.

Clinical research is defined as (1) patient-oriented research, (2) 
epidemiologic and behavioral studies, and (3) outcomes research and 
health services research.  Patient-oriented research is research 
conducted with human subjects (or on material of human origin such as 
tissues, specimens and cognitive phenomena) for which an investigator 
(or colleague) directly interacts with human subjects. Excluded from 
this definition are in vitro studies that utilize human tissues but do 
not deal directly with patients.  Patient-oriented research includes 
mechanisms of human disease, therapeutic interventions, clinical trials 
and development of new technologies.

Although research programs will vary among institutions according to 
local expertise, interests, and resources, each SCOR should have a 
central theme related to the disease area to which individual projects 
relate and which 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 the disease area 
addressed.  Collaboration among institutions is encouraged within a 
given SCOR to share scarce patient resources.

Funding may also be requested for one or more core resources.  A core 
is defined as a resource shared by multiple investigators that enhances 
research productivity and increases the functional capacity of the 
SCOR.  Ongoing projects may be absorbed into the SCOR if their original 
funding source is relinquished.

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.  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.

SPECIAL REQUIREMENTS

The director and co-director should budget for an annual one-day 
meeting in Bethesda, MD with NIAMS staff.  The director should be 
prepared to devote at least 15 percent effort as the director and 20 
percent effort as a project PI.  Each project and core PI should be 
prepared to devote at least 20 percent effort.

To be funded, a SCOR must include at least three highly meritorious 
projects approved for five years.  One of these must have the SCOR 
director as the principal investigator, and the highly meritorious 
projects must include both basic and clinical research.

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 sub-populations must be included in all NIH-supported 
clinical research projects unless a clear and compelling justification 
is provided indicating that inclusion is inappropriate with respect to 
the health of the subjects or the purpose of the research. This policy 
results from the NIH Revitalization Act of 1993 (Section 492B of Public 
Law 103-43).

All investigators proposing clinical research should read the AMENDMENT 
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research - Amended, October, 2001," published in the NIH Guide 
for Grants and Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a 
complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.  
The amended policy incorporates: the use of an NIH 
definition of clinical research; updated racial and ethnic categories 
in compliance with the new OMB standards; clarification of language 
governing NIH-defined Phase III clinical trials consistent with the new 
PHS Form 398; and updated roles and responsibilities of NIH staff and 
the extramural community.  The policy continues to require for all NIH-
defined Phase III clinical trials that: a) all applications or 
proposals and/or protocols must provide a description of plans to 
conduct analyses, as appropriate, to address differences by sex/gender 
and/or racial/ethnic groups, including subgroups if applicable; and b) 
investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN 
SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age 
of 21) must be included in all human subjects research, conducted or 
supported by the NIH, unless there are scientific and ethical reasons 
not to include them.  This policy applies to all initial (Type 1) 
applications submitted for receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should 
read the "NIH Policy and Guidelines on the Inclusion of Children as 
Participants in Research Involving Human Subjects" that was published 
in the NIH Guide for Grants and Contracts, March 6, 1998, and is 
available at the following URL address: 
http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators also may obtain a copy of this policy from the program 
staff listed under INQUIRIES.  Program staff may also provide 
additional relevant information concerning the policy.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS

NIH policy requires education on the protection of human subject 
participants for all investigators submitting NIH proposals for 
research involving human subjects.  This policy announcement is found 
in the NIH Guide for Grants and Contracts Announcement dated June 5, 
2000, at the following website: 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

URLS IN NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals for NIH funding must be self-contained 
within specified page limitations.  Unless otherwise specified in an 
NIH solicitation, internet addresses (URLs) should not be used to 
provide information necessary to the review because reviewers are under 
no obligation to view the Internet sites.  Reviewers are cautioned that 
their anonymity may be compromised when they directly access an 
Internet site.

LETTER OF INTENT

Prospective applicants are asked to submit, by September 16, 2002, 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 plan the review.  
The letter of intent is to be sent to Dr. Julia B. Freeman at the 
address listed under INQUIRIES.

APPLICATION PROCEDURES

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

The PHS 398 research grant application instructions and forms (rev. 
5/2001) available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html must be used in 
applying for these grants. This version of the PHS 398 is available in 
an interactive, searchable format.  For further assistance contact 
GrantsInfo, Telephone 301/435-0714, Email:  GrantsInfo@nih.gov.

The RFA label available in the PHS 398 (rev. 5/01) application form 
must be affixed to the bottom of the face page of the application.  The 
sample RFA label is available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.  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, "Specialized Centers of Research" and number, 
"AR-02-005" 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:

CENTER FOR SCIENTIFIC REVIEW
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:

Tommy L. Broadwater, Ph.D.
Chief, 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 October 16, 2002.  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 CSR and 
for responsiveness to the RFA by the NIAMS staff.  Incomplete and/or 
non-responsive applications will be returned to the applicant without 
further consideration.  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 
the review criteria stated below.  As part of the initial merit review, 
a process may be used by the initial review group in which all 
applications receive a written critique and undergo a process in which 
only those applications with the highest scientific and technical merit 
will be discussed, assigned a priority score, and receive a second 
level review by the National Arthritis and Musculoskeletal and Skin 
Diseases Advisory Council.

Site visits will not be made.

Review Criteria

Major factors to be considered in evaluation of applications will 
include:

1.  How the proposed SCOR combines basic and clinical research into the 
scientific goals and research theme;

2.  If a competing continuation application, the quality and 
significance of the progress made in the previous funding period;

3.  Scientific merit of each proposed project.  [Each project will 
receive a priority score.  This score reflects not only the feasibility 
of the project and adequacy of the experimental design, but also the 
design of the project to advance both the theme of the SCOR and the 
interaction between basic research and clinical investigation];

4.  Scientific merit of combining the component parts into a SCOR;

5.  Technical merit and justification of each core unit;

6.  Competence of the investigators to accomplish the proposed research 
goals, their commitment, and the time they will devote to the research 
program;

7.  Adequacy of facilities to perform the proposed research, including 
laboratory and clinical facilities, instrumentation, and data 
management systems, when needed;

8.  Adequacy of plans for interaction among investigators, and the  
integration of the various projects and core units;

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

10.  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;

11.  Institutional commitment to the program, and the appropriateness 
of resources and policies for the administration of a SCOR;

12. Adequacy of plans to include both genders and minorities and their 
subgroups and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects will 
also be evaluated.

AWARD CRITERIA

The anticipated award date is July 1, 2003. The primary factors 
determining the award will be the priority score, the overall balance 
of meritorious projects (clinical and basic research) within the 
application relative to the disease area, and the availability of 
funds.  Since the NIAMS is interested in funding only the best 
research, individual projects or cores of lesser quality may not be 
funded, even if approved, under the "umbrella" of the SCOR 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
Bethesda, MD  20814 (for express/courier service)
Telephone:  (301) 594-5052
FAX:  (301) 480-4543
Email:  Julia_B_Freeman@nih.gov

Copies of the guidelines for the NIAMS SCOR program may be obtained from:

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

Guidelines are also available on the internet:

http://www.nih.gov/niams/grants/ep7.htm
http://www.niams.nih.gov/rtac/funding/grants/scorwww.htm

Direct inquiries regarding fiscal matters to:

Melinda Nelson
Chief 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:  nelsonm@exchange.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 Parts 52 and 45 CFR Parts 74 and 92.  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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