MULTIDISCIPLINARY CLINICAL RESEARCH CENTERS FOR ARTHRITIS, MUSCULOSKELETAL, 
AND SKIN DISEASES

Release Date:  March 23, 2000

RFA:  AR-00-004

National Institute of Arthritis and Musculoskeletal and Skin Diseases
http://www.nih.gov/niams/

Letter of Intent Receipt Date:  December 1, 2000   
Application Receipt Date:       January 17, 2001

PURPOSE

The National Institute of Arthritis and Musculoskeletal and Skin Diseases 
(NIAMS) invites applications for a new program of Multidisciplinary Clinical 
Research Centers (MCRCs) in arthritis and/or musculoskeletal disorders and/or 
skin diseases.  The goals of this new program are to prevent disease and to 
assess and improve outcomes for patients with arthritis and other rheumatic 
diseases; musculoskeletal disorders including orthopaedics, bone diseases and 
muscle diseases; and skin diseases. For a comprehensive listing of the disease 
areas covered in the NIAMS extramural programs, please see 
http://www.nih.gov/niams/grants/gen2.html

Each MCRC will be organized around a methodology core and will be expected to 
include a minimum of three highly meritorious projects encompassing clinical 
research drawing from different disciplines. The methodology core will be the 
foundation of the center, providing key support for development and 
implementation of clinical projects.  Each project must address a critical 
issue that directly involves prevention, assessment and/or outcomes for 
patients with one or more of the many chronic diseases within the mission of 
the NIAMS.

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), 
Multidisciplinary Clinical Research Centers for Arthritis, and Musculoskeletal 
and Skin Diseases, is related to one or more of the priority areas.  Potential 
applicants may obtain "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.  Foreign institutions are not eligible for center 
grants.  Racial/ethnic minority individuals, women and persons with 
disabilities are encouraged to apply as Principal Investigators.  An 
established clinical research program in arthritis and/or musculoskeletal 
disorders including orthopaedics, bone diseases and muscle diseases; and/or 
skin diseases must be present.
 
MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) P60 award mechanism. 
Responsibility for the planning, direction, and execution of the proposed 
project will be solely that of the applicant.  The total project period for an 
application submitted in response to this RFA should be five years.  New and 
competing continuing applications may be submitted only in response to an RFA. 
The anticipated award date is January 1, 2002.

FUNDS AVAILABLE

The NIAMS intends to commit approximately $3.6 million in FY 2002 to fund up 
to three applications responding to this RFA. The applicant should request a 
project period of five years.  The direct costs requested cannot exceed 
$800,000 each year (exclusive of facilities and administrative costs of 
subcontracts with collaborating organizations).  

Although the financial plans of the NIAMS provide support for this program, 
awards pursuant to this RFA and future RFAs are contingent upon the 
availability of funds and the receipt of a sufficient number of meritorious 
applications.  This RFA is the second of three RFAs to establish the new NIAMS 
MCRC program.  A previous RFA was issued November 25, 1999, for applications 
due August 25, 2000 for FY 2001 funding.  A third RFA is planned for funding 
up to two applications in FY 2003.

RESEARCH OBJECTIVES

Background:

NIAMS has completed a review of its Centers Program.  The Institute, guided by 
the report from the Centers Working Group II (see 
http://www.nih.gov/niams/reports/cenrptfn.htm ), discussions with the National 
Arthritis and Musculoskeletal and Skin Diseases Advisory Council and 
discussions with the research community in various formats, including a series 
of nationwide video conferences during the summer of 1998, determined that the 
Multipurpose Arthritis and Musculoskeletal Diseases Centers (MAMDCs) will be 
discontinued.  Centers formerly funded as MAMDCs will be eligible to apply for 
both the new Multidisciplinary Clinical Research Centers (P60) and for Core 
Centers (P30s).  The new P60 centers will be known generically as 
Multidisciplinary Clinical Research Centers (MCRCs), although each center will 
identify itself by one or more of the NIAMS three broad disease areas: 
arthritis, musculoskeletal diseases/disorders, skin diseases.

Description of the new MCRC program

The goals of the new Multidisciplinary Clinical Research Center (MCRC) program 
are to prevent disease and to assess and improve outcomes for patients with 
arthritis and other rheumatic diseases; musculoskeletal disorders including 
orthopaedics, bone diseases and muscle diseases; and skin diseases. For a 
comprehensive listing of the disease areas covered in the NIAMS extramural 
programs, please see http://www.nih.gov/niams/grants/gen2.html 

o  Any given MCRC will not be expected to include all disease areas defined 
above or all clinical approaches included in the NIH definition of clinical 
research.  An MCRC can focus on one or more disease areas, but should not   
focus on just one disease.  Two or more clinical approaches (patient-oriented 
research, epidemiologic and behavioral studies, outcomes research and health 
services research) must be encompassed by the projects supported in the MCRC.

o  Each MCRC will define its research base, goals for promoting clinical 
research utilizing that research base, and how multidisciplinary research will 
be promoted.  The interaction with a General Clinical Research Center (GCRC), 
if present, must be documented.  

o  An MCRC is not a mechanism to support a large clinical trial, but proof of 
concept trials may be appropriate.  In addition, research on animals and 
animal models should not be proposed in the MCRC application.  

The key elements of an MCRC will include:

1.  a Center Director, Associate Director and an executive committee with 
outstanding credentials for promoting clinical research;

2.  a research base that encompasses diseases/disorders within the NIAMS 
mission and provides professional and patient resources for developing 
clinical projects using more than one clinical research approach;  

3.  a methodology core that will play a key role in the design and 
implementation of ALL projects supported through the center; and 

4.  a minimum of three highly meritorious clinical research projects that 
encompass one or more of the disease areas (but not one disease) within the 
NIAMS mission and utilize the methodology core.  

Optional elements of an MCRC are (a) a development and feasibility project 
supported by the methodology core and lasting no more than three years and (b) 
other core(s) supportive of two or more of the proposed projects.

The Director of the MCRC, aided by an Associate Director,  an executive 
committee and the methodology core, is expected to provide leadership to focus 
all research projects on clinically relevant issues to improve patient 
outcomes and to assure a rigorous research approach. The proposed director 
should document this leadership with examples of the ability to network with 
colleagues from clinical and other areas of biomedical research.

A methodology core is a required component of the MCRC and must serve all 
projects proposed in the center. The core should have sufficient professional 
personnel to provide an interactive leadership role not only in supporting the 
projects within the MCRC, but also promoting rigorous methodologic and 
biostatistical support for the research base.  Other cores supporting two or 
more of the research projects proposed may be requested. 

A minimum of three highly meritorious clinical research projects, each with a 
focus to prevent disease or to assess and/or improve outcomes for patients, 
must be present in an MCRC. Each project will define the patient problem under 
study and the anticipated improvement in assessment and/or outcome for the 
patient that might be realized through this project. The projects must 
represent two or more general areas of clinical research.

An optional component in an MCRC is a development and feasibility project 
lasting no more than three years. The goal of the development and feasibility 
project should be to gather preliminary data or to develop a resource for a 
future study.

SPECIAL REQUIREMENTS

The Director and Associate Director should budget for an annual one-day 
meeting in Bethesda, MD with NIAMS staff.

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 subpopulations must be included in all NIH supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification is provided 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 research involving human subjects should read the 
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research,"  which was published in the Federal Register of March 28, 1994 (FR 
59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 
11, March 18, 1994, available on the web at:  
http://grants.nih.gov/grants/guide/notice-files/not94-100.html 

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 copies of these policies from the program staff 
listed under INQUIRIES. Program staff may also provide additional relevant 
information concerning the policy. 

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 December 1, 2000, 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 this RFA.  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 selection of reviewers.  

The letter of intent is to be sent to Dr. Julia B. Freeman at the address 
listed under INQUIRIES.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used in 
applying for these grants.  These forms are available at most institutional 
offices of sponsored research and may be obtained from the Division of 
Extramural Outreach and Information Resources, National Institutes of Health, 
6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 
301/435-0714, email: grantsinfo@nih.gov.

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

The RFA label available in the PHS 398 (rev. 4/98) application form must be 
affixed to the bottom of the face page of the application.  Type the RFA 
number on the label.  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, "Multidisciplinary Clinical 
Research Centers", and number, "AR-00-004", must be typed on line 2 of the 
face page of the application form and the YES box must be marked.

The sample RFA label available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to 
allow for this change.  Please note this is in pdf format.

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 and 
all six copies of the appendices to:

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 January 17, 2001.  If an application is 
received after that date, it will be returned to the applicant without review. 
 
REVIEW CONSIDERATIONS

Applications for MCRC grants will first be screened for completeness by the 
Center for Scientific Review and for responsiveness by the NIAMS. Incomplete 
and/or non-responsive applications will be returned to the applicant without 
further consideration. 

Applications which are complete and responsive will be further evaluated for 
scientific merit in accordance with the review criteria stated below by a 
group of expert consultants convened by the Review Branch of the NIAMS.  As 
part of the initial merit review, all applications will receive a written 
critique and undergo a process in which only those applications deemed to have 
the highest scientific merit, generally the top half of the applications under 
review, will be discussed, assigned a priority score, and receive a second 
level review by the Advisory Council for NIAMS.   

Review Criteria

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments reviewers will be asked to discuss the following aspects 
of the application in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals.  Each of these 
criteria will be addressed and considered in assigning the overall score, 
weighting them as appropriate for each application.  Note that the application 
does not need to be strong in all categories to be judged likely to have major 
scientific impact and thus deserve a high priority score.  For example, an 
investigator may propose to carry out important work that by its nature is not 
innovative but is essential to move a field forward.

Each project and core (including the administrative unit) will be individually 
reviewed for scientific merit and a rating assigned by committee consensus.  
Merit ratings will also be voted for the center elements: qualifications of 
the center leadership, the research base, the institutional environment and 
resources.  If this is an application from a group that formerly worked under 
a MAMDC, the progress under the Education, Epidemiology and Health Services 
Research component progress during the last funding cycle will also be 
evaluated.  To be funded, there must be a highly meritorious methodology core 
and at least three highly meritorious projects (not including the 
developmental/feasibility project, if any). 

Review Criteria for MCRC leadership:
Do the Director and Associate Director have the leadership and research 
qualifications to lead a Center?  Does the leadership team (Director, 
Associate Director, and executive committee) have the collective expertise to 
assure focused development and implementation of high quality and meaningful 
clinical research projects?

Review Criteria for Research Base:

Is there a substantial productive and funded research base?  Is the research 
base sufficiently broad to foster new interdisciplinary research?  Is there a 
definition of who will be a Center investigator and what this designation 
might mean?

Review Criteria for Institutional Base:
Is there evidence of a supportive institutional environment for the proposed 
MCRC?  Will the MCRC add an important multidisciplinary element to the 
institutional environment?  Does the proposed MCRC utilize available resources 
well?  Is there support and commitment from the institutional authorities?

Review Criterion for applications from previous Multipurpose Arthritis and 
Musculoskeletal Diseases Centers (MAMDCs):
Does the progress report reflect significant accomplishments that were derived 
from the MAMDC clinical component as reflected in new concepts and 
publications?  

Review Criteria for Administrative Unit: 
1. Do the proposed MCRC Director, Associate Director and executive committee 
have the collective expertise and leadership to identify and focus research 
projects on clinically relevant issues?

2. Is the management proposed appropriate for scientific administration as 
well as fiscal administration, procurement, property and personnel management, 
planning, budgeting, etc.?  

3. Is there a plan for establishment and maintenance of internal communication 
and cooperation among the MCRC investigators, core leaders and executive 
committee?  Are there plans for outside review and input?  

4. Is there scientific and administrative leadership, commitment and ability, 
and adequate time commitment of the MCRC Director and Associate Director for 
the effective management of the MCRC program?

5.  Is there documentation of institutional support for the MCRC by the parent 
institution? 

Review Criteria for Methodology Core:

1.  Does the methodology core serve all projects proposed in the Center 
(mandatory)?    Have issues relating to data and safety monitoring been 
addressed?   Is there a plan for offering teaching services to the research 
base?

2.  Are the services offered appropriate and of high quality, especially for 
the projects directly supported?  How is cost reimbursement proposed?

3.  Will the core likely promote interdisciplinary research?  Are unique 
services offered?  Is there a plan for prioritizing services to the research 
base?

4.  Are the qualifications of the professional and support personnel 
appropriate?  Is there a plan for interactive leadership of the methodology 
core and the proposed projects?

5.  Are the facilities and equipment adequate?  Is there institutional 
commitment to the core?

Review Criteria for Other Cores:
1.  Will the core have utility to at least two of the MCRC projects?

2.  Are the services of high quality?  Are there procedures for quality 
control? Is the core cost effective?  

3.  Do the services offered best fit within a core structure?  If this is an 
add-on to a preexisting core, what is the benefit to the Center over direct 
purchase of services from the existing core?  If the core offers new services 
that may be used by non-MCRC projects, how will the non-MCRC projects purchase 
these services from the core?

4.  Are the personnel appropriate?

5.  Are the facilities and equipment adequate?  Is there institutional 
commitment to the core?

Review Criteria for Research Projects:

Significance:  Does this study address an important clinical issue, especially 
one not well studied?  Is it likely that the research may have a clinically 
important impact?  Will these studies influence concepts or methods that drive 
this field?

Approach:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project?  Does the investigator acknowledge potential problem areas and 
consider alternative tactics?  Does the project utilize the multidisciplinary 
resources of the Center, especially the Methodology Core?  

Innovation:  Are the aims original and innovative?  Does the project challenge 
existing paradigms or develop new methodologies or technologies?   (The 
quality of the idea or the extent to which the research will advance theory or 
practice should outweigh an emphasis on technical excellence.)

Investigator:  Is the investigator appropriately trained and well suited to 
carry out this work? Is the work proposed appropriate to the experience level 
of the principal investigator and collaborators?

Environment:  Does the scientific environment of the Center contribute to the 
probability of success? Do the proposed experiments take advantage of unique 
features of the Center and employ useful collaborative arrangements? 

Review Criteria for Development and Feasibility Project (Optional):

Significance:  Does this study address an important problem?  If the aims of 
the application are achieved, will the work be the basis for a full research 
proposal?

Approach: Does the study utilize the expertise of the methodology core?  Does 
the investigator acknowledge potential problem areas and consider alternative 
tactics?  Does the project utilize the multidisciplinary resources of the 
MCRC?  

Innovation:  Does the project employ sound concepts, approaches or method?  
Are the aims original and innovative?  Does the project challenge existing 
paradigms or develop new methodologies or technologies?   (The quality of the 
idea or the extent to which the research will advance theory or practice 
should outweigh an emphasis on technical excellence.)

Investigator:  Is the investigator appropriately trained and well suited to 
carry out this work? Is the work proposed appropriate to the experience level 
of the principal investigator and collaborators?

Environment:  Does the scientific environment of the Center contribute to the 
probability of  success?  Do the proposed experiments take advantage of unique 
features of the Center and employ useful collaborative arrangements?  

After the review of the individual components of the application, an 
application may be unscored or assigned an overall priority score.  This score 
will reflect not only the individual quality of the projects, cores, and 
administration, but also how the proposed MCRC will bring together all these 
elements in a workable unit.  The overall score may be higher or lower than 
the "average" of the descriptors based on the assessment of whether the "whole 
is greater than the sum of its parts."  The overall priority score will 
reflect:

1.  The scientific excellence of the Center's research base as well as the 
relevance and interrelation of these separately-funded research projects to 
the goals of the Center and the likelihood for meaningful collaboration among 
Center investigators.  The application must convey how the proposed Center 
will enhance significantly the established research base of the host 
institution.  

2.  The overall environment for a Center.  This includes the institutional 
commitment to the program, including lines of accountability regarding 
management of the Center, and the institution's partnership with the Center, 
and the institutional commitment to individuals responsible for conducting 
essential Center functions. This also includes the academic environment and 
resources in which the activities will be conducted, including the 
availability of space, equipment, facilities, and the potential for 
interaction with scientists from other departments and schools.

3.  The overall priority score assigned to the application will also reflect 
how well the policy regarding the inclusion of women, minorities and children 
in study populations has been addressed.

Schedule

Letter of Intent Receipt Date:   December 1, 2000
Application Receipt Date:        January 17, 2001
Peer Review Date:                June-July, 2001
Council Review:                  September 24 - 25, 2001

Earliest Anticipate Start Date:  January 1, 2002

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o  scientific merit (as determined by peer review)
o  availability of funds
o  programmatic priorities.  Since the NIAMS is interested in funding only the 
most highly meritorious research, individual components of lesser quality may 
not be funded, even if approved, under the "umbrella" of the Center grant 
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 MCRC 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

Direct inquiries regarding fiscal matters to:

Sally A. Nichols 
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:  nicholss@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 are 
made under authorization of Sections 301 and 405 of the Public Health Service 
Act as amended (42 USC 241 and 284) and administered under NIH grants policies 
and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  This program is 
not subject to the 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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