MULTIDISCIPLINARY CLINICAL RESEARCH CENTERS FOR ARTHRITIS AND MUSCULOSKELETAL 
AND SKIN DISEASES

Release Date:  April 5, 2001

RFA:  RFA-AR-01-006

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

Letter of Intent Receipt Date:  February 1, 2002
Application Receipt Date:       March 12, 2002

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 orthopaedic disorders, 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 orthopaedic 
disorders, 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, 2003.

FUNDS AVAILABLE

The NIAMS intends to commit approximately $3.6 million in FY 2003 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 final of three RFAs to 
establish the new NIAMS MCRC program.  Previous RFAs were AR-00-001 for 
FY 2001 funding and AR-00-004 for FY 2002 funding.

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 and other rheumatic diseases, 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 orthopaedic disorders, 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) one 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 one 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 UPDATED "NIH Guidelines for Inclusion of Women and Minorities 
as Subjects in Clinical Research," published in the NIH Guide for 
Grants and Contracts on August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a 
complete copy of the updated Guidelines is available at  
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm.  
The revisions relate to NIH defined Phase III clinical trials and 
require: a) all applications or proposals and/or protocols to 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) all   investigators to report accrual, 
and to conduct and report 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/funding/children/children.htm 
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 February 1, 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 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 
plan the review.

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-
01-006", 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 five copies of the appendices to:

Dr. Tommy L. Broadwater
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 March 12, 2002.  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 scientific review group 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 assigned by a priority 
score.  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:   February 1, 2002
Application Receipt Date:        March 12, 2002
Peer Review Date:                June-July, 2002
Council Review:                  September 26 - 27, 2002
Earliest Anticipate Start Date:  January 1, 2003

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 recommended as part of the 
overall 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:

Melinda Nelson 
Chief Grants Management Officer, Extramural Program
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 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 7the American 
people.


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