HIGH RISK ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES RESEARCH

Release Date:  November 6, 2001

RFA:  RFA-AR-01-008

National Institute of Arthritis and Musculoskeletal and Skin Diseases

Letters of Intent Receipt Date:  January 15, 2002
Application Receipt Date:        February 14, 2002

THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  MODULAR 
INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS REQUESTING 
LESS THAN $250,000 PER YEAR IN ALL YEARS. MODULAR BUDGET INSTRUCTIONS 
ARE PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT 
http://grants.nih.gov/grants/funding/phs398/phs398.html. 

PURPOSE

The purpose of this initiative is to broaden the base of inquiry in 
fundamental biomedical, bio-behavioral, and biomedical technology 
research by encouraging applications for research projects that involve 
an especially high degree of innovation and novelty and, therefore, 
require a preliminary test of feasibility.  The research projects 
proposed under this Request for Applications (RFA) may involve 
substantial experimental risks such that their potential for highly 
significant outcomes may be difficult to judge by the standard criteria 
used in evaluating investigator initiated (R01) proposals. Preliminary 
data are not required.  The work proposed may not overlap with the aims 
of currently supported projects in which the Principal Investigator has 
participated during the last five years.  Proposed projects must 
support the mission of the National Institute of Arthritis and 
Musculoskeletal and Skin Diseases (NIAMS).

Two kinds of experienced investigators are sought.  First, established 
investigators in arthritis or musculoskeletal or skin diseases are 
encouraged to present a proposal for testing the feasibility of a novel 
idea, resource or technology.  The project should represent a clear and 
distinct departure from the investigator's ongoing research.  Second, 
established investigators with no previous work in arthritis or 
musculoskeletal or skin diseases are encouraged to apply their 
expertise to research that is relevant to arthritis or musculoskeletal 
or skin diseases.

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 RFA, “High 
Risk Arthritis and Musculoskeletal and Skin Diseases Research,” is 
related to the priority area of chronic diseases.  Potential applicants 
may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople/.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign, for-profit and 
nonprofit organizations, public and private, such as universities, 
colleges, hospitals, laboratories, units of State and local 
governments, and eligible agencies of the Federal government.  
Racial/ethnic minority individuals, women, and persons with 
disabilities are encouraged to apply as Principal Investigators.  
Participation in the program by investigators at minority institutions 
is strongly encouraged.

The proposed work must be new and not overlap with projects in which 
the Principal Investigator has participated during the last five years.  
Projects that could reasonably be considered a logical and immediate 
extension of current work are not within the scope of this RFA.  
(Information on past projects is to be provided as part of the 
Principal Investigator's Biographical Sketch, as described below under 
Application Procedures.)  Applications will be programmatically 
reviewed by NIAMS staff for eligibility before they are formally 
accepted.  Applications that do not meet the above criteria will be 
returned to the Principal Investigator prior to review. Investigators 
who have questions about eligibility should contact one of the program 
officials listed under INQUIRIES.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) 
exploratory/developmental research grant, R21, award mechanism.  
Responsibility for the planning, direction, and execution of the 
proposed project will be solely that of the applicant.  Applicants may 
request up to $50,000 (direct costs) per year for up to two years.  
These awards are not renewable.  If desired, the specific aims of the 
R21 project may be incorporated into a research project grant 
application (R01) submitted prior to the termination of the R21 award. 
This RFA is a one-time solicitation. 

FUNDS AVAILABLE					

It is anticipated that for FY 2002, approximately $1,200,000 total 
costs will be available for the first year of support for this 
initiative.  Award of grants is contingent upon the receipt of such 
funds for this purpose.  It is anticipated that up to 20 new grants 
will be awarded under this program.  The specific number to be funded 
will depend on the merit and scope of the applications received and on 
the availability of funds.  Direct costs are limited to $50,000 and 
will be awarded in modules of $25,000, less any overlap or other 
necessary administrative adjustments.  Facilities and Administrative 
costs will be awarded based on the negotiated rates.  Applicants may 
request up to two years of support.

RESEARCH OBJECTIVES

The NIAMS seeks to broaden the base of inquiry in fundamental 
biomedical, bio-behavioral, and biomedical technology research by 
encouraging research projects that involve a high degree of innovation 
and novelty.  Because innovative projects may require a preliminary 
test of feasibility, this initiative will provide short-term support 
for such preliminary work.  Each research plan should begin with a 
short paragraph describing how the proposed project represents a high 
degree of innovation and novelty that does not overlap with the 
applicant’s recently funded research. The projects must support the 
NIAMS mission as detailed in the NIAMS World Wide Web home page, which 
can be found at http://www.nih.gov/niams/about/ep1.htm.  In brief, the 
NIAMS supports research in:  a) rheumatic diseases; b) cartilage 
biology and diseases; c) bone biology and diseases (e.g., osteogenesis 
imperfecta, Paget's disease); d) skin biology and skin diseases; e) 
autoimmune diseases (e.g., lupus, rheumatoid arthritis); f) connective 
tissue diseases; g) musculoskeletal diseases (e.g., osteoarthritis, 
osteoporosis) h) musculoskeletal imaging; i) injuries and disorders of 
the musculoskeletal system; j) muscle biology and diseases (e.g., 
muscular dystrophy); k) exercise physiology and musculoskeletal 
fitness; l) sports injuries; m) occupational diseases and injuries; and 
n) orthopaedic and bioengineering topics.

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 
biomedical and behavioral research projects involving human subjects, 
unless a clear and compelling rationale and justification are 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 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 
and additional information can be found at:
http://grants.nih.gov/grants/funding/women_min/women_min.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 the 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 or ethical reasons not 
to include them.  This policy applies to all initial (Type 1) 
applications submitted for receipt dates after October 1, 
1998. http://grants.nih.gov/grants/funding/children/children.htm

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.

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 web site:   
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 specific page limitations.  Unless otherwise specified in an NIH 
solicitation, Internet addresses (URL) 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.
 
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT
 
The Office of Management and Budget (OMB) Circular A-110 has been 
revised to provide public access to research data through the Freedom 
of Information Act (FOIA) under some circumstances.  Data that are (1) 
first produced in a project that is supported in whole or in part with 
Federal funds and (2) cited publicly and officially by a Federal agency 
in support of an action that has the force and effect of law (i.e., a 
regulation) may be accessed through FOIA.  It is important for 
applicants to understand the basic scope of this amendment.  NIH has 
provided guidance at: 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this RFA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application 
should include a description of the archiving plan in the study design 
and include information about this in the budget justification section 
of the application. In addition, applicants should think about how to 
structure informed consent statements and other human subjects 
procedures given the potential for wider use of data collected under 
this award.
 
LETTER OF INTENT

Prospective applicants are asked to submit, by January 15, 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, does not commit the sender 
to submit an application, and does not enter into the review of a 
subsequent application, the information that it contains allows IC 
staff to estimate the potential review workload and plan the review. 
The letter of intent is to be sent (e-mail, fax or post) to Dr. Tommy 
Broadwater at the address listed under INQUIRIES.

APPLICATION PROCEDURES

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.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS

The modular grant concept establishes specific modules in which direct 
costs may be requested as well as a maximum level for requested 
budgets. Only limited budgetary information is required under this 
approach.  The just-in-time concept allows applicants to submit certain 
information only when there is a possibility for an award. It is 
anticipated that these changes will reduce the administrative burden 
for the applicants, reviewers and NIH staff.  The research grant 
application form PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used 
in applying for these grants, with modular budget instructions provided 
in Section C of the application instructions. For further assistance 
contact GrantsInfo, Telephone 301/435-0714, Email: GrantsInfo@nih.gov.

The Background and Significance Section of application should 
specifically state how the project represents a new direction for the 
work performed at the PI’s laboratory. This should include a brief 
section (one page or less) entitled “Qualifications for High Risk” in 
which the PI specifically addresses the following concerns:
	
  Innovation & Novelty: Does the proposed project represent a high degree 
  of innovation and novelty?

  Departure from current work:  Does the proposed project specifically 
  overlap with work  from the PI during the last five years?  
  
  How does the proposed work represent a significant departure from the PI's 
  current line of work?

  High risk: Explain how the high gain potential of the project, if 
  successful, offsets the high  risk of failure.

A Preliminary Data section is not required. If included in R21 
applications, it should  not exceed one page. The research plan (a-d) 
is limited to 10 pages.  Applications that exceed the page limit will 
be returned without review. An appendix may be included in the 
application; however, the appendix is not to be used to circumvent the 
page limit of the research plan. 

The RFA label available in the PHS 398 (rev. 5/2001) 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 and number must be typed on line 2 of the face page of the 
application form and the YES box must be marked. The RFA label is also 
available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.

Submit a signed, typewritten original of the application and three 
signed photocopies, 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, two additional copies of the application 
must be sent to:

Tommy L. Broadwater, Ph.D.
Scientific Review Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
45 Center Drive, Room 5AS-25U - MSC 6500
Bethesda, MD  20892-6500
In order not to delay review, it is important that applicants comply 
with this request.

Applications must be received by February 14, 2002.  If an application 
is received after that date, it will be returned to the applicant 
without review. A Principal Investigator may submit only one R21 grant 
application.

The Center for Scientific Review (CSR) will not accept any application 
in response to the RFA that is essentially the same as one currently 
pending initial review, unless the applicant withdraws the pending 
application.  The CSR will not accept any application that is 
essentially the same as one already reviewed.  This does not preclude 
the submission of substantial revisions of applications already 
reviewed, but such applications must include an Introduction addressing 
the previous critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by CSR and 
responsiveness by NIAMS.  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, all 
applications will receive a written critique; however, 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 NIAMS 
Advisory Council.

REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  
For this initiative, the proposed project must have the potential for 
developing ground-breaking technology or methodology that may lead to 
significant expansion of biomedical research horizons, precipitate a 
paradigm shift in research, or lead to substantial improvements in 
human health.  In the written review, comments on the following aspects 
of the application will be made 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 the assignment of the overall score.

(1) Significance.  Does the proposed study clearly not overlap with 
recently funded research? Does this study address an important problem?  
If the aims of the application are achieved, how will scientific 
knowledge be advanced?  What will be the effect of these studies on the 
concepts or methods that drive this field?

(2) 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?

(3) Innovation.  Does the project employ novel concepts, approaches or 
methods? Are the aims original and innovative?  Does the project 
challenge existing paradigms or seek to develop new methodologies or 
technologies?  Does the proposed project specifically overlap with work 
from the PI during the last five years?  Does the proposed work 
represent a significant departure from the PI's current line of work?  
Does the high gain potential of the project, if successful, offsets the 
high risk of failure?

(4) Investigator.  Is the investigator appropriately trained and well 
suited to carry out this work?  Is the proposed work appropriate to the 
experience level of the principal investigator and other researchers 
(if any)?

(5) Environment.  Does the scientific environment in which the work 
will be done contribute to the probability of success?  Do the proposed 
experiments take advantage of unique features of the scientific 
environment or employ useful collaborative arrangements?  Is there 
evidence of institutional support?

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

o The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of 
the research and in conformance with the NIH Guidelines for the 
Inclusion of Women and Minorities as Subjects in Clinical Research 
and Inclusion of Children as Participants in Research Involving 
Human Subjects.  Plans and  for recruitment and retention of 
subjects will also be evaluated.

o The adequacy of the proposed protection for humans, animals, or the 
environment, to the extent they may be adversely affected by the 
project proposed in the application.  

o The appropriateness of staffing based on the requested percent 
effort and the personnel budget.  The direct costs budget request 
will be reviewed for consistency with the proposed methods and 
specific aims.  Any budgetary adjustments recommended by the 
reviewers will be in $25,000 modules.  The duration of support will 
be reviewed to determine if it is appropriate to ensure successful 
completion of the requested scope of the project.

o The potential for ground-breaking, precedent setting significance of 
the proposed research with particular emphasis on novel and 
innovative approaches that clearly require additional preliminary 
data for their value to be established.

SCHEDULE
 
Letter of Intent Date:            January 15, 2002
Application Receipt Date:         February 14, 2002
Council Review:                   September 26, 2002
Earliest Anticipated Start Date:  September 30, 2002
 
AWARD CRITERIA
 
The following will be considered in making funding decisions:
 
o Scientific merit of the proposed project as determined by peer 
review
o Programmatic importance of the area to NIAMS research
o Availability of funds
 
INQUIRIES
 
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 the most appropriate 
person listed on the web site 
(http://www.niams.nih.gov/rtac/prog_staff/director.htm) according to 
scientific area or for general inquiries about this RFA contact: 
 
Dr. Gayle E. Lester
45 Center Drive, Room 5AS-43C
Bethesda, MD  20892-6500
Telephone:  (301) 594-5055
FAX:  (301) 480-4543
Email:  gl83g@nih.gov

Direct inquiries regarding review matters to:

Dr. Tommy L. Broadwater
Scientific Review Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
45 Center Drive, Room 5AS-25U - MSC 6500
Bethesda, MD  20892-6500
Telephone:  (301) 594-4952
FAX:  (301) 480-4543
Email:  broadwat@mail.nih.gov

Direct inquiries regarding fiscal matters to:

Melinda B. Nelson
Grants Management Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
45 Center Drive, Room 5AS-49F, MSC 6500
Bethesda, MD  20892-6500
Telephone:  (301) 594-3535
FAX:  (301) 480-5450
Email:  nelsonm@mail.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance 
No. 93.846.  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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