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 301/710-0267, 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 301/710-0267, 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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