HIGH RISK RHEUMATIC AND MUSCULOSKELETAL AND SKIN DISEASES RESEARCH
RELEASE DATE: January 7, 2003
RFA: AR-03-009
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
(http://www.niams.nih.gov/)
LETTER OF INTENT RECEIPT DATE: February 18, 2003
APPLICATION RECEIPT DATE: March 18, 2003
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
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 goal is to solicit
research applications with 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. 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 or those in which the Principal
Investigator has participated during the past five years. Proposed
projects must support the mission of the National Institute of
Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
Two kinds of experienced and established investigators are sought.
First, experienced and established investigators in rheumatic 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 distinctly different approach
from the investigator's current and previous (past 5 years) research.
Second, experienced and established investigators with no previous work
in rheumatic or musculoskeletal or skin diseases are encouraged to
apply their expertise to research that is relevant to rheumatic or
musculoskeletal or skin diseases. This request for applications should
not be considered for new investigators without previous grant
experience.
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 include a brief
description of how the proposed project represents a high degree of
innovation and novelty that complements but does not duplicate the
applicant's currently funded research. The projects must support the
NIAMS mission as detailed in the NIAMS Web 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.
MECHANISM(S) 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 expanded and serve as the basis for a larger
research grant application (R01) submitted prior to the termination of
the R21 award. This RFA is a one-time solicitation.
This RFA uses just-in-time concepts. It also uses the modular
budgeting format. (see
https://grants.nih.gov/grants/funding/modular/modular.htm).
Specifically, when an application is submitted with direct costs in
each year of $250,000 or less, the modular format should be used.
FUNDS AVAILABLE
It is anticipated that for FY 2003, 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.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) if your institution has any of the
following characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges,
hospitals, and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic or foreign
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
For this solicitation, individuals with an established research career
and the skills, knowledge, and resources necessary to carry out the
proposed research are invited to work with their institutions to
develop an application for support. Individuals from underrepresented
racial and ethnic groups as well as individuals with disabilities are
strongly encouraged to apply for support from NIAMS programs.
SPECIAL REQUIREMENTS
The Background and Significance Section of application must include a
brief section (one page or less) entitled "Eligibility for High Risk
RFA" that states the innovative and high risk aspects of the project
that distinguish it from currently funded projects in the PI's and
collaborators' laboratories. The following concerns should be
specifically addressed:
1) Innovation & Novelty: Does the proposed project represent a high
degree of innovation and novelty?
2) Lack of overlap with current work: Does the proposed project
have specific overlap with current work from the PI? If
the proposed work is complementary to on-going research,
why couldn't it be carried out within the framework of
currently funded studies?
3) High risk: Explain how the high gain potential of the project, if
successful, offsets the high risk of failure.
4) Justification of eligibility of PI: Provide evidence of PI's
established research career.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity
to answer questions from potential applicants. Inquiries may fall into
three areas: programmatic/general, peer review, and financial or
grants management issues:
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.
For general inquiries about this RFA contact:
Gayle E. Lester, Ph.D.
Musculoskeletal Diseases Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
One Democracy Plaza
6701 Democracy Blvd., Suite 800
Bethesda, MD 20892-4872
Telephone: (301) 594-5055
FAX: (301) 480-4543
Email: gl83g@nih.gov
Direct your questions about peer review issues to:
Richard Bartlett, Ph.D.
Review Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
One Democracy Plaza
6701 Democracy Blvd, Suite 800
Bethesda, MD 20892-4872
Telephone: 301-594-4956
Fax: 301-402-2406
Email: bartletr@mail.nih.gov
Direct your questions about financial or grants management matters to:
Melinda Nelson
Grants Management Officer
National Institute of Arthritis and Musculoskeletal and Skin Diseases
One Democracy Plaza
6701 Democracy Blvd. Suite 800
Bethesda, MD 20892-4872
Telephone: (301) 594-3535
FAX: (301) 480-5450
Email: nelsonm@mail.nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit, by February 18, 2003, a
letter of intent that includes:
Descriptive title of the proposed research;
Name, address, and telephone number of the Principal Investigator;
Names of other key personnel;
Other participating institutions
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 should be sent to:
Richard Bartlett, Ph.D.
Review Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
One Democracy Plaza
6701 Democracy Blvd, Suite 800
Bethesda, MD 20892-4872
Telephone: 301-594-4956
Fax: 301-402-2406
Email: bartletr@mail.nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant
application instructions and forms (rev. 5/2001). The PHS 398 is
available at https://grants.nih.gov/grants/funding/phs398/phs398.html in
an interactive format. For further assistance contact GrantsInfo,
Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.
SPECIAL APPLICATION PROCEDURES: The research plan (a-d) is limited to
10 pages. APPLICATIONS THAT EXCEED THE PAGE LIMIT WILL BE RETURNED
WITHOUT REVIEW. A Preliminary Data section is not required. If
included in R21 applications, it should not exceed one page. The
Background and Significance Section of application must include, at the
beginning, a brief section (one page or less) entitled "Eligibility for
High Risk RFA" in which the PI specifically addresses the following
concerns: 1) Innovation & Novelty: Does the proposed project represent
a high degree of innovation and novelty? 2) Lack of overlap with
current work: Does the proposed project have specific overlap with
current work from the PI? If the proposed work is complementary to on-
going research, why couldn't it be carried out within the framework of
currently funded studies? 3) High risk: Explain how the high gain
potential of the project, if successful, offsets the high risk of
failure. 4) Justification of eligibility of PI: Provide evidence of
PI's established research career. 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.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications
requesting up to $250,000 per year in direct costs must be submitted in
a modular grant format. The modular grant format simplifies the
preparation of the budget in these applications by limiting the level
of budgetary detail. Applicants request direct costs in $25,000
modules. Section C of the research grant application instructions for
the PHS 398 (rev. 5/2001) at
https://grants.nih.gov/grants/funding/phs398/phs398.html includes step-
by-step guidance for preparing modular grants. Additional information
on modular grants is available at
https://grants.nih.gov/grants/funding/modular/modular.htm.
USING THE RFA LABEL: 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 (AR-03-009) 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:
https://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten
original of the application, including the Checklist, 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:
Richard Bartlett, Ph.D.
Review Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
One Democracy Plaza
6701 Democracy Blvd, Suite 800
Bethesda, MD 20892-4872
Telephone: 301-594-4956
Fax: 301-402-2406
Email: bartletr@mail.nih.gov
APPLICATION PROCESSING: Applications must be received by the
application receipt date listed in the heading of this RFA. If an
application is received after that date, it will be returned to the
applicant without review.
The Center for Scientific Review (CSR) will not accept any application
in response to this 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. This Introduction SHOULD NOT exceed 1 page.
Such revised applications will be allotted a total length of 11 pages
for sections a-d and including the one page Introduction.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR
and responsiveness by the NIAMS. Incomplete applications will be
returned to the applicant without further consideration. In addition,
applications will be reviewed by NIAMS for responsiveness to the RFA
after receipt of application and prior to review. If the application
is not determined to be responsive to the RFA, NIAMS staff will either
return the application to the applicant or contact the applicant to
clarify questions of suitability.
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:
o Receive a written critique
o 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 and assigned a priority score
o Receive a second level review by the National Arthritis and
Musculoskeletal and Skin Diseases 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 comments, reviewers will be asked to
discuss the following aspects of your application in order to judge the
likelihood that the proposed research will have a substantial impact on
the pursuit of these goals:
o Significance
o Approach
o Innovation
o Investigator
o Environment
Each of these criteria will be addressed and considered in the
assignment of the overall score.
(1) Significance. Does the proposed study have potential for the
development of 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? 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 high gain potential of the project, if
successful, offset the high risk of failure?
(4) 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?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your
application will also be reviewed with respect to the following:
o PROTECTIONS: 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 INCLUSION: The adequacy of plans to include subjects from both
genders, all racial and ethnic groups (and subgroups), and children as
appropriate for the scientific goals of the research. Plans for the
recruitment and retention of subjects will also be evaluated. (See
Inclusion Criteria included in the section on Federal Citations, below)
o BUDGET: The feasibility of the proposed budget and the requested
period of support in relation to the proposed research.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: February 18, 2003
Application Receipt Date: March 18, 2003
Peer Review Date: June/July, 2003
Council Review: September, 2003
Earliest Anticipated Start Date: December, 2003
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Novelty, innovation, and high risk nature of the proposal
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
REQUIRED FEDERAL CITATIONS
MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research
components involving Phase I and II clinical trials must include
provisions for assessment of patient eligibility and status, rigorous
data management, quality assurance, and auditing procedures. In
addition, it is NIH policy that all clinical trials require data and
safety monitoring, with the method and degree of monitoring being
commensurate with the risks (NIH Policy for Data Safety and Monitoring,
NIH Guide for Grants and Contracts, June 12, 1998:
https://grants.nih.gov/grants/guide/notice-files/not98-084.html).
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy
of the NIH that women and members of minority groups and their sub-
populations must be included in all NIH-supported clinical research
projects unless a clear and compelling justification is provided
indicating that inclusion is inappropriate with respect to the health of
the subjects or the purpose of the research. This policy results from
the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43).
All investigators proposing clinical research should read the AMENDMENT
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research - Amended, October, 2001," published in the NIH Guide
for Grants and Contracts on October 9, 2001
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a
complete copy of the updated Guidelines is available at
https://grants.nih.gov/grants/funding/women_min/guidelines_amended_
10_2001.htm.
The amended policy incorporates: the use of an NIH definition
of clinical research; updated racial and ethnic categories in
compliance with the new OMB standards; clarification of language
governing NIH-defined Phase III clinical trials consistent with the new
PHS Form 398; and updated roles and responsibilities of NIH staff and
the extramural community. The policy continues to require for all NIH-
defined Phase III clinical trials that: a) all applications or
proposals and/or protocols must provide a description of plans to
conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN
SUBJECTS: The NIH maintains a policy 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 is available at
https://grants.nih.gov/grants/funding/children/children.htm.
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. You will find this policy
announcement in the NIH Guide for Grants and Contracts Announcement,
dated June 5, 2000, at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of
research on hESCs can be found at
https://grants.nih.gov/grants/stem_cells.htm and at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human
Embryonic Stem Cell Registry will be eligible for Federal funding (see
http://escr.nih.gov). It is the responsibility of the applicant to
provide the official NIH identifier(s)for the hESC line(s)to be used in
the proposed research. Applications that do not provide this
information will be returned without review.
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
https://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.
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. Furthermore, we caution reviewers that their
anonymity may be compromised when they directly access an Internet
site.
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 is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance No. 93.846, and is not subject to the
intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review. 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 described
at https://grants.nih.gov/grants/policy/policy.htm and under Federal
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.
The PHS strongly encourages all grant recipients to provide a smoke-
free workplace and discourage the 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.