and Human Services (HHS)
EXPIRED
MICROCIRCULATION AND TARGET ORGAN DAMAGE IN RHEUMATIC AND SKIN DISEASES
RELEASE DATE: November 25, 2002
RFA: AR-03-005
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
(http://www.niams.nih.gov)
National Eye Institute (NEI)
(http://www.nei.nih.gov/)
Office of Research on Women's Health (ORWH)
(http://www4.od.nih.gov/orwh/)
LETTER OF INTENT RECEIPT DATE: February 10, 2003
APPLICATION RECEIPT DATE: March 20, 2003
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanisms of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
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 National Institute of Arthritis and Musculoskeletal and Skin
Diseases (NIAMS), the National Eye Institute (NEI) and the Office of
Research on Women's Health (ORWH) invite applications to address the
mechanisms of end organ damage and alterations in the microcirculation
in rheumatic and autoimmune skin diseases. This initiative has three
primary purposes. The first purpose is to promote research targeted
towards identification and evaluation of cellular, molecular and
genetic pathways involved in target organ damage and altered
microcirculation in rheumatic and skin diseases. The second purpose of
this request for applications is to stimulate and encourage: a)
innovative and multidisciplinary basic, translational and clinical
studies and b) discovery research projects using new technologies (e.g.
microarrays, high throughput sequencing, multi-color flow cytometry,
differential display, proteomics, etc). Finally, the purpose of this
initiative is to encourage applications as collaborations or as
research teams combining interdisciplinary approaches between
autoimmune disease researchers and experts in other related scientific
fields, such as nephrology and neurology, and vascular biology. The
applications in response to this RFA may be for individual research
projects (R01) or for exploratory/developmental grants (R21). This RFA
solicits basic, translational, and clinical research projects but not
epidemiological or clinical treatment projects.
RESEARCH OBJECTIVES
Background
Although immune dysregulation plays a major role in the induction of
autoimmunity, recent evidence suggests that structural and functional
properties of target/end organs, such as eyes, kidneys, synovium, skin,
thyroid gland, and islet cells, may contribute significantly to the
development of tissue damage and clinical disease. In animal models, a
variable threshold to renal and cardiac damage has been clearly
demonstrated. This finding is consistent with clinical observations
showing that individuals with the same serologic abnormality do not
necessarily have the same tissue abnormality. Some of the deleterious
effects of autoreactivity are likely due to interactions between
autoantibodies and specific cellular elements in the target organ
beyond the activation of the complement cascade. For example,
autoantibodies may bind to cell surface receptors and trigger cell
activation, modify cell function, or induce apoptosis. Further, the
type of interaction may influence clinical expression. In lupus
nephritis, immunoglobulins produce distinguishable deposit patterns in
specific glomerular locations and this is associated with different
disease profiles. The differences appear to be based on the
differential reactivity of the autoantibodies with specific glomerular
antigens, suggesting that antigen display in the target organ
influences tissue damage.
Recent advances indicate that other end organ processes may be related
to the induction and maintenance of damage in the context of rheumatic
and autoimmune skin diseases. These include expression of proteins
related to organ development, either spontaneously or induced by the
cytokine milieu created by the inflammatory response, events related to
single cell death during organ development and repair, and newly
identified binding properties of autoantibodies present in sera from
patients with autoimmune diseases that trigger apoptosis, cell
activation or block binding of the natural ligand.
Vulnerability of the target organ to immune-mediated damage also
appears to be genetically determined. In fact, the genetic mapping of
susceptibility genes in diabetes and lupus suggests an important role
for the target organ in the induction of tissue injury, with
contributions made by the cellular components and their interactions
with the extracellular matrix, independent of other known factors such
as HLA. For example, in murine models of systemic lupus, nephritis is
differentially induced in different strains of mice, in spite of
similar autoantibody profiles and in the presence of similar T-cell
reactivity. Recent data from genetic analysis of backcrosses of
autoimmune- disease-prone mice in a model of autoimmune myocarditis
also suggest that genetic factors unrelated to immune-related
susceptibility loci are important in the development and severity of
symptoms.
The vasculature is often a direct target of autoimmune damage. End
organ damage may be secondary to primary damage to the vasculature in
some cases, or vascular damage and compromised circulation may further
contribute to target organ damage. Indeed, the microcirculation has
been shown to be involved in the pathogenesis and target organ damage
in several rheumatic diseases. Scleroderma is fraught with
microvascular alterations resulting in general changes in
vasoreactivity as seen in Raynaud's syndrome, as well as decreased
angiogenesis. On the other hand, increased angiogenesis is seen in
rheumatoid arthritis and skin manifestations of lupus. Increased
levels of angiogenic growth factors may be a biomarker for ankylosing
spondylitis. The immune complex deposition and thrombotic events
leading to stroke and myocardial infarction in systemic lupus
erythematosus (SLE, lupus) occur in the microcirculation. Where the
microcirculation lies in the cause and effect of rheumatic diseases is
unclear, but its involvement warrants study.
In recent years, knowledge of angiogenesis and the microcirculation has
dramatically increased, as has the ability to manipulate genetic
material and cell behavior. Several aspects of angiogenesis have
undergone substantial growth and development and, in a parallel
fashion, several new technologies and methodologies have been applied
to the study of the cells that make up the microcirculation,
endothelial cells, pericytes and smooth muscle cells. Insights into
mechanisms associated with embryonic development, cancer, and vascular
remodeling during injury or inflammation could have a strong impact on
rheumatic and skin diseases. For example, integrins, growth factors,
chemokines and/or inflammatory cytokines as well as receptors for any
of them, are all current targets for therapeutic blockers of
inflammation. Angiostatins, found to be effective in starving tumors
of their blood supply, are now in clinical trials for cancer patients.
In addition, gene therapies are being developed for constitutive or
inducible production of a particular protein for systemic or tissue
specific application. Previous results have shown that angiogenesis
inhibitors may delay or prevent onset of experimental arthritis in mice
and rats. Preliminary work is underway to identify angiogenesis
inhibitors for use in humans with rheumatoid arthritis (RA).
Therefore, the application of current concepts in vascular biology to
the study of rheumatic and autoimmune skin diseases may provide new
insights into disease progression and expand the therapeutic options.
Scope
The focus of the studies is to be on the immune and nonimmune
mechanisms of induction and development of injury, and dissection of
the genetics, of microcirculation and end organ involvement in the
context of rheumatic and autoimmune skin diseases. Relevant rheumatic
diseases covered under this RFA include but are not limited to lupus,
rheumatoid arthritis, scleroderma, dermatomyositis, vasculitis,
juvenile rheumatic diseases and Sjogren's syndrome, as well as ocular
manifestations of rheumatic diseases (e.g. uveitis, retinopathy).
Relevant skin diseases include but are not limited to psoriasis, atopic
dermatitis, autoimmune bullous diseases, alopecia areata, vitiligo and
vasculitis. Knowledge gained by research in this area will make it
possible to construct a more comprehensive picture of disease
pathogenesis. Definition of discrete pathogenic processes involving
the target organs may provide the scientific rationale for new forms of
interventions.
Appropriate research areas may include, but are not limited to, the
following:
o Development and evaluation of new experimental systems, including
the generation of transgenic and other genetically engineered
animal models, to study cellular, molecular, and genetic aspects
of target organ involvement.
o Development of new in vitro models to analyze the effects of
inflammatory, immune, and other mechanisms of injury on target
organ/cell function and structure.
o Identification and characterization of cellular and molecular
pathways involved in target/end organ damage.
o Mechanistic studies on the initiation and perpetuation of local
immune and inflammatory responses that occur in organs involved
in autoimmune diseases.
o Mechanistic studies of sex differences in susceptibility and
severity of altered microcirculation and end organ damage in
autoimmune diseases.
o Studies on the changes in target organ structure and function due
to the presence of local immune, inflammatory, and other forms of
tissue injury related to autoimmune disease.
o Studies of the effects of immune and nonimmune mechanisms of
tissue damage and their effects on target organ cell structure
and function.
o Studies on the effects of autoreactive or other relevant immune
or inflammatory responses on target/end organ repair processes.
o Studies of mechanisms underlying phenotypic changes in cellular
components of target organs during different phases of disease.
o Identification of biochemical, structural, or other markers that
may correlate with early, preclinical target organ involvement
and that may predict disease progression or severity.
o Studies to identify mediators and mechanisms that may protect
target organs from the inflammatory, immune, and other forms of
tissue injury involved in rheumatic and skin diseases.
o Immediate and long term effects on the microvascular function of
antibody therapy for rheumatic and skin diseases.
o Molecular approaches to affect vascular dysfunction in rheumatic
diseases, such as use of angiostatins or angiogenic factors.
o Targeting molecules involved in maintaining vascular structure
and function for local or systemic therapy using gene therapy and
other pharmacologic interventions (constitutive or inducible) in
rheumatic and skin diseases.
o Translational research aimed at correlating clinical findings
with markers of end organ damage.
o New methodologies to facilitate studies of gene expression and
characterization of the phenotype of involved tissues.
o Application of new genetic, molecular, biochemical, imaging or
bioinformatics methodologies to the study of end organ damage and
its manifestations.
This list is intended to be illustrative and not exclusive or
restrictive.
MECHANISM OF SUPPORT
This RFA will use the NIH Research Project Grant (R01) and the
Exploratory/Developmental Research Project (R21). As an applicant you
will be solely responsible for planning, directing, and executing the
proposed project. This RFA is a one-time solicitation. Future
unsolicited, competing-continuation applications, based on this project
will compete with all investigator-initiated applications and will be
reviewed according to the customary peer review procedures. The
anticipated award date is September 30, 2003.
This RFA uses just-in-time concepts. It also uses either the modular
or the non-modular budgeting formats
(see http://grants.nih.gov/grants/funding/modular/modular.htm).
Specifically, if you are submitting an application with direct costs in
each year of $250,000 or less, use the modular format. Otherwise follow
the instructions for non-modular research grant applications.
R01 Applications: An R01 applicant may request a project period of up
to 4 years and a budget for direct costs not to exceed $500,000 per
year.
R21 Applications. The R21 application may request a project period up
to two years with a budget not to exceed $100,000 per year in direct
costs, not including indirect costs for collaborating institutions, if
any.
The R21 projects solicited under this RFA are exploratory/developmental
grants. In the context of this RFA, exploratory/ developmental grants
are to be used to either a) gather preliminary data to develop a
research basis for a subsequent application through other mechanisms,
i.e., R01, P01, or b) to explore the feasibility of an innovative or
conceptually creative research question or approach that may not be
justifiable through existing research to compete as a standard research
project grant (e.g., R01). Because innovative projects may require a
preliminary test of feasibility, the R21 mechanism could provide short-
term support for such preliminary work. Exploratory/developmental
studies are not intended for large-scale undertakings, nor are they
intended to support or supplement ongoing research.
Investigators with expertise in the physiology, pathology, and genetics
of organs and tissues involved in rheumatic, skin, and autoimmune
diseases who wish to establish research programs in the context of
autoimmune diseases are encouraged to apply. Also encouraged are
investigators with expertise in immune mechanisms of disease and
autoimmunity who wish to expand their research to mechanisms of target
organ damage.
FUNDS AVAILABLE
The estimated total funds (direct and facilities and administrative
(F&A) costs) available for the first year of support for all awards
made under this RFA will be $3,250,000. Because the nature and scope
of the proposed research will vary from application to application, it
is anticipated that the size and duration of each award will also vary.
Although the FY 2003 financial plans of the NIAMS provide support for
this program, awards pursuant to the RFA are contingent upon the
availability of funds and the receipt of a sufficient number of
meritorious applications. At this time, it is not known if this RFA
will be reissued.
ELIGIBLE INSTITUTIONS
You may submit an application if your institution has any of the
following characteristics:
o For-profit or non-profit organization
o Public or private institutions such as universities, colleges,
hospitals, and
o Laboratories
o National 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
Any individuals with 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 always encouraged to apply for NIH programs.
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: scientific/research, peer review, and financial or grants
management issues:
o Direct your questions about scientific/research issues to:
J. Elizabeth Gretz, Ph.D.
Director, Immunology and Inflammation Program
Rheumatic Diseases Branch, NIAMS, NIH
One Democracy Plaza
6701 Democracy Boulevard, Suite 800, MSC 4872
Bethesda, MD 20872-4872
Telephone: (301) 594-5032
FAX: (301) 480-4543
Email: [email protected]
Alan Moshell, M.D.
Director, Skin Diseases Program, NIAMS, NIH
One Democracy Plaza
6701 Democracy Boulevard, Suite 800, MSC 4872
Bethesda, MD 20872-4872
Telephone: (301) 594-5017
FAX: (301) 480-4543
Email: [email protected]
Richard S. Fisher, Ph.D.
Director, Corneal Diseases Program
Division of Extramural Research
6120 Executive Blvd, MSC 7164 Bethesda, MD 20892-7164
National Eye Institute, NIH
Executive Plaza South, Suite 350
Bethesda, MD 20892-7164
(For FEDEX use: Rockville, MD 20852)
FAX: 301-402-0528
Telephone: 301-451-2020
Email: [email protected]
Lisa Begg, Dr.P.H., R.N.
Director of Research Programs
Office of Research on Women's Health
Office of the NIH Director, NIH
Building 1, Room 201
9000 Rockville Pike
Bethesda, MD 20892-0161
Telephone: 301/402-1770
FAX: 301/402-1798
Email: [email protected]
o Direct your questions about peer review issues to:
Tracy Shahan, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases
One Democracy Plaza
6701 Democracy Boulevard, Suite 800, MSC 4872
Bethesda, MD 20872-4872
Telephone: (301) 594- 4952
FAX: (301) 402- 2406
Email: [email protected]
o Direct your questions about financial or grants management matters
to:
Mr. Michael G. Morse
Deputy Grants Management Officer
National Institute of Arthritis and Musculoskeletal and Skin Diseases
One Democracy Plaza
6701 Democracy Boulevard, Suite 800, MSC 4872
Bethesda, MD 20872-4872
Telephone: (301) 594-3535
FAX: (301) 480- 5450
Email: [email protected]
William W. Darby
Grants Management Officer
Division of Extramural Research
National Eye Institute Executive Plaza South, Suite 350
6120 Executive Blvd, MSC 7164 Bethesda, MD 20892-7164
Telephone: (301) 496-5884
FAX: (301- 496-9997
Email: [email protected]
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that
includes the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o 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 a subsequent application, the information
that it contains allows NIAMS staff to estimate the potential review
workload and plan the review.
The letter of intent is to be sent by the date listed at the beginning
of this document. It is preferred that the letter of intent be sent
electronically. If necessary, the letter of intent can be sent by
regular mail. The letter of intent should be sent to:
J. Elizabeth Gretz, Ph.D.
Director, Immunology and Inflammation Program
Rheumatic Diseases Branch, NIAMS, NIH
One Democracy Plaza
6701 Democracy Boulevard, Suite 800, MSC 4872
Bethesda, MD 20872-4872
Telephone: (301) 594-5032
FAX: (301) 480-4543
Email: [email protected]
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 http://grants.nih.gov/grants/funding/phs398/phs398.html in
an interactive format. For further assistance contact GrantsInfo,
Telephone (301) 710-0267,
Email: [email protected].
SUPPLEMENTAL INSTRUCTIONS:
RESEARCH PLAN - The research plan (a-d) is limited to 25 pages for R01
applications and 10 pages for R21 applications. 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.
For the R21 application, preliminary data supporting feasibility of
approach are not required, however, if included, the section may not
exceed 1 page. In addition, a paragraph should be included in the
Significance section of the application that specifies either how the
project presents a new direction for the work performed in the PI's
laboratory or the innovative nature of the research question or
approach, and how it may advance the understanding of the mechanisms of
target organ damage or altered microcirculation in rheumatic and
autoimmune skin diseases.
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
http://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
http://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 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
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:
Tracy Shahan, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases
One Democracy Plaza
6701 Democracy Boulevard, Suite 800, MSC 4872
Bethesda, MD 20872-4872
Telephone: (301) 594-4952
FAX: (301) 402-2406
Email: [email protected]
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.
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. And, if the
application is not responsive to the RFA, NIAMS staff may contact the
applicant to determine whether to return the application to the
applicant or submit it for review in competition with unsolicited
applications at the next appropriate NIH review cycle.
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 an appropriate council or board
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 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
The scientific review group will address and consider each of these
criteria in assigning your application's overall score, weighting them
as appropriate for each application. Your 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,
you may propose to carry out important work that by its nature is not
innovative but is essential to move a field forward.
(1) SIGNIFICANCE: Does your study address an important problem? If the
aims of your application are achieved, how do they advance scientific
knowledge? 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? Do you acknowledge potential problem areas and
consider alternative tactics?
(3) INNOVATION: Does your project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does your project
challenge existing paradigms or develop new methodologies or
technologies?
(4) INVESTIGATOR: Are you appropriately trained and well suited to
carry out this work? Is the work proposed appropriate to your
experience level as the principal investigator and to that of other
researchers (if any)?
(5) ENVIRONMENT: Does the scientific environment in which your 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 DATA SHARING: The adequacy of the proposed plan to share data.
o BUDGET: The reasonableness of the proposed budget and the
requested period of support in relation to the proposed research.
OTHER REVIEW CRITERIA:
In addition to the above criteria, in accordance with NIH policy, all
R21 applications will also be reviewed with respect to the following:
o In the context of this RFA, the R21 exploratory/developmental
grants are to be used to either: a) gather preliminary data to
develop a research basis for a subsequent application through
other mechanisms, i.e., R01, P01, or b) explore the feasibility
of an innovative or conceptually creative research question or
approach that may not be justifiable through existing research to
compete as a standard research project grant (e.g., R01).
o Preliminary data supporting feasibility of approach are not
required.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: February 10, 2003
Application Receipt Date: March 20, 2003
Peer Review Date: July 2003
Council Review: September 2003
Earliest Anticipated Start Date: September 2003
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review).
o Use of interdisciplinary team/approaches.
o Availability of funds.
o Programmatic priorities.
REQUIRED FEDERAL CITATIONS
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
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a
complete copy of the updated Guidelines is available at
http://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
http://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
http://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
http://grants.nih.gov/grants/stem_cells.htm and at
http://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
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this initiative 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. Nos. 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 http://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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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