and Human Services (HHS)
EXPIRED
Department
of Health and Human Services
Participating Organizations
National Institutes of Health
(NIH), (http://www.nih.gov)
Components of Participating Organizations
National Institute of Mental
Health (NIMH), (http://www.nimh.nih.gov)
National Institute on Deafness and Other Communication
Disorders (NIDCD), (http://www.nidcd.nih.gov)
National Institute of Child Health and Human Development
(NICHD), (http://www.nichd.nih.gov)
National Institute of Neurological Disorders and Stroke
(NINDS), (http://www.ninds.nih.gov)
National Institute of Environmental Health Sciences (NIEHS),
(http://www.niehs.nih.gov)
National Institute of Nursing Research (NINR), (http://www.ninr.nih.gov)
Office of Dietary Supplements (ODS), (http://ods.od.nih.gov)
Title: Research On Autism And Autism Spectrum
Disorders (R01)
Announcement Type
This is a reissue of PA-04-085, which was previously released April 2, 2004, and is now divided into separate FOAs for R01, R21, and R03 funding mechanisms.
Update: The following update relating to this announcement has been issued:
Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government, during FY 2006 the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. Therefore, once the transition is made for a specific grant mechanism, investigators and institutions will be required to submit applications electronically using Grants.gov. For more information and an initial timeline, see http://era.nih.gov/ElectronicReceipt/. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html). Specific funding opportunity announcements will also clearly indicate if Grants.gov submission and the use of the SF424 (R&R) is required. Investigators should consult the NIH Forms and Applications Web site (http://grants.nih.gov/grants/forms.htm) for the most current information when preparing a grant application.
Program
Announcement (PA) Number: PA-06-390
Catalog of Federal Domestic Assistance Number(s)
93.242,
93.113, 93.115, 93.173, 93.361, 93.865, 93.853
Key Dates
Due Dates for E.O. 12372 Table of Contents Part I Overview Information Section I. Funding Opportunity
Description
1. Research
Objectives The purpose of this Funding Opportunity Announcement
(FOA) is to encourage grant applications for the support of research designed
to elucidate the diagnosis, epidemiology, etiology, genetics, treatment, and
optimal means of service delivery in relation to Autistic Disorder
("autism") and autism spectrum disorders (Rett's Disorder, Childhood
Disintegrative Disorder, Asperger's Disorder, Pervasive Developmental Disorder-Not
Otherwise Specified, or "Atypical Autism"). This FOA is meant to support the broad research goals
of the Autism Research Matrix (http://www.nimh.nih.gov/autismiacc/researchmatrix.pdf).
In February 2003, Congress requested that the Department of Health and Human
Services (HHS) develop a set of autism research goals and activities for the
next several years (House Report 109-10). Input into this activity included a
meeting of autism investigators with a range of scientific expertise, as well
as input from community members. Preparation for specifying this matrix
involved a two-day meeting of an expert panel of scientists; public
presentation and discussion of a draft matrix at the Autism Summit Conference
in Washington DC on November 20, 2003; and adoption of the matrix by the
Federal Interagency Autism Coordinating Committee (IACC). RESEARCH
OBJECTIVES Current classification systems (e.g., DSM-IV) include
five separate diagnoses under the Pervasive Developmental Disorders: Autistic
Disorder, Rett's Disorder, Childhood Disintegrative Disorder, Asperger's
Disorder, and Pervasive Developmental Disorder Not Otherwise Specified.
Collectively, these Pervasive Developmental Disorders are often referred to as
Autism Spectrum Disorders. These disorders share a cluster of impairments in
reciprocal social interaction and communication and/or the presence of
stereotyped behavior, interests, and activities. These complex disorders are
usually of lifelong duration and affect multiple aspects of development,
learning, and adaptation in the community, and thus represent a pressing public
health need. The etiologies of these disorders are poorly understood, but are
thought to include genetic, metabolic, immunologic, or infectious or other
environmental influences. Clinical research involving these disorders requires
well-integrated, multi-disciplinary, methodologically-rigorous scientific
approaches and access to a sufficient number of well-characterized patients
with these disorders. Basic research into the pathophysiology of autism and
autism spectrum disorders, including research on brain mechanisms and genetics,
is of special interest. Also of high priority are clinical and applied investigations
that may lead to the development of diagnostic research instruments,
treatments, and intervention strategies. Specific areas of interest thus
include epidemiology, early identification and diagnosis, genetic studies,
brain mechanisms, communication skills, cognitive neuroscience, psychosocial
(behavioral) interventions, pharmacological and other biological interventions,
and support and rehabilitative services across the life-span, including adulthood and
the transition to adulthood. Areas of interest include, but need not be limited to,
the following: Epidemiology: Studies of the genetic and
environmental epidemiology of autism to determine risk and protective processes
in the etiology of autism, including environmental exposures during pregnancy
and early childhood; longitudinal studies of high-risk populations;
epidemiologic research on interactive genetic and environmental processes that
increase or decrease risk for autism; research on the expression of the full
range of autism spectrum disorders; studies of their developmental course
across the life-span; studies that characterize the range of expression within
families; and research on co-occurring features, especially research that
characterizes and quantifies risk and protective processes associated with
co-occurrence. Also of interest are clinical epidemiologic studies of autism
spectrum disorders in clinical settings, including studies of clinical
decision-making in personal-encounter care for individuals and families. Screening, Early Identification, and Diagnosis: Key diagnostic and
phenotypic features associated with various stages of development; development
of new screening tools for use in a variety of settings; assessment of comorbid
features including hyperactivity, attentional dysfunctions, epilepsy, and
obsessive and compulsive symptoms; the creation of new measures to be used in
longitudinal studies and measures that further differentiate the subtypes of
autism spectrum disorders; and, developmental factors relevant to reliable and
valid diagnosis. Genetic Studies: Family-based association
analysis and other linkage disequilibrium approaches that aim to identify
specific susceptibility genes; studies of epigenetic mechanisms and long range
control of gene expression; high-resolution mapping and positional cloning
studies; resolution of locus heterogeneity; analysis of the interaction of
autism susceptibility genes with environmental exposures and/or genes
responsive to environmental insult; testing for potential candidate genes. An
area of particular interest is the effect of genetic factors on therapeutic
drug response in autistic individuals (see Pharmacogenomics, below). Brain Mechanisms: Studies of brain mechanisms
underlying the development, regulation, and modulation of behaviors
characterizing autism and autism spectrum disorders, particularly those
mechanisms involving communication and social interaction; studies of brain
mechanisms and biological factors underlying autistic regression, or the loss
of previously acquired skills; studies of brain mechanisms involved in the
development of abnormal electroencephalograms and epilepsy and studies to
clarify the subtypes of seizures and seizure disorders in autism; studies to
define the neurobiological basis of neurological abnormalities and
neuropsychiatric symptoms, including motor stereotypies, gait abnormalities,
akinesias, dyskinesias, obsessive/compulsive traits, and the exacerbation of
these symptoms, including the role of neuroimmune/autoimmune factors; studies
that seek to define basic processing deficits using neuropsychological and
cognitive neuroscience techniques; studies to develop animal models of brain
dysfunction in autism and autism spectrum disorders, based on either genetic or
environmental factors or their interaction. Cognitive Science: Developmental studies of
relevant behaviors during infancy including attention to social and nonsocial
stimuli, affective behavior, gaze, vocalization, imitation, initiative,
reciprocity, attachment, play, compliance, and self-recognition and their
emergence in children with autism and autistic spectrum disorders; research on
the delays and deviations in social behavior and cognition during preschool and
middle school, including empathy, receptive social cognitive deficits (i.e.,
difficulties understanding others), and expressive difficulties; studies
leading to more sophisticated tests of higher cognitive functioning, especially
in social, communicative, reasoning, and problem-solving areas, as well as
tests of basic attentional, emotional and cognitive deficits that may underlie
these deficits or be precursors to them; studies of theory of mind, of
unconventional verbal behaviors, and of the sensory-motor factors involved in
relevant social cognition; and the development, validation, and refinement of
interventions designed to address deficits in complex social and cognitive
abilities or their developmental precursors; interventions designed to lessen
or remediate cognitive deficits. Communication Skills: Longitudinal, developmental
studies of behaviors that are precursors to later communication and their
emergence in children with autism and autistic spectrum disorders; sensory,
motor, and social-cognitive impairments that impact upon interaction and
communication; predictors of loss of or regression in expressive language
abilities; interventions designed to remediate communication and related
deficits across the life-span. Pharmacological/Biological Interventions: Studies aimed at developing
and testing the efficacy and safety of pharmacological agents that specifically
target the core features of autism and autistic spectrum disorders; studies of
the efficacy and safety of pharmacological and combined treatments for the most
common and impairing psychopathology associated with autism (e.g.,
hyperactivity, impulsivity, aggression, self-injury, and obsessive-compulsive
symptoms); studies that relate characteristics of individuals (or diagnostic
subtypes) to therapeutic response and treatment outcomes (also see Pharmacogenomics ,
below); new approaches to treatment that build on advances in neuroscience,
genetics, immunology, and other neurobiologic fields; focused interventions
that test specific theories or hypotheses regarding possible neuropathogenesis;
studies that address the benefits of combined drug and cognitive, behavioral,
or psychosocial interventions; development of innovative methodologies and
outcome measures. Pharmacogenomic Studies: Construction and analysis of
SNP haplotypes that predict therapeutic response or adverse reactions to drugs;
correlation of drug response profiles with intermediate phenotypes (e.g., brain
imaging, neurophysiology, learning and memory, sustained attention);
identification of biomarkers to resolve clinical heterogeneity and heterogeneity
of therapeutic drug response; application of high-throughput approaches to
screen for drug candidates metabolized by or inhibitors of polymorphic
drug-metabolizing enzymes, e.g., CYP2D6; studies of genetically determined
functional changes in nuclear and cell surface receptors to explain the
ineffectiveness of therapeutic agents and adverse or paradoxical drug
responses; studies of allelic variation occurring in individual transporter
genes that are associated with a functional consequence. Psychosocial Interventions: Studies developing new
treatments (e.g., behavioral, cognitive-behavioral) and studies validating,
refining, and comparing approaches to the treatment of persons with autism and
autism spectrum disorders and their families, as well as studies that analyze
and define the critical features of effective intervention; studies that relate
characteristics of individuals (or diagnostic subtypes) to treatment outcomes;
research on relevant contextual factors including physical and community
environments, parent-child and sibling-child relationship factors, and
peer-child interactions; studies addressing generalization or the transfer of
learning from one setting to another; studies that develop and test
interventions for infants and toddlers with confirmed or suspected autism
spectrum disorders; studies that develop and test interventions to outcome in
school and community settings throughout the lifespan; development of
innovative methodologies and outcome measures. Services Research: Research on the
organization, delivery, coordination, and financing of services for persons
with autism spectrum disorders, and their families, within or across service
settings; studies aimed at better identifying and addressing changes in service
and rehabilitative needs across the life-span, including during transitions
from childhood to adolescence, and adolescence to adulthood; interventions to
improve the quality and outcomes of treatment and rehabilitation services;
studies to develop improved measures of adaptive capabilities for children,
adolescents, and adults with autism spectrum disorders; studies of ways to
coordinate or integrate services across settings including specialty mental
health, general health, and other settings such as educational, vocational, and
housing services, in order to maximize receipt of appropriate services; and
research on the economic factors effecting the delivery of needed services and
treatments including cost-benefit, cost-effectiveness, and cost utility
analyses of service interventions. See Section VIII, Other
Information - Required Federal Citations, for policies related to this
announcement. 1.
Mechanism of Support This funding opportunity uses just-in-time
concepts. It also uses the modular as well as the non-modular budget 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 budget format described in the PHS
398 application instructions. Otherwise follow the instructions for non-modular
research grant applications. 2. Funds Available Facilities and administrative costs requested by
consortium participants are not included in the direct cost limitation, see NOT-OD-05-004. Section III. Eligibility Information
1. Eligible
Applicants 1.B. Eligible Individuals Any individual with the
skills, knowledge, and resources necessary to carry out the proposed research
is invited to work with their institution 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 support. Not applicable. Section IV. Application and
Submission Information 1. Address to Request Application
Information Telecommunications
for the hearing impaired: TTY 301-451-5936. 2. Content and Form of Application
Submission Proposed research should
provide special opportunities for furthering research programs through the use
of unusual talent, resources, populations, or environmental conditions in other
countries that are not readily available in the United States or that augment
existing U.S. resources. 3. Submission Dates and Times Application Submission Date(s): See http://grants.nih.gov/grants/funding/submissionschedule.htm. 3.A.1. Letter of Intent A letter of intent is not
required for the funding opportunity. 3.B. Sending an Application to the NIH Applications must be submitted on or before the application
receipt dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.
Upon receipt, applications will be evaluated for
completeness by CSR. Incomplete applications will not be reviewed. The NIH will not accept any application in response to
this funding opportunity that is essentially the same as one currently pending
initial review unless the applicant withdraws the pending application. The NIH
will not accept any application that is essentially the same as one already
reviewed. This does not preclude the submission of a substantial revision of an
application already reviewed, but such application must include an Introduction
addressing the previous critique. Information on the status of an application should be
checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/. 4. Intergovernmental Review All NIH awards are subject to the terms and conditions,
cost principles, and other considerations described in the NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/policy.htm).
Applications requesting up to $250,000 per year in
direct costs must be submitted in a modular budget format. The modular budget
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 at http://grants.nih.gov/grants/funding/phs398/phs398.html
includes step-by-step guidance for preparing modular budgets. Applicants must
use the currently approved version of the PHS 398. Additional information on
modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.
Specific Instructions
for Applications Requesting $500,000 (direct costs) or More per Year. Applicants requesting
$500,000 or more in direct costs for any year must carry out the following
steps: 2) Obtain agreement from the IC staff that the IC will accept your
application for consideration for award; and, This policy applies to all investigator-initiated new
(type 1), competing continuation (type 2), competing supplement, or any amended
or revised version of these grant application types. Additional information on
this policy is available in the NIH Guide for Grants and Contracts, October 19,
2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing). A data sharing plan is not required; however, one may be
proposed. The precise content of the data-sharing plan will vary, depending on
the data being collected and how the investigator is planning to share the
data. Applicants who are planning to share data may wish to describe briefly
the expected schedule for data sharing, the format of the final dataset, the
documentation to be provided, whether or not any analytic tools also will be
provided, whether or not a data-sharing agreement will be required and, if so,
a brief description of such an agreement (including the criteria for deciding
who can receive the data and whether or not any conditions will be placed on
their use), and the mode of data sharing (e.g., under their own auspices by
mailing a disk or posting data on their institutional or personal website,
through a data archive or enclave). Investigators choosing to share under their
own auspices may wish to enter into a data-sharing agreement. References to data
sharing may also be appropriate in other sections of the application. The
reasonableness of the data sharing plan or the rationale for not sharing
research data may be assessed by the reviewers. However, reviewers will not
factor the proposed data sharing plan into the determination of scientific
merit or the priority score. Applications for genetic studies must include a data sharing
plan. Data and biomaterials from subjects included in genetic projects funded
under this opportunity will be made available and distributed to the broader
scientific community, in accordance with existing procedures and protocols for
the NIMH Human Genetics Initiative. Pharmacogenomic studies are expected to
make data available for inclusion in PharmGKB (http://www.pharmgkb.org), an NIH-supported
knowledge base for pharmacogenetic information (see below). It is expected
that the information to be shared includes all genetic, clinical and diagnostic
information, in addition to cell lines and DNA. It is preferable that data and
materials generated in genetics projects funded under this opportunity should
be placed in common, public cell repositories and databases that are widely
accessible by investigators in the scientific community. An NIMH-supported
data management facility and cell repository - the NIMH Center for
Collaborative Genetic Studies on Mental Disorders (http://nimhgenetics.org)- is such a
community resource. Further information is available from the NIMH program
staff contact listed below. It is expected that the investigator’s data sharing plan
will specify the following elements: (1) the creation of comprehensive and
verified databases that contain all clinical, diagnostic, and genetic
information collected and produced in the project; (2) the establishment of
high-quality cell lines, from which DNA will be extracted and stored, for all
subjects studied from whom blood samples have been obtained; (3) mechanisms by
which all databases and biomaterials (DNA samples, cell lines) are widely
distributed to qualified investigators in the scientific community; (4) a
protocol for wide dissemination of these data and biomaterials; (5) a timetable
for distribution; and (6) an assurance that data and biomaterials are
disseminated in a manner comparable to pre-existing protocols and procedures
for distributing such data and biomaterials in the NIMH Human Genetics
Initiative (see http://zork.wustl.edu/nimh/NIMH_initiative/NIMH_initiative_link.html). NIMH, in consultation with NIH’s Office of the General
Counsel, the National Human Genome Research Institute's Ethical, Legal, and
Social Implications Research Program and the Department of Health and Human
Services' Office for Human Research Protections, has developed a model consent
form for use in human genetic research at http://zork.wustl.edu/nimh/NIMH_initiative/NIMH_initiative_link.html. Consent forms
for pharmacogenomic studies should also include explicit disclosure that
de-identified data will be posted to PharmGKB. Sharing
Research Resources The
adequacy of the resources sharing plan and any related data sharing plans will
be considered by Program staff of the funding organization when making
recommendations about funding applications. The effectiveness of the resource
sharing will be evaluated as part of the administrative review of each
non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm).
See Section VI.3. Reporting. Section V. Application Review Information
1. Criteria
The following will be considered in making funding
decisions: The goals of NIH supported research are to advance our
understanding of biological systems, to improve the control of disease, and to
enhance health. In their written critiques, reviewers will be asked to comment
on each of the following criteria in order to judge the likelihood that the
proposed research will have a substantial impact on the pursuit of these goals.
Each of these criteria will be addressed and considered in assigning the
overall score, weighting them as appropriate for each application. Note that an
application does not need to be strong in all categories to be judged likely to
have major scientific impact and thus deserve a high priority score. For
example, an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward. Biohazards: If materials or procedures
are proposed that are potentially hazardous to research personnel and/or the
environment, determine if the proposed protection is adequate. Section VI. Award
Administration Information
1. Award
Notices If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant. For
details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions
of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
We
encourage your inquiries concerning this funding opportunity 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: Judith Cooper, Ph.D. Alice Kau, Ph.D. Deborah Hirtz, M.D. Cindy P. Lawler, Ph.D. Kathy Mann Koepke, Ph.D. Paul M. Coates, Ph.D. 2. Peer
Review Contacts: 3. Financial or Grants Management Contacts: Christopher Robey Christopher
Myers Edward Myrbeck Lerlita Garcia Diane E. Drew Section VIII. Other
Information
Required
Federal Citations NIH Public Access Policy:
Release/Posted Date: May 4, 2006
Letters of Intent
Receipt Date(s): Not applicable.
Application Submission Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
for
details.
AIDS Application Receipt Date(s): Not applicable.
Peer Review Date(s): See http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Council Review
Date(s): See http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Earliest
Anticipated Start Date(s): See http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Additional
Information To Be Available Date (Url Activation Date): Not applicable.
Expiration Date for R01 Non-AIDS Applications: November 2, 2006
Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007
Not Applicable
Additional Overview
Content
Executive Summary
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility
Information
1. Eligible Applicants
A. Eligible
Institutions
B. Eligible
Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and
Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review and
Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy
Requirements
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II
- Full Text of Announcement
Section II. Award Information
This FOA will use
the NIH Research Project Grant (R01) award mechanism. As an applicant, you
will be solely responsible for planning, directing, and executing the proposed
project. The total project period for an R01 application submitted in response
to this FOA may not exceed 5 years.
1.A. Eligible Institutions
You may submit (an)
application(s) if your organization has any of the following characteristics:
2. Cost Sharing or Matching
The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.
3. Other-Special Eligibility Criteria
The PHS 398 application
instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html
in an interactive format. Applicants must use the currently approved version of
the PHS 398. For further assistance contact GrantsInfo, Telephone (301)
710-0267, Email: GrantsInfo@nih.gov.
Applications must be
prepared using the most current PHS 398 research grant application instructions
and forms. Applications must have a D&B Data Universal Numbering System
(DUNS) number as the universal identifier when applying for Federal grants or
cooperative agreements. The D&B number can be obtained by calling (866)
705-5711 or through the web site at http://www.dnb.com/us/.
The D&B number should be entered on line 11 of the face page of the PHS 398
form.
The title and number of this funding opportunity must
be typed on line 2 of the face page of the application form and the YES box
must be checked.
Foreign Organizations
Several special provisions apply to applications
submitted by foreign organizations:
See Section IV.3.A for details.
3.A.
Submission, Review and Anticipated Start Dates
Peer Review
Date(s): See http://grants.nih.gov/grants/funding/submissionschedule.htm.
Council Review Date(s): See http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date(s): See http://grants.nih.gov/grants/funding/submissionschedule.htm
Applications must be
prepared using the research grant application forms found in the PHS 398
instructions for preparing a research grant application. Submit a signed,
typewritten original of the application, including the checklist, and five
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 (U.S. Postal Service Express
or regular mail)
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Personal deliveries of
applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
3.C.
Application Processing
This initiative is not subject to intergovernmental review.
5. Funding Restrictions
Pre-Award Costs are allowable. A grantee may, at
his/her own risk and without NIH prior approval, incur obligations and
expenditures to cover costs up to 90 days before the beginning date of the
initial budget period of a new or competing continuation award if such costs:
are necessary to conduct the project, and would be allowable under the grant,
if awarded, without NIH prior approval. If specific expenditures would
otherwise require prior approval, the grantee must obtain NIH approval before
incurring the cost. NIH prior approval is required for any costs to be incurred
more than 90 days before the beginning date of the initial budget period of a
new or competing continuation award.
The incurrence of
pre-award costs in anticipation of a competing or non-competing award imposes
no obligation on NIH either to make the award or to increase the amount of the
approved budget if an award is made for less than the amount anticipated and is
inadequate to cover the pre-award costs incurred. NIH expects the grantee to be
fully aware that pre-award costs result in borrowing against future support and
that such borrowing must not impair the grantee's ability to accomplish the
project objectives in the approved time frame or in any way adversely affect
the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission Requirements
Specific
Instructions for Modular Grant Applications:
1) Contact the IC
program staff at least 6 weeks before submitting the application, i.e., as you
are developing plans for the study;
3) Include a cover letter with the application that
identifies the staff member and IC who agreed to accept assignment of the
application.
Plan for Sharing Research Data
NIH policy requires
that grant awardee recipients make unique research resources readily available
for research purposes to qualified individuals within the scientific community
after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm
and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan for
sharing research resources addressing how unique research resources will be
shared or explain why sharing is not possible.
Only the review
criteria described below will be considered in the review process.
2. Review and Selection Process
Applications
submitted for this funding opportunity will be assigned to the ICs on the basis
of established PHS referral guidelines.
Appropriate scientific review groups convened in
accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm)
will evaluate applications for scientific and technical merit.
As part of the
initial merit review, all applications will:
Significance: Does this study address an
important problem? If the aims of the application are achieved, how will
scientific knowledge or clinical practice be advanced? What will be the effect
of these studies on the concepts, methods, technologies, treatments, services,
or preventative interventions that drive this field?
Approach: Are the conceptual or clinical
framework, design, methods, and analyses adequately developed, well integrated,
well reasoned, and appropriate to the aims of the project? Does the applicant
acknowledge potential problem areas and consider alternative tactics?
Innovation: Is the project original and
innovative? For example: Does the project challenge existing paradigms or
clinical practice; address an innovative hypothesis or critical barrier to
progress in the field? Does the project develop or employ novel concepts,
approaches, methodologies, tools, or technologies for this area?
Investigators: Are the investigators
appropriately trained and well suited to carry out this work? Is the work
proposed appropriate to the experience level of the principal investigator and
other researchers? Does the investigative team bring complementary and
integrated expertise to the project (if applicable)?
Environment: Does the scientific
environment in which the work will be done contribute to the probability of
success? Do the proposed studies benefit from unique features of the scientific
environment, or subject populations, or employ useful collaborative
arrangements? Is there evidence of institutional support?
2.A. Additional Review
Criteria:
In addition to the
above criteria, the following items will continue to be considered in the
determination of scientific merit and the priority score:
Protection
of Human Subjects from Research Risk: The involvement of human subjects and protections from
research risk relating to their participation in the proposed research will be
assessed (see the Research Plan, Section E on Human Subjects in the PHS Form
398).
Inclusion
of Women, Minorities and Children in Research: 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 will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated (see the Research Plan, Section E on Human Subjects in
the PHS Form 398).
Care and
Use of Vertebrate Animals in Research: If vertebrate animals are to
be used in the project, the five items described under Section F of the PHS
Form 398 research grant application instructions will be assessed.
2.B. Additional Review Considerations
Budget: The reasonableness of the proposed
budget and the requested period of support in relation to the proposed research
may be assessed by the reviewers. Is the percent effort listed for the PD/PI
appropriate for the work proposed? Is each budget category realistic and
justified in terms of the aims and methods?
2.C. Sharing
Research Data
The reasonableness of the data sharing plan or the
rationale for not sharing research data will be assessed by the reviewers.
However, reviewers will not factor the proposed data sharing plan into the
determination of scientific merit or the priority score. The presence of a data
sharing plan will be part of the terms and conditions of the award. The funding
organization will be responsible for monitoring the data sharing policy.
2.D. Sharing
Research Resources
NIH policy requires that grant awardee recipients make
unique research resources readily available for research purposes to qualified
individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr.
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The
effectiveness of the resource sharing will be evaluated as part of the
administrative review of each Non-Competing Grant
Progress Report (PHS 2590), See Section VI.3. Reporting.
3. Anticipated Announcement and Award Dates
Not applicable.
After the peer review of the application is completed,
the PD/PI will be able to access his or her Summary Statement (written
critique) via the eRA Commons.
A formal notification in the form of a Notice of Award
(NoA) will be provided to the applicant organization. The NoA signed by the
grants management officer is the authorizing document. Once all administrative
and programmatic issues have been resolved, the NoA will be generated via email
notification from the awarding component to the signing official shown on the
electronic application.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Also Section
IV.5. Funding Restrictions.
2. Administrative and National
Policy Requirements
All NIH grant and cooperative agreement awards include
the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart
A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
3. Reporting
Awardees will be required to submit the PHS
Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm)
and financial statements as required in the NIH Grants Policy Statement.
Section VII. Agency
Contacts
1. Scientific/Research
Contacts:
Lisa Gilotty, Ph.D.
Division of Pediatric Translational Research and Treatment Development
National Institute of Mental Health
6001 Executive Blvd, Room 6179, MSC 9617
Bethesda, MD 20892-9617
Telephone: (301) 443-3825
FAX: (301) 480-4415
Email: gilottyl@mail.nih.gov
Division of Scientific Programs
National Institute on Deafness and
Other Communication Disorders
Executive Plaza South,
Room 400C-11 - MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 496-5061
FAX: (301) 402-6251
Email: cooperj@nidcd.nih.gov
Mental Retardation and Developmental
Disabilities Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B09F,
MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-1383
FAX: (301) 496-3791
Email: kaua@mail.nih.gov
Extramural Research Program
National Institute of Neurological
Disorders and Stroke
6001 Executive Boulevard, Room 2212, MSC
9250
Bethesda, MD 20892-9250
Telephone: (301) 496-5821
FAX: (301) 480-1080
Email: dh83f@nih.gov
Cellular, Organ and Systems
Pathobiology Branch
National Institute of Environmental
Health Sciences
P.O. Box 12233, MD EC-23
Research Triangle Park, NC 27709
Telephone: (919) 316-4671
FAX: (919) 541-5064
Email: lawler@niehs.nih.gov
Office of Extramural Programs
National Institute of Nursing Research
6701 Democracy Boulevard, Suite
7101, MSC 4870
Bethesda, MD 20892-4870
Telephone: (301496-9623
FAX: (301) 480-8260
Email: koepkek@mail.nih.gov
Director, Office of Dietary
Supplements
National Institutes of Health
6100 Executive Boulevard, Suite
3B01, MSC 7517
Bethesda, MD 20892-7517
Telephone: (301) 435-2920
FAX: (301) 480-1845
Email: pc61s@nih.gov
Not applicable.
Joy Knipple
Grants Management Branch
Division of Extramural Activities
National Institute of Mental
Health
6001 Executive Blvd, Room 6131, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-8811
Fax: (301) 443-6885
Email: knipplej@mail.nih.gov
Grants Management Branch
National Institute of Child Health and Human
Development
6100 Executive Boulevard, Room 8A17K - MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 435-6996
FAX: (301) 480-4783
Email: robeyj@mail.nih.gov
Grants
Management Branch
National Institute on
Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400B, MSC 7180
Bethesda, MD 20892-7180
Telephone: 301-435-0713
Fax: 301-402-1758
Email: myersc@mail.nih.gov
Grants Management Branch
National Institute of Neurological Disorders and
Stroke
6001 Executive Boulevard, Room 3290, MSC 9537
Rockville, MD 20852-9537
Telephone: (301) 496-3938
FAX: (301) 402-0219
Email: myrbecke@ninds.nih.gov
Grants Management Branch
National Institute of Environmental Health
Sciences
P.O. Box 12233, MD EC-22
Research Triangle Park, NC 27709
Telephone: (919) 316-4638
FAX: (919) 541-2860
Email: garcial@niehs.nih.gov
Office of Grants and Contracts Management
National Institute of Nursing Research
6701 Democracy Boulevard, Suite 7101, MSC 4870
Bethesda, MD 20892-4870
Telephone: (301) 594-2807
FAX: (301) 451-5651
Email: diane_drew@nih.gov
Human Subjects Protection:
Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
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 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 funding opportunity 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.
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 "NIH Guidelines
for Inclusion of Women and Minorities as Subjects in Clinical Research (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 SF424 (R&R); 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 Clinical
Research:
The NIH maintains a policy that children (i.e.,
individuals under the age of 21) must be included in all clinical research,
conducted or supported by the NIH, unless there are scientific and ethical
reasons not to include them.
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 (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 applications
for research involving human subjects and individuals designated as key
personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
NIH-funded investigators are requested to submit to
the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov)
at PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole or
in part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.
NIH is requesting that authors submit manuscripts
resulting from 1) currently funded NIH research projects or 2) previously
supported NIH research projects if they are accepted for publication on or
after May 2, 2005. The NIH Public Access Policy applies to all research grant
and career development award mechanisms, cooperative agreements, contracts,
Institutional and Individual Ruth L. Kirschstein National Research Service
Awards, as well as NIH intramural research studies. The Policy applies to
peer-reviewed, original research publications that have been supported in whole
or in part with direct costs from NIH, but it does not apply to book chapters,
editorials, reviews, or conference proceedings. Publications resulting from
non-NIH-supported research projects should not be submitted.
For more information about the Policy or the
submission process please visit the NIH Public Access Policy Web site at http://PublicAccess.nih.gov/ and
view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_manual.htm).
Standards for Privacy of Individually Identifiable
Health Information:
The Department of Health and Human Services (DHHS)
issued final modification to the "Standards for Privacy of Individually
Identifiable Health Information," the "Privacy Rule," on August
14, 2002. The Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the protection
of individually identifiable health information, and is administered and
enforced by the DHHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
Website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
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 FOA 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 at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under the authorization of Sections 301
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy Statement. The NIH Grants Policy Statement
can be found at http://grants.nih.gov/grants/policy/policy.htm.
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.
Loan Repayment Programs:
NIH encourages applications for educational loan
repayment from qualified health professionals who have made a commitment to
pursue a research career involving clinical, pediatric, contraception,
infertility, and health disparities related areas. The LRP is an important component
of NIH's efforts to recruit and retain the next generation of researchers by
providing the means for developing a research career unfettered by the burden
of student loan debt. Note that an NIH grant is not required for eligibility
and concurrent career award and LRP applications are encouraged. The periods of
career award and LRP award may overlap providing the LRP recipient with the
required commitment of time and effort, as LRP awardees must commit at least
50% of their time (at least 20 hours per week based on a 40 hour week) for two
years to the research. For further information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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