and Human Services
9000 Rockville Pike
Bethesda, Maryland 20892
RESEARCH ON AUTISM AND AUTISM SPECTRUM DISORDERS
RELEASE DATE: April 2, 2004
PA NUMBER: PA-04-085
EXPIRATION DATE: March 2, 2007
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENTS OF PARTICIPATING ORGANIZATION:
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.nih.gov/ninr)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.113, 93.115, 93.173, 93.242,
93.361, 93.865, 93.853
THIS PA CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS PA
This PA replaces PA-01-051.
The purpose of this program announcement 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 PA 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:
o 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.
o 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.
o 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).
o 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.
o 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.
o 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.
o 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.
o 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.
o 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.
o 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.
MECHANISMS OF SUPPORT
This PA will use the NIH research project grant (R01), small grant (R03), and
exploratory/developmental grant (R21) award mechanisms. As an applicant, you will
be solely responsible for planning, directing, and executing the proposed project.
Competing supplements to existing studies can also be used.
The Small Grant (R03) provides 2 years of funding with a maximum of $50,000 direct
costs for each year. Instructions for the R03 application can be found at
(http://grants.nih.gov/grants/guide/pa-files/PA-03-108.html). Applicants
considering use of this mechanism for an application to NINDS should contact NINDS
staff (below) for information about specific restrictions.
The Exploratory/Developmental Grant (R21) provides 2 years of funding with a
maximum of $275,000 direct costs over the entire budget period; with no 1 year
exceeding $200,000. Instructions for the R21 application may be found at:
http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html. Applicants considering
use of this mechanism for an application to NINDS should contact NINDS staff
(below) for information about specific restrictions.
This PA uses just-in-time concepts. It also uses the modular budgeting as well as
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 budget format. Otherwise follow the instructions for non-modular
budget research grant applications. This program does not require cost sharing as
defined in the current NIH Grants Policy Statement at
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm
Investigators might also want to consider relevant Institute-specific mechanisms,
including the NIMH collaborative R01 mechanism “Collaborative R01s for Clinical and
Services Studies of Mental Disorders and Aids,” PA-01-123, which is located at
http://grants.nih.gov/grants/guide/pa-files/PA-01-123.html; the NIMH R34 mechanism
for exploratory interventions and services research grants “From Intervention
Development to Services: Exploratory Research Grants”, PAR-03-078, which is
located at http://grants.nih.gov/grants/guide/pa-files/PAR-03-078.html and the NIH
R34 mechanism, which is available at
http://grants.nih.gov/grants/guide/pa-files/PA-04-008.html.
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 institutions/organizations
o Faith-based or community-based organizations
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
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 programs.
SPECIAL REQUIREMENTS
Dissemination of Data, Biomaterials for Genetic Studies
Applications for genetic studies must include a data sharing plan. Data and
biomaterials from subjects included in genetic projects funded under this PA 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 PA 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.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this PA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into two areas:
scientific/research and financial or grants management issues:
o Direct your questions about scientific/research issues to:
Ann Wagner, Ph.D.
National Institute of Mental Health
6100 Executive Boulevard, Room 7149, MSC 9633
Bethesda, MD 20857-9633
Telephone: (301) 443-4283
FAX: (301) 443-4045
Email: awagner@mail.nih.gov
Judith Cooper, Ph.D.
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
Alice Kau, Ph.D.
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
Deborah Hirtz, M.D.
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
Cindy P. Lawler, Ph.D.
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
Kathy Mann Koepke, Ph.D.
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
o Direct your questions about financial or grants management matters to:
Rebecca Claycamp, CRA
Chief Grants Management Officer
National Institute of Mental Health
6001 Executive Boulevard, Room 6122, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2811
FAX: (301) 443-6885
Email: rc253d@nih.gov
Christopher Robey
Grants Management Team Leader
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
Sara Stone
Chief, Grants Management Branch
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, EPS-400-B MSC-7180
Bethesda, MD 20892-7180
Telephone: (301) 402-0909
FAX: (301) 402-1758
Email: stones@nidcd.nih.gov
Rita V. Sisco
Grants Management Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 3265, MSC 9537
Rockville, MD 20852-9537
Telephone: (301) 496-7488
FAX: (301) 402-0219
Email: siscor@ninds.nih.gov
Lerlita Garcia
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
Diane E. Drew
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
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet
(D&B;) Data Universal Numbering System (DUNS) number as the Universal Identifier
when applying for Federal grants or cooperative agreements. The DUNS number can be
obtained by calling (866) 705-5711 or through the web site at
http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of
the face page of the PHS 398 form. 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) 435-0714, Email:
GrantsInfo@nih.gov.
The title and number of this program announcement must be typed on line 2 of the
face page of the application form and the YES box must be checked.
APPLICATION RECEIPT DATES: Applications submitted in response to this program
announcement will be accepted at the standard application deadlines, which are
available at http://grants.nih.gov/grants/dates.htm. Application deadlines are
also indicated in the PHS 398 application kit.
SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS: Applications
requesting up to $250,000 per year in direct costs must be submitted in a modular
budget grant format. The modular budget 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.
SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR:
Applications requesting $500,000 or more in direct costs for any year must include
a cover letter identifying the NIH staff member within one of NIH institutes or
centers who has agreed to accept assignment of the application.
Applicants requesting more than $500,000 must carry out the following steps:
1) Contact the IC program staff at least 6 weeks before submitting the application,
i.e., as you are developing plans for the study;
2) Obtain agreement from the IC staff that the IC will accept your application for
consideration for award; and,
3) Identify, in a cover letter sent with the application, the staff member and IC
who agreed to accept assignment of the application.
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.
SENDING AN APPLICATION TO THE NIH: 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
Bethesda, MD 20817 (for express/courier service)
APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates
described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR
will not accept any application in response to this PA 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 a substantial
revision of an unfunded version of an application already reviewed, but such
application must include an Introduction addressing the previous critique.
Although there is no immediate acknowledgement of the receipt of an application,
applicants are generally notified of the review and funding assignment within 8
weeks.
PEER REVIEW PROCESS
Applications submitted for this PA will be assigned 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:
o Undergo a selection process in which only those applications deemed to have the
highest scientific merit, generally the top half of applications under review, will
be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the appropriate national advisory 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 evaluate application in order to judge the
likelihood that the proposed research will have a substantial impact on the pursuit
of these goals. The scientific review group will address and consider each of the
following criteria in assigning the application’s overall score, weighting them as
appropriate for each application.
o Significance
o Approach
o Innovation
o Investigator
o Environment
The 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.
SIGNIFICANCE: Does this study address an important problem? If the aims of the
application are achieved, how will scientific knowledge be advanced? What will be
the effect of these studies on the concepts or methods that drive this field?
APPROACH: Are the conceptual framework, design, methods, and analyses adequately
developed, well-integrated, and appropriate to the aims of the project? Does the
applicant acknowledge potential problem areas and consider alternative tactics?
INNOVATION: Does the project employ novel concepts, approaches or methods? Are the
aims original and innovative? Does the project challenge existing paradigms or
develop new methodologies or technologies?
INVESTIGATOR: Is the investigator 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 (if any)?
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?
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 criteria included in the section on Federal
Citations, below).http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
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 Inclusion Criteria in the sections on Federal Citations, below).
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 398
research grant application instructions (rev. 5/2001) will be assessed.
ADDITIONAL REVIEW CONSIDERATIONS
SHARING RESEARCH DATA: Applicants requesting more than $500,000 in direct costs in
any year of the proposed research are expected to include a data sharing plan in
their application. 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 priority score http://grants.nih.gov/grants/policy/data_sharing
BUDGET: The reasonableness of the proposed budget and the requested period of
support in relation to the proposed research.
AWARD CRITERIA
Applications submitted in response to a PA will compete for available funds with
all other recommended applications. The following will be considered in making
funding decisions:
o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities
REQUIRED FEDERAL CITATIONS
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
DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all
types of clinical trials, including physiologic, toxicity, and dose-finding studies
(phase I); efficacy studies (phase II), efficacy, effectiveness and comparative
trials (phase III). The establishment of data and safety monitoring boards (DSMBs)
is required for multi-site clinical trials involving interventions that entail
potential risk to the participants. (NIH Policy for Data and Safety Monitoring,
NIH Guide for Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date,
investigators submitting an NIH application seeking $500,000 or more in direct
costs in any single year are expected to include a plan for data sharing or state
why this is not possible http://grants.nih.gov/grants/policy/data_sharing.
Investigators should seek guidance from their institutions, on issues related to
institutional policies, local IRB rules, as well as local, state and Federal laws
and regulations, including the Privacy Rule. Reviewers will consider the data
sharing plan but will not factor the plan into the determination of the scientific
merit or the priority score.
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 - 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 are 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://stemcells.nih.gov/index.asp 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, in the project description and
elsewhere in the application as appropriate, 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 PA 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.
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). Those who
must comply with the Privacy Rule (classified under the Rule as “covered entities”)
must do so by April 14, 2003 (with the exception of small health plans which have
an extra year to comply).
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 PA is related to one or
more of the priority areas. Potential applicants may obtain a copy of "Healthy
People 2010" at http://www.healthypeople.gov/.
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.
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