Release Date:  March 6, 2002

RFA:  RFA-MH-03-005

National Institute of Mental Health (NIMH)
National Institute of Child Health and Human Development (NICHD)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Environmental Health Sciences (NIEHS)



o  Purpose of this RFA
o  Research Objectives
o  Mechanism(s) of Support
o  Funds Available
o  Eligible Institutions
o  Individuals Eligible to Become Principal Investigators
o  Special Requirements
o  Where to Send Inquiries
o  Letter of Intent
o  Submitting an Application
o  Peer Review Process
o  Review Criteria
o  Receipt and Review Schedule
o  Award Criteria
o  Required Federal Citations


The National Institutes of Health Autism Coordinating Committee (NIH/ACC) is 
implementing the aspects of the Children's Health Act of 2000 that relate to 
support of autism research by NIH.  The NIH/ACC is composed of the NIH 
Institutes currently funding autism research:  NIMH, NICHD, NINDS, NIDCD, and 
NIEHS.  An important aspect of these activities is the establishment of 
Centers of Excellence in Autism Research, and in this RFA the participating 
institutes invite research grant applications for such Centers.  The first 
round of competition for this type of center support was initiated by RFA-MH-
02-001 (  
This RFA initiates a second round of competition under the same guidelines, 
except for deadlines, that governed the first round.  These Centers will 
constitute a cohesive program, operating under an NIH cooperative agreement, 
which will be called the STAART Centers Program (Studies to Advance Autism 
Research and Treatment).

The primary goal of the STAART initiative is to establish several research 
centers, each of which will bring together expertise, infrastructure and 
resources focused on major questions about autism.  The research issues to be 
addressed will include causes, diagnosis, early detection, prevention, and 
treatment, with approaches such as developmental neurobiology, genetics, and 
psychopharmacology being represented.  Centers should use innovative research 
designs and state-of-the-art technologies.  Centers should draw upon 
established basic and clinical scientists to form unique collaborations 
optimally suited to address the research questions posed.  Achieving high 
levels of expertise and resources may require multi-institutional consortia 
to be formed.  Centers are expected to provide an environment and core 
resources that will enhance ongoing research by bringing together biomedical, 
behavioral, and clinical science investigators to study autism.  The centers 
will provide investigators with well-characterized patients and control 
subjects, family information, and other scientific resources that will 
facilitate research projects.  Each center should develop in accordance with 
available expertise, interests, and resources, but should also be responsive 
to national needs related to autism.  Although the types of activities that 
should be included are indicated in these guidelines, specific approaches to 
accomplish them are left to applicants.

In addition to the self-contained activities of individual centers, the 
STAART Centers Program will conduct collaborative studies among centers which 
will be overseen by a Steering Committee for the Program involving 
representation from each center and from NIH.  The STAART Centers Program 
will be funded through an NIH Cooperative Agreement mechanism, the goal of 
which is to maximize the collaborative utilization of the unique resources in 
infrastructure, expertise, and clinical recruitment that will be created.

Investigators interested in applying for support of autism research using 
mechanisms other than this RFA should see NIH PA-01-051 
( for a 
description of NIH's broad support of autism spectrum research.



o  Organization of initiatives relevant to the STAART Program.  Public Law 
106-310, The Children's Health Act of 2000, authorizes the Director of NIH, 
acting through the Director of the National Institute of Mental Health 
(NIMH), to expand autism research activities in general and to support the 
planning and establishing of no fewer than five Centers of Excellence in 
Autism Research.  This RFA solicits applications for such center support 
under the STAART Centers Program.

o  Appropriateness of proposed research for center support rather than R01 
support.  The NIH has long supported a variety of autism research projects 
through R01, P01, small grant, and career development mechanisms.  Those 
types of support will continue, and many new and continuing projects will be 
more appropriate for those mechanisms.  What distinguishes a research program 
that is appropriate for STAART support from a research program that is better 
supported through a series of R01 grants?  The STAART Program, funded through 
the U54 mechanism, supports major multidisciplinary research programs, 
consisting of interdependent and interrelated subprojects, cores, and 
infrastructure.  "Multidisciplinary" is defined as having subprojects 
representing different disciplines, approaches, and expertise exploring a 
common or unifying theme.  This feature alone does not constitute a rationale 
for the use of a center mechanism, since many individual investigator-
initiated research grants (R01s) are multidisciplinary in nature.  Meaningful 
and committed interactions among the disciplines must be evident. 
"Interdependent" means that materials, results, data, patient populations, or 
methodologies are shared among the subprojects.  Results of one subproject 
may well affect the understanding and interpretation of data from another 
project and thereby influence the nature of the research being performed in 
one or more of the other subprojects.  The feasibility of the research 
proposed on any subproject might be significantly diminished if that 
subproject were submitted as a traditional individual research grant (R01) 
application.  However, diminished feasibility is not, in itself, 
justification for inclusion of an independent subproject in a Centers 
application.  In addition, each subproject must have goals and objectives 
that focus on the common unifying theme to be considered interrelated.

In all cases, the necessity for concurrent funding of the subprojects and 
cores must be specified and fully justified (e.g., longitudinal study on a 
unique and difficult to acquire subject population; the data must be 
collected from the same subjects in a time-dependent fashion; the data from 
one subproject directly impact the conduct of the research on one or more of 
the other subprojects).  Core support must be justified as providing 
essential resources to the center's projects.

Goals of the STAART Centers Program

Even given the promising growth of the clinical and basic research fields 
relevant to autism, and the interaction among investigators in the field that 
has been cultivated by sustained NIH support of the Network on the 
Neurobiology and Genetics of Autism, 10 Collaborative Programs of Excellence 
in Autism (CPEA) program, the STAART Centers Program will represent a 
substantial increase in the scope of the scientific enterprise related to 
this disorder, particularly as it provides a specific emphasis on and direct 
funding for treatment research.  An application for STAART support must 
include at least one proposed treatment project, and to be funded a STAART 
Center must include at least one fundable treatment project.

The primary goal of the present initiative is to support cohesive teams of 
accomplished investigators focused on basic and clinical issues related to 
autism.  STAART support will provide investigators within each center the 
opportunity to pursue common goals and objectives, work as an integrated, 
interactive research team, and develop the resources, equipment, or 
administrative support needed to operate an interdisciplinary center.  This 
type of multidisciplinary, multi-faceted research is of paramount importance 
in elucidating the etiology, pathophysiology, and evidence-based treatment of 
autism.  It is expected that the STAART Centers will produce innovative, 
potentially high-impact approaches to fundamental research problems.  It is 
also anticipated that STAART Centers will attract outstanding investigators 
who have not been part of the autism field.

Examples of scientific areas that could be appropriate foci for STAART 
Centers activities are:

o  development of new or improved treatments, in behavioral/psychosocial, 
pharmacological, and other biological modalities

- testing safety & efficacy of treatments now used
- translation of basic research into novel therapies
- pharmacogenetics
- pharmacokinetics
- development of new outcome measures

o  development of methods for early diagnosis and screening, including 
biological and behavioral indices for early detection

o  investigation of neural bases and pathways for abnormal behaviors

o  investigation of potential environmental etiologies and risk factors 

- prenatal
- infectious
- toxic
- immunizations

o  description and characterization of co-morbidities, and how they relate to 
etiology, pathology, and prevention: for example, brain - gut connection, 
gastrointestinal abnormalities, epilepsy, obsessive-compulsive disorder

o  neuroimaging investigations using functional magnetic resonance imaging, 
brain mapping, other new technologies to determine neuroanatomic and 
localized functional abnormalities and how they change over time

o  genetic studies including gene-environment interactions, candidate genes, 
and genotype-phenotype correlations

o  studies of language and disorders of communication

o  interventional, descriptive, and neuroimaging studies which utilize a 
related comparison group such as fragile X, obsessive-compulsive disorder, 
mental retardation, tuberous sclerosis, Williams syndrome

o  development of novel animal models

These are examples and by no means all inclusive.  There are many other 
potential areas of study that applicants might choose to emphasize.

The Children's Health Act.  As noted above, the Children's Health Act 
contains specific provisions regarding the centers it mandates.  All of these 
will be considered in the review of the Centers applications.  The relevant 
text of the Act is as follows:

"(1) IN GENERAL.— The Director [of NIH] shall under subsection (a)(1) make 
awards of grants and contracts to public or nonprofit private entities to pay 

all or part of the cost of planning, establishing, improving, and providing 
basic operating support for centers of excellence regarding research on 

"(2) RESEARCH.— Each center under paragraph (1) shall conduct basic and 
clinical research into autism.  Such research should include investigations 
into the cause, diagnosis, early detection, prevention, control, and 
treatment of autism.  The centers, as a group, shall conduct research 
including the fields of developmental neurobiology, genetics, and 


"(A) IN GENERAL.— A center under paragraph (1) may expend amounts provided 
under such paragraph to carry out a program to make individuals aware of 
opportunities to participate as subjects in research conducted by the 

"(B) REFERRALS AND COSTS.— A program under subparagraph (A) may, in 
accordance with such criteria as the Director may establish, provide to the 
subjects described in such subparagraph, referrals for health and other 
services, and such patient care costs as are required for research.

"(C) AVAILABILITY AND ACCESS.— The extent to which a center can demonstrate 
availability and access to clinical services shall be considered by the 
Director in decisions about awarding grants to applicants which meet the 
scientific criteria for funding under this section.

"(4) COORDINATION OF CENTERS; REPORTS.- The Director shall, as appropriate, 
provide for the coordination of information among centers under paragraph (1) 
and ensure regular communication between such centers, and may require the 
periodic preparation of reports on the activities of the centers and the 
submission of the reports to the Director.

"(5) ORGANIZATION OF CENTERS.- Each center under paragraph (1) shall use the 
facilities of a single institution, or be formed from a consortium of 
cooperating institutions, meeting such requirements as may be prescribed by 
the Director.


"(A) IN GENERAL.- The Director shall provide for the establishment of not 
less than 5 centers under paragraph (1).

"(B) DURATION.- Support for a center established under paragraph (1) may be 
provided under this section for a period not to exceed 5 years.  Such period 
may be extended for 1 or more additional periods not exceeding 5 years if the 
operations of such center have been reviewed by an appropriate technical and 
scientific peer review group established by the Director and if such group 
has recommended to the Director that such period should be extended."

The specific provisions of this RFA are intended to implement these 
provisions of the Act.  For example, the requirement of the Act that each 
center shall conduct basic and clinical research is interpreted in this RFA 
to mean that it is mandatory for applications to include both clinical and 
basic studies to be considered responsive to this RFA.  For this purpose, 
clinical research is considered to be research involving individuals with 
autism that deals with biomedical and/or behavioral aspects of the disorder.  
Basic research is considered to be studies dealing with normative processes 
in people, animals, or in vitro preparations.  As another example, the Act 
indicates a spectrum of targeted research topics that are appropriate for 
centers.  For the review of STAART applications, a principal criterion for 
evaluation will be the extent to which the center projects directly, and as 
comprehensively as possible, address these topics.  However, although a 
comprehensive representation of these topics is desirable, it is expected 
that a given proposed center may have only a limited capacity to address 
certain topics.  Thus, it is expected that each funded center will address a 
majority of these topics with substantive, high-quality research proposals 
and will develop additional capacity for more comprehensive efforts over 

o  Collaborative studies.  In addition to these issues that are focused on 
individual centers, a major goal of the STAART Centers Program is to 
establish a major research network that, as a whole, will be capable of 
implementing large treatment, diagnostic, genetic, neuroscientific and other 
studies, which are not currently feasible.  To accomplish this, the U54 
mechanism is being used to support the centers, and there will be active 
involvement of NIH staff in coordinating collaborative studies that will be 
defined and implemented after the initial centers are funded.  Also, there 
will be funds from the overall funding pool that will be designated for 
collaborative studies so that appropriate budget supplements and/or increases 
can be distributed to the participating centers.  However, it is expected 
that each center will contribute reasonable subject recruitment and follow-up 
functions to these collaborative studies without budget supplementation.

It is expected that the STAART-wide collaborative studies will emerge from 
common scientific interests among the funded centers.  Therefore, it is 
appropriate for applicants to describe studies they would be particularly 
interested in that might utilize the resources of the STAART Centers Program.  
Such a study might, for example, be a pharmacological or psychosocial 
treatment study or an investigation of early signs of autism that would not 
have sufficient power without the resources of the program.


Each STAART Center will have a Center Director (the Center Principal 
Investigator) who will make scientific and administrative decisions relating 
to the center, will oversee identification and selection of key personnel, 
and will be responsible for allocation and monitoring of STAART funds.  These 
responsibilities and decisions will be undertaken with the advice of the 
executive committee and the External Consultants Committee described below.  
There will also be a Co-Director.  The Director and Co-Director should have a 
demonstrated capability to organize, administer and direct the center.  It is 
expected that the Director and Co-Director will have a substantial investment 
in the center and be its scientific leaders.  Thus, each should have a 
minimum total (including core and project commitments) time commitment of 20% 
to the STAART Center.

Each center will have a team of appropriate investigators, a set of research 
projects, a collection of support cores, and appropriate infrastructure and 
institutional support that will allow the proposed center to accomplish the 
goals of the STAART Centers Program.

STAART support is not intended to be a substitute for individual grant 
support.  It is, therefore, expected that project and core leaders will have 
independent, peer-reviewed research support.  Neither should the STAART 
Center be the primary source of research funding for the investigators 
associated with the Center.  It is desirable for STAART-supported research to 
complement other funded research related to autism taking place at the 
applicant institution, including activities supported by R01, P01, P30, P50, 
and other mechanisms.  Investigators with the qualifications to be members of 
the research team, and to contribute to such a unique enterprise, may be 
located in different geographic locations.  Therefore, collaborations among 
different institutions are encouraged, if scientifically appropriate.  The 
proposed team will be responsible for the definition of the research goals 
and objectives of the research enterprise, as well as ongoing activities. 

Each STAART Center applicant must demonstrate the ability to perform the 
necessary administrative, clinical, and information utilization functions.  A 
possible structure is outlined below, in which these functions are organized 
into new cores that would be established with STAART funding.  However, there 
are no mandatory cores, and applicants may propose other ways of 
accomplishing these functions, such as integrating them with already existing 
structures.  Also, other cores may be proposed.

There should be institutional resources set in place to provide the 
components that make the site(s) competitive for Center of Excellence 
support.  There should be substantive departmental and institutional support 
for and commitment to the proposed center.

Applications should provide a description of the clinical populations, 
patient, family, and control subject information, tissue resources, genetics 
resources, and other resources that will be involved as part of the team's 
clinical research component.  It is anticipated that resources and projects 
that are in place due to funding from sources other than the STAART Program 
will synergistically interact with STAART infrastructure, cores, and 
projects.  The application should explain how STAART support would facilitate 
the development and significance of related projects that may not be an 
integral component of the STAART itself.  In such cases, it will also be 
necessary to address, in detail, questions of possible overlap of support 
from other grants or funding sources.

STAART Centers must commit to cooperate fully and to share data concerning 
patients, control subjects and specimen resources within the STAART Centers 
Program, and with the broad scientific community, as specified by NIH.


A core is a shared central laboratory or clinical research facility, service, 
or resource.  Each core is directed by a faculty investigator (the Core 
Director) with substantial expertise related to the core.  Two important and 
related considerations are (1) the degree to which currently funded 
investigators within or outside the center will use and will benefit from 
core resources and (2) the degree to which the resources will promote new 
and/or expanded autism research efforts locally, regionally or nationally.  
Applicants should document and describe briefly the projects, both existing 
and planned, whether funded by the center or not, that will depend upon 
resources provided by the cores (clinical cores, in particular).

o  Administrative core.  The successful operation of each STAART Center will 
require the integration of the activities of several projects and cores, as 
well effective organization of the efforts of scientific and professional 
personnel from a variety of disciplines and subspecialties.  This requires 
the presence of an administrative structure to organize the flow of 
information, distribution of effort, allocation of resources, and to 
implement other necessary administrative functions.  This will require an 
administrative core or its equivalent.

The administrative requirements of each STAART Center will necessitate the 
assistance of an administrator with business management expertise.  It is 
important that such an individual be identified and directly involved with 
the fiscal and administrative aspects of the STAART application and grant.  
It is expected that the STAART Center administrative structure will 
facilitate the following:

1) coordination and integration of STAART components and activities

2) planning and review of utilization of funds

3) provide support and advice for the STAART Director in his/her oversight of 
the activities of the center

4) interact with the scientific and lay communities to develop relevant goals 
for the STAART Center within the immediate environment of the Center

5) interact with other STAART Centers and the centers' NIH Science Officers 
to develop trans-STAART research projects.  The Science Officer is the NIH 
representative who implements the NIH aspects of the Cooperative Agreement in 
each center.

An executive committee (composed of core directors, project leaders, and the 
administrator) will be established in each center to assist the Center 
Director and Co-Director in making scientific and administrative decisions.  
The executive committee should be encouraged to seek outside advice and 
consultation, both from within the institution and from other institutions, 
in its monitoring and development of the scientific content and direction of 
the program.

An External Consultants Committee to each STAART Center, consisting of 
scientists from outside of the institution or consortium, will also be 
established.  Unless already appointed, External Consultants Committee 
members should not be recruited until the NIH review process is complete.  
This committee will be used to evaluate the programs of the center, research 
progress, the effectiveness of communications within the center, and any 
other activities for which outside expertise is required or desirable.  The 
committee should meet annually and prepare a report including recommendations 
to assist the center.  The NIH Science Officer for that center and the 
Program Officer for the STAART Program should be invited to attend each 
meeting as observers.  A copy of the advisory committee report should be sent 
to the appropriate NIH Science Officer and to the Program Officer.

o  Clinical core.  The STAART Center will provide well-characterized 
patients, patient and family information, and biological samples from persons 
with autism and appropriate control subjects for center research projects and 
for collaborative research projects across the STAART Centers Program.  The 
clinical core serves the functions of patient and control subject 
recruitment, evaluation, and diagnosis; establishing and maintaining a 
subject registry; longitudinal follow up of patient and control subjects; 
acquisition of clinical and laboratory data; and data coordination and 
biostatistical analysis (if not included as a function of the administrative 
core or a separate data core).  A research database that maintains 
confidentiality of all patient and control subject records should be 
established at each STAART Center.

A clinical core may perform a limited amount of developmental work, but 
should not directly be used as a mechanism to fund research per se.  The 
developmental work allowable in a clinical core must be directly related to 
the function of the core.  It may be directed toward improving and expanding 
the core functions, e.g., improving existing diagnostic strategies, or 
developing additional methodologies, techniques or services.  Proposed 
developmental work should be described as completely as possible in the 
application.  Planning for patient and appropriate control subject 
recruitment should include sensitivity to ethical concerns, research design 
and biostatistical analysis.  While conducting clinical treatment trials is 
one function of a clinical core, it should not be the major effort of the 
core.  The application should include a description of the types (with 
specific examples) of research projects and clinical trials that will use the 
core and what benefits will obtain to other research activities from the 
existence of the clinical core.  The proposed procedures for allocating 
access to patient and control subjects across the STAART projects within the 
center should be described.

It is important to note that the only patient care costs that can 
appropriately be supported by STAART funds are those that are essential for 
research activities.  Thus, it is important for each application, whether or 
not a clinical core is proposed, to describe the local resources available, 
the institutional commitment to maintaining clinical resources, and the way 
in which the already existing and the planned resources would be used to 
provide recruitment, referral, and information resources for patients and 
their families.  The aspects of the Act relevant to these issues should be 
directly and comprehensively addressed in the application.

Applicants must demonstrate a data management capability either by creating a 
feasible data core or by having a clearly defined data management section in 
the administrative or clinical core.  In any case, data management should 
also include biostatistical consulting to the scientific members of the 

o  Scope of appropriate subject populations.  STAART studies can 
appropriately focus on any of the autism spectrum disorders and on either 
children or adults with these disorders or at risk for these disorders, and 
comparison groups appropriate for the scientific questions proposed, for 
example, people with fragile X, obsessive compulsive disorder, Williams 
syndrome, mental retardation, schizophrenia, or normally developing children 
or adults.  The primary criteria for determining inclusion of a particular 
subject pool are scientific.  That is, the applicant must justify the 
inclusion of particular subject groups as being of scientific interest and as 
being justified given the hypothesis being tested, the experimental design, 
and feasibility issues.

Efforts to recruit diverse population subgroups including children, 
minorities and women must be outlined.

o  Neuropathology and genetics activities.  It is anticipated that the STAART 
Centers Program will offer important opportunities for enhanced collaborative 
collection of materials and data in the areas of genetics and neuropathology.  
Although, not every center may wish to propose substantive cores or projects 
in these areas, each center applicant should indicate, through core and 
project proposals, or through a statement of intent included in the 
application, their intention to participate in collaborative STAART 
activities in these areas.

Possible Additional Cores

The STAART Centers Program will support additional cores that provide 
opportunities for scientific accomplishments beyond those attainable solely 
through support of the suggested cores.  It is important to note that support 
should not be requested for cores that only replace or centralize resources 
supported on individual project grants.  In a Center grant application, it is 
not sufficient for the principal investigator merely to identify such 
centralized resources.  Rather, it must be demonstrated exactly how each core 
would augment or enhance the present capabilities of the investigators and 
make possible new activities.  There should be a thorough discussion of the 
project(s) that will use resources of additional cores.

Genetics Data Sharing in the STAART Program

NIH has a strong interest in the sharing of data and other resources produced 
through its funding, and has long-standing policies in this area (for the 
most recent statement, see the NIH Grants Policy Statement, page II-62, 
"Unique Research Resources," published in October 1998, related to the 
distribution of unique research resources produced with DHHS funding 
More specific policies have been promulgated from time to time to address the 
needs of particular areas of research.  For example, NIH has worked with 
journals and databases to encourage the rapid placement of unpublished DNA 
sequence data and crystallographic coordinates into public databases.  The 
National Human Genome Research Institute has a policy that all genomic data, 
whether published or not, should be shared as rapidly as possible and placed in 
the public domain
tml.  For grantees engaged in large-scale sequencing, the policy specifies 
data release within 24 hours of generation

After extensive discussion with mental health and human genetics researchers 
and advocacy members, a Genetics Workgroup of the National Advisory Mental 
Health Council (NAMHC) recommended that the National Institute of Mental 
Health (NIMH) draft a policy that provides for the sharing of genetic 
materials after a 12- to 18-month proprietary period.  The workgroup report 
is available at  It was also 
recommended that this policy include all elements of the guidelines developed 
by NIH and the Department of Energy (DOE) to address the special needs of 
genome research 
Sharing within the scientific community of genetic material and data 
collected in large-scale human genetic studies has been a guiding principle 
of NIMH's Human Genetics Initiative

Each application for STAART support must include a plan for the sharing of 
genetic materials and data.  This plan will be evaluated during the peer 
review of the application.  This sharing plan should address the issues 
raised in the following paragraphs.  The timeline for sharing of genetic data 
will be compatible with the timeline for sharing of other types of data as 
6. Public Domain of Data (below).

Creation of high-quality lymphoblastoid cell lines from blood samples 
establishes an infinitely renewable source of DNA for subsequent genetic 
analyses.  In addition, these biological materials will be an invaluable 
resource for future studies that employ genetic maps of much higher density 
(e.g., those with single nucleotide polymorphisms as a basis) and that employ 
efficient technologies to study gene function and expression.  Cell lines are 
an essential resource to permit broad sharing of data and biomaterials for 
genetic analyses in the wider scientific community.  Therefore, it is 
expected that permanent cell lines will be established for subjects studied 
in STAART projects and that these will be shared with the scientific 
community.  Any proposed use of cell lines in STAART projects other than for 
sharing will require a compelling scientific rationale in the application.  
Appropriate arrangements should be included in the proposed sharing plan.

It is expected that the information to be shared includes clinical, 
diagnostic, and pedigree structure information (excluding all personal 
identifiers), in addition to cell lines and DNA.  It is expected that the 
data sharing plan will include the following elements: 1) the creation of 
comprehensive and verified databases that contain clinical, diagnostic, 
pedigree structure, and genotypic information collected and produced in the 
STAART Center; 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 
biological materials (DNA samples, cell lines) are widely distributed to 
qualified investigators in the scientific community; 4) a protocol and 
criteria for wide dissemination of these data and materials; and 5) a 
timetable for distribution.  The plan will be considered part of the 
scientific methodology for carrying out the research and, as such, the 
adequacy of the plan will be considered in determining whether the project 
shall be funded.  The sharing plan as approved, after negotiation with the 
applicant when necessary, will be a condition of the award.

It is NIH's position that dissemination of data and biomaterials via 
individual laboratories and Web sites is not sufficient, as it would force 
interested investigators to have to search several different data collections 
to make use of the results.  In addition, differences in protocols across 
projects for creating databases, establishing cell lines, and extracting DNA 
may make it impossible for researchers to combine information for integrated 
genetic analyses.  It is highly preferable that data and materials generated 
in such grants should be placed in common, accessible cell repositories and 
databases that are widely available to investigators in the scientific 
community.  Such data management and cell repository facilities include the 
NIMH Center for Genetic Studies ( and the 
Autism Genetic Resources Exchange (AGRE;

General Data Sharing Policies and Data Coordination Facility for the STAART 
Centers Program

It is expected that the STAART Program will become a valuable resource for 
research advances in the study of autism.  The data generated by this 
resource will be extremely important and their impact will be optimized only 
by implementing successful data sharing policies and data storage and 
management infrastructure.  The specifics of the policies that will 
eventually be implemented will be determined among the funded centers and NIH 
staff in meetings and negotiations conducted after the initial group of 
centers is funded.  These policies will include a variety of types of data 
and materials.

It is anticipated that the STAART Program will establish and support a 
centralized data management facility that will collect, store, coordinate and 
distribute data from all member centers.  This will facilitate the 
standardization and usefulness of the information collected at the various 
sites.  A separate RFA for proposals to establish and operate the centralized 
data facility will be issued in the future.


Applications must include a minimum of three and a maximum of six proposed 
research projects.  The research projects should be proposed for five years 
of funding and incorporate the latest techniques and propose studies that 
will advance our understanding of the basic and clinical underpinnings of 
autism in areas such as etiology, genetics, pathogenesis, epidemiology, 
diagnosis, therapeutic interventions, patient management, and care giver 
issues.  The projects should be similar in quality and scope to moderately 
sized R01 grants and subprojects of program project grants.  For projects 
using patients, it is essential that the expectations for numbers of subjects 
be clearly stated and that the proposed source of these subjects be 
identified so that the overall picture of subject recruitment and 
availability can be critically evaluated for the entire center.  It is 
preferable that the center projects demonstrate a high level of 
interrelatedness among themselves.  The rationale for inclusion in the 
center, rather than implementing these as individually supported projects 
(e.g., via R01 support) should be provided.

In order for an application to receive funding as a STAART Center, there must 
be at least 3 fundable research projects, at least one of which must be a 
treatment study.


In order to assure active collaboration with other STAART Centers, the 
Director, Co-Director, project directors, and other key personnel should 
attend STAART Centers Program annual meetings and other ad hoc meetings that 
may be called to share research findings and plan for collaborative research 
projects or to refine and standardize operating procedures among the Centers.  
The STAART application should include funds for this travel.  In the first 
year of STAART funding for each center, funding should be requested for an 
additional initial meeting of Center Directors and key personnel with NIH 
staff to decide on common diagnostic procedures, research tools, and to 
implement decision-making processes that are appropriate for the cooperative 
agreement mechanism. 


This RFA will use the National Institutes of Health (NIH) specialized 
cooperative research center (U54) award mechanism, an "assistance" mechanism 
(rather than an "acquisition" mechanism) in which substantial NIH scientific 
and/or programmatic involvement with the awardee is anticipated during 
performance of the activity.  Under the cooperative agreement, the NIH 
purpose is to support and/or stimulate the recipient's activity by 
involvement in and otherwise working jointly with the award recipient in a 
partner role, but it is not to assume direction, prime responsibility, or a 
dominant role in the activity.  Details of the responsibilities, 
relationships, and governance of the studies to be funded under cooperative 
agreements are discussed below under Terms and Conditions of Award.  
Potential applicants may obtain the NICHD U54 Specialized Cooperative 
Research Center Grant Guidelines at  
With certain exceptions, specified below, the information provided there is 
applicable to this RFA, including the preparation of applications.

Applicants should request five years of support.  It is anticipated that 
competitive renewal applications for a second 5-year period will be allowed.  
Individual projects that are developed as outgrowths of a STAART Center grant 
and are no longer an integral part of the center should seek independent 


The use of a Cooperative Agreement Mechanism for this RFA is intended to 
enhance coordination among STAART Centers in order to increase the impact of 
the STAART Centers Program on the public health issues of autism and to 
better achieve the goals of the Children's Health Act.  The U54 mechanism 
implements a process of NIH coordination, guidance, and ongoing evaluation.  
For example, it will permit NIH participation in a process of standardizing 
diagnostic and other tools across the STAART Centers in collaboration with 
the Center Directors and investigators.  It will permit awardee and NIH 
participation in the Steering Committee (described below) that will make 
decisions about collaborative studies that will use the resources of multiple 
centers, thus exceeding the capabilities present in any one center.


Each center application may request a maximum of $1.2 million per year direct 
costs.  Facilities and Administration (F&A) costs on subcontracts will be 
listed as direct costs on budget pages as is the usual NIH practice, but they 
will not count against the cap of $1.2 million.  The estimated total funds 
(direct and F&A costs) available for support for all awards made under this 
and subsequent RFAs for the STAART Centers Program are anticipated to be $12 
million per year.  This total amount will be used to fund the complement of 
at least 5 centers, a data coordination center, and collaborative projects 
among the centers.  The number of centers funded through the two rounds of 
competition will be at least 5 and the total number will depend upon the 
merit of the applications received and the funds available.  The award of 
grants pursuant to this RFA is contingent upon the availability of funds for 
this purpose.  Only applications of sufficiently high merit will be funded.

The majority of the $12 million pool of funds will be distributed to 
successful center applicants to support the activities specific to each 
center.  A separate portion of this pool of funds will be distributed to 
centers to fund specific cooperative projects among the centers, and another 
portion of the pool will be used to fund a data coordination center for which 
there will be a separate RFA in the future.  The exact nature of the 
cooperative studies will be determined by the Steering Committee of the 
STAART Centers Program.  Investigator-initiated requests for competitive 
supplements will not be allowed in the STAART Program.


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

Applications prepared for this competition may propose multi-institutional 
consortium arrangements.  While the applicant institution must be domestic, 
foreign institutions may be involved in a consortium.  For example, a project 
within the center may be located at a foreign institution and supported 
through a subcontract.


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.



As part of the U54 Cooperative Center Grant process, the following Terms and 
Conditions of Award and details of the arbitration procedures pertaining to 
the scope and nature of the interaction between the NIH staff and the 
participating awardees will be incorporated into the Notice of Grant Award 
and provided to the Principal Investigator and the institutional official at 
the time of award.  These procedures will be in addition to the customary 
programmatic and financial negotiations that occur in the administration of 

Cooperative agreements are assistance mechanisms subject to the same 
administrative requirements as grants.  The special Terms and Conditions of 
Award are in addition to, and not in lieu of, otherwise applicable OMB 
administrative guidelines, HHS Grant Administration Regulations at 45 CFR 
Part 74 and 92, and other HHS, PHS, and NIH grant administration policies and 
procedures.  Cooperative Agreements are subject to the administrative 
requirements outlined in pertinent OMB, HHS, PHS, and NIH guidelines, with 
particular emphasis on HHS regulations at 42 CFR Part 52 and 45 CFR Part 74.  
Facilities and Administrative Cost (indirect cost) award procedures will 
apply to cooperative agreement awards in the same manner as for grants.

The administrative and funding instrument used for this program is a 
Cooperative Agreement (U54), an "assistance" mechanism (rather than an 
"acquisition" mechanism) in which substantial NIH scientific and/or 
programmatic involvement with the awardee is anticipated during performance 
of the activity.  Under the cooperative agreement, the NIH purpose is to 
support and/or stimulate the recipient's activity by involvement in and 
otherwise working jointly with the award recipient in a partner role, but it 
is not to assume direction, prime responsibility, or a dominant role in the 
activity.  Consistent with this concept, the dominant role and prime 
responsibility for the activity resides with the awardee(s) for the project 
as a whole, although specific tasks and activities in carrying out the 
studies will be shared among the awardees and an NIH Science Officer.

Failure of the awardees to meet the performance requirements, including these 
special terms and conditions of award, or significant changes in level of 
performance, may result in a reduction of budget, withholding of support, 
suspension and/or termination of the awards.

1.  Awardee Rights and Responsibilities

Awardees have primary authorities and responsibilities to define objectives 
and approaches, and to plan, conduct, analyze, and publish results, 
interpretations, and conclusions of their studies.  The primary 
responsibilities of the awardees are to:

o  Define the research objectives

o  Design the necessary research protocols

o  Conduct specific studies

o  Analyze and interpret research data

o  Propose protocol modifications as required

o  Establish an External Consultants Committee to the center

o  Participate in STAART collaborative projects approved by the Steering 

o  Serve on the STAART Steering Committee

o  Agree to sharing of data and biological materials in accordance with 
approved data sharing plans

o  Agree to participate according to Steering Committee policies in a 
centralized data facility that will be established

o  Interact with the FDA concerning clinical investigations, when appropriate

o  Provide information to the NIH Science Officer and NIH Program Officer 
concerning progress

o  Maintain career development opportunities to encourage new investigators 
to work in the field of autism research

o  Abide by all scientific, practical and policy decisions of the Steering 

Awardees will retain custody of and primary rights to their data and 
intellectual property developed under the award subject to current government 
policies regarding rights of access as consistent with current HHS, PHS, and 
NIH policies and subject to the terms and conditions of this RFA.

2.  NIH Responsibilities

NIH Science Officers:

NIH Science Officers will be NIH program staff who will have substantial 
scientific involvement during the conduct of this activity, through technical 
assistance, advice, and coordination above and beyond normal program 
stewardship for grants.  Each center will have a designated NIH Science 
Officer, and a given individual may be the NIH Science Officer for more than 
one center.  The NIH Science Officers will be selected by the NIH/ACC.  The 
degree of involvement by the NIH Science Officers will include the following:

o  Assist in avoiding unwarranted duplication of effort across centers; help 
coordinate collaborative research efforts that involve multiple centers

o  Review and comment on critical stages in the research program before 
subsequent stages are implemented

o  Assist in the interaction between the awardee and the FDA, when 

o  Assist in the interaction between the awardee and investigators of other 
institutions as well as between the awardee and potential commercial sponsors

o  Retain the option of recommending termination of studies if technical 
performance falls below acceptable standards, or when specific lines of 
research cannot be effectively pursued in a timely manner

o  Retain the option to recommend additional research endeavors within the 
constraints of the approved research and negotiated budget

o  Serve on the STAART Steering Committee

NIH Program Officer:

NIH will appoint a Program Officer who will have program oversight 
responsibilities for each center and for the entire STAART Program.  This 
individual will not be a Science Officer(s).  The Program Officer will:

o  Have the option to recommend withholding support to a participating 
institution if technical performance requirements are not met

o  Exercise the normal stewardship responsibilities of an NIH Program Officer

o  Carry out continuous review of all activities to ensure objectives are 
being met

o  Will not be a member of the STAART Steering Committee

3.  Data Safety and Monitoring Board  

NIH will establish a Data Safety and Monitoring Board (specifics below).

4.  Collaborative Responsibilities/Steering Committee

Overall coordination of the Program, consistent with the stated intent of the 
RFA, will be done by a Steering Committee consisting of the Directors of each 
of the participating centers, the PI of the Data Coordination Center, and NIH 
Science Officers.  Each Center Director (or designee) will have one vote.  
Science Officers may vote, and their total votes will count 1/2 as much as 
the total votes of the Center Directors.  Center membership on the Steering 
Committee becomes effective upon issuance of the Notice of Grant Award.  The 
Steering Committee may establish additional by-laws, subcommittees, or 
workgroups for specific tasks.  Science Officers may not chair any committee 
or subcommittee.  The Steering Committee meetings will be convened at least 
once yearly.  The purpose of these meetings is to assess scientific progress, 
identify new research opportunities, establish priorities, and discuss 
strategy.  Decisions will be made by a majority vote of a quorum, with an 
attempt for consensus when possible.  A quorum is the presence of a majority 
of the Center Directors and at least one Science Officer.  The Steering 
Committee can convene through telephone conference or in person.  Outside 
consultants/experts may be asked to participate in these discussions as 
nonvoting advisors.  Collaborative projects among the STAART Centers will 
require Steering Committee approval.  The Steering Committee may also be used 
to endorse research instruments that will be used across multiple centers.

Responsibilities of the Steering Committee members include:

o  Finalizing collaborative study plans, including design, assessment 
instruments, component protocols, and detailed implementation procedures

o  Abiding by and directing the study plan for collaborative projects 
determined by the Steering Committee

o  Monitoring collaborative studies and developing and implementing quality 
control procedures 

o  Conserving grant funds in the service of the common objectives and of the 
research plan agreed on by the Steering Committee

o  Facilitating the analysis of data and the eventual release to the larger 
scientific community (see "Public Domain" below); submitting data on time in 
the form and on the schedule determined by the Steering Committee

o  Evaluating and reporting study results: defining rules regarding access to 
data and publication of findings from analyses of the data set

o  Abiding by all scientific, practical, and policy decisions of the Steering 

Any Center Director who considers a Steering Committee decision unacceptable 
may appeal by following the arbitration procedure described below.

5.  Arbitration Process

When agreement between an awardee and NIH staff or between awardees cannot be 
reached on scientific/programmatic issues that may arise after the award is 
made, an arbitration panel will be formed.  The arbitration panel will 
consist of one person selected by the Directors of the Centers, one person 
selected by the NIH, and a third person selected by both NIH staff and the 
Directors.  The decision of the arbitration panel, by majority vote, will be 
binding.  The special arbitration procedure in no way affects the right of an 
awardee to appeal any adverse action in accordance with PHS Regulations at 42 
CFR Part 50, Subpart D, and HHS Grant Administration Regulations at 45 CFR 
Part 74, section 304, and HHS Regulations at 45 Parts 16 and 75.

6.  Public Domain of Data

The data from this cooperative agreement will first be available to be 
analyzed and interpreted by the collaborators in the project.  However, since 
the creation of the data set is funded through public monies and because the 
data set will constitute a national scientific resource for the research 
community, the awardees will make data of all types available to the larger 
research community no more than 24 months from the date after which the final 
wave of data for a particular project have been collected and cleaned.  More 
rapid sharing of data is encouraged.

7.  Scientific Advisory Board  

The Steering Committee will appoint a Scientific Advisory Board of 
independent experts in the research areas represented among the centers.  
This board will advise the Steering Committee on the scientific aspects of 
STAART activities, including providing review of collaborative studies that 
will need to be approved by the Steering Committee before being implemented.

8.  Funding of Collaborative Projects

Collaborative projects developed by the Steering Committee will be submitted 
to the NIH Program Officer for potential funding after the Steering Committee 
has obtained feedback from the Scientific Advisory Board.  The Program 
Officer will make a final decision based on Steering Group deliberations, 
Scientific Advisory Board feedback to the Steering Group, Steering Group 
responses to that feedback, and Program Officer consultations with individual 
outside experts.  The Program Officer may decide to have a collaborative 
project submitted by the Steering Group as a competitive supplement that 
undergoes NIH-organized peer review prior to the Program Officer's final 

9.  Progress Reviews

Progress of the project will be reviewed annually by the NIH Program Officer 
at the time each continuation application is considered for funding to assure 
that satisfactory progress is being made in achieving the project objectives 
and that each site is following the procedures recommended and approved by 
the Steering Committee.  During the first year of funding, and during 
subsequent years, if deemed necessary by the Program Officer, reviews will be 
more frequent.  Should problems arise in the conduct of the study, the NIH 
Program Officer may require that the awardee submit quarterly reports on 
progress and fiscal matters.  By acceptance of this award, the awardee agrees 
to abide by decisions and policies of the project Steering Committee and the 
other terms and conditions listed above or referenced in the Notice of Grant 


We encourage inquiries concerning this RFA and welcome the opportunity to 
answer questions from potential applicants.  In addition, the NIH will 
establish an internet site at: in order to provide 
answers to commonly asked questions from potential applicants and to post 
points of clarification regarding this RFA.  Inquiries may fall into three 
areas:  scientific/research, peer review, and financial or grants management 

o  Direct your questions about scientific/research issues to:

Steve Foote, Ph.D.
Division of Neuroscience and Basic Behavioral Science 
National Institute of Mental Health
6001 Executive Boulevard, Room 7204, MSC-9645
Bethesda, MD  20892-9645
Rockville, MD  20852(For express/overnight services)
Telephone:  (301) 443-3563
FAX:  (301) 443-1731

L.R. Stanford, Ph.D.
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B09, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1383
FAX:  (301) 496-3791

Deborah Hirtz M.D.
Clinical Trials, Division of Extramural Research
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 2212, MSC 9523
Bethesda, MD  20892-9523
Telephone:  (301) 496-5821
FAX:  (301) 480-1080

Judith A. Cooper, Ph.D.
Scientific Programs Branch
Division of Extramural Research
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400C, MSC-7180 
Bethesda, MD  20892-7180 
Telephone:  (301) 496-5061
FAX:  (301) 402-6251  

Cindy P. Lawler, Ph.D.
Division of Extramural Research and Training
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

Direct your questions about financial or grants management matters to:

Carol J. Robinson
Grants Management Branch
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6118, MSC 9605
Bethesda, MD  20892-9605
Telephone:  (301) 443-3858
FAX:  (301) 443-6885

Mary E. Daley
Grants Management Branch
National Institute of Child Health and Human Development
Building 6100, Room 8A17, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1305
FAX:  (301) 402-0915

Gladys Melendez-Bohler, M.S.
Grants Management Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 3290, MSC 9537
Bethesda, MD  20892-9537
Telephone:  (301) 496-3929 
Fax:  (301) 402-0219

Sara Stone
Grants Management Branch
National Institute on Deafness and Other Communication Disorders 
6120 Executive Boulevard, Room 400B, MSC-7180 
Bethesda, MD  20892-7180 
Telephone:  (301) 402-0909 
FAX:  (301) 402-1758  

Laura Williams-Boyd
Grants Management Branch
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-23
Research Triangle Park, NC  27709
Telephone:  (919) 541-7629
FAX:  (919) 541-2860


Prospective applicants are asked to submit a letter of intent that includes 
the following information:

o  Descriptive title of the proposed research
o  Name, address, and telephone number of the Principal Investigator
o  Names of other key personnel 
o  Participating institutions
o  Number and title of this RFA 

Although a letter of intent is not required, is not binding, and does not 
enter into the review of a subsequent application, the information that it 
contains allows IC staff to estimate the potential review workload and plan 
the review.

The letter of intent is to be sent by the date listed at the beginning of 
this document.  The letter of intent is to be sent to Dr. Steve Foote at the 
address listed under INQUIRIES.


Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 710-0267, 

Applicants are strongly encouraged to call one of the NIH program staff 
listed under INQUIRIES with any questions regarding the responsiveness of 
their proposed project to the goals of this RFA.  Applications for the U54 
grant are to be prepared in a manner consistent with the information 
presented in this RFA.  Applicants may also wish to consult the NICHD U54 
Cooperative Specialized Research Center Grant Guidelines, available from the 
contacts listed under INQUIRIES below, and at:


Applications are to be submitted on Form PHS 398 
(  All instructions 
and guidelines accompanying the PHS 398 are to be followed, with the 
exception of the sections modified by the specific instructions described 
below.  Also, applicants can obtain any updated information about preparing 
an application at:

In lieu of the preprinted Table of Contents outline on Form Page 3 of PHS 
398, a Table of Contents should be prepared listing all of the major sections 
described below and paginated to enable reviewers to find specific 
information readily.

The Table of Contents should contain the information described below.  It 
should be divided into the following sections:  Section I - General 
Information, Section II - Research Plan, and Section III - Appendix.  The 
following guidelines will provide directions and descriptions for preparing 
each section.  Major areas to be listed and paginated in the Table of 
Contents are underlined.



Complete all items on the application's face page.  This is Form Page 1 of  
the application; number succeeding pages consecutively.

On line 2, enter the appropriate Request for Applications (RFA) number and 
title, and mark the YES box.


On Form Page 2, describe briefly the research program, indicate the emphasis 
of the component research projects, and identify the purposes of the proposed 

List key scientific and technical personnel participating in the Center.  Use 
continuation pages as necessary, numbering consecutively.


Prepare the Table of Contents as noted above.  The major areas to be listed 
are enumerated in these instructions.


Prepare a series of composite Budget Tables for the center as requested 
below.  A separate detailed budget is required for each research project and 
for each core unit.

1.  Composite Budget

398 to present the total direct cost budget for all requested support for the 
first year.  For each category, such as "PERSONNEL," "EQUIPMENT," etc., list 
the amount requested for each research project and for each core unit.

If consortium arrangements have been made involving other institutions or 
organizations, include total costs (direct and F&A) associated with such 
third party participation in the "CONSORTIUM/CONTRACTUAL COSTS" category.  
Costs for purchased services should be itemized under "OTHER EXPENSES."

398 to prepare a budget, by category, that provides direct cost totals for 
each year of requested support.

2.  Individual Project and Core Budgets

a.  First year (use Form Page 4 of PHS 398 for each)

b.  Total project period (use Form Page 5 of PHS 398 for each)

Consortium Budgets (if applicable) should be presented as described in Item 1 
(Composite Budget), including a budget for the entire proposed project 
period.  Total Direct and F&A costs of sub-awardees are to be shown under 
"CONSORTIUM/CONTRACTUAL COSTS" on individual research project or core budgets 
and a detailed consortium budget is to be inserted following the appropriate 
research project or core budgets.

Budget Justifications: Describe the specific functions of key scientific and 
technical personnel, consultants, collaborators, and support staff.  For all 
years, explain and justify any unusual items such as major equipment or 
alterations and renovations.  For future years of support requested, justify 
any significant increases in any category over the first 12-month budget 
period.  Identify such significant increases with asterisks against the 
appropriate amounts. 


Biographical sketches are required for all key scientific and technical 
personnel participating in the research projects and core units as listed on 
Form Page 2.

Beginning with the Center Director, and following in alphabetical order, 
submit biographical sketches as described in the "Instructions for Form PHS-
398," using Form Page 6.


Complete the "RESOURCES" section on Form Page 8 of the PHS 398 for the 
overall Center.  Briefly describe the features of the institutional 
environment that are or would be relevant to the effective implementation of 
the proposed program.  As appropriate, describe available resources, such as 
clinical and laboratory facilities, participating and affiliated units, 
patient populations, geographical distribution of space and personnel, and 
consultative resources.  Use continuation pages as needed.


Include a detailed Table of Contents with pagination (numeric only) at the 
beginning of Section II.  Identify each research project or core unit by 
title, and assign each research project a number (I, II, III) and each core 
unit a capital letter (A,B,C) that reflects the order in which the research 
projects and core units are presented in the application research plan.  For 
each research project and core unit, provide the name of the Principal 
Investigator or Core Director, and biographical sketches for personnel not 
identified previously.

REVISED APPLICATIONS:  In order for revised applications to be accepted for 
review, there must be substantial changes in the content of the application.  
Include an Introduction to Revised Application (3-page limit; insert just 
before the Introductory Overview) that summarizes the substantial additions, 
deletions, and changes, and responds to the criticisms and issues raised in 
the summary statement.  The changes in the Research Plan must be clearly 
marked by appropriate bracketing, indenting, or changing of typography, 
unless the changes are so extensive as to include most of the text.  This 
exception should be explained in the Introduction to Revised Application.  Do 
not underline or shade changes.  The Preliminary Studies/Progress Report 
sections should incorporate any work done since the prior version was 
submitted.  For each core or project that is substantially revised, an 
additional, one-page Introduction to Revised Application can be inserted just 
before the Research Project Plan or just before the individual core 
description.  Acceptance of a revised application automatically withdraws the 
prior version, since two versions of the same application cannot be 
simultaneously pending.


Provide an overview of the entire proposed center describing the central 
theme and goals.  Describe how the overall center can achieve its major 
objectives.  Explain the proposed contribution of each of the projects in 
achieving the objectives of the center.  Furthermore, the administrative 
arrangements and support necessary to effect the research should be carefully 
described in the application.  Shared resources should be described.  In 
addition, provide detailed information on collaborations, recruitment, 
facilities and resources.

1.  Purpose and Objectives of the Center.  Discuss the philosophy and 
objectives of the Center and general plans for the proposed grant period. 
Discuss the composite research program, highlighting its central theme.  List 
by title and investigator the component research projects and core units, 
showing the interrelationship between the research projects and the core 
units and their relationship to the central theme.  Describe relevant history 
leading up to the Center application.

2.  Administration, Organization, and Operation of the Center.  Include 
information on the support and commitment of the parent institution for the 
Center, the authority of the Center Director, the use of advisory committees, 
and the method of determining core access and space assignment.  Describe 
organizational framework and provide an organizational chart.

3.  Assurances and Collaborative Agreements.  Any arrangements for 
collaborative and cooperative endeavors or subcontracting should be 
highlighted.  Letters of Intent to Collaborate and Letters of Agreement from 
consultants should be referenced here and included at the end of the 
appropriate research project or core unit. 


This section should be used to present, in condensed form, previously 
published and/or preliminary data that are relevant to proposed center 
activities and research projects that will be unique to the center and will 
involve collaboration across projects and/or cores within the center.  Since 
individual projects, and preliminary data relevant to them, will be described 
in the following section, only those collaborative activities/projects that 
bear directly on the proposed center activities should be summarized here.  
For ongoing projects or existing cores, list relevant publications published 
or accepted for publication during the past five-years.  The list of 
publications does not count against the page limit.


Identify each project by a Roman numeral (I, II, III…) and a title.

For each component research project, a full description is to be provided 
following the format presented in Form PHS 398.  Begin the  presentation of 
each component research project on a separate cover page.  For each project, 
include the following information:

1.  Introductory Information

a.  Indicate:

Project Title

Project Principal Investigator, title, location

Other investigators, consultants, and collaborators, titles (Associate 
Professor, Postdoctoral Fellow, student).

b.  Abstract of Research Plan (use Form Page 2 of PHS 398)

2.  Research Project Plan (Do not exceed 25 pages for Sections a-d): 

Discuss the purpose and nature of the project and its relevance to the 
application's overall theme.  Address the following:

a.  Specific Aims 

b.  Background and Significance 

c.  Preliminary Studies

d.  Research Design and Methods.  In addition to usual contents of this 
section, describe the research project's use of core unit services, including 
need for the services, and the advantages and cost effectiveness of core unit 
usage for the project.

e.  Human Subjects.  For research involving human subjects, this section must 
address the inclusion of women, minorities and their subgroups, and children 
as research subjects, following relevant policy announcements.

f.  Vertebrate Animals

g.  Consultants 

h.  Collaborative arrangements, including pertinent letters of assurance and 

i.  Literature Cited


Identify each proposed core unit by a letter (A, B, C...) and a title 
(Administrative, Molecular/Cellular...).

For each core unit, a full description is to be provided following the format 
presented below.  Do not exceed a total of 25 pages for each core 

1.  Overall Introduction (Do not exceed 3 pages, excluding the summary table)

Identify the proposed core units by title; briefly summarize the overall 
objectives of each core unit; present the organizational framework or chart; 
highlight the decision-making process for use of core unit services 
described; and present plans for quality control.

Complete a summary table for the first year of the proposed grant by showing 
the quantitative use (percent) of each core unit by the component research 
projects, presented in a format such as that suggested in Table II (see 

Begin the presentation of each core unit on a separate cover page.  For each 
proposed core, address cost effectiveness and plans for quality control, as 
appropriate.  For each core, or its equivalent in the center, include the 
following information:

2.  Administrative Core Unit (if applicable)

a.  Objective

b.  Staffing: Description of key professional and support staff functions 

c.  Resources: Description of space and physical resources

d.  Services Provided: Describe current and projected services to other core 
units and research projects, and the center as a whole

3.  Research Core Units

a.  Objective

b.  Staffing: Brief description of scientific, technical, as well as support 
staff functions

c.  Resources

d.  Administration: Description of overall management of the research core 

e.  Justification: Description of services provided and their bearing on 
productivity and quality, as well as documentation of cost-effectiveness and 
quality control

f.  Utilization: Indicate past and/or current usage (e.g., assays performed, 
animals supplied, etc.) and list projects proposed for core usage, identified 
by full title, such as displayed in sample format shown in Table II at

g.  If core service involves human subjects (e.g., recruitment; screening), 
discuss the inclusion of women, minorities and their subgroups, and children 
as research subjects, following relevant policy announcements (see RFA for 

E.  CHECKLIST - As required in Form PHS 398


Include materials as appropriate (see PHS 398).

Other Support and Core Usage information should be provided in the format 
shown in sample Tables I and II at


USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) 
application form must be affixed to the bottom of the face page of the 
application.  Type the RFA number on the label.  Failure to use this label 
could result in delayed processing of the application such that it may not 
reach the review committee in time for review.  In addition, the RFA title 
and number must be typed on line 2 of the face page of the application form 
and the YES box must be marked.  The RFA label is also available at:

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the Checklist, and three signed, photocopies, in 
one package to:

Center For Scientific Review
National Institutes Of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

At the time of submission, 2 additional copies of the application, including 
all appendix material, must be sent to:

Jean G. Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD  20892-9609
Rockville, MD  20852 (for courier/express service)
Telephone:  (301) 443-3367
FAX:  (301) 443-4720

APPLICATION PROCESSING: Applications must be received by the application 
receipt date listed in the heading of this RFA.  If an application is 
received after that date, it will be returned to the applicant without 

The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application.  The 
CSR will not accept any application that is essentially the same as one 
already reviewed.  This does not preclude the submission of substantial 
revisions of applications already reviewed, but such applications must 
include an Introduction addressing the previous critique.

All applications will initially be assigned to NIMH.  Following review, all 
of the participating institutes will make decisions about their respective 
roles in funding and in the distribution of the responsibilities of NIH 
staff.  These decisions will be based on the relevance of scientific 
activities in specific centers to institute missions and the expertise of NIH 

Applicants from institutions that have a General Clinical Research Center 
(GCRC) funded by the NIH National Center for Research Resources may wish to 
identify the GCRC as a resource for conducting the proposed research.  If so, 
a letter of agreement from either the GCRC Program Director or Principal 
Investigator should be included with the application.


Upon receipt, applications will be reviewed for completeness by the CSR and 
for responsiveness to this RFA by NIH program staff.  Incomplete and/or non-
responsive applications will be returned to the applicant without further 

Applications that are complete and responsive to the RFA will be evaluated 
for scientific and technical merit by an appropriate peer review group 
convened by NIH in accordance with the review criteria stated below.  As part 
of the initial merit review, all applications will:

o  Receive a written critique
o  Undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications under 
review, may be discussed and assigned a priority score
o  Receive a second level review by the appropriate Institute's National 
Advisory Council.


The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to discuss the following 
aspects of your application in order to judge the likelihood that the 
proposed research will have a substantial impact on the pursuit of these 

o  Significance
o  Approach
o  Innovation
o  Investigator
o  Environment

The scientific review group will address and consider each of these criteria 
in assigning your application's overall score, weighting them as appropriate 
for each application.  Your application does not need to be strong in all 
categories to be judged likely to have major scientific impact and thus 
deserve a high priority score.  For example, you may propose to carry out 
important work that by its nature is not innovative but is essential to move 
a field forward.

1.  Significance.  Does this study address an important problem?  If the aims 
of the application are achieved, how will scientific knowledge be advanced?  
What will be the effect of these studies on the concepts or methods that 
drive this field?

2.  Approach.  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project?  Does the applicant acknowledge potential problem areas and consider 
alternative tactics?

3.  Innovation.  Does the project employ novel concepts, approaches or 
method?  Are the aims original and innovative?  Does the project challenge 
existing paradigms or develop new methodologies or technologies?  Special 
emphasis will be placed on integration of basic and clinical research 
components relevant to autism into promising synergistic proposals.

4.  Investigator.  Are the investigators appropriately trained and well 
suited to carry out this work?

5.  Environment.  Does the scientific environment in which the work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements?  Is there evidence of institutional 

The initial review group will also examine:  The appropriateness of proposed 
project budget and duration; the adequacy of plans to include children and 
both genders and minorities and their subgroups as appropriate for the 
scientific goals of the research and plans for the recruitment and retention 
of subjects; the provisions for the protection of human and animal subjects; 
and the safety of the research environment.


Listed below are additional review criteria to be used in the evaluation of 
STAART Center applications; these criteria will be applied to applications by 
evaluating preliminary work to organize the center, history of autism 
research by the applicants, and plans for implementation of the proposed 

Applicants should clearly demonstrate the ways in which the STAART Center 
would contribute to the growth of local research programs, support on-going 
projects, cooperate with other STAART Centers in collaborative research, and 
attract both senior and new investigators to autism research.

A.  Center as a Whole

1) The potential for impact of the STAART Center on the progress of autism 
research locally and nationally.

2) Extent of "centerness," i.e., does the center as a whole serve a purpose 
greater than the sum of the individual components?

3) Effectiveness of the proposed center in meeting the requirements of the 
Children's Health Act.

B.  Cores

1) How effective is the overall organization of the proposed cores in 
relation to the center's total research program?  

2) Will each core enhance collaborative and/or interdisciplinary research 
within the STAART Center and the wider research community?  

3) Would any proposed optional cores duplicate existing resources or 
services?  If so, are the requested new resources justified?

4) Is the core useful to multiple projects?  each core must provide essential 
facilities or service for two or more subprojects judged to have substantial 
scientific merit.

5) The quality of the facilities or services provided by this core (including 
procedures, techniques, and quality control and criteria for prioritization 
of usage).

6) The qualifications, experience, and commitment of the personnel involved 
in the core.

C.  Projects

Projects will be evaluated by the standard NIH criteria listed above and by 
their integration into the center and their potential contributions to other 
projects in the center.

It should be noted that each meritorious subproject will receive a priority 
score and that these ratings will appear in the summary statement.  
Individual subprojects judged as "Not Recommended for Further Consideration" 
(because the proposed research is not significant and substantial when judged 
against the above criteria, or there are other significant concerns) will be 
deleted from the center.  It is anticipated that inclusion of a 'weak' or 
'non-essential' project in the application will reflect poorly on the overall 
program.  In addition, NIH retains the right to delete individual projects 
when making final funding decisions regarding STAART Center applications, for 
example, those that score below the current R01 funding level.  It will be 
mandatory for each successful application to include at least 3 fundable 
research projects.  At least one of the fundable projects must be a treatment 
study dealing with a topic such as outcome measures, treatment development, 
innovative treatment possibilities, effects of pretreatment measures on 
treatment selection, treatment efficacy or a similar topic.

D.  Data Management

1) Are data management and support procedures developed sufficiently to allow 
STAART investigators to access and utilize data, for example, data from the 
clinical core?  Does the center provide statistical design and support to 
STAART investigators?

2) Is there a sound plan to manage and utilize clinical and neuropathological 
data?  Are adequate safeguards to protect patient confidentiality addressed?  
Are staffing, hardware and software adequate?

E.  Program Administration

1) Does the PI have the scientific and organizational vision and experience 
to serve effectively as the Center Director? 

2) Is there evidence of management capabilities for the Center that include 
fiscal administration, procurement, property and personnel management, 
planning, and budgeting?

F.  Facilities

1) Are facilities adequate for the overall functions of the center and to 
implement the goals of the STAART Centers Program?

G.  Institutional Commitment

1) Is there evidence for institutional commitment to the program, including 
provision of funding, space, faculty positions for autism research and other 
essential STAART functions, and/or commitments for construction or 

2) Are the research environment and resources, including equipment and 
facilities, adequate?  Is there potential for interaction with scientists 
from other departments and components?

A site visit is not a required part of the review process.  Applicants should 
ensure that their written applications are complete and self-contained.


Letter of Intent Receipt Date:  June 27, 2002
Application Receipt Date:       August 29, 2002
Scientific Review Date:         February/March 2003
Advisory Council Date:          May 2003
Earliest Date of Award:         July 1, 2003


Award criteria that will be used to make award decisions include:

o  Scientific merit (as determined by peer review)
o  Availability of funds
o  Programmatic priorities


involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 
1998:  For 
the STAART Centers Program, an independent panel of experts, constituting a 
Data Safety and Monitoring Board, will be appointed by NIH to monitor safety, 
quality of data collection, and integrity of the study.  The costs of the 
DSMB will come from an NIH source independent of the cooperative agreement.

the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of 
the research.  This policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43).

All investigators proposing clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 (
files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are 
available at

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 

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

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

HUMAN EMBRYONIC STEM CELLS (hESC):  Criteria for federal funding of research 
on hESCs can be found at 
and at  
Only research using hESC lines that are registered in the NIH Human Embryonic 
Stem Cell Registry will be eligible for Federal funding 
It is the responsibility of the applicant to provide the official NIH 
identifier(s)for the hESC line(s)to be used in the proposed research.  
Applications that do not provide this information will be returned without 

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

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.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES:  All applications and proposals 
for NIH funding must be self-contained within specified page limitations. 
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) 
should not be used to provide information necessary to the review because 
reviewers are under no obligation to view the Internet sites.   Furthermore, 
we caution reviewers that their anonymity may be compromised when they 
directly access an Internet site.

HEALTHY PEOPLE 2010:  The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of "Healthy 
People 2010," a PHS-led national activity for setting priority areas.  This 
RFA is related to one or more of the priority areas.  Potential applicants 
may obtain a copy of "Healthy People 2010" at

AUTHORITY AND REGULATIONS:  This program is described in the Catalog of 
Federal Domestic Assistance Nos 93.242 (NIMH), 93.865 (NICHD), 93.853 
(NINDS), 93.173 (NIDCD), and 93.113 (NIEHS).  Awards are made under 
authorization of Sections 301 and 405 of the Public Health Service Act as 
amended (42 USC 241 and 284) and administered under NIH grants policies and 
Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  This program is 
not subject to the intergovernmental review requirements of Executive Order 
12372 or Health Systems Agency review.

The Public Health Service strongly encourages all grant and contract 
recipients to provide a smoke-free workplace and promote the non-use of all 
tobacco products.  In addition, Public Law 103-227, the Pro-Children Act of 
1994, prohibits smoking in certain facilities (or, in some cases, any portion 
of a facility) in which regular or routine education, library, day care, 
health care or early childhood development services are provided to children.  
This is consistent with the PHS mission to protect and advance the physical 
and mental health of the American people.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS) - Government Made Easy

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