This Program Announcement expires on November 1, 2004, unless reissued.

ADVANCED CENTERS FOR INTERVENTIONS AND SERVICES RESEARCH (ACISR)

Release Date:  May 7, 2001

PA NUMBER:  PAR-01-089 (This PAR has been reissued, see PAR-05-161)

National Institute of Mental Health
 (http://www.nimh.nih.gov)

Letter of Intent Receipt Date:  August 1 annually
Application Receipt Date:       October 1 annually

This program announcement (PA) and PAR-01-090, Developing Centers for 
Interventions and Services Research (DCISR), supercede the following center 
announcements: Prevention Research Centers (PA-99-074), Social Work Research 
Development Centers (PAR-99-130), Specialized Mental Health Interventions 
Research Centers (PAR-98-020), and Centers for Research on Services for 
People with Mental Health Disorders (PAR-94-073).

PURPOSE

The National Institute of Mental Health (NIMH) encourages investigator-
initiated research grant applications for Advanced Centers for Interventions 
and Services Research (ACISRs).  The goal of these multidisciplinary research 
centers is to establish core infrastructure support to enhance the national 
capacity to test interventions (treatment, rehabilitative, and preventive) 
through studies in multiple settings and to improve the utilization of 
research-based prevention, treatment and service interventions in community 
and practice settings.  The centers are expected to provide a research 
infrastructure that will promote investigator-initiated applications aimed at 
preventing and minimizing the impact of mental disorders, and that inform the 
provision of adequate treatment and rehabilitation services for people of all 
age groups who have mental disorders.  This PA addresses several major 
recommendations set forth in reports by the National Advisory Mental Health 
Council: Bridging Science and Service 
(http://www.nimh.nih.gov/research/bridge.htm), Translating Behavioral Science 
into Action (http://www.nimh.nih.gov/tbsia/tbsiatoc.cfm), and Priorities for 
Prevention Research at NIMH (http://www.nimh.nih.gov/research/priorrpt/index.htm).  
These reports called for increasing the relevance of behavioral, intervention 
and services research for community practice.

Applicants who do not have the capacity to mount the extensive and integrated 
research effort expected in this program announcement, but would like support 
for a center at an earlier stage of development, should consult PAR-01-090 
(http://grants.nih.gov/grants/guide/pa-files/PAR-01-090.html), Developing 
Centers for Interventions and Services Research.  Applicants interested in 
funding a center for basic neuroscience research relevant to mental illnesses 
should see PAR-98-057, Silvio Conte Centers for Neuroscience Research 
(http://grants.nih.gov/grants/guide/pa-files/PAR-98-057.html) and those 
interested in a center for translational research between basic and clinical 
neuroscience research on severe mental illnesses should consider PAR-98-058, 
Silvio Conte Centers for the Neuroscience of Mental Disorders 
(http://grants.nih.gov/grants/guide/pa-files/PAR-98-058.html).  Applicants 
interested in funding for a center for research at the interface between 
basic behavioral research and neuroscience should see PAR-00-130, 
Interdisciplinary Behavioral Science Centers for Mental Health 
(http://grants.nih.gov/grants/guide/pa-files/PAR-00-130.html).  Applicants 
interested in a center that would foster research projects on the translation 
of basic behavioral research to mental disorders and public health 
applications should consider PAR-01-027, Translational Research Centers in 
Behavioral Science (http://grants.nih.gov/grants/guide/pa-files/PAR-01-027.html).  
Those interested in a center with a focus on HIV/AIDS should apply for funding 
through PAR-99-153, Core Support Program for Mental Health/AIDS Research 
(http://grants.nih.gov/grants/guide/pa-files/PAR-99-153.html).

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, Advanced Centers 
for Interventions and Services Research, is related to the priority area of 
mental health and mental disorders.  Potential applicants may obtain a copy 
of “Healthy People 2010” at:  http://www.health.gov/healthypeople/.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic, for-profit and non-profit 
organizations, public and private, such as universities, colleges, hospitals, 
laboratories, units of State and local governments, and eligible agencies of 
the Federal Government.  Racial/ethnic minority individuals, women, and 
persons with disabilities are encouraged to apply as principal investigators.  
A single institution may have more than one ACISR but they must address 
distinctly different research topics.  In such situations, it is expected 
that there will be significant savings from sharing some infrastructure 
resources among the centers at the institution.  Foreign institutions are not 
eligible for support under this PA.

Applicants should demonstrate the capacity to become an advanced center 
through evidence of previous commitment of institutional resources, 
development of a critical mass of intervention and/or services researchers, 
the presence of substantial recent topical peer-reviewed publications in the 
research area chosen, and partnerships with stakeholders such as policy 
makers, providers, payers, consumers and families.  Advanced centers should 
be a major national scientific resource with the ability to impact practice 
and public mental health policy.  They should demonstrate a capability to 
study questions among various populations in different community and practice 
settings.

MECHANISM OF SUPPORT

This PA will use the National Institutes of Health (NIH) Center Core Grants 
(P30) mechanism.  Support for these advanced centers may be requested for an 
initial period of up to 5 years, followed by competitive renewals for each 5-
year period.  Once awarded, centers are subject during the term of the award 
to administrative review for performance and are not transferable to another 
institution.  Applicants may request up to $800,000 in direct costs per year, 
plus Facility and Administrative costs (formerly known as indirect costs).  
Up to $400,000 per year in additional direct costs may be requested to create 
or expand partnerships between centers and community clinical or service 
systems (see Research Network Development Core below).  Criteria for these 
centers are described below.

Allowable Costs

ACISR funds can support research participant recruitment and outreach 
activities to ensure appropriate participation by all populations, especially 
women, children and adolescents, elderly populations and traditionally 
underserved populations such as racial and ethnic minorities and people in 
rural areas.  For those centers that will support clinical trials, funds may 
be used to set up a Data and Safety Monitoring Board for these trials.  Funds 
may be requested to initiate specific pilot studies in the scientific areas 
chosen as the focus of the center and to support data bases and/or maintain 
tracking of research participants while new grants are developed to address 
follow-up questions raised by early studies.  Funds may also be used for 
travel, salaries, meeting expenses, subcontracts and to pay consultants.  
Applicants are referred to the General Clinical Research Center program at 
the NIH/National Center for Research Resources 
(http://www.ncrr.nih.gov/clinical/cr_gcrc.asp) as a potential resource for 
inpatient and outpatient facility costs.

RESEARCH OBJECTIVES

Background

The purpose of the ACISR center announcement is to provide core 
infrastructure support that will increase the capacity in the mental health 
field to test interventions (treatment, rehabilitative, and preventive) and 
conduct research to improve the utilization of research-based prevention, 
treatment and service interventions in the community.  The centers are 
expected to:  1) build and maintain networks to conduct clinical trials of 
interventions, and/or conduct practice and service system research to improve 
service delivery, 2) foster interdisciplinary collaboration, 3) develop new 
research methods, and 4) cultivate training opportunities for new 
investigators.

Three recent reports by the NIMH National Advisory Mental Health Council help 
to define the research agenda that should be supported by these centers 
(Bridging Science and Service, Priorities for Prevention Research at NIMH, 
and Translating Behavioral Science into Action).  Bridging Science and 
Service defines the major focus of research for the ACISRs, and the other two 
reports provide some specific recommendations for studies that would 
integrate prevention and behavioral research with treatment and services 
research.  Through these centers, the NIMH intends to expand the clinical 
trials and services research capacity of the mental health field to address 
the most pressing mental health problems facing public health today.  Thus, 
applicants are expected to focus on specific areas in which current research 
indicates that an opportunity exists to improve prevention, treatment and 
services through findings from larger studies conducted in or using data from 
multiple sites (preferably in the community).  In this announcement, the term 
community is used to indicate both clinical and non-clinical settings outside 
traditional academic research locations.  The term network is used to 
indicate an assemblage of research sites (e.g., outpatient clinics, large 
groups of individual practice settings, schools, public health clinics, 
managed care systems, etc.).  In an effort to simplify the announcement, the 
term intervention refers to preventive, treatment, and rehabilitative 
interventions.  Service interventions are subsumed under the topic of 
practice and service system research.

This advanced center mechanism provides funding for infrastructure only.  The 
availability of such an infrastructure is intended to provide multi-
disciplinary teams either at a single institution or across institutions the 
support they need to develop integrated, theoretically and empirically 
informed, prevention, treatment and services research proposals.  Applicants 
must show how the multidisciplinary teams and research proposals focus on a 
major public mental health problem.  Investigators seeking funding for 
specific individual research projects, or for a coordinated set of research 
projects, should use other mechanisms (e.g., R01, R21, R03).  Centers are 
expected to develop studies that will inform healthcare by using a variety of 
academic, community, and practice settings incorporated into networks 
supported by the center.  However, there may be some areas of research that 
lend themselves currently to more limited arrangements among academic and 
non-academic sites.  Applicants with such limited arrangements should justify 
why this is best for addressing the research area they have chosen.

PROGRAM SPECIFICATIONS

Principal Investigator Specifications

The ACISR Director should have overall responsibility for leadership of the 
center as a major national scientific resource and be recognized as a leader 
in the research area chosen as a focus for the center.  This individual must 
have demonstrated capability to organize, administer, and direct the center, 
and have a minimum time commitment of 30 percent to the center.

Each ACISR must have the following cores:  1) Operations Core, 2) Research 
Methods Core and 3) Principal Research Core.  An optional Research Network 
Development Core may be added (see below).

Operations Core

Each center must have a clearly articulated Operations Core that should 
integrate the scientific and infrastructure aims.  This core includes 
administrative functions, data management and statistical analysis, 
dissemination activities, and specialized interdisciplinary components.  
Applicants should describe under the Operations Core section how the ACISR 
will:  1) foster an environment of research excellence through 
multidisciplinary teams operating at a high level of methodological 
sophistication, 2) support innovation by integrating productive partnerships 
with academic disciplines that may be relative newcomers to these areas of 
research, and 3) actively engage and retain community stakeholders in all 
aspects of the research process.  These stakeholders could include 
individuals with mental illness and their families, mental health care 
providers, community organizations and institutions (e.g., schools, group 
homes, extended care facilities), public and private purchasers of mental 
health care (jails, employers, state government), and insurers and managed 
care organizations.  

For those centers conducting clinical trials, the Operations Core should 
include a data management and statistical analysis unit as well as a trials 
operation management unit.  These units may be located at a single 
institution or across multiple institutions.  Depending on the research 
focus, other specialized interdisciplinary components might be included in 
the Operations Core (e.g., economics unit).  Applicants should describe 
efforts for recruitment of research participants and data collection 
activities within this Core.

The ACISR center may consist of several collaborating sites that are not all 
located in a single institution or geographic region.  ACISRs are strongly 
encouraged to foster cross-site collaborations and networks of affiliated 
sites.  The collaboration among multiple institutions and settings to create 
a “virtual” center, or “virtual cores”, must be specified and explained in 
the Operations Core of the lead institution receiving the funding so the 
feasibility of such arrangements can be evaluated.  

The Operations Core section of the application should outline the scientific 
leadership for all anticipated research.  It should describe an 
administrative structure that maximizes efficiency through program planning 
and monitoring, an infrastructure development and maintenance plan, 
opportunities for investigators to do integrative work, and plans for 
accountability.  The Operations Core should also address knowledge and 
technology transfer, and enhancing the availability of center accomplishments 
(e.g., data, methods, networks) within and beyond the center.  Centers are 
encouraged to consider support for scientific meetings through the NIH R13 
mechanism.
 
Applications should address potential training opportunities within the ACISR 
under the Operations Core section.  The center should include established 
investigators in the areas chosen for research, and thereby expand 
opportunities for mentorship and career development for new and mid-level 
investigators.  ACISRs should contain plans for facilitating and evaluating 
innovative and interdisciplinary training, education, career development, and 
research apprenticeships.  Centers that consist of multiple research sites 
should describe how they would take advantage of the training opportunities 
offered by such an arrangement.  This could include having trainees spend 
time at various settings or institutions.  The direct support of training 
efforts (e.g., stipends) should be sought through NIH training and career 
development mechanisms.  Direct support for short-term educational programs 
can be sought from the R25 mechanism.  Applicants must include plans for 
attracting and retaining physicians and other clinically trained individuals 
into interventions and services research careers.  In addition, applicants 
should address the ways in which training opportunities will seek to reduce 
disparities in the mental health of traditionally underserved populations.

Research Methods Core

Every ACISR must include a research methods core.  New technology, research 
designs and innovative analytic approaches are needed for interventions, 
practice, and service systems research questions.  Centers are expected to 
develop, enhance and provide state-of-the-art, sophisticated methodological 
expertise to all ACISR related research projects.  This function includes, 
but is not limited to: sample recruitment and retention, methods and 
instrument development, research design, novel data base management 
techniques, new statistical analytic methods, and use of mixed methodologies.  
Conducting the kinds of research called for in this PA will require the 
development and adaptation of sophisticated methods from other sciences.  
Thus, this Core should seek to encourage collaboration of methodologists from 
diverse academic backgrounds including epidemiology, statistics, behavioral 
and social science, engineering, computer science, marketing and others to 
focus on the challenges of the types of research supported by the ACISR.  
Applicants should seek funding through traditional mechanisms (R01, R21, R03) 
for specific projects.  As part of this core, centers may develop plans to 
stimulate technological innovation through collaboration with small 
businesses using either the Small Business Technology Transfer (STTR) program 
or the Small Business Innovation Research (SBIR) program. Information on the 
SBIR and STTR programs may be obtained at:  
http://grants.nih.gov/grants/funding/sbir.htm.

There are a large number of potential areas of investigation that could be 
included in this core.  The following are some examples of research areas 
that could fit in this core.  These are not meant to be comprehensive, nor 
are the examples meant to be exclusive of other topics.  For example, a 
center might develop and evaluate ways to adapt assessment and treatment 
protocols previously used in restricted settings for use in community 
settings.  Of special interest is research on ways to integrate qualitative 
and quantitative methods into intervention, practice or service system 
studies.  Developing new designs for conducting clinical trials and 
statistical techniques to analyze data from novel research designs would be 
important areas to address in centers that are conducting clinical trials.  
Other potential efforts in this core might include: new methods for retention 
and recruitment of research participants, new technology for data entry and 
database management, and new measures to broaden assessment of the effect of 
interventions at the individual and system level.  In addition, centers could 
improve methods that increase the relevance of research findings for 
community stakeholders such as payers and public policy makers (e.g., 
economic analyses in clinical trials or expanded measures of impact such as 
disability and functional status).  A center might develop ways to improve 
intervention and services research studies through utilization of theory and 
methods from fields outside health (e.g., decision analysis, marketing and 
engineering).  Applicants are encouraged to focus on how this core will 
enhance the research activities chosen in the principal research core (see 
below).

Principal Research Core

An ACISR must have a principal research core focused on interventions 
research and/or practice and service systems research.  Although not 
mandatory, applicants are encouraged to consider ways in which both areas 
(interventions and practice/service systems research) can be integrated into 
a focused research agenda.  The research area chosen should be the primary 
research focus of the center and all other cores should clearly relate to the 
efforts pursued in this core.  A separate description must be provided for 
the principal research core area, including potential research proposals in 
this area, summary descriptions of exploratory and developmental research 
projects, and how these proposals and projects will relate to and support one 
another as well as projects in other cores.  Applicants should describe how 
the Operations Core, the Research Methods Core, and the optional Research 
Network Development Core (see below) are integrated in the service of the 
Principal Research Core and related research projects.

A Principal Research Core that focuses on interventions research should build 
capacity to facilitate the testing of interventions with the eventual goal of 
increasing the number of evidence-based interventions applicable to community 
care.  Integrating two or more intervention approaches (efficacy, 
effectiveness, preventive, treatment and rehabilitative) to address the 
central research focus is encouraged.  The Bridging Science and Service 
report identified 12 areas (Recommendations 7-18) where efficacy, 
effectiveness, practice and services research could be integrated.  
Priorities for Prevention Research at NIMH recommended that prevention 
research become more integrated with treatment and rehabilitative research 
across the life course.  

Applicants should select a major mental health problem as the focus of the 
research core and propose studies that will seek to determine the best 
interventions for that problem.  Applicants can propose both efficacy trials 
to test newer interventions, as well as effectiveness trials that assess the 
generalizability and acceptability of interventions.  Support can be used to 
pilot test interventions for estimating feasibility and effect sizes and 
exploring both short- and long-term outcomes.  Capacity building activities 
include the provision of operations for multi-site clinical trials, research 
participant recruitment, data base development, supporting protocol 
development for new clinical trials, and refining approaches for sample 
identification and deployment of intervention protocols in community sites.

There are a number of possible topics in interventions research that would 
benefit from infrastructure support.  Applicants are encouraged to develop a 
solid set of proposed research topics that will seek to provide information 
on the best interventions for the major mental health problem chosen for 
focus by the ACISR.  The following provides some examples of research areas 
that could fit in this core.  This is not meant to be comprehensive, nor are 
the examples meant to be exclusive of other topics.  For example, an ACISR 
could propose to test interventions that target multiple levels of risk and 
severity, test various ways of delivering interventions such as sequenced 
approaches or algorithms and test interventions in large community 
populations that have shown some promise in small restricted populations.  
Applicants could propose to develop new ways of identifying groups most 
likely to benefit from various intervention approaches as well as determining 
factors that would predict variability in response to interventions.  Other 
possible research topics might include research to determine optimal dosing 
and duration of interventions to prevent relapse and recurrence.  In 
addition, applicants could test ways of improving adherence to interventions 
and how to minimize side effects from interventions.  A center might also 
test new intervention models that take into account the service context in 
which the intervention will be embedded and the impact of an intervention on 
much broader measures of outcome (e.g., disability and functional status).  

An ACISR can choose to focus the Principal Research Core on practice and 
service systems research. The ability to translate research findings into 
sustainable improvements in clinical practice and outcomes is one of the 
largest obstacles in improving the quality and effectiveness of mental health 
care.  Little is known about what happens in routine community care 
especially across different practice settings.  In order to improve community 
care it is critical that studies identify and understand how organizational, 
sociocultural, and interpersonal factors are associated with improved quality 
of care and optimal outcomes.  Practice research, as described in the 
Bridging Science and Service report, seeks to examine how and which 
treatments or services are provided in community practice settings and to 
identify better ways to disseminate and implement research-based 
interventions and services in community settings.  Practice research is based 
in three areas of research investigation: clinical epidemiology, quality of 
care research, and dissemination/implementation research.  Service systems 
research addresses broad organizational, financing and policy questions.  A 
Principal Research Core focused in this area should seek to integrate service 
systems research and practice-based research.

Applicants should choose a major mental health problem and describe how the 
proposed practice research and service systems research studies will seek to 
address this problem.  The following provides some examples of research areas 
that could fit in this core.  This is not meant to be comprehensive, nor are 
the examples meant to be exclusive of other topics.  There are a number of 
possible topics in practice research and service systems research that would 
benefit from infrastructure support.  For example, applicants could propose 
to conduct research on the various factors that may enhance or detract from 
the effective delivery of interventions and test ways of modifying these 
factors to improve the delivery of care.  Other potential topics include how 
consumer and clinician choices impact effective delivery of interventions and 
the outcomes from the intervention, how perspectives on quality of care vary 
by stakeholder and how those differences can be used to improve care.  In 
addition, centers could propose to test various dissemination or 
implementation strategies for incorporating and sustaining the delivery of 
effective interventions in community settings.  An ACISR might choose to 
examine usual care in the community and how an improvement in such care is 
influenced by individual, clinician and system factors.  Research on the 
feasibility and utility of alternative methods to deliver interventions 
(e.g., telehealth) or studies to improve delivery of interventions in 
traditionally underserved areas (e.g., rural and frontier areas) would be 
other possible research topics for study in this core.

Research Network Development Core

Center applications may include a component devoted to creating and expanding 
the relationships between the primary application site and other sites, 
particularly community clinical or service systems.  This is not a required 
core for an ACISR application but additional funds up to $400,000 direct 
costs a year may be requested to support activities under this core. The 
purpose is to create research networks for new intervention or services 
research.  This core uses the same principles as those articulated in PAR-00-
096, Intervention and Practice Research Infrastructure Program (IP-RISP), 
(http://grants.nih.gov/grants/guide/pa-files/PAR-00-096.html) and provides 
support for research infrastructure development by partnering academic 
settings with community clinical and services systems that have large and 
diverse consumer and provider populations.  However, these systems may lack 
the resources needed to conduct strong scientific research programs.  
Potential applicants are referred to the IP-RISP program announcement for 
details and examples of the types of activities that are supportable.  
Clinical and service systems of interest may include general and primary 
health care, community specialty care, long-term care, public mental health 
or health care systems, schools, and prisons, jails and other correctional 
systems.  The community settings can benefit from research by providing 
empirical validation for treatment approaches and variations in care, 
creating robust evaluations of programmatic benefit and outcome, and 
assessing ways to improve care.  The academic settings can benefit from these 
partnerships by strengthening and diversifying their study populations and 
perspectives.  A central principle underlying this core is that different 
clinical and service systems will require different types of research 
infrastructure support and development activities.  Funding requests should 
be guided by focusing on specific research needs and questions.  It is 
expected that virtually all the financial support provided in this core will 
be targeted to the community clinical and service systems.  It is permissible 
to request funds in this core to set up research networks with other academic 
sites when those sites do not have infrastructure funding available for 
clinical or services research.

Applicants that request funds under this core are not eligible to apply for 
an IP-RISP grant.  Those who currently have such a grant must describe how 
funds received under the Research Network Development Core would offset 
funding provided in the IP-RISP until the IP-RISP is finished.

Organization of Centers

An ACISR may be organized in a variety of ways and may include one 
institution or several.  There is no single model for a center: the structure 
will depend upon the research questions and approaches selected to study 
them.  One type of center could adopt a Clinical Research Organization type 
approach, providing administrative, management, and operational support to a 
large set of ongoing and planned intervention or services studies in various 
community sites.  Another type of center could adopt a decentralized, multi-
site focus in which specialized activities are supported in different sites.  
A conceptual and theoretical rationale for the organizational structure 
should be discussed in the application.  However, they must include the 
required cores outlined above.

The following are suggested to indicate the range over which centers might be 
organized, although they are not limited to these:

o  A center focused on interventions at a single institution might use the 
research network development core to incorporate community health systems 
throughout the state (e.g., school clinics, public clinics, etc.).  The core 
is based at a single institution that supports the operations, training and 
methods cores.  Research questions involving implementation of evidence-based 
preventive and treatment interventions could be tested using this network of 
sites.

o  A center focused on testing treatment interventions might share resources 
with several institutions to develop a network of sites in which research 
participants could be recruited.  The operations core might be at one site 
while the methods core could be at another site.  Funds from the research 
network development core may or may not be used in this case.

o  A center focused at a single institution provides the operations, training 
and methods core for a practice and service systems research center.  Funds 
are requested for the research network development core to incorporate 
several managed care and public systems.

AWARD MANAGEMENT

Because of the complexities of this funding mechanism and associated 
scientific aims, applicants should note that higher levels of program 
scrutiny, both pre- and post-award, may be necessary.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS 

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 biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification are 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 research involving human subjects should read the 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contracts on 
August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), 
a complete copy of the updated Guidelines is available at  
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm.  The 
revisions relate to NIH defined Phase III clinical trials and require: a) all 
applications or proposals and/or protocols to 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) all 
investigators to report accrual, and to conduct and report analyses, as 
appropriate, by sex/gender and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH 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 was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
address:  http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators also may obtain copies of these policies from the program staff 
listed under INQUIRIES. Program staff may also provide additional relevant 
information concerning the policy.

NIH GRANTS POLICY STATEMENT

The NIH Grants Policy Statement (NIHGPS) has been revised and reissued.  The 
provisions of the revised NIHGPS are effective for all funded NIH grants and 
cooperative agreements with budget periods beginning on or after March 1, 
2001.  The revised NIHGPS is available at:  
http://grants.nih.gov/grants/policy/nihgps_2001.

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.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.

LETTER OF INTENT

Prospective applicants are asked to submit, by the date indicated in the 
heading of this PA, a letter of intent that includes:  a descriptive title of 
the proposed center, the name, address, and telephone number of the Principal 
Investigator, the identities of other key personnel and participating 
institutions, and the number and title of this PA.

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 NIMH staff to estimate the potential review workload and to 
plan the review.  The letter of intent should be sent to the appropriate program 
contact, at the address listed under INQUIRIES, below.

APPLICATION PROCEDURES

Applicants are strongly encouraged to contact the program contacts listed 
under INQUIRIES with any questions regarding their proposed project and the 
goals of this PA.  

Applications are to be submitted on the grant application form PHS 398 (rev. 
4/98).  Application kits are available at most institutional offices of 
sponsored research and from the Division of Extramural Outreach and 
Information Resources, National Institutes of Health, 6701 Rockledge Drive, 
MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, Email: 
GrantsInfo@nih.gov.  Applications are also available on the Internet at: 
http://grants.nih.gov/grants/forms.htm.

Submit a signed, typewritten original of the application, including the 
Checklist of the documents included, and three signed photocopies in one 
package to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)

At the time of submission, two additional copies of the application must be
sent to:

Jean G. Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD  20892-9663
Bethesda, MD  20817 (for courier/express service)

Applications must be received by the application receipt date indicated in 
the heading of this PA.  If an application is received after that date it 
will be returned to the applicant without review.

APPLICATION PAGE LIMITS

The Introduction and description of the Operations, Research Methods and 
Principal Research cores is limited to 30 pages.  The description of the 
Research Network Development core (if chosen) is limited to an additional 15 
pages.

REVIEW CONSIDERATIONS

Applications will be reviewed by CSR for completeness and by NIMH program 
staff for responsiveness.  Applications that are incomplete and/or non-
responsive, will be returned to the applicant without further consideration.  
Applications that are complete and responsive will be evaluated for 
scientific and technical merit by an appropriate scientific review group 
convened by NIMH in accordance with the standard NIH peer review procedures. 
As part of the initial merit review, all applications will receive a written 
critique and undergo a process in which only those applications deemed to 
have the highest scientific merit, generally the top half of applications 
under review, will be discussed, assigned a priority score, and receive a 
second level review by the National Advisory Mental Health Council.

Review Criteria 

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments reviewers will be asked to discuss the following aspects 
of the application in order to judge the likelihood that the proposed 
research will have a substantial impact on the pursuit of these goals.  Each 
of these criteria will be addressed and considered in assigning the overall 
score, weighting them as appropriate for each application.  Note that the 
application does not need to be strong in all categories to be judged likely 
to have major scientific impact and thus deserves 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.

(1) Public Health Significance:  Will the center be seen as a national 
resource for interventions and/or services research on a major mental health 
problem?  Are the areas chosen for study those in which the field is ready to 
take advantage of larger intervention and services research studies?  Will 
the center and its affiliated studies have a major impact on care in 
community settings?  If the aims of the application are achieved, how will 
scientific knowledge of intervention and/or services research be advanced?

(2) Innovation:  Does the center propose to develop novel concepts, 
approaches, measures or methods in the development and assessment of 
interventions and/or services research?  Are the aims original and 
innovative? Does the center extend existing approaches or develop new 
methodologies or technologies appropriate to the assessment of interventions 
and services?

(3) Approach:  Is there adequate rationale to support the importance of a 
center approach as opposed to other mechanisms (e.g., individual R01 
application)?  Does a conceptual and theoretical framework focused on a major 
topic in intervention and/or services research inform the center organization 
and infrastructure development?  Is the concept of a center fulfilled, 
including:  (1) an integrated theme bringing together a multidisciplinary 
team of investigators in a common mission related to the mental health 
problem chosen for investigation, (2) development of a pooled, core database 
or access to research participants that can yield results beyond that 
accomplished with individual projects alone, (3) attraction of established 
investigators and development of collaboration among investigators with 
diverse backgrounds and areas of expertise, (4) a research mentorship 
component for new investigators through research training and career 
development mechanisms, and (5) a process for stimulation and evaluation of 
new pilot study proposals?  Is the approach for the center adequately 
developed, well integrated, and appropriate to the general aims of the 
center?  Does the applicant acknowledge potential problem areas and consider 
alternative tactics?  Are collaborations across sites well justified and 
reasonable to carry out the research activities?  

(4) Leadership:  Are the center director and other senior investigators 
recognized as leaders in their fields? Do they have the experience and 
authority necessary to organize, administer and direct a national center?

(5) Environment:  Does the scientific environment of the center contribute to 
the probability of success? Does the center take advantage of unique features 
of the scientific environment or employ useful collaborative arrangements?  
Is the center able to gain and sustain access to a representative range of 
people in a broad set of academic and community settings?  Is there evidence 
of institutional support?  Are the collaborating sites chosen for the center 
the best ones to address the research questions proposed?  Is there evidence 
of significant ongoing research in intervention and/or services research?

(6) Maturation (for developing centers seeking to become an advanced center):   
Has the center developed a significant national research identity and focus 
on a major mental health problem?  Has the leadership of the center been 
successful in establishing core structures, articulating the program of each 
core and in encouraging inter-core collaborations?  Has the leadership of the 
center been successful in developing administrative procedures and practices 
that foster research of the highest quality and national significance?  Has 
there been success in attracting productive investigators and promising 
trainees to the center (e.g., obtained training or career development 
funding)?  Is there evidence of strong collaborative relationships with 
community systems?

(7) Research Network Development (optional core):  Are the networks 
representative of community settings and populations?  Are the networks the 
appropriate choices for addressing the principal research questions?  Is the 
infrastructure proposed for the network adequate to sustain research capacity 
in the sites?  Is there strong evidence of commitment by the network sites?

(8) Renewal of Advanced Centers (applicable only to ACISRs seeking 
competitive renewal):  Is the center recognized as a national research 
resource for a major mental health problem?  Has the center mechanism been 
instrumental in advancing the state of science in interventions and/or 
services research?  Is the center mechanism the most appropriate mechanism to 
continue to advance knowledge in the research area chosen?  Has the center 
attracted productive investigators and provided training opportunities for 
junior or new investigators?  Has the body of research knowledge in the area 
chosen for investigation expanded significantly since the last review?  Are 
collaborations across sites and within networks firmly established?  Are 
there any performance problems, especially related to the ability to provide 
support for funded research projects?

In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:

The reasonableness of the proposed budget and duration in relation to the 
proposed research.

The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of research participants 
will also be evaluated.

The adequacy of the proposed protection for humans to the extent they may be 
adversely affected by the activities proposed in the application.

AWARD CRITERIA

Applications will compete for available funds with all other recommended 
applications. The following will be considered in making funding decisions: 
Quality of the proposed project as determined by peer review, availability of 
funds, and program priority.

INQUIRIES

Inquiries are encouraged.  The opportunity to clarify any issues or questions 
from potential applicants is welcome.  Applicants may also consult NIH staff 
for advice concerning collaborations and access to research participant 
material.

Direct inquiries regarding programmatic issues about practice and service 
systems research to:

Junius Gonzales, M.D.
Division of Services and Intervention Research 
National Institute of Mental Health
6001 Executive Boulevard, Room 7141, MSC 9631
Bethesda, MD 20892-9631
Telephone:  (301) 443-3364
FAX:  (301) 443-4045
Email:  jgonzale@nih.gov

Direct inquiries regarding programmatic issues about intervention research 
for adults and the elderly to:

Barry Lebowitz, Ph.D.
Division of Services and Intervention Research 
National Institute of Mental Health
6001 Executive Boulevard, Room 7162, MSC 9635
Bethesda, MD 20892-9635
Telephone:  (301) 443-1185
FAX:  (301) 443-4045
Email:  blebowit@nih.gov

Direct inquiries regarding programmatic issues about intervention research 
for children and adolescents to:

Benedetto Vitiello, M.D.
Child and Adolescent Treatment and Preventive Intervention Research Branch
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7147, MSC 9633
Bethesda, MD 20892-9633
Telephone:  (301) 443-4283 
FAX:  (301) 443-4045 
Email:  bvitiell@nih.gov
 
Direct inquiries regarding fiscal matters to:

Joy R. Knipple
Grants Management Branch
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-8811
FAX:  (301) 443-6885
Email:  jknipple@nih.gov

AUTHORITY AND REGULATIONS 

This program is described in the Catalog of Federal Domestic Assistance No. 
93.242 (NIMH).  Awards are made under authorization of Sections 301 and 405 
of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as 
amended by Public Law 99-158, 42 USC 241 and 285) and administered under NIH 
grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74.  This 
program is not subject to the intergovernmental review requirements of 
Executive Order 12372 or Health Systems Agency review.

The PHS 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. 



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