SPECIALIZED MENTAL HEALTH INTERVENTIONS RESEARCH CENTERS

Release Date:  January 9, 1998

PA NUMBER:  PAR-98-020

P.T.

National Institute of Mental Health

Application Receipt Date:  April 9, 1998; January 15 each year thereafter

PURPOSE

The National Institute of Mental Health (NIMH) invites research grant
applications for Specialized Mental Health Intervention Research Centers (IRCs). 
The goal of this program is to provide the scientific infrastructure that
facilitates the process of scientific discovery in the area of interventions for
major mental disorders.  IRCs will focus on the assessment of treatments, and on
preventive and rehabilitative interventions tied to those treatments.

IRCs provide infrastructure support rather than support for specific, fully
developed research studies.  The availability of such an infrastructure is
intended to enable a greater efficiency and breadth in the capacity to pursue
intervention research. Investigators seeking support for individual research
projects or for a coordinated set of research projects should use mechanisms
other than the IRC, such as a program project grant, interactive research project
grant, or multi-institutional collaborative research project.  Program assignment
of new and competing research project grant applications will follow established
NIMH referral guidelines.

This program announcement supersedes the prior announcement for Specialized
Mental Health Clinical Research Centers (PAR 95-044) and will govern future
competitive renewals for existing Mental Health Clinical Research Centers as well
as applications for new IRCs.

There are two categories of grant applications under the IRC program:  Core
center grants (P30) for mature IRCs and resource-related research projects (R24)
for developing IRCs.  A mature IRC provides support for the infrastructure of a
research program organized around one or more broad integrating themes.  Through
core facilities and laboratories, the IRC provides an efficient and easily
accessible resource to be used as the basis for independently funded research
projects.  An IRC supports the development of innovative investigations through
a pilot study program, with projects selected through internal scientific review. 
Pilot projects should be time limited, and the IRC should establish
administrative procedures for monitoring their progress and for solicitation and
selection of new ones.  Through design consultation, data base management and
statistical advice, all research affiliated with the IRC (pilots or independently
funded projects) should be carried out at the highest levels of methodological
sophistication.  The data base of the IRC permits intensive use of data and data
analytic resources through a well-coordinated research effort and may result in
a reduced burden on human subjects.  A well-managed data base has the potential
for the development and testing of innovative and unexpected hypotheses by
providing access to already collected data.  Finally, by adopting common measures
and procedures, IRCs can enter into multi-center collaborative relationships and
thereby accelerate the progress of scientific development.

A developing IRC is appropriate for those groups of investigators that show
evidence of strong track records in intervention research through support of
individual project grants and show promise, by virtue of the commitment of
institutional resources, recruitment of research scholars, and identification of
a research focus, to develop into mature IRCs.  An institution with little or no
peer reviewed, extramurally funded research activity would not be eligible for
a developing IRC.  Such institutions should consider application for the NIMH
Research Infrastructure Support Program (RISP) (see PAR-94-096).  A developing
IRC could aim at recruiting promising investigators and other professional
personnel, improving clinical and research methodology, improving inpatient or
outpatient clinical sites for research, strengthening existing research programs,
and addressing other areas of research potential. It may contain a developmental
program of core research to determine the specific form and direction that a
fully developed CRC might take in future years.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2000," a PHS-led national
activity for setting priority areas.  This PA, Specialized Mental Health
Intervention Research Centers is related to the priority area mental health and
mental disorders.  Potential applicants may obtain a copy of "Healthy People
2000" (Full Report:  Stock No. 017-001-00474-0 or Summary Report: Stock No.
017-001-00473-1) through the Superintendent of Documents, Government Printing
Office, Washington, DC 20402-9325 (telephone 202-512-1800).

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.  Foreign institutions are not eligible for center core grants
(P30) or resource-related research projects (R24).  (Racial/ethnic minority
individuals, women, and persons with disabilities are encouraged to apply as
Principal Investigators.

MECHANISM OF SUPPORT

The mechanisms available for support of this program are resource-related
research projects (R24) for developing IRCs and center core grants (P30) for
mature IRCs.  The first year funding cap for mature IRCs is $1 million for direct
costs; indirect costs are added as appropriate.  The funding cap for developing
IRCs is $300,000 for direct costs; indirect costs are added as appropriate.
Developing IRCs can be supported for a single 5-year term.  Competitive renewal
requests may only be for a mature IRC.  Mature IRCs may be supported for an
initial period of up to 5 years followed by a competitive renewal application for
a second 5 year period.  NIMH will not support mature IRCs for longer than two
consecutive funding periods.  Exceptions to this policy will be made only if a
thorough evaluation of needs and opportunities, conducted by a committee composed
of non-federal experts, determines that there are extraordinarily important
reasons to continue a specific IRC program.  This would be made at the request
of the Principal Investigator, in the ninth year of the award.

An applicant planning to submit a new (Type 1) or competing renewal (Type 2)
investigator-initiated grant application requesting $500,000 or more in direct
costs for any year is advised that he or she must contact NIMH program staff
before submitting the application, i.e., as plans for the study are being
developed.  Furthermore, the applicant must obtain agreement from the program
staff that the NIMH will accept the application for consideration for an award. 
Finally, the applicant must identify, in a cover letter sent with the
application, the NIMH program staff member that agreed to accept assignment of
the application.

Any application subject to this policy that does not contain the required
information in a cover letter sent with the application will be returned to the
applicant without review.

For additional information concerning large grant applications, see the NIH
Guide, Vol. 25, No. 14 (May 3, 1996).

RESEARCH OBJECTIVES

Summary

The objective of the IRC program is to accelerate the development and widespread
application of new approaches to intervention in the mental disorders of children
and adolescents, adults, and older persons. The IRC provides a research
infrastructure for facilitating the research of investigators who receive primary
project support through NIH and other peer reviewed sources for a broad array of
research on treatments, rehabilitative interventions, and preventive
interventions.  The research facilitated by the IRC should have major public
health significance and includes intervention studies that are broadly inclusive
with respect to the heterogeneity of patients, the severity and chronicity of
disorders, types of interventions, variety of community and institutional
settings in which interventions are provided, and the range of factors examined
as outcomes.  IRCs include research on the diagnosis, course, and assessment of
outcomes of the psychiatric disorders that are needed to guide the design and
implementation of intervention research.  IRCs provide support for the
development of a concentrated focus of excellence.  They accommodate the needs
of large, long term clinical trials by providing a predictable source of well
characterized and accessible clinical samples that are representative of general
clinical populations and appropriate control samples.  They create efficiencies
through pooled resources and facilitate the translation of research findings to
improvements in clinical care.  IRCs attract established investigators to the
area of interventions research and expand opportunities for mentorship and
research career development for new investigators.

Common Elements of IRCs

Models for IRCs vary, as do the elements they contain, but they all are enabling
mechanisms for the conduct of sophisticated intervention research studies and the
development and application of health services research methods to such
intervention studies.  All NIMH IRCs, whether mature or developing, provide core
support for patient recruitment and follow-up, diagnosis and assessment, data
base management and statistical analysis, and laboratories.  IRCs must contain
a program of training, career development, and research apprenticeships in
intervention research, but IRC funds cannot be used for direct support of trainee
stipends.

Although the specific structure and organization of individual IRCs will vary,
all of the following characteristics must be apparent in each application:

Each IRC must provide an environment of scientific excellence that will ensure
the highest quality research and leadership in its particular area(s) of
investigation.

Through its activities, the IRC must already be, or demonstrate that it has the
potential to become, a major national scientific research resource.  Applicants
should describe the overall benefit of the IRC structure and the unique role and
contribution of the IRC.  For IRCs seeking renewal, applicants should identify
the initial findings and scientific discoveries made in the previous funding
period.

Each IRC must have a scientifically and administratively qualified IRC Director. 
The IRC Director is appointed by the applicant academic or research institution
to provide leadership for the scientific program and have final responsibility
for the scientific, administrative, and operational aspects of the IRC.  The
Director is responsible for overall coordination and for development of the IRC
as a unique national resource.

The IRC must have an administrative structure that will ensure maximum efficiency
of scientific program planning, monitoring, execution, and, for preparation of
the budget, control of expenditures and sound financial practices.  An IRC must
have sufficient authority to establish the necessary administrative and
management procedures to carry out its responsibility within the context of the
institution in which it is housed.

The IRC must have access to those facilities that will ensure availability and
representativeness of patients and other research subjects.  Specific agreements
must be documented, establishing access of the IRC to the academic and non-
academic clinical facilities identified for inclusion.  The IRC must provide
state-of-the-art patient recruitment, diagnosis, assessment, and sample
maintenance/subject retention services.

IRCs must provide infrastructure support for independently funded projects that
require the breadth and depth of facilities available through the IRC.  These
would include studies where subjects are assessed from multiple perspectives,
studies of unique or rare populations, long-term longitudinal studies, and others
of the sort that are not easily supported by individual research project grants. 
Applications must include, for each integrating theme, a description of all
independently funded research project grants and IRC funded pilot studies.

Expertise in experimental methodology, data-base maintenance, statistical
analysis, and statistical consultation must be provided and managed through core
IRC support.  Consultation should be proactive and provided to IRC-affiliated
investigators very early in the planning of their research studies and projects. 
This core often includes the development of a common data-set format which allows
the examination of data from a variety of theoretical perspectives and can lead
to new analyses and interpretations of the data.

IRCs should provide outreach, patient education, public information, and
professional education to increase awareness of the importance of IRC research
for addressing important public health issues of patient care and clinical
treatment.

IRCs may request patient bed costs or research ward costs as well as additional
personnel for outpatient facilities. Such funds will be made available, however,
only when it is clear that no other funds are available for such purposes and the
beds or facilities are essential to the conduct of the research.  IRC funds can
also support subject recruitment and incentive costs and outreach activities to
ensure appropriate participation by women and minorities.

IRCs may request pilot or seed money programs that provide start-up funds for new
innovative pilot projects.  Such high-risk preliminary studies have the potential
for developing into larger projects that could then compete for funds on their
own from other Federal, State, or private sources.  IRCs must provide a process
of scientific review for the pilot study program.

The primary purpose of an IRC is to support the conduct of intervention research. 
However, an important product of the research effort is to develop new
investigators in the complex techniques and advanced theories of contemporary
mental health-related research.  Each IRC must include a research development
component.  IRCs may take advantage of National Research Service Award (NRSA)
Fellowships, Institutional Research Training Grants, and Research Scientist
Development Awards for support of developing scientists.

An institution may have more than one IRC, provided that the themes differ
significantly in content.  There is the expectation that shared resources would
significantly reduce the cost of both IRCs.

Research topics

The following topics are listed as examples of broad research areas within the
IRC program mission.  The list is not meant to be comprehensive, nor are the
examples meant to be exclusive of other topics

o  Infrastructure in support of treatment assessment: randomized controlled
clinical trials to establish short- and long-term outcomes of a broad range of
single and combination approaches including pharmacologic, somatic, and
psychotherapeutic strategies

o  Infrastructure in support of studies to establish the generalizability of new
or established interventions: identification of optimal approaches to studies of
broad, clinically representative populations in various settings (specialty and
primary care as well as academic and non- academic)

o  Infrastructure in support of development and assessment of new approaches to
treatment, rehabilitative intervention and preventive intervention, and for
assessment of innovative applications of established approaches

o  Infrastructure in support of research that broadens the measurement of
outcomes of interventions, including functional status, service utilization, etc.

o  Infrastructure in support of clinical pharmacokinetic and pharmacodynamic
studies to guide dosing and duration of treatment in specific subgroups and
populations

o  Infrastructure in support of research to develop approaches to the
identification and selection of the types of patients who would most likely
benefit from different approaches to treatment

o  Infrastructure in support of psychosocial and biological studies of correlates
and predictors of variability in response to treatment (speed, completeness,
"brittleness", etc.) including life events, neurophysiological, circadian,
neuroimaging, and pharmacogenetic variables

o  Infrastructure in support of studies of treatment adherence and compliance,
including psychosocial interventions to improve compliance and pharmacologic
measures of treatment adherence

o  Infrastructure in support of research to critically evaluate clinical care
that has developed without a base of research support

o  Infrastructure in support of research on the process of informed consent in
intervention studies, including the assessment of competence and the
identification of diminished capacity

o  Infrastructure is support of research on the incidence, severity, duration,
and prevention of side effects and adverse reactions to treatment

o  Infrastructure in support of large-scale, multi-site clinical trials including
clinical monitoring, database management, and statistical analysis

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
subpopulations must be included in all NIH supported biomedical and behavioral
research projects involving human subjects, unless a clear and compelling
rationale and justification is provided that inclusion is inappropriate with
respect to the health of the subjects or the purpose of the research.  This new
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
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical
Research," which have been published in the Federal Register of March 28, 1994
(FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23,
Number 11, March 18, 1994.

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

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev.
5/95) and will be accepted on the single receipt date of April 9, 1998 and on
January 15 each year thereafter.  Earliest possible funding would be December 1.
Application kits are available at most institutional offices of sponsored
research and may be obtained from the Office of Extramural Outreach and
Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC
7910, Bethesda, MD 20892-7910, telephone (301) 710-0267; fax: (301) 480-0525
Email: [email protected].  The title and number of the program announcement must
be typed in Section 2 on the face page of the application.

The completed original application and three legible copies must be sent or
delivered to:

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

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

Henry Haigler, Ph.D.
National Institute of Mental Health
Parklawn Building, Room 9C-18
Rockville, MD  20857

REVIEW CONSIDERATIONS

Applications that are complete will be evaluated for scientific and technical
merit by an appropriate peer review group convened by the 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 may 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 appropriate national
advisory council or board, when applicable.

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 their
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.

Public Health Significance:  Does this center address an important problem? If
the aims of the application are achieved, how will knowledge of interventions be
advanced? What will be the effect of the center and its affiliated studies on the
care of patients?

Approach: Is the concept of a center fulfilled, including (1) an integrated theme
bringing together different types of investigators in a common mission, (2)
development of a pooled, core database that can yield results beyond that
accomplished with individual projects alone, (3) attraction of established
investigators and development of collaborations among investigators with diverse
backgrounds and areas of expertise, (4) a research development component for new
investigators through research training and career development mechanisms, (5)
a process for stimulation and evaluation of new pilot study proposals?  Is the
approach to the center adequately developed, well-integrated, and appropriate to
the public health aims of the project?  Does the applicant acknowledge potential
problem areas and consider alternative tactics?

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

Leadership: Are the center director and other senior investigators at the
forefront of their respective fields? Do they have the experience and authority
necessary to organize, administer and direct the center?

Environment:  Does the scientific and clinical 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 access to a representative range of
patients in a broad set of academic and non-academic clinical settings?  Is there
evidence of institutional support?

Maturation (for developing IRCs seeking competing renewal as mature IRCs):  Has
the center developed a significant research identity and focus?  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 interventions research of the
highest quality and significance?  Has there been success in attracting
productive investigators and promising trainees to the center?

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
as appropriate for the scientific goals of the research.  Plans for the
recruitment and retention of subjects will also be evaluated.

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

Availability of special opportunities for furthering research programs through
the use of unusual talent resources, populations, or environmental conditions in
other countries which are not readily available in the United States, or which
provide augmentation of existing U.S. resources (for foreign applications only).

Special Conditions

Funding for developing IRCs is for a maximum 5-year period. Any renewal
application must be for a mature IRC.

Funding for mature IRCs can be for a maximum project period of 5 years; a single
additional project period may be funded following application for competitive
renewal.  Funds may be requested for core support related to the administrative
functions and research infrastructure of the IRC and for specific activities
including inpatient bed costs, outpatient costs, subject incentive fees, pilot
studies, cost of conducting community-based studies, cost of specialized
consultation such as statistical and/or computer science and scientist
development activities.  Training costs and service costs not related to the
research program are not covered under IRC grants.  Actual amounts and years of
support that may be approved and awarded will depend on the appropriate level of
support necessary for the scientifically meritorious work which is proposed.

Since IRCs constitute a sustained research resource within a specific institution
and provide infrastructure for training and funded research, IRCs may not be
transferred to another institution without a competitive review.  Departing
investigators may submit competitive applications for a developing or mature IRC
under the auspices of the new institution.  The original sponsoring institution
must notify the NIMH project officer and indicate either the date of termination
or the new staffing plan.  In the latter case, the project officer will determine
if the new staffing plan must be peer-reviewed.

A submitted application will be reviewed as a developing or mature IRC as
requested; the IRG will not change categories as part of its review.

AWARD CRITERIA

Applications will compete for available funds with all other approved
applications assigned to NIMH.  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.

Direct inquiries regarding programmatic issues to:

Barry D. Lebowitz, Ph.D., Chief
Division of Services and Intervention Research
National Institute of Mental Health
Parklawn Building, Room 10-75
Rockville, MD  20857
Telephone:  (301) 443-1185
FAX:  (301) 594-6784
Email:  [email protected]

Benedetto Vitiello, M.D., Chief
Division of Services and Intervention Research
National Institute of Mental Health
Parklawn Building, Room 10C-09
Rockville, MD  20857
Telephone:  (301)443-4283
FAX:  (301) 443-4045
Email:  [email protected]

Direct inquiries regarding fiscal matters to:

Diana S. Trunnell
Grants Management Branch
National Institute of Mental Health
Parklawn Building, Room 7C-08
Rockville, MD  20857
Telephone:  (301) 443-2805
FAX:  (301) 443-6885
Email:  [email protected]

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.242.  Awards are made under authorization 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 PHS 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.
Awards will be administered under PHS grants policy as stated in the Public
Health Service Grants Policy Statement (April 1, 1994).

PHS strongly encourages all grant and contract recipients to provide a smoke-free
workplace and promote the nonuse 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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