Full Text PAR-95-044

SPECIALIZED MENTAL HEALTH CLINICAL RESEARCH CENTERS

NIH GUIDE, Volume 24, Number 12, March 31, 1995

PAR AVAILABLE:  PAR-95-044

National Institute of Mental Health

PURPOSE

The National Institute of Mental Health (NIMH) invites research grant
applications for Specialized Mental Health Clinical Research Centers
(CRCs).  A CRC provides the infrastructure that facilitates the
process of scientific discovery.  A CRC contains research resources
that are to be used by a cooperating group of researchers as the
foundation for a research program focused around a single theme or a
set of broad integrating themes such as diagnostic groups, treatment
development, or age categories.  As a CRC evolves, the integrating
themes can be expanded or redefined through the addition or deletion
of scientific expertise and funded projects.  In this way, the CRC
and associated projects may be used to define a broad and
comprehensive perspective on clinical research and related basic
science.  CRCs 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
broaden the extent of the institution's clinical research capacity.
Investigators seeking support for individual research projects or for
a coordinated set of research projects should use mechanisms other
than the CRC, such as a program project grant, interactive research
project grant, or multi-institutional collaborative research project.
The NIMH General CRC program, for CRCs lacking a specific thematic
focus, has been discontinued.

This program announcement supersedes the prior announcements for
Specialized (SMHCRCs) and General Mental Health Clinical Research
Centers (GMH-CRCs) and will govern future competitive renewals for
existing CRCs as well as applications for new CRCs.

NIMH support of the CRC program is based upon the view that each CRC
provides a unique and essential contribution to the Nation's
infrastructure for mental health research.  From the national
perspective, the CRCs provide the sustained and intensive focus that
contribute to the development and progress of the field.  The renewal
of each CRC is predicated on the vital role that the CRC has in the
overall development of the field and in the Nation's efforts to
understand and treat severe mental disorders.

The contribution of the CRC to the institutions, investigators and
trainees affiliated with it should be substantial and demonstrable.
Initially, a CRC is built upon a base of peer-reviewed research
projects.  By pooling resources from these projects and by providing
common infrastructure for such components as patient acquisition,
laboratories, and statistical and data base management, the CRC
allows for a new, more sophisticated and more cost-effective level of
research to emerge.  This new level of research capitalizes upon the
synergistic potential of the CRC resources, the multidisciplinary
perspectives that are brought to bear upon emergent questions, and
the ability to pursue innovative, high-risk research through pilot
study support.  Each CRC should develop procedures for scientific
review of proposed protocols using its resources, and, by doing so,
provide internal review, audit, and scientific guidance.  This
guidance is particularly valuable for research trainees and junior
faculty who are beginning their research careers.

There are two categories of grant applications under the CRC program:
Core center grants (P30) for mature CRCs and resource-related
research projects (R24) for developing CRCs.  A mature CRC provides
support for the infrastructure of a research program organized around
one or more broad integrating themes.  Through core facilities and
laboratories, the CRC provides an efficient and easily accessible
resource to be used as the basis for independently funded research
projects.  A CRC 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 CRC 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 CRC (pilots or
independently funded projects) should be carried out at the highest
levels of methodological sophistication.  The data base of the CRC
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, CRCs can enter into multi-center
collaborative relationships and thereby accelerate the progress of
scientific development.

A developing CRC is appropriate for those institutions that show
evidence of strong track records in clinical 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 CRCs.  An institution with little or no peer reviewed,
extramurally funded research activity would not be eligible for a
developing CRC.  Such institutions should consider application for
the NIMH Research Infrastructure Support Program (RISP).  A
developing CRC 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 Program
Announcement (PA), Specialized Mental Health Clinical Research
Centers (CRCs), is related to the priority area of 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) 783-3238).

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.

MECHANISM OF SUPPORT

The mechanisms available for support of this program are
resource-related research projects (R24) for developing CRCs and
center core grants (P30) for mature CRCs.  The first-year funding cap
for mature CRCs is $1 million direct costs plus indirect costs. The
funding cap for developing CRCs is $300,000 direct costs plus
indirect costs.  An annual rate of growth consistent with the
Biomedical Research and Development Price Index is allowable.
Developing CRCs can be supported for a single 5-year term.
Competitive renewal requests may only be for a mature CRC.

FUNDS AVAILABLE

In fiscal year 1994, the NIMH allocated approximately $24 million in
total costs to this program.  Funds available for new and competing
awards in any particular year will vary.

RESEARCH OBJECTIVES

An NIMH CRC provides a clinical research infrastructure for
investigators who receive their primary research support through
other peer-reviewed sources.  The purpose of CRCs is to provide a
stimulating and productive research environment in which
state-of-the- art clinical research and basic science can be applied
to problems of diagnosis, etiology, mechanisms, and treatment of
mental disorders throughout the full life cycle.

Common Elements of CRCs

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

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

o  Each CRC 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 CRC
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 CRC structure and the unique role
and contribution of the CRC.  For CRCs seeking renewal, applicants
should identify the initial findings and scientific discoveries made
in the previous funding period.

o  Each CRC must have a scientifically and administratively qualified
CRC Director.  The CRC 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 CRC.  The Director is
responsible for overall coordination and for development of the CRC
as a unique national resource.

o  The CRC must have an administrative structure that will ensure
maximum effectiveness and efficiency of scientific program planning,
monitoring, execution, and, for preparation of the budget, control of
expenditures and sound financial practices.  A CRC must have
sufficient authority to establish the necessary administrative and
management procedures to carry out its responsibility.  However, CRC
activities must also be appropriately coordinated and integrated with
the scientific, educational, and clinical programs of the parent
department or institution.

o  The CRC must have access to, and appropriate levels of
administrative control over, sufficient inpatient and/or outpatient
facilities to ensure availability of patients and other research
subjects.  Specific agreements must be documented, establishing
access of the CRC to the clinical facilities identified for
inclusion.  The CRC must provide state-of-the-art patient
recruitment, diagnosis, assessment, and sample maintenance/subject
retention services.

o  CRCs must provide infrastructure support for independently funded
projects that require the breadth and depth of facilities available
through the CRC.  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 CRC funded
pilot studies.

o  Expertise in experimental methodology, data-base maintenance,
statistical analysis, and statistical consultation must be provided
and managed through core CRC support.  Consultation should be
proactive and provided to CRC-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.

o  CRC-supported research laboratory facilities at both the basic and
clinical levels, such as neuroimaging, biochemical or neuroendocrine
assays, neuropsychology and or psychophysiological studies, or
neuropathology laboratories, must serve the needs of several
CRC-related individual research projects with accuracy and
efficiency.

o  CRCs 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.  CRC funds can also support
subject recruitment and incentive costs and outreach activities to
ensure appropriate participation by women and minorities.

o  CRCs 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.  CRCs must provide a process of
scientific review for the pilot study program.

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

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

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) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations), which
have been in effect since 1990.  The new policy contains some
provisions that are substantially different from the 1990 policies.

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 reprinted
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

Potential applicants are asked to send, 90 days prior to the
anticipated application submission date, a letter of intent that
includes a descriptive title of the proposed center, the name,
address, and telephone number of the CRC Directors, identities of
other key personnel, and additional participating institutions.
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 offer technical
assistance.  The letter of intent is to be sent to the appropriate
individual listed under INQUIRIES.

Applications are to be submitted on the grant application form PHS
398 (rev. 9/91) and will be accepted at the standard application
deadlines as indicated in the application kit.  Application kits are
available at most institutional offices of sponsored research and may
be obtained from the Office of Grants Information, Division of
Research Grants, National Institutes of Health, 5333 Westbard Avenue,
Room 240, Bethesda, MD 20892, telephone (301) 710-0267.  The title
and number of the program announcement must be typed in Section 2a on
the face page of the application.

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

Division of Research Grants
National Institutes of Health
6701 Rockledge Drive, Room 1040-MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express mail)

REVIEW CONSIDERATIONS

Applications that are complete and responsive to the program
announcement will be evaluated for scientific and technical merit by
an appropriate peer review group convened 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 will be assigned a priority score, and receive a
second-level review by the appropriate National Advisory Council.

Review Criteria

The following criteria apply for both developing and mature CRCs
except where noted.

I.  Conceptualization

o  Quality of the conceptualization and overall approach to research
on the organizing themes of the CRC

o  Overall scientific quality, quantity and direction of current peer
reviewed research and of the proposed research projects and pilot
studies that will use CRC core resources (independently supported
projects are not evaluated separately, but are used in the assessment
of the contribution of cores.)

o  Nature of the unique contributions of the CRC,including
importance, innovativeness, scientific productivity, and recognition
including publications, new research grants, and honors and awards

o  Scientific investigations and related research grant support
associated with each of the major themes of the CRC; contribution of
projects to overall scientific aims of the CRC

o  Extent of collaboration among investigators affiliated with the
CRC and between the CRC and other research institutions

II.  Center Structure and Administration

o  Quality and appropriateness of the organizational structure

o  Quality and experience of the administrative staff

o  Quality and appropriateness of the plans for evaluation of CRC
themes, directions, and overall organization through in-house
consultation and outside review

o  Quality of the plans for the allocation and monitoring of
resources (patients, laboratory capacity, pilot study funds,
biostatistical consultation)

III.  Center Cores

o  Quality of the administrative functions and overall infrastructure
to support ongoing center themes and peer reviewed projects

o  Quality of the recruitment, diagnosis, patient accrual and sample
maintenance functions and patient tracking across protocols

o  Quality of the experimental methodology functions:
accomplishments, activities, and plans

o  Quality of the data analytic functions and procedures for database
management including completeness, quality assessment and control
procedures, accessibility of the data, extent of utilization of the
data for analysis, publication, and development of exploratory
hypotheses.  For competing renewal applications, a thorough database
survey to determine the quality and accessibility of the database
will be part of the review.  For developing Center applications,
review emphasis will be on skills and background of personnel
involved in data base management, quality control, and statistical
consultation.

o  Quality of the core laboratories

o  Quality and innovativeness of pilot studies and quality of
procedures for evaluation and selection of new pilot study proposals

o  Kind and degree of cross-core activities and synergistic potential
of the cores and independently funded projects

IV.  Personnel

o  Scientific qualifications of the CRC investigators

o  Quality of the depth and breadth of basic and clinical research
expertise

o  Quality of the planned personnel recruitment, training and
supervision including plans for recruiting underrepresented minority
and women investigators and research staff

o  Quality and degree of synergistic potential among the research
groups

V.  Center Director

o  Scientific and administrative qualifications of the CRC director

o  Quality of scientific expertise and track record

o  Quality of administrative skills and institutional authority

VI.  Resources and Environment

o  Availability and accessibility of appropriate research and control
subjects

o  Availability and accessibility of appropriate research
laboratories

o  Availability and accessibility of appropriate clinical facilities

o  Quality of institutional resources

o  Quality and degree of institutional support and commitment

VII.  Scientist Development

Track record and quality of plan for training and career development
record including recruitment and retention of promising investigators
and launching of scientific careers

VIII.  Budget

o  Appropriateness of budget and time frame for the proposed
activities

o  Appropriateness of procedures for determining allocations to cores
and pilot projects

IX.  Information Dissemination

o  Quality of plans to participate in meetings and present research
abstracts

o  Quality of plans for internal peer review of research papers,
chapters, and grant applications including procedures for determining
authorship and other sensitive matters

o  Quality of plans for participating in or sponsoring workshops and
conferences for non-CRC investigators, clinicians, primary care
providers, or patients and their families

o  Quality of plans for development of materials and instruments for
use by clinicians and investigators not affiliated with the CRC

X.  Women and Minority Subjects

o  Quality of plans to include both genders and 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 initial review group will also examine the provisions for the
protection of human and animal subjects and the safety of the
research environment.

The following specific review criteria apply to applications for
developing CRCs seeking renewal as mature CRCs.

o  Development of a research identity and focus

o  Success in establishing core structures, articulating the
scientific program of each core and in encouraging inter-core
collaborations

o  Success in developing administrative procedures and policies that
foster the highest quality science

o  Success in attracting productive investigators and promising
trainees

Terms and Conditions

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

Funding for mature CRCs can be for a maximum project period of 5
years; additional project periods may be funded following
applications for competitive renewal.  Funds may be requested for
core support related to the administrative functions and research
infrastructure of the CRC 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 CRC
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 CRCs constitute a sustained research resource within a specific
institution and provide
infrastructure for training and funded research, CRCs may not be
transferred to another institution without a competitive review.
Departing investigators may submit competitive applications for a
developing or mature CRC 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.

Grants must be administered in accordance with the PHS Grants Policy
Statement (rev. April 1, 1994).

A submitted application will be reviewed as developing or mature CRC
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 the 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
priorities and balance.

INQUIRIES

Inquiries are encouraged.  The opportunity to clarify any issues or
questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Mary C. Blehar, Ph.D., Acting Chief
Mood, Anxiety, and Personality Disorders Research Branch
Division of Clinical and Treatment Research
5600 Fishers Lane, Room 10C-16
Rockville, Maryland  20857
Telephone:  301/443-1636
FAX:  (301) 443-6000
Email:  MBLEHAR@AOAMH4.SSW.DHHS.GOV

Barry D. Lebowitz, Ph.D., Chief
Mental Disorders of the Aging Research Branch
National Institute of Mental Health
5600 Fishers Lane, Room 18-105
Rockville, MD  20857
Telephone:  (301) 443-1185
FAX:  (301) 594-6784
Email:  BLEBOWIT@AOAMH4.SSW.DHHS.GOV

Peter S. Jensen, M.D., Chief
Child and Adolescent Disorders Research Branch
Division of Clinical and Treatment Research
5600 Fishers Lane, Room 18C-17
Rockville, Maryland  20857
Telephone:  (301) 443-5944
FAX:  (301) 443-6000
Email:  PJENSEN@AOAMH4.SSW.DHHS.GOV

Althea M. Wagman, Ph.D., Acting Chief
Schizophrenia Research Branch
Division of Clinical and Treatment Research
5600 Fishers Lane, Room 18C-14
Rockville, Maryland  20857
Telephone:  (301) 443-4707
FAX:  (301) 443-6000
Email:  AWAGMAN@AOAMH4.SSW.DHHS.GOV

Robert F. Prien, Ph.D., Chief
Clinical Treatment Research Branch
Division of Clinical and Treatment Research
5600 Fishers Lane, Room 18-105
Rockville, Maryland  20857
Telephone:  (301) 443-4527
FAX:  (301) 594-6784
Email:  RPRIEN@AOAMH4.SSW.DHHS.GOV


Direct inquiries regarding fiscal matters to:

Diana S. Trunnell
Office of Resource Management
National Institute of Mental Health
5600 Fishers Lane, Room 7C-08
Rockville, MD  20857
Telephone: (301) 443-3065
FAX:  (301) 443-6885
Email:  DTRUNNEL@AOAMH1.SSW.DHHS.GOV

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.

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 routing 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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