Full Text MH-94-007


NIH GUIDE, Volume 23, Number 6, February 11, 1994

RFA:  MH-94-007



National Institute of Mental Health

Application Receipt Date:  May 6, 1994


Clinical mental health services research focuses on the process and
quality of care and the effectiveness in "real world" settings of
clinical interventions whose efficacy has been demonstrated in
controlled clinical research environments.  The purpose of this
Request for Applications (RFA) is to stimulate the development of
programs of clinical mental health services research at institutions
that currently have strong programs in mental health clinical
research, but are not engaged in extensive clinical mental health
services research.  A second goal of this RFA is to bring the
expertise of mental health clinical researchers and general health
services researchers into the clinical mental health services
research field and to promote their collaborations with each other
and with clinical mental health services researchers.  Collaborations
of this kind are greatly needed to bring new resources and talents to
bear on the task of improving delivery of clinical mental health
services in the nation.

The development of programs focusing on the special mental health
services issues of the following populations are strongly encouraged:
minorities; persons who are homeless; persons who live in rural
areas; or persons with AIDS, who are HIV positive, or are at risk of
contracting the AIDS virus.  Expansion of the nation's clinical
mental health services research infrastructure is a major priority of
the National Institute of Mental Health (NIMH) and is in response to
recommendations made by the National Advisory Mental Health Council
and by the Extramural Science Advisory Board.

This RFA addresses recommendations set forth in the Clinical Services
Research section of Caring for People with Severe Mental Disorders: A
National Plan of Research to Improve Services and in the National
Plan for Research on Child and Adolescent Mental Disorders.


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 RFA,
Research Transition Grant Program in Clinical Mental Health Services,
is related to the priority areas of alcohol and other drugs, mental
health, mental disorders, and violent adn abusive behaviors.
Potential applicants may obtain a copy of "Healthy People 2000" (Full
Report:  Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary
Report:  Stock No. 017-001-00473-1) through the Superintendent of
Documents, Government Printing Office, Washington, DC 20402-9325
(telephone 202/783-3238).


Applications may be submitted by domestic public and private non-
profit and for-profit organizations, including universities,
colleges, hospitals, laboratories, units of State or local
governments, and eligible agencies of the Federal government except
for those institutions with extensive, ongoing collaborations between
clinical mental health investigators and mental health services
researchers.  Women and minority investigators are encouraged to


This RFA will use the resource-related research project (R24).  The
R24 mechanism is used to support research projects that will enhance
the capability of resources to serve biomedical research.  The
Research Transition Grant Program (RTGP) will be used by the National
Institute of Mental Health (NIMH) to enhance research capability and
clinical mental  health services research program.  Each award will
be limited to five years of funding and is nonrenewable.  This RFA is
a one-time solicitation.


It is anticipated that at least $2.5 million in total costs will be
made available so that a minimum of five awards can be made.  Each
award will have a maximum yearly total cost amount of $500,000.


Background.  The Research Transition Grant Program (RTGP) in Clinical
Mental Health Services is part of an integrated NIMH approach to
institutional infrastructure development made up of several types of
grants including:  NIMH Developing Clinical Research Centers,
Research Infrastructure Support Program (RISP) grants, Child and
Adolescent Mental Health Services Research Centers, and Social Work
Research Development Center grants.  Together these provide a
continuum of research infrastructure support for institutions with
varying levels and types of mental health research activity.

The RTGP grants are designed to enable institutions with current
programs in clinical mental health research to develop into major
clinical mental health services research settings, thus increasing
the number of investigators obtaining extramural funding for work in
the services research field.  Expansion of the nation's clinical
mental health services research infrastructure is a major priority
for NIMH because it is essential for improving the care received by
adults (including the elderly), adolescents, and children who suffer
from mental and emotional disorders, particularly the most severe

Mental Health Services Research.  The field of mental health services
research examines the impact of the organization, financing,
management, and delivery of mental health services on the quality,
cost, access to, and outcomes of care.  There are two major
components of services research:  service systems research and
clinical services research.  Service systems research focuses on
questions related to the organization, financing, and integration of
mental health services.  Clinical mental health services research
focuses on the process and quality of care and the effectiveness in
community settings of clinical interventions whose efficacy has been
demonstrated in controlled clinical research environments.  This RFA
seeks to enhance the clinical mental health services component of
services research.

The four major areas of clinical mental health services research are
assessment research, treatment research, rehabilitation research, and
outcomes research.  Examples of research topics in these four areas
include, but are not limited, to:

Assessment Research

o  Studies of the barriers to the accurate recognition and diagnosis
of mental disorders, with special attention to (a) patient variables,
such as culturally related beliefs or response patterns; and (b)
provider variables, such as knowledge and attitudes about mental

o  Research on the reliability, validity, and stability of symptom,
quality-of-life, functioning, social status, and vocational status
measures, particularly for individuals from different socioeconomic,
ethnic, or cultural groups

Treatment Research

o  Research on the applicability and effectiveness of clinically
efficacious treatments in "real world" settings, such as community
mental health centers, nursing homes, or primary care practices.

o  Studies of the relationship between the process of providing
mental health services (e.g., therapeutic alliance) and outcomes of
care (e.g., continuation in care and improved functioning)

Rehabilitation Research

o  Studies to determine what types and combinations of rehabilitation
services are most beneficial for severely mentally ill individuals
with different clinical, social, and economic circumstances

o  Research on ways to maximize effective use of family expertise and
client preferences in planning rehabilitation services

Outcomes Research

o  Studies of the reliability and validity of instruments in multiple
outcome domains (clinical, rehabilitative, humanitarian, and public
welfare), particularly for understudied populations, e.g., persons
who are homeless, migrants, minorities, rural residents

o  Research testing the performance over time of instruments
measuring inherently unstable patient or client characteristics


Applicant institutions should describe a comprehensive and coherent
plan of modification to the institution's current research
environment that will expand the capacity of the clinical research
program to carry out extramurally-funded, clinical services research.
The plan must demonstrate the actual commitment of institutional
resources, which may include hiring mental health services
researchers, providing mental health training to institutional
investigators experienced in health services research, and/or
providing services research training to clinical investigators.
However, a substantial commitment to a services research perspective
is essential.

A central philosophical principle underlying this program is that
different institutions will require different types and amounts of
development in clinical services research.  Therefore, this RFA does
not prescribe in any detail the nature of the activities to be
applied for or supported.

The following types of support may be requested under this program:

o  Partial salary support for clinical mental health services
research faculty

o  Training expenses in clinical mental health services research,
such as tuition remission or course fees, for junior clinical faculty

o  Research patient recruitment, diagnosis, assessment, and follow-up

o  Consultation from clinical mental health services research

o  Biostatistical and data-base management

o  Small equipment and research instruments

o  Research technicians and assistants

o  Developmental, feasibility, and/or pilot studies

The application should present a plan for the proposed RTGP.  It
should assess the current institutional and faculty capacity to
conduct clinical mental health services research, identify unmet
needs, and describe the activities to develop the institutional
infrastructure and faculty capacity to conduct this research.

The application should contain the following:

o  Statements of objectives, substantive clinical services research
focus, and justification

o  Specification of the proposed research area and plan for
development, including brief abstracts of ongoing and proposed
clinical services research projects

o  Overview of the research development plan for the institution,
including plans for recruitment and retention of faculty skilled in
clinical services research

o  Assessment of institutional capacity, including interest and
availability of senior faculty and experienced clinical mental health
services investigators

o  Description of the institutional commitment to substantial
financial support of a clinical mental health services research

o  Description of equipment, space, and other facility resources that
are available for clinical mental health services research and
identification of needed enhancement

o  Assessment of junior faculty interest and capability to engage in
clinical mental health services research and identification of
training, mentoring, and consultation proposed to enhance the
capacity to develop extramurally- fundable research

o  Description of procedures to be used to solicit, review for
scientific merit, monitor, and evaluate the outcome of pilot or
feasibility studies, including measures to assure the protection of
human subjects

o  Abstracts of pilot projects approved for support pending the award
of funding for the RTGP

Applications are limited to 25 pages.



NIH policy is that applicants for NIH clinical research grants and
cooperative agreements will be required to include minorities and
women in study populations so that research findings can be of
benefit to all persons at risk of the disease, disorder or condition
under study; special emphasis should be placed on the need for
inclusion of minorities and women in studies of diseases, disorders
and conditions which disproportionately affect them.  This policy is
intended to apply to males and females of all ages.  If women or
minorities are excluded or inadequately represented in clinical
research, particularly in proposed population-based studies, a clear
compelling rationale should be provided.

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group.  In addition, gender and
racial/ethnic issues should be addressed in developing a research
design and sample size appropriate for the scientific objectives of
the study.  This information should be included in the form PHS 398
in Sections 1-4 of the Research Plan AND summarized in Section 5,
Human Subjects.

Applicants are urged to assess carefully the feasibility of including
the broadest possible representation of minority groups.  However,
NIH recognizes that it may not be feasible or appropriate in all
research projects to include representation of the full array of
United States racial/ethnic minority populations (i.e., Native
Americans (including American Indians or Alaskan Natives),
Asian/Pacific Islanders, Blacks, Hispanics).

The rationale for studies on single minority population groups should
be provided.

For the purpose of this policy, clinical research includes human
biomedical and behavioral studies of etiology, epidemiology,
prevention (and preventive strategies), diagnosis, or treatment of
diseases, disorders or conditions, including but not limited to
clinical trials.

The usual NIH policies concerning research on human subjects also
apply.  Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are excluded.  However,
every effort should be made to include human tissues from women and
racial/ethnic minorities when it is important to apply the results of
the study broadly, and this should be addressed by applicants.

For foreign awards, the policy on inclusion of women applies fully;
since the definition of minority differs in other countries, the
applicant must discuss the relevance of research involving foreign
population groups to the United States' populations, including

If the required information is not contained within the application,
the application will be returned.

Peer reviewers will address specifically whether the research plan in
the application conforms to these policies.  If the representation of
women or minorities in a study design is inadequate to answer the
scientific question(s) addressed AND the justification for the
selected study population is inadequate, it will be considered a
scientific weakness or deficiency in the study design and will be
reflected in assigning the priority score to the application.

All applications for clinical research submitted to NIH are required
to address these policies.  NIH funding components will not award
grants or cooperative agreements that do not comply with these


Applicants are to use the  research grant application form PHS 398
(rev. 9/91).  These forms are available at most institutional offices
of sponsored research; from the Office of Grants Information Division
of Research Grants, National Institutes of Health, 5333 Westbard
Avenue, Room 449, Bethesda, MD 20892, telephone 301/710-0267; and
from the Grants Management Branch, National Institute of Mental
Health, 5600 Fishers Lane, Room 7C-05, Rockville, MD 20857, telephone
301/443-4414.  The RFA number MH-94-007 and the title, Research
Transition Grant Program in Clinical Mental Health Services, must be
typed in item number 2a on the face page of the PHS 398 application
form; the YES box must also be marked.  Applicants must specify that
the R24 mechanism is being used.

Applicant institutions will need to demonstrate that they: (1) have a
strong base of ongoing clinical mental health research activities;
(2) need additional support to establish and maintain collaborative
working relationships between clinical and services researchers; and
(3) have the potential for building a mental health services research
program that will equip them to compete effectively in future years
for clinical mental health services research grants.

The RFA label available in the PHS 398 application form must be
affixed to the bottom of the face page of the application.  Failure
to use this label could result in delayed processing of the
application such that it may not reach the review committee in time
for review.

All applications must be received by May 6, 1994 and will be reviewed
in July.  Applications received after the receipt date will be
returned to the applicant without review.

Submit, in one package, a signed original of the application,
including the Checklist, and three signed copies to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

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

Wright Williamson, M.S.W.
Division of Extramural Activities
National Institute of Mental Health
5600 Fishers Lane, Room 9C-14
Rockville, MD  20857


Upon receipt, applications will be reviewed for completeness and
responsiveness.  Incomplete or nonresponsive applications will be
returned to the applicant without further consideration.

Applications will be reviewed for scientific and technical merit by
an initial review group (IRG) convened by the NIMH composed primarily
of non-Federal scientific experts.  Final review is by the
appropriate National Advisory Council; review by Council may be based
on policy considerations as well as scientific merit.  By law, only
applications recommended for consideration for funding by the Council
may be supported.  Summaries of IRG recommendations are sent to
applicants as soon as possible following IRG review.

Criteria to be considered in evaluating applications for
scientific/technical merit include:

o  Scientific and technical significance and originality of the focus
of the proposed development plan and research

o  Appropriateness and adequacy of the proposed development plan and
the potential for the plan to effect significant and lasting
improvements in the institution's ability to conduct
extramurally-funded clinical mental health services research

o  Nature, amount, and duration of non-Federal commitment to the

o  Capability of the Principal Investigator and other senior staff to
provide leadership in the effort to enhance the institution's
clinical mental health services research capacity

o  Adequate representation of minorities and women

o  Appropriateness of the proposed budget

o  Adequacy of the proposed means for protecting against or
minimizing adverse effects to human subjects


Awards will be made on or before September 30, 1994.

As part of the NIMH Public-Academic Liaison (PAL) initiative, special
encouragement is given to applications that involve active
collaborations between academic researchers and public sector
agencies in planning, undertaking, analyzing, and publishing research
pertaining to persons with severe mental disorders.  The PAL
initiative is based on the premise that important new advances in
understanding and treatment of severe mental disorders can result
from improved linkages between the Nation's scientific resources and
the public sector agencies and programs in which many persons with
severe mental disorders receive their care.  The scope of the PAL
initiative encompasses public sector agencies of all types that deal
with children, adolescents, adults, and elderly persons with severe
mental disorders.  Factors considered in determining which
applications will be funded include IRG and Council recommendations,
PHS program needs and priorities, and availability of funds.


Potential applicants should contact NIMH staff as early as possible
for information and assistance in initiating the application process.
The NIMH program staff member listed below may be contacted for
further information about mental health services research and for
technical assistance in developing an application.

Ann A. Hohmann, Ph.D., M.P.H.
Services Research Branch
National Institute of Mental Health
5600 Fishers Lane, Room 10C-06
Rockville, MD  20857
Telephone:  (301) 443-3364

For further information on grants management issues, applicants may

Diana S. Trunnell
Grants Management Branch
National Institute of Mental Health
5600 Fishers Lane, Room 7C-15
Rockville, MD  20857
Telephone:  (301) 443-3065


This program is described in the Catalog of Federal Domestic
Assistance 93.242, Mental Health Research Grants.  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 RFA is not subject to
the intergovernmental review requirements of Executive Order 12372,
as implemented through DHHS regulations at 45 CFR Part 100.


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