INTERVENTIONS INFRASTRUCTURE PROGRAM

Release Date: February 11, 1999

PA NUMBER:  PAR-99-064 (superceded by PAR-04-015)

P.T.

National Institute of Mental Health

Application Receipt Date:  June 1

PURPOSE

The National Institute of Mental Health (NIMH) is seeking to expand the
capacity of the field to support state-of-the-art public health-oriented
studies in the treatment, rehabilitation, and prevention of mental disorders
in children and adolescents and in mid- and late-life adults.  The
Interventions Infrastructure Program (IIP) will encourage the expansion of
intervention research collaborations between academic health centers and
health care provider organizations that are oriented to community care, and
have access to large, stable, and diverse patient populations.  The IIP is a
response by the NIMH to recommendations made by the National Advisory Mental
Health Council Clinical and Services Research Workgroup.  The purpose of the
IIP is to provide the infrastructure for the support of research that has
sufficient power to define standards of appropriate and cost-effective care
for the diverse populations of patients with mental disorders seen in all
health care settings.

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, Interventions Infrastructure
Program, is related to the priority area of mental health and mental
disorders. Potential applicants may obtain a copy of "Healthy People 2000" at
http://www.crisny.org/health/us/health7.html

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

Grants awarded in the IIP program will use the resource related research
projects mechanism (R24) of the National Institutes of Health. This mechanism
is used to support projects that enhance capabilities to contribute to
extramural research of the PHS.  Grants funded under this PA are awarded
directly to the applicant institution.  The award is made to a particular
institution and is not transferable.  Grants must be administered in
accordance with the NIH Grants Policy Statement (effective 10/1/98). The
annual single receipt date for this program announcement is June 1.

The funding cap for each year for the IIP awards is $250,000 maximum direct
costs, plus negotiated facilities and administrative (formerly known as
indirect) costs.  Support is limited to a period of five years and is not
renewable.  Annual awards will be made subject to continued availability of
funds and progress achieved.

RESEARCH OBJECTIVES

Summary

IIP is designed to develop the capacity for mental health interventions
research in the real world settings of actual medical practice and health care
delivery.  The IIP will support development of collaborative research
arrangements between single and multiple academic settings and non-academic
settings including managed care organizations, community facilities, primary
care and specialty care, long term care, rehabilitation, public sector
programs in health and mental health, and practice research networks.  IIP
awards will provide the base upon which studies of samples of patients
(representative by age, sex, disease severity, and comorbidity) can be carried
out in usual settings of care.

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

o  Adaptation of assessment and treatment protocols developed in the academic
health center for specially selected patients for more general use in varied
settings

o  Database construction and ongoing database management for a core data set
for use in various settings

o  Computer hardware and software for development of local area networks and
wide area networks for purposes of data sharing

o  Instrument development and adaptation for various settings, particularly in
screening, diagnosis, and outcomes assessment

o  Methods development and adaptation for evaluation of cost-effectiveness,
medical outcomes, quality of life and appropriateness of different
intervention approaches

o  Methods development for the design, execution, and analysis of intervention
studies in multiple settings with representative samples of patients (i.e.
minimal exclusions) and with broad and multiple outcome measures.

o  Developmental, pilot, and feasibility studies

o  Partial salary support and research training for investigators
inexperienced in mental health effectiveness studies

o  Consultation on particular issues of program development or on general
directions of the IIP

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 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, Vol. 23,
No. 11, March 18, 1994 available on the web at the following URL address: 
https://grants.nih.gov/grants/guide/notice-files/not94-100.html

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://www.nih.gov/grants/guide/notice-files/not98-024.html

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.
4/98) and will be accepted on the single receipt date of June 1, annually. 
Application kits are available at most institutional offices of sponsored
research and may be obtained from the Division 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 application is also available at
http://www.nih.gov/grants/forms.htm

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 five 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)

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 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.

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.

(1) Significance: Does the IIP address important problems?  If the aims of the
application are achieved, how will knowledge of interventions be advanced?
What will be the effect on the practitioner community and on the care of
patients?

(2) Approach: Is the approach to interventions broadly conceived?  Is it
likely to develop the partnerships necessary to carry out studies of public
health significance?  Are potential problem areas identified and alternative
tactics considered?

(3) Innovation: Is the approach to interventions likely to yield new insights
to guide the treatment of major mental disorders?  Are the aims of the IIP
original and innovative?

(4) Leadership: Does the Director of the IIP have the experience and authority
necessary to organize, administer, and direct this project.  Do the site
directors and other senior investigators have a commitment to the mission of
the IIP and the expertise necessary to fulfill their roles?

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

(6)  Appropriateness of the proposed budget and duration in relation to the
proposed research;

Adequacy of plans to include genders, children and adolescents, and
minorities and their subgroups as appropriate for the scientific goals of the
research, or justification for their exclusion.  Plan 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, the safety of the research environments, and
conformance with the NIH Guidelines for the Inclusion of Women, Children and
Adolescents and Minorities as Subjects in Clinical Research

Adequacy of plans for including children as appropriate for the scientific
goals of the research, or justification for exclusion.

AWARD CRITERIA

Applications will compete for available funds with all other approved
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.

Direct inquiries regarding programmatic issues to:

John K. Hsiao, M.D. (Adult and Geriatric)
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7160 MSC 9635
Bethesda, MD  20892-9635
Telephone:  (301) 443-1185
FAX: (301) 594-6784
Email: [email protected]

Benedetto Vitiello, M.D.  (Child and Adolescent)
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7149 MSC 9633
Bethesda, MD 20892-9633
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
6001 Executive Boulevard, Room 6115 MSC 9605
Bethesda, MD  20892-9605
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 NIH Grants Policy
Statement (effective 10/1/98).

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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