Full Text MH-94-008

SERVICES RESEARCH COMPETITIVE SUPPLEMENTS TO CLINICAL THERAPEUTIC
RESEARCH GRANTS

NIH GUIDE, Volume 23, Number 14, April 8, 1994

RFA:  MH-94-008

P.T.


Keywords: 


National Institute of Mental Health

Letter of Intent Receipt Date:  May 8, 1994
Application Receipt Date:  June 8, 1994

PURPOSE

The National Institute of Mental Health (NIMH) announces the
availability of support in the form of competitive supplements to
expand ongoing funded clinical therapeutic research grants into the
area of services research.  The purpose of these supplements is to
help move mental health treatments from the testing of efficacy
(i.e., whether the treatment works under highly controlled conditions
in a population with a well defined mental disorder) into testing of
effectiveness (i.e., whether the same promising treatment works when
applied to a wider and diverse range of settings, providers,
populations, and outcome assessment).

Services research is a major NIMH priority and is responsive to
Public Law 102-321 (July 10, 1992), which requires the NIMH to
obligate not less than 15 percent of its budget to health services
research.

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 Request
for Applications (RFA), Services Research Competitive Supplements to
Clinical Therapeutic Research Grants, 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 "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).

ELIGIBILITY

Applications will only be considered for currently funded grants with
at least one year remaining, ending no later than March 30, 1996.
Such funding could be supplementary to a competitive renewal grant.
Women and minority investigators are encouraged to apply.

MECHANISMS OF SUPPORT

This RFA will use the National Institutes of Health (NIH) competitive
supplement mechanism (S01) and can supplement the following types of
grants: R01, R10, R37, P01, P20, P30, P50.  Supplemental request may
not exceed the tenure left on the parent grant.  Annual awards will
be made, subject to continued availability of funds and progress
achieved.

FUNDS AVAILABLE

It is anticipated that at least $1,000,000 in direct costs will be
made available.  Awards will have a maximum yearly direct cost amount
of $200,000, but will not exceed the total costs of the prior year of
the parent grant.

RESEARCH OBJECTIVES

Background

Despite the upsurge of research on the treatment of mental illness,
both within the NIMH and in the field, there are still critical needs
that were highlighted in a recent report by the NIMH Treatment
Research Initiative Task Force.  The basic goal of the initiative is
to take advantage of emerging knowledge and technology to develop and
refine more efficient and effective treatment programs for
individuals with mental illness.  Specific recommendations include
(1) development of more effective treatments for patients who fail to
respond to standard therapies; (2) enhanced research on the treatment
of chronic or recurrent mental illness; (3) strengthening research
directed at populations that are not often the focus of treatment
research; (4) improved criteria and instruments for assessing a wider
range of treatment outcomes and; (5) development of more effective
integrated interventions involving biological, psychosocial, and
rehabilitative therapies.  The report places special emphasis on
strengthening the linkage between clinical therapeutic research and
clinical services research in advancing the effective use of
available treatments in clinical practice.

The aim of this RFA is to encourage the transition from clinical
therapeutic efficacy research into clinical services effectiveness
research (NIMH Caring for People with Severe Mental Disorders:  A
National Plan of Research to Improve Services.  DHHS Pub. No. (ADM
91-1762.  Washington, DC: Superintendent of Documents, U.S.
Government Printing Office, 1991), thereby expanding the
generalizability of the intervention.  Ultimately, this transition
should result in improved outcomes and increased numbers of
individuals benefiting from promising mental health treatments.

Following are examples of the types of clinical services research
issues that would benefit from expansion of ongoing clinical
therapeutic research grants.  The list is illustrative rather than
comprehensive.  It is expected that additional relevant and important
research topics will be identified by investigators responding to
this RFA.

o  Studies testing promising treatments with new populations, such as
racial or ethnic minorities, patients with co-occurring mental,
substance abuse, or medical conditions.

o  Studies testing the effectiveness of proven mental health
treatments when employed in everyday practice and settings (e.g.,
primary care settings, nursing homes, community mental health
centers, outpatient clinics)

o  Studies testing the effectiveness of proven mental health
treatments when administered by providers who more fully represent
the range and expertise of providers expected to deliver the
treatment in everyday practice and settings

o  Studies of the delivery of treatment, such as how to provide
coordinated treatment and rehabilitation services and select
modalities that best match the patient's/client's needs.

o  Studies that measure an expanded range of outcomes (beyond symptom
reduction), such as functional capacity, and quality of life, or
cost.

o  Financing and cost issues relating to therapeutic interventions,
e.g., cost-effectiveness, cost-benefit, and cost-utility research.

Program Specifications

Supplementary requests should address the need to establish the
effectiveness of efficacious treatments, thereby increasing the
generalizability of research findings.

STUDY POPULATIONS

SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF FEMALES AND MINORITIES IN RESEARCH
STUDY POPULATIONS

It is the policy of the NIH that women and member 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) which have
been in effect since 1990.  the new policy contains some new
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 9, 1994 (FR 59 11146-11151), and reprinted
in the NIH Guide For Grants and Contracts of March 18, 1994, Volume
23, Number 11.

Investigators may obtain copies from these sources or from the
program staff or contact person listed below.  Program staff may also
provide additional relevant information concerning the policy.

LETTER OF INTENT

Prospective applicants are asked to submit, by May 8, 1994, a letter
of intent.  This should include the title and number of the parent
grant to be supplemented a descriptive title of the proposed
research, 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 RFA.

Although a letter of intent is not required, is not binding, and does
not enter into the review of subsequent applications, the information
that it contains is helpful in planning for the review of
applications. It allows NIMH staff to estimate the potential review
workload and to avoid conflict of interest in the review.  The letter
of intent is to be sent to Dr. Robert Prien at the address listed
under INQUIRIES.

APPLICATION PROCEDURES

Applicants are to use the grant applications form PHS 398 (rev.
9/91).  Application kits containing the necessary forms and
instructions for regular research grants may be obtained from the
office of sponsored research at most universities, colleges, medical
schools, and other major research facilities; from the Office of
Grants Information, Division of Research Grants, National Institutes
of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone
301/435-0714; and from the  program office listed under INQUIRIES.

The RFA label available in the PHS 398 (rev. 9/91) 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.  In addition, the RFA title and number must be typed on
line 2a of the face page of the application form and the YES box must
be marked.

The signed original and five legible copies of the completed
application must be sent to:

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

Schedule

Letter of Intent Receipt Date:  May 8, 1994
Application Receipt Date:       June 8, 1994
IRG Review:                     July/August 1994
Council Review:                 September 1994
Approximate Start Date:         September 1994

Terms and Conditions of Support

Supplemental funds may be used for expenses clearly related and
necessary to conduct the proposed supplemental services research,
including both direct and allowable indirect costs.  Supplemental
funds may not be used to operate a treatment, rehabilitation, or
other service program, nor may such funds be used to fund research
that is an integral part of the parent grant.

Public-Academic Liaison

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 people with severe mental disorders.  The PAL
initiative is based upon the premise that important new advances in
the understanding and treatment of severe mental illness can result
from improved linkages between the Nation's scientific resources and
the public sector agencies and programs in which many people with
severe mental disorders receive their care.  The scope of the PAL
initiative encompasses public sector agencies of all types that
provide services for people with severe mental disorders.

REVIEW CONSIDERATIONS

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 NIMH Initial Review Group (IRG) 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 discussions are sent to
applicants as soon as possible following IRG review.

Review Criteria

Criteria for scientific/technical merit review of applications will
include the following: significance of the goals of the proposed
research plan and its relationship to the parent grant; evidence of
familiarity with relevant research literature; adequacy of the
conceptual and theoretical framework for the research; adequacy of
the methodology proposed to carry out the research; feasibility of
the proposed research; qualifications and research experience of the
principal investigator and other key research personnel; availability
of adequate facilities, other resources, and collaborative
arrangements necessary for the research; appropriateness of budget
estimates for the proposed research activities; adequacy of plans to
include women and minorities in study populations; and adequacy of
provisions for the protection of human subjects and the welfare of
animal subjects, as applicable.

AWARD CRITERIA

In granting awards, the following criteria are consider:  program
relevance, quality of application as documented by IRG and Council
recommendation, and program balance.

INQUIRES

Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcome.

Direct inquiries regarding programmatic is and address the letter of
intent to:

Robert F. Prien, Ph.D.
Division of Clinical and Treatment Research
National Institute of Mental Health
5600 Fishers Lane, Room 18-105
Rockville, MD  20857
Telephone:  (301) 443-4527
FAX:  (301) 443-6000

Matthew V. Rudorfer, M.D.
Division of Clinical and Treatment Research
National Institute of Mental Health
5600 Fishers Lane, Room 18-105
Rockville, MD  20857
Telephone:  (301) 443-4527
FAX:  (301) 443-6000

Barry E. Wolfe, Ph.D.
Division of Clinical and Treatment Research
National Institute of Mental Health
5600 Fishers Lane, Room 18-105
Rockville, MD  20857
Telephone:  (301) 443-4527
FAX:  (301) 443-6000

George Niederehe, Ph.D.
Division of Clinical and Treatment Research
National Institute of Mental Health
5600 Fishers Lane, Room 18-105
Rockville, MD  20857
Telephone:  (301) 443-1185
FAX:  (301) 594-6784

Peter S. Jensen, M.D.
Division of Clinical and Treatment Research
National Institute of Mental Health
5600 Fishers Lane, Room 18-105
Rockville, MD  20857
Telephone:  (301) 443-5944
FAX:  (301) 443-6000

Thomas Lalley
Division of Epidemiology and Services Research
National Institute of Mental Health
5600 Fishers Lane, Room 10C-06
Rockville, MD  20857
Telephone:  (301) 443-3364
FAX:  (301) 443-4045

Direct inquiries regarding grants management issues to:

Diana Trunnell
Grants Management Branch
National Institute of Mental Health
5600 Fishers Lane, Room 7C-08
Rockville, MD  20857
Telephone:  (301) 443-3065
FAX:  (301) 443-6885

AUTHORITY AND REGULATION

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 PSC 241 and 285) and administered
under PHS grants and Federal Regulations 42 CFR, Part 52 "Grants for
Research Projects" and 45 CFR Part 74.  This program is not subject
to the intergovernmental review requirements of Execute Order 12372.

The Public Health Service (PHS) strongly encourages all grant
recipients to provide a smoke-free workplace and promote the non-use
of all tobacco products.  This is consistent with the PHS mission to
protect and advance the physical and mental health of the American
people.

.

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