Full Text MH-95-001

SERVICES RESEARCH SUPPLEMENTS TO CLINICAL THERAPEUTIC GRANTS

NIH GUIDE, Volume 24, Number 1, January 13, 1995

RFA:  MH-95-001

P.T. 34

Keywords: 
  Mental Disorders 
  0730057 


National Institute of Mental Health

Letter of Intent Receipt Date:  April 15, 1995
Application Receipt Date:  May 5, 1995

PURPOSE

The National Institute of Mental Health (NIMH) announces the
continued availability 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 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 RFA,
Services Research Supplement to Clinical Therapeutic Grants, is
related to the priority areas 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 REQUIREMENTS

These supplemental applications will only be considered for currently
funded NIMH grants with at least one year remaining at the time of
award, and ending no later than June 30, 1998.  Applicants who
previously submitted supplemental applications in response to the
original RFA are eligible to resubmit.  Applications may be submitted
by foreign and domestic, for-profit and non-profit organizations,
public and private, such as universities, colleges, hospital,
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.

MECHANISMS OF SUPPORT

This RFA will use the National Institutes of Health (NIH) competitive
supplement (S01) mechanism and can supplement the following types of
grants:  R01, R10, R37, P01, P20, P30, P50.  PHS policy prohibits any
foreign institution from applying for a P mechanism.

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 may not exceed the total costs of the prior year of
the parent grant.

RESEARCH OBJECTIVES

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 which best match the patient's/client's needs

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

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

SPECIAL REQUIREMENTS

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

o  Supplemental funds may be used for expenses clearly related and
necessary to conduct the proposed additional services research,
including both direct and allowable indirect costs.

o  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.

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.

LETTER OF INTENT

Prospective applicants are asked to submit, by April 15, 1995, a
letter of intent that includes 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 the RFA in response to
which the application may be submitted.  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 estimate the potential review workload and avoid
conflict of interest in the review.

The letter of intent is to be sent to Dr. Robert F. Prien at the
address listed under INQUIRIES.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these grants.  These forms are available at most
institutional offices of sponsored research and from the Office of
Grants Information, Division of Research Grants, National Institutes
of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892,
telephone 301/435-0714.

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.

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

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

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

Mary Lou Prince
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

Applications must be received by May 5, 1995.  If an application is
received after this date, it will be returned to the applicant
without review.  The Division of Research Grants (DRG) will not
accept any application in response to this RFA that is essentially
the same as one currently pending initial review, unless the
applicant withdraws the pending application.  The DRG will not accept
any application that is essentially the same as one already reviewed.
This does not preclude the submission of substantial revisions of
applications already reviewed, but such applications must include an
introduction addressing the previous critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by DRG
and responsiveness by the NIMH.  Incomplete applications will be
returned to the applicant without further consideration.  If the
application is not responsive to the RFA, DRG staff may contact the
applicant to determine whether to return the application to the
applicant or submit it for review in competition with unsolicited
applications at the next review cycle.  Applications that are
complete and responsive to the RFA will be evaluated for scientific
and technical merit by an appropriate peer review group convened by
the NIMH in accordance with the review criteria stated below.

As part of the initial merit review, a process (triage) may be used
by the initial review group in which applications will be determined
to be competitive or non-competitive based on their scientific merit
relative to other applications received in response to the RFA.
Applications judged to be competitive will be discussed and be
assigned a priority score.  Applications determined to be non-
competitive will be withdrawn from further consideration, and the
Principal Investigator and the official signing for the applicant
organization will be notified.

Review Criteria

o  Ability to 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).

o  Capability to expand and complement an existing parent grant

o  Scientific, technical, or medical significance and originality of
proposed research

o  Appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research

o  Qualifications and research experience of the Principal
Investigator and staff, particularly, but not exclusively, in the
area of the proposed research

o  Availability of the resources necessary to perform the research

o  Appropriateness of the proposed budget and duration in relation to
the proposed research

o  Adequacy 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.

AWARD CRITERIA

Applications recommended for further consideration by the National
Advisory Mental Health Council will be considered for funding on the
basis of overall scientific and technical merit of the proposal as
determined by peer review, appropriateness of budget estimates,
program needs and balance, policy consideration, adequacy of
provisions for the protection of human subjects, and availability of
funds.

Upon completion of the project's period of award made under this RFA,
grantees may submit competitive renewal applications.

INQUIRIES

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

Direct inquiries regarding programmatic issues 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
Email:  rprien@aoamh4.ssw.dhhs.gov

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
Email:  gniedere.aoamh4.ssw.dhhs.gov

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
Email:  pjensen.aoamh4.ssw.dhhs.gov

Kathryn Magruder, Ph.D., M.P.H.
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
Email:  kmagrude.aoamh2.ssw.dhhs.gov

Direct inquiries regarding fiscal matters 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
Email:  dtrunnel.aoamh1.ssw.dhhs.gov

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, a
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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