TRAINING FUTURE MENTAL HEALTH CLINICAL RESEARCHERS

Release Date:  August 25, 1998

RFA:  MH-99-001

P.T.

National Institute of Mental Health

Letter of Intent Receipt Date:  October 12, 1998
Application Receipt Date:  December 10, 1998

PURPOSE

Clinical research is an important part of the mission of the National
Institute of Mental Health (NIMH).  Recent trends, pointing to a decline in
numbers of clinical research applications, are of particular concern in an era
when the rapid growth of knowledge from fundamental research is ripe for
translation to the clinical realm.  Although a variety of measures are being
taken at NIH and NIMH to shore up any future shortfall of clinical
researchers, NIMH intends to tap the creativity in our nation's medical
schools and other research institutions to help solve this problem.  The focus
will be on integrative programs designed to attract, train and retain medical
and graduate students and postdoctoral fellows and clinical residents who wish
to devote their careers to clinical research.  The NIMH intends to solicit
applications from departments such as psychiatry, neuroscience, etc., that
have a record of cutting-edge clinical and basic-clinical research
contributions in mental health fields, thus the capability to propose creative
and innovative new ways to accomplish the objectives of this initiative.

The National Institutes of Health (NIH) defines clinical research as patient-
oriented research, epidemiologic and behavioral studies, and outcomes or
health services research.  However, for the purposes of this award, the NIMH
will use the narrower definition of patient-oriented research; i.e., research
conducted with human subjects (or on material of human origin such as tissues,
specimens, and cognitive phenomena) for which an investigator directly
interacts with human subjects.  This area of research includes the development
of new technologies, mechanisms of human disease, therapeutic interventions
and clinical trials.

NIMH realizes that there are serious obstacles to accomplishing the objectives
of this program.  New physicians are faced with the rather severe demands
placed on them to perform clinical duties.  This reality is compounded by the
difficulties of the NIH funding channels, as well as the real disincentives of
both time and money involved in clinicians devoting their careers to research. 
New Ph.D.s are also challenged by the need to obtain grant support and at the
same time acquire the clinical knowledge to function effectively in
translational research activities.  For these reasons, NIMH intends to invest
significant funds to develop programs that will provide education/training for
a "hybrid" generation of clinical researchers that will have the motivation
and skills to devote significant time and effort to studies of the etiology,
pathophysiology, and treatment of mental illnesses.

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),
Training Future Mental Health Clinical Researchers, 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) from the Superintendent of
Documents, Government Printing Office, Washington, DC 20402-9325 (telephone
202-512-1800).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic, for-profit and non-profit
organizations engaged in health-related education or research, 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 mechanism of support for this RFA is the Mental Health Education Grant
(R25).  This RFA shares many common features with PAR-97-095, which is
available at the following Web site:  http://www.nimh.nih.gov/grants/rtcd.htm

This mechanism provides a flexible approach to develop creative and innovative
new educational/training programs, to help institutions encourage outstanding
young individuals to pursue mental health research and to enhance research and
career skills in critical areas of clinical need.  This program will
complement the NIH-wide Clinical Research Curriculum Award (K30) program (OD-
98-007) by encouraging activities such as curriculum development for didactic
training in methodology in order to produce well-trained, independent,
clinical researchers.  And, although this program could naturally integrate
with existing National Research Service Award (NRSA) training program(s)
within an institution, it should be noted that the NRSA program is governed by
separate and specific regulations.

FUNDS AVAILABLE

One million dollars have been made available to this program in the first
year.  NIMH anticipates funding approximately four to five such unique
programs.  Facilities and administrative costs (formerly known as indirect
costs) may be allowed based on 8% of total direct costs exclusive of tuition
and fees and expenditures for equipment.

Education Grants may be made for three to five years; the length of the grant
period should be consistent with the objectives of the program.  In some
cases, these awards will be made to develop new educational approaches for
which the institution will subsequently assume support. In other cases, the
awards will strengthen ongoing activities that the NIMH will support over
periods of three to five years.  Education Grants are renewable (see
"additional considerations for competitive renewals").  Competitive
supplemental funding requests for program evaluation may be submitted at such
a time when there is significant data accumulated for meaningful statistical
analysis.

RESEARCH OBJECTIVES

This is a special new initiative at NIMH.  Education and training cover large
numbers of activities at medical schools and other institutions of higher
education.  This specific program can best be viewed as part of a larger
"education and training center" at an institution where there exists a
critical mass of outstanding research faculty and students, postdocs and
residents, and where cutting-edge basic and clinical research is a particular
strength.  Therefore, it is expected that any proposed program will take full
advantage of these existing strengths in developing unique activities that are
not mere duplications of ongoing training activities.  Rather, the program
should be utilized to develop new resources and new educational/training
activities that are not covered by other programs, for the purpose of training
or re-training individuals in state-of-the-art clinical research.  A
particularly timely activity would be efforts that foster interactions and
collaborations among basic researchers and clinicians; for example, between
molecular neurobiologists and psychiatrists.

Although the NIMH expects the applicant institutions to propose their own
creative and innovative new programs, following are a few examples of the
types of educational/training activities that might be proposed:

o  A program that will increase the attractiveness of careers in clinical
research, and encourage M.D., Ph.D., or M.D./Ph.D. students and postdoctoral
fellows/residents to embark on research projects more directly applicable to
clinical needs.  As alluded to above, there are real disincentives for highly
trained young individuals to devote their careers to clinical research.  A
successful program should provide incentives in the form of funds, and even
more importantly in the form of specific didactic courses and other
educational/training experiences in clinical research taught by highly
experienced clinical investigators who can also serve as role models.

o  At least part of the effort to recruit, train and retain medical and
graduate students into clinical research could initially entail providing
research funds and later "seed" money for those postdoctoral fellows and
residents who wish to continue clinical research after the training period.
For example, students may be supported to take a year off from
medical/graduate school to engage in ongoing clinical research at the
institution.  Seed money may be provided for research proposals from
outstanding young physicians or postdoctoral fellows to pursue promising new
clinical or basic-clinical research leads under the supervision of a mentor.

o  A critically important aspect of such a program must by necessity be its
ability to attract outstanding clinical and basic-clinical investigators to
devote more time and effort to mentoring medical and graduate students and
post-doctoral fellows and residents.  This point can not be overemphasized,
given the recent decline in qualified mentors committing their time and effort
to train clinical researchers.  Thus, the success of the program might well
hinge upon mentors who can serve as role models for both clinical and
integrative basic-clinical research.

Activities Supported:

Potential applicants are strongly encouraged to contact appropriate NIMH staff
listed under INQUIRIES to ascertain whether or not their application meets the
program priorities of the NIMH.  As the intent of this initiative is to train
the clinical researchers of the future, the NIMH is seeking applications for
programs that are characterized by innovation and cutting-edge clinical
research.

Support for educational activities may include courses, seminars, short or
long-term research experiences (e.g., 1-2 years educational and research
experiences that foster exchanges between basic and clinical neuroscience),
curriculum development or the design, implementation, and evaluation of the
educational/training program.  Examples of programs that would be desirable
include, but are not limited to, the following:

o  Mentored clinical research opportunities designed specifically for students
enrolled in graduate or medical school degree programs and postdoctoral
fellows and clinical residents.

o  Clinical research career enhancement opportunities for young scientists
(M.D., Ph.D., or M.D./Ph.D.) at the intersection of basic and clinical
research.

o  Courses or seminars designed to increase awareness about ethical issues
surrounding clinical research.

o  Courses or seminars to address issues of relevance to women and
underrepresented minorities in clinical research.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

For research projects 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 has been published in the Federal Register of March 28,1994
(FR 59 14508-14513), and in the NIH GUIDE FOR GRANTS AND CONTRACTS of March
18, 1994, Vol. 23, No 11.  It is also available electronically at
https://grants.nih.gov/grants/guide/notice-files/not94-100.html

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.

NIH POLICY AND GUIDELINES ON THE 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
NIH, unless there are scientific and ethical reasons not to include them. This
policy applies to all applications submitted in response to this Program
Announcement.  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: https://grants.nih.gov/grants/guide/notice-files/not98-024.html


LETTER OF INTENT

Prospective applicants are asked to submit, by October 12, a letter of intent
that includes a descriptive title of the proposed education program, the name,
address, and telephone number of the Program Director, 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 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.
Henry Khachaturian at the address listed under INQUIRIES.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev.
5/95).  Applications 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,
Email:  GrantsInfo@nih.gov.

Applicants must use the forms for regular research grants and follow the
specific instructions on pages 6-20 in the PHS 398 application kit, with the
exceptions listed below.  As in the standard PHS 398 instructions, sections
A-D of the Research Plan in R25 applications are limited to 25 pages.

NOTE:  Applications that do not conform to the specific instructions detailed
below will be returned without review.

Specific Instructions for R25 Applications

1. Application face page: item number two on this page must include the
program announcement number and the title, "Training the Next Generation of
Mental Health researchers."

2. Resources (Form page 8): describe the educational/training environment;
include a description of the facilities, laboratories, participating
departments, computer services, and any other resources to be used in the
conduct of the proposed program.  Use continuation pages, as necessary.

3. Research Plan: part C of this section should be re-titled "Preliminary Data
and Activities" and included if applicable.  This section should contain
information on steps that have led to the proposed program. A section entitled
"Progress Report" is required for competing continuation and supplemental
applications.

4. Research Plan: part D of this section should be re-titled
"Education/Training Program Plan" and should contain material organized under
the following subheadings, as appropriate to the specific project:

a) Program Direction - describe arrangements for administration of the
program; provide evidence that the Program Director is actively engaged in
clinical or basic-clinical research and mentoring in an area related to mental
health, and can organize and administer the program, as well as evidence of
institutional commitment and support for the proposed program.

b) Program Faculty/Staff - describe the characteristics and responsibilities
of the faculty; provide evidence that participating faculty and preceptors are
actively engaged in clinical or basic-clinical research activities related to
mental health.

c) Proposed Program - provide programmatic detail on the special activities
proposed (e.g., courses, curricula), including description of plans to provide
education/training to participants regarding the responsible conduct of
research.

d) Program Participants - provide detail about the proposed participants;
include a description of plans for recruiting as participants individuals from
underrepresented racial/ethnic groups.

e) Evaluation Plan - include provisions for an evaluation plan to determine
the success of the program in achieving its goals and objectives.  Although
supplemental funds may be requested at a future date for detailed evaluation,
no application will be funded without an evaluation plan.

5. Research Plan: if applicable, under part H of this section,
"Consortium/Contractual Arrangements," include a description of plans for
collaborating with other institutions for purposes of exchange and sharing of
resources, including faculty, equipment, and facilities.

Allowable Costs

Allowable costs must be consistent with PHS policy and be reasonable,
allocable, and well documented and justified for the proposed program:

Personnel costs - faculty members participating in the design and
implementation of the program may request salary and fringe benefits
appropriate for the percent of time devoted to the program.  Salaries
requested may not exceed the levels commensurate with the institution's policy
for similar positions.  (Mentoring of, and routine interactions and activities
with students are considered a regular part of a faculty member's academic
duties and are non-reimbursable).

Administrative and clerical salary costs associated with the program may be
direct charges to the grant only when specifically identified and justified as
reflecting significantly greater effort than the level of such services
routinely provided by academic departments.  Requests for consultant costs,
equipment, supplies, travel (including foreign travel for uniquely qualified
foreign faculty), and other project related expenses must be justified as
specifically required by the program proposed and not duplicate items
generally available at the institution for other educational/training 
programs.

Attendance - participants in the program may receive subsistence allowance,
which includes costs of meals and lodging (unless furnished as part of the fee
for registration).  They may also receive partial tuition, other
education-related, and travel expenses, including foreign travel, if strongly
justified.

An original and five legible copies of the completed and signed application
are to 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 express/courier service)

REVIEW CONSIDERATIONS

Applications will be reviewed for completeness by the Center for Scientific
Review (CSR) and for responsiveness by NIMH.  Applications that are complete
and responsive 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 well as specific review criteria
stated in this RFA.  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 National Advisory Mental
Health Council.

Review Criteria

The goals of NIH supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. The
reviewers will comment on the following aspects of the application in their
written critiques in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals.  Each of the
criteria below will be addressed and considered by the reviewers in assigning
the overall score weighing them as appropriate for each application.  Note
that the application does not need to be strong in all categories to be judged
likely to have a major scientific impact and thus deserve a high priority
score.  For example, an investigator may propose to carry out important work
that by its nature is not innovative but is essential to move the field
forward.

(1) Significance: The degree to which the proposed program addresses issues
that are of great importance to the NIMH; the program must demonstrate how its
achievements will advance the objectives of this RFA as well as the overall
mission of NIMH.

(2) Approach: The proposed specialized curriculum must be appropriate and
adequate to augment the objectives and goals outlined above.  Course
requirements and sequence, and timetable for completing the planned activities
must be presented.  A plan for evaluating the effectiveness of the program in
achieving its objectives must be specified.

(3) Innovation: The curriculum must include original and unique approaches or
methods for addressing the needs put forth in the goals and objectives.  Plans
to challenge existing paradigms or develop new approaches or techniques must
be described.

(4) Investigator: The program leadership must demonstrate outstanding record
of achievements and qualifications appropriate to meeting the proposed goals
and implementing the stated plan.

(5) Environment:  The scientific/educational/training environment must be
described, indicating the unique features and probability of success of the
program.  Institutional commitment to the proposed program must be documented.

(6) Budget: Justifications must be provided for each budgeted item and for
each year of support that is requested.

Additional considerations for competitive renewals:

Applicants seeking a continuation of support will be evaluated by peer
reviewers in terms of the progress reported from prior support, the viability
of the proposed program extension, and continuing need for the proposed
program activities.

Schedule

Letter of Intent Receipt Date:  October 12, 1998
Application Receipt Date:       December 10, 1998
Review Meeting:                 February/March 1999
NIMH Council Meeting:           May 1999
Earliest Possible Start Date:   September 1, 1999

AWARD CRITERIA

Applications will compete for available funds with all other approved
applications assigned to NIMH in response to this RFA.  However, although $1
million have been earmarked for this program, only highly meritorious
applications will be considered for funding.  The following will be considered
in making funding decisions: innovativeness, novelty, and quality of the
application as determined by peer review, program priority, length of proposed
program, balance among types of grants supported by NIMH, and ultimately
availability of funds.

INQUIRIES

Applicants are strongly encouraged to contact NIMH staff for technical
assistance and information concerning current program priorities before
applying for an award.  For information about NIMH policy on training,
contact:

Henry Khachaturian, Ph.D.
Office of Science Policy and Program Planning
Telephone:  (301) 443-4335
FAX:  (301) 443-3225
Email:  hk11b@nih.gov

For information on specific program priorities and application information,
contact:

Walter Goldschmidts, Ph.D.
Division of Basic and Clinical Neuroscience Research
Telephone:  (301) 443-3563
FAX:  (301) 443-1731
Email:  wg8u@nih.gov

Fred Altman, Ph.D.
Division of Mental Disorders, Behavioral Research and AIDS
Telephone:  (301) 443-6100
FAX:  (301) 443-6000
Email:  fa2w@nih.gov

Kenneth G. Lutterman, Ph.D.
Division of Services and Intervention Research
Telephone:  (301) 443-3373
FAX:  (301) 443-4045
Email:  kl21o@nih.gov

Direct inquiries regarding fiscal matters to:

Diana S. Trunnell
Grants Management Branch
Telephone:  (301) 443-2805
FAX:  (301) 443-6885
Email:  diana_trunnell@nih.gov

The mailing address for NIMH is:

National Institute of Mental Health
5600 Fishers Lane
Rockville, MD  20857

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 PHS grants policy as
stated in the Public Health Service Grants Policy Statement (April 1, 1994).

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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