RESEARCH ON CO-MORBIDITY: ETIOLOGY AND PREVENTION

Release Date:  March 11, 1999

PA NUMBER:  PA-99-071

P.T.

National Institute of Mental Health

THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  THIS PA INCLUDES
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED
WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS PA.

PURPOSE

An abundance of epidemiologic data has established that mental disorders,
substance abuse, and other medical conditions (including HIV disease) are
frequently co-morbid.  Sometimes these disorders co-occur and have equally
devastating impact on an individual, while at other times one disorder is
clearly secondary to another; for example, when depression develops as the
result of a life-threatening physical disease.  The suffering experienced by
individuals as a result, and the cost to the nation in lost productivity and
health expenditures, is magnified well beyond the suffering and costs
associated with individual categories of disorder alone.  While the data in
some areas of co-morbidity are stronger than in others, relatively little is
known about the risk factors that increase the probability of co-morbidity or
the protective factors that decrease its probability.  Even less is known
about the biological, psychosocial, and developmental processes contributing
to co-morbidity.  As a result, research lags on preventive interventions aimed
at modifying these as yet unspecified mediators and moderators to reduce the
incidence and prevalence of the various co-morbid disorders.

The overall purpose of this program announcement is to expand and to refocus
NIMH-supported studies on co-morbid disorders, including, but not limited to,
areas traditionally known as "behavioral medicine" or "health psychology." 
Studies elicited by this announcement should  target the outcomes of co-morbid
mental disorders, substance abuse, and other medical conditions.  In addition,
this announcement calls for research on mechanisms of behavior change that
might be applicable to intervention development across a variety of disorders. 
Finally, the announcement solicits intervention development studies based on
empirical findings about biological, psychological, psychosocial,
developmental, and environmental risk and protective factors and processes
that affect the likelihood of co-occurring or secondary disorders.

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 Program Announcement, Research on
Co-Morbidity: Etiology and Prevention, 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 and foreign, 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.  Foreign institutions are not eligible for
the Small Grant (R03) mechanism.  Racial/ethnic minority individuals, women,
and persons with disabilities are encouraged to apply as principal
investigators.

MECHANISM OF SUPPORT

This PA will use the following research grant mechanisms:  Small Grants (R03),
Exploratory/Developmental Grants (R21), and Research Project Grants (R01). 
The Small Grant (R03) provides two years of funding with a maximum of $50,000
direct costs for each year.  The  Exploratory/Developmental Grant (R21)
provides three years of funding with a maximum of $100,000 direct costs for
each year; it is intended for pilot testing of interventions and other aspects
of intervention development.  The Research Project Grant (R01) provides up to
five years of funding that is commensurate with the science proposed.
Applications requesting $500,000 or more in direct costs for any one year must
be approved by NIMH staff before submission (See APPLICATION PROCEDURES).

Specific application instructions have been modified to reflect the "MODULAR
GRANT APPLICATION AND AWARD" process, which has been adopted by the NIH (see
the NIH Guide, December 15, 1998).

For this PA, funds must be requested in $25,000 direct cost modules.  A
feature of the modular grant is that no escalation is provided for future
years, and all anticipated expenses for all years of the project must be
included within the number of modules being requested.  Only limited budget
information is required and any budget adjustments made by the Initial Review
Group will be in modules of $25,000.

More detailed information about modular grant applications, including a sample
budget narrative justification pages and a sample biographical sketch, is
available via the Internet at:
http://www.nih.gov/grants/funding/modular/modular.htm

RESEARCH OBJECTIVES

Summary

The NIMH encourages studies on the co-occurrence and co-morbidity of mental
disorders, substance abuse, and with other medical conditions.  An important
goal of this program announcement is to identify potent, modifiable risk and
protective factors amenable to intervention, and to translate the results of
such studies into initial tests of theory-driven prevention and early
intervention strategies.  Major emphasis is placed on the identification of
principles motivating and sustaining behavior changes critical to reducing the
risk for co-occurring and secondary regulatory and physical disorders,
especially behavior change that is relevant to more than one disorder. 
Applications for research on behavior change focusing primarily on a single
disease outcome such as cancer or heart disease, for example, should be
submitted to the relevant NIH institute, such as the National Cancer Institute
or the National Heart, Lung, and Blood Institute.

Research applications solicited under this program announcement include, but
are not limited to, studies of:

o  Risk and protective factors and processes that increase or decrease the
likelihood of the co-morbidity of mental disorders, substance abuse, and other
medical conditions, as well as studies of processes which increase resilience
to these disorders.

o  Biological, developmental, behavioral, cognitive, psychosocial, social, and
other environmental factors involved in the initiation and perpetuation of
health-damaging or health-enhancing behavior, including studies of social
support and adaptive coping.

o  Tests of etiological models through experiments that probe the causal role
of risk factors and presumed mediators and moderators of risk.

o  The development and preliminary testing of strategies for intervening with
important risk factors, mediators, and moderators.

o  The development and testing of new intervention technologies and new
methods for assessing preventive effects on co-morbid mental disorders,
substance abuse, and other medical conditions.  This includes the development
and testing of measures and instruments for the accurate assessment of co-
morbid disorders.

o  The impact of treatment for a secondary physical disorder on a primary or
co-occurring mental disorder.

o  The central nervous system as the target of environmental and behavioral
factors that increase or decrease the probability of physical disorder.

o  Studies of the role played by psychological variables (e.g., stress,
personality, learning and conditioning, and psychopathology) in disorder
susceptibility and/or progression, as well as the impact of such variables on
human immune and neuroendocrine system function.

o  The development of models of co-occurring mental disorders, substance
abuse, and other medical conditions that specify the mediators and moderators
responsible for translating risk into co-morbidity over time, or for
protecting from risk over time.

o  The role of sub-clinical symptoms on the development and modulation of co-
morbid disorders.

o  Disorders of behavior critical to maintaining life such as biological
rhythms, reproductive and sexual behavior, and pain.

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 these policies from the program staff
listed under INQUIRIES.  Program staff may also provide additional relevant
information concerning the policy.

APPLICATION PROCEDURES

Applicants are strongly encouraged to contact the program contacts listed
under INQUIRIES with any questions regarding the goals of this PA.

The research grant application form PHS 398 (rev. 4/98) is to be used in
applying for these grants.  Application kits are available at most
institutional offices of sponsored research and 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: [email protected].  Applications are also available on the World
Wide Web at: http://www.nih.gov/grants/forms.htm.

BUDGET INSTRUCTIONS

o  FACE PAGE:  Items 7a and 7b should be completed, indicating Direct Costs
(in $25,000 increments) and Total Costs [Modular Total Direct plus Facilities
and Administrative (F&A) costs] for the initial budget period.  Items 8a and
8b should be completed indicating the Direct and Total Costs for the entire
proposed period of support.

o  DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4
of the PHS 398.  It is not required and will not be accepted with the
application.

o  BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the
categorical budget table on Form Page 5 of the PHS 398.  It is not required
and will not be accepted with the application.

o  NARRATIVE BUDGET JUSTIFICATION - Use a Modular Grant Budget Narrative page.
(See http://www.nih.gov/grants/funding/modular/modular.htm for sample pages.) 
At the top of the page, enter the total direct costs requested for each year.

o  Under Personnel, list key project personnel, including their names, percent 
of effort, and roles on the project. No individual salary information should
be provided.

For Consortium/Contractual costs, provide an estimate of total costs (direct
plus facilities and administrative) for each year, each rounded to the nearest
$1,000. List the individuals/organizations with whom consortium or contractual
arrangements have been made, the percent effort of key personnel, and the role
on the project.  The total cost for a consortium/contractual arrangement is
included in the overall requested modular direct cost amount.

Provide an additional narrative budget justification for any variation in the
number of modules requested.

o  BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by
reviewers in the assessment of each individual's qualifications for a specific
role in the proposed project, as well as to evaluate the overall
qualifications of the research team.  A biographical sketch is required for
all key personnel, following the instructions below.  No more than three pages
may be used for each person.  A sample biographical sketch may be viewed at:
http://www.nih.gov/grants/funding/modular/modular.htm

- Complete the educational block at the top of the form page;
- List current position(s) and then previous positions;
- List selected peer-reviewed publications, with full citations;
- Provide information, including overall goals and responsibilities, on
research projects ongoing or completed during the last three years.

o  OTHER SUPPORT - Form Page 7.  This form must be completed for applications
in response to this PA to allow awards to be negotiated and made on or before
September 30, 1999.

o  CHECKLIST - This page should be completed and submitted with the
application.  If the F&A rate agreement has been established, indicate the
type of agreement and the date. It is important to identify all exclusions
that were used in the calculation of the F&A costs for the initial budget
period and all future budget years.

The applicant should provide the name and phone number of the individual to
contact concerning fiscal and administrative issues if additional information
is necessary following the initial review.

Applications not conforming to these guidelines will be considered
unresponsive to this PA and will be returned without further review.

Applicants planning to submit an investigator-initiated new (type 1),
competing continuation (type 2), competing supplement, or any amended/revised
version of the preceding grant application types requesting $500,000 or more
in direct costs for any year are advised that he or she must contact the
Institute or Center (IC) program staff before submitting the application,
i.e., as plans for the study are being developed.  Furthermore, the
application must obtain agreement from the IC staff that the IC will accept
the application for consideration for award.  Finally, the applicant must
identify, in a cover letter sent with the application, the staff member and
Institute or Center who agreed to accept assignment of the application.

This policy requires an applicant to obtain agreement for acceptance of both
any such application and any such subsequent amendment.  Refer to the NIH
Guide for Grants and Contracts, March 20, 1998 at 
http://www.nih.gov/grants/guide/notice-files/not98-030.html

The title and number of the program announcement must be typed on line 2 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 five signed photocopies in one package 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 assigned on the basis of established PHS referral
guidelines.  Applications will be evaluated for scientific and technical merit
by an appropriate scientific review group convened 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
the 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.  Note that the application
does not need to be strong in all categories to be judged likely to have 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 a field forward.

(1) Significance:  Does this study address an important problem?  If the aims
of the application are achieved, how will scientific knowledge be advanced? 
What will be the effect of these studies on the concepts or methods that drive
this field?

(2) Approach:  Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of the
project?  Does the applicant acknowledge potential problem areas and consider
alternative tactics?

(3) Innovation:  Does the project employ novel concepts, approaches or method?
Are the aims original and innovative?  Does the project challenge existing
paradigms or develop new methodologies or technologies?

(4) Investigator:  Is the investigator appropriately trained and well suited
to carry out this work?  Is the work proposed appropriate to the experience
level of the principal investigator and other researchers (if any)?

(5) 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?

The initial review group will also examine: the appropriateness of proposed
project budget and duration; the adequacy of plans to include both genders,
minorities and their subgroups, and children as appropriate for the scientific
goals of the research and plans for the recruitment and retention of subjects;
the provisions for the protection of human and animal subjects; and the safety
of the research environment.

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:

Peter Muehrer, Ph.D.
Division of Mental Disorders, Behavior, and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6225, MSC 9621
Bethesda, MD  20892-9621
Telephone:  (301) 443-4708
FAX:  (301) 443-4611
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.

The PHS strongly encourages all grant and contract recipients to provide a
smoke-free workplace and promote the non-use 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, and 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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