NEURAL, ENDOCRINE, IMMUNE, AND VIRAL INTERACTIONS, BEHAVIOR, ANDMENTAL HEALTH



NIH GUIDE, Volume 21, Number 38, October 23, 1992



PA NUMBER:  PA-93-009



P.T. 34



Keywords:

  Neuroscience 

  Immunology 

  Endocrine System 

  Viral Studies (Virology) 



National Institute of Mental Health

National Institute of Neurological Disorders and Stroke



PURPOSE



The National Institute of Mental Health (NIMH) and the National

Institute of Neurological Disorders and Stroke (NINDS) invite

research grant applications for studies of neuro-endocrine-immune

interactions, neuroimmunomodulation, psychoneuroimmunology, and the

effects of viral and other infectious challenges on such

interactions.  Applications are also invited for studies of the

health and treatment implications of such interactions.  The goal of

this program announcement is to promote research which will advance

understanding of how the brain influences, and is influenced by, the

various systems that maintain homeostasis and defend/repair the

body's tissues.  This research will increase knowledge of the

interrelationships between psychological states and physical health.

Research is encouraged to improve behavioral and medical outcomes by

the application of knowledge about neuro-endocrine-immune

interactions.

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, Neural, Endocrine, Immune, and Viral Interactions,

Behavior, and Mental Health, is related to the priority areas of

mental health and mental disorders, HIV infection, and immunization

and infectious diseases.  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 202-783-3228).



ELIGIBILITY REQUIREMENTS



Applications may be submitted by domestic, public and private, non-

profit and for-profit organizations such as universities, colleges,

hospitals, laboratories, research institutions, units of State and

local governments, and eligible agencies of the Federal Government.

Foreign organizations may apply for traditional research (R01) and

small (R03) grants only.  Women and minority investigators are

encouraged to apply.



MECHANISMS OF SUPPORT



Applications are requested under the following mechanisms:

traditional research grants (R01), First Independent Research Support

and Transition (FIRST) awards (R29), small grants (R03) program

projects (P01), career development awards (K-series), institutional

training grants (T32), and individual fellowships (F-series).



RESEARCH OBJECTIVES



Proposed research can be directed at any level of biological

organization from molecular to organismic.  However, at whatever

level studies are directed, applications must contain well-developed

research plans addressing questions of clear and direct biological

relevance.  Specifically, proposed in vitro experiments should

ideally seek mechanistic explanations for well-documented in vivo

phenomena or should be carried out in conjunction with in vivo

experiments.  Applications solely based on the use of cell lines

should be justified by inability to realize research objectives in

vivo or by using primary cell or organ cultures.



Support is also provided for studies aimed at improving available

methods for investigating the areas covered by this announcement.

The following are examples of broad research topics that would be of

interest.  This list is not intended to be comprehensive, nor are the

examples meant to be exclusive.



o  Mechanisms mediating functional interactions among the nervous,

endocrine, and immune systems



o  Innervation of immune and endocrine organs and the functions

accomplished by the innervating cell



o  Mechanisms involved in the conditioning of immune responses



o  Temporal and spatial distribution of immunocytes in brains of

normal and ill individuals



o  Effects of cytokines and other products of immunocytes on neural

cell function; expression and function of cytokines in the nervous

system



o  Impact of immune deficiencies on function of the central nervous

system and susceptibility to mental illness



o  Central neural circuitry and mechanisms of secretion of hormones

which cooperate in the regulation of the immune response



o  Identification and characterization of molecules coordinating

regulation of neuroendocrine and immune systems



o  Characterization of pathways of viral entry into the central

nervous system and roles of neural and non- neural cells in this

process



o  Roles of the blood-brain-barrier in impeding/facilitating

brain-immunocyte-virus interactions



o  Mechanisms of viral neuropathogenesis; regional specificity;

tropism for neural cells; replication and latency of slow-acting

viruses such as HIV and other lentiviruses; effects on neuronal

function and their mechanisms



o  Characterization of viral effects on psycho-neuro-

endocrine-immune interactions



o  Use of transgenic, immunodeficient, and other mutant animals to

investigate neuro-endocrine-immune interactions



o  Applications of novel techniques, such as in situ polymerase chain

reaction and homologous recombination, to investigate immune and

viral bases of mental disorders



o  Characterization of the effects of various mental states (e.g.,

stress and coping, sleep, intellectual activity, meditation) on

endocrine and immune function and on health outcomes



o  Characterization of immune effects on psychological states and

behavior



SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH

POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL

RESEARCH STUDY POPULATIONS



NIH policy is that applicants for NIH clinical research grants and

cooperative agreements are required to include minorities and women

in study populations so that research findings can be of benefit to

all persons at risk of the disease, disorder or condition under

study; special emphasis must be placed on the need for inclusion of

minorities and women in studies of diseases, disorders and conditions

which disproportionately affects them.  This policy is intended to

apply to males and females of all ages.  If women or minorities are

excluded or inadequately represented in clinical research,

particularly in proposed population-based studies, a clear compelling

rationale must be provided.



The composition of the proposed study population must be described in

terms of gender and racial/ethnic group.  In  addition, gender and

racial/ethnic issues should be addressed in developing a research

design and sample size appropriate for the scientific objectives of

the study.  This information must be included in the form PHS 398 in

Sections 1-4 of the Research Plan AND summarized in Section 5, Human

Subjects.  Applicants are urged to  assess carefully the feasibility

of including the broadest possible representation of minority groups.

However, NIH recognizes that it may not be feasible or appropriate in

all research projects to include representation of the full array of

United States racial/ethnic minority populations (i.e., Native

Americans (including American Indians or Alaskan natives),

Asian/Pacific Islanders, Blacks, Hispanics).  The rationale for

studies on single minority population groups must provided.



For the purpose of this policy, clinical research is defined as human

biomedical and behavioral studies of etiology, epidemiology,

prevention (and preventive strategies), diagnosis, or treatment of

diseases, disorders or conditions, including but not limited to

clinical trials.



The usual NIH polices concerning research on human subjects also

apply.  Basic research or clinical studies in which human tissues

cannot be identified or linked to individuals are excluded.  However,

every effort should be made to include human tissues from women and

racial/ethnic minorities when it is important to apply the results of

the study broadly, and this should be addressed by applicants.



For foreign awards, the policy  on inclusion of women applies fully;

since the definition of minority differs in other countries, the

application must discuss the relevance of research involving foreign

population groups to the United States' populations, including

minorities.



If the required information is not contained within the application,

the review will be deferred until the information is provided.



Peer reviewers will address specifically whether the research plan in

the application conforms to these polices.  If the representation of

women or minorities in a study design is inadequate to answer the

scientific question(s) addressed AND the justification for the

selected study population is inadequate, it will be considered a

scientific weakness or deficiency in the study design and will be

reflected in assigning the priority score to the application.



All applications for clinical research submitted to NIH are required

to address these policies.  NIH funding components will not award

grants or cooperative agreements that do not comply with these

policies.



APPLICATION PROCEDURES



Application submission should follow the PHS review and award

schedule as published in the current version of Instructions for

Grant Application Form PHS 398 (rev. 9/91).



Dates for the submission of new research applications (R01, R29, R03,

P01, and K-series) and review cycles are as follows:



Receipt           IRG         Council     Earliest

Dates             Review      Review      Award Dates



Feb 1/Mar 1*      May/June    Sep/Oct     Dec 1

Jun 1/Jul 1*      Oct/Nov     Jan/Feb     Apr 1

Oct 1/Nov 1*      Feb/Mar     May/Jun     Jul 1



*Amended research applications, supplemental applications and

competing renewals are to be submitted on the latter dates.



Applications received after the above receipt dates are subject to

assignment to the next review cycle or may be returned to the

applicant.



Because institutional training grants (T32) and individual fellowship

applications (F-series) have different deadlines and application

procedures, applicants should contact program staff listed on page 8

and obtain necessary documentation pertaining to those mechanisms.



Applicants are to use the grant application form PHS 398 (rev. 9/91)

for all grants except the F-series for which form PHS 416-1 (rev.

10/91) is to be used.  The number and title of the program

announcement, "PA-93-009: Neural, Endocrine, Immune, and Viral

Interactions, Behavior, and Mental Health," must be typed in item

number 2a on the face page of the PHS 398 application form.



Application kits containing the necessary forms and instructions for

regular research grants may be obtained from business offices or

offices of sponsored research at most universities, colleges, medical

schools, and other major research facilities.  If such a source is

not available, the program officials listed under INQUIRIES may be

contacted for the necessary application material.



The signed original and five legible copies of the completed

application form PHS 398 or two copies of the form PHS 416-1 (rev.

10/91) must be sent to:



Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892**



REVIEW PROCEDURES



The Division of Research Grants (DRG), NIH, serves as a central point

of receipt of applications for most discretionary PHS grant programs.

Interest areas indicated in this announcement overlap with those of

other Institutes, so applications received under this announcement

will be assigned to an initial review group (IRG) in accordance with

established PHS Referral Guidelines.



The IRGs, consisting primarily of non-Federal scientific and

technical experts, will review the applications for scientific and

technical merit.  Notification of the review recommendations will be

sent to the applicant after the initial review.  Applications will

receive a second-level review by the appropriate Advisory Council

whose review may be based on policy considerations as well as

scientific merit.  Only applications recommended for approval by the

Council may be considered for funding.



AWARD CRITERIA



Criteria for scientific/technical merit review of applications will

include the following: significance and originality, from a

scientific or technical standpoint, of the goals for the proposed

research; 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.



Applications recommended for approval by the appropriate National

Advisory Council will be considered for funding on the basis of

overall scientific and technical merit of the research as determined

by peer review, Institute program needs and balance, and availability

of funds.



Grant funds may be used for expenses clearly related and necessary to

conduct research projects, including both direct costs which can be

specifically identified with the project and allowable indirect costs

of the institution.  Funds may not be used to establish, add a

component to, or operate a treatment, rehabilitation, or prevention

intervention service program.  Support for research-related

treatment, rehabilitation, or prevention services and programs may be

requested only for costs required by the research.  These costs must

be justified in terms of research objectives, methods, and designs

which promise to yield generalizable knowledge and/or make a

significant contribution to theoretical concepts.



Grants must be administered in accordance with the PHS Grants Policy

Statement (rev. 10/90), which should be available from an office of

sponsored research.  Federal regulations at 42 CFR Part 52, Grants

for Research Projects, and Title 45 CFR Parts 74 and 92, generic

requirements concerning the administration of grants, are applicable

to these awards.



Support may be requested for a period of up to five years. The small

grants (R03) are for up to two years and are non- renewable.  The

period of individual fellowships may not exceed five years in the

aggregate for pre-doctoral training and three years in the aggregate

for post-doctoral training.  Annual awards will be made subject to

continued availability of funds and progress achieved.  A competing

supplemental application may be submitted during an approved period

of support to expand the scope or protocol of a project during the

approved period.  A competing continuation (i.e., renewal)

application may be submitted before the end of an approved period of

support to continue a project.



INQUIRIES



Written and telephone inquiries are encouraged.  The opportunity to

clarify any issues or questions from potential applicants is welcome.



Direct inquiries regarding programmatic issues to:



Ljubisa Vitkovic, Ph.D.

Chief, Neuroimmunology/Neurovirology Program

Division of Neuroscience and Behavioral Science

National Institute of Mental Health

5600 Fishers Lane, Room 11C-05

Rockville, MD  20857

Telephone:  (301) 443-5288

FAX:  (301) 443-4822

BITNET:  LV5@NIHCU



N. Herbert Spector, Ph.D.

Division of Fundamental Neurosciences

National Institute of Neurological Disorders and Stroke

Federal Building, Room 916

7550 Wisconsin Avenue

Bethesda, MD  20892

Telephone:  (301) 496-5745

FAX:  (301) 402-1501



For further information on grants management issues, applicants may

contact:



Diana Trunnell

Assistant Chief, Grants Management Branch

National Institute of Mental Health

5600 Fishers Lane, Room 7C-23

Rockville, MD  20857

Telephone:  (301) 443-3065



Mary Whitehead

Chief, Grants Management Branch

National Institute of Neurological Disorders and Stroke

Federal Building, Room 1004

Bethesda, MD  20892

Telephone:  (301) 496-9231



AUTHORITY AND REGULATION



This program is described in the Catalog of Federal Domestic

Assistance No. 93.242 and 93.853.  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

385) 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.



.

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