kristoff@GENBANK.BIO.NET (Dave Kristofferson) (03/09/91)
$$XID RFA MH9105 MH-91-05 P1O1 *****************************************
SHORT-TERM GRANTS FOR TRAINING MEDICAL STUDENTS IN THE
DIAGNOSIS AND TREATMENT OF DEPRESSIVE DISORDERS
RFA: MH-91-05
P.T. 34; K.W. 0720005, 0715072, 0745020, 0745060, 0745070
National Institute of Mental Health
Letter of Intent Receipt Date: May 1, 1991
Application Receipt Date: May 22, 1991
(Catalog of Federal Domestic Assistance 93.244)
Under the authority of Section 303 of the Public Health
Service Act, U.S.C. 242a; 42 CFR, Part 64, the National
Institute of Mental Health will accept applications for
short-term grants to provide training to medical
students in the diagnosis and treatment of depressive
disorders under the single receipt date of May 22,
1991.
Darrel A. Regier, M.D., M.P.H.
Director
Division of Clinical Research
Alan I. Leshner, Ph.D.
Acting Director
National Institute of Mental Health
INTRODUCTION
Serious depressive disorders are a major public health
problem in the United States. Because of the existence
of effective psychological and pharmacological
treatments, which are often used in combination, most
people with depressive disorders can be successfully
treated. Evidence suggests, however, that clinical
depression is all too frequently poorly recognized and
underdiagnosed, with resulting undertreatment.
Although more than half of all clinically depressed
patients are initially seen in the general medical
system, their symptoms are frequently not diagnosed as
a depressive syndrome and, thus, they are not likely to
receive the proper treatment.
The National Institute of Mental Health (NIMH) has
developed the Depression Awareness, Recognition, and
Treatment (D/ART) program to provide the most up-to-
date research knowledge to the general public, primary
care providers, and mental health specialists.
This grant program is responsive to the need for
addressing the special issues relating to the diagnosis
and treatment of clinical depression in a medical
setting as well as to the need for training greater
numbers of primary care physicians at early stages of
their professional development.
PURPOSE
As part of the D/ART program, NIMH seeks applications
from medical schools to develop and implement training
of pre-doctoral medical students in the diagnosis and
treatment of clinical depression according to a basic
curriculum presented in this request for application.
Support is available for the detailed development of
this curriculum, its implementation, and evaluation of
its educational effectiveness and impact. The goal of
the training is to prepare medical students to deal
with depressive disorders (including major depression
and bipolar disorder) as these disorders appear in
medical settings. It is not designed to provide
specialty training for psychiatric residents.
ELIGIBILITY
Applications may be submitted by accredited schools of
medicine and osteopathy. There is special interest in
applications submitted by departments of family
medicine, internal medicine, obstetrics and gynecology,
and other nonpsychiatric specialties.
APPLICATIONS CHARACTERISTICS
The applicant should provide:
o a description of the applying entity, its
relevant personnel, and its training
resources
o a conceptualization of the training program,
including its goals and objectives
o a detailed description of the proposed
training program, including the curriculum
which must include, but need not be limited
to the following elements:
1) Epidemiology and Overview of Depression, including
issues of prevalence and incidence, drawing data from
the NIMH Epidemiological Catchment Area Study; risk
factors; disability of clinical depression relative to
chronic medical illness; etiology; and accessibility to
medical treatment of clinical depression
2) Diagnosis and Assessment, including the major
categories of depression in DSM-III R (or subsequent
revisions); overview of major screening instruments for
depression; impact of patient and physician attitudes
on diagnosis (and treatment); and determining severity
of depression
3) Depression within a Medical Setting, including
disability from depression; depression presenting with
somatic symptoms, depression comorbid with alcohol and
substance abuse, depression secondary to medical
disorder; medication-induced depression; the primary
physician's role in diagnosis and treatment of clinical
depression; issues of relapse, recurrence and
chronicity; referral and relationships with other
practitioners; and dealing with suicidality
4) Biological Treatments of Depression, including
pharmacologic treatments, their indications for use,
relative efficacy and side effects, and use in
combination; ECT, light therapy, sleep deprivation
5) Psychosocial Aspects of Depression, including the
psychosocial context in which clinical depression
occurs; the impact on the family; the role and
effectiveness of short-term psychotherapies
(specifically cognitive and interpersonal therapy); the
relative effectiveness of psychosocial therapies; and
the use of pharmacological and psychosocial treatments
in combination
6) Special Issues, including depression in the
elderly, adolescents, the chronically ill, and other
groups of concern.
The applicant should also provide:
o for each component of the curriculum, a
description of the content to be addressed,
the teaching materials to be used, the
proposed faculty, the time frames to be
allotted to each training module, and the
teaching methods to be used
o a detailed description of how the curriculum
will be implemented
o the proposed number and level of students to
be trained
TERMS AND CONDITIONS OF SUPPORT
The mechanism of support for these awards will be the
Continuing Education Grants (T15).
Period of Support
The period of support is 1 year.
Average Size of Award
It is expected that up to 10 awards will be made, each
award not to exceed $15,000 total (direct and indirect)
costs per award. Funds made available under this grant
may not be used to supplement existing training or
other support for such training.
Direct Costs
Grants described in this announcement are awarded
directly to eligible applicants. Direct cost items are
allowable for teaching costs associated with this
program. They include personnel, consultants,
materials, supplies, reproduction and printing costs,
rental equipment, minor equipment items, and other
items which are directly related to the proposed
training program and are otherwise unavailable from the
institution. Funds are not available for tuition or
other subsidies of medical students. Funds may be used
only for those expenses which are directly related and
necessary to carry out the project and must be expended
in conformance with DHHS cost principles, the Public
Health Service Grants Policy Statement,* and conditions
set forth in this document. Regulations at 42 CFR Part
242 A are applicable to this awards.
* Public Health Service Grants Policy Statement, DHHS
Publication No. (OASH) 90-50,000 (rev. 10/1/90)
APPLICATIONS PROCEDURES
It is suggested that those who apply send a brief
letter of their intention to Harold Goldstein, Ph.D.,
Director of Training, D/ART. Dr. Goldstein is also
available for consultation on program development. A
letter of intent is not binding, nor a
necessary requirement of applications but is useful in
planning the review of applications. This letter
should be received by May 1, 1991 at the address below.
Preparation of the application may proceed
simultaneously.
For questions of eligibility, fiscal and administrative matters
and for assistance in
developing applications, prospective applicants should
consult:
Harold Goldstein, Ph.D.
Director of Training
Prevention Research Branch
Division of Clinical Research
National Institute of Mental Health
Parklawn Building, Room 14C-02
5600 Fishers Lane
Rockville, MD 20857
Telephone: (301) 443-4140
Applicants should use the grant application kit (PHS
398, revised 10/88) available from the Prevention
Research Branch, Rm 14C-02, Parklawn Bldg., 5600
Fishers Lane, Rockville, MD 20857, (301) 443-4140.
To identify this application as a response to an RFA,
check 'yes' on item 2 page one of the PHS 398 form.
Also enter in item 2 the number and shortened title of
this RFA (MH-91-05, Short-Term Grants for Training
Medical Students in the Diagnosis and Treatment of
Depressive Disorders). THE RFA LABEL FOUND ON THE PHS
KIT MUST BE AFFIXED TO THE BOTTOM OF THE FACE PAGE OF
THE ORIGINAL COMPLETED APPLICATION FORM. FAILURE TO
USE THIS LABEL COULD RESULT IN DELAYED PROCESSING OF
YOUR APPLICATION SUCH THAT IT MAY NOT REACH THE REVIEW
COMMITTEE IN TIME FOR REVIEW.
Applications must be complete and contain all
information needed for initial and Advisory Council
review. No addenda will be accepted later unless
specifically requested by the Executive Secretary of
the review committee. No site visits will be made.
The applicant should include a project abstract which
should not exceed two single-spaced typewritten pages.
The narrative section of the application should not
exceed 20 pages; appendices may not be used
inappropriately to expand the narrative section.
Applications exceeding this limitation will be
returned.
The original and five copies of the application must
be submitted to:
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD 20892**
One additional copy of the application must be
submitted directly to:
NIMH Division of Extramural Activities
Parklawn Building, Room 9C-15
5600 Fishers Lane
Rockville, MD 20857
Attention: Mrs. Edna Hardy-Hill
REVIEW
Review Procedures
A dual review system is used to insure knowledgeable,
objective review of the quality of applications.
Initial peer review for scientific, educational, and/or
technical merit is by groups of non-Federal experts
called Initial Review Groups. Final review is by the
National Advisory Mental Health Council.
Applications submitted in response to this announcement
are not subject to the intergovernmental review
requirements of Executive Order 12372 as implemented through DHHS
regulations at 45 CFR Part 100.
Review Criteria
Each grant application is evaluated on its own merits
and will be reviewed according to the following
criteria:
o experience in education on mental disorder
issues
o compliance with the requested application
characteristics
o appropriateness and feasibility of the
content, methods and organization of the
project to specified project goals and
objectives
o quality of the proposed program evaluation
o quality of the resources of the applying
organization
o qualifications of the program director and
other staff
o number and range of students to be trained,
especially the minorities and women
RECEIPT AND REVIEW SCHEDULE
National Advisory
Receipt of Initial Mental Health Earliest
Application Review Council Review Start Date
May 22, 1991 July 1991 September 1991 September 1991
Applications submitted after the receipt date will be
returned to the applicant without review.
AWARD CRITERIA
The responsibility for award decisions on applications
recommended for approval by the National Advisory
Mental Health Council lies solely with authorized NIMH
program staff. The basic criteria to be used in making
award decisions will be the quality of the proposed
project as determined during the review process and the
availability of funds.
$$XID RFA MH9104 MH-91-04 P1O1 *****************************************
SHORT-TERM CLINICAL TRAINING GRANTS
IN DIAGNOSIS AND TREATMENT OF DEPRESSIVE DISORDERS
RFA: MH-91-04
P.T. 34; K.W. 0720005, 0715072, 0745020, 0745060, 0745070
National Institute of Mental Health
Letter of Intent Receipt Date: May 1, 1991
Application Receipt Date: May 22, 1991
(Catalog of Federal Domestic Assistance 93.244)
Under the authority of Section 303, of the Public
Health Service Act, U.S.C. 242a; 42 CFR, Part 64, the
National Institute of Mental Health will accept
applications for short term clinical training grants in
diagnosis and treatment of clinical depression under
the single receipt date of May 22, 1991.
Darrel A. Regier, M.D., M.P.H.
Director
Division of Clinical Research
Alan I. Leshner, Ph.D.
Acting Director
National Institute of Mental Health
BACKGROUND
Serious depressive disorders are a major public health
problem in the United States. Because of the existence
of effective psychological and pharmacological
treatments, which are often most effective when used in
combination, most people with depressive disorders can
be successfully treated. Evidence suggests, however,
that depression is poorly recognized, undertreated, or
incorrectly treated in the health and mental health
system. The National Institute of Mental Health (NIMH)
developed the Depression Awareness, Recognition and
Treatment (D/ART) program to provide the most up-to-
date research information on depressive disorders to
the general public, primary care providers, and mental
health specialists.
PURPOSE
As part of the D/ART program, NIMH seeks applications
for programs of short-term (not to exceed 5-days
duration) continuing education. Each program will be
carried out at multiple locations (minimum of six
different sites per year) and will provide continuing
education for primary care providers and mental health
professionals. Support is available for the
development, implementation, and evaluation of training
programs that are designed to foster the more effective
recognition, diagnosis, and treatment of major
depressive disorders, including manic depression and
clinical depression. This initiative is intended to
provide for the development of effective training that
is directly tied to major recent research findings and
clinical knowledge and which incorporates both didactic
and experiential modes of teaching; it is not, however,
designed to test training models. The focus is on
training providers to more effectively diagnose and
treat clinical depression in adults and adolescents;
childhood depression does not fall within the scope of
this announcement.
The training is intended to give primary care providers
and mental health professionals with a didactic and
experiential program that will increase their capacity
to recognize, diagnose, and treat clinical depression
effectively, in a manner appropriate to their
discipline. Training must include recent major
research findings on psychosocial and pharmacological
aspects of treatment. Priority in funding will be
given to approved applications from geographic areas,
particularly rural, which have not yet been served by
D/ART grants.
ELIGIBILITY
Applications may be submitted by:
o a department of psychiatry in, or associated
with, a school of medicine, or a free-
standing mental health institution with an
approved psychiatric residency program
o a university-based department of psychology
offering doctoral training in clinical
psychology, or a school of professional
psychology with appropriate accreditation for
doctoral training in clinical psychology
o a college or university school of nursing
which offers a graduate program in
psychiatric nursing
o a school of social work with a graduate
program
All applicants must have experience and demonstrated
capacity in the provision of continuing education tied
to research on depressive disorders and must use
multidisciplinary teams of trainers.
AREAS OF INTEREST
NIMH particularly encourages applications for programs
which contain the following:
o a focus in part of the curriculum on such
special populations as the aged, adolescents,
women, and minorities which include, but are
not limited to, Blacks, Hispanics, American
Indians, Alaskan Natives, and Native
Hawaiians.
o A coherent plan for training staff of
Employee Assistance Programs (EAP).
o a coherent plan to address issues of co-
morbidity and depression.
APPLICATION CHARACTERISTICS
The applicant must provide:
o a description of the applying entity, its
relevant personnel, its training resources,
and its prior experience in the provision of
continuing education in the area of clinical
depression
o the rationale underlying the
conceptualization of the training
program,including specific assumptions,
goals, and objectives
o a concise review and critical assessment of
the most up-to-date research in clinical
depression and a discussion of how the
research will be incorporated into the
training program
o the concepts of depressive disorders on which
the training program is to be based
o a detailed description of the proposed
training program, including proposed
curriculum, which contains the following
elements:
1) a balanced approach to psychosocial and
biological aspects of depression
2) didactic components, i.e., lectures and
formal presentations which include
research and clinical knowledge to be
developed to provide students with the
context for better diagnoses and
treatment of depressive disorders
3) selection and development of the
experiential components in which the
students will be directly involved
4) explanation of how the integration of
the didactic and experiential components
will provide students with the
attitudes and competencies to provide
effective services
5) a plan for materials development as
appropriate
6) for each area of training, the content
to be addressed, the teaching materials
to be used, the proposed faculty, the
time frames to be allotted to each
training module, and the teaching
methods to be employed
o a description of the proposed participants,
their manner of recruitment and selection,
and the relevance of the training to their
specific needs
o a description of the number of training
programs to be offered, the sites at which
the training is to be presented, the
rationale for site selection, and the total
number of proposed students to be trained
o a comprehensive and detailed plan for an
evaluation to establish the program's
effectiveness and generalizability, including
before and after measures as well as a plan
for a followup of students who have completed
training and an assessment of the value of
curricular content and training experiences
o a focus on improving the skills and knowledge
of health care professionals in the
pharmacological and psychological treatments
for depressive disorders
o a comprehensive scope, addressing issues of
diagnosis, treatment, case management,
development of coordinated treatment plans,
and relationships with other health care
professionals
o a focus particularly on the early diagnosis
and treatment of outpatients with depressive
disorders
o a broad base in their approach to continuing
education, including experiential,
interactive, and didactic teaching methods
o innovative plans on how to recruit mental
health and health professionals as students
TERMS AND CONDITIONS OF SUPPORT
The mechanism of support for these awards will be the
Continuing Education Grants (T15).
Period of Support
The period of support is up to 3 years (with a maximum
of $125,000 per year), though no firm commitment can be
made beyond the first year. Therefore, activities in
the first year must be significant with a minimum of
six programs provided at six different sites in each
grant year.
Average Size of Award
It is expected that up to four awards may be made, each
award generally not to exceed $125,000 total (direct
and indirect) costs per award in fiscal year 1991.
Funds made available under this grant may not be used
to replace currently existing training or other support
for such training.
Direct Costs
Grants described in this announcement are awarded
directly to eligible applicants. Funds may be used
only for those expenses which are directly related and
necessary to carry out the project and must be expended
in conformance with DHHS cost principles, the Public
Health Service Grants Policy Statement,* and conditions
set forth in this document. Regulations at 42 CFR Part
242a are applicable to these awards.
*Public Health Service Grants Policy Statement, DHHS
Publication No. (OASH) 90-50,000 (rev. 10/1/90).
All budget items must be fully justified at the level
requested. Grantees are expected to be familiar with
and comply with applicable cost policies.
Teaching Costs
Direct cost items are allowable for teaching costs
associated with these programs. They include
personnel, consultants, materials, supplies, travel,
reproduction and printing costs, rental equipment,
minor equipment items, and other items which are
directly related to the proposed training program and
are otherwise unavailable from the institution.
Trainee Expenses
Trainee expenses are not allowable for support.
Participants may not be charged for training.
APPLICATION PROCEDURES
Harold Goldstein, Ph.D., Director of Training, D/ART
Program is available for consultation on program
development and may be reached at the address below.
It is further suggested that those who apply send a
brief letter of their intention to Dr. Goldstein. The
letter of intent is not binding, nor is it a
requirement for applications. (This letter should be
received by May 1, 1991.) Preparation of application
may proceed simultaneously.
Questions regarding eligibility, application
development, and fiscal and administrative matters should be directed
to:
Harold Goldstein, Ph.D.
Director of Training
D/ART Program
Prevention Research Branch
Division of Clinical Research
NIMH
Parklawn Building, Room 14C-02
5600 Fishers Lane
Rockville, MD 20857
Telephone: (301) 443-4140
Applicants must use the grant application kit (PHS
398, revised 10/88). Application kits are available
from the Prevention Research Branch, Room 14C-02,
Parklawn Building, 5600 Fishers Lane, Rockville,
Maryland 20857, (301) 443-4140.
To identify this application as a response to an RFA,
check 'yes' on item 2 page one of the PHS 398 form.
Also enter in item 2 the number and modified title of
this RFA (MH-91-04, Short-Term Clinical Training Grants
on Depressive Disorders). THE RFA LABEL FOUND IN THE
PHS 398 KIT MUST BE AFFIXED TO THE BOTTOM OF THE FACE
PAGE OF THE ORIGINAL COMPLETED APPLICATION FORM.
FAILURE TO USE THIS LABEL COULD RESULT IN DELAYED
PROCESSING OF YOUR APPLICATION SUCH THAT IT MAY NOT
REACH THE REVIEW COMMITTEE IN TIME FOR REVIEW.
Applications must be complete and contain all
information needed for initial and Advisory Council
review. No addenda will be accepted unless
specifically requested by the Executive Secretary of
the review committee. No site visits will be made.
The applicant should include a project abstract that
should not exceed two single-spaced typewritten pages.
The narrative section of the application should not
exceed 20 pages; appendices may not be used
inappropriately to expand the narrative section.
Applications exceeding this limitation will be
returned. Applicants submitting revised proposals of
earlier applications should follow the instructions in
the application kit regarding such revisions.
If the application submitted in response to this RFA is
substantially similar to a research grant application already
submitted to the NIH for review, but has not yet been reviewed,
the applicant will be asked to withdraw either the pending
application or the new one. Simultaneous submission of identical
applications will not be allowed, nor will essentially identical
applications be reviewed by different review committees.
Therefore, an application cannot be submitted in response to this
RFA that is essentially identical to one that has already been
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.
The original and five copies of the application must
be submitted to:
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD 20892**
Because of the short time available for initial and
Council review, one (1) additional copy of the
application should also be sent directly to:
NIMH
Division of Extramural Activities
Parklawn Building, Room 9C-15
5600 Fishers Lane
Rockville, MD 20857
Attention: Mrs. Edna Hardy-Hill
REVIEW
Review Procedures
A dual review system is used to insure knowledgeable,
objective review of the quality of applications.
Initial peer review for scientific, educational, and/or
technical merit is by groups of non-Federal experts
called Initial Review Groups. Final review is by the
National Advisory Mental Health Council.
Review Criteria
Applications submitted in response to this announcement
are not subject to the intergovernmental review
requirements of Executive Order 12372 as implemented through DHHS
regulations at 45 CFR Part 100.
Each grant application is evaluated on its own merits.
The following criteria will be used:
o relationship of the goals of the proposed
project to the purposes of this announcement
o appropriateness and feasibility of the
content, methods, and organization of the
project to specified project goals and
objectives
o quality of the training program plan and its
linkages to major research findings and
clinical knowledge
o balance in the curriculum between
psychosocial and pharmacological treatments
o multidisciplinary team of trainers
o multi-model training using a variety of
educational techniques including didactic and
experiential training methods
o effectiveness of the plans for recruiting
trainees outreach to geographic locations
throughout the training area
o previous experience in the provision of
continuing education programs.
o quality of the resources of the applying
organization
o qualifications of the program director and
other staff
o adequacy of the evaluation plan
o adequacy of the budget projections and other
resources for carrying out the project
activities
RECEIPT AND REVIEW SCHEDULE
National Advisory
Receipt of Initial Mental Health Earliest
Application Review Council Review Start Date
May 22, 1991 July 1991 September 1991 September 1991
Applications submitted after this date will be returned
to the applicant.
AWARD CRITERIA
The responsibility for award decisions on applications
recommended for approval by the National Advisory
Mental Health Council lies solely with authorized NIMH
program staff. The basic criteria to be used in making
award decisions will be the quality of the proposed
project as determined during the review process and the
availability of funds.
$$XID RFA HD9110 HD-91-10 P1O1 *****************************************
REQUEST FOR RESEARCH APPLICATIONS
RFA: HD-91-10
EFFECT OF SPECIFIC COMPONENTS OF HUMAN MILK ON THE NURSLING
P.T. 34; K.W. 0750015, 0775015, 1003008, 0760020, 0760025
National Institute of Child Health and Human Development
Application Receipt Date: July 24, 1991
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, Effect
of Specific Components of Human Milk on the Nursling, is related to the
priority areas of Nutrition and Maternal and Infant Health. 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, D.C. 20402-9325 (telephone
202-783-3238).
The Endocrinology, Nutrition, and Growth Branch of the Center for
Research for Mothers and Children of the National Institute of Child
Health and Human Development (NICHD) invites research grant applications
on the effects of specific components of human milk on the nursing
infant with respect to nutrition, physiological maturation of specific
tissues or organ systems, and susceptibility to infection and
malignancies, endocrinopathies, and degenerative disorders. Of
particular interest are studies designed to determine the mechanisms of
these effects.
BACKGROUND
Over the last twenty years we have become aware that human milk is a
complex mixture which contains many substances besides those which meet
the classical nutritional requirements of newborn infants. Many of
these substances are not present in cow milk or infant formula or are
present there only in much lower concentrations. They include enzymes,
hormones, growth factors, antibodies, specific proteins of other
classes, non-protein nitrogenous substances, and oligosaccharides. Some
of these substances which are of large molecular size can nevertheless
be absorbed intact from the immature gastrointestinal tract. Many of
them have powerful biological actions in other in vivo and in vitro
contexts, but for only a few have we learned the physiological import of
their presence in milk. Whether the others have significant
developmental effects on the nursing infant or are only incidental
passengers of the milk secretion process is unknown.
It seems likely that hormones present in human milk at levels
several-fold greater than those in plasma, like somatostatin or growth
hormone, or five-fold greater, like oxytocin, or 20-90 times greater,
like calcitonin, have some effect on the nursing infant, but even those
hormones with low milk/plasma ratios may have functional significance in
milk. In rats, prolactin ingested by the pups in milk is necessary for
the development of normal pituitary control over prolactin secretion in
later life. Whether any of the other hormones of milk, which include
insulin, TRH, TSH, corticosteroids, estrogen, progesterone, EGF, NGF,
IGF 1 and 2, TGFs, erythropoietin, bombesin, neurotensin, VIP, and
prostaglandins, have any physiological significance to the infant
remains to be determined.
There are a number of other compounds which are present in much higher
concentrations in human milk than in formula. These include small
molecules like lactoferrin, an iron chelator with putative antibacterial
or other immunologic properties, enzymes like bile salt-stimulated
lipase, lysozyme, and amylase, purine and pyrimidine nucleotides, and
secretory IgA. There are also leukocytes, leukocyte migration factors,
and probably polysaccharides or glycoproteins which mimic intestinal
receptors for pathogenic organisms, binding to those organisms and
serving as a defense against infection. There are unknown materials
which facilitate the absorption of iron and other elements and factor(s)
which stimulate the establishment of normal intestinal flora.
Many infants have been raised successfully on non-human milks.
Nevertheless, it is important to learn whether various components of
human milk affect development and maturation, not only for the basic
science information to be gained, but also for the potential benefit to
infants who do not receive beikost at an early age, as well as those who
must be maintained on parenteral nutrition, those who are suckled in
unsanitary environments, and those who are of low birth-weight. Even
for normal infants in favorable surroundings there may be long-term
benefits from specific components of human milk, as suggested by
case-control studies of juvenile diabetes and childhood lymphoma.
It is difficult to do this kind of research in human infants, and
sometimes non-rigorous inferences must be drawn from research on animal
models. Until recently taurine, which is the second most common amino
acid in human milk, was not present in any commercial infant formula.
However, because of evidence that taurine deficiency produces abnormal
electroretinographic responses in infant animals, and because a study in
low-birth-weight human infants suggested that they developed mature
auditory evoked responses more rapidly when given taurine, this
substance is now routinely added to all infant formulas. As a result,
ethical considerations now forbid the intentional induction of taurine
deprivation in human babies, and studies of taurine function in the
newborn demand model systems. Similarly, there is a delay in the
maturation of rod cells in the retina when premature infants are fed
formulas which differ from human milk by containing relatively low
levels of omega-3 fatty acids. Because of this and because of
convincing animal studies on the effect of such fatty acids on
maturation of the visual system, the addition of linolenic acid to
formula intended for low-birth-weight infants is now mandated in Canada.
Although it is commonly stated that human milk is the optimal food for
newborn humans, it might be possible to develop artificial formulae
which enhance infant development and health even more than does human
milk, especially in situations where the infant is stressed, ill,
handicapped with congenital defects or inborn errors of metabolism, or
developmentally delayed. The development of such formulas will depend
on knowledge of how specific components of human milk affect the
nursling.
RESEARCH GOALS
Most full-term infants thrive on artificial formulas which lack high
concentrations of the human milk-specific components. Their development
apparently proceeds satisfactorily without any specific stimulation that
these substances may provide. On the other hand, the maturation of
low-birth-weight infants proceeds less smoothly, and is complicated by
conditions such as the respiratory distress syndrome, bronchopulmonary
dysplasia, and necrotizing enterocolitis which seem to result from
maturational deficiencies. An understanding of how human milk
components influence intestinal maturation, lung function, intellectual
development, specific or nonspecific immunity, or other variables in the
neonatal period could lead to specific therapeutic uses of these
components in undersized, developmentally delayed, or ill infants.
Studies of human milk components could also provide important, broadly
applicable information about their biological functions in general.
This RFA is issued to encourage investigators to undertake clinical
studies of the role of specific components of human milk in normal
development and disease resistance, and to develop animal or
organ/tissue models when studies in humans are impractical or unethical.
Nonclinical model studies must focus on the effects of components of
human milk. Studies of these topics are expected to increase our
understanding of the physiologic role and pharmacologic potential of
human milk components, and to lead to improved formulas for artificially
fed infants. This is an underinvestigated area of research on
maternal-infant interactions, with potentially important clinical
applications.
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF
NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN
CLINICAL RESEARCH STUDY POPULATIONS
NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical
research grants and cooperative agreements will be 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
should be placed on the need for inclusion of minorities and
women in studies of diseases, disorders and conditions which
disproportionately affect 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 should 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 should be
included in the form PHS 398 in Section 2, A-D of the Research
Plan AND summarized in Section 2, E, Human Subjects.
Applicants/offerors 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
should be provided.
For the purpose of this policy, clinical research includes 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 policies 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 applicant 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 application will be returned.
Peer reviewers will address specifically whether the research
plan in the application conforms to these policies. 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.
MECHANISM OF SUPPORT
Applications in response to this RFA will be funded through the
traditional individual research award (RO1) program of the NIH. This
announcement is for a single competition with the application receipt
deadline of July 24, 1991. The earliest possible start date for these
grants is March 1, 1992. It is anticipated that four (4) grants will be
awarded under this program, contingent upon receipt of a sufficient
number of meritorious applications and the availability of funds.
$600,000 has been set aside for fund these awards.
REVIEW PROCEDURES AND CRITERIA
Applications will be reviewed by NICHD staff for responsiveness to the
RFA. Applications judged to be nonresponsive will be returned. The
applicant may resubmit the application and have it assigned for review
in the same manner as unsolicited grant applications. If the
application submitted in response to this RFA is substantially similar
to a research grant application already submitted to the NIH for review,
but has not yet been reviewed, the applicant will be asked to withdraw
either the pending application or the new one. Simultaneous submission
of identical applications will not be allowed, nor will essentially
identical applications be reviewed by different review committees.
Therefore, an application cannot be submitted in response to this RFA
that is essentially identical to one that has already been 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.
Responsive applications may be subjected to a triage by a peer-review
group to determine their scientific merit relative to the other
applications received in response to this RFA. NIH will withdraw from
competition those applications judged to be noncompetitive and notify
the applicant and institutional business official. Those applications
judged to be competitive will be further evaluated for
scientific/technical merit by a group review convened solely for this
purpose by the Scientific Review Program, NICHD. Criteria for the
initial review will include the significance and originality of research
goals and approaches; the feasibility of research and adequacy of the
experimental design; the research experience and competence of the
investigator(s) to conduct the proposed work; the adequacy of
investigator effort devoted to the project; and the appropriateness of
the project duration and cost relative to the work proposed. Following
review by the Initial Review Group, applications will be evaluated by
the Institute's Advisory Council for program relevance and policy issues
before awards for meritorious proposals are made.
APPLICATION PROCEDURE
Applications must be submitted on form PHS 398 (rev. 10/88), available
in business or grants offices at most academic research institutions or
from the Division of Research Grants, NIH. The phrase RFA HD-91-10
EFFECT OF SPECIFIC COMPONENTS OF HUMAN MILK ON THE NURSLING must appear
in item 2 of the face page. The RFA label available in the 10/88
version of form PHS 398 must be affixed to the bottom of the face page.
Failure to use this label could result in delayed processing of an
application, so that it may not reach the initial review group in time
for review. The original and four (4) copies are to be sent no later
than July 24, 1991, to:
Application Receipt Office
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD 20892**
In addition to the copies sent to the Division of Research Grants, two
(2) copies of the application should be sent to:
Laurance Johnston, Ph.D.
Scientific Review Program
National Institute of Child Health and Human Development
Executive Plaza North, Room 520A
Rockville, MD 20852
Any inquiries about this RFA should be directed to:
Ephraim Y. Levin, M.D.
Medical Officer, Endocrinology, Nutrition and Growth Branch
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
Executive Plaza North, Room 637
Rockville, MD 20852
Telephone: (30l) 496-5593
For fiscal and administrative matters, contact:
Mr. E. Douglas Shawver
Office of Grants and Contracts
National Institute of Child Health and Human Development
Executive Plaza North, Room 501
Rockville, MD 20852
Telephone: (301) 496-1303
This program is described in the catalog of Federal Domestic Assistance
No. 93.865, Research for Mothers and Children. Awards will be made
under the authority of the Public Health Service Act, Section 301 (42
USC241), and administered under PHS grant policies and Federal
Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not
subject to review by a Health Systems Agency.