kristoff@GENBANK.BIO.NET (Dave Kristofferson) (01/25/91)
RESEARCH CENTER OF EXCELLENCE IN PEDIATRIC NEPHROLOGY AND
UROLOGY
RFA AVAILABLE: DK-91-07
P.T. 04; K.W. 0785095, 0785220, 0770005
National Institute of Diabetes and Digestive and Kidney Diseases
Application Receipt Date: April 2, 1991
The Division of Kidney, Urologic and Hematologic Diseases
(DKUHD) of the National Institute of Diabetes and Digestive
and Kidney Diseases (NIDDK) invites applications for a
pediatric kidney and urology research center grant (P50) to
be awarded in fiscal year 1991. NIDDK anticipates the award
of one pediatric kidney and urology center grant from this
solicitation.
BACKGROUND
Kidney and urologic diseases account for substantial and
increasing morbidity and financial burden in the United
States. They threaten the health and well-being of over 13
million Americans and accounted for an estimated cost of at
least $50 billion in 1990. Although considerable progress
has been made in understanding the basic physiology and
pathophysiology of the normal renal and urinary systems,
there has been only limited progress in unraveling the
mechanisms of disease processes. Renal failure is more
frequent in adults, but the majority have their onset in
childhood. A significant proportion of disorders that lead
to end-stage renal disease (ESRD) or cause severe metabolic
imbalances in children are inherited (or are presumed to be)
renal diseases. The majority of inherited diseases seem to
result from single gene defects, providing an opportunity to
identify and study genes integral to normal renal and
urinary tract development and differentiation of normal
function. Alport syndrome is an X-linked, dominant disorder
leading to end-stage glomerular disease and is due to
alterations in basement membrane collagen. Polycystic
kidney disease, inherited as an autosomal recessive or
autosomal dominant trait, results in a gross distortion of
renal architecture and progressive renal insufficiency,
representing the single most common inherited renal disease
leading to ESRD. Vitamin D resistant rickets, congenital
nephrogenic diabetes insipidus, and inherited forms of renal
tubular acidosis are manifestations of abnormalities in
specific renal tubular transport mechanisms and result in
severe metabolic disturbances.
To date, investigations have provided only detailed
morphologic descriptions of basement membrane abnormalities
in only a few of the inherited glomerular disorders and have
characterized the tubular pathology in the various inherited
cystic diseases. However, at present, the understanding of
the molecular, cellular, and biochemical basis of these
disorders is lacking.
Developmental disorders of the kidney account for about one
third of all childhood diseases. These disorders are often
of such severity that renal replacement therapy with
dialysis or renal transplantation is required during infancy
or childhood. Examples of these disorders include renal
tubular cystic disease, dysplasia/hypoplasia, and congenital
obstructive uropathy. They represent a most important group
of disorders because they constitute a major preventable cause
of chronic renal failure. Vesicoureteral reflux and reflux
nephropathy, posterior urethral valves, prune belly
syndrome, and dysfunctional voiding and neurogenic bladder,
are the lower urinary tract diseases most commonly
encountered in the pediatric population. These problems
affect different structures within the kidney and urinary
tract causing renal function derangements. They often lead
to chronic renal disease and renal insufficiency resulting
ultimately in ESRD. Previous studies have elucidated the
anatomical components of these disorders, however, the basic
mechanisms at the cellular and molecular levels resulting in
these disorders are not understood.
The many basic aspects of the renal and urinary tract
development have been defined only at the structural and
immunohistochemical level. The cell and molecular biologic
aspects of the development of the glomerular, tubular, and
lower urinary tract system are incompletely defined.
Examples include the cellular derivation of the glomerular
mesangium, composition and characteristics of the embryonic
mesangial matrix and endothelial cells, events involved in
cellular communication and transformation, and mechanisms by
which differentiating and growing cells influence and are
influenced by the extracellular matrix. Further definition
of those events occurring at the cellular and subcellular
levels during normal renal and urinary tract development
will greatly facilitate our understanding of renal and
urologic developmental disorders and may provide insights
into disease processes.
Very little is known about the control of normal kidney and
urologic function in the small pre-term or normal newborn
infant. Similarly, the response of these systems to stress
or disease is not fully understood. Enhanced understanding
of the biology of maturation and differentiation and the
developmental physiology of the kidney and urinary tract
should result in a better understanding of the management of
infants and children with renal/urological disease. It is
reasonable to expect that further understanding of these
processes will result in the elucidation of the causes and
many of the important consequences of renal diseases that
affect both children and adults.
Chronic renal insufficiency and ESRD in children represents
a significant problem. The needs and requirements and the
risks and complications associated with chronic renal
insufficiency in infants and children are very different
from those in the adult. Growth retardation for example, is
seen in more than half the children with reduced renal
function. Other serious complications include impaired
development, marked central nervous system dysfunction,
severe bone disease, presence of metabolic derangements,
early severe anemia leading to limited energy and exercise
capacity, hypertension, cardiovascular complications leading
to morbidity and mortality, and enhanced clinical response
to infection and stress.
Added risks directly associated with dialysis include blood
access related problems, recurrent infections such as
peritonitis, sepsis, and death. Risks associated with
transplantation include graft loss due to acute or chronic
rejection and graft loss due to recurrent or de novo
disease, complications of the immunosuppressive therapy such
as infections, hypertension and cataracts, hypoglycemia,
which may be severe in children leading to seizures,
multiple technical problems, and even death. Enhancing the
understanding of the basic mechanisms responsible for these
serious complications of renal insufficiency should result
in the greatest benefits for affected infants and children,
their families, and society in general.
The proposed multidisciplinary Research Center of Excellence
in Pediatric Nephrology and Urology should: (a) provide the
necessary expertise to investigate topical areas of research
related to the pathogenesis of pediatric kidney and urologic
diseases, some of which were referred to above; (b) represent
a stimulating scientific environment designed to secure
the appropriate exposure to a new generation of
investigators who should, in a continuum, enhance the scope of
the investigations initiated by the Center; and (c) bring
together the strength of multiple basic and clinical
disciplines to unravel the problems of kidney and urinary
tract disease processes that affect the pediatric patient
population or have their origins in childhood.
OBJECTIVES AND SCOPE
The emphases of this initiative are threefold: (1) to
attract new scientific expertise into the study of the basic
mechanisms of pediatric kidney and urological diseases; (2)
to encourage interdisciplinary research in this area; and
(3) to extend these basic investigations into areas that
will provide the background for future innovative clinical
and epidemiologic studies of the causes, therapy, and
prevention of pediatric kidney and urologic diseases and
disorders. In approaching the study of these disease
processes, it is anticipated that extensive collaboration
will be required between clinical and basic scientists such
as those in cell biology, molecular biology, immunology,
genetics, epidemiology, biochemistry, physiology, and
pathology. Individual institutions with both basic and
clinical research capabilities are eligible to apply.
Interinstitutional collaborative research arrangements are
permitted and encouraged whenever appropriate.
PEDIATRIC NEPHROLOGY
Representative areas of research appropriate for
investigation include: (1) studies of renal disorders of
genetic and congenital origin that may lead to progressive
loss of renal function or cause severe metabolic imbalances
in children; (2) identification and study of genes integral
to normal renal and urinary tract development and to
differentiation of renal function, including studies of
cellular derivation of the glomerular components,
composition, and characteristics of the embryonic
extracellular matrix and endothelial cells; (3) definition
of the events involved in cellular communication and
mechanisms by which differentiating and growing cells
influence and are influenced by the extracellular matrix;
(4) studies of the ontogeny of the glomerulus and various
nephron segments, growth, and renal function adaptation seen
as a continuum; (5) studies of neonatal risk factors
contributing to renal disease in children and identification
of early determinants and predisposing factors for renal
diseases initiated in childhood and expressed in adult life;
(6) investigation of the pathophysiology of progressive
nephron loss in renal diseases most frequently observed in
children, including primary glomerulopathies, congenital
nephrotic syndrome, polycystic kidney disease, IgA
nephropathy, hypertension, renal tubulopathies, and
pyelonephritis; (7) studies of the pathophysiology of renal
growth in children with renal disease and factors affecting
sex maturation and fertility, prior to and after
transplantation; (8) modulation of growth and development in
children receiving exogenous recombinant hormones, and
development of animal models to quantitate the contribution
of selective variables on growth retardation, (9) improved
methods for measuring renal function including glomerular
filtration rate in the pediatric population.
PEDIATRIC UROLOGY
Examples of representative areas of research appropriate for
investigation include: (1) the pathophysiology of bladder
function and dysfunction in the pediatric population; (2)
the development of diagnostic methodology for the evaluation
of these defects; (3) the relationship between the
pathogenesis of dysfunction and the development of sequelae
in the adolescent and adult; (4) clinical studies of pre-
and neonatal bladder obstruction, enuresis, its
pathogenesis, treatment, and adult sequelae; (5) the effects
of urethral obstruction, such as posterior urethral valves
and meatal stenosis, on subsequent bladder function; (6) the
effect of bladder dysfunction on ureteral and renal
development and function; and the pathogenesis, treatment,
and sequelae of vesicoureteral reflux.
This initiative encourages applicants to utilize
technologies that explore the basic genetic, biochemical,
and cellular mechanisms involved in the development of
pediatric urological disorders. Also encouraged are studies
of the basic physiology and pathophysiology of neonatal and
pediatric urological disorders. The development of animal
or cellular models that can elucidate the basic mechanisms
in these disorders is also an area for potential
exploration. The ontogeny of bladder function, penile
erectile function, renal and ureteral musculature function
should also be investigated at genetic, biochemical, and
cellular levels. The association between pediatric
urological disorders and adult disorders is a fertile area
for investigation. These studies would determine a
molecular or cellular basis for such adult disorders as
bladder dysfunction that have their origin in a pediatric
event.
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
NIDDK expects to award one pediatric kidney and urology
research center grant (P50) in fiscal year 1991 on a
competitive basis. Foreign institutions are not eligible to
apply. The anticipated award is for five years and is
contingent upon the availability of appropriated funds. The
total amount of available funds to support this program is
anticipated to be no more than $750,000 per year. No
applicant may request more than $750,000 in total costs
(both direct and indirect costs) in the initial budget
period. Subsequent budget periods may include a standard
escalation factor.
Applications should include the following items:
A Table of Contents;
Rationale for the proposed Center and Statement of
Objectives;
Institutional Environment and Resources;
Organization and Administrative Structure of the Center;
Specific Managerial Responsibilities for the Center;
Travel funds in the proposed budget for an annual meeting of
Center Directors;
A description of the method for the replacement of the
Center Director (should the need arise);
A description of the procedure to be used for the
addition/deletion of cores and projects during the proposed
period of operation;
A description of the administrative relationship of the
Center to the Applicant Institution.
Consultation relating this Request for Applications (RFA) and
suggested guidelines for
preparation of applications may be obtained from:
Dr. Ralph L. Bain
Kidney and Urology Research Centers Program Director
DKUHD/NIDDK
Federal Building Room 102
9000 Rockville Pike
Bethesda, MD 20892
Telephone: (301) 496-8218
All potential applicants are strongly encouraged to consult
with the Program Director.
REVIEW PROCEDURES
Applications for an award of a research center grant will be
evaluated in a national competition by the NIH peer review
process. Applications will be reviewed initially by a
special review committee convened by the NIDDK and reviewed
subsequently by the National Diabetes and Digestive and
Kidney Diseases Advisory Council.
Applications are unlikely to be reviewed by a site visit
team; therefore, the written application should be complete
so as to facilitate review without a site visit. Extensive
additional material submitted subsequent to the stated
receipt date will not be accepted.
Receipt Date: April 2, 1991
Council Review: September 12-13, 1991
Earliest Award Date: September 30, 1991
In cases where the number of applications is large compared
to the number of awards to be made, the NIH may conduct a
preliminary scientific peer review to eliminate those
applications that are clearly not competitive. The NIH
will administratively withdraw from competition those
applications judged to be noncompetitive and so notify the
applicant and the institutional business official. Those
applications judged to be both competitive and responsive to
the RFA will be further evaluated according to the review
criteria stated below.
REVIEW CRITERIA
A. The review criteria for individual research projects
include:
The scientific, technical, or medical significance and
originality of the proposed research;
The feasibility and adequacy of the experimental design;
The qualifications and research experience of the proposed
personnel;
The availability of resources necessary for the research;
The appropriateness of the budget and timetable in relation
to the scope of the proposed research.
B. The review criteria for scientific cores include;
The appropriateness and utility of the core to the proposed
Center; each core unit must provide facilities or services
to at least two research projects recommended for approval;
The quality of the proposed facilities or services including
administrative arrangements for utilizing the core;
The qualifications, experience, and commitment of the
personnel involved in the core;
The appropriateness of the budget.
C. The review criteria for the overall Center program include:
The scientific merit of the program as a whole;
The significance of the overall goals of the Center;
The cohesiveness and multidisciplinary scope of the Center
and the coordination and interrelationship of the projects
and cores to the common theme of the Center;
The leadership, scientific expertise, and commitment of the
proposed Center Director.
D. Administrative Considerations
For all Center applications the review will assess:
The institutional environment for and resources available to
Center investigators;
The institutional commitment to the proposed Center;
The administrative leadership necessary to provide for the
quality control of supported projects in the Center, the
allocation of funds, and the ability to foster communication
and cooperation among Center investigators;
The appropriateness of the budget in relation to the
proposed activities of the Center;
The adequacy of addressing the protection of human subjects,
animal welfare, and biohazard issues.
METHOD OF APPLYING
Potential applicants are urged to submit a letter of intent
to the Program Director by February 15, 1991, regarding their
application. The letter of intent is nonbinding and is not
a precondition for an award. The letter of intent should
include the name(s) of the Principal Investigator(s),
principal collaborators, a descriptive title of the proposed
research center, and the organization(s) involved.
Applications must be submitted using PHS Form 398 (Rev.
10/88). The RFA label contained in the application kit must
be affixed to the bottom of the face page of the original
copy of the application. Failure to use this label could
result in delayed processing and review of the application.
Complete line 2 of the application face page by inserting the
title and number of this RFA.
Mail the completed application (original and four copies)
to:
Application Receipt Office
Division of Research Grants
Westwood Building, Room 240
National Institutes of Health
Bethesda, MD 20892**
Simultaneously submit two copies under separate cover to:
Review Branch, NIDDK
5333 Westbard Avenue
Westwood Building Room 406
Bethesda, MD 20892
The special single receipt date for submissions in response
to this announcement is April 2, 1991, with earliest funding
September 30, 1991.
This program is described in the Catalog of Federal Domestic
Assistance No. 93.849, Kidney, Urologic, and Hematologic
Diseases Research. Awards will be made under the authority
of the Public Health Service Act, Title III,Section 301
(Public Law 78-410, as amended; 42 USC 241) and administered
under PHS grant policies and Federal Regulations 42 CFR Part
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.
REQUESTS FOR COOPERATIVE AGREEMENT APPLICATIONS
SPECIAL CARE UNITS FOR ALZHEIMER'S DISEASE
RFA AVAILABLE: AG-91-06
P.T. 34; K.W. 0710010, 0715180, 0785035
National Institute on Aging
Letter of Intent Receipt Date: February 20, 1991
Application Receipt Date: April 10, 1991
I. INTRODUCTION
The National Institute on Aging (NIA) invites applications for
cooperative agreements (U01) for social and behavioral
research on the impacts of Special Care Units (SCUs).
Special Care Units are defined here as specialized facilities
designed for people with Alzheimer's disease (AD) in long-
term care institutional settings (e.g., nursing homes, board
and care, assisted living environments, adult day care). The
impacts of SCUs refer to direct or indirect outcomes of this
form of care on 1) persons with AD and at least one of the
following: 2) family members/caregivers, 3) health care
administrators, 4) staff, and 5) other (non-demented) persons
receiving care in the same institutional settings.
This Request for Applications (RFA) supplements, but does not
replace, previous NIA program announcements on related issues
(see NIH Guide for Grants and Contracts Vol. 16, No. 19, June
5, 1987, for Aging and Health Care and Vol. 18, No. 6,
February 24, 1989, for Alzheimer's Disease and Related
Disorders: Issues in Caregiving). The announcement is
coordinated with relevant programs in the Agency for Health
Care Policy and Research; National Center for Nursing
Research; and National Institute of Mental Health.
II. SCIENTIFIC BACKGROUND
It is estimated that Alzheimer's disease and similar
disorders afflict some 4 million American adults (Cross and
Gurland, 1986; Evans et al., 1989) and that 40-60 percent of
nursing home residents suffer from some type of dementia,
primarily Alzheimer's disease (Katzman, 1985; Hu et al.,
1986; Rovner et al., 1990). As the population ages, this
number may increase dramatically to more than 14 million by
the year 2040. Because the disease follows a course of
progressive deterioration that often lasts 10-15 years, the
burden of care is extremely heavy and increases as the
afflicted person moves through the several stages of the
disease. Recent estimates indicate that dementia costs the
American economy nearly $90 billion, with the majority of
costs reflecting the value of the time that relatives spend
caring for patients at home (Hu et al., 1986; Huang et al.,
1988). Most of the remaining cost of care is associated with
formal care provided by a nursing home.
Apart from the costs, institutional care of persons with AD
presents a unique set of problems, including design of the
most appropriate model of care (Buckwalter, 1990). One recent
controversy concerns whether residents with dementia should
be integrated ("mainstreamed") with residents who are not
cognitively impaired, or segregated in a unit designed and
operated specifically for them. Many nursing home
professionals and researchers agree on the potential benefits
of an SCU (Johnson, 1989; Kane, 1987; Grossman et al., 1986;
Wolanin and Philips, 1981), although a few writers have argued
the advantages of mainstreaming and questioned the benefits
or need for SCUs (Ohta and Ohta, 1988; Chafetz and West,
1987; Rabins, 1986; Salisbury and Goehner, 1983). While over
1500 of this country's nursing homes are known to have
established such units over the last decade, this number
represents only about 7.5 percent of all the institutional
facilities for people with AD. This means that over 90
percent of nursing homes have no such unit at this time (Leon
et al., 1990).
Nevertheless, interest in the SCU concept among nursing home
administrators and staff appears high, and new units are
being established so rapidly that the number is expected to
double by 1991 (Leon et al., 1990). However, few studies
have attempted to determine what patterns of care in SCUs
produce the best results, and results so far identified are
often mixed or disappointing (Chafetz and West, 1987; Mathew
et al., 1988). Thus, research is needed to specify the
outcomes for persons with AD and the different participants
in their care as a function of the features of SCUs.
III. SPECIFIC OBJECTIVES AND METHODOLOGICAL CONSIDERATIONS
The goal of the desired research is to provide systematic
data on outcomes of care in SCUs, and on the factors and
processes associated with particular outcomes. A further
objective is to develop measures that can be standardized
across studies and subjected to comparable analyses.
Specific eligibility requirements for this RFA include:
o Proposed research must be conducted in established SCUs
(e.g, those that have been in operation for at least six
months).
o Investigative teams must have prior experience in
conducting health care research in demented populations.
o Consideration of outcomes in persons with AD and at
least one other participant in care (e.g., family
members, health care administrators, staff, or other
non-demented persons receiving care).
Scientific Focus. The focus of the research is on the
outcomes of care in SCUs, and on the factors and processes
producing particular types of outcomes.
Outcomes must refer to persons with Alzheimer's disease
and also to one or more sets of participants in care
(e.g, the administrators or staff of the institution,
family caregivers, or other non-demented residents).
Factors affecting outcomes may include characteristics
of the institution (e.g., proprietary/non-proprietary,
size, physical setting, administrative policies,
staffing patterns) or characteristics of persons with
AD as residents of the institution
(e.g., socio-economic status, personal preferences,
stage of the disease and presence of behavioral
disorders, family availability, and support). The effects
of the unique characteristics of AD and changes in the
progress of the disease are especially important
factors.
Processes concern how the outcomes are produced,
including the effects of experimental or "natural"
interventions in the care setting (e.g., changes in
activity or family programs, in environmental design, or
in staff training); or including the complex
interactions among different participants in care (e.g.,
how administrative policies, by controlling family
visiting, in turn affect the person with AD).
Research Methods. The research should make use of the most
up-to-date theories, knowledge, and empirical procedures and
may draw from the areas of aging, dementia, health services
research, and behavioral and social sciences generally (e.g.,
sociology, psychology, economics, anthropology).
A range of research designs is acceptable, depending on
the study objective, including: in-depth ethnographic
studies of single institutions; analyses of large
samples of institutions; or experimental manipulation to
test the effects of varying specific aspects of care.
The level of analysis requires special attention. Some
studies will be based on the institution as the research
case but will also require analysis of individual
characteristics. Other studies will be based on
individuals as the research case and will treat
characteristics of the SCU as contextual variables
referring to individuals.
In drawing samples or matching them for comparison,
samples of institutions should take into account such
characteristics as case-mix or regulatory arrangements;
whereas samples of individuals with AD
should take into account such characteristics as the
level of function, diagnosis and severity of the
disease, educational level, or history of care.
Measurement instruments to be used on persons with
AD must be validated on cognitively
impaired residents of long-term care facilities. The
development and testing of new measures may be required
for particular research questions.
Investigator Coordination. To achieve standardization and
comparability in research design, sampling, data collection,
measurement, and analysis of the research approaches that
each investigator presents, cooperative agreement awardees
will meet periodically with the Program Administrator and
other awardees (see terms and conditions under description of cooperative
agreement mechanism in Section V).
IV. EXAMPLES OF SPECIFIC RESEARCH QUESTIONS
Possible research questions the applicant may elect to
address are illustrated below. These are examples only.
Applicants are welcome to pose other research questions. The
only requirement is that the outcome focus on the person with
AD and on either family caregiver or health
care staff, or on non-demented residents.
1. Persons with AD being cared for in an SCU
compared with a regular unit in the long-term care
institution.
o What differences in health and functional status can be
observed in the residents' a) physical functioning, b)
cognitive abilities, c) life satisfaction and emotional
status, d) social behavior, e) incidence of falls or
injuries, or f) primary or secondary symptoms of the
disease (e.g., wandering, agitation, belligerence,
screaming, inappropriate sexual behavior)?
o What dynamics, processes, interventions influence
different phenomena and outcomes in areas such as (a) to
(f) above?
o What aspects of the SCU matter most to persons with
Alzheimer's diseases? What matter least?
o How does the impact of the SCU vary with co-existing
morbidities and stage of AD? How does this impact
change over the clinical course of the disease?
o How does movement of the person with AD
through the health system affect experiences with the
SCU and, in turn, how do different experiences in the
SCU affect the person's movement through the health care
system?
2. Family caregivers of persons with AD
being cared for in an SCU compared with those in a regular
unit.
o How readily do family caregivers accept placement in an
SCU? How satisfied are they with this form of care?
What particular aspects of care are judged most
satisfactory? What are least satisfactory?
o How does SCU placement affect the family caregiver's
quality of life, morale, general functional status,
relations with staff, and interactions with persons with
AD?
3. Administrators or managers of the SCU
o What role do SCUs play in the hiring practices and staff
retention of the long-term care institution?
o How do SCUs influence administrators' ability to track
and monitor nursing care (with consideration of new
federal nursing home guidelines)?
o How does the SCU affect the overall efficiency of
operation?
4. Professional or nonprofessional staff of the SCU
o How do SCUs affect staff morale, work behavior, and
effectiveness compared with those of similar staff not
working in the SCU?
o From the point of view of staff, what aspects of the SCU
are most satisfactory? What are least satisfactory? Why?
o What is the impact on the staff outside the SCU
of having persons with AD treated
in a specialized unit?
5. Non-demented residents in institutions containing SCUs
compared with those in institutions without SCUs.
o Do non-demented residents feel relieved of the daily
aggravation of having to live and interact with peers
who are not mentally intact? Are they less anxious
about possible deterioration of their own mental and
physical condition?
o To what extent is dementia more or less stigmatized and
feared when its victims are segregated, even if for
special care?
6. The dynamic interactions among the different
participants in care (topics 1 through 5 above).
o How does the SCU affect staff-family relations as these,
in turn, influence resident outcomes?
o How do patient-family interactions in the SCU affect
staff morale and functioning?
o How do different patterns of family involvement
influence program operation and resident outcomes either
positively or negatively?
o How are the effects of administrative policies on
residents with AD mediated by staff
behavior?
V. MECHANISMS OF SUPPORT
Cooperative Agreement: The administrative and funding
mechanism to be used to support these awards will be
Cooperative Agreements between each awardee and NIA.
Assistance via a Cooperative Agreement differs from the
traditional research grant in that, in addition to the normal
programmatic and administrative stewardship responsibilities,
the component awarding the Cooperative Agreement anticipates
substantial programmatic involvement during performance of
the project. However, the applicant institution must define
its objective in accord with its own interests in social and
behavioral research on the impacts of SCUs and must develop
the details of the research design following the guidance
given in this RFA. It is the primary responsibility of the
Principal Investigator to clearly state research objectives
and approaches, to plan and conduct the research stipulated
in the application, and to ensure that the results obtained
are analyzed and published in a timely manner. The data
obtained will be the property of the awardee.
The impacts of SCUs is a relatively new research area. The
nature and structure of SCUs, as well as the identification
and measurement of relevant sociodemographic, health and
functioning variables for AD residents, family members,
administrators and staff, and other non-demented care
residents, need to be assessed. The need for significant
programmatic involvement results from an effort to maximize
the information obtainable from the set of funded projects.
The involvement of the designated Program Administrator will
center on assisting with the: 1) study design and protocol;
2) the elements of care being tested; and 3) the outcomes
being measured.
During performance of the award, the NIA Program
Administrator may provide assistance in the design of group
activities, the selection of sources or resources,
replacement of staff, the collection and/or analysis of
data, and the preparation of publications. However, the role
of NIA will be to facilitate and not to direct the
activities. It is anticipated that decisions in all
activities outlined below will be reached by consensus of the
group and the NIA Program Administrator will be given the
opportunity to offer input to this process. The manner of
reaching this consensus and the final decision-making
authority will rest with the Principal Investigators.
The designated Program Administrator will meet with the
Principal Investigators and key staff three times in the
first year and every six months thereafter to assist in protocol
development, standardization of key measurements, and
appropriate analysis techniques. Applicants should request
support for such travel in their proposals. It is our
experience that four to six months of time at the beginning
of the study will be needed to assist with standardizing
definitions and measurements across sites. This should be
indicated in the individual project's timelines.
Additionally, each applicant should nominate and budget funds
for one outside expert to serve on an Advisory Panel for this
set of projects. The Advisory Panel, consisting of expertise
in aging, AD, behavioral and social
sciences, health services research, biostatistics, and ethics
will be nominated at the first meeting of the Principal
Investigators. The composition and selection of this
Advisory Panel will be discussed and voted on by the
Principal Investigators.
The Program Administrator will seek scientific expertise from the
Advisory Panel as needed.
Budgetary Considerations
o This initiative seeks to fund 4-6 research projects.
o Total costs for each project should not exceed $250,000
in the first year.
o Depending on scientific merit, we anticipate spending up
to $1,000,000 on these projects.
o This RFA is a one-time solicitation. In addition to FY
1991 awards, other proposals responding to this RFA may
be funded in Fiscal Year 1992, depending on quality of
proposals and availability of funds. Issuance of awards
pursuant to this RFA is contingent on the availability
of funds for this purpose.
There is not intention to change the mechanism after award.
Cooperative Agreements are subject to the same administrative
requirements as grants. Projects will be supported by the
Research Project (Cooperative Agreement) (UO1) mechanism.
The regulations (Code of Federal Regulations, Title 42, Part
52 and Title 45, Part 74) and policies that govern the
research grant programs of the PHS will prevail. The
awarding of funds pursuant to this RFA is contingent on
availability of funds. All pertinent DHHS, PHS, and NIH grant
regulations, policies and procedures are applicable.
Business management aspects of these awards will be
administered by the NIH in accordance with DHHS and PHS grant
administration requirements.
VI. REVIEW PROCEDURES AND CRITERIA
Applications will be received by the NIH Division of Research
Grants and will be assigned to the NIA. Responsive
applications will be assigned to a special Institute review
group for review. Proposals judged by the NIA to be non-
responsive (those not directed at the goals of this RFA) will
be administratively withdrawn and returned to the applicant
without review. Proposals may first receive a preliminary
review by a subcommittee of the review panel to establish
those applications deemed to be competitive. Those proposals
judged non-competitive will be so designated, and an
abbreviated summary statement noting the major areas of
concern will be sent to the Principal Investigator.
Applications judged to be competitive will be given full
review. Following review by the initial review group, the
applications will be considered by the National Advisory
Council on Aging.
Listed below are the major review criteria to be used in the
evaluation of the applications received in response to this
RFA:
o scientific merit of the research proposed.
o significance of the research project to the goals
of the RFA.
o appropriateness and adequacy of the experimental
approach and methodology proposed to carry out the
research
o qualifications, experience, and commitment of the
investigators and their ability to devote the
required time and effort to the project.
o appropriateness of the total budget and budgetary
requests.
o institutional commitment to the requirements of the
project.
o adequacy of inclusion of women and minorities
VII. 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/ADMHA
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,
together with a rationale for its choice. 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 recognize 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.
VIII. METHOD OF APPLYING
Researchers considering an application in response to this
RFA are strongly encouraged to discuss their project with the
program contacts in advance of formal submission. Applicants
are strongly encouraged, but not required, to send a letter
of intent giving the title of the proposed project, the
name of the
Principal Investigator and, when known, other key
participants. This letter should be received by the staff
contacts listed below by February 20, 1991.
Applications must be submitted on the standard PHS 398
(revised 10/88 reprinted 9/89) application form (available at
most institutional business offices) and from the Division of
Research Grants, NIH, 301-496-7441. The deadline for receipt
of applications is April 10, 1991.
The RFA label contained in the application kit must be
affixed at the bottom of the face page of the application.
Failure to use this label could delay processing of the
application.
On item 2 of the face page of the application, applicants
must enter: NIA RFA AG-91-06--Special Care Units for
Alzheimer's Disease. The completed application and four
copies must be sent to:
Application Receipt Office
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD 20892**
At the same time the application is submitted to the Division
of Research Grants, two
copies of the application must be sent to:
Chief, Scientific Review Office
National Institute on Aging
Building 31, Room 5C12
9000 Rockville Pike
Bethesda, MD 20892
Failure of these copies to be received by the deadline may
prevent the application from being reviewed under this
announcement in time to be considered for an award as in
NIH Manual 4815.
IX. STAFF CONTACTS
Potential applicants interested in obtaining further
information may write or call:
Program Coordinator
Marcia G. Ory, Ph.D., Chief, Social Science Research on Aging
Behavioral and Social Research Program
National Institute on Aging
Building 31, Room 5C32
National Institutes of Health
Bethesda, MD 20892
Telephone: (301) 496-3136
Alternate Program Coordinator
Neil Buckholtz, Ph.D.
Neuroscience and Neuropsychology of Aging
National Institute on Aging
Building 31, Room 5C35
National Institutes of Health
Bethesda, MD 20892
Telephone: (301) 496-9350
Other institutes and agencies are also interested in research
dealing with AD and related disorders. For
information concerning related research interests, contact:
1) National Center for Nursing Research
Dr. Patricia Moritz
Building 31, Room 5B09
Bethesda, MD 20892
Telephone: (301) 496-0523
2) National Institute of Mental Health
Dr. Enid Light
Parklawn Building, Room 11C03
5600 Fishers Lane
Rockville, MD 20857
Telephone: (301) 443-1185
3) Agency for Health Care Policy and Research
Ms. Linda Siegenthaler
Maxima Building, Room 634
Rockville, MD 20852
Telephone: (301) 443-6990
This program is described in the Catalog of Federal Domestic
Assistance No. 93.866, Aging Research. Awards will be made
under the authority of the Public Health Service Act, Title
III, Section 301 (Public Law 78-410, as amended; 42 USC 241)
and administered under PHS grant policies and Federal
Regulations 42 CFR Part 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.
REFERENCES
Advisory Panel on Alzheimer's Disease, Report of the Advisory
Panel on Alzheimer's Disease. Washington, DC: Office of
Technology Assessment, 1989.
K.C. Buckwalter, Segregating the cognitively impaired: Are
dementia units successful? In Katz, Kane, and Meze (eds.)
Advances in Long-term Care New York: Springer Publishing,
1990, pp. 43-60.
P. K. Chafetz and H. L. West, Longitudinal control group
evaluation of a special care unit for dementia patients:
Initial findings. Presented at the Annual Meeting of the
Gerontological Society of America, Washington, DC, 1987.
P. S. Cross and B. J. Gurland, The epidemiology of dementing
disorders. Contract report prepared for the Office of
Technology Assessment, U. S. Congress, 1986.
D. A. Evans, P. A. Scherr, N. R. Cook, M. S. Albert, H. H.
Funkenstein, L. A. Smith, L. E. Hebert, T. T. Wetle, L. G.
Branch, M. Chown, C. H. Hennekens, and J. O. Taylor, Impact
of Alzheimer's disease in the United States population. In
R. Suzman and D. P. Willis (eds.), The Oldest Old. London:
Oxford University Press, 1989.
H. Grossman, A. S. Weiner, M. J. Salamon, and L. Burros, The
milieu standard for care of dementia in a nursing home.
Journal of Gerontological Social Work, 1986, vol. 9, 73-89.
L.F. Huang, W.S. Cartwright, and T.H. Hu, The economic cost
of senile dementia in the United States, Public Health
Reports 1988, vol. 103 (Jan-Feb): 3-7.
T. Hu, L. Huang, and W. Cartwright, Evaluation of the costs
of caring for the senile demented elderly: A pilot study.
The Gerontologist, 1986, vol. 26, 158-163.
C. J. Johnson, Sociological intervention through developing
low stimulus Alzheimer's wings in nursing homes. The
American Journal of Alzheimer's Care and Related Disorders
and Research, 1989, vol. 4, 33-41.
R. Kane, Considerations before developing a special care unit
for Alzheimer's patients. Beyond Folklore III: Standards of
Care in Managing Alzheimer's Patients. Symposium conducted
by the University of Minnesota and the Veteran's
Administration, Minneapolis, Minnesota, 1987.
R. Katzman, Aging and age-dependent disease: Cognition and
dementia. In America's Aging: Health in an Older Society.
Washington, DC: National Academy Press, 1985.
L. Mathew, P. Sloane, M. Kilby, and R. Flood, What's
different about a special care unit for dementia patients? A
comparative study. The American Journal of Alzheimer's Care
and Related Disorders & Research, 1988, 16-23.
R. J. Ohta and B. M. Ohta, Special units for Alzheimer's
disease patients. The Gerontologist, 1988, vol. 28, 803-808.
P. V. Rabins, Establishing Alzheimer's disease units in
nursing homes: Pros & cons. Hospital and Community
Psychiatry, 1986, vol. 37, 120-121.
B. Rovner, et al., The prevalence and management of dementia
and other psychiatric disorders in nursing homes.
International Psychogeriatrics, 1990, vol. 2, 13-24.
S. Salisbury and P. Goehner, Separation of the confused or
integration with the lucid? Geriatric Nurse, 1983, vol. 6,
157-159.
M. Wolanin and L. Phillips, Confusion: Prevention and Care.
St. Louis: Mosby, 1981.
CHILD HEALTH RESEARCH CENTERS
RFA: HD-91-04
P.T. 04; K.W. 0710030, 0770005, 0775000, 0785170, 0785035
National Institute of Child Health and Human Development
Application Receipt Date: April 9, l991
I. General
The information in this Request for Applications (RFA) is not
identical to that in the RFA of January 1990 on this subject
(HD-90-03) which is obsolete.
The National Institute of Child Health and Human Development
(NICHD) supports a program of Child Health Research Centers
(CHRC) intended to provide resources to speed the transfer of
knowledge gained through studies in basic science to clinical
applications that will benefit the health of children. This is
to be accomplished by increasing the number of pediatric medical
centers that can stimulate and facilitate the application of
research findings to pressing pediatric problems and increasing
the number and effectiveness of pediatric investigators who have
a grounding in basic science and research skills that can be
applied to the clinical problems of children. The mechanism
chosen for funding of these Centers is the P30 grant that
provides core support for laboratories and administrative
resources applicable to a number of different research projects.
A CHRC grant allows an institution to identify and develop a
scientific area or theme that is relevant to the pediatric
research mission of the NICHD. It is an opportunity for
institutions, both developing and established, to build a greater
capacity for training pediatric investigators. Established
investigators, whose research is already funded by NIH or other
sources through competitively reviewed grants or contracts,
combine to establish in their institution a center of excellence
in the chosen subject area. Individuals with a wide range of
scientific backgrounds, especially those with basic science
orientation, are thus encouraged to interact with each other and
with newly trained pediatricians just embarking on their research
careers. A shared core laboratory that provides services to
complement and extend the capabilities of the established
investigators to facilitate the career development of new
investigators may be a major part of the Center. The established
investigators make available their expertise, guidance, and
laboratory facilities that, together with the shared core
laboratory comprise the laboratory resources of the Center to be
utilized by junior investigators for new research projects that
will enhance their basic science knowledge and skills. Support
for conducting these projects is provided by the Center.
The CHRC grant may provide funds for three purposes:
A. Administration of the Center.
B. Improvements in the child health-related research program
of an institution in an area of scientific excellence through the
establishment and maintenance of a shared core laboratory.
C. Support for new projects, conducted by junior
investigators, designed to enhance their research skills and
produce preliminary data that could lead to successful
competitive grant applications to the NIH or other agencies (New
Project Development Funds), thereby providing a bridge between
formal research training and the receipt of independent research
grants.
The novel feature of these grants is the flexibility in the use
of the funds awarded for research support and career development,
so that decisions about which new projects and which junior
investigators are to be supported are made by the grantee
institution. Both competing (renewal) and noncompeting
continuations of a CHRC grant are contingent on demonstration of
good judgment in these decisions as indicated by scientific
progress, success in the initiation of new competitively awarded
research grants and contracts, and the development of new
pediatric investigators.
II. Requirements for CHRC applicant institutions
A CHRC grant is an award made to a children's hospital or to a
department of pediatrics of an approved medical school that has
as a primary teaching site either a general acute children's
hospital or a children's program with an identifiable
organizational structure that is part of a larger medical
institution. Either one must have the clinical pediatric
specialties and subspecialties and discrete clinical and research
facilities sufficient to ensure the linkage of basic research and
clinical application that will meet the purposes of the CHRC
program. The applicant institution must also meet the standard
eligibility requirements for research grants established in the
Public Health Service Grants Policy Statement #(OASH) 90-50,000
Revised 10/1/90. The award will support a center of excellence
that will use its professional and laboratory resources to
increase the institutional capabilities for developing pediatric
investigators skilled in basic science research methods. The
CHRC must have a strong, well-established research base, resting
on the interests of established investigators who make their
expertise available to the junior investigators and act as
mentors or senior collaborators for them. The CHRC must focus on
a theme that relates to the current areas of interest of the
research program of the NICHD. The theme should be broadly
defined within a specific research area of pediatric interest and
not be limited to a specific disease or single organ system.
There should be an adequate pool of junior investigators likely
to benefit from career development under the guidance of
established investigators. In addition, each Center must have a
scientifically sound and equitable system for choosing which
junior investigators and which projects are to be supported.
Finally, there should be evidence of an institutional commitment
to support the Center resources and to develop and retain
pediatric investigators.
III. Components of a CHRC
A. Principal Investigator
The Principal Investigator of the CHRC is the chairperson of
the department of pediatrics or the chief of the pediatric
service. He or she is responsible for development and
maintenance of the Center as an institutional resource and for
its general oversight, appointing the program director and
members of the advisory committee (see below). He or she makes
the decisions about appropriate recipients of the Center funds
for research and career development, taking into consideration
recommendations from the Center advisory committee. The
Principal Investigator does not receive salary or fringe benefit
support from the CHRC for this responsibility.
B. Administrative Staff
The day-to-day administration of the Center grant may be made
the responsibility of a senior faculty member, called the program
director, supported for up to 10% time and effort for this
activity. The program director must be a physician knowledgeable
about the scientific area that is the theme of the Center with a
record of success at laboratory or clinical investigation and a
demonstrated skill in career development. The Principal
Investigator may also serve as program director with appropriate
support. The program director may be assisted by a part-time
Center-supported secretary. Administrative staff funds may also
be used for a well-qualified recruitment officer, supported up to
20% time and effort, to enhance participation in the program by
women and by members of minority groups under-represented in
pediatric research (see below).
C. Advisory Committee
The advisory committee is a group of scientists, drawn from
the pediatric department and from other departments or
institutions as appropriate, who have interests and expertise
relevant to the theme of the Center. The advisory committee
should be chaired by the Principal Investigator and should
include the program director, the core laboratory director, and
the established investigators. It may also include the
recruitment officer and any other persons considered potentially
contributory by the Principal Investigator. It is the function
of the advisory committee to evaluate applications for the use of
the Center's New Project Development Funds and the Pediatric
Scientist position, and to make recommendations to the Principal
Investigator about appropriate awardees. It evaluates ongoing
activities annually, makes recommendations abouto their
continuation, and recommends to the Principal Investigator
priorities for use of the resources of the core laboratory. For
these functions the committee may utilize institutional or
outside consultants as necessary.
The advisory committee provides expert counsel essential to
the principal investigator for his or her administration of the
Center. It should meet regularly and formalize its evaluation
activities. Minutes of the advisory committee meetings will be
submitted as part of the Center's annual progress reports.
D. Established Investigators
At least three established investigators supported by NIH or
other competitively-awarded grants are required for a CHRC. They
should be expert in the application of new advances in basic
science methodology to problems of human development and
pediatric disease that are relevant to the mission of the NICHD
and within its authority to support. Their research interests
must converge upon a single theme that unifies their programs and
justifies their collective designation as a Center, making the
CHRC attractive to recently trained pediatricians as a place to
develop their investigative careers. The established
investigators need not be pediatric department members. Linkage
to other departments can enhance the power of the CHRC and is
expected to be a key feature of each Center. When a junior
investigator is to be supported by the Center through New Project
Development Funds, one or more of the established investigators
must agree to provide his or her expertise as a mentor and
collaborator and allow the junior investigator access to his or
her laboratories. The established investigators do not receive
support for their salaries or fringe benefits from the Center
grant. Established investigators may be added to the Center
roster with approval from NICHD staff.
E. Laboratory Resources
The laboratory resources of the CHRC are comprised of the
research laboratories of the established investigators and a
shared core laboratory, to be utilized by the established
investigators and the Center-supported junior investigators whose
activities they will supervise. The justification for the shared
core laboratory is its provision of a cost-effective expansion or
centralization of research resources and support of the theme
which makes the Center a magnet for beginning investigators. The
CHRC grant may support professional supervision of the shared
core laboratory (core laboratory director, maximum 50% time and
effort), as well as technical assistance, supplies, equipment
purchase, and equipment maintenance. The Principal Investigator,
program director, and core laboratory director are responsible
for efficient and equitable utilization of the core laboratory on
the basis of recommendations from the advisory committee. Core
laboratory log books are subject to review by NICHD staff and
outside consultants upon request of the former.
There must be an institutional commitment to this shared core
laboratory, which may take the form of alterations and
renovations to establish it, the purchase of research equipment,
the assignment of research space, and/or the support of
personnel. Creative approaches to stimulating interactions
between diverse investigators who can contribute to Center goals
are particularly desirable.
The laboratories of the established investigators are not
supported directly by the Center grant. Funds for supplies,
small equipment, and technical assistance needed for the conduct
of Center-supported research projects in these laboratories are
provided through New Project Development Funds. Support for
projects conducted in the core laboratory by recipients of New
Project Development Funds may come either from those funds, from
the core laboratory budget, or from both.
F. New Project Development Funds
The Principal Investigator, after considering recommendations
from the advisory committee, is to use Center funds to make
annual awards to junior faculty members for the pursuit of
research projects that will utilize the Center laboratory
resources and established investigator expertise. The projects
may be clinical or non-clinical, as long as they relate closely
to the theme of the Center. The junior investigators must be
under the mentorship of an established investigator who will
provide supervision of the research to be undertaken. The
maximum award for a project in this category is $30,000 per year,
except that one recipient may be appointed as a Center Pediatric
Scientist with greater funding (see below). These funds are used
to defray the costs of materials, supplies, technical assistance,
and miscellaneous expenses generated by these projects in the
laboratories of the established investigators who serve as
preceptors and collaborators of the awardees; for supplies needed
for work in the core laboratory that are beyond the capacity of
that laboratory's budget; for small equipment; for travel; and
for a portion of the salaries and fringe benefits of the junior
investigators. These funds may not be used for patient care
costs, such as inpatient bed days or outpatient visits except for
clinical laboratory analyses essential for the research.
The recipient of a New Project Development Award should be a
physician who has completed pediatric training, who has not
previously been the Principal Investigator of a competitively
awarded NIH research grant or contract, and who is no more than
three years beyond fellowship training at the time the award is
made. The awards are renewable at the discretion of the
Principal Investigator, subject to the restriction on
post-fellowship time, contingent upon presentation of evidence of
satisfactory progress to the advisory committee and the NICHD in
the Center annual progress report. Recipients should make a
commitment of time and effort to research that is appropriate for
the magnitude of the award.
Institutions with CHRC grants are encouraged to develop novel
mechanisms for recruiting qualified women and minority
pediatricians to become investigators in the Center. Such
mechanisms could include, for example, part-time appointments for
investigators with families and special efforts to recruit
members of minority groups.
In exceptional circumstances, one particularly promising
junior investigator may be selected by the Principal Investigator
(after consideration of recommendations from the advisory
committee) to receive more substantial support from New Project
Development Funds for research in the Center area of scientific
specialization. The qualification requirements for this
individual are the same as those for other recipients of New
Project Development Funds except that he or she should have
already demonstrated substantial research ability as indicated by
publications, abstracts, or unpublished data. The Pediatric
Scientist must be appointed as a pediatric department faculty
member. He or she may be supported by CHRC funds for a period of
up to three years (subject to the restriction on post-fellowship
time), while developing an investigative career under the
tutelage of one of the established investigators in the Center.
Recipients of these awards make a commitment to spend at least
85% of their time in research.
Although candidates for the Pediatric Scientist position are
to be selected by the Principal Investigator with advice from the
advisory committee, support will be contingent upon evidence that
the institution has recruited an appropriately qualified
candidate with a meritorious research proposal. Continuing
support will be dependent upon evidence of productivity. The
following information must be submitted for NICHD staff and
outside consultant review and approval before the award for this
position may begin: a biographical sketch of the candidate, a
description of the project and its relationship to the Center
theme, an outline of how it will use the Center resources, and a
letter of support from the established investigator who will
serve as mentor for the proposed Pediatric Scientist.
Not every Center will wish to appoint a Pediatric Scientist
every year, and this position is not an essential component of a
CHRC grant.
IV. Allowable Budgetary Items and Supportable Activities
Allowable costs in NIH grants are governed by rules set forth in
the Public Health Service Grants Policy Statement and the NIH
Guide for Grants and Contracts unless otherwise stated on the
Notice of Grant Award. Under these rules the Principal
Investigator may exercise flexibility to meet unexpected Center
requirements by rebudgeting or requesting approval to rebudget
among categories within the total direct cost budget of the
Center (as shown on the Notice of Grant Award), within the
ceilings set in these guidelines.
CHRC grants are for five years, at a maximum level set by
Congressional action of $400,000 (direct plus indirect cost)
annually, and are renewable. Competing continuation (renewals)
are limited by Congressional action to one two-year period. No
institution will be funded for a CHRC for more than seven years
in any twelve-year period.
Items fundable under a CHRC grant include:
A. Administration
1. Salaries and support for a Center program director
(maximum 10% time and effort), a part-time secretary, and a
recruiting officer (maximum 20% time and effort).
2. Administrative support services, including supplies,
duplicating equipment, telephone, or maintenance contracts for
equipment when not covered by institutional overhead charges.
3. Travel of Principal Investigator and program director to
administrative meetings with NICHD staff and to an annual
scientific meeting of Centers.
B. Shared Core Laboratory (maximum $200,000 annually)
1. Salaries and support for shared core laboratory staff.
2. Supplies and animals.
3. Scientific equipment (purchase and maintenance).
4. Computer facilities.
C. New Project Development Funds (maximum $200,000 annually)
Each junior investigator may receive up to $30,000 annually
for projects of that are pursued in their own laboratories, in
the shared core laboratory, and/or in the laboratories of the
established investigators. For each project supported in this
category, the maximum expenditure for equipment is $5,000
annually and for travel $1,000 annually. The grant application
should indicate the number of awards proposed for each year and
provide evidence that this number of worthwhile projects is
likely to be forthcoming. No investigator may receive more than
one such award per year.
One particularly promising investigator who is designated as
the Center's Pediatric Scientist may be awarded up to $100,000
from this budget category, of which up to $50,000 may be
allocated to salary and fringe benefits, $5,000 to small
equipment, and $1,000 to travel. The rest of the award may be
used for technical assistance, supplies, and miscellaneous
expenses. Salary may be supplemented from other sources.
It is not a requirement that any CHRC grant be funded at the
allowable budgetary maximum in any particular year. The number
of New Project Development Awards to be supported must be
commensurate with the institution's capacity to develop and
recruit appropriate candidates. A Pediatric Scientist candidate
should be nominated only when an unusually qualified and
promising person is identified. Small size of the budget request
is not a disadvantage for Center funding, provided the support
for core resources (administration, shared core laboratory) is in
proportion to the activity in new investigator development which
is the Center's primary purpose. To encourage use of these funds
only for the most deserving candidates, requests will be
considered for carry over of unexpended New Project Development
Funds into subsequent budget periods.
Items not fundable under a CHRC grant include:
1. Direct support of the laboratories, salaries, fringe
benefits, travel, and research projects of the established
investigators, except for reimbursement for costs from New
Project Development Funds within the Center.
2. Salary and support for central institutional
administrative personnel usually paid from institutional overhead
charges, such as budget officers, grant assistants, and building
maintenance personnel.
3. Salary and support for administrative activities such
as public relations or health and educational services.
4. Travel of Principal Investigator, program director,
core laboratory director, or established investigators to
scientific meetings.
5. Costs of clinical care, such as patient bed days or
outpatient visit charges.
6. Alterations and renovations.
V. Review Criteria
A. The review criteria for the evaluation of new and
competing continuation CHRC applications include the following:
1. Relevance of the theme or area of emphasis of the
Center to programmatic needs of the NICHD.
2. Probable impact of the Center on enhancing the
capacity of the grantee institution to develop well-qualified
pediatric investigators, thereby advancing pediatric research at
the grantee institution, in the local medical environment, and in
the Nation, especially with regard to the integration of basic
research with clinical problems in pediatrics.
3. Quality and productivity of the research activities
of the participating established investigators, and relevance of
their programs to the Center theme or area of emphasis.
4. Nature and quality of the shared core laboratory:
technical merit, scientific justification, evidence of
cost-effectiveness, procedures for quality control and allocation
of resources, qualifications of the core laboratory director and
technical staff, and probable utility to the investigators.
5. Institutional commitment to the requirements of the
program, such as recruitment efforts, salaries, equipment, or
other forms of cost sharing.
6. Evidence for a pool of prospective investigators,
trained locally or recruited from elsewhere, who could benefit
from receiving support from the Center.
7. Procedures established for evaluating candidates for
New Project Development Funds and the Pediatric Scientist
position of the Center, and providing internal quality control of
ongoing research.
8. Efforts to develop novel mechanisms for recruiting
candidates for New Project Development Awards from groups
under-represented in pediatric research.
9. Opportunities for faculty positions emphasizing
research for recipients of New Project Development Funds at the
applicant institution or elsewhere.
10. Previous success of the institution in developing new
pediatric investigators.
11. For renewal (competing continuation) applications, or
subsequent new applications from an institution with a
previously-funded Center, success of the Center-funded junior
investigators in producing research publications and in obtaining
independent, competitively awarded support for pediatric
research.
B. Non-competing continuations:
Annual progress reports of a CHRC grant will be reviewed with
particular care by NICHD staff and outside consultants in order
to confirm that the Center is continuing to meet its goal of
recruiting promising new pediatric investigators and stimulating
and facilitating their career development. In addition, each
Center will be asked to send some of its recent recipients of
research support, as well as the Principal Investigator and/or
program director, to an annual meeting. One purpose of this
meeting will be to allow these junior investigators to present
results of their Center-supported research to their peers as well
as to other critics. Center program directors and Principal
Investigators will have an opportunity at these meetings to
exchange ideas about common problems and make suggestions to
NICHD staff about possible modifications in the program.
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.
VI. Application Procedure
A. Text Format
Applicants should follow the instructions for applications
included in the "National Institute of Child Health and Human
Development Research Center Programs P30 Center Core Grant
Guidelines," except where these are at variance with these
specific guidelines for CHRC grants. Since P30 Guidelines were
not designed primarily to be used for CHRC-type applications,
considerable flexibility in format will be permitted. Applicants
should take care, however, that adequate information is provided
for evaluation with respect to the eleven review criteria
described in Section V. The Letter of Intent described in the P30
guidelines is not required, but prospective applicants are urged
to discuss their plans with Institute staff. The information
provided in the application should be sufficient to allow
reviewers to evaluate the proposal on the basis of the criteria
listed in Section V.A., above. Specific research projects
proposed for support need not be described in the initial
application. However, a brief description of examples of junior
investigators who might be supported through this award, research
areas in which they would work, and established investigators who
would supervise them might provide evidence that enough worthy
projects will be available to justify the requested budget.
B. Budget Format
Each application submitted in response to this RFA should
include several separate budget pages (plus any budget
justification pages):
1. A composite budget, the sum of the other budgets, in
categories, for the first year. New Project Development Funds
should be listed under Other Expenses.
2. A budget for the administrative core (unless no funds
are requested for this core), including personnel or supplies,
travel for the Principal Investigator and program director to the
Centers' meeting, and any other expenses requested, for the first
year.
3. A budget for the shared core laboratory (unless no
funds are requested for this purpose), including personnel,
equipment, supplies, and other expenses.
4. A budget for New Project Development, providing under
Other Expenses the total dollars and minimum number of positions
requested, according to the following format:
(Example)
New Project Development Awards: 3 @$ 30,000 = $ 90,000
Pediatric Investigator Award: 1 @$100,000 = $100,000
Total $190,000
The New Project Development Funds budget need not be
allocated into categories because these will vary with the
situations of the recipients. However, it should be specified to
what extent these funds will be used for salaries. The number of
such awards planned should be appropriate for the size of the
institution, the number and skills of the established
investigators, and the magnitude of the request for Center
administration and core laboratory resources.
5. The usual future-year continuation page, listing New
Project Development Awards (including the Pediatric Investigator
Award, if any) under Other Expenses.
VII. Mechanism of Support
Support for this program will be through NICHD Center Core Grant
(P30) awards. Policies that govern grant-in-aid award programs
of the Public Health Service will prevail.
The support of grants pursuant to the RFA is contingent upon
ultimate receipt of appropriated funds for this purpose. The
number of awards will be influenced by the amount of funds
available to the Institute, by the overall merit of proposals,
and by their relevance to program goals. It is anticipated that
four meritorious applications will be funded from responses to
this RFA.
VIII. Review Procedures
Applications will be reviewed by NICHD staff for responsiveness
to the RFA. A non-responsive application will be returned to the
applicant. 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. NICHD will withdraw from competition those applications
judged to be noncompetitive and notify the applicant and
institutional business official.
Applications considered responsive to this RFA will be reviewed
for technical merit by an Initial Review Group convened by the
scientific review staff of the NICHD solely to evaluate these
applications. Criteria for the initial review have been
described above. 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 are
made.
Applications should be submitted on form PHS-398 (rev. 10/88),
which is available in the business or grants and contracts office
at most academic and research institutions and from the Division
of Research Grants, NIH. Applications prepared in response to
this RFA should be received by April 9, 1991.
The RFA label available in the 10/88 revision of Application Form
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 review committee in time
for review.
The title of the grant application should be indicative of the
scientific area or theme of the Center, and should not be simply
"Child Health Research Center." The phrase "PREPARED IN RESPONSE
TO RFA HD-91-04: CHILD HEALTH RESEARCH CENTERS" should be typed
on line two of the face page of the application. The original
and four copies of the application must be sent or delivered to:
Application Receipt Office
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD 20892**
In addition to applications and copies mailed to the Division of
Research Grants, two copies of the application must be sent under
separate cover to:
Laurance Johnston, Ph.D.
Scientific Review Program
National Institute of Child Health
and Human Development, NIH
Room 520, Executive Plaza North
Rockville, MD 20852
IX. Timetable
Application receipt date April 9, 1991
Initial review date July 1991
Review by Advisory Council September 1991
Anticipated award date September 30, 1991
X. Inquiries may 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
Room 637, Executive Plaza North
Rockville, MD 20852
Telephone: (301) 496-5593
Grants Management Contact:
Mr. E. Douglas Shawver
Office of Grants and Contracts
National Institute of Child Health and Human Development
Room 501, Executive Plaza North
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.