Full Text HD-93-01

MENTAL RETARDATION RESEARCH CENTERS

NIH GUIDE, Volume 21, Number 10, March 13, 1992

RFA:  HD-93-01

P.T. 04

Keywords: 
  Mental Retardation 
  Diagnosis, Medical 
  Disease Prevention+ 
  Behavioral/Social Studies/Service 
  Child Psychology/Development 
  Biomedical Research, Multidiscipl 


National Institute of Child Health and Human Development

Letter of Intent Receipt Date:  April 17, 1992
Application Receipt Date:  July 17, 1992

PURPOSE

The National Institute of Child Health and Human Development (NICHD),
through the Mental Retardation and Developmental Disabilities Branch
(MRDD), Center for Research for Mothers and Children (CRMC), invites
research center core grant applications as part of the NICHD Mental
Retardation Research Program to develop new knowledge in the field of
diagnosis, prevention, treatment, and amelioration of mental
retardation and developmental disabilities.

A Mental Retardation Research Center (MRRC) is a center to facilitate,
through organization and operation, a program of biomedical and/or
behavioral research related to mental retardation.  MRRC core grants
support multidisciplinary research in areas that may lead to diagnosis,
prevention, treatment, and/or amelioration of mental retardation and
developmental disabilities.  These grants fund core support services,
administration, and development of a limited number of new research
programs.

The primary objective of the NICHD Mental Retardation Research Centers
Program is to provide support and facilities for a cohesive,
interdisciplinary program of research and research training in mental
retardation and related aspects of human development.  Public Law
88-164, Title I, Part A authorized construction of mental retardation
research centers.  The NICHD has provided partial support for a limited
number of these centers through the provision of core grants, which
facilitate program coordination and support central research
facilities.  Funds for the research projects using these core
facilities come from independent sources including Federal, State, and
private organizations.  This announcement seeks applications not only
from these constructed centers, but also from other comparable
institutions that meet the qualifications for a program of mental
retardation research.

A major goal of the MRDD's Mental Retardation Research Centers Program
is to prevent and/or ameliorate mental retardation.  The degree of
impairment associated with mental retardation varies in relation to the
cause.  Moderate and more severe mental retardation often results from
problems that produce profound alterations in brain development and/or
function.  Diminished intellectual and adaptive capacity can often be
traced to defective genes, teratogenic agents, toxic substances,
infections, nutritional deficits, accidents, diseases, and other
disorders causing brain damage.  A larger proportion of cases of mental
retardation is related to environmental conditions and disorders of
unknown etiology.  These complex problems require integrated,
multidisciplinary approaches involving biomedical and behavioral
sciences in a variety of settings.

More than 400 mental retardation syndromes have been identified and new
ones are being discovered.  Each requires fundamental research into the
underlying processes, and studies designed to meet the unique needs of
the afflicted children.  Therefore, one of the missions of the MRDD is
to support research on the etiology, pathophysiology, epidemiology,
diagnosis and evaluation, and prevention or amelioration of mental
retardation.

The purpose of an MRRC is to provide a research environment which
facilitates interdisciplinary collaboration among investigators who are
working in areas of relevance to the prevention and amelioration of
mental retardation.  Such research will cover a broad spectrum of
scientific approaches ranging from laboratory research on fundamental
processes of normal and abnormal development, to clinical and
behavioral research in which persons with mental retardation are
studied.  It is thought that major solutions to the problems of mental
retardation may be found as a result of multidisciplinary collaboration
involving a variety of approaches in the MRRC.  As a result of the
administrative and scientific organization within a MRRC and across the
network of MRRCs, opportunities for breakthroughs will be enhanced.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This Request
for Applications (RFA), Mental Retardation Research Centers, is related
to several priority areas including nutrition, alcohol and other drugs,
mental health and mental disorders, environmental health, maternal and
fetal health, HIV infection, immunization and infectious diseases.
Potential applicants may obtain a copy of "Healthy People 2000" (Full
Report:  Stock No. 017-011-00474-0) or "Healthy People 2000" (Summary
Report:  Stock No. 017-001-00473-1) through the Superintendent of
Documents, Government Printing Office, Washington, DC 20402-9325
(telephone 202-783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic for-profit and non-profit
organizations, public and private, such as universities, colleges,
hospitals, laboratories, and units of State and local governments.  As
stated in the NICHD Center Guidelines, the NICHD will not support more
than one center grant (P30 or P50) in a given department or specialty
unit.  To be eligible for award as an MRRC, the Center must provide
core support for a minimum of 10 projects funded from non-university
sources.

MECHANISM OF SUPPORT

MRRC grants will be supported through the Center Core (P30) grant.
Awards will be made for a period of five years.

The total direct costs requested for the first year of a new Center
Core Grant (P30) may not exceed $500,000.  Competing renewal
applications from existing P30 Centers may not request initial year
direct costs exceeding 120 percent of the Notice of Grant Award level
of direct costs for the final year of the preceding project period, or
$500,000 direct costs, whichever is greater.  Budget increments for
subsequent years generally will be limited to four percent.  Budgets of
new and renewal applications will be stringently reviewed within these
guidelines.  An application with a budget request exceeding these
guidelines will be administratively withdrawn by NICHD and returned to
the applicant.

The anticipated date of award is August 1, 1993.

FUNDS AVAILABLE

This is the fifth in a series of annual announcements.  Plans are to
make four awards in fiscal year 1993.  The estimated funds available
for the first year of support related to this RFA is $3.1 million total
costs.

This level of support is dependent on the receipt of a sufficient
number of applications of high scientific merit.  Although this program
is provided for in the financial plans of the NICHD, awards pursuant to
this RFA are also contingent upon the availability of funds for this
purpose.

RESEARCH SCOPE

MRRC core grants are intended to bring together in a center scientists
from a variety of disciplines to work on the common problems of mental
retardation.  Consequently, applications for MRRCs must include
investigators studying a range of topics in basic and clinical or
applied research.  Applicants are encouraged, but are not required, to
include both biomedical and behavioral components among the topics
addressed within the center.  Center grant applications must include at
least five of the following topics:

o  Developmental neurobiological studies relevant to MRDD:
neurophysiological, neuroanatomical, neurochemical, and
neuropharmacological.

o  Inborn errors of metabolism relevant to MRDD:  pathophysiology,
recombinant DNA technology, screening, and applied clinical and
experimental studies including treatment.

o  Genetic/cytogenetic disorders associated with MRDD:  antenatal
diagnosis research, particularly non-invasive methods during the early
stages of pregnancy, on prevalent genetic causes of mental retardation,
such as Down's syndrome or Fragile X syndrome; research on rare genetic
disorders associated with mental retardation.

o  Molecular biology:  gene localization, structure, function and
organization; gene mapping; gene therapy; and development of animal
models.

o  Toxicology and physical environmental factors in the etiology,
treatment, and prevention of MRDD including lead, mercury, and alcohol;
developmental and behavioral teratology; and subclinical levels of
toxic agents and their effects on morphological and behavioral changes
associated with mental retardation.

o  Effects of malnutrition (protein, calorie, micronutrients) on
intellectual, behavioral, social, and physical development and the
intergenerational effects of malnutrition.

o  Developmental pharmacology and psychopharmacology:  medication used
with MRDD populations.

o  Infectious diseases in the etiology, prevention, and treatment of
MRDD; neurological, neuropathological, behavioral, and intellectual
consequences of AIDS in children.

o  Diagnosis:  development and application of biomedical and behavioral
methods and measures; identification of children and infants at risk
for MRDD.

Predictive and developmental studies of perinatal problems associated
with MRDD: developmental studies of low-birth weight, small for
gestational age, preterm, and neonatally sick infants.

o  Psychobiological processes in MRDD of conditions such as autism and
Rett syndrome using methods of behavioral genetics, embryology, and
teratology, and developmental neuroscience and psychophysiology.

o  Psychological processes in MRDD:  studies of cognitive and
information processing; attention and perception; sensory and motor
development; family, social, and affective behavior; and motivation and
personality.

o  Early interventions for infants at risk to develop MRDD:  research
into the process of early intervention strategies.

o  Behavioral analyses:  manipulations of interaction between behavior
and environments of individuals with MRDD to reduce problem behaviors,
facilitate vocational training, improve social and self-help skills,
and increase acquisition of adaptive behaviors.

o  Family and community studies:  parent-child and family interactions;
sexual behaviors; family structure and demographic variables; family
and community factors influencing developmental outcomes and
adjustment; community resources; caregiver behavior; social support
networks; and the effects of children with MRDD on family life in
different ethnic groups.

o  Language and communication of MRDD populations:  studies on
development of alternative communication systems; ontogeny of
linguistic processes.

o  Learning disabilities, dyslexia, and attention deficit disorder.

o  Residential and educational setting:  effects on behavior and
adjustment of MRDD individuals; learning and social behavior in
educational settings; adaptation to residential environments; aberrant
behavior, e.g., self-injury.

o  Socioeconomic status, ethnicity, and ecological processes:
interaction of MRDD individuals in multiple settings (naturalistic
observation); ethnographic research; life history reporting; systematic
observation of specific activities.

o  Epidemiology of MRDD:  analytic and case-control studies of
etiology, prevalence, follow-up of outcomes.

STUDY POPULATIONS

NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS

NIH policy requires applicants for NIH grants that include clinical
research to include minorities and women in study populations so that
research findings can be of benefit to all persons at risk of the
disease, disorder or condition under study; special emphasis must be
placed on the need for inclusion of minorities and women in studies of
diseases, disorders and conditions which disproportionately 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 must be provided.

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group.  In addition, gender and
racial/ethnic issues must be addressed in developing a research design
and sample size appropriate for the scientific objectives of the study.
This information must be included in the form PHS 398 in section 2, 1-4
of the Research Plan and summarized in Section 2, E, Human Subjects.
Applicants are urged to assess carefully the feasibility of including
the broadest possible representation of minority groups.  However, NIH
recognizes that it may not be feasible or appropriate in all research
projects to include representation of the full array of United States
racial/ethnic minority populations (i.e., Native Americans [including
American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks,
Hispanics).  In that case, the rationale for studies on single minority
population groups should be provided.

For the purpose of this policy, clinical research is defined as human
biomedical and behavioral studies of etiology, epidemiology, prevention
(and preventive strategies), diagnosis, or treatment of diseases,
disorders or conditions, including but not limited to clinical trials.

The usual NIH 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 the applicants.  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 reflected in assigning
the priority score to the application.  In addition, NIH funding
components will not award grants or cooperative agreements that do not
comply with these policies.

Because P30 funds do not directly support research projects, the issue
of minority/gender representation will need to be addressed at the
individual project level (i.e., R01 level).  However, the application
will specifically need to address these issues for any new program
development projects or core units that focus on subject recruitment.

LETTER OF INTENT

Prospective applicants are asked to submit, by April 17, 1992, a letter
of intent that includes a descriptive title of the proposed research,
the name, address, and telephone number of the Principal Investigator,
the names of other key personnel and participating institutions, the
core unit directors and principal investigators of the research
projects that would use the core units, and the number and title of the
RFA in response to which the application may be submitted.

Although a letter of intent is not required, is not binding, and does
not enter into the review of subsequent applications, the information
that it contains is helpful in planning for the review of applications.
It allows NICHD staff to estimate the potential review workload and to
avoid possible conflict of interest in the review.

The letter of intent is to be sent to:

MRDD Branch, CRMC
National Institute of Child Health and Human Development
Room 631, Executive Plaza North
6130 Executive Boulevard
Bethesda, MD  20892
Telephone:  (301) 496-1383

APPLICATION PROCEDURES

The applicant is to submit the application using PHS 398 (rev. 9/91).
Application kits containing this form and the necessary instructions
are available in most institutional business offices and may be
obtained from the Office of Grants Inquiries, Division of Research
Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449,
Bethesda, MD 20892, telephone 301/496-7441, and from the NIH program
administrator named below.  The NICHD recommends that the application
be developed in consultation with the MRDD Program staff, CRMC, who
will provide appropriate guidance in relation to both scientific and
administrative issues.

The application must be prepared in a manner consistent with the
general guidelines presented in the publication titled P30 CENTER CORE
GRANT GUIDELINES that are available form the MRDD Branch office listed
below.

Applicants for the MRRC grants must propose a program with a theme
relevant to the mission of the MRDD as outlined above.  The program
must consist of at least 10 externally funded research projects grouped
according to relevant topics.  These projects must be of high quality,
providing a multidisciplinary approach to the problem(s) being
investigated.  Each project is to be summarized in accordance with the
NICHD P30 Center Core Grant Guidelines.

The MRRC Director must be a scientist or science administrator who can
provide effective administrative and scientific leadership.  The
Director will be responsible for the organization and operation of the
MRRC and for communication with the NICHD on scientific and operational
matters.  Scientific personnel and institutional resources capable of
providing a strong research base in the fields specified must be
available.  In addition, the institution and pertinent departments have
to show a strong commitment to the center's support.  Such commitment
may be provided as dedicated space, salary support for investigators,
dedicated equipment, or other financial support for the proposed MRRC.

Each core unit proposed for funding under the MRRC grant must be
utilized by at least three Federally funded research projects, one of
which is NIH funded, exclusive of research contracts, interagency
agreements, and NIH-supplemental projects funded by other agencies.
Subprojects within a program project (P01) will be considered as
individual projects comparable to an R01.  A detailed description of
each core unit proposed as part of the center must be provided with
detailed budget and budget justification.  A scientist must be named as
responsible for each core unit proposed.  The description of the core
units proposed must include a rationale to show how they will support
the research effort in a cost-effective manner.  Facilities must be
available for the primary needs of the MRRC Program and require no more
than modest alteration and/or renovation.  Funds for new construction
will not be provided.  Promoting interdisciplinary collaboration among
scientists working within a Center is a major goal of the MRRC Program.
Each MRRC applicant must submit a plan, as part of the application, to
ensure continuing interaction among participating scientists from
different disciplines.

Another goal of the MRRC Program is to attract scientists to the field
of mental retardation research.  Therefore, where appropriate, the
applicant may request "New Program Development" funds for direct
research support of one or more projects not to exceed a total of
$50,000 per year or 10 percent of total direct cost, whichever is less.
Such funds might serve to attract new investigators to the Center, to
develop a new area or program of research, or to facilitate the
development of research programs for newly trained investigators.
Descriptions of New Program Development projects should be comparable
to R01 research applications in the amount of detail and development.
Each such project can provide support for only two years for any one
investigator.

It is a major goal of the NICHD to promote active collaboration among
MRRCs.  To accomplish this goal, the successful applicants will be
encouraged to participate in the collaborative efforts of established
MRRC programs.  Some consideration should be given, in planning the
program, to potential collaborative studies and projects that might be
proposed for the MRRC network.

The RFA label available in the PHS 398 application form must be affixed
to the bottom of the face page of the application.  Failure to use this
label could result in delayed processing of the application such that
it may not reach the review committee in time for review.  Applications
must be identified by checking the YES box in item number 2a on the
face page of the application and typing in RFA HD-93-01, Mental
Retardation Research Centers, and then insert P30 in Item Number 2b.

Submit a signed, typewritten original of the application, including the
Checklist, and three signed, photocopies, in one package to:

DIVISION OF RESEARCH GRANTS
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

At the time of submission, two additional copies of the application
must also be sent to:

Acting Director, Division of Scientific Review
National Institute of Child Health and Human Development
Executive Plaza North, Room 520
6130 Executive Boulevard
Bethesda, MD  20892

Applications must be received on or before July 17, 1992.  If an
application is received after that date, it will be returned to the
applicant.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed by NIH staff for
completeness and responsiveness to the RFA.  Incomplete applications
will be returned to the applicant without further consideration.  Under
certain circumstances, applications may be triaged by a peer review
group on the basis of relative competitiveness.  The NIH will withdraw
from further competition those applications judged to be
non-competitive for award and notify the applicant Principal
Investigator and institutional official.  Applications judged to be
competitive will undergo further scientific merit review.  Applications
that are complete and responsive will then be evaluated for scientific
and technical merit by the NICHD Mental Retardation Research Committee
at its March 1993 meeting, in accordance with the criteria stated
below.  Because a site visit is not a prerequisite for MRRC
consideration, each application should be thorough and complete enough
to stand on its own.  The second-level review will be made by the
National Advisory Child Health and Human Development Council at its
June 1993 meeting.

Review Criteria

Criteria for the initial review of applications include:

o  scientific, technical, or medical significance of the application;

o  qualifications and research experience of the Principal Investigator
and staff;

o  scientific and administrative leadership of the Principal
Investigator;

o  quality of proposed core facilities;

o  availability and quality of resources and research environment;

o  appropriateness of the proposed budget;

o  adequacy of plans for the protection of human subjects;

o  adequacy of plans to protect against or minimize adverse effects on
animals;

o  inclusion of women and minority subjects in research;

o  quality and relevance to mental retardation of research projects
that will be using the core facilities;

o  plans for interdisciplinary/multidisciplinary collaboration;

o  cost-effectiveness of the proposed MRRC;

o  institutional commitment.

AWARD CRITERIA

In addition to the scientific and technical merit of the application,
the following factors will be considered in making awards:

o  centers addressing research areas of high programmatic interest to
the MRDD, the CRMC, and NICHD; and areas targeted by Congress;

o  availability and quality of resources, especially institutional
commitment and support;

o  access to unique study populations

o  potential to increase productivity and quality of research within
the center, and stimulate interdisciplinary/multidisciplinary
collaborations;

o  providing unique resources for the use of other Centers, and the
greater research community; and

o  cost-effectiveness of the core facilities

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.
Direct inquiries regarding programmatic issues to:

Felix F. de la Cruz, M.D., M.P.H.
Chief, MRDD Branch, CRMC
National Institute of Child Health and Human Development
Executive Plaza North, Room 631
6130 Executive Boulevard
Bethesda, MD  20892
Telephone:  (301) 496-1383

Direct inquiries regarding fiscal matters to:

Mr. Edgar D. Shawver
Supervisory Grants Management Specialist
Office of Grants and Contracts
National Institute of Child Health and Human Development
Executive Plaza North, Room 505
6130 Executive Boulevard
Bethesda, MD  20892
Telephone:  (301) 496-1303

AUTHORITY AND REGULATIONS

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, Title IV, Part A
(Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and
285) and administered under PHS grants policies and Federal Regulations
42 CFR 52 and 45 CFR Part 74.  This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review.

.

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