Full Text HD-94-020

MENTAL RETARDATION RESEARCH CENTERS

NIH GUIDE, Volume 23, Number 12, March 25, 1994

RFA:  HD-94-020

P.T.


Keywords: 


National Institute of Child Health and Human Development

Letter of Intent Receipt Date:  May 15, 1994
Application Receipt Date:  July 15, 1994

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.  Four centers may be
supported in response to this RFA.

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.
Mental Retardation Research Center 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 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.  NICHD has provided partial support for a limited
number of these centers through the provision of core grants (P30),
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 Request for Applications (RFA) 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 Branch's Mental Retardation Research Centers
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, as well as studies designed to meet
the unique needs of the afflicted children.  Therefore, one of the
missions of the MRDD Branch is to support research on the etiology,
pathophysiology, epidemiology, diagnosis and evaluation, prevention,
and amelioration of mental retardation.

The purpose of a Mental Retardation Research Center is to provide a
research environment that 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 Mental Retardation Research Centers.  As a result of the
administrative and scientific organization within an 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 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 or 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.

MECHANISM OF SUPPORT

Mental Retardation Research Center grants will be supported through
the center core grant (P30) mechanism.  The application should be
prepared in a manner consistent with the general guidelines presented
in the publication titled P30 CENTER CORE GRANT GUIDELINES, which is
available from the MRDD Branch office listed below.

Awards will be made for a period of five years.  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.

The total direct costs requested for the first year of a new Center
Core Grant (P30) should not exceed $500,000.  Renewal applications
from existing P30 Centers may request initial year direct costs up
to, but not 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.  Applications with budget requests exceeding
these guidelines will be administratively withdrawn by NICHD and
returned to the applicant.

FUNDS AVAILABLE

This is the seventh in a series of annual announcements.  Plans are
to make four awards in fiscal year 1995.  The estimated funds
available for the first year of support for the entire program is
$3.3 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 OBJECTIVES

Mental Retardation Research Center 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 Mental Retardation Center Core Grants (P30) should
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 their center.  Center grant applications
must include, but are not limited, among these topics at least five
of the following:

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

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

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

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

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

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

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

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

9.  Diagnosis:  development and application of biomedical and
behavioral methods and measures; identification of children and
infants at risk for MRDD.  Early interventions for infants at risk to
develop MRDD:  research into the process of early intervention
strategies.

10. 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;
hypoxic or ischemic insults.

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

12. 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.

13. 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.

14. Family and community studies: parent-child and family
interactions; sexual behaviors; family structure and demographic
variables, including ethnic minority families with members with MRDD;
family and community factors influencing developmental outcomes and
adjustment; community resources; caregiver behavior; and social
support networks.

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

16. Learning disabilities, dyslexia, and attention deficit disorder.

17. Residential, educational, and occupational settings throughout
the life- span:  effects on behavior and adjustment of MRDD
individuals; learning and social behavior in educational settings;
adaptation to residential environments; aberrant behavior, including
stereotypies, destructive behavior, and self-injury.

18. 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.

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

20. Behavior and life-styles that could affect mortality and
morbidity.

STUDY POPULATIONS

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS

It is the policy of the NIH that women and members of minority groups
and their subpopulations must be included in all NIH supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations), which
have been in effect since 1990. The new policy contains some
provisions that are substantially different from the 1990 policies.

All investigators proposing research involving human subjects should
read the "NIH Guidelines For Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 9, 1994 (FR 59 11146-11151) and reprinted
in the NIH Guide for Grants and Contracts, Volume 23, Number 11,
March 18, 1994.

Investigators also may obtain copies of the policy from the program
staff listed under INQUIRIES.  Program staff may also provide
additional relevant information concerning the policy.

(NOTE:  When the proposed study or studies in the RFA or PA involves
a gender specific study or a single or limited number of minority
population groups, this should also be stated to inform potential
applicants and reviewers.)

LETTER OF INTENT

Prospective applicants are asked to submit, by May 15, 1994, 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 evaluating relevance to MRDD and in
planning for the review of applications.

The letter of intent is to be sent to:

Felix F. de la Cruz, M.D., M.P.H.
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B-09
Bethesda, MD  20892
Telephone:  (301) 496-1383

APPLICATION PROCEDURES

Applications are to be submitted using PHS 398 (rev. 9/91).
Application kits containing this form and the necessary instructions
are available in most institutional offices of sponsored research;
from the Office of Grants Information, Division of Research Grants,
National Institutes of Health, 5333 Westbard Avenue, Room 449,
Bethesda, MD 20892, telephone 301/435-0714; and from the NIH program
administrator listed under INQUIRIES.  The NICHD recommends that the
application be developed in consultation with the MRDD Program staff,
who will provide whatever guidance is possible and appropriate in
relation to both scientific and administrative issues.

Applicants for P30 Mental Retardation Research Center grants should
propose a program with a theme relevant to the mission of the MRDD
Branch as outlined above.  The program should 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 should 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 are expected 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, at
least one of which is funded by the MRDD Branch of NICHD, exclusive
of research contracts, training grants, interagency agreements, and
NIH-supplemental projects funded by other agencies.  Program staff
will make exceptions to this requirement in instances where research
relevant to MRDD is assigned elsewhere within NICHD.  Subprojects
within a program project (P0l) will be considered as individual
projects comparable to an R0l.  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 should 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 should 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 newly trained investigators' research
programs.  New Program Development projects should be comparable to
R0l research applications in their 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.

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, a copy of the covering letter and 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
6100 Executive Boulevard, Room 5E-03
Bethesda, MD  20892

Applications must be received by July 15, 1994.  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 and/or
nonresponsive applications will be returned to the applicant without
further consideration.  Applications may be triaged by a peer review
group on the basis of relative competitiveness.  If so, 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 by the NICHD
Mental Retardation Research Committee at its March 1995 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 1995 meeting.  The
anticipated date of award is August 1, 1995.

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 scientific collaborators;
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  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;
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.

AWARD CRITERIA

In addition to the scientific and technical merit of the application,
other factors will be considered in making the awards.  Among these
are:

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

o  availability and quality of resources, especially institutional
commitment;

o  access to unique 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.
Inquiries regarding programmatic issues may be directed to:

Felix F. de la Cruz, M.D., M.P.H.
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B-09
Bethesda, MD  20892
Telephone:  (301) 496-1383

Inquiries regarding fiscal matters may be directed to:

Mr. Edgar D. Shawver
Office of Grants and Contracts
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A-17
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.

The Public Health Service strongly encourages all grant recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products.  This is consistent with the PHS mission to protect and
advance the physical and mental health of the american people.

.

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