Full Text HD-94-003

MENTAL RETARDATION RESEARCH CENTERS

NIH GUIDE, Volume 22, Number 11, March 19, 1993

RFA:  HD-94-003

P.T. 04

Keywords: 
  Mental Retardation 
  Disease Prevention+ 
  Treatment, Medical+ 
  Biomedical Research, Multidiscipl 


National Institute of Child Health and Human Development

Letter of Intent Receipt Date:  April 16, 1993
Application Receipt Date:  July 16, 1993

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 (P30) as part of the
Institute's Mental Retardation Research Program to develop new
knowledge in the field of diagnosis, prevention, treatment, and
amelioration of mental retardation and developmental disabilities.
Three centers may be supported in response to this announcement.

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.  The
NICHD has provided partial support for a limited number of these
centers through the provision of core grants (P30), that 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 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 or
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 Request for
Application (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.

MECHANISM OF SUPPORT

Mental Retardation Research Center grants will be supported through the
customary grant-in-aid mechanism.  The application should be prepared
in a manner consistent with the general guidelines presented in the
publication, 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 cost of a center will be a material consideration in the selection
of applications for funding.  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, but not
exceed, initial year direct costs of up to 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 the
NICHD and returned to the applicant.

FUNDS AVAILABLE

This is the sixth in a series of annual announcements.  Plans are to
make three awards in fiscal year 1994.  The estimated funds available
for the first year of support for the entire program is $2.4 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

MRRC core grants (P30) 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  MRRC 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 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

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 and 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 sections 1-4
of the Research Plan and summarized in Section 5, Human Subjects.
Applicants are urged to assess carefully the feasibility of including
the broadest possible representation of minority groups.  However, NIH
recognizes that it may not be feasible or appropriate in all research
projects to include representation of the full array of United States
racial/ethnic minority populations (i.e., Native Americans [including
American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks,
Hispanics).  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 in general 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

If an investigator is satisfied that his/her institution meets the
qualifications prescribed and elects to apply for a Mental Retardation
Research Center (P30), a letter of intent may be submitted to the MRDD
Branch at the address given below by April 16, 1993.  The letter of
intent should include 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

The applicant is to submit the application using PHS 398 (rev. 9/91).
Application kits containing this form and the necessary instructions
are available from most institutional offices of sponsored research;
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, 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 must
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 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, at least
one of which is funded by the MRDD Branch of the 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 the NICHD.  Subprojects
within a program project (POl) will be considered as individual
projects comparable to an ROl.  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 assure 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 ROl 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 2a on the face page
of the application and entering the words "In response to RFA HD-94-03,
Mental Retardation Research Centers," and then insert P30 in Item 2b.
In addition, a brief cover letter may accompany the application
indicating that it is in response to this RFA.

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 cover 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 16, 1993.  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.  In that case, 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 1994 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 1994 meeting.  The
anticipated date of award is August 1, 1994.

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 and support;

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.

.

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