Full Text HD-95-012

MENTAL RETARDATION RESEARCH CENTERS

NIH GUIDE, Volume 24, Number 12, March 31, 1995

RFA:  HD-95-012

P.T. 04

Keywords: 
  Mental Retardation 
  Biomedical Research, Multidiscipl 
  Disease Prevention+ 


National Institute of Child Health and Human Development

Letter of Intent Receipt Date:  May 12, 1995
Application Receipt Date:  July 14, 1995

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 (P30) applications 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.
Four centers may be supported in response to this Request for
Applications (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 MRRCs 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), 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 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 result
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 large 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.  Several 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 affected 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 MRRCs.  As a result of the administrative and scientific
organization within a Center 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, and immunization and infectious diseases.  Potential
applicants may obtain a copy of "Healthy People 2000" (Full Report:
Stock No. 017-001-00474-0 or 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.
Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as Principal Investigators.  For
the purpose of this RFA, the NICHD will not support more than one
mental retardation and developmental disabilities research center
grant (P30 or P50) in a given university or other applicant
institution.

MECHANISM OF SUPPORT

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

Awards will be made for a period of five years.  To be eligible for
an award, 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 funding
decision.  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 eighth in a series of annual announcements.  Plans are to
make four awards in fiscal year 1996.  The estimated funds available
for the first year of support for the entire program is $3.5 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 Research 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 among these topics at least five of the following that
are focused specifically on mental retardation and developmental
disabilities:

1.  Developmental neurobiological studies relevant to MRDD:
neurophysiology, neuroanatomy, neurochemistry, neuropharmacology,
neuroplasticity.

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,
essential fatty acids) 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.

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

11.  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.

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

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

14.  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.

15.  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.

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

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

18.  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
stereotypes, destructive behavior, and self-injury.

19.  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.

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

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

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 are
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 28, 1994 (FR 59 14508-14513) 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.  The Director, Division of Scientific
Review, NICHD, may also provide additional relevant information
concerning the policy.

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 (e.g., R01 level).
However, the application will specifically need to address these
issues for any new program development projects involving human
subjects or core units that focus on human subject recruitment.

LETTER OF INTENT

Prospective applicants are asked to submit, by May 12, 1995, a letter
of intent that includes a descriptive title of the proposed research,
the name, address, and telephone number of the Principal
Investigator, the identities of other key personnel and participating
institutions, 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 a subsequent application, the information that it contains allows
NICHD staff to estimate the potential review workload and avoid
conflict of interest in the review.
The letter of intent is to be sent to Dr. Felix F. de la Cruz at the
address listed under INQUIRIES.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these grants.  These forms are available at 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 program administrator listed
under INQUIRIES.  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.

SPECIAL REQUIREMENTS

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 Center.

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-supplemented 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 Center 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 costs, 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.  The descriptions of New Program Development projects in
the application should be comparable to ROl research grant
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
Centers' programs.  Some consideration should be given, in planning
the program, to potential collaborative studies and projects that
might be proposed for the  Mental Retardation Research Centers
network.

The RFA label available in the PHS 398 (rev. 9/91) application kit
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.  In addition, the RFA title and number must be typed on
line 2a of the face page of the application form and the YES box must
be marked.

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
6701 Rockledge Drive, Room 1040-MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express or courier service)

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

Susan Streufert, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health
and Human Development
Building 6100, Room 5E03
6100 Executive Boulevard, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1485

Applications must be received by July 14, 1995.  If an application is
received after that date, it will be returned to the applicant
without review.  The Division of Research Grants (DRG) will not
accept any application in response to this RFA that is essentially
the same as one currently pending initial review, unless the
applicant withdraws the pending application.  The DRG will not accept
any application that is essentially the same as one already reviewed.
This does not preclude the submission of substantial revisions of
applications already reviewed, but such applications must include an
introduction addressing the previous critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by DRG
and responsiveness by NICHD staff.  Incomplete applications will be
returned to the applicant without further consideration.  If the
application is not responsive to the RFA, NICHD staff will return the
application without further consideration.  Applications that are
complete and responsive to the RFA will be evaluated for scientific
and technical merit by the NICHD Mental Retardation Research
Committee at its March 1996 meeting in accordance with the review
criteria stated below.

As part of the initial merit review, a process (triage) may be used
by the initial review group in which applications will be determined
to be competitive or non-competitive based on their scientific merit
relative to other applications received in response to the RFA.
Applications judged to be competitive will be discussed and be
assigned a priority score.  Applications determined to be non-
competitive will be withdrawn from further consideration and the
Principal Investigator and the official signing for the applicant
organization will be notified.

The second-level review will be made by the National Advisory Child
Health and Human Development Council at its June 1996 meeting.  The
anticipated date of award is
August 1, 1996.

Review Criteria

In addition to the specific criteria listed in the NICHD P30
Guidelines, reviewers will evaluate:

o  scientific, technical, or medical significance and originality of
proposed research;

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 of research projects that will be using the core
facilities;

o  plans for interdisciplinary/multidisciplinary collaboration;

o  institutional commitment;

o  appropriateness of the proposed budget;

o  adequacy of plans to include both genders and minorities and their
subgroups as appropriate for the scientific goals of the research.
Plans for the recruitment and retention of subjects (if applicable)
will also be evaluated.

The initial review group will also examine the provisions for the
protection of human and animal subjects and the safety of the
research environment.

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  relevance of research projects accessing the core facilities to
mental retardation and related developmental disabilities.

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

Inquiries concerning this RFA are encouraged.  The opportunity to
clarify any issues or questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues 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
Building 6100, Room 4B09
6100 Executive Boulevard, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1383
FAX:  (301) 496-3791
Email:  CRUZF@HD01.NICHD.NIH.GOV

Direct inquiries regarding fiscal matters to:

Mr. Edgar D. Shawver
Office of Grants and Contracts
National Institute of Child Health
and Human Development
Building 6100, Room 8A07
6100 Executive Boulevard, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1303
FAX:  (301) 402-0915
Email:  SHAWVERD@HD01.NICHD.NIH.GOV

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.865 Research for Mothers and Children.  Awards are
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 PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products.  In addition, Public Law 103-227, the Pro-Children Act of
1994, prohibits smoking in certain facilities (or in some cases, any
portion of a facility) in which regular or routing education,
library, day care, health care or early childhood development
services are provided to children.  This is consistent with the phs
mission to protect and advance the physical and mental health of the
american people.

.

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