RESEARCH ON PSYCHOPATHOLOGY IN MENTAL RETARDATION
Release Date: December 8, 2000
PA NUMBER: PA-01-028 (see replacement PA-04-044)
National Institute of Mental Health
(http://www.nimh.nih.gov)
National Institute of Child Health and Human Development
(http://www.nichd.nih.gov)
THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. THIS PA INCLUDES
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED
WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS PA.
PURPOSE
The National Institute of Mental Health (NIMH) and the National Institute of
Child Health and Human Development (NICHD) invite research grant applications
for research designed to elucidate the epidemiology, etiology, treatment, and
prevention of mental disorders, including emotional and behavioral problems,
in persons of any age with mental retardation.
Adequate epidemiological data regarding persons with both mental illness and
mental retardation have yet to be gathered; however, clinical experience has
shown that the full range of psychiatric disorders may be found among
individuals with mental retardation. This includes co-occurrence with
schizophrenia, affective disorders, obsessive-compulsive disorder, anxiety
disorders, and behavior disturbances with injurious and aggressive behavior
directed towards self, others, or objects. Proper identification and
effective treatment of these mental disorders are especially important for
people with mental retardation. In fact, while it is usually not possible to
correct and reverse the underlying cognitive deficits, treatment of the
behavioral and emotional problems that can be associated with mental
retardation can significantly improve functioning and quality of life.
Both basic research into the pathogenesis of mental disorders among
individuals with mental retardation and studies aimed at clinical diagnosis,
treatment, rehabilitation, and service delivery are of interest. This
initiative calls for more research on: (1) the prevalence rates of mental and
emotional disturbance among persons with mental retardation; (2) the
improvement of current diagnostic categories and the development of
appropriate psychiatric assessment instruments for use with persons who are
mentally retarded; (3) the precursors of childhood behavioral and emotional
disorders in children who are mentally retarded or who are at risk for mental
retardation; (4) the effectiveness of mental health services for persons with
mental retardation, including the monitoring of drug effects and methods for
enhancing treatment compliance while living in the community or attending
special education classes; (5) early intervention programs designed to
prevent emotional and behavior problems in infants with mental retardation;
(6) integrated service delivery models that provide a range of supportive and
therapeutic services to those suffering from both mental illness and mental
retardation; and (7) translation of basic neuroscience findings into clinical
applications and development of novel approaches to diagnosing and treating
mental illness in the context of mental retardation.
This program announcement (PA) expires three years from the Release Date
shown directly above, unless reissued.
HEALTHY PEOPLE 2010
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2010," a PHS-
led national activity for setting priority areas. This PA, Research on
Psychopathology in Mental Retardation, is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by domestic and foreign, for-profit and non-
profit organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State and local governments, and eligible
agencies of the Federal government. Foreign Institutions are not eligible
for R03 Small Research Grants. Racial/ethnic minority individuals, women,
and persons with disabilities are encouraged to apply as principal
investigators.
MECHANISM OF SUPPORT
This PA will use the National Institutes of Health (NIH) R01 (Research
Project Grants), collaborative R01, R21 (Exploratory/Development Grants) and
R03 (Small Research Grants) award mechanisms. Note that responsibility for
the planning, direction, and execution of the proposed project will be solely
that of the applicant. The total project period for an application submitted
in response to this PA may not exceed five years (three years for the R21;
two years for the R03). Awards made under the R21 and R03 support mechanisms
are not renewable past the original project period.
For all competing R01 applications requesting up to $250,000 per year in
direct costs and all R03 and R21 applications, specific applications
instructions have been modified to reflect MODULAR GRANT and JUST-IN-TIME
streamlining efforts being undertaken at NIH. More detailed information
about modular grant applications, including sample budget narrative
justification pages and a sample biographical sketch, is available via the
Internet at: http://grants.nih.gov/grants/funding/modular/modular.htm.
Applications that request more than $250,000 in any year must use the
standard PHS 398 (rev. 4/98) application instructions.
For the purposes of this PA, the guidelines provided in PAR-98-017
(http://grants.nih.gov/grants/guide/pa-files/PAR-98-017.html)are to be
followed for applications using the Collaborative R01 mechanism.
For the purposes of this PA, the guidelines provided in PA-99-134
(http://grants.nih.gov/grants/guide/pa-files/PA-99-134.html)are to be
followed for applications using the R21 mechanism.
Information and application instructions for the NIMH Small Grant are
available in the NIH Guide for Grants and Contracts at:
http://grants.nih.gov/grants/guide/pa-files/PAR-99-140.html.
Information and application instructions for the NICHD Small Grant are
available in the NIH Guide for Grants and Contracts at:
http://grants.nih.gov/grants/guide/pa-files/PAR-99-126.html.
RESEARCH OBJECTIVES
Background
Prevalence estimates of mental and emotional disturbance among persons with
mental retardation in community and institutional settings vary widely
depending on how the data were collected. The most often quoted figures
indicate that mental disorders occur substantially more often in persons with
mental retardation than they do in populations without mental retardation.
Among the reasons for difficulty in estimating these prevalence rates are
sampling bias due to self-selection and difficulty in making reliable and
valid psychiatric diagnoses. Research designs that can remedy these and other
problems are needed. Inherent in efforts to improve our knowledge of the
epidemiology of emotional disturbance among persons with mental retardation
is the development of better diagnostic criteria.
One of the most important elements in prevention of mental disorders among
individuals with mental retardation is early identification. Research that
can illuminate the precursors of childhood behavioral and emotional disorders
in children who are mentally retarded or who are at risk for mental
retardation is lacking. Early identification and diagnosis of co-existing
mental and emotional disorders in those with mental retardation may provide
an opportunity for early intervention and mitigation of psychopathology.
Since many individuals with mental retardation are already receiving
treatment and support services, the development of effective regimens for
treatment of behavioral and emotional dysfunction is of high priority. Many
individuals with mental retardation are receiving psychotropic medication.
Careful analysis of both positive and negative effects of such drugs,
including the effects on learning and adaptive behaviors and/or tardive
dyskinesia, is especially needed.
Persons with mental retardation who also exhibit emotional problems may
present great difficulties to their families, whether they live at home or
elsewhere. Research on family structure, process, and interaction may
illuminate ways in which family-focused treatment and intervention programs
might be devised.
One of the most difficult problems faced by persons with mental retardation
and emotional disturbance is their relationship with the service delivery
systems. Since many local jurisdictions have separate service systems for
mental retardation and mental illness, the extent of coordination between
these systems is an important area for study.
Some illustrative examples of research topics that may be addressed under
this program announcement are:
o Research on prevalence estimates of mental and emotional disturbance that
controls for common problems such as sampling bias due to self-selection and
difficulty in making reliable and valid psychiatric diagnoses
o Improving the validity of the diagnosis of mental disorders in persons
with mental retardation
o Understanding the factors of prenatal and perinatal pathophysiology as
well as psychosocial and ecological variables that might precede the
emergence of emotional and behavioral disorders in children with mental
retardation
o Developing and testing early intervention programs designed to prevent
emotional and behavior problems in infants and young children with mental
retardation, using a variety of research methodologies
o Studying the precursors of childhood behavioral and emotional disorders in
children who are mentally retarded or who are at risk for mental retardation
o Developing and testing effective regimens for treatment of behavioral and
emotional dysfunction among persons with mental retardation, especially
research designs comparing psychosocial and pharmacological treatment
programs and their combinations
o Careful analysis of both positive and negative effects of psychotropic
medications, including the effects on learning and adaptive behaviors and/or
tardive dyskinesia
o Studying the effectiveness of mental health services for persons with
mental retardation
o Developing and testing methods for enhancing treatment compliance while
living in the community or attending special education classes
o Examining family structure, process, and interaction in order to
illuminate ways in which family-focused treatment and intervention programs
might be devised
o Examining models of family involvement in delivery of services
o Identifying and characterizing individual, family, and/or cultural factors
that facilitate or impede early identification, detection, and treatment of
mental illness in persons with mental retardation
o Identifying and characterizing current practice patterns for persons with
mental retardation with chronic and impairing mental illness, studying
variables that affect quality of care, and developing and testing
interventions designed to improve quality of care for persons with these
disorders
o Comparing family-driven service delivery with provider-driven services
o Investigating integrated service delivery models that provide a range of
supportive and therapeutic services to persons suffering from both mental
illness and mental retardation (may include broad survey studies as well as
smaller, more focused clinical investigations)
o Examining the cost-effectiveness of various models of coordinated services
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 sub-populations 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 indicating that inclusion
is inappropriate with respect to the health of the subjects or the purpose of
the research. This policy results from the NIH Revitalization Act of 1993
(Section 492B of Public Law 103-43).
All investigators proposing research involving human subjects should read the
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research," published in the NIH Guide for Grants and Contracts on
August 2, 2000
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html);
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The
revisions relate to NIH defined Phase III clinical trials and require: a) all
applications or proposals and/or protocols to provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b) all
investigators to report accrual, and to conduct and report analyses, as
appropriate, by sex/gender and/or racial/ethnic group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by
the NIH, unless there are scientific and ethical reasons not to include them.
This policy applies to all initial (Type 1) applications submitted for
receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects" that was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html
Investigators also may obtain copies of these policies from the program staff
listed under INQUIRIES. Program staff may also provide additional relevant
information concerning the policy.
URLS IN NIH GRANT APPLICATIONS OR APPENDICES
All applications and proposals for NIH funding must be self-contained within
specified page limitations. Unless otherwise specified in an NIH
solicitation, Internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no obligation
to view the Internet sites. Reviewers are cautioned that their anonymity may
be compromised when they directly access an Internet site.
APPLICATION PROCEDURES
Applicants are strongly encouraged to contact the program contacts listed
under INQUIRIES with any questions regarding their proposed project and the
goals of this PA.
Applications are to be submitted on the grant application form PHS 398 (rev.
4/98) and will be accepted at the standard application deadlines as indicated
in the application kit. Application kits are available at most institutional
offices of sponsored research and from the Division of Extramural Outreach
and Information Resources, National Institutes of Health, 6701 Rockledge
Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, Email:
mailto:GrantsInfo@nih.gov. Applications are also available on the Internet
at: http://grants.nih.gov/grants/forms.htm.
SPECIFIC APPLICATION INSTRUCTIONS FOR MODULAR GRANTS
The modular grant concept establishes specific modules in which direct costs
may be requested as well as a maximum level for requested budgets. Only
limited budgetary information is required under this approach. The
just-in-time concept allows applicants to submit certain information only
when there is a possibility for an award. It is anticipated that these
changes will reduce the administrative burden for the applicants, reviewers
and Institute staff. The research grant application form PHS 398 (rev. 4/98)
is to be used in applying for these grants, with the modifications noted
below.
BUDGET INSTRUCTIONS
Modular Grant applications will request direct costs in $25,000 modules, up
to a total direct cost request of $250,000 per year ($125,000 for R21 and
$50,000 for R03). (Applications that request more than $250,000 direct costs
in any year must follow the traditional PHS 398 application instructions.)
The total direct costs must be requested in accordance with the program
guidelines and the modifications made to the standard PHS 398 application
instructions described below:
PHS 398
o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs
(in $25,000 increments up to a maximum of $250,000 or $125,000 for R21 and
$50,000 for R03) and Total Costs [Modular Total Direct plus Facilities and
Administrative (F&A) costs] for the initial budget period Items 8a and 8b
should be completed indicating the Direct and Total Costs for the entire
proposed period of support.
o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD: Do not complete Form Page
4 of the PHS 398. It is not required and will not be accepted with the
application.
o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT: Do not complete the
categorical budget table on Form Page 5 of the PHS 398. It is not required
and will not be accepted with the application.
o NARRATIVE BUDGET JUSTIFICATION: Prepare a Modular Grant Budget Narrative
page. (See: http://grants.nih.gov/grants/funding/modular/modular.htm for
sample pages.) At the top of the page, enter the total direct costs
requested for each year. This is not a Form page.
o Under Personnel, list ALL project personnel, including their names,
percent of effort, and roles on the project. No individual salary
information should be provided. However, the applicant should use the NIH
appropriation language salary cap and the NIH policy for graduate student
compensation in developing the budget request.
o For Consortium/Contractual costs, provide an estimate of total costs
(direct plus facilities and administrative) for each year, each rounded to
the nearest $1,000. List the individuals/organizations with whom consortium
or contractual arrangements have been made, the percent effort of all
personnel, and the role on the project. Indicate whether the collaborating
institution is foreign or domestic. The total cost for a
consortium/contractual arrangement is included in the overall requested
modular direct cost amount. Include the Letter of Intent to establish a
consortium.
o Provide an additional narrative budget justification for any variation in
the number of modules requested.
o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by
reviewers in the assessment of each individual's qualifications for a
specific role in the proposed project, as well as to evaluate the overall
qualifications of the research team. A biographical sketch is required for
all key personnel, following the instructions below. No more than three
pages may be used for each person. A sample biographical sketch may be
viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm.
- Complete the educational block at the top of the form page
- List position(s) and any honors
- Provide information, including overall goals and responsibilities, on
research projects ongoing or completed during the last three years
- List selected peer-reviewed publications, with full citations
o CHECKLIST - This page should be completed and submitted with the
application. If the F&A rate agreement has been established, indicate the
type of agreement and the date. All appropriate exclusions must be applied
in the calculation of the F&A costs for the initial budget period and all
future budget years.
o The applicant should provide the name and phone number of the individual
to contact concerning fiscal and administrative issues if additional
information is necessary following the initial review.
Applications not conforming to these guidelines will be considered
unresponsive to this PA and will be returned without further review.
Applicants planning to submit an investigator-initiated new (type 1),
competing continuation (type 2), competing supplement, or any amended/revised
version of the preceding grant application types requesting $500,000 or more
in direct costs for any year are advised that he or she must contact the
Institute program staff before submitting the application, i.e., as plans for
the study are being developed. Furthermore, the application must obtain
agreement from the Institute staff that the Institute will accept the
application for consideration for award. Finally, the applicant must
identify, in a cover letter sent with the application, the staff member and
Institute who agreed to accept assignment of the application.
This policy requires an applicant to obtain agreement for acceptance of both
any such application and any such subsequent amendment. Refer to the NIH
Guide for Grants and Contracts, March 20, 1998 at
http://grants.nih.gov/grants/guide/notice-files/not98-030.html. Any
application subject to this policy that does not contain the required
information in a cover letter sent with the application will be returned to
the applicant without review.
The title and number of the program announcement must be typed on line 2 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 five signed photocopies in one package to:
CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)
REVIEW CONSIDERATIONS
Applications will be assigned on the basis of established PHS referral
guidelines. Applications will be evaluated for scientific and technical
merit by an appropriate scientific review group convened in accordance with
the standard NIH peer review procedures. As part of the initial merit review,
all applications will receive a written critique and undergo a process in
which only those applications deemed to have the highest scientific merit,
generally the top half of applications under review, will be discussed,
assigned a priority score, and receive a second level review by the
appropriate national advisory council.
Review Criteria
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In
the written comments reviewers will be asked to discuss the following aspects
of the application in order to judge the likelihood that the proposed
research will have a substantial impact on the pursuit of these goals. Each
of these criteria will be addressed and considered in assigning the overall
score, weighting them as appropriate for each application. Note that the
application does not need to be strong in all categories to be judged likely
to have major scientific impact and thus deserves a high priority score. For
example, an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.
(1) Significance: Does this study address an important problem? If the aims
of the application are achieved, how will scientific knowledge be advanced?
What will be the effect of these studies on the concepts or methods that
drive this field?
(2) Approach: Are the conceptual framework, design, methods, and analyses
adequately developed, well integrated, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics?
(3) Innovation: Does the project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does the project challenge
existing paradigms or develop new methodologies or technologies?
(4) Investigator: Is the investigator appropriately trained and well suited
to carry out this work? Is the work proposed appropriate to the experience
level of the principal investigator and other researchers (if any)?
(5) Environment: Does the scientific environment in which the work will be
done contribute to the probability of success? Do the proposed experiments
take advantage of unique features of the scientific environment or employ
useful collaborative arrangements? Is there evidence of institutional
support?
The initial review group will also examine: the appropriateness of proposed
project budget and duration; the adequacy of plans to include both genders,
minorities and their subgroups, and children as appropriate for the
scientific goals of the research and plans for the recruitment and retention
of subjects; the provisions for the protection of human and animal subjects;
and the safety of the research environment.
AWARD CRITERIA
Applications will compete for available funds with all other recommended
applications. The following will be considered in making funding decisions:
Quality of the proposed project as determined by peer review, availability of
funds, and program priority.
INQUIRIES
Inquiries are encouraged. The opportunity to clarify any issues or questions
from potential applicants is welcome. Applicants may also consult NIH staff
for advice concerning collaborations and access to patients and patient
material.
Direct inquiries regarding programmatic issues about diagnosis and detection
of mental disorders to:
David Stoff, Ph.D.
Center for Mental Health Research on AIDS
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6193, MSC 9617
Bethesda, MD 20892-9617
Telephone: (301) 443-4625
FAX: (301) 480-9719
Email: dstoff@nih.gov
Direct inquiries regarding programmatic issues about testing effects of
treatment and preventive interventions to:
Benedetto Vitiello, M.D.
Child and Adolescent Treatment and Preventive Intervention Research Branch
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7147, MSC 9633
Bethesda, MD 20892-9633
Telephone: (301) 443-4283
FAX: (301) 443-4045
Email: bvitiell@nih.gov
Direct inquiries regarding programmatic issues in mental retardation and
developmental disabilities to:
Mary Lou Oster-Granite, Ph.D.
Mental Retardation and Developmental Disabilities Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B09, MSC 7510
Bethesda, MD 20892-7510
Telephone : (301) 435-6866
FAX : (301) 496-3791
Email : mailto:mo96o@nih.gov
Direct inquiries regarding fiscal matters to:
Diana S. Trunnell
Grants Management Branch
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2805
FAX: (301) 443-6885
Email: Diana_Trunnell@nih.gov
Douglas Shawver
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 435-6999
FAX : (301) 402-0915
Email : es65o@nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance No.
93.242 (NIMH) and 93.865 (NIHCD). Awards are made under authorization of
Sections 301 and 405 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 NIH 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 routine 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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