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) 435-0714, 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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