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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