EXPIRED
This Program Announcement expires on March, 2004, unless reissued. RESEARCH ON AUTISM AND AUTISM SPECTRUM DISORDERS Release Date: February 13, 2001 PA NUMBER: PA-01-051 (see replacement PA-04-085) National Institute on Deafness and Other Communication Disorders National Institute of Mental Health National Institute of Child Health and Human Development National Institute of Neurological Disorders and Stroke National Institute of Environmental Health Sciences THIS PA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA. PURPOSE The purpose of this program announcement is to encourage grant applications for the support of research designed to elucidate the diagnosis, epidemiology, etiology, genetics, treatment, and optimal means of service delivery in relation to Autistic Disorder ("autism") and autism spectrum disorders (Rett"s Disorder, Childhood Disintegrative Disorder, Asperger"s Disorder, Pervasive Developmental Disorder-Not Otherwise Specified, or "Atypical Autism"). 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 Program Announcement (PA), Research on Autism and Autism Spectrum Disorders, 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. 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 award mechanism. 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. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at http://grants.nih.gov/grants/funding/modular/modular.htm RESEARCH OBJECTIVES Although it has long been recognized that the pervasive developmental disorders, including autism, are highly variable in their clinical manifestations and likely the result of multiple etiologies, only recently have efforts been directed toward a meaningful subtyping of this group of disorders. Current classification systems (e.g., DSM-IV) include five separate diagnoses under the pervasive developmental disorders: Autistic Disorder, Rett"s Disorder, Childhood Disintegrative Disorder, Asperger"s Disorder and Pervasive Developmental Disorder Not Otherwise Specified (also called "Atypical Autism"). Autistic disorder, or "autism," is considered the most classic of the pervasive developmental disorders in that it was the first of these disorders to be recognized as a distinct disorder. These disorders share a cluster of impairments in reciprocal social interaction and communication and/or the presence of stereotyped behavior, interests and activities. These complex disorders are usually of lifelong duration and affect multiple aspects of development, learning, and adaptation in the community, and thus represent a pressing public health need. The etiologies of these disorders are poorly understood, but are thought to include genetic, metabolic, immunologic and infectious or other environmental influences. Etiology research involving these requires well integrated, multi- disciplinary, methodologically-rigorous scientific approaches and access to a sufficient number of well-characterized patients with these disorders. Basic research into the pathophysiology of autism and autism spectrum disorders, including research on brain mechanisms and genetics, is of special interest. Also of interest are clinical and applied investigations that may lead to the development of diagnostic research instruments, treatments, and intervention strategies. Specific areas of interest thus include epidemiology, early identification and diagnosis, genetic studies, brain mechanisms, communication skills, cognitive neuroscience, psychosocial (behavioral) interventions, pharmacological and other biological interventions, and services. Areas of interest include, but need not be limited to, the following: o Epidemiology: Development of new screening tools for use in a variety of settings, research on the expression of the full range of autism spectrum disorders, studies on their developmental course, studies that characterize the range of expression within families, research on co-occurring features, and studies to determine risk factors in the etiology of autism, including environmental exposures during pregnancy and early childhood. o Early Identification and Diagnosis: Key diagnostic features associated with various stages of development, assessment of comorbid features including hyperactivity, attentional dysfunctions, epilepsy, and obsessive and compulsive symptoms, assessment and further differentiation of subtypes of autistic spectrum disorders including Autistic Disorder, Asperger"s Disorder, Rett"s Disorder, and Childhood Disintegrative Disorder, and, developmental factors relevant to reliable and valid diagnosis. o Genetic Studies: Large-scale linkage studies of affected relative pairs or extended pedigrees to identify chromosomal regions harboring disease susceptibility genes, family-based association analysis and other linkage disequilibrium approaches that aim to identify a specific susceptibility gene, high-resolution mapping and positional cloning studies, resolution of locus heterogeneity, analysis of the interaction of autism susceptibility gene(s) with environmental exposures and/or genes responsive to environmental insult, testing for potential candidate genes. o Brain Mechanisms: Studies of brain mechanisms underlying the development, regulation, and modulation of behaviors characterizing autism and autism spectrum disorders, particularly those mechanisms involving communication and social interaction, studies of brain mechanisms and biological factors underlying autistic regression, or the loss of previously acquired skills, studies of brain mechanisms involved in the development of abnormal electroencephalograms and epilepsy and studies to clarify the subtypes of seizures and seizure disorders in autism, studies to define the neurobiological basis of neurological abnormalities and neuropsychiatric symptoms, including motor stereotypies, gait abnormalities, akinesias, dyskinesias, obsessive/compulsive traits, and the exacerbation of these symptoms, including the role of neuroimmune/autoimmune factors, studies that seek to define basic processing deficits using neuropsychological and cognitive neuroscience techniques, studies to develop animal models of brain dysfunction in autism and autism spectrum disorders, based on either genetic or environmental factors or their interaction. o Communication Skills: Longitudinal, developmental studies of behaviors that are precursors to later communication (e.g., imitation, joint attention, early vocalization) and their emergence in children with autism and autistic spectrum disorders, sensory, motor and social- cognitive impairments that impact upon interaction and communication, predictors of loss of or regression in expressive language abilities, the nature of severe spoken language deficits when other areas of function, such as written language skills, are relatively preserved, interventions designed to remediate communication and related deficits. o Cognitive Science: Developmental studies of relevant behaviors during infancy including attention to social and nonsocial stimuli, affective behavior, gaze, vocalization, imitation, initiative, reciprocity, attachment, play, compliance, and self- recognition and their emergence in children with autism and autistic spectrum disorders, research on the delays and deviations in social behavior and cognition during preschool and middle school, including empathy, receptive social cognitive deficits (i.e., difficulties understanding others), and expressive difficulties, studies leading to more sophisticated tests of higher cognitive functioning, especially in social, communicative, reasoning, and problem-solving areas, as well as tests of basic attentional, emotional and cognitive deficits that may underlie these deficits or be precursors to them, studies of theory of mind, of unconventional verbal behaviors, and of the sensory-motor factors involved in relevant social cognition, and the development, validation and refinement of interventions designed to address deficits in complex social and cognitive abilities or their developmental precursors. o Psychosocial Interventions: Studies developing new treatments (e.g., behavioral, cognitive-behavioral) and studies validating, refining and comparing approaches to the treatment of autism and autism spectrum disorders, as well as studies that analyze and define the critical features of effective intervention, studies that relate characteristics of individuals (or diagnostic subtypes) to treatment outcomes, research on relevant contextual factors including physical environments, parent-child and sibling-child relationship factors, and peer-child interactions, studies addressing generalization or the transfer of learning from one setting to another. o Pharmacological/Biological Intervention: Studies aimed at developing and testing the efficacy and safety of pharmacological agents that specifically target the core features of autism and autistic spectrum disorders, studies of the efficacy and safety of pharmacological and combined treatments for the most common and impairing psychopathology associated with autism (e.g., hyperactivity, impulsivity, aggression, self-injury, and obsessive-compulsive symptoms), new approaches to treatment that build on advances in neuroscience, genetics, immunology, and other neurobiologic fields, focused interventions that test specific theories or hypotheses regarding possible neuropathogenesis, studies that address the benefits of combined drug and psychosocial interventions. 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 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 may be obtained 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: [email protected]. 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 or Center (IC) program staff before submitting the application, i.e, as plans for the study are being developed. Furthermore, the application must obtain agreement from the IC staff that the IC 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 or Center 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. 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. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS 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. 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. (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) 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. 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. 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. 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 or board. 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 deserve 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 method? 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? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. 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. Questions and discussion of programmatic issues from potential applicants may be addressed to: Judith Cooper, Ph.D. Division of Extramural Research National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400C-11 - MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 496-5061 FAX: (301) 402-6251 Email: [email protected] Steve Foote, Ph.D. National Institute of Mental Health NSC, 6100 Executive Boulevard, Room 7204 Bethesda, MD 20857-MSC-9645 Telephone: (301) 443-3563 FAX: (301) 443-1731 Email: [email protected] Marie Bristol-Power, Ph.D. National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B09E, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1383 FAX: (301) 496-3791 Email: [email protected] Deborah Hirtz, M.D. National Institute of Neurological Disorders and Stroke 6001 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-5821 FAX: (301) 480-1080 Email: [email protected] Cindy P. Lawler, Ph.D. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD EC-23 Research Triangle Park, NC 27709 Telephone: (919) 316-4671 FAX: (919) 541-5064 Email: [email protected] Direct inquiries regarding fiscal matters to: Diana Trunnell Grants Management Branch 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: [email protected] Mary E. Daley Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A07 - MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1305 FAX: (301) 402-0915 Email: [email protected] Sara Stone Chief, Grants Management Branch National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, EPS-400-B MSC-7180 Bethesda, MD 20892-7180 Telephone: (301) 402-0909 FAX: (301) 402-1758 Email: [email protected] Gladys Melendez-Bohler Grants Management Office National Institute of Neurological Disorders and Stroke NSC, Room 3262 Bethesda, MD 20892 Telephone: (301) 496-3929 FAX: (301) 402-0219 Email: [email protected] Laura Williams-Boyd Grants Management Branch National Institute of Environmental Health Sciences P.O. Box 12233, MD EC-23 Research Triangle Park, NC 27709 Telephone: (919) 541-7629 FAX: (919) 541-2860 Email: [email protected] AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.173. Awards are made under authorization of sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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, and 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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
| ||||||
Department of Health and Human Services (HHS) |
||||||
NIH... Turning Discovery Into Health® |