and Human Services (HHS)
EXPIRED
This Program Announcement expires on June 1, 2004, unless reissued. BASIC AND APPLIED RESEARCH RELATED TO ADHD Release Date: April 24, 2001 PA NUMBER: PA-01-083 National Institute of Mental Health (http://www.nimh.nih.gov) National Institute on Alcohol Abuse and Alcoholism (http://www.niaaa.nih.gov/) National Institute on Drug Abuse (http://www.nida.nih.gov/) National Institute of Environmental Health Sciences (http://www.niehs.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 Attention-deficit/Hyperactivity Disorder (ADHD) is a commonly diagnosed behavioral disorder of childhood. Although some ADHD symptoms decrease with age, longitudinal studies find varying rates (10-60 percent) of persistent disabling ADHD symptoms into adolescence and adulthood. Individuals diagnosed with ADHD can experience difficulties across multiple settings (home, school, peers) and can face long-term adverse effects on academic performance, occupational success, and social-emotional development that have a profound influence on individuals, families, schools, and society. Despite progress in the assessment, diagnosis, and treatment of ADHD, there are many areas in which our knowledge may be expanded. Through this Program Announcement (PA) the participating institutes seek to encourage investigator-initiated research to enhance the scientific understanding of underlying mechanisms and risk processes related to ADHD and their implication for the development of effective interventions. Major areas of research interest are: (1) basic behavioral and neuroscience research in dimensions of attention, inhibitory control, emotion and other executive functions relevant to the etiologies, nosology, identification, prevention and/or treatment of ADHD, (2) basic or applied research on etiologies, risk factors, diagnosis, treatment and/or prevention of ADHD, and (3) research on the development of new interventions for use with individuals diagnosed with ADHD and their families. This announcement encourages research involving collaboration between basic scientists and clinical researchers in the study of related dimensions of cognitive and emotional functioning. During the 1998 NIH Consensus Development Conference on ADHD, evidence was presented indicating wide variations in clinical and research approaches for identifying, diagnosing and treating ADHD. This variation reflects in part the absence of a theoretical consensus of underlying mechanisms involved in ADHD. Collaborative interdisciplinary research is needed to facilitate the expansion and translation of basic behavioral and neuroscience research that may improve the prevention, identification, diagnosis and treatment of ADHD. Similarly, communication of clinical findings is critical for identifying new questions to be addressed by basic research and to assist in interpreting findings. It is believed that increased collaboration between basic and clinical scientists will enhance our understanding of the causal mechanisms underlying ADHD and subsequently improve our classification of the disorder and interventions. 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, Basic and Applied Research Related to ADHD, is related to the priority area of mental health and mental disorders. 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) Research Project Grant (R01) award mechanism. The Research Project Grant (R01) provides up to 5 years of funding that is commensurate with the science proposed. The total project period for an application submitted in response to this PA may not exceed 5 years. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Specific application instructions have been modified to reflect MODULAR GRANT and JUST-IN-TIME streamlining efforts being examined by the NIH. Complete and detailed information about modular grant applications can be found at: http://grants.nih.gov/grants/funding/modular/modular.htm. Applicants are encouraged to consult the Program Contact in the relevant institute listed under INQUIRIES for information on other research and career development grant mechanisms that are applicable to ADHD. RESEARCH OBJECTIVES Background It is estimated that between 3-5 percent of elementary school-aged children meet diagnostic criteria for ADHD. Core symptoms of ADHD include developmentally inappropriate levels of inattention, concentration difficulties, hyperactivity, distractibility, and impulsivity. Individuals diagnosed with ADHD sometimes experience pronounced difficulties and impairment resulting from the disorder across multiple settings (home, school, and with peers). For instance, children with ADHD are often rejected by peers, experience academic failure, and may engage in a broad array of disruptive behaviors. Children diagnosed with ADHD followed into adulthood often have high levels of academic failure, poor work histories, poor social interactions and low self-esteem. Although approximately 50 percent of children diagnosed with ADHD no longer meet diagnostic criteria for the disorder in adolescence, the persistent disorder in others often increases their risk for accidental injury, antisocial behavior and/or violence, poor school outcomes, and contact with the justice system. More research is needed on the clinical, behavioral and cognitive trajectories of ADHD from childhood to adolescence and adulthood. The high degree of restlessness, impulsivity, inattention, and oppositional behavior demonstrated by children diagnosed with ADHD is often associated with increased rates of parental frustration and marital discord. Given the degree of impairment noted among individuals diagnosed with ADHD and the challenges it poses for families, the disorder is often considered a costly public health problem. The fourth edition of the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV) describes three different subtypes of ADHD: primarily hyperactive/impulsive, primarily inattentive, and a combined subtype. Prevalence estimates of the various ADHD subtypes are complicated by different methodological approaches. Community-based samples are typically composed of an increased number of ADHD inattentive subtypes (1 in 10), while clinic-based samples find predominantly combined type ADHD diagnoses. There is also increasing evidence that the nature of ADHD symptoms changes over time and development. Hyperactive-impulsive symptoms appear to decrease with age, whereas inattentive symptoms show more stability. Consequently, preschool children diagnosed with ADHD appear to more frequently meet diagnostic criteria for the Hyperactive/Impulsive subtype than older children, adolescents and adults. In addition, different functional impairments appear to be related to the different ADHD subtypes across development. For instance, conduct problems and/or substance abuse in adolescence seems more related to the presence of hyperactive/impulsive symptoms than inattention. Despite the distribution of ADHD characteristics across the population, the majority of research on ADHD continues to center around school-aged males with a combined type diagnosis. Consequently, there is a continued need to better understand the presentation of ADHD and its comorbid disorders across the life span (particularly preschool children, adolescents and adults), in females, and the ADHD Inattentive and Hyperactive/Impulsive subtypes. ADHD symptoms rarely present themselves in isolation. It is estimated that 40-90 percent of children with ADHD present with comorbid aggression or conduct problems, 25 percent with comorbid anxiety disorders, and 15-20 percent with comorbid mood disorders. High rates of comorbid antisocial, mood and anxiety disorders have also been reported for adults with childhood- onset ADHD. The presentation of ADHD symptoms and comorbid conditions varies widely across gender, ethnicity, and age. Evidence also suggests that this variation in subtype and comorbidity status may affect identification rates, differential treatment outcomes, and long-term prognosis. Given the heterogeneity within the ADHD diagnosis, research is needed to determine whether ADHD is best thought of as a single disorder with subtypes or distinctly different disorders with unique etiologies. During the 1998 National Institute of Health (NIH) Consensus Development Conference on ADHD (see http://odp.od.nih.gov/consensus/cons/110/110_intro.htm), evidence was presented indicating wide variations in clinical and research approaches for identifying and diagnosing ADHD. This variation reflects in part the paucity of normative information on the developmental progression of ADHD-relevant cognitive functions (e.g., attention regulation, inhibitory control) across age and gender. The need for better normative data is supported by repeated findings that the dimensions of functioning relevant to ADHD exist along a continuum with blurred boundaries between normal and abnormal. Approach differences in the identification of ADHD likely also stem from the absence of a theoretical consensus of underlying mechanisms specific to ADHD and the use of relatively subjective assessment tools. Prevention efforts continue to be minimal in part due to the undefined pathways to ADHD symptom development. Various theories of ADHD etiology are currently being investigated. Genetics research has indicated a familial aggregation and heritability associated with ADHD symptoms. Geneticists have further identified a relationship between the diagnosis of ADHD in some individuals and the dopamine transporter (DAT) and/or D4 dopamine receptor (DRD4) genes. Cognitive neuroscience research indicates a central nervous system basis for ADHD including a possible dopamine deficit. Research on prenatal development suggests that ADHD symptom etiology may in some cases be related to alcohol or toxin exposure (e.g., lead) or episodes of oxygen deprivation for the fetus, however, further research is needed to investigate the specific impact of these factors on cognitive development among children with hyperactive, impulsive or inattentive symptoms. Moreover, it may be the case that some percentage of children with ADHD-like symptoms respond favorably to diet alterations. Clearly, unique combinations of environment and genetics contribute to the incidence and presentation of ADHD. Genetic factors might also impact interventions. These various and often complimentary etiologic theories of ADHD have implications for which interventions will be most successful for different individuals. Research has indicated that one size does not fit all with regard to ADHD treatment. Consequently, there is a great need for scientists to translate basic science findings to applications for ADHD etiology, differential diagnosis, and implications for targeted prevention and intervention. Randomized clinical trials have been conducted that established the efficacy of stimulants for ameliorating some symptoms of ADHD and associated aggressiveness. These studies have further indicated that stimulants are generally more effective than psychosocial therapies in treating these symptoms, however, results indicate inconsistent post-treatment improvements in functional impairments. Compared to treatment studies with child populations, fewer studies examine effects of medication on adults with ADHD, yet preliminary controlled studies also find positive responses to both stimulants and nonstimulants. Initial findings of the NIMH-sponsored Multi- Modal Treatment Study of Children with ADHD (MTA) (see Archives of General Psychiatry, December 1999) suggest that the combination of medication management and behavioral intervention may have a slightly greater impact on positive functional outcomes (e.g., reading achievement, parent/child relations) than medication alone. Furthermore, the MTA provides preliminary evidence that children with ADHD and various comorbid conditions may respond differentially to treatment modalities. For instance, children with ADHD and comorbid anxiety may be less responsive to stimulant medications and more receptive to behavioral interventions. These findings suggest the importance of matching children and families to treatments to which they will be most responsive, however, there is still relatively little information to guide treatment. Much work continues to be needed to develop treatments that address specific long-term functional impairments and comorbid conditions. Many of the outstanding questions related to ADHD would benefit from the collaborative work of basic behavioral or neuroscience researchers with clinical scientists who specialize in ADHD. The participating institutes hope to stimulate and encourage these interdisciplinary research efforts. Examples of potential collaborations could include, but are not limited to the following: o Experts in functional imaging with cognitive scientists whose expertise lies in the development of cognitive tasks o Psychopharmacologists collaborating with neuroscientists to identify neural mediators responsible for therapeutic effects of medications used to treat ADHD o Developmental psychologists collaborating with basic behavioral and neuroscientists to study emotion regulation, inhibitory control and/or attention regulation across the life span o Behavioral and molecular geneticists collaborating with attentional experts who could identify more objective measures of attention to supplement rating scales o Interventionists collaborating with basic social or behavioral scientists who have expertise in domains such as family functioning, peer relations, information processing or cognitive performance to develop interventions as well as measures of treatment process and outcome The following 4 sections expand upon areas of need regarding basic and applied research related to ADHD etiology, identification, diagnosis and intervention. Sample research topic areas are not exhaustive, but are meant to provide examples of research from which researchers can generate further questions. Basic Research Related to ADHD Research on the biological, cognitive, and/or genetic processes related to ADHD deficits (e.g., selective and/or sustained attention, inhibitory control, information processing, memory, vigilance, motor control, etc.) and their development among ADHD and non-ADHD children, adolescents, and/or adults is needed to facilitate and clarify ADHD nosology and taxonomy. It is hoped that research in this area will have implications for the understanding of ADHD subtype clusters, heterogeneous presentation across gender and age, comorbid conditions and functional impairments that co-occur with ADHD. It is also hoped that this research will impact the prevention and/or intervention strategies for this disorder. Listed below are examples of research topics. This list is illustrative, not exhaustive, it is expected that researchers who respond to this PA will identify additional important research topics. o Studies of the normative development of attention, inhibitory control, motivation and other executive functions across the life span o Studies that aim to understand the genetic, physiological, cognitive or neurobiological mechanisms underlying the cognitive deficits and behavioral symptoms associated with ADHD, its subtypes and/or co-occurring behavior problems o Application of imaging studies to understand basic neural circuits underlying ADHD o Studies that attempt to standardize, validate, or gather normative data on laboratory measures of cognitive functioning for potential application to clinical ADHD or related populations o Research on complex cognitive factors and functioning associated with the clinical presentation of ADHD (e.g., motivation, performance decay, response variability) incorporating the potential changes in these factors over time and across situations in ADHD and non-ADHD samples o Development of animal models that incorporate the cognitive or behavioral deficits associated with ADHD and/or examine the role of medication within these animal models o Identification of ADHD clinical measures that may be modeled in animals to identify neural systems mediating those behaviors, effects of age, etc. o Neuroimaging studies of treatment na ve children with ADHD o Studies of genetic epidemiology and ADHD o Basic and clinical research that links ADHD-related cognitive and motivational deficits to genotypes and/or behavioral phenotypes o Development of a cognitive test battery to diagnose core symptoms of ADHD Investigators who wish to submit applications involving structural magnetic resonance imaging (MRI) or magnetic resonance spectroscopy (MRS) may wish to familiarize themselves with the NIH MRI Study of Normal Brain Development, which will establish a normative magnetic resonance (MR) database for ages 0- 18. Interested parties may contact Dr. Judith Rumsey at: [email protected] or 301-443-1692. Etiologies, Risk Factors, and Prevention Given the heterogeneous nature of ADHD, research on the differential risk factors and nosology of ADHD subtypes and comorbid conditions is very important. There is a need to define risk and protective factors for the identification of ADHD as well as the developmental processes (behavioral, biobehavioral, social, emotional, and cognitive) that lead to the disorder. An understanding of these factors and developmental course of ADHD could then be translated into new prevention, early intervention and treatment strategies. Listed below are examples of research projects that could advance scientific knowledge on the etiologies, risk factors, prevention and treatment of ADHD. The list is not exhaustive, and it is expected that those who respond to the announcement may identify additional important research topics. Studies in these areas can include, but are not limited to: o Research that links basic attentional, motivational or emotional processes to risk assessments and ADHD nosology within a developmental model o Research on the heterogeneity in the disorder to determine whether ADHD is best thought of as a single disorder with subtypes or distinctly different disorders (identification of genetic, behavioral, and neurochemical markers) o Behavioral and neuroscience research that studies children with ADHD across time and in multiple situations, including those which tend to normalize their symptomatic behavior (e.g., highly stimulating and/or novel activities) o Taxonomy research to move the diagnosis of ADHD from a subjective criteria- based approach to one based on more objective markers o Research that investigates the course, diagnostic characteristics and long-term prognosis of ADHD within female populations, preschool children, adolescents and adults o Research that examines the influence of race, culture and socio-economic status on the etiology, longitudinal course and symptom presentation of ADHD o Epidemiological research which attempts to link early risk factors and/or developmental history (e.g., exposure to alcohol prenatally or to environmental toxins) to specific cognitive deficits o Research that examines mediating and moderating variables in the trajectory from ADHD-symptom development to functional impairment (e.g., academic underachievement, accidental injury) o Research that investigates the influence of comorbid conditions and various subtype profiles on the identification, diagnosis, and course of ADHD o Research to improve our knowledge about risk and protective factors within various contexts in order to develop new approaches for preventing the onset or exacerbation of ADHD o Research that relates work from early childhood developmental research in areas such as temperament, infancy behaviors, development of effortful control or emotion regulation to ADHD onset, course and prevention o Research on the development of preventative interventions that build upon the body of literature surrounding risk factors and the early identification of specific deficits associated with ADHD Treatment Development Numerous treatments have been designed for individuals diagnosed with ADHD, however, many of these interventions continue to have little impact on long- term functional outcomes. Furthermore, several treatments have been tested within narrowly defined populations, such as boys with a combined type diagnosis. Consequently, the development of interventions that specifically consider treatment impact on age-appropriate functional outcomes (e.g., academic achievement, peer functioning, vocational success) as well as ADHD symptoms, is encouraged. Interventions that target females diagnosed with ADHD, preschool children, adolescents and adults as well as individuals with co-occurring disorders are particularly underrepresented. Treatment development includes the conceptualization, development, standardization, and/or testing (pilot testing, field studies, or small scale experiments) of a theory-driven, empirically based intervention approach. Listed below are examples of research projects that could advance scientific knowledge on the treatment of ADHD. The list is not exhaustive, and it is expected that those who respond to the announcement may identify additional important research topics. Studies in these areas can include, but are not limited to: o Research on the development of innovative interventions for individuals diagnosed with ADHD derived from basic behavioral and/or neuroscience findings o Research that integrates new findings on the neurodevelopment of attention and behavior regulation into novel treatment approaches o Research to clarify which treatments are most effective in not only treating core ADHD and co-occurring symptoms, but also age-related functional impairments (e.g., academic achievement, vocational success) o Treatment development research that examines the influence of race, culture and socio-economic status on treatment response o Research that investigates the influence of comorbid conditions or diagnostic subtypes for predicting treatment process and outcome o Research on the development of early intervention strategies for young children identified as having ADHD or at risk for the development of ADHD o Research on provider behavior and decision making as factors that not only influence client identification and treatment, but could also serve as potential targets for intervention Researchers interested in developmental psychopharmacology should see a complementary announcement, Developmental Psychopharmacology, at: http://grants.nih.gov/grants/guide/pa-files/PA-00-114.html, which is aimed at understanding the mechanisms, both therapeutic and adverse, of long-term pharmacological treatment. NIAAA will consider funding alcohol-relevant applications submitted in response to this PA. For example, attention deficits are consistently identified in children with fetal alcohol syndrome (FAS) or alcohol-related neurodevelopmental disorder (ARND). In addition, offspring of male alcoholics, who are at increased risk for alcohol problems as adults, also display more problems during childhood and adolescence, particularly problems and disorders of attention, anxiety, and conduct. Insufficient research has been devoted to the underlying genetic, neurobiological and environmental factors that may influence the expression and severity of ADHD, or the response to treatment, in these populations. More studies are needed on the impact of ADHD on cognitive and social functioning across the life span, particularly with respect to risk for alcohol abuse and/or alcoholism in adolescence and adulthood. Many of the research topics listed above address issues that would advance scientific knowledge to improve prevention, diagnosis, and treatment of FAS and ARND, and elucidate the role of ADHD in the initiation of drinking and progression to alcohol use problems. Of interest to NIDA is animal and human research that (a) examines the relationship between childhood ADHD, and/or the treatment of childhood ADHD, on subsequent vulnerability to drug abuse in adolescence or adulthood, (b) analyzes the adult co-morbidity for ADHD and drug abuse, (c) studies the influence of caregiver drug abuse on the etiology of ADHD, (d) addresses prenatal and/or perinatal exposure to drugs of abuse as potential etiological factors in ADHD, and (e) explores treatment responsivity in ADHD patients as a function of prior exposure to drugs of abuse. Of particular interest in all of these areas are specific studies of cognitive and behavioral processes. 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 on the 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 review the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. NIH GRANTS POLICY STATEMENT The NIH Grants Policy Statement (NIHGPS) has been revised and reissued. The provisions of the revised NIHGPS are effective for all funded NIH grants and cooperative agreements with budget periods beginning on or after March 1, 2001. The revised NIHGPS is available at: http://grants.nih.gov/grants/policy/nihgps_2001. 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: [email protected]. Applications are also available on the World Wide Web 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. 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 3 years, and, - 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. 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 PA 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 by NIH 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 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? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o 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 Reasonableness of the proposed budget and duration in relation to the proposed research o 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. The opportunity to clarify any issues or questions from potential applicants is welcome. Potential applicants are encouraged to consult with the Program Staff listed below for information and guidance on other research and career development mechanisms that are applicable to ADHD. Direct inquiries regarding programmatic issues to: Farris Tuma, Sc.D. Developmental Psychopathology and Prevention Research Branch Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6200, MSC 9617 Bethesda, MD 20892-9617 Telephone: (301) 443-5944 Fax: (301) 480-4415 Email: [email protected] Beth-Anne Sieber, Ph.D. Molecular and Cellular Neuroscience Research Branch Division of Neuroscience and Basic Behavioral Science National Institute of Mental Health 6001 Executive Boulevard, Room 7186, MSC 9641 Bethesda, MD 20892-9641 Telephone: (301) 443-5288 Fax: (301) 402-4740 Email: [email protected] Laurie Foudin, Ph.D. Program Administrator Biomedical Research Branch Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 402, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-0912 Fax: (301) 594-0673 Email: [email protected] Cora Lee Wetherington, Ph.D. Behavioral and Cognitive Sciences Research Branch National Institute on Drug Abuse 6001 Executive Boulevard, Room 4282, MSC 9555 Bethesda, MD 20892-9555 Telephone: (301) 443-1263 Fax: (301) 594-6043 Email: [email protected] Annette Kirshner, Ph.D. Organs and Systems Toxicology Branch Division of Extramural Research and Training National Institute of Environmental Health Sciences Box 12233 MD EC-23 Research Triangle Park, NC 27709 Telephone: (919) 541-0488 Fax: (919) 541-5064 Email: [email protected] Direct inquiries regarding fiscal matters to: Diana S. 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] Judy Simons Grants Management Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 504, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-2434 Fax: (301) 443-3891 Email: [email protected] Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 Fax: (301) 594-6849 Email: [email protected] Laura Williams-Boyd Grants Management Branch Division of Extramural Research and Training National Institute of Environmental Health Sciences Box 12233 MD EC-22 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. 93.242 (NIMH), 93.273 (NIAAA), 93.279 (NIDA), and 93.114 (NIEHS). Awards are made under authorization 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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
|
| ||||||
|
|
|
Department of Health and Human Services (HHS) |
|
|||
|
NIH... Turning Discovery Into Health® |
||||||