RFA-MH-02-002: RESEARCH UNITS ON PEDIATRIC PSYCHOPHARMACOLOGY AND PSYCHOSOCIAL INTERVENTIONS (RUPP-PI)

Department of Health
and Human Services (HHS)

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RESEARCH UNITS ON PEDIATRIC PSYCHOPHARMACOLOGY AND PSYCHOSOCIAL INTERVENTIONS (RUPP-PI) Release Date: August 31, 2001 RFA: RFA-MH-02-002 National Institute of Mental Health (http://www.nimh.nih.gov/) Letter of Intent Receipt Date: December 11, 2001 Application Receipt Date: January 11, 2002 PURPOSE The National Institute of Mental Health (NIMH) requests applications from qualified research institutions for funding Research Units on Pediatric Psychopharmacology and Psychosocial Interventions (RUPP-PI). The RUPP-PI network will be supported under a cooperative agreement, for multi-site clinical trials to study the efficacy and effectiveness of mental health interventions for children and adolescents. The purpose of the initiative is to expand the research network of the existing Research Units on Pediatric Psychopharmacology (RUPP), which has been supported by NIMH under a contract mechanism. The initiative will expand the scope of the RUPP research by including multi- site clinical trials on psychosocial treatments in addition to psychopharmacologic interventions, and will encourage the development of multimodal treatment models as clinically appropriate. Emphasis will be on testing the efficacy, safety, and effectiveness of interventions already in use without adequate testing, conducting pilot studies for innovative, theoretically-driven and conceptually-based interventions, and promoting innovative clinical trial designs, especially those involving research in community practice settings. The research units will also provide sites for training promising clinicians and junior investigators. 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 RFA, Research Units on Pediatric Psychopharmacology and Psychosocial Interventions, 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 from children’s hospitals or their equivalent or educational institutions with accredited medical schools, within the United States. Each RUPP-PI must be an identifiable unit within its institution, with a history of exemplary treatment research. Existing RUPP sites, which have been funded under contract mechanisms, are eligible to compete under this initiative, but an existing RUPP is not a requirement for application. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal Investigators. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) clinical research cooperative agreement (U10) award mechanism. See below for TERMS AND CONDITIONS OF AWARDS. The total project period for an application submitted in response to this RFA may not exceed five years. This RFA is a one-time solicitation. Future unsolicited competing continuation applications originating from this RFA will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. FUNDS AVAILABLE The NIMH intends to commit approximately $4,600,000 in FY 2002 to fund up to 8 RUPP-PIs in response to this RFA. An applicant may request a project period of up to five years and a budget for direct costs of up to $350,000 per year. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. Although the financial plans of NIMH provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. RESEARCH OBJECTIVES Background The recent Report of the Surgeon General’s Conference on Children’s Mental Health: A National Action Agenda (2000) (http://www.surgeongeneral.gov/cmh/childreport.htm) documented the need for continued efforts in preventing and treating child mental illness. The document reports that 1 in 10 children in the U.S. suffers from mental illness severe enough to interfere with normal development and functioning. Children with mental illness are at greater risk for school failure and impairment as adults. Yet, only about 1/5 of those children receive specialty mental health services. Advances in the neurosciences, behavioral sciences, and social sciences, have prompted an increased national interest in child mental health. While there have been significant advances, the National Action Agenda specifies significant gaps in knowledge and several areas in need of further investigation. At this time, the opportunity is great for productive interdisciplinary exchange to stimulate collaborative research. The network of Research Units on Pediatric Psychopharmacology was started in 1996 through competitive contracts, with subsequent additions in 1997, for a total of 7 units currently active at academic research settings. Research has focused on short-term efficacy and safety studies of psychotropic medications commonly used in children and adolescents with mental disorders. The current RUPP includes studies of: selective serotonin reuptake inhibitor (SSRI) for children with Anxiety Disorders (Walkup, JT et al (2001). Fluvoxamine for the Treatment of Anxiety Disorders in Children and Adolescents. The New England Journal of Medicine, 334(17), 1279-1285), risperidone for children with Autism and behavioral disturbance (data analysis in progress), SSRI for depressed children with Bipolar Disorder, and sequential treatments for children with co-morbid ADHD and Anxiety Disorders. The purpose of RUPP-PI is to continue and expand the research scope of the RUPP in psychopharmacology research and add psychosocial treatment research. Gaps in pediatric mental health interventions research remain. For example, there are insufficient data on the treatment of youths with bipolar disorders, depression (especially in pre-pubertal children), psychosis, obsessive-compulsive disorder, and with two or more co-existing conditions (e.g., ADHD and comorbid mood disorders). Mental illness in the context of autism, pervasive developmental disorders, and mental retardation, are under- studied conditions. Data are needed to guide the management of aggression and extreme mood instability in various clinical contexts. Research is needed on the long-term effects of medications, especially when pharmacological treatment is started in early childhood. Some widely used psychosocial interventions have not been tested for efficacy and effectiveness. Scientifically proven interventions have not been adequately disseminated to the clinics, schools, and other community programs where they can be easily accessed. Research is needed to identify the barriers to dissemination, and a new model of intervention development is needed that addresses dissemination from the beginning. Research is also needed to compare psychosocial and pharmacological interventions, and to study the potential advantage of combining pharmacological with psychosocial interventions. One intention of this RFA is to encourage the formation of partnerships between investigators familiar with psychosocial treatments and those with pharmacology expertise. Objectives and Scope The purpose of this RFA is to expand the scope of the currently ongoing research network, RUPP, which has been funded under the contract mechanism and is approaching completion. Studies conducted under the expanded RUPP (RUPP-PI) will be clinical and for the pediatric (child/adolescent) age group. It is expected that the RUPP-PIs will be involved in collaborative psychopharmacological and/or psychosocial clinical trials with other units in the network and staff at NIMH, using peer-reviewed protocols determined by consensus. The overarching aim of the expanded RUPP-PIs will be to address through research, important clinical questions about the efficacy, safety, and effectiveness of interventions for youths with emotional and behavioral disturbances. Of particular interest are studies that address the current gaps in pediatric treatment research, including innovative treatment for developmental disorders such as Autism/PDD, and severe mental illnesses. Another important objective is to provide training experiences for promising clinicians and junior investigators. The following are examples of possible areas of investigation: o Study the therapeutic effects of psychosocial and/or pharmacological interventions that are commonly used in the community but have not been adequately tested for efficacy, safety, or effectiveness o Compare alternative psychosocial or pharmacological interventions for the treatment of a specific disorder with respect to efficacy, safety, effectiveness, and cost-effectiveness o Develop approaches to examine the effects of combined behavioral and psychopharmacological treatments, as compared to unimodal treatments o Test the effectiveness of interventions in community practice settings, including identification of social contextual variables that influence whether an intervention is adopted in a community setting o Identify clinically meaningful moderators and mediators of treatment response that can inform choices of treatment in the community o Study the relationship between dose, intensity, and duration of treatment, on one hand, and treatment effects, on the other o Study the pharmacokinetics and pharmacodynamics of psychotropic medications, as clinically indicated o Conduct pilot testing for innovative, conceptually-driven and theoretically-oriented psychosocial interventions o Develop and test effective treatments of symptoms that are often the targets of psychopharmacology management for children in practice settings (e.g., aggression, sleep disorders, self-injurious behaviors) o Study the long-term effects of treatments, with respect to both safety and effectiveness, especially on distal outcomes such as illness recurrence, emergence of comorbid disorders, academic achievement, and social adaptation o Test the comparative effectiveness and safety of different treatment strategies and approaches (i.e., study of alternative algorithms rather than single interventions) o Develop effective approaches to pharmacological management of children with two or more co-existing disorders (e.g., ADHD and moods disorder), medication side effects, and treatment resistance o Develop developmentally sensitive measures of treatment outcomes, including behavioral and neurobiological outcome measures that are hypothesized to be associated with behavior change o Study the effects of polypharmacy, including interactions of drugs with each other and with nutrients, in situations when polypharmacy is clinically justified o Test the efficacy and safety of promising alternative treatment approaches, such as dietary interventions or supplements, for youths with emotional and behavioral disturbances Management Structure Multi-site collaboration will be an essential feature of the RUPP-PI network. Units will be involved in collaborative clinical trials with other units in the network through one or more protocols determined by the consensus of the Steering Committee (see Terms and Conditions below). Units will likely have different and complementary research expertise in child/adolescent interventions research, but should be capable, through training and addition of staff, of obtaining any additional necessary expertise that the protocols will require for each unit. The management of the RUPP-PI network includes two main committees: (1) The project Steering Committee, and (2) a Data Safety and Monitoring Board (DSMB)(see below). TERMS AND CONDITIONS OF AWARDS 1. Applicability These special Terms of Award are in addition to and not in lieu of otherwise applicable Office of Management and Budget (OMB) administrative guidelines, Department of Health and Human Services (DHHS) grants administration regulations in 45 CFR part 74 and 92, and other HHS, PHS, and NIH grant administration policy statements. Under the cooperative agreement, the NIMH purpose is to support and/or stimulate the recipients activities by involvement in and otherwise working jointly with the awards recipients in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with the above concept, the dominant role and prime responsibility for the activity reside with the awardees for the project as a whole, although specific tasks and activities in carrying out the study will be shared between the awardees and the NIMH scientific collaborators or designee. Under the cooperative agreement, a relationship will exist between the awardees and the NIMH, in which the performers of the activities are responsible for the requirements and conditions described below and agree to accept program assistance from NIMH staff collaborators in achieving project objectives. Failure of the awardees to meet the performance requirements, including these special terms and conditions of award, or significant changes in level of performance, may result in a reduction of budget, withholding of support, suspension and/or termination of the awards. 2. Awardee Rights and Responsibilities The awardees have the primary authority and responsibility for defining objectives and approaches and for planning, conducting, analyzing, and publishing results, interpretations, and conclusions of the study. The awardees shall retain custody of and primary rights to the data developed under this award, subject to Government rights of access and consistent with current HHS, PHS, and NIH policies, however, the data base will be put into the public domain no more than 36 months after the last wave of data has been cleaned. The awardees will be responsible for planning and participating collaboratively with NIMH under this cooperative agreement. Through participation in meetings of the Steering Committee for this project and conference calls, the awardees will work with the NIMH staff collaborators in the development and implementation of one or more multi-site protocols, and in the establishment of quality control and monitoring procedures which are to be reported in non-competing continuation applications. Management of the multisite database and final statistical analyses will be provided under a separate NIMH contract mechanism. However, some capability of data management functions will need to be present at each RUPP-PI. These functions will include: (1) ongoing monitoring of the data collected at the unit for clarity, completion, and accuracy as compared with the source documents, (2) transferring of data to the central database by batching, copying, and mailing the data, or faxing them to the data management center, and (3) addressing possible queries from the data management center about the data. 3. NIMH Responsibilities At least one NIMH staff collaborator or a designee will have scientific involvement in the conduct of this activity, through membership on the project Steering Committee. The participation of NIMH staff collaborator(s) is intended to assist the project Steering Committee in its efforts to ensure that the broad scientific goals of NIMH are reflected in the final design, implementation, and reporting of results of the studies. Specifically, the staff collaborators will participate in decisions about study design, instrumentation, and clinical assessment. The NIMH staff collaborators will participate in all major project meetings and may cooperate with the awardees as author or co-author of resulting publications in accordance with publication policies developed by the Steering Committee of this project. Publications involving NIMH staff must follow NIH and NIMH publication policies. In addition to the NIMH staff collaborators, an NIMH Project Officer will be responsible for normal stewardship, and will provide technical assistance, programmatic monitoring, and assistance in the coordination of the overall project, but will not be a voting member of the project Steering Committee. An independent panel of experts in clinical trials, forming a Data Safety and Monitoring Board (DSMB) will be appointed by NIMH to monitor safety, quality of data collection, and integrity of the study. The costs of the DSMB will come from an NIMH source independent of the cooperative agreement. NIMH will obtain the advice of independent experts in the field(s) of interest for suggestions regarding methodology, scientific content, and other aspects of the proposed research. NIMH will support, through a separate contract mechanism, the management of the multisite database and final statistical analyses. 4. Collaborative Responsibilities The project Steering Committee will be the principal decision-making body for the study. It will have overall responsibility for the study and will make modifications in the protocols as necessary. The NIMH staff collaborator(s) will jointly have one vote on the project Steering Committee. Each awardee will jointly have one vote, although up to three persons from each site may be members of the project Steering Committee. A representative of the contracted database management component will participate on the Steering Committee, but will not be a voting member. A quorum will require one NIMH staff collaborator or designee and at least four representatives, each from one of the participating sites. The project Steering Committee will elect a chairperson, and may establish additional by-laws, subcommittees, or workgroups for specific tasks, including a Publications Committee to develop policies on publication and authorship. An NIMH staff collaborator may not chair any committee or subcommittee. Membership on the project Steering Committee becomes effective for the site upon receipt of the notice of award. Decisions will be made by majority vote of a quorum, with an attempt for consensus when possible. Any project Steering Committee member who considers a committee decision unacceptable may appeal by following the arbitration procedure described below. The project Steering Committee will meet annually, and convene through telephone conferences or in person, as needed, for the duration of the study. Responsibilities of the project Steering Committee members (collaborators) include: (1) collaboratively selecting, from among the peer-reviewed protocols, the one(s) to be implemented, (2)collaboratively finalizing the study plan, including design, assessment instruments, component protocols, and detailed implementation procedures, (3)abiding by and directing the study plan determined by the project Steering Committee, (4) monitoring the study and developing and implementing quality control procedures, (5) conserving grant funds in the service of the common objectives and of the research plan agreed on by the project Steering Committee, (6) facilitating the analysis of data and the eventual release to the larger scientific community (see Public Domain below), submitting data on time in the form and on the schedule determined by the project Steering Committee, (7) evaluating and reporting study results: defining rules regarding access to data and publication of findings from analyses of the data set, and (8) abiding by all scientific, practical, and policy decisions of the project Steering Committee. 5. Progress Reviews After the initial year, for which the NIMH requires a mid-year report, progress of the project will be reviewed by the NIMH Project Officer annually at the time of each continuation application. These reports will be assessed to assure that satisfactory progress is being made in achieving the project objectives, especially with respect to enrollment and quality of data collection, and that the site is following the procedures recommended and approved by the project Steering Committee. By acceptance of these awards, the awardees agree to abide by decisions and policies of the project Steering Committee and the other terms and conditions listed above or referenced in the Notice of Grant Award. 6. Arbitration Procedures If a decision related to a scientific or programmatic issue between/among NIMH and the awardee(s) is not acceptable to the awardee(s) or NIMH, either may, within 30 days of notification of the decision, request a review by an arbitration panel composed of one arbitrator nominated by the awardee(s), one nominated by NIH, and one chosen by the first two nominees. This panel will make a decision within 60 days of the request. Failure to comply with the decision of the panel may result in termination of support for the awardee(s) by NIMH. This arbitration procedure in no way affects the right by the awardee(s) to appeal any adverse action in accordance with PHS regulations at 42 CFR Part 50, subpart D, and HHS Grant Administration Regulations at 45 CFR Part 74, section 304, and HHS regulations at 45 Parts 16 and 75. This procedure may also be used for disagreements between the awardees and the NIMH staff collaborator(s) if the disagreement relates specifically to a scientific or programmatic issue. 7. Data and Safety Monitoring The study data will be reviewed by the NIMH DSMB every 3-6 months. The DSMB will receive a report from the study data management and statistical center usually about 4 weeks before each review date. Such a report will include the major variables necessary for monitoring safety and quality of data collection and integrity of the study. As study protocol and consent forms are relevant to safety and quality of data, the DSMB will also review these documents before the onset of the study. Based on this review, the DSMB has the authority to prevent the study from starting or to stop the study after it has started. 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. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. This policy announcement is found in the NIH Guide for Grants and Contracts Announcement dated June 5, 2000, at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 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. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at: http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. 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. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the principal investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to Ann Wagner, Ph.D. by the letter of intent receipt date listed. APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in applying for these grants. This version of the PHS 398 is available in an interactive, searchable PDF format. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Submit a signed, typewritten original of the application, including the Checklist, and three 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) At the time of submission, two additional copies of the application must be sent to: Jean G. Noronha, Ph.D. Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6154, MSC 9609 Bethesda, MD 20892-9609 Rockville, MD 20852 (for express/courier service) Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. SPECIFIC REQUIREMENTS FOR APPLICANTS Research Unit Specifications Cooperative agreements awarded under this RFA will provide support for research units that demonstrate the knowledge, expertise, and resources to conduct empirically sound interventions research with a pediatric population (children and adolescents). Applications can be related to (1) psychopharmacological intervention, (2) psychosocial intervention, or (3) multimodal interventions. There is no preference for one of the three types of research, but the applicant will be reviewed and awards will be given based on the clinical significance of the proposed research, scientific strength of the proposed design and methods, innovation, and conceptual/theoretical framework of the study. Evidence that the research plan is feasible must be presented, including evidence of the investigators expertise, access to an appropriate subject pool, and the necessary institutional support. The application should address the following areas: (A) Research resources, (B) Exemplary research protocol, (C) Training capabilities, and (D) Budget justification. A. Research Resources Awardees will have a successful track record of pediatric mental health research. Applications should document the expertise of the principal investigator and other important personnel and discuss the possibility of adding certain expertise to existing resources in order to conduct future studies in the RUPP-PI network (e.g., site with existing strong expertise in psychosocial intervention research, but in need of additional expertise in psychopharmacology research, or vice versa). Qualifications and academic productivity of the principal investigator must be documented. The principal investigator must be well-established, preferably holding independent peer- reviewed grant or contract support, actively publishing in the field. The principal investigator will be required to devote at least 25% of her/his time to the RUPP-PI activities. Applicants who are current RUPP principal investigators should describe their participation in the project research during the current award period. New applicants should describe their research achievements and their participation in randomized trials, especially of a collaborative and/or multisite nature. Applications must document that there is access to a sufficient number of eligible research subjects in the pediatric age group: infants, children, and adolescents. This is an essential component of the application and must be detailed in the proposal. The application should address whether the subject pool is sufficiently representative with regard to sex, ethnicity, and SES. The application must present convincing evidence (such as prior recruitment success) that the investigator will be able to recruit and retain a sufficient and appropriate sample. Applications must include a description of the available infrastructure and facility, including necessary clinic and/or laboratory equipment. Evidence of departmental and institutional support, documented by letters to the investigator, must be provided. The institution should have a history of past support and clinical research productivity. Long-term institutional commitment to the RUPP-PI may take various forms, including (but not limited to) waiver of facility fees for use of an outpatient clinic or research ward for patients on protocol, equipment and space for a core laboratory, release time for faculty to perform clinical trials research, and/or funding for support personnel. Research units will need statistical support and/or consultation within their institution for assistance with research design and plan of analysis. Costs for centralized data management and statistical analysis will not be incurred by the institution, as this will be provided separately by the NIMH, but each RUPP-PI must include resources to manage research data locally, as previously described. B. Exemplary Research Protocol Applicants should submit an application for a collaborative study, in which three to five RUPP-PIs would coordinate clinical trials utilizing a protocol determined by consensus. The application should include a research proposal in the form of a draft protocol to address a clinically important issue relevant to the mental health treatment of children and adolescents. The protocol can be a research project in psychopharmacology, psychosocial treatments, or combined treatment interventions, to be conducted at multiple sites. Because this is a collaborative effort, NIMH recognizes that a fully described protocol is not possible at this phase in the process. Nevertheless, in order to evaluate the merit of the proposed research goals and objectives, and the applicant’s ability to successfully complete the study, a well-described draft protocol should be submitted. The protocol should contain enough detail to explain the rationale, methods, experimental design, time line, general statistical plan, and budget outline. Individual RUPP-PIs may have different and complementary research strengths in pediatric research. Applications should address the expertise available at their site, as well as additional expertise that would need to be supplied by coordinating sites. The full range of expertise needed to successfully carry out the study should be described. Collaborating sites may be determined ahead of time by the applicant, in which case documentation of the collaborator(s)" commitment to participate, and available resources, should be included in the application. Alternatively, the collaborating sites may be left unspecified, and the protocol should be described in a way that would be transportable to collaborating institutions. After a cooperative agreement is funded and the Steering Committee is in place, there may be adjustments or changes to the proposed protocol(s). The RUPP-PI steering committee will finalize the protocol(s) for implementation based on various factors, such as comments and recommendations of the peer review process at the initial review group, programmatic priorities, and funds availability. C. Training Capabilities Applicants should describe how the RUPP-PI will provide research education and training opportunities for junior investigators or established investigators willing to redirect their effort to interventions research. Training must be relevant to treatment research in the area of child and adolescent mental health. D. Budget Justification Allowable costs in NIH cooperative agreements are governed by rules set forth in the NIH Grants Policy Statement and as stated on the Notice of Grant Award. Under these rules the PI may exercise flexibility to meet unexpected requirements by rebudgeting or requesting approval to rebudget among categories within the total direct cost budget of the RUPP-PI (as shown on the Notice of Grant Award), within the ceilings set in these guidelines. RUPP-PI grants are for up to five years, at a maximum level of $350,000 in direct costs for each year, plus negotiated Facilities and Administrative Costs, formerly known as indirect costs. Items fundable through a RUPP-PI cooperative agreement may include: 1. Personnel: Principal investigator (minimum 25 percent time and effort, which can include mentoring junior investigators), other senior investigators, junior investigator, nurse coordinator, research nurse, clinical pharmacologist, and data coordinator (time and effort as needed, with appropriate justification). 2. Support services directly related to the project: project-specific supplies, duplication costs, dedicated telephone line. 3. Clinical costs: Cost of clinical care that is directly related to the research project, and is not covered by other sources. Cost of pharmaceuticals to be used in the study, other pharmacy and laboratory costs, as justified by the research protocol. 4. Travel: Travel for the principal investigator and one co-investigator for a yearly network meeting, additional travel for training in multi-site protocols as needed. The following items are not fundable through a RUPP-PI grant: Costs of routine clinical care that are not directly related to the research project, or are covered by other sources, rent, administrative or secretarial services. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIMH. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIMH in accordance with the review criteria stated below. 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 the applications under review, will be discussed, assigned a priority score, and receive a second level review by the NIMH 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 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? How does the proposed study contribute to knowledge in understudied populations, understudied conditions, untested interventions, or otherwise address gaps in the current empirical base. 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? Is there sufficient attention to testing for efficacy, safety, and/or effectiveness? Does the protocol reflect an understanding of the implications of developmental level on treatment delivery and outcome measures? Does the protocol demonstrate sensitivity to social contextual variables that would influence implementation in the community? Are plans for recruitment and retention of subjects feasible and well-described? 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? Does the project involve novel targets of treatment or outcome variables? (4) Investigators: Is the proposed team of investigators at the RUPP-PI 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? Is the combined expertise of the investigators sufficient to cover all aspects of the project (e.g., expertise in both pharmacology and psychosocial interventions for multimodal studies)? Do the primary investigators have a history of successful completion of collaborative research? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Does the institution (and its collaborators, if specified) have a history of rigorous scientific productivity? Do the proposed studies take advantage of unique features of the participating institution(s)? Are the institutions suited to recruiting and treating children and adolescents? Is there evidence of institutional support for conducting clinical research? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to: (1) adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research, (2) provisions for the protection of human and animal subjects, the safety of the research environment, (3) plans for the recruitment and retention of subjects, and (4) the reasonableness of the proposed budget and duration in relation to the proposed research. SCHEDULE Letter of Intent Receipt Date: December 11, 2001 Application Receipt Date: January 11, 2002 Peer Review Date: March/April 2002 Council Review: May 2002 Earliest Anticipated Start Date: July 1, 2002 AWARD CRITERIA Award criteria that will be used to make award decisions include: o scientific merit (as determined by peer review) o availability of appropriate study populations o extent of investigators experience and expertise o adequacy of research facilities o availability of funds o programmatic priorities INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or answer questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Ann Wagner, Ph.D. Division of Services and Intervention Research National Institute of Mental Health 6001 Executive Boulevard, Room 7149, MSC 9633 Bethesda, MD 20892-9633 Telephone: (301) 443-4283 FAX: (301) 443-4045 Email: awagner@mail.nih.gov Direct inquiries regarding fiscal matters to: Joy Knipple Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-8811 Fax: (301) 443-6885 Email: jk173r@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.242. 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 recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-277, 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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