and Human Services (HHS)
EXPIRED
This Program Announcement expires on November 1, 2004, unless reissued. ADVANCED CENTERS FOR INTERVENTIONS AND SERVICES RESEARCH (ACISR) Release Date: May 7, 2001 PA NUMBER: PAR-01-089 (This PAR has been reissued, see PAR-05-161) National Institute of Mental Health (http://www.nimh.nih.gov) Letter of Intent Receipt Date: August 1 annually Application Receipt Date: October 1 annually This program announcement (PA) and PAR-01-090, Developing Centers for Interventions and Services Research (DCISR), supercede the following center announcements: Prevention Research Centers (PA-99-074), Social Work Research Development Centers (PAR-99-130), Specialized Mental Health Interventions Research Centers (PAR-98-020), and Centers for Research on Services for People with Mental Health Disorders (PAR-94-073). PURPOSE The National Institute of Mental Health (NIMH) encourages investigator- initiated research grant applications for Advanced Centers for Interventions and Services Research (ACISRs). The goal of these multidisciplinary research centers is to establish core infrastructure support to enhance the national capacity to test interventions (treatment, rehabilitative, and preventive) through studies in multiple settings and to improve the utilization of research-based prevention, treatment and service interventions in community and practice settings. The centers are expected to provide a research infrastructure that will promote investigator-initiated applications aimed at preventing and minimizing the impact of mental disorders, and that inform the provision of adequate treatment and rehabilitation services for people of all age groups who have mental disorders. This PA addresses several major recommendations set forth in reports by the National Advisory Mental Health Council: Bridging Science and Service (http://www.nimh.nih.gov/research/bridge.htm), Translating Behavioral Science into Action (http://www.nimh.nih.gov/tbsia/tbsiatoc.cfm), and Priorities for Prevention Research at NIMH (http://www.nimh.nih.gov/research/priorrpt/index.htm). These reports called for increasing the relevance of behavioral, intervention and services research for community practice. Applicants who do not have the capacity to mount the extensive and integrated research effort expected in this program announcement, but would like support for a center at an earlier stage of development, should consult PAR-01-090 (http://grants.nih.gov/grants/guide/pa-files/PAR-01-090.html), Developing Centers for Interventions and Services Research. Applicants interested in funding a center for basic neuroscience research relevant to mental illnesses should see PAR-98-057, Silvio Conte Centers for Neuroscience Research (http://grants.nih.gov/grants/guide/pa-files/PAR-98-057.html) and those interested in a center for translational research between basic and clinical neuroscience research on severe mental illnesses should consider PAR-98-058, Silvio Conte Centers for the Neuroscience of Mental Disorders (http://grants.nih.gov/grants/guide/pa-files/PAR-98-058.html). Applicants interested in funding for a center for research at the interface between basic behavioral research and neuroscience should see PAR-00-130, Interdisciplinary Behavioral Science Centers for Mental Health (http://grants.nih.gov/grants/guide/pa-files/PAR-00-130.html). Applicants interested in a center that would foster research projects on the translation of basic behavioral research to mental disorders and public health applications should consider PAR-01-027, Translational Research Centers in Behavioral Science (http://grants.nih.gov/grants/guide/pa-files/PAR-01-027.html). Those interested in a center with a focus on HIV/AIDS should apply for funding through PAR-99-153, Core Support Program for Mental Health/AIDS Research (http://grants.nih.gov/grants/guide/pa-files/PAR-99-153.html). 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, Advanced Centers for Interventions and Services Research, 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, 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. A single institution may have more than one ACISR but they must address distinctly different research topics. In such situations, it is expected that there will be significant savings from sharing some infrastructure resources among the centers at the institution. Foreign institutions are not eligible for support under this PA. Applicants should demonstrate the capacity to become an advanced center through evidence of previous commitment of institutional resources, development of a critical mass of intervention and/or services researchers, the presence of substantial recent topical peer-reviewed publications in the research area chosen, and partnerships with stakeholders such as policy makers, providers, payers, consumers and families. Advanced centers should be a major national scientific resource with the ability to impact practice and public mental health policy. They should demonstrate a capability to study questions among various populations in different community and practice settings. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) Center Core Grants (P30) mechanism. Support for these advanced centers may be requested for an initial period of up to 5 years, followed by competitive renewals for each 5- year period. Once awarded, centers are subject during the term of the award to administrative review for performance and are not transferable to another institution. Applicants may request up to $800,000 in direct costs per year, plus Facility and Administrative costs (formerly known as indirect costs). Up to $400,000 per year in additional direct costs may be requested to create or expand partnerships between centers and community clinical or service systems (see Research Network Development Core below). Criteria for these centers are described below. Allowable Costs ACISR funds can support research participant recruitment and outreach activities to ensure appropriate participation by all populations, especially women, children and adolescents, elderly populations and traditionally underserved populations such as racial and ethnic minorities and people in rural areas. For those centers that will support clinical trials, funds may be used to set up a Data and Safety Monitoring Board for these trials. Funds may be requested to initiate specific pilot studies in the scientific areas chosen as the focus of the center and to support data bases and/or maintain tracking of research participants while new grants are developed to address follow-up questions raised by early studies. Funds may also be used for travel, salaries, meeting expenses, subcontracts and to pay consultants. Applicants are referred to the General Clinical Research Center program at the NIH/National Center for Research Resources (http://www.ncrr.nih.gov/clinical/cr_gcrc.asp) as a potential resource for inpatient and outpatient facility costs. RESEARCH OBJECTIVES Background The purpose of the ACISR center announcement is to provide core infrastructure support that will increase the capacity in the mental health field to test interventions (treatment, rehabilitative, and preventive) and conduct research to improve the utilization of research-based prevention, treatment and service interventions in the community. The centers are expected to: 1) build and maintain networks to conduct clinical trials of interventions, and/or conduct practice and service system research to improve service delivery, 2) foster interdisciplinary collaboration, 3) develop new research methods, and 4) cultivate training opportunities for new investigators. Three recent reports by the NIMH National Advisory Mental Health Council help to define the research agenda that should be supported by these centers (Bridging Science and Service, Priorities for Prevention Research at NIMH, and Translating Behavioral Science into Action). Bridging Science and Service defines the major focus of research for the ACISRs, and the other two reports provide some specific recommendations for studies that would integrate prevention and behavioral research with treatment and services research. Through these centers, the NIMH intends to expand the clinical trials and services research capacity of the mental health field to address the most pressing mental health problems facing public health today. Thus, applicants are expected to focus on specific areas in which current research indicates that an opportunity exists to improve prevention, treatment and services through findings from larger studies conducted in or using data from multiple sites (preferably in the community). In this announcement, the term community is used to indicate both clinical and non-clinical settings outside traditional academic research locations. The term network is used to indicate an assemblage of research sites (e.g., outpatient clinics, large groups of individual practice settings, schools, public health clinics, managed care systems, etc.). In an effort to simplify the announcement, the term intervention refers to preventive, treatment, and rehabilitative interventions. Service interventions are subsumed under the topic of practice and service system research. This advanced center mechanism provides funding for infrastructure only. The availability of such an infrastructure is intended to provide multi- disciplinary teams either at a single institution or across institutions the support they need to develop integrated, theoretically and empirically informed, prevention, treatment and services research proposals. Applicants must show how the multidisciplinary teams and research proposals focus on a major public mental health problem. Investigators seeking funding for specific individual research projects, or for a coordinated set of research projects, should use other mechanisms (e.g., R01, R21, R03). Centers are expected to develop studies that will inform healthcare by using a variety of academic, community, and practice settings incorporated into networks supported by the center. However, there may be some areas of research that lend themselves currently to more limited arrangements among academic and non-academic sites. Applicants with such limited arrangements should justify why this is best for addressing the research area they have chosen. PROGRAM SPECIFICATIONS Principal Investigator Specifications The ACISR Director should have overall responsibility for leadership of the center as a major national scientific resource and be recognized as a leader in the research area chosen as a focus for the center. This individual must have demonstrated capability to organize, administer, and direct the center, and have a minimum time commitment of 30 percent to the center. Each ACISR must have the following cores: 1) Operations Core, 2) Research Methods Core and 3) Principal Research Core. An optional Research Network Development Core may be added (see below). Operations Core Each center must have a clearly articulated Operations Core that should integrate the scientific and infrastructure aims. This core includes administrative functions, data management and statistical analysis, dissemination activities, and specialized interdisciplinary components. Applicants should describe under the Operations Core section how the ACISR will: 1) foster an environment of research excellence through multidisciplinary teams operating at a high level of methodological sophistication, 2) support innovation by integrating productive partnerships with academic disciplines that may be relative newcomers to these areas of research, and 3) actively engage and retain community stakeholders in all aspects of the research process. These stakeholders could include individuals with mental illness and their families, mental health care providers, community organizations and institutions (e.g., schools, group homes, extended care facilities), public and private purchasers of mental health care (jails, employers, state government), and insurers and managed care organizations. For those centers conducting clinical trials, the Operations Core should include a data management and statistical analysis unit as well as a trials operation management unit. These units may be located at a single institution or across multiple institutions. Depending on the research focus, other specialized interdisciplinary components might be included in the Operations Core (e.g., economics unit). Applicants should describe efforts for recruitment of research participants and data collection activities within this Core. The ACISR center may consist of several collaborating sites that are not all located in a single institution or geographic region. ACISRs are strongly encouraged to foster cross-site collaborations and networks of affiliated sites. The collaboration among multiple institutions and settings to create a virtual center, or virtual cores , must be specified and explained in the Operations Core of the lead institution receiving the funding so the feasibility of such arrangements can be evaluated. The Operations Core section of the application should outline the scientific leadership for all anticipated research. It should describe an administrative structure that maximizes efficiency through program planning and monitoring, an infrastructure development and maintenance plan, opportunities for investigators to do integrative work, and plans for accountability. The Operations Core should also address knowledge and technology transfer, and enhancing the availability of center accomplishments (e.g., data, methods, networks) within and beyond the center. Centers are encouraged to consider support for scientific meetings through the NIH R13 mechanism. Applications should address potential training opportunities within the ACISR under the Operations Core section. The center should include established investigators in the areas chosen for research, and thereby expand opportunities for mentorship and career development for new and mid-level investigators. ACISRs should contain plans for facilitating and evaluating innovative and interdisciplinary training, education, career development, and research apprenticeships. Centers that consist of multiple research sites should describe how they would take advantage of the training opportunities offered by such an arrangement. This could include having trainees spend time at various settings or institutions. The direct support of training efforts (e.g., stipends) should be sought through NIH training and career development mechanisms. Direct support for short-term educational programs can be sought from the R25 mechanism. Applicants must include plans for attracting and retaining physicians and other clinically trained individuals into interventions and services research careers. In addition, applicants should address the ways in which training opportunities will seek to reduce disparities in the mental health of traditionally underserved populations. Research Methods Core Every ACISR must include a research methods core. New technology, research designs and innovative analytic approaches are needed for interventions, practice, and service systems research questions. Centers are expected to develop, enhance and provide state-of-the-art, sophisticated methodological expertise to all ACISR related research projects. This function includes, but is not limited to: sample recruitment and retention, methods and instrument development, research design, novel data base management techniques, new statistical analytic methods, and use of mixed methodologies. Conducting the kinds of research called for in this PA will require the development and adaptation of sophisticated methods from other sciences. Thus, this Core should seek to encourage collaboration of methodologists from diverse academic backgrounds including epidemiology, statistics, behavioral and social science, engineering, computer science, marketing and others to focus on the challenges of the types of research supported by the ACISR. Applicants should seek funding through traditional mechanisms (R01, R21, R03) for specific projects. As part of this core, centers may develop plans to stimulate technological innovation through collaboration with small businesses using either the Small Business Technology Transfer (STTR) program or the Small Business Innovation Research (SBIR) program. Information on the SBIR and STTR programs may be obtained at: http://grants.nih.gov/grants/funding/sbir.htm. There are a large number of potential areas of investigation that could be included in this core. The following are some examples of research areas that could fit in this core. These are not meant to be comprehensive, nor are the examples meant to be exclusive of other topics. For example, a center might develop and evaluate ways to adapt assessment and treatment protocols previously used in restricted settings for use in community settings. Of special interest is research on ways to integrate qualitative and quantitative methods into intervention, practice or service system studies. Developing new designs for conducting clinical trials and statistical techniques to analyze data from novel research designs would be important areas to address in centers that are conducting clinical trials. Other potential efforts in this core might include: new methods for retention and recruitment of research participants, new technology for data entry and database management, and new measures to broaden assessment of the effect of interventions at the individual and system level. In addition, centers could improve methods that increase the relevance of research findings for community stakeholders such as payers and public policy makers (e.g., economic analyses in clinical trials or expanded measures of impact such as disability and functional status). A center might develop ways to improve intervention and services research studies through utilization of theory and methods from fields outside health (e.g., decision analysis, marketing and engineering). Applicants are encouraged to focus on how this core will enhance the research activities chosen in the principal research core (see below). Principal Research Core An ACISR must have a principal research core focused on interventions research and/or practice and service systems research. Although not mandatory, applicants are encouraged to consider ways in which both areas (interventions and practice/service systems research) can be integrated into a focused research agenda. The research area chosen should be the primary research focus of the center and all other cores should clearly relate to the efforts pursued in this core. A separate description must be provided for the principal research core area, including potential research proposals in this area, summary descriptions of exploratory and developmental research projects, and how these proposals and projects will relate to and support one another as well as projects in other cores. Applicants should describe how the Operations Core, the Research Methods Core, and the optional Research Network Development Core (see below) are integrated in the service of the Principal Research Core and related research projects. A Principal Research Core that focuses on interventions research should build capacity to facilitate the testing of interventions with the eventual goal of increasing the number of evidence-based interventions applicable to community care. Integrating two or more intervention approaches (efficacy, effectiveness, preventive, treatment and rehabilitative) to address the central research focus is encouraged. The Bridging Science and Service report identified 12 areas (Recommendations 7-18) where efficacy, effectiveness, practice and services research could be integrated. Priorities for Prevention Research at NIMH recommended that prevention research become more integrated with treatment and rehabilitative research across the life course. Applicants should select a major mental health problem as the focus of the research core and propose studies that will seek to determine the best interventions for that problem. Applicants can propose both efficacy trials to test newer interventions, as well as effectiveness trials that assess the generalizability and acceptability of interventions. Support can be used to pilot test interventions for estimating feasibility and effect sizes and exploring both short- and long-term outcomes. Capacity building activities include the provision of operations for multi-site clinical trials, research participant recruitment, data base development, supporting protocol development for new clinical trials, and refining approaches for sample identification and deployment of intervention protocols in community sites. There are a number of possible topics in interventions research that would benefit from infrastructure support. Applicants are encouraged to develop a solid set of proposed research topics that will seek to provide information on the best interventions for the major mental health problem chosen for focus by the ACISR. The following provides some examples of research areas that could fit in this core. This is not meant to be comprehensive, nor are the examples meant to be exclusive of other topics. For example, an ACISR could propose to test interventions that target multiple levels of risk and severity, test various ways of delivering interventions such as sequenced approaches or algorithms and test interventions in large community populations that have shown some promise in small restricted populations. Applicants could propose to develop new ways of identifying groups most likely to benefit from various intervention approaches as well as determining factors that would predict variability in response to interventions. Other possible research topics might include research to determine optimal dosing and duration of interventions to prevent relapse and recurrence. In addition, applicants could test ways of improving adherence to interventions and how to minimize side effects from interventions. A center might also test new intervention models that take into account the service context in which the intervention will be embedded and the impact of an intervention on much broader measures of outcome (e.g., disability and functional status). An ACISR can choose to focus the Principal Research Core on practice and service systems research. The ability to translate research findings into sustainable improvements in clinical practice and outcomes is one of the largest obstacles in improving the quality and effectiveness of mental health care. Little is known about what happens in routine community care especially across different practice settings. In order to improve community care it is critical that studies identify and understand how organizational, sociocultural, and interpersonal factors are associated with improved quality of care and optimal outcomes. Practice research, as described in the Bridging Science and Service report, seeks to examine how and which treatments or services are provided in community practice settings and to identify better ways to disseminate and implement research-based interventions and services in community settings. Practice research is based in three areas of research investigation: clinical epidemiology, quality of care research, and dissemination/implementation research. Service systems research addresses broad organizational, financing and policy questions. A Principal Research Core focused in this area should seek to integrate service systems research and practice-based research. Applicants should choose a major mental health problem and describe how the proposed practice research and service systems research studies will seek to address this problem. The following provides some examples of research areas that could fit in this core. This is not meant to be comprehensive, nor are the examples meant to be exclusive of other topics. There are a number of possible topics in practice research and service systems research that would benefit from infrastructure support. For example, applicants could propose to conduct research on the various factors that may enhance or detract from the effective delivery of interventions and test ways of modifying these factors to improve the delivery of care. Other potential topics include how consumer and clinician choices impact effective delivery of interventions and the outcomes from the intervention, how perspectives on quality of care vary by stakeholder and how those differences can be used to improve care. In addition, centers could propose to test various dissemination or implementation strategies for incorporating and sustaining the delivery of effective interventions in community settings. An ACISR might choose to examine usual care in the community and how an improvement in such care is influenced by individual, clinician and system factors. Research on the feasibility and utility of alternative methods to deliver interventions (e.g., telehealth) or studies to improve delivery of interventions in traditionally underserved areas (e.g., rural and frontier areas) would be other possible research topics for study in this core. Research Network Development Core Center applications may include a component devoted to creating and expanding the relationships between the primary application site and other sites, particularly community clinical or service systems. This is not a required core for an ACISR application but additional funds up to $400,000 direct costs a year may be requested to support activities under this core. The purpose is to create research networks for new intervention or services research. This core uses the same principles as those articulated in PAR-00- 096, Intervention and Practice Research Infrastructure Program (IP-RISP), (http://grants.nih.gov/grants/guide/pa-files/PAR-00-096.html) and provides support for research infrastructure development by partnering academic settings with community clinical and services systems that have large and diverse consumer and provider populations. However, these systems may lack the resources needed to conduct strong scientific research programs. Potential applicants are referred to the IP-RISP program announcement for details and examples of the types of activities that are supportable. Clinical and service systems of interest may include general and primary health care, community specialty care, long-term care, public mental health or health care systems, schools, and prisons, jails and other correctional systems. The community settings can benefit from research by providing empirical validation for treatment approaches and variations in care, creating robust evaluations of programmatic benefit and outcome, and assessing ways to improve care. The academic settings can benefit from these partnerships by strengthening and diversifying their study populations and perspectives. A central principle underlying this core is that different clinical and service systems will require different types of research infrastructure support and development activities. Funding requests should be guided by focusing on specific research needs and questions. It is expected that virtually all the financial support provided in this core will be targeted to the community clinical and service systems. It is permissible to request funds in this core to set up research networks with other academic sites when those sites do not have infrastructure funding available for clinical or services research. Applicants that request funds under this core are not eligible to apply for an IP-RISP grant. Those who currently have such a grant must describe how funds received under the Research Network Development Core would offset funding provided in the IP-RISP until the IP-RISP is finished. Organization of Centers An ACISR may be organized in a variety of ways and may include one institution or several. There is no single model for a center: the structure will depend upon the research questions and approaches selected to study them. One type of center could adopt a Clinical Research Organization type approach, providing administrative, management, and operational support to a large set of ongoing and planned intervention or services studies in various community sites. Another type of center could adopt a decentralized, multi- site focus in which specialized activities are supported in different sites. A conceptual and theoretical rationale for the organizational structure should be discussed in the application. However, they must include the required cores outlined above. The following are suggested to indicate the range over which centers might be organized, although they are not limited to these: o A center focused on interventions at a single institution might use the research network development core to incorporate community health systems throughout the state (e.g., school clinics, public clinics, etc.). The core is based at a single institution that supports the operations, training and methods cores. Research questions involving implementation of evidence-based preventive and treatment interventions could be tested using this network of sites. o A center focused on testing treatment interventions might share resources with several institutions to develop a network of sites in which research participants could be recruited. The operations core might be at one site while the methods core could be at another site. Funds from the research network development core may or may not be used in this case. o A center focused at a single institution provides the operations, training and methods core for a practice and service systems research center. Funds are requested for the research network development core to incorporate several managed care and public systems. AWARD MANAGEMENT Because of the complexities of this funding mechanism and associated scientific aims, applicants should note that higher levels of program scrutiny, both pre- and post-award, may be necessary. 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 is 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. 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. 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. LETTER OF INTENT Prospective applicants are asked to submit, by the date indicated in the heading of this PA, a letter of intent that includes: a descriptive title of the proposed center, 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 this PA. 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 NIMH staff to estimate the potential review workload and to plan the review. The letter of intent should be sent to the appropriate program contact, at the address listed under INQUIRIES, below. 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). 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: GrantsInfo@nih.gov. Applications are also available on the Internet at: http://grants.nih.gov/grants/forms.htm. Submit a signed, typewritten original of the application, including the Checklist of the documents included, 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 20892-9663 Bethesda, MD 20817 (for courier/express service) Applications must be received by the application receipt date indicated in the heading of this PA. If an application is received after that date it will be returned to the applicant without review. APPLICATION PAGE LIMITS The Introduction and description of the Operations, Research Methods and Principal Research cores is limited to 30 pages. The description of the Research Network Development core (if chosen) is limited to an additional 15 pages. REVIEW CONSIDERATIONS Applications will be reviewed by CSR for completeness and by NIMH program staff for responsiveness. Applications that are incomplete and/or non- responsive, will be returned to the applicant without further consideration. Applications that are complete and responsive will be evaluated for scientific and technical merit by an appropriate scientific review group convened by NIMH 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 National Advisory Mental Health Council. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserves a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Public Health Significance: Will the center be seen as a national resource for interventions and/or services research on a major mental health problem? Are the areas chosen for study those in which the field is ready to take advantage of larger intervention and services research studies? Will the center and its affiliated studies have a major impact on care in community settings? If the aims of the application are achieved, how will scientific knowledge of intervention and/or services research be advanced? (2) Innovation: Does the center propose to develop novel concepts, approaches, measures or methods in the development and assessment of interventions and/or services research? Are the aims original and innovative? Does the center extend existing approaches or develop new methodologies or technologies appropriate to the assessment of interventions and services? (3) Approach: Is there adequate rationale to support the importance of a center approach as opposed to other mechanisms (e.g., individual R01 application)? Does a conceptual and theoretical framework focused on a major topic in intervention and/or services research inform the center organization and infrastructure development? Is the concept of a center fulfilled, including: (1) an integrated theme bringing together a multidisciplinary team of investigators in a common mission related to the mental health problem chosen for investigation, (2) development of a pooled, core database or access to research participants that can yield results beyond that accomplished with individual projects alone, (3) attraction of established investigators and development of collaboration among investigators with diverse backgrounds and areas of expertise, (4) a research mentorship component for new investigators through research training and career development mechanisms, and (5) a process for stimulation and evaluation of new pilot study proposals? Is the approach for the center adequately developed, well integrated, and appropriate to the general aims of the center? Does the applicant acknowledge potential problem areas and consider alternative tactics? Are collaborations across sites well justified and reasonable to carry out the research activities? (4) Leadership: Are the center director and other senior investigators recognized as leaders in their fields? Do they have the experience and authority necessary to organize, administer and direct a national center? (5) Environment: Does the scientific environment of the center contribute to the probability of success? Does the center take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is the center able to gain and sustain access to a representative range of people in a broad set of academic and community settings? Is there evidence of institutional support? Are the collaborating sites chosen for the center the best ones to address the research questions proposed? Is there evidence of significant ongoing research in intervention and/or services research? (6) Maturation (for developing centers seeking to become an advanced center): Has the center developed a significant national research identity and focus on a major mental health problem? Has the leadership of the center been successful in establishing core structures, articulating the program of each core and in encouraging inter-core collaborations? Has the leadership of the center been successful in developing administrative procedures and practices that foster research of the highest quality and national significance? Has there been success in attracting productive investigators and promising trainees to the center (e.g., obtained training or career development funding)? Is there evidence of strong collaborative relationships with community systems? (7) Research Network Development (optional core): Are the networks representative of community settings and populations? Are the networks the appropriate choices for addressing the principal research questions? Is the infrastructure proposed for the network adequate to sustain research capacity in the sites? Is there strong evidence of commitment by the network sites? (8) Renewal of Advanced Centers (applicable only to ACISRs seeking competitive renewal): Is the center recognized as a national research resource for a major mental health problem? Has the center mechanism been instrumental in advancing the state of science in interventions and/or services research? Is the center mechanism the most appropriate mechanism to continue to advance knowledge in the research area chosen? Has the center attracted productive investigators and provided training opportunities for junior or new investigators? Has the body of research knowledge in the area chosen for investigation expanded significantly since the last review? Are collaborations across sites and within networks firmly established? Are there any performance problems, especially related to the ability to provide support for funded research projects? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: The reasonableness of the proposed budget and duration in relation to the proposed research. 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 research participants will also be evaluated. The adequacy of the proposed protection for humans to the extent they may be adversely affected by the activities 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. Applicants may also consult NIH staff for advice concerning collaborations and access to research participant material. Direct inquiries regarding programmatic issues about practice and service systems research to: Junius Gonzales, M.D. Division of Services and Intervention Research National Institute of Mental Health 6001 Executive Boulevard, Room 7141, MSC 9631 Bethesda, MD 20892-9631 Telephone: (301) 443-3364 FAX: (301) 443-4045 Email: jgonzale@nih.gov Direct inquiries regarding programmatic issues about intervention research for adults and the elderly to: Barry Lebowitz, Ph.D. Division of Services and Intervention Research National Institute of Mental Health 6001 Executive Boulevard, Room 7162, MSC 9635 Bethesda, MD 20892-9635 Telephone: (301) 443-1185 FAX: (301) 443-4045 Email: blebowit@nih.gov Direct inquiries regarding programmatic issues about intervention research for children and adolescents to: Benedetto Vitiello, M.D. Child and Adolescent Treatment and Preventive Intervention Research Branch Division of Services and Intervention Research National Institute of Mental Health 6001 Executive Boulevard, Room 7147, MSC 9633 Bethesda, MD 20892-9633 Telephone: (301) 443-4283 FAX: (301) 443-4045 Email: bvitiell@nih.gov Direct inquiries regarding fiscal matters to: Joy R. Knipple Grants Management Branch Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-8811 FAX: (301) 443-6885 Email: jknipple@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.242 (NIMH). Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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NIH Funding Opportunities and Notices
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