DEVELOPING TRANSLATIONAL RESEARCH IN BEHAVIORAL SCIENCE Release Date: November 8, 2000 RFA: MH-01-005 National Institute of Mental Health (http://www.nimh.nih.gov/) National Institute on Drug Abuse (http://www.nida.nih.gov/) Letter of Intent Receipt Date: February 11, 2001 Application Receipt Date: April 11, 2001 THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA. PURPOSE The National Institute of Mental Health (NIMH) and the National Institute on Drub Abuse (NIDA) seek to encourage the development of collaborative partnerships between scientists who study basic behavioral processes (e.g., cognition, emotion, decision making, social networks, culture) and those who study the etiology, diagnosis, treatment, and prevention of mental and behavioral disorders (including drug abuse and addiction) and the delivery of services to those suffering from those disorders. NIMH and NIDA are issuing this Request for Applications (RFA) as a catalyst for a major, long-term commitment to (a) encourage the systematic translation of basic behavioral theory, methods, and findings into research designed to reduce the burden of mental illness and behavioral disorders and (b) encourage basic behavioral scientists to seek a further understanding of behavioral processes through an exploration of how those processes are altered by mental and behavioral disorders. This RFA was developed in response to a report written by the National Advisory Mental Health Council’s Behavioral Science Workgroup, entitled Translating Behavioral Science into Action, http://www.nimh.nih.gov/tbsia/tbsiatoc.cfm. This RFA contains three mechanisms to support varying types of translational research partnerships: (1) networking grants for the initiation of research partnerships; (2) developmental grants for the initial instantiation of translational research projects; and (3) research project grants for single and multisite translational research projects. 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, Developing Translational Research in Behavioral Science, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for projects to be funded for this program. 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) Exploratory/Developmental Grant (R21), Research Project Grant (R01), and Collaborative R01 award mechanisms. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed 5 years. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. The anticipated award date is September 30, 2001. For all competing R21 and R01 applications requesting up to $250,000 direct costs per year, specific application instructions have been modified to reflect MODULAR GRANT and JUST-IN-TIME streamlining efforts being examined by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at http://grants.nih.gov/grants/funding/modular/modular.htm. FUNDS AVAILABLE The NIMH intends to commit approximately $2,750,000 in FY 2001 to fund 6 to 10 new grants in response to this RFA, and NIDA plans to commit approximately $300,000 in FY 2001. For a networking grant (R21), an applicant may request a project period of up to 3 years and a budget for direct costs of up to $150,000 per year; this award is nonrenewable. For networking grants that include more than one institution, direct costs of up to $175,000 per year may be requested to allow for facilities and administrative (F&A) costs on consortium arrangements. For a developmental grant (R21), an applicant may request a project period of up to 5 years and a budget for direct costs of up to $350,000 per year, excluding F&A costs on consortium arrangements; this award is also nonrenewable, and is not transferable to another institution. Finally, a translational research project (R01) may involve either a single Principal Investigator or a group of investigators using the Collaborative R01 mechanism; applicants may request a project period of up to 5 years, with a budget determined by the work proposed. Applicants for the Collaborative R01 Grant are strongly encouraged to familiarize themselves with the NIMH announcement (http://grants.nih.gov/grants/guide/pa-files/PAR-98-017.html), and direct questions to program staff listed in this announcement. While the F&A costs associated with all contractual and consortium arrangements are considered as direct costs to the applicant organization, for the purposes of this announcement only, these will not count against the direct cost limits noted above for developmental grant applications over the modular grant limit of $250,000. (However, these costs should be indicated as instructed on Form 398, rev. 4/98.) Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. It is expected that direct costs for R01 applications will be awarded in modules of $25,000 up to the modular grant limit of $250,000; however, program and grants management adjustments may be necessary prior to the award. Although the financial plans of the Institute 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 applications of outstanding scientific and technical merit. At this time, it is not known if competing renewal applications will be accepted and/or if this RFA will be reissued. RESEARCH OBJECTIVES Background NIMH and NIDA have for many decades been primary sponsors of research in the basic behavioral sciences. This long-term investment in behavioral research has resulted in the development of a large body of knowledge in such areas as emotion, motivation, self-concept, personality, cognition, memory, social cognition and influence, family processes, social networks, and sociocultural variations (see http://www.nimh.nih.gov/publicat/basbehav.cfm). However, the theory, methods, knowledge, and insights from the basic behavioral sciences have not been fully utilized in understanding pressing public health issues in mental health and drug abuse: the etiology and assessment of disorders; the development of innovative preventive and treatment interventions; and the effects of interventions and services for diverse types of people in disparate social, economic, cultural, and environmental contexts. In 1999, the NIMH Director and the National Advisory Mental Health Council convened the Behavioral Science Workgroup to explore ways to increase the impact of behavioral science research on public mental health issues. The Workgroup was comprised of experts in social, cognitive, developmental, and clinical psychology, psychophysiology, anthropology, sociology, public health, and biostatistics. In their report, "Translating Behavioral Science into Action," they highlighted three priority areas of translational behavioral science research: o Basic behavioral processes in mental illness o Functional abilities in mental illness o Contextual influences on mental illness and its care Regarding these three areas, the Workgroup wrote: "These priority research areas are critical starting points for progress in translational science because they are at the interface of what end-users have identified as important and what behavioral science researchers regard as areas of opportunity. They offer the prospect of conducting exciting research, advancing scientific understanding of behavior-in health and in illness-and improving the mental health of our Nation." The workgroup recommended that NIMH "establish and publicize translational behavioral science research as a priority funding area...and develop a coherent strategy for its systematic development." As a first step, they recommended an RFA to "jump-start" research in each of the three priority areas. With this current RFA, NIMH and NIDA begin a long-term commitment to translational behavioral science research. Some researchers, working singly or in small groups, have already accomplished significant research of this nature, to a degree that augurs the significant potential value of this approach. At the current time, however, there is a clear need to foster a significant increase in collaborative efforts among basic and clinical researchers in order to realize the fullest potential of translational research. The RFA is designed to address the needs of investigators at all stages in the collaborative research process. For investigators who are just beginning to explore translational research questions, there is the networking R21 grant. For investigators who have initiated some collaborative partnerships and want to build a translational research capability, there is the developmental R21 grant. For investigators who have a specific translational research question, there is the R01 research project grant or the investigator-initiated Collaborative R01. Each of these mechanisms will be discussed below. General Characteristics Regardless of mechanism, all applications to this RFA must demonstrate that a research partnership between basic behavioral scientists and clinical and/or services researchers exists or will be developed and nurtured. The minimum collaborative arrangement would thus involve two investigators, although larger groups of actual and potential collaborators are encouraged. While the emphasis in this RFA is on behavioral science, networks that include relevant biological measures as integrative components are also encouraged, particularly from disciplines such as behavioral neuroscience and psychophysiology in which such integration is implicit. Networks are to be conceptualized by the nature of the translational research goals and need not be limited by geographical or department boundaries. Collaborations among different institutions are encouraged in view of the typical distinctions between basic sciences and clinical/services settings. However, the applicants must show how communication will occur across these boundaries so that fully developed collaborative research partnerships can occur. Networking R21 Grants The primary purpose of networking R21 grants is to provide an avenue for basic and clinical investigators to initiate and explore the potential of research collaborations. These research networks will have the following characteristics: o The purpose of this mechanism is to foster initial development of collaborative work; accordingly, investigators need not demonstrate any history of prior collaboration. However, those factors in the investigators background and/or institutional circumstances that would facilitate success in collaboration should be clearly delineated. o A research network application must contain a cogent description of one or more specific topics in basic behavioral science, the clinical/services domains to which the basic science is to be applied, and a compelling justification for the potential of the research collaboration with respect to the translation of one or more basic science areas into clinical research. o Relevant areas of basic behavioral science can include models of behavior, cognition, social functioning, etc.; specific paradigms developed for the investigation of basic behavioral processes; and statistical models or methodologies. In all cases, however, a strong knowledge base should already be available that is germane to the translational effort. o Networks should provide a clear plan for the development of the collaboration. Such efforts could include travel among sites for informal meetings; workshops and small conferences; consultants; and analyses of extant data sets, using new methodologies or approaches. The purpose of these activities will be to refine conceptual frameworks for organizing translational research and to identify which specific research questions show greatest promise for advancement. o Networks may also include pilot studies, with subjects drawn from clinical, high-risk, and/or non-clinical populations, in order to demonstrate feasibility of certain aspects of the research approaches and develop further translational research projects. o Networks may provide for salary support for faculty, research assistants, and other professional staff involved with the project. o Each network should present a description of the anticipated longer-term goals of the collaboration as it develops. Such goals might variously include an application for a developmental grant (R21), an R01-based research collaboration, or a larger center mechanism. Grants for Translational Research Development The primary purpose of these larger R21 grants is to provide support for the beginning implementation of translational research capabilities and pilot projects. As such, it is expected that the primary components of these projects will involve activities designed to foster such development. These developmental activities will have the following characteristics: o The principal investigator must have demonstrated the capability to organize, administer, and direct the activity, and show a minimum time commitment of 25 percent. Other investigators must also allot a percentage of effort that is commensurate with their role in the project. o A development project is expected to include a group of investigators who integrate ideas from diverse scientific and disciplinary realms. While it is not necessary that all members of the project have independent research funding, investigators are expected to demonstrate a strong record of scientific productivity and innovation. o The investigators are expected to develop a specific set of hypotheses related to translational research that define the mission of the project. The project should address relevant theoretical and empirical literature in both the basic and clinical/services areas to be studied, and identify the goals of the translational research effort. o The goal of a project of this type is to support the development of a significant potential for conducting innovative translational behavioral science research. Accordingly, the project should clearly describe the scope and goals of intended future work, including scientific goals and anticipated mechanisms of support (e.g., Collaborative R01 submissions, centers) that are anticipated to emerge from the developmental process. o The project will be expected to develop methodological and/or statistical strengths in a range of areas. Such methodologies could be developed initially in basic research areas, and then applied to issues in clinical or services research. o Projects should include plans for the common reduction, management, and analysis of data across multiple activities and sites. Such work should be directed towards facilitation of comparing multiple data sets, and allowing direct comparisons (where relevant) of data bases from clinical and non-clinical populations. o As part of the developmental activity, seed money and start-up funds may be requested to support new, innovative pilot projects that reflect: (1) research that is needed to facilitate the development of basic behavioral science to prime its relevance to applied research; and (2) research in clinical and/or services domains that incorporates the theories and/or methods of basic behavioral science. o A developmental project must include plans for research apprenticeships. These should include opportunities for at least two young investigators to be mentored in one or more areas of specialization, and specifically address the application of basic research principles to clinical or services issues. Projects are expected to make maximum use of the variety of mechanisms available to foster the development of scientists with expertise in translational research. Translational R01 Grants The primary purpose of the R01 grants is to support fully implemented research projects with a translational focus. Applications submitted with a single principal investigator will be expected to include one or more additional investigators forming a collaborative team that includes basic and clinical/services expertise, clearly defining the roles of all investigators in the translational research; for investigators at multiple institutions, the collaborative arrangements will typically be indicated via one or more consortium/subcontract arrangements. The NIMH Collaborative R01 mechanism may also be used for investigators at a number of institutional sites, with a separate principal investigator for each constituent R01 application. These research projects will have the following characteristics: o Translational grants must include one or more components of basic behavioral science. The inclusion of relevant physiological measures, in addition to concepts, paradigms, and theories drawn from basic behavioral science, is encouraged but not required. o The principal investigator of a single-R01 project may be an individual with a primary research background in either basic or clinical/services areas. Submissions using the Collaborative R01 mechanism may include one or more separate R01 applications in each of the basic and clinical/services domains. o The clinical or services component of the proposed application may include any aspect of relevant work. This component is to include research with patient populations, that is, studies conducted with persons diagnosed with mental disorders, including drug abuse and addiction, or with organizations that provide mental health or drug abuse services. The clinical/services research program will reflect the contributions of basic behavioral science, including concepts, principles, extant literatures, paradigms, measures, statistical approaches, etc.; integration of comparable work from neuroscience is also encouraged where appropriate. o The clinical or services component of the proposed application must focus on populations in need of treatment or services for the symptoms and/or functional deficits associated with mental disorders and/or drug abuse. o The basic behavioral science component must represent a meaningful contribution to the overall program of research, rather than serving a limited consultative role. Although not required, this component could include an active program of experimentation, methodological or statistical development, or other scientific work that is relevant to the clinical/services application. These efforts might involve initial studies laying a necessary groundwork for projects with clinical/services populations, and/or studies to address basic research questions arising from results with samples drawn from clinical or services settings. Basic behavioral studies typically involve non-clinical populations, but may also involve high-risk populations. o Each application must demonstrate the ability to translate and integrate data between basic and clinical studies. Each component must demonstrate the ability to inform, and be informed by, the results of the other component(s). Research Topics The following are examples of broad research topics that might be the focus of translational research. This list is not meant to be comprehensive, nor are the examples meant to be exclusive of other topics. o Research pertaining to the factors that maintain the engagement of patients with treatments for mental disorders, including drug abuse or addiction, whether psychosocial or pharmacologic o Studies of cognitive, attentional, and/or emotional processes in attention- deficit/hyperactivity disorder o Research devoted to an understanding of the nature of specific functional deficits in mental or drug abuse disorders (e.g., deficits in attention, memory, emotion-regulation, social interactions and relationships), and development of targeted interventions for rehabilitation and relapse prevention o Research regarding neurocognitive and emotional functioning related to severely disabling mental disorders or drug abuse, such as schizophrenia, bipolar illness, depression, and addiction o Studies of cultural factors involved in the diagnosis, prevention, treatment, and delivery of services in mental disorders, including drug abuse and addiction o Research regarding behavioral and neurodevelopmental factors in disorders characterized by impaired affiliative behavior and social functioning such as autism and schizophrenia o Studies of decision making as it affects the behavior of patients and providers in mental health or drug abuse services settings 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 the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. 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 the program staff listed under INQUIRIES by the letter of intent receipt date listed. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms 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. The application is also available at http://grants.nih.gov/grants/funding/phs398/phs398.html. The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. Applications that request more than $250,000 in any year must use the standard PHS 398 (rev. 4/98) application instructions. SPECIFIC APPLICATION INSTRUCTIONS FOR MODULAR GRANTS BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. (Applications that request more than $250,000 direct costs in any year must follow the traditional PHS 398 application instructions.) The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD: Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT: Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION: Prepare a Modular Grant Budget Narrative page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the total direct costs requested for each year. This is not a Form page. NOTE: Applications for R21 or R01 mechanisms that exceed $250,000 in direct costs in any one year must not be submitted in the modular format, and should be submitted following the traditional application instructions, including complete detailed budget pages and justification in the application. Under Personnel, list all project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of all personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH: The Biographical Sketch provides information used by reviewers in the assessment of each individual's qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than 3 pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm. - Complete the educational block at the top of the form page; - List position(s) and any honors; - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last 3 years; - List selected peer-reviewed publications, with full citations. o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. Applicants planning to submit an R01 application requesting $500,000 or more in direct costs for any year are advised that he or she must contact the Institute program staff before submitting the application, i.e., as plans for the study are being developed. Note that this limit includes the overall total annual funding for Collaborative R01 applications. Furthermore, the applicant must obtain agreement from the Institute staff that the Institute will accept the application for consideration for award. Finally, the applicant must identify, in a cover letter sent with the application, the staff member and Institute who agreed to accept assignment of the application. This policy requires an applicant to obtain agreement for acceptance of both any such application and any such subsequent amendment. Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at http://grants.nih.gov/grants/guide/notice-files/not98-030.html. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. Type the RFA number (MH-01-005) 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, Developing Translational Research in Behavioral Science (MH-01-005), must be typed on line 2 of the face page of the application form and the YES box must be marked. The sample modified mailing label is available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Please note this is in pdf format. Submit a signed, typewritten original of the application, including the Checklist, and 3 signed photocopies, in 1 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, 2 additional copies of the application must be sent to: Bruce N. Cuthbert, Ph.D. Adult Psychopathology and Prevention Research Branch Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6184, MSC 9625 Bethesda, MD 20892-9625 Rockville, MD 20852 (for express/courier service) Applications must be received by the application receipt date listed in the heading of this RFA (April 11, 2001). If an application is received after that date, it will be returned to the applicant without review. 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. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIMH or NIDA staff. 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 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 respective Institute’s 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 to deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project and to the type of application, i.e., networking R21, developmental R21, translational R01? Does the applicant acknowledge potential problem areas and consider alternative tactics? Are the basic research components and clinical or services research questions suitably chosen to represent a feasible and potentially valuable translational project? (3) Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the principal investigator appropriately trained and well suited to carry out this work? Does the collaborative network or team involve both basic and clinical/services expertise? Is the work proposed appropriate to the experience level of the principal investigator and collaborative researchers? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research. o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. Schedule Letter of Intent Receipt Date: February 11, 2001 Application Receipt Date: April 11, 2001 Peer Review Date: July 2001 Council Review: September 2001 Earliest Anticipated Start Date: September 30, 2001 AWARD CRITERIA Award criteria that will be used to make award decisions are: o scientific merit (as determined by peer review); o availability of funds; o programmatic priorities. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Bruce N. Cuthbert, Ph.D. Adult Psychopathology and Prevention Research Branch Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6184, MSC 9625 Bethesda, MD 20892-9625 Telephone: (301) 443-3728 FAX: (301) 443-4611 Email: bcuthber@mail.nih.gov Lisa Onken, Ph.D. Behavioral Treatment Development Branch Division of Treatment Research and Development National Institute on Drug Abuse 6001 Executive Boulevard, Room 4123, MSC 9551 Bethesda, MD 20892-9551 Telephone: (301) 443-0107 FAX: (301) 443-8674 Email: lo10n@nih.gov Herbert Weingartner, Ph.D. Behavioral Sciences Research Branch Division of Neuroscience and Behavioral Research National Institute on Drug Abuse 6001 Executive Blvd., Room 4258, MSC 9555 Bethesda, MD 20892-9555 Telephone: (301) 443-1263 FAX: (301) 594-6043 Email: hw6g@nih.gov Direct inquiries regarding fiscal matters to: Diana S. Trunnell Grants Management Branch Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-2805 FAX: (301) 443-6885 Email: Diana_Trunnell@nih.gov Gary Fleming, J.D., M.A. Grants Management Branch Office of Planning and Resource Management National Institute on Drug Abuse 6001 Executive Boulevard, Room 3119, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX: (301) 594-6849 Email: gfleming@nida.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 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 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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