DEVELOPING DISASTER MENTAL HEALTH RESEARCH CAPACITY THROUGH EDUCATION (R25) RELEASE DATE: March 19, 2003 RFA: MH-03-009 National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/) National Institute of Nursing Research (NINR) (http://www.ninr.nih.gov/) Substance Abuse and Mental Health Services Administration (SAMHSA) (http://www.samhsa.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.242, 93.361, 93.982 LETTER OF INTENT RECEIPT DATE: May 16, 2003 APPLICATION RECEIPT DATE: June 13, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Background o Research Education Program Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to become Principal Investigators o Special Requirements o Where to send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The National Institute of Mental Health (NIMH), the National Institute of Nursing Research (NINR), and the Substance Abuse and Mental Health Services Administration (SAMHSA) seek to encourage collaborative partnerships among scientists from various disciplines and State and local health and mental health authorities to facilitate interdisciplinary research and disaster mental health research education, and to establish the capacity for rapid data collection after disasters, including acts of terrorism. To this end, this Request for Applications (RFA) is designed to create disaster mental health research education and rapid response programs to improve the capacity for high-quality disaster mental health research, speed the process for timely data collection in the aftermath of unforeseen events, and ultimately improve connections between evidence-based practice and the public health response to disasters. Accordingly, programs will be supported for (1) the development of and instruction of others in state of the art disaster mental health research methodology, including new methods and measures, and (2) the formation of interdisciplinary disaster research teams and research protocols, in conjunction with Federal, State and local public health authorities, for rapid data collection efforts after disasters and acts of mass violence. The sponsoring Institutes and SAMHSA propose to fund the development of programs to establish and conduct educational and training activities and to create disaster research partnerships and protocols, with the option of supplemental funding for implementing rapid data collection activities in response to unforeseen events. BACKGROUND Although disasters are disconcertingly prevalent in modern culture, prospective systematic studies of them have been relatively few, in part because of the difficulties inherent in field research that are compounded by circumstances associated with disaster scenes. Additionally, the ability to generalize about psychological effects of disasters has been limited by vast differences in methodologies used, including critical items such as time frames, identification of populations, sampling, and instruments. The diverse conceptualizations and methodologies that exist today reflect the fact that disasters are studied by a wide range of clinicians and behavioral scientists who can have quite different conceptualizations of disaster effects. The attacks of September 11, 2001, and the anthrax aftermath highlight the need for a systems orientation to planning for and responding to terrorism at both the population/community and individual/clinical levels. The nation's health can be better assured with a system-wide public health infrastructure, incorporating various scientific and practice disciplines relevant to mental health. The mental health and nursing research communities have important roles to play in developing a comprehensive framework for public health response. Such efforts can only be successful if there is adequate mental health research capacity relevant to terrorism and biodefense. The framework for research should include biomedical, behavioral, and health systems perspectives and should be applied to developing research capacity through education and training. There are many barriers to conducting rigorous research in the context of emergencies, including the need to establish collaborative relationships among investigators, emergency health care workers, and public health officials. The feasibility of gaining insight into public health preparedness and public health and clinical response will be enhanced when opportunities to learn and validation by research are embedded in response planning. The need for interdisciplinary researchers capable of designing and implementing studies using state of the art research methods in partnership with state and local public health officials responsible for disaster preparedness and response provides the rationale for this RFA. RESEARCH EDUCATION PROGRAM OBJECTIVES This RFA is the result of a confluence of issues related to the mental health consequences of disasters and acts of mass violence. The terrorist attacks of September 11, 2001, and the ensuing national reaction have highlighted the need to learn what we can from these unfortunate situations so as to reduce mental health complications, improve national response, and better address the consequences of such situations in the future. At its January 2002 meeting, the National Advisory Mental Health Council requested that NIMH enhance its capacity for supporting rapid data collection in the days and weeks following acts of mass violence. At its January 2002 meeting, the National Advisory Council for Nursing Research encouraged initiation of NINR biodefense research activities to prevent physical and behavioral complications after exposure to chemical or biologic agents. This request was made based on the recognition that research advances in the understanding of the neurobiological nature, cause, pathogenesis, treatment, and prevention of posttraumatic psychopathology must be obtained sooner than is currently possible with existing funding mechanisms. Moreover, research to understand and address the behavioral health implications of a bioterrorist attack will require new approaches. Prior to preparing an application, potential applicants are strongly encouraged to contact the appropriate Institute or SAMSHA staff person (listed in the section WHERE TO SEND INQUIRIES) to determine whether their application meets the program goals of the NIMH, NINR, and/or SAMHSA. This action is of utmost importance, as applications that do not adequately address the educational needs identified in the section PURPOSE OF THIS RFA will not be accepted for review. The sponsoring Institutes and SAMHSA expect applicant institutions to propose their own set of creative and innovative programs that address both of the activities identified in the section PURPOSE OF THIS RFA (the development of and the instruction of others in state of the art disaster mental health research methodology and the formation of interdisciplinary disaster research partnerships and protocols). Examples of potential program components include, but are not limited to, the following: o Cross-disciplinary education and networking to prospectively develop research protocols and improve access to disaster-exposed populations, involving leading researchers and State and local health and mental health authorities responsible for disaster preparedness and response. o Develop and deliver educational and practical training experiences that enhance the participation and commitment of both early career and established clinical researchers interested in disaster mental health research. o Educational and training activities integrating epidemiological methods and analysis, other advanced research methods, and statistics in the study of risk/protective factors, etiology, interventions, and/or services for adverse mental and behavioral health outcomes. o State of the science seminars for advancing consistency in methods/measures and promoting the use of a standard taxonomy for characterizing study designs, samples, measures, and phases of disasters and disaster research, including intervention research. o Interdisciplinary approaches to the development, adaptation, and modification of treatment, prevention, and rehabilitative interventions to increase the public health relevance of these interventions to disaster- impacted communities and diverse settings. o Interdisciplinary and collaborative educational activities that will lead to developing, testing, and refining assessment instruments and tools for evaluating the impact of disasters, including bioterrorism, on a community (psychological, biological, and behavioral reactions to loss of life, contaminated facilities, loss of social and economic resources, and other stressors, including the impact on schools and children), and tools for assessing individual risk and for facilitating triaging based on severity of risk. o Instruction in field research methods, emphasizing approaches to addressing unique challenges associated with disaster-impacted communities. o Interdisciplinary and collaborative educational activities that will illuminate the implications of communications about, and actual efforts involving, testing, evacuation, vaccination, treatment, and quarantine in the context of bioterrorism. o Mentored educational and training activities for evaluating systems response and for carrying out research on public health communications, risk appraisal and public behavior using innovative methods (virtual disasters and response simulation.) o Cross-disciplinary education and networking, informed by biological, behavioral, cognitive, and health systems perspectives, to improve strategies for communication to the public about vaccination programs and to improve guidance to State and local health agencies that may be establishing population-based vaccination programs. o Educational and training activities to facilitate collaborations among scientists knowledgeable about behavioral health and risk communication and public health officials who will disseminate information to prevent negative consequences (e.g., panic, stigma, blaming, etc.) and to promote adaptive and responsible behavior before, during, and after acts of terrorism. o Collaborative and interdisciplinary educational activities designed to evaluate unique aspects of disasters involving biohazards; to develop predictive models for group behavior; to evaluate and further develop public health communication guidance and message-framing strategies; and to develop measures unique to these types of events to assess reactions to loss of life, physical injuries, exacerbation of chronic illnesses, contaminated facilities, loss of social and economic resources and other stressors. o Mentored educational and practical experiences in translational research, drawing on basic behavioral research, to improve risk assessment, reduce panic, and guide appropriate health-seeking and protective behaviors. o Educational and clinical research opportunities regarding environmental risk factors associated with collective emergencies, such as community and agency response; origin, duration, severity, and type of emergency event or threat; and potential for re-occurrence. o Training in and the development of research protocols that are sensitive to anticipated regional/local needs, to facilitate rapid data collection on epidemiology of exposure; risk and protective factors; diverse neurobiological and behavioral outcomes; and mental health interventions (both short-term crisis intervention and long-term mental health treatment.) o Provide mentored clinical research opportunities in diverse settings designed for students enrolled in medical or graduate school degree programs and clinical residents. o Develop or enhance the research curricula and mentoring provided during postdoctoral training or residency training; and/or create research-training tracks within residency training. o Improve the quality of mentoring in disaster mental health-relevant research areas, particularly improving in the retention and advancement of physician scientists and nursing, pediatric, and geriatric researchers interested in disaster mental health. o Educational/research experiences that enhance underrepresented minorities' and/or women's participation in and commitment to disaster mental health research. o Cross-disciplinary educational/research experiences that prepare mental health researchers and/or nursing researchers to conceptualize and conduct research that integrates more than one discipline (e.g., integrate public health/epidemiological, neuroscience, clinical, computational, technical, and economic perspectives) or to translate approaches from the basic behavioral, social, and/or neurosciences to clinical and emergency services research issues. o Education and training for improved research on disaster and intervention response, including, but not limited to, early detection of symptoms; symptom management, such as functioning, impairment, and disability; short- and long- term effects of environmental stress, toxicity, and trauma; and response to intervention. o Educational and training activities related to ethical issues (e.g., privacy, confidentiality, assessing and monitoring participants' understanding of risks and benefits over time, etc.) in disaster mental health research. SAMHSA is particularly interested in, and will give additional funding consideration to, program(s) attempting to establish the capacity to provide technical assistance focused on needs assessment, empirically based program design, and evaluation of services provided by public sector mental health providers. Examples of these potential program components for SAMHSA funding include the following: o Establishment of Empirically Based Needs Assessment Strategies - Describe specific activities designed to assist State Mental Health Authorities in further defining, planning for, and enhancing internal procedures for needs assessment after disasters and large-scale crises. Before disasters, assistance to States would be designed to help States develop potential needs assessment approaches based on factors shown through research to have potentially significant mental health effects. After disasters, assistance to States would include technical assistance in conducting needs assessments and refining needs assessment methodologies to address unique needs related to each disaster and to assist in shifting resources if warranted. o Evaluation of Training Efforts - Describe a method for evaluating the efficacy of various training and educational endeavors most frequently used to prepare mental health professionals and paraprofessionals for field work at the site of a major disaster or catastrophic event. o Establishment of State and Local Research Plans - Describe plans to provide technical assistance to State and/or local public mental health authorities for establishing research and education plans. Assistance to State Mental Health Authorities should be designed to ensure that State and local planners and service providers will contribute to and benefit from the collection and analysis of research data. This collaboration would occur through participation in at least one technical assistance meeting to be arranged by SAMHSA. Potential applicants interested in these issues are encouraged to consult with SAMHSA program staff identified in the section WHERE TO SEND INQUIRIES. The activities supported by Mental Health Research Education Grants can involve educational/research experiences of short duration (e.g., 3 months with or without provisions for further ongoing contacts) or longer-term programs. Formats for the programs may vary to include a series of short courses, seminars, workshops, or structured short-term or long-term research experiences. Content areas may include curriculum development, design, implementation, and evaluation. Individuals supported by NIH training and career development mechanisms (K, T, or F Grants) may obtain, and indeed are encouraged to obtain, educational experiences supported by this R25 RFA, but may not receive salary or stipend supplementation from the R25 program. Mental Health Research Education Grants support educational activities focused on basic, clinical, services and other applied mental health and/or nursing research, and may not be used for support of non-research clinical training. This mechanism may be used, however, to provide Mental Health Research educational experiences to those in clinical training or in a clinical research track within a clinical training program. MECHANISM OF SUPPORT This RFA will use the NIH Education Research Program grant (R25) award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. Applicants who wish to submit again in response to PAR-02-087 (http://grants.nih.gov/grants/guide/pa-files/PAR-02-087.html), should subsequently submit a new R25 application. Mental Health Research Education Grants may be awarded for two to five years. The length of the grant period should be consistent with the objectives of the program. In some cases, these awards will be made to develop new educational approaches for which the institution will subsequently assume support. In other cases, the awards will strengthen activities that the NIMH and NINR will support over periods of two to five years. The anticipated award date is March 2004. This RFA uses the non-modular budgeting format. Applicants must use the forms for regular research grants, follow the specific instructions in the PHS 398 application kit, and provide a complete detailed budget (Form Pages 4 & 5) with narrative justifications. FUNDS AVAILABLE The participating Institutes and Agency intend to commit approximately $750,000 in FY 2004 to fund 2 to 3 new applications in response to this RFA. An applicant may request a project period of up to 5 years and a budget for direct costs of up to $250,000 per year. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of NIMH, NINR, and SAMHSA 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. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic o Faith-based or community-based organizations Foreign institutions are not eligible to apply. It is anticipated that in most cases these programs will complement other ongoing research training occurring at the applicant institution and that a substantial number of program faculty would have active research projects in which students can gain relevant experiences. If multiple sites are to be used, the applicant institution must be one of those sites. Institutions with existing Institutional National Research Training Grants (T32) or other federally funded training programs may apply for an education research grant provided the proposed educational experiences are distinct from those training programs receiving NIH support. In situations where contractual arrangements are an integral part of the proposed research education, all costs associated with the contractual arrangement (direct and F&A) must be considered as a direct cost and included in the $250,000 direct costs limitation. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research education program is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. Since this is an educational mechanism, and not a training mechanism, non-US citizens may participate in this program. However, requests for the appointment and participation of non-US personnel into this education grant should be made with the understanding that this mechanism is not to be used to circumvent or supplement standard NRSA training mechanisms, and unless strongly justified on the basis of high NIMH or NINR Program relevance, should be used primarily for the education of US citizens. Applicants are strongly encouraged to contact Program staff to discuss the appropriate utilization of this mechanism with respect to the eligibility, appointment, and participation of non-US citizens. SPECIAL REQUIREMENTS Allowable costs must be consistent with NIH policy and be reasonable, allocable, and well documented and justified for the research education program. Grant funds may not be used to supplant funds otherwise available at the applicant institution. Personnel Costs - individuals participating in the design and implementation of the research education program may request salary and fringe benefits appropriate for the percent of time devoted to the program. Normally, all personnel costs (including administrative and clerical costs) associated with directing, coordinating, and administering the program are not expected to exceed 25% of the total direct cost. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. (If mentoring interactions and other activities with students is considered a regular part of an individual's academic duties, then mentoring and other interactions with students are non-reimbursable from grant funds). Limited administrative and clerical salary costs associated distinctly with the program that are not normally provided by the applicant organization may be direct charges to the grant only when specifically identified and justified. Consultation costs, equipment, supplies, necessary travel (including foreign travel for uniquely qualified foreign faculty), and other program related expenses must be justified as specifically required by the program proposed and not duplicate items generally available for educational programs at the host institution. Participant Support - participants in the education program may receive subsistence allowance, which includes partial costs of meals and lodging (unless furnished as part of the fee for registration). They may also receive partial tuition, other education-related, and travel expenses, including foreign travel, if strongly justified. Note that effort and how the dollar amount is determined must be included when describing the participant support and also be listed in the budget justification area. Individuals supported by NIH training and career development mechanisms (K, T or F Grants) may not receive stipend or salary support from the Mental Health Research Education Grant. However, if funds are not available from other sources, limited support to defray participation costs (e.g., travel, meals, lodging) may be provided. Partial costs for off-site rental space will be considered if it is short term and shown to be necessary for the implementation and execution of the educational program (seminar, workshop, etc.). Matching funds from applicant institutions or other organizations for such off-site costs are strongly encouraged. Facilities and Administrative (F&A) Costs, formerly known as "indirect costs," may be allowed for the applicant organization and any approved subcontract based on 8% of total direct costs exclusive of tuition and fees and expenditures for equipment. Normally, funds will not be provided for fringe benefits or health insurance for participants involved in this education program. Note that all costs associated with consortium/contractual arrangements, both direct and F&A costs, are considered direct costs and are included in the $250,000 direct costs ceiling limitation for this program. Normally, funds for the research education evaluation plan are not expected to exceed 5% of the total direct cost. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Farris Tuma, Sc.D. Division of Mental Disorders, Behavioral Research, and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6200, MSC 9617 Bethesda, MD 20892-9589 Telephone: (301) 443-5944 FAX: (301) 480-4415 Email: ftuma@nih.gov Hilary D. Sigmon, Ph.D., RN National Institute of Nursing Research 6701 Democracy Boulevard, Room 710, MSC 4870 Bethesda, MD 20892-4870 Telephone: (301) 594-5970 FAX: (301) 480-8260 Email: hilary.sigmon@nih.gov Charles G. Cook, LSW Center for Mental Health Services Substance Abuse and Mental Health Services Administration 17C-20, Parklawn Drive Rockville, MD 20857 Telephone: (301) 443-4736 FAX: (301) 443-8040 Email: ccook@samhsa.gov o Direct your questions about peer review issues to: Michael Kozak, Ph.D. Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6138, MSC 9608 Bethesda, MD 20892-9608 Telephone: (301-) 443-6471 FAX: (301) 443-4720 Email: mkozak@nih.gov o Direct your questions about financial or grants management matters to: Brian Albertini Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-0004 FAX: (301) 443-0219 Email: albertib2@mail.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA 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 by the date listed at the beginning of this document. The letter of intent should be sent to: Farris Tuma, Sc.D. Division of Mental Disorders, Behavioral Research, and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6200, MSC 9617 Bethesda, MD 20892-9589 Telephone: (301) 443-5944 FAX: (301) 480-4415 Email: ftuma@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. SPECIFIC INSTRUCTIONS FOR APPLICATIONS IN RESPONSE TO THIS RFA: 1. Applicants must use the forms for regular research grants and follow the specific instructions in the PHS 398 application kit, with the exceptions listed below. Note that the page limitations given in the instructions apply to this mechanism. A complete detailed budget (Form Pages 4 & 5) with narrative justifications is required. Applications that do not conform to the specific instructions detailed below will be returned without review. 2. Application face page: item number two on this page must include the RFA number and the title, Developing Disaster Mental Health Research Capacity Through Education. 3. Description, Performance Sites, and Key Personnel (Form Page 2): under Performance Sites include "Consortium/Contractual Arrangements," with a description of plans for collaborating with other institutions for purposes of exchange and sharing of resources, including faculty, equipment, and facilities. If multiple sites are to be used, the applicant institution must be one of those sites and for other sites a strong justification must be included. 4. Resources (Resources Format Page): describe the educational environment; include a description of the facilities, laboratories, participating departments, computer services, and any other resources to be used in the conduct of the proposed education program. Use continuation pages, as necessary. 5. Research Plan: part "c" of this section should be retitled "Preliminary Data and Activities" and included if applicable. This section should contain information on steps that have led to the proposed Research Education program. 6. Research Plan: part "d" of this section should be retitled " Research Education Program Plan" and should contain material organized under the following subheadings, as `appropriate to the specific program: a) Program Direction - describe arrangements for administration of the program; provide evidence that the Program Director is actively engaged in research and/or teaching in an area related to mental health, and can organize and administer the education program, as well as evidence of institutional and community commitment and support for the proposed program. b) Program Faculty/Staff - describe the characteristics and responsibilities of the faculty; provide evidence that participating faculty and preceptors are actively engaged in research or other scholarly activities related to mental health. c) Proposed Research Education Program - provide programmatic detail on the special activities proposed (e.g., courses, curricula), including a description of plans to provide education to participants regarding the responsible conduct of research. d) Program Participants - provide detail about the proposed participants; include a description of plans for recruiting as participants individuals from underrepresented racial/ethnic groups, women and persons with disabilities. Competing continuation applications must include a detailed account of experiences in recruiting and retaining individuals from underrepresented groups during the previous award period. e) Research Education Evaluation Plan - include evaluation plans for determining success of the program in achieving its goals and objectives. Please note that applications that do not have an adequate evaluation plan will be considered non-responsive to this RFA. The inclusion of evaluation instruments is encouraged. f) Provide detail about the commitment, support, cooperation, and nature of proposed collaboration of state/local community agencies or other entities or settings outside the applicant organization whose support is essential for the conduct of the program activities. Describe plans for implementation of the EDUCATION PROGRAM OBJECTIVES, particularly those involving protocol development, should include procedures for obtaining and maintaining the necessary community relations, IRB review and approval, training and supervising project staff, insuring implementation fidelity, securing ongoing access to the potential subject population pools, recruiting a representative sample of the target population, recruiting minorities for the staff of the research intervention, and monitoring subject participation over time. USING THE RFA LABEL: 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. SENDING AN APPLICATION TO THE NIH: 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. NIMH Referral Liaison National Institute of Mental Health 6001 Executive Boulevard, Room 6154, MSC 9609 Bethesda, MD 20892-9609 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-3367 FAX: (301) 443-4720 Email: jnoronha@mail.nih.gov APPLICATION PROCESSING: Applications must be received on or before 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 review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. 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. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes. While the investigator may still benefit from the previous review, the RFA application is not to state explicitly how. PEER REVIEW PROCESS 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 participating ICs in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o 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 and assigned a priority score o Receive a second level review by the National Advisory Councils of the participating ICs. REVIEW CRITERIA Applications in response to this RFA should be characterized by innovation, scholarship, and responsiveness to the special and/or changing needs of disaster mental health research. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment (1) SIGNIFICANCE: Does the proposed research education program address the objectives stated in this RFA and the overall mission of the NIMH and NINR? (2) APPROACH: Are the proposed specialized curriculum, educational experiences, and collaborations with state/local public health programs appropriate and adequate to achieve the research education goals outlined. Are the course requirements and sequence, including mentored experiences and collaborations, and timetable for completing the planned activities also appropriate. Is there an adequate plan for evaluating the effectiveness of the program in achieving its objectives? (3) INNOVATION: Do the curriculum, educational, and collaborative plans include original and unique approaches or methods for addressing the needs put forth in the goals and objectives? Are plans to challenge existing paradigms or develop new approaches or techniques for improving disaster mental health research and practice described? (4) INVESTIGATOR: Does the program leadership demonstrate a record of achievements and are their qualifications appropriate to meeting the proposed goals and implementing the stated plan? (5) ENVIRONMENT: Is the scientific/education environment described, indicating the unique features and probability of success of the program? Is institutional commitment to the proposed program documented? If multiple sites are to be used, is this adequately justified in terms of the educational and collaborative experiences provided? Are plans provided for the coordination and communication between multiple sites and state/local collaborators? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed educational research program. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: May 16, 2003 Application Receipt Date: June 13, 2003 Peer Review Date: October 2003 Council Review: January 2004 Earliest Anticipated Start Date: March 1, 2004 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: 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 clinical research projects unless a clear and compelling justification is 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 clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/ NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/ guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must 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) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy 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 is available at http://grants.nih.gov/grants/funding/children/children.htm. 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. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 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 PA 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. 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. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. 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 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. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the 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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