RAPID ASSESSMENT POST-IMPACT OF DISASTER RELEASE DATE: July 24, 2002 (see NOT-DA-05-013 and NOT-MH-04-001) PA NUMBER: PAR-02-133 March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date, all R03, R21, R33 and R34 applications must be submitted through Grants.gov using the electronic SF424 (R&R) application. Replacement R03 (PAR-06-252) and R21 (PAR-06-253) funding opportunity announcements have been issued for the submission date of June 1, 2006 and submission dates thereafter. EXPIRATION DATE: December 2, 2005 (Program extended, see NOT-MH-05-018) National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/) THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA This Program Announcement (PA) replaces PA-91-04, which was published in the NIH Guide for Grants and Contracts, Vol. 19, No. 40, November 1990, revised in October 1995 (http://www.nimh.nih.gov/grants/research/910004.cfm), and amended by a NIH Guide notice in October 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-MH-01-012.html). The purpose of this PA is to provide a rapid funding mechanism for research on the post-impact of disasters, in order to permit access to a disaster area in the immediate aftermath of the event. The regular grant submission, review, and funding process is lengthy, such that it requires investigators who would conduct such studies to wait a minimum of 9 months after the submission of the application to obtain the research funds, during which time important data may be lost. An emergency event of potential significance for mental health may occur with little or no warning (e.g., Hurricane Andrew, Los Angeles earthquake, the Oklahoma bombing, or the terrorist attacks of September 2001, including bioterrorism) and therefore modified procedures are required to expedite the funding of research applications on such events. The Traumatic Stress Research Program of the NIMH recognizes that prompt assessment may be crucial to many kinds of mental health disaster studies, including those that focus on service seeking, on efficacy of outreach or prevention efforts, and on identifying high-risk victims on the basis of early response. Advances regarding post-traumatic psychopathology, which build on findings from basic research on cognitive processing, arousal, and memory, highlight the need for rapid data collection in the days and weeks following natural and human caused events. Rapidly supported pilot-type studies on the symptoms and course of traumatic stress reactions, the organization and delivery of mental health services, and approaches to intervention, can lay the foundation for larger studies on the neurobiological nature, cause, pathogenesis, treatment and prevention of these conditions. This kind of research most often has a serious urgency with regard to availability of, or access to, data or facilities. The Rapid Assessment Post-Impact of Disaster (RAPID) grants described in this program announcement are designed to provide a limited sum of money for early assessment to investigators who intend to follow up with a full research application, using the preliminary data from this initial effort as a basis for their larger application. RESEARCH OBJECTIVES 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. Disasters and acts of mass violence are a terrible reality, with the potential to cause great public health and economic burdens. Unlike individual traumatic events, disasters tend to strike without preference to personal characteristics that increase the risk of exposure to other kinds of traumatic events. Individual characteristics predisposing to traumatic events are also associated with vulnerability to post-traumatic psychopathology, thus confounding the effects of the event with predisposing characteristics. Disasters and acts of mass violence provide for a unique scientific aperture, the need to learn more about the biological and behavioral consequences of traumatic stress can be uniquely addressed with careful and sensitive research involving disaster exposed populations. The Traumatic Stress Research Program is the focal point in the NIMH for support of research projects on the mental health sequelae of emergencies resulting from events in the external environment, which include natural and human-made situations. Such events range from individual to community and to larger- than-community catastrophes, and they encompass natural disasters (e.g., flood, tornado, drought), human-made emergencies (e.g., toxic waste spill, fire, bridge collapse), and violence (e.g., riot, combat, school-based shootings, suicides, workplace violence, terrorism). The Program supports research on psychological, physiological, biological, and behavioral reactions to emergencies, risk factors for developing prolonged mental health sequelae (including post-traumatic stress disorder) resulting from exposure to such emergencies, service delivery and treatment of victims, and effectiveness of programs designed to prevent mental health problems. In order to respond appropriately and in a timely manner to the psychological distress likely to occur in the context of any disaster, it is necessary to better understand the nature of problems people experience, the types of help they seek, and the readiness of the health and human service delivery system to provide needed care and treatment. Collecting information following a disaster presents special challenges, foremost among them is the need for investigators to attach the highest priority to standards of privacy, dignity, and courtesy in their interactions with participants who were affected in any way by an event under study. Any information gathering activities in this context must acknowledge and adhere to the imperatives of doing no harm, placing the care and safety of victims and survivors above all else, and coordinating with assistance efforts. This may involve coordination with state and local response efforts as well as federally supported counseling and outreach activities such as those funded by the Federal Emergency Management Agency (FEMA) and administered by the Center for Mental Health Services (CMHS) in the Substance Abuse and Mental Health Services Administration (SAMHSA) http://www.mentalhealth.org//cmhs/EmergencyServices/default.asp The Traumatic Stress Research Program is concerned with research topics including but not limited to: psychological, physiological, biological, and behavioral reactions to trauma, risk factors for mental health sequelae (including post-traumatic stress disorder, depression and substance abuse), optimal provision of mental health services, prevention and treatment. Applications for research support may include a substantive emphasis in any one or more of the following areas: o Epidemiological research on exposures and reactions - the mental and physical health impact on victims/survivors, families, emergency workers, and community members. In the case of events involving biological or otherwise unseen agents, research on the implication of perceived and actual exposure may be relevant. o Differential risk of negative effects among different population subgroups (age, race/ethnicity, sex, those with prior mental health/substance abuse disorders). o Rapid assessment of early psychological, biological, and behavioral reactions to loss of life, contaminated facilities, loss of social and economic resources and other stressors (to guide the allocation of resources and targeted intervention). o The effects of possible toxic exposure on the central nervous system, the mechanisms underlying impaired functioning, clinical phenomena of toxin-related neuropsychological and neuropsychiatric disorders. o Research on developing and communicating strategies to facilitate realistic individual risk assessment and protective strategies, to prevent negative consequences (e.g., panic, stigma, blaming, requests for unnecessary/ inappropriate services) and promote adaptive and responsible behavior to minimize risk and injury. o Research on the settings in which direct and indirect victims/survivors present for care, including studies of the impact of co-locating mental health services into non-traditional mental health settings (e.g., places of worship, community centers, work settings, health clinics, schools, etc) on access, referral, and acceptability of services. o Research on methods for assessing risk, and for triaging based on severity of risk. o Observational and descriptive studies to identify factors that promote or impede effective health provider training in screening, assessment, referral and treatment. o Research on the organization, delivery and outcome (intended and unintended) of individual and public-health level interventions by mental health and non- mental health providers and Federal, state and local agencies. o Research on the mental and behavioral health implications of communications about and actual efforts involving evacuation, vaccination, and quarantine. o Research on social support systems, including families, spiritual affiliations, and coping mechanisms as mediators of psychological response to emergency events. o Research on intervention and treatment to reduce the risk of psychopathology, symptom severity, and disability. o The mental health consequences of the subjective appraisal of traumatic events, including such aspects as extreme fear, perceived responsibility, perception of lasting consequences, and expectation of the reoccurrence of such an event. MECHANISM(S) OF SUPPORT This PA will use the NIH Small Grant (R03) and Exploratory/Developmental Grant (R21) award mechanisms. The applicant is solely responsible for planning, directing, and executing the proposed project. The Small Grant (R03) award may not exceed $50,000 in direct costs per year. Exploratory/Developmental Grants (R21) submitted under this PA may request up to two years of funding and may not exceed $125,000 in direct costs per year. Potential applicants should note the Peer Review Process section of this Program Announcement as there are some additional review criteria for these applications. RAPID awards are non-renewable and may not exceed two years, although one year is appropriate in most cases. Continued support may be requested only through submission of a complete regular research application that will be reviewed through the regular peer review system. This PA uses just-in-time concepts. It also uses the modular budgeting format (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, applications with direct costs in each year of $250,000 or less should use the modular format, thus all applications in response to this PA should use the modular format. ELIGIBLE INSTITUTIONS See SUBMITTING AN APPLICATION before preparing a formal application for submission. 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 or foreign o Faith-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, experience, and resources necessary to carry out the proposed research 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. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA 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: Child Trauma Studies Farris Tuma, Sc.D. Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6197, MSC 9617 Bethesda, MD 20892-9617 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-5944 FAX: (301) 480-5514 Email: ftuma@nih.gov Adult Trauma Studies Regina T. Dolan-Sewell, Ph.D. Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6183, MSC 9625 Bethesda, MD 20892-9625 Telephone: (301) 443-6802 FAX: (301) 480-4611 Email: rdolan@nih.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 6139, MSC 9608 Bethesda, MD 20892-9608 Telephone: (301) 443-1340 FAX: (301) 443-4720 Email: mkozak@nih.gov o Direct your questions about financial or grants management matters to: Diana S. Trunnell Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-2805 FAX: (301) 443-6885 Email: diana_trunnell@nih.gov SUBMITTING AN APPLICATION RAPID applications involve expedited peer review and funding consideration processes. Potential applicants are strongly encouraged to contact Dr. Farris Tuma (child studies) or Dr. Regina T. Dolan-Sewell (adult studies) before submitting a RAPID application to determine whether the proposed work meets the guidelines of this program, whether requested RAPID funding is likely to be available, and whether the idea should be considered for initial submission as a fully developed application. Inquires not meeting the RAPID guidelines will be guided to other grant mechanisms and to program contacts to discuss alternatives. To meet the goals of the RAPID program, applications should be submitted within approximately 6 weeks of the identified disaster event. RAPID applications will be handled on an expedited external peer review and award basis to meet the goals of this program. 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) 710-0267, Email: GrantsInfo@nih.gov. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. SENDING AN APPLICATION TO THE NIH The title and number "RAPID ASSESSMENT POST-IMPACT OF DISASTER--PAR-02-133" must be entered in Section 2 of the face page of the application. In addition, "NIMH Expedited Review" must be typed in the top margin of the face page. 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) In addition, applicants must simultaneously send two complete copies to the Program Officer, Farris Tuma, Sc.D. at the address listed under INQUIRIES, in order to permit an expedited review of the application. The project description should be brief (not to exceed 10 pages for both the R03 and R21) and include clear statements as to why the proposed research should be considered urgent, how this effort would relate to future research plans, and why a RAPID award is the appropriate mechanism for supporting the work. Applications should propose a clearly discernible research design, involving generation and/or testing of hypotheses, and a justification for the proposed methodology. Brief biographical information is required for principal or co-principal investigators only, and should list no more than five significant publications or other research products. Additional material (e.g., an elaborate literature review, an extended discussion of significance) is discouraged. In all other respects, applications must meet the conditions set out in form PHS 398 (rev. 5/01), including a standard cover page, a statement of current and pending research support, and a budget. PEER REVIEW PROCESS An appropriate scientific review group convened by the NIMH will evaluate applications for scientific and technical merit. As part of the initial merit review, applications will: o Receive a written critique o Exploratory/Developmental Grant (R21) applications will receive a second level review by the National Advisory Mental Health Council. This second level review will be expedited to the extent possible. o Small Grant (R03) applications will not necessarily 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. The NIMH mission is to diminish the burden of mental illness through 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 The scientific review group will address and consider each of these criteria in assigning your application"s overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you 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 your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? 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 clearly discernible, adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? Do you discuss the relationship between proposed methodology and that employed in prior disaster research? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Do you have experience with trauma/disaster research? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your work will be done contribute to the probability of success? Do the proposed activities take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of existing collaborative relationships with community contacts where participants will be recruited from? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: PROTECTIONS: 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. INCLUSION: 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 included in the section on Federal Citations, below). BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. OTHER REVIEW CRITERIA o Urgency and suitability of the research to the RAPID award mechanism o Relation of the project to future research plans AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND 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 Safety and 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 AMENDMENT "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 PA 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 No. 93.242, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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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