INTEGRATING THE BASIC BEHAVIORAL SCIENCES AND PUBLIC MENTAL HEALTH Release Date: March 15, 2000 PA NUMBER: PA-00-078 National Institute of Mental Health THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. THIS PA INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS PA. PURPOSE Both the behavioral and public health sciences have a long, rich history in basic and applied research aimed at improving the lives of all Americans. These disciplines have complementary expertise in areas such as biometrics, research design, intervention development and implementation, and outcome analyses, to name just a few research topics. Both disciplines have contributed to major improvements in our Nation"s mental and medical health through advances in prevention and treatment. Even greater improvements can be achieved if behavioral and public health scientists increase their collaboration in areas of clearly shared interests. The purpose of this program announcement is to solicit applications that integrate basic behavioral science and public health expertise in collaborative research on mental health and disorders. The program announcement is in response to the Report of the National Advisory Mental Health Council Behavioral Science Workgroup, Translating Behavioral Science into Action. The full report, which indicates the scientific topics encouraged under this program announcement, may be found at http://www.nimh.nih.gov/tbsia/tbsiatoc.cfm. The basic behavioral sciences offer expertise that could be applied to a range of public health problems relevant to mental disorders, symptoms, or related disability. Pertinent areas of expertise in the basic behavioral sciences include research on emotion and motivation, cognitive and emotional functioning, persuasion, family processes and networks, and socio-cultural and environmental processes. Public health areas of expertise include descriptive and experimental epidemiology, and the development and implementation of preventive intervention technologies. Proposals under this announcement should include collaborations between investigators from both the basic behavioral sciences and public health to address a range of critical problems focused on mental disorders, symptoms, and related disabilities. Translating Behavioral Science into Action highlights three specific areas of study: (1) understanding basic behavioral processes in mental illness, (2) understanding how mental illnesses and their treatments affect the abilities of individuals to function in diverse settings and roles, and (3) understanding how social or other environmental contexts influence the etiology and prevention of mental illness and the treatment and care of those suffering from mental disorders. 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 Program Announcement, Integrating the Basic Behavioral Sciences and Public Mental Health, is related to the priority area of Mental Health and Mental Disorders. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, 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 the Small Grant (R03) mechanism. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT This PA will use the following research grant mechanisms: R01 (Research Project Grants), and Investigator-Initiated Interactive Research Project Grants (IRPG), R03 (Small Grants), and R21 (Exploratory/Developmental Grants). The Research Project Grant (R01) provides up to five years of funding that is commensurate with the science proposed. An IRPG group consists of the coordinated submission of two or more RO1 applications for related research project grants that do not require extensive shared physical resources. Although IRPG applications must describe the objectives and scientific importance of the collaboration, each project could be accomplished independently. The principal investigators may be from one or more institutions. An IRPG group must include a minimum of two independent applications. The Small Grant (R03) provides two years of funding with a maximum of $50,000 direct costs for each year. The Exploratory/Developmental Grant (R21) provides three years of funding with an average of $125,000 direct costs for each year, it is intended for pilot testing of interventions and other aspects of intervention development. For all R03 and R21 applications, and for all competing 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 undertaken at NIH. More detailed information about modular grant applications, including a sample budget narrative justification pages and a sample biographical sketch, is available via the Internet at: http://grants.nih.gov/grants/funding/modular/modular.htm. Applications that request more than $250,000 in any year must use the standard PHS 398 (rev. 4/98) application instructions. Because the various grant mechanisms have special eligibility requirements, application formats, and review criteria, applicants are strongly encouraged to consult with program staff (listed under INQUIRIES) and to obtain the appropriate additional announcements for those grant mechanisms. Information specific to the R03 grants may be found at: http://grants.nih.gov/grants/guide/pa-files/PAR-99-140.html. Information specific to the R21 grants may be found at http://grants.nih.gov/grants/guide/pa-files/PA-99-134.html. Information specific to the IRPG grants may be found at http://grants.nih.gov/grants/guide/pa-files/PA-96-001.html RESEARCH OBJECTIVES A broad range of research would benefit from integrating the basic behavioral sciences and public mental health. Translating Behavioral Science into Action, which indicates the scientific topics encouraged under this program announcement, may be found at http://www.nimh.nih.gov/tbsia/tbsiatoc.cfm. Topics include, but are not limited to: o Understanding basic behavioral processes in mental illness, o Understanding how mental illnesses and their treatments affect the abilities of individuals to function in diverse settings and roles, o Understanding how social or other environmental contexts influence the etiology and prevention of mental illness and the treatment and care of those suffering from mental disorders, o Examining risk and protective processes associated with co-morbid mental and medical disorders (e.g., heart disease and depression, anxiety disorders and cancers), developing conceptual models of new interventions, and initial testing of the new interventions, o Using principles and findings from the basic behavioral sciences to improve adherence to interventions for mental disorders, developing models of preventive, treatment, and rehabilitative interventions and innovative strategies to enhance adherence to them, o Investigating various informed-consent procedures, advance directives, and other research ethics topics in groups at risk for or suffering from mental disorders, o Examining principles and findings from the basic behavioral sciences that affect individuals willingness to participate in interventions, response to interventions, functioning/disability, and other outcomes. o Investigating how interpersonal communication styles of providers (e.g., authoritarian, egalitarian) and client preferences for particular styles interact to affect willingness to participate in interventions, response to interventions, functioning/disability, and other outcomes, o Examining approaches to decrease stigma related to mental disorders, including studies of the social context of stigma as well as studies of individuals who are stigmatized, o Examining cultural explanations for disorder and how they affect receptivity and response to interventions, particularly when the client’s and family’s explanations differ from those of the mental health provider, 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 is provided 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 "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994 available on the web at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not94-100.html INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applicants are strongly encouraged to contact the program contacts listed under INQUIRIES with any questions regarding their proposed project and the goals of this PA. Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, Email: GrantsInfo@nih.gov. Applications are also available on the World Wide Web at: http://grants.nih.gov/grants/forms.htm. SPECIFIC APPLICATION INSTRUCTIONS FOR MODULAR GRANTS 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. 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. o Under Personnel, list key 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. o 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 key 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. o 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 three 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 three 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 investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended/revised version of the preceding grant application types 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. Furthermore, the application 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 Any application subject to this policy that does not contain the required information in a cover letter sent with the application will be returned to the applicant without review. The title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and five 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) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened by NIH in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria The goals of NIH-supported research are to advance our understanding of behavioral and biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Significance: Does this study address an important problem? 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? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (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? The initial review group will also examine: the appropriateness of proposed project budget and duration, the adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects, the provisions for the protection of human and animal subjects, and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Peter Muehrer, Ph.D. Health and Behavioral Science Research Branch Division of Mental Disorders, Behavior, and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6190, MSC 9615 Bethesda, MD 20892-9615 Telephone: (301) 443-4708 FAX: (301) 480-4415 E-mail: pmuehrer@nih.gov Junius J. Gonzales, M.D. Division Services Research & Clinical Epidemiology Branch National Institute of Mental Health 6001 Executive Boulevard, Room 7141, MSC 9631 Bethesda, MD 20892-9631 Telephone: (301) 443-3364 FAX: (301) 443-4045 Email: jgonzale@mail.nih.gov Direct inquiries regarding fiscal 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 E-mail: Diana_Trunnell@nih.gov The National Cancer Institute, although not formally participating in this Program Announcement, is very interested in applications relating to basic behavioral processes and public health as they relate to cancer or cancer risk. If you are planning research which focuses upon issues related to family concerns, adherence, co-morbidity and other areas noted in this Program Announcement relating specifically to cancer and/or cancer risk, please contact: Michael Stefanek, Ph.D Chief, Basic Biobehavioral Research Branch Behavioral Research Program National Cancer Institute 6130 Executive Blvd., EPN 211 Bethesda, MD 20892 Telephone (301) 496-8776 FAX (301) 435-7547 E-mail: ms496r@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 PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74, and the NIH Grants Policy Statement, effective 10/1/98. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, and 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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