BEHAVIORAL THERAPY DEVELOPMENT AND BEHAVIORAL SCIENCE Release Date: December 23, 1998 RFA NUMBER: P.T. National Institute on Drug Abuse Letter of Intent Receipt Date: March 29, 1999 Application Receipt Date: April 29, 1999 THIS RFA USE THE JUST-IN-TIME CONCEPT. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS RFA. PURPOSE The National Institute on Drug Abuse (NIDA) requests applications for research aimed at the development of behavioral therapies (Stage I research) for drug addiction based upon basic behavioral and cognitive science. The purpose of this Request for Applications (RFA) is to encourage innovative research on the development of new and refinement of existing behavioral interventions for the treatment of drug addiction. The translation of ideas from basic behavioral and cognitive science into novel behavioral interventions for drug addicts is the ultimate goal of this program. Research projects will be considered that integrate basic behavioral and/or cognitive science with behavioral therapy development research, with the aim of developing new or refining existing behavioral therapies for individuals in drug abuse treatment. HEALTHY PEOPLE 2000 The Public Health Service is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA is related to the priority area of alcohol and other drugs. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) from the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/512-1800) or electronically at http://odphp.osophs.dhhs.gov/pubs/hp2000 ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and nonprofit organizations, public and private; such as, colleges, universities, hospitals, laboratories, units of state and local government, and eligible agencies of the federal government. Racial/ethnic minority individuals, women and persons with disabilities are encouraged to apply as Principal Investigators. Awards to foreign institutions under other research (R-series) mechanisms are generally limited to 3 years. MECHANISM OF SUPPORT Research support mechanisms under this RFA are the National Institutes of Health (NIH) research project grant (R01) and the exploratory/developmental grant (R21) mechanisms. The total project period for an application submitted in response to this RFA may not exceed five years. The anticipated award date is September 30, 1999. This RFA is a one-time solicitation. Future unsolicited competitive supplement applications will compete with all investigator-initiated applications and be reviewed according to standard peer review procedures. Exploratory/Developmental (R21) applications are limited to three years and $90,000 direct costs per year. The R21 mechanism is intended to encourage exploratory research projects with sound methodology and strong rationales in underdeveloped research areas. There are additional special requirements for this mechanism; if an applicant intends to apply for R21 award under this RFA, he or she should contact the program official listed under the INQUIRIES section for further information. Specific information on individual research mechanisms can be obtained from the NIDA home page at: www.nida.nih.gov/Funding.html. Applications submitted in response to this RFA will use the Just-In-Time (JIT) submission procedures. These procedures were published in the NIH Guide, Vol. 25, No. 10, March 29, 1996, with additional instructions published in Vol. 25, No. 16, May 17, 1996. Copies of these two Guide publications are available from the contact person listed under INQUIRIES and on the NIH Guide website at: https://grants.nih.gov/grants/guide/ FUNDS AVAILABLE A total budget for FY 1999 of $1.5 million will be committed to fund applications submitted in response to this RFA. This funding level is dependent upon the receipt of a sufficient number of applications of high merit. It is anticipated that approximately five to eight awards will be made in FY 1999. RESEARCH OBJECTIVES Behavioral therapy alone or in combination with medication remains the mainstay of drug addiction treatment. However, even though many forms of behavioral therapy have been shown to be efficacious, some patients do not succeed in treatment and some have only limited success. In addition, drugs of abuse and populations of drug abusers are continually changing. Hence, there is a need to develop new or modify existing behavioral therapies for patients who do not respond or do not respond fully to currently available treatments. Basic behavioral and cognitive research has been useful in explicating basic principles of behavior and behavior change, and there exists the potential for these principles to be applied in the treatment of addiction. Similarly, research paradigms used in the basic behavioral and cognitive sciences could be adapted for use with patient populations, with the ultimate goal being the development of behavioral therapies for drug addiction. The objective of this announcement is to encourage "Stage I" behavioral therapy research based on knowledge gained and/or research paradigms from other areas of cognitive and behavioral science. Stage I, the initial stage of behavioral therapy development research, is an iterative process involving: 1) identifying promising behavioral and cognitive theories and research relevant to treatment; 2) generating and formulating new cognitive or behavioral therapies (or modifying an existing therapy) based upon this theory and research; 3) creating therapy manuals in which the therapies are operationally defined and the principles underlying the therapies are explicated; 4) pre- or pilot-testing of the therapies; 5) refining and modifying the therapies as needed. Translational Stage I research integrates theories, research findings, and paradigms from basic behavioral and cognitive science into research aimed at the development of a new behavioral therapy, or the modification of an existing therapy. It also involves testing the theory or hypothesis upon which the proposed new therapy or therapy modification is based. Although some researchers conduct both behavioral therapy and basic behavioral or cognitive research, many conduct one type of research or the other. Therefore, collaboration among investigators is encouraged where appropriate. Stage I research is encouraged that is based upon basic behavioral or cognitive science and also integrates such research into the therapy development process. Such translational research may be based on ideas, principles, and/or research paradigms in various areas of behavioral and cognitive science including, but not limited to, the following areas: Behavioral economics Cognition and cognitive biases Decision-making Emotion Memory and memory biases Motivation Psycholinguistics Theoretically-driven research based in any of the above or other areas of behavioral and cognitive science is encouraged. Examples of translational Stage I research proposals include: o A proposal to develop, utilizing a radical behavioral research paradigm, a novel form of behavioral therapy for nicotine-addicted individuals. o A proposal to develop a more efficacious form of cognitive-behavioral therapy for heroin-addicted, depressed individuals based upon research on differential cognitive schemas in depressed versus normal individuals. o A proposal to develop an improved version of family therapy for poly-drug abusing adolescents based upon research on the expression of hostility and criticism within the family. Applicants are not limited to the examples listed above and may propose to develop any behavioral therapy/intervention that is based in behavioral or cognitive science and is aimed at the treatment of any population of drug addicted individuals. 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 subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided 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. 3, No. 11, March 18, 1994. 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: https://grants.nih.gov/grants/guide/notice-files/not98-024.html NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS The National Advisory Council on Drug Abuse recognizes the importance of research involving the administration of drugs to human subjects and has developed guidelines relevant to such research. Potential applicants are encouraged to obtain and review these recommendations before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA's Home Page at http://www.nida.nih.gov under "Funding" or may be obtained by calling (301) 443-2755. LETTER OF INTENT Prospective applicants must submit, by March 29, 1999, a letter of intent that includes a descriptive title of the proposed program, the name, address, telephone, FAX, and E-mail numbers of the Program Director; the names of other key personnel and participating institutions; and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not binding and does not enter into the review of subsequent applications, the information that it contains permits the NIDA to estimate the potential review workload. The letter of intent is to be sent to: Director Office of Extramural Program Review National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Telephone: (301) 443-2755 FAX: (301) 443-0538 APPLICATION PROCEDURES Prospective applicants are encouraged to contact the staff person listed under INQUIRIES early in the planning phase of the application. NIDA program staff can provide guidance and discuss responsiveness issues with prospective applicants. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and information Resources, National institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: GrantsInfo@nih.gov. "Just-in-time" (JIT) is an initiative of the National Institutes of Health (NIH) Extramural Reinvention Laboratory under the auspices of the National Performance Review and government-wide efforts to create a government that works better and costs less. JIT postpones the collection of certain information that currently must be included in all competing applications when submitted. The information for the applications with a likelihood of funding is submitted "just-in-time" for awards to be made. This program announcement is incorporating JIT procedures as described below. Some sections are modified and others in the application do not need to be completed for the submission of the application, but WILL be requested if your application receives a priority score in the fundable range. Form DD - Page 4 - DETAILED BUDGET PLAN FOR INITIAL BUDGET PERIOD Do not complete this form on page 4 of the PHS 398 (rev. 5/95). It is not required nor will it be accepted at the time of the application. Form EE - Page 5 - BUDGET FOR THE ENTIRE PROPOSED PROJECT Do not complete the categorical budget table form on page 5 in the PHS 398 (rev. 5/95). Only the requested total direct costs for each year and total direct costs for the entire proposed period of support should be shown. Begin the budget justification in the space provided, using continuation pages as needed. Budget Justification o List the name, role on project, and percent effort for all project personnel (salaried or unsalaried) and provide a narrative justification for each person based on his/her role on the project and proposed level of effort. o Identify all consultants by name and organizational affiliation and describe the services to be performed. o Provide a narrative justification for any major budget items, other than personnel, that are requested for the conduct of the project that would be considered unusual for the scope of the research. No specific costs for items or categories should be shown. o Indirect costs will be calculated at the time of the award using the institution's actual indirect cost rate. Applicants will be asked to identify the indirect cost exclusions prior to award. o If consortium/contractual costs are requested, provide the percentage of the subcontract total costs (direct and indirect) relative to the total direct costs of the overall project. The subcontract budget justification should be prepared following the instructions provided above. Biographical Sketch - A biographical sketch is required for all key personnel, following the modified instructions below. Do not exceed the two-page limit for each person. o Complete the education block at the top of the form page; o List current position(s) and those previous positions directly relevant to the application; o List selected peer-reviewed publications directly relevant to the proposed project, with full citation; o Provide information on research projects completed and/or research grants participated in during the last five years that are relevant to the proposed project. Title, principal investigator, funding source, and role on project must be provided. Other Support - Do not complete the other support page (format page 7 of the PHS 398 (rev. 5/95)). Information on active support for key personnel will be requested prior to award. Checklist - Do not submit the checklist page. For amended and competing continuation applications, applicants must complete the block in the upper right corner of the face page to indicate the previous grant number. A completed checklist will be required prior to award. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. 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. 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: Director Office of Extramural Program Review National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Applications must be received by April 29, 1999. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Research (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIDA. Applications that are complete and responsive will be evaluated for scientific and technical merit by a peer review group convened by the NIDA 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 the applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Drug Abuse Council. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in the 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. Relevance: What is the extent the aims of the proposal are relevant to the purpose and objectives of the RFA? 2. Significance: Does the proposal address an important problem? If the aims of the proposal are realized, how will scientific knowledge be advanced? 3. Innovation: Does the proposed clinical research involve theory, methods, or concepts derived from basic behavioral science that are new to behavioral therapy research? Are the goals creative and original? Does the proposal challenge existing research paradigms or facilitate the development of new methodologies? 4. Integration: Does the proposal successfully integrate basic behavioral science theory, concepts and/or methods into research on the development of a therapy? Where collaboration is necessary to achieve this goal, is the collaborative effort well-conceptualized? 5. Approach: Are the conceptual framework, design, methods, and analyses satisfactorily developed and appropriate to the aims of the project? Is the project feasible? Does the applicant acknowledge potential problem areas and consider alternative approaches? 6. Investigator: Is the investigator well-qualified to conduct this research? If collaboration is proposed, are the co-investigators similarly well-qualified? 7. Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The reasonableness of the proposed budget and duration in relation to the proposed research. 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. The above criteria apply to R01 applications, and there are additional criteria for the R21 mechanism. When applying under the R21 mechanism, the applicants should obtain a copy of program announcement PA-98-004 from either their office of sponsored research or from the NIH Guide website (https://grants.nih.gov/grants/guide/pa-files/PA-98-004.html). This program announcement contains instructions for the preparation of R21 grant applications. AWARD CRITERIA Award criteria that will be used to make award decisions include: scientific merit (as determined by peer review), availability of funds, and programmatic priorities. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic issues may be directed to: Lisa Onken, Ph.D. Division of Clinical and Services Research National Institute on Drug Abuse 6001 Executive Boulevard, Room 4229, MSC 9563 Bethesda, MD 20892-9563 Telephone: (301) 443-0107 Email: lo10n@nih.gov Direct inquires regarding fiscal matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 Email: gf6s@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.855 and 93.856. Awards are made under the authority of Title III, Section 301, of the PHS Act as amended. The Code of Federal Regulations, Title 42 Part 52 and Title 45 Part 74, are applicable to this program. This program is not subject to the intergovernmental review requirements of Executive Order 12372 to Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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