NIDA'S NATIONAL PREVENTION RESEARCH INITIATIVE: USING BASIC SCIENCE TO DEVELOP NEW DIRECTIONS IN DRUG ABUSE PREVENTION RESEARCH Release Date: December 17, 2001 RFA: RFA-DA-02-010 National Institute on Drug Abuse (http://www.nida.nih.gov) Letter of Intent Receipt Date: March 29, 2002 Application Receipt Date: April 29, 2002 THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. MODULAR INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS REQUESTING LESS THAN $250,000 PER YEAR IN ALL YEARS. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT https://grants.nih.gov/grants/funding/phs398/phs398.html. PURPOSE The National Institute on Drug Abuse (NIDA) is committed to a comprehensive program of research on drug abuse prevention. The purpose of this initiative is to: (1) support basic behavioral, cognitive, developmental, social and neurobiological research necessary to inform the development of innovative and novel prevention interventions; and (2) support translational research that would begin to apply basic science knowledge to the development and improvement of prevention interventions. It is NIDA's intention to: (1) encourage new directions in prevention science, attract new investigators from diverse and multiple scientific disciplines to prevention research, foster creativity and novel approaches, and develop new, innovative prevention interventions; and (2) support scientifically sound, model or theory-driven research that will have the greatest impact upon the public health. This announcement is one initiative in NIDA's new National Drug Abuse Prevention Research Initiative (NNPRI). The NNPRI uses a conceptual model of research and development to provide comprehensive support for all aspects of prevention research, along a continuum ranging from basic science through efficacy testing of promising new interventions, to effectiveness testing to large-scale systems trials. This RFA focuses on basic and translational science and the critical knowledge gaps that must be filled to lay the groundwork for developing, testing, and expanding innovative interventions to prevent drug abuse and addiction. It exclusively targets: (1) basic science research with demonstrated application to the development of novel and innovative prevention interventions; and (2) preliminary prevention intervention development that is truly novel, and unique. The research proposals submitted under this announcement do not need to conduct prevention research, but investigators need to demonstrate and provide a clear statement indicating how proposed research will advance the understanding of preventing drug abuse and addiction. Research that proposes to modify, expand or test previously developed and existing drug abuse preventions programs would not be appropriate under this particular RFA. Investigators interested in conducting this type of research should contact NIDA staff to discuss other support and opportunities for this research at NIDA. 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, NIDA's National Prevention Research Initiative: Using Basic Science to Develop New Directions in Drug Abuse Prevention Research, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic 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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project award (R01) and exploratory/development award (R21) (https://grants.nih.gov/grants/guide/pa-files/PA-01-012.html) mechanism. The R21 application is limited to a 3-year effort and a maximum of $100,000 in direct costs per year. Applicants using the R21 mechanism should consult with NIDA staff before requesting budgets exceeding $100,000 in direct cost. Applicants are advised to contact NIDA program staff listed under INQUIRIES for additional information. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts that have been adopted by the NIH. Complete and detailed instructions and information on Modular Grant applications have been incorporated into the PHS 398 (rev. 5/2001). Additional information on Modular Grants can be found at https://grants.nih.gov/grants/funding/modular/modular.htm. FUNDS AVAILABLE NIDA intends to commit approximately $2 million in FY 2002 in total funds to fund five to ten new Basic Science or Preliminary Prevention Intervention Development awards. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. Although the financial plans of NIDA 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. RESEARCH OBJECTIVES Background and Rationale Despite significant progress in the field of drug abuse prevention, critical knowledge gaps need to be filled to improve ongoing prevention efforts and develop wholly new and innovative strategies. There are exciting opportunities to build on recent advances in behavioral, developmental, cognitive, and social sciences and neuroscience by integrating basic science with prevention research. For example, discoveries from the field of neuroscience might facilitate the identification of biological mediators or moderators as targets for intervention. Behavioral scientists could provide important information on how environmental, neurobiological and/or genetic factors interact and/or can be manipulated to reverse or attenuate vulnerability to drug abuse behaviors. Cognitive scientists might contribute through model-driven research aimed at processes that guide decision-making under different contexts associated with risk taking. Researchers studying human development could focus on cognitive, behavioral, social or neurobiological processes that lead to, or influence drug abuse and addiction. This RFA invites qualified researchers from diverse and multiple scientific disciplines to consider unique and "out-of-the-box" research proposals that address critical knowledge gaps in drug abuse prevention research. Epidemiological research and etiological research have identified numerous risk and resiliency factors that predict initiation of drug abuse. However, many of these influences are distal to drug abuse behaviors, occurring well before the onset of drug abuse. While the impact of some of these risk factors cannot be easily overcome with prevention interventions, many are malleable and can be modified with existing prevention interventions. However, many of these interventions may not be appropriate for implementation on a large-scale basis (e.g., intensive family interventions). Research on multiple determinants and pathways to drug abuse has advanced our understanding of factors that lead to drug abuse, but has had little impact in helping us to develop interventions to change these determinants and pathways, and to ultimately prevent drug abuse. Additional research is needed to: (1) characterize distal factors in terms of their underlying mechanisms, processes, and critical components that predict future drug abuse; and (2) develop approaches to modify these critical components to prevent the initiation of drug abuse or the escalation to addiction. Also there have been relatively few studies of interventions that target proximal determinants of drug abuse initiation, but such research has great promise for preventing the initiation of drug abuse. For example, research on decision-making (particularly the decision to use a drug of abuse) and cognitive expectancies (particularly concerning the expectation about the effects of drugs of abuse) might have some direct relevance to prevention interventions aimed at changing the actual decision to abuse drugs. Similarly, research examining biases in information processing and memory (of, for example, experiences with drugs of abuse) and the role of emotion as expressed in cognition and automatic cognitive operations, might hold potential for application to new prevention interventions. Areas of Interest: This announcement focuses exclusively on supporting (1) basic research that will have direct application to the development of innovative and novel prevention interventions, and (2) preliminary prevention intervention development research that involves research to develop, refine, and pilot test new, innovative prevention interventions. Preliminary prevention intervention development includes model-driven, theory-based research aimed at translating basic research findings into novel or improved prevention interventions. This initiative targets for funding, in a systematic way, essential research needed for developing prevention interventions for drug abuse and dependence. This includes, in particular, critical areas of research that have been overlooked in the past. This RFA will support model or theory-driven research involving human volunteers in laboratory-based or (where appropriate) field settings. Interdisciplinary research, as well as research that targets particular populations, including children and adolescents, is encouraged. Research directly aimed at studying drug abuse prevention could target a specific drug of abuse (e.g., cigarettes, marijuana) or drugs of abuse, and/or related drug abuse behaviors more broadly defined. Studies employing preclinical models that can directly inform our understanding on the development of drug abuse prevention interventions would also be appropriate under this RFA. And finally, given that there is growing evidence that (a) the risk and resiliency factors and the basic mechanisms of drug abuse may differ for males and females and that (b) cognitive, social, and developmental processes are often gender-sensitive, researchers are strongly urged to incorporate a gender-based approach in their research design. This announcement does not support research that proposes to modify, expand, decompose or test previously developed and existing drug abuse preventions programs. Applicants interested in conducting this type of research are encouraged to contact NIDA staff to discuss other support and opportunities for this research at NIDA. Illustrative examples of research described below serves as a guide and are not meant to subsume all research topics that would be appropriate under this announcement. -Basic Research- o Research on social cognition across development. o Research on how the use of language and verbal representation of information influences thinking about drug abuse. o Research on the psychobiology of normal cognitive development, as well as abnormal development (including the development of executive and motivational inhibitory processes). o Studies of normal and impaired decision-making (including the study of decision making processes in adolescents or younger school-age children). o Studies of the role of emotion in cognition as it relates to susceptibility and resistance to drug abuse. o Studies of the development of controlled and automatic behaviors and their modification (including issues related to self-regulation, impulsive behavior and learned associations). o Studies using animal models to determine if exposure to known risk factors (e.g., stress, maternal separation or neglect, environmental isolation) for drug abuse can be ameliorated or overcome to reduce vulnerability to drug abuse. -Preliminary Prevention Intervention Development Research- o Studies that apply or translate what is known from, basic social or cognitive and neurobiological development to improve or develop novel, innovative prevention strategies. o Studies aimed at developing prevention interventions to positively alter proximal motivators of drug-using behavior. o Studies that adapt or modify existing non-drug abuse theory-driven, empirically-supported prevention interventions that have been used to address problems other than drug abuse (e.g., adolescent pregnancy). o Studies that use models of decision-making and executive function to develop novel prevention interventions. o Studies of the training of inhibitory or self-regulation skills. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing 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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html). A complete copy of the updated Guidelines is available at https://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 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. 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. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. 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. This policy announcement is found in the NIH Guide for Grants and Contracts Announcement dated June 5, 2000, at the following website: https://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: https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this announcement 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. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the letter of intent receipt date listed to: Director Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Rockville, MD 20852 (for courier or express delivery) Telephone: (301) 443-2755 APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) at https://grants.nih.gov/grants/funding/phs398/phs398.html must be used in applying for these grants. This version of the PHS 398 is available in an interactive, searchable format. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. This announcement focuses on Basic and Prevention Intervention Development Research. Applicants who respond to this announcement must clearly specify whether, how, and why their research falls under Basic and Prevention Intervention Development Research. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS 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 NIH staff. The research grant application form PHS 398 (rev. 5/2001) at https://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in applying for these grants, with modular budget instructions provided in Section C of the application instructions. 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: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf. 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 Affairs National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Rockville, MD 20852 (for courier or express delivery) Applications must be received by 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. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NIDA. 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 NIDA in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Council on Drug Abuse. Review Criteria The goals of NIH-supported research are to advance the understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. (1) Significance: Does this study address an important problem? Does this research target gaps in knowledge that can contribute to drug abuse prevention? If the aims of the application are achieved, how will scientific knowledge in drug abuse prevention program development 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 methods that have not previously been applied to the design of drug abuse prevention interventions? Are the aims original and innovative in their application to drug abuse prevention? 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? (6) The relevance of the proposed work to the purpose of the RFA. In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research. o The adequacy of the proposed protection for humans (including data safety monitoring plans), animals or the environment, to the extent they may be adversely affected by the project proposed in the application. Schedule Letter of Intent Receipt Date: March 29, 2002 Application Receipt Date: April 29, 2002 Peer Review Date: June/July 2002 Council Review: September 2002 Earliest Anticipated Start Date: September 30, 2002 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 are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: David Shurtleff, Ph.D. Division of Neuroscience and Behavioral Research National Institute on Drug Abuse 6001 Executive Boulevard, Room 4282, MSC 9555 Bethesda, MD 20892-9555 Telephone: (301) 443-1887 FAX: (301) 594-6043 Email: dshurtle@mail.nih.gov Direct inquiries regarding review matters to: Teresa Levitin, Ph.D. Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Telephone: (301) 443-2755 FAX: (301) 443-0538 Email: tl25u@nih.gov Direct inquiries 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 FAX: (301) 594-6847 Email: gf6s@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. 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 and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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