NIDA NATIONAL PREVENTION RESEARCH INITIATIVE (NNPRI): COMMUNITY MULTI-SITE PREVENTION TRIALS (CMPT) Release Date: December 31, 2001 RFA: RFA-DA-02-004 National Institute on Drug Abuse (http://www.nida.nih.gov) Letter of Intent Receipt Date: March 26, 2002 Application Receipt Date: April 26, 2002 PURPOSE The National Institute on Drug Abuse (NIDA) invites applications to participate in NIDA's National Prevention Research Initiative (NNPRI), which is comprised of three components: 1) Community Multi-Site Prevention Trials (CMPT), 2) Transdisciplinary Prevention Research Centers (TPRCs), and 3) Basic Prevention Science grants. This Request for Applications (RFA) calls for investigator-initiated research project grant applications (R01) for the Community Multi-Site Prevention Trials component. The overall goal of the CMPT is to accelerate research on the processes and mechanisms that 1) contribute to the adoption, adaptation, and implementation of science-based prevention models, and 2) examine prevention delivery factors such as structural features, management practices, and financial strategies that foster the sustainability of such models in community settings. This goal will be accomplished through the support of several field trials, each of which will study one science-based drug abuse prevention intervention in several experimental and control sites. Strong collaboration among researchers, prevention practitioners, and state and local agency partners is an essential component of CMPT field trials. 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 National Prevention Research Initiative (NNPRI): Community Multi-Site Prevention Trials (CMPT)," 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 nonprofit organizations, private and public, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal Government. Faith-based organiztions are eligible to apply for these grants. Racial/ethnic minority individuals, women and persons with disabilities are encouraged to apply as principal investigators. Because of 1) the objective to conduct rigorous research on aspects of prevention practice and 2) the complexity of the required research designs, it is important for the principal investigator to commit a minimum of 30% time to the CMPT. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) R01 award mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed five (5) years. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator- initiated applications and be reviewed according to the customary peer review procedures. The anticipated award date is September 2002. FUNDS AVAILABLE NIDA has set aside $4 million to support the total costs of establishing Community Multi-Site Prevention Trials (CMPT) in FY 2002. This level of support is dependent on the receipt of a sufficient number and diversity of applications of high scientific merit. NIDA expects to make up to 4 to 8 awards under this RFA for project periods of up to five years of support. Because the nature and scope of the research activities proposed in response to this RFA may vary, it is anticipated that the size of individual awards will also vary. Budget requests should be carefully justified and commensurate with the complexity of the project. Although this program is provided for in the financial plans of the NIDA, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background Over the past 25 years, the field of drug abuse prevention science has demonstrated the efficacy and effectiveness of a number of prevention programs and strategies. The most successful have focused on skill and competency building in the personal, social, and academic arenas among a variety of populations and in a variety of settings. Interventions generally include content that addresses key mediators of subsequent drug use such as: school bonding and commitment, drug refusal skills, alternative behaviors, decision-making and management skills, and parental monitoring skills. Of the large number of interventions that have undergone testing, a limited number have been subjected to Field Trials (FTs)(see Definitions). These FTs have provided important data on the ability to maintain significant program- related reductions in initiation and progression of drug abuse across contexts and over time. However, they have not examined the processes and mechanisms associated with the successful implementation of science-based interventions in communities. NIDA has identified this gap area in prevention research as a priority. The CMPT FTs will conduct research on processes and mechanism that influence the successful adoption, adaptation, and sustainability of programs at the community level. Specific Objectives o Conduct research on barriers and facilitators to the adoption, adaptation, implementation and successful outcomes of science-based drug abuse prevention interventions; o Conduct research to identify strategies that maximize human, financial, and temporal resources that contribute to the affordability and practicality of implementing science-based drug abuse interventions in communities; o Conduct research on structural, management and financial delivery features that contribute to sustainability of prevention approaches when taken to scale. Inclusion Criteria for Interventions Each CMPT FT can include only one intervention with demonstrated high standards of evidence of effectiveness. At a minimum, the intervention must have successfully undergone a randomized control group design efficacy study and a small-scale controlled effectiveness trial [see Definitions]. Examples The types of studies appropriate to the CMPT FTs include, but are not limited to, those that take to scale research-based drug abuse prevention interventions to determine adoption, adaptation, and implementation strategies that influence successful outcomes and sustainability in "real world" settings. Intervention types could include family-, school-, community-, workplace-, media-based, or multi-component programs that have shown reductions in initiation or progression of drug use through efficacy and small-scale effectiveness trials. Research on diverse populations and communities is encouraged. Specific examples might include: o Studies that examine the mechanism and processes that account for differential effectiveness of interventions with specific populations defined by for example level of risk, gender, or location; o Multidisciplinary research to improve the likelihood that a successfully implemented prevention intervention continues to remain effective over time; o Studies to determine how a prevention intervention shown to be efficacious in a controlled experimental study can sustain its effectiveness when implemented on a large scale; and o Studies to examine critical organizational, managerial, or economic components of an effective intervention for at-risk youth. Definitions Efficacy Studies test theory-based models of interventions to demonstrate hypothesized prevention outcomes in small, randomized, control-group design studies. Small-scale Effectiveness Trials test the effectiveness of efficacious interventions in larger populations (i.e., several hundred subjects per condition) with control-experimental group designs. These trials are less stringent in their control of contextual influences, but are comprehensive in the documentation of these influences. Field Trials test adaptability, practicality and transportability in a variety of populations, contexts, and geographic locations of interventions shown to be effective in small-scale trials. These studies focus on the explication of delivery and implementation features that lead to effective adoption, adaptation, outcomes and sustainability of interventions taken to scale. Characteristics of CMPT FTs: Each study must: o Select, in accordance with the Inclusion Criteria, a single prevention intervention to test, and provide documentation on availability of tools and training materials for replication and adaptation; o Include both experimental communities and control communities; o Establish and define roles and responsibilities for a Community Practitioner Advisory Board (CPAB), composed of representatives of local organizations that support drug abuse prevention programming, which will actively collaboration with scientific and site-specific implementation staff, in the design and implementation of the FT research. SPECIAL REQUIREMENTS Applicants should document their ability to recruit a sufficient number of participants and implementation sites, and should demonstrate their ability and willingness to work collaboratively with the CPAB and implementation site practitioners. 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 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. 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. 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. 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 RFA 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. DATA AND SAFETY MONITORING PLAN As of the October 2000 receipt date, applicants must supply a general description of the Data and Safety Monitoring Plan for ALL clinical trials; this must be included in the application https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html. For purposes of reviewing applications submitted to the NIH, a clinical trial is operationally defined as a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). The degree of monitoring should be commensurate with risk. NIH Policy for Data and Safety Monitoring requires establishment of formal Data and Safety Monitoring Boards for multi- site clinical trials involving interventions that entail potential risk to the participants. The absence of this information will negatively affect the priority score. 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 PI, 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 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 (express/courier service) 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 Grants Info, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. SPECIAL INSTRUCTIONS: Specific content must be present in the application to document the technical and scientific merit of the applicant's plan for an FT that will be able to address the fundamental goals of the RFA. Unlike the usual 25-page length limitation of the R01, applicants may use up to 35 pages to present their plans, as described below. The use of tables, diagrams, organizational and flow charts is strongly encouraged and must be included within the page limitation. APPLICATION PACKAGE: Application package should include the following: Scientific and community collaboration: o The application must provide letters of commitment from implementation site officials, representing themselves, their facilities, and site-specific practitioners. o Documentation must be provided about the formation, membership and responsibilities of a Community Practitioner Advisory Board (CPAB) including a description of how collaboration among the scientists, the CPAB, and site- specific officials and intervention staff will be established and maintained. The CPAB is expected to be an active participant in the research process; letters of commitment must be included. o Documentation shall describe how coordination and involvement of relevant state and local authorities will be achieved. Research concepts and planning: o The research plans for the proposed FT should include descriptions of: site- specific selection criteria for and description of the intervention and tools and materials needed for implementation; study design and statistical considerations; access to appropriate subjects and sites; procedures for data management, quality control and follow-up; procedures for monitoring and reporting adverse events. o The plans must document the availability of appropriate expertise within the FT to design, implement, and analyze the results of the proposed trial. o The plans must describe the framework and procedures for training and supervision of implementation staff in the experimental condition. o The application must be specific about how the FT will recruit and retain sufficient subjects to participate in the ongoing trial and how subjects within sites or sites themselves will be randomly assigned to experimental or control condition. o Applicants must describe how implementation site staff will function in partnership with the scientific staff in terms of study design, execution and administration. Applicants should anticipate problems and challenges related to this process, and propose mechanisms for collaborative resolutions. The NIH policy regarding consortium agreements should be considered in describing the relationship between the implementation site, implementation staff and scientists. o The PI must describe his/her own qualifications and experiences and ability to access and utilize other professionals with specialized expertise needed to design and implement the proposed FT. o The PI must demonstrate the ability to provide scientific commitment and leadership to the research agenda and the proposed trial (a minimum of 30% time). o Justification for a FT to serve either a defined or diverse racial, ethnic or geographic population should be described. o Evidence of current or previous successful collaborations with community prevention programs and participation in collaboration with other research centers is desirable. o Plans for data management and information management systems should be specified. Budget: o The applicant should prepare a composite budget as well as separate detailed budget estimates for: 1) infrastructure including personnel, facilities, equipment, supplies, training costs, logistical support, travel, etc.; 2) support to conduct the FT; 3) study specific costs, such as training (of implementers, or data manager), data management, monitoring costs, publication costs, for the research project; and 4) travel to participate in an annual CMPT meeting. o Composite budget: Use page 4, "Detailed Budget for Initial Budget Period," of Form PHS-398 to present the total budget for all requested support for the first year. For each category, such as "Personnel," "Equipment," etc., give the amount requested. Use page 5, "Budget for Entire Proposed Project Period," of Form PHS-398 to prepare a budget, by category that provides totals for each year of requested support. Requests for any increases in succeeding years must be justified. o Budget justifications and explanations: First year--use page 4 of the PHS- 398; total project period Years 2-5--use page 5 of the PHS-398. Describe the specific functions of all key personnel, consultants, collaborators, data management staff, training staff, and administrative and other support staff. For all years, explain and justify resources necessary for the operational management, data information systems, travel, and any unusual items such as major equipment. For additional years of support requested, justify any significant increases or decreases in any category over the first 12-month budget period, identifying such changes with asterisks against the appropriate amounts. If a recurring annual increase in personnel or other costs is anticipated, give the percentage; however, current NIH practice limits escalation to 3%. Biographical sketches (as described in the Instructions for Form PHS-398) are required for all key personnel corresponding to personnel listed on page 2. Begin with PI, Co-PIs in alphabetical order, and thereafter other key staff in alphabetical order. Page limits: The total length of the Research Plan, including the CMPT descriptions and research concepts, and administrative and management plan should not exceed 35 pages. No specific page limits apply to the Budget, Human Subjects, Literature Cited, or Consortium/Contractual Arrangements sections. 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, MSC-7710 6701 ROCKLEDGE DRIVE, ROOM 1040 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier/overnight services) 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 Blvd., Room 3158, MSC 9547 Bethesda, MD 20892-9547 Rockville, MD 20852 (for courier/overnight services) Telephone: (301) 443-2755 Applications must be received by April 29, 2002. If an application is received after this 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 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. 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 review criteria stated below. As part of the initial merit review, all applications will receive a written critique. Those applications deemed to have the highest scientific merit will be discussed assigned a priority score, and receive a second level review by the National Advisory Council on Drug Abuse. Review Criteria Applications will be reviewed for scientific and technical merit using the following criteria. Applicants should note that the criteria incorporate consideration of the quality and feasibility of the proposed activities as well as consideration of past performance. Significance. Does this study address an important research problem related to the theme of the Community Multi-site Prevention Trials? Does the scientific merit and experimental design of the project adequately address issues of substantive importance for informing prevention trial development efforts. Will the study contribute to the overall goal of the CMPT through the acceleration of research on the processes and mechanism that contribute to the adoption, adaptation, and sustainability of research-based drug abuse prevention programming? Approach. Is the feasibility of the proposed trial supported by prior efficacy studies and small-scale effectiveness trials with demonstrated positive effects? Are the conceptual research framework, design, methods, and analyses adequately developed, well integrated and appropriate to the aims of the project? Does the approach demonstrate knowledge of state-of-the-art prevention research designs and methodologies? Are there adequate criteria for selecting community-based programs as implementation sites, balanced by the constraints of reasonable management? Where feasible and appropriate to the research aims, does the application document the ability to accrue a demographically diverse population? Is there an adequate plan for subject recruitment, enrollment, retention and program evaluation, including the ability to accrue subjects at an adequate rate to support the FT? Are there adequate plans for overall management and operations as well as for data management, including adequacy of the plan for implementing data standards, data collection, analysis and training? Innovation. Does the project develop new methodologies or technologies in the conduct of prevention field trials? Investigators. Are the investigators appropriately qualified with demonstrated competence to conduct the proposed CMPT FT? Is the proposed work appropriate to the experience level of the principal investigator and project researchers? Does the PI have adequate time commitment, qualifications and research experience, including but not limited to, previous experience with design, administration and management of prevention intervention effectiveness studies or multi-site trials? Are there appropriate qualifications among key personnel and scientific staff in their project-related research roles, including: statistical and data management, project administration, operational management, intervention implementation, and data information systems. Is there previous experience and adequate plans for training intervention implementers and research associates in implementing the FT? Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Is there adequate documentation of on-going communication, coordination and involvement with relevant state and local practitioners and agencies? Is there adequate documentation of the establishment of a Community Practitioner Advisory Board and the collaborative roles and responsibilities of the CPAB in the design and progression of the research? Is there adequate documentation of commitment and intent to participate by implementation site officials, representing themselves, their facilities, and their staff? 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, including requests for: 1) infrastructure including personnel, facilities, equipment, supplies, training costs, logistical support, travel, etc.; 2) support to conduct the field trial; 3) study specific costs, such as training (of implementers, or data manager), data management, monitoring costs, publications costs, for the research project and 4) travel to participate in an annual CMPT meeting. o The adequacy of the proposed plans for protection 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. AWARD CRITERIA Applications recommended for further consideration by the National Advisory Council on Drug Abuse will be considered for funding based upon: (a) scientific and technical merit; (b) program balance; (c) applicant organization; and (d) availability of funds. SCHEDULE Letter of Intent Receipt Date: March 26, 2002 Application Receipt Date: April 26, 2002 Scientific Review Date: June/July 2002 Council Meeting Date: September 2002 Earliest Award Date: September 30, 2002 INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applications is welcome. Direct inquiries regarding programmatic issues to: Elizabeth Robertson, Ph.D. Chief, Prevention Research Branch Division of Epidemiology, Services, and Prevention Research National Institute on Drug Abuse 6001 Executive Boulevard, MSC 9589 Bethesda, MD 20892-9589 Telephone: (301) 443-1514 FAX: (301) 443-2636 Email: er52h@nih.gov S. Jackie Kaftarian, Ph.D. Prevention Research Branch Division of Epidemiology, Services, and Prevention Research National Institute on Drug Abuse 6001 Executive Boulevard, MSC 9589 Bethesda, MD 20892-9589 Telephone: (301) 443-1514 FAX: (301) 443-2636 Email: jkaftari@nida.nih.gov Direct inquiries regarding peer review issues to: Teresa Levitin, Ph.D. Office of Extramural Program Review National Institute on Drug Abuse 6001 Executive Boulevard Bethesda, MD 20892-9547 Telephone: (301) 443-2755 Email: tlevitin@nida.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 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 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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