SERVICES RESEARCH ON THE NATIONAL DRUG ABUSE TREATMENT CLINICAL TRIALS NETWORK Release Date: September 6, 2000 RFA: DA-01-003 National Institute on Drug Abuse (http://www.nida.nih.gov) Letter of Intent Receipt Date: November 20, 2000 Application Receipt Date: December 19, 2000 BOTH MODULAR AND NONMODULAR GRANT APPLICATIONS MAY BE SUBMITTED IN RESPONSE TO THIS RFA. FOR MODULAR GRANTS, THE "JUST-IN-TIME" CONCEPT IS USED, AND THERE ARE DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST ALSO BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA. FOR NONMODULAR APPLICATIONS (APPLICATIONS HAVING AT LEAST ONE YEAR"S REQUESTED DIRECT COSTS EXCEEDING $250,000), THE MODIFIED INSTRUCTIONS FOR MODULAR GRANTS AND JUST-IN-TIME PROCEDURES ARE NOT USED, AND THE TRADITIONAL PHS 398 INSTRUCTIONS SHOULD BE FOLLOWED INSTEAD. PURPOSE This Request for Applications (RFA) encourages (a) research on changes in clinical management and organizational practices of community treatment providers participating in the National Institute on Drug Abuse’s National Drug Abuse Treatment Clinical Trials Network (CTN), (b) research to improve the ability of non-network providers to adopt new research-based treatments, and (c) research on the cost-effectiveness of treatments tested in the CTN compared with typical treatment. Research on other health services issues related to the CTN and its overarching goal to improve drug abuse treatment nationwide is also encouraged. 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 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 for-profit and nonprofit 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 grant (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 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 July 2001. FUNDS AVAILABLE NIDA intends to commit approximately $2.0 million in FY 2001 to fund up to five new and/or competitive continuation grants in response to this RFA. The level of support is dependent upon the receipt of a sufficient number and diversity of applications of high scientific merit. Because of the nature and scope of the research proposed, it is anticipated that the size of an 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. At this time, it is not known if this RFA will be reissued. RESEARCH OBJECTIVES This RFA encourages research on health services issues related to the National Drug Abuse Treatment Clinical Trials Network (CTN). Specific areas of research focus include studies on the process of change in clinical practices and organizational processes and structures of community treatment providers participating in the CTN, research on the effectiveness of strategies to help non-network providers adopt new research-based treatments, and research on economic issues related to treatments being tested in the CTN. Background The potential public health benefit of new behavioral and pharmacological treatments for drug abuse has not been fully realized because many providers have not adopted these new treatments. In 1999, the National Institute on Drug Abuse (NIDA) established the National Drug Abuse Treatment Clinical Trials Network, a cooperative research program to conduct coordinated multi- site clinical trials of behavioral and pharmacological therapies for drug abuse and addiction. Funded under RFA 99-004, the CTN presently consists of six nodes representing the Delaware Valley, Mid-Atlantic, New England, New York, Pacific Northwest, and West Coast regions. Each node consists of a regional research and training center, all currently based in academic institutions, and five or more participating community treatment providers. Plans call for the addition of new community treatment providers in each node. Additionally, the CTN is expected to be expanded in fiscal year 2000 by the addition of up to six more nodes, and further nodes may be added in the future. The CTN’s overarching goal is to improve the quality of drug abuse treatment in the nation by conducting clinical trials to test behavioral and pharmacological therapies for a broad range of patients in a variety of clinical settings, and by finding ways to integrate these tested medications and behavioral interventions into mainstream clinical practice. In addition, the CTN is expected to provide an infrastructure and a platform to research other questions relevant to the improvement of community-based treatment practice. References made in this RFA to "CTN-tested treatments" include treatment interventions being tested in the CTN as well as those under consideration in the CTN. In addition, studies may be proposed using science-based, effective interventions similar to those being tested in the CTN if the research focuses on processes or models that are not dependent upon a specific treatment intervention. I. Organizational and Practitioner Adaptation and Change in CTN Community Treatment Providers and in Other Community Treatment Providers Adopting new treatment methods into clinical practice, be they pharmacological or behavioral in nature, involves change at both the organizational and practitioner levels. The introduction of new treatment approaches into an existing provider organization may require adaptation of clinical and business practices to sustain treatment advances over the longer term. There has been little research to understand organizational adaptation and change by organizations or practitioners in the drug abuse treatment system, with the consequence that little is known about the processes by which change occurs or how to facilitate change to improve the overall quality of drug abuse treatment. Understanding the process of adaptation and change includes research in the areas of organizational culture, readiness and motivation for organizational change, and change management and follow-through. Research is needed to understand the process of change with regard to how treatments being tested in the CTN can be successfully assimilated by the treatment organizations, including: - adoption of behavioral and pharmacological therapies tested in clinical trials by community treatment providers, and effective models and practices to plan and manage such adoption, - readiness and capacity to successfully adopt new treatment methods, - business practices that increase motivation for change and improvement, and - effects of change in clinical and business practices on organizational climate and culture, particularly with regard to innovation in clinical practices. Organizational culture. Sustained change in clinical practice may require reframing of the organizational culture to accommodate new values, beliefs, and therapeutic and business practices. The reframing process can include altering organizational structures, modifying fiscal and resource management procedures, acquiring new job skills, revising treatment philosophies, renegotiating the nature of linkage relationships, or revising staff and client interactions. Research is needed to determine how participation in the CTN may improve the quality of drug abuse treatment services and outcomes through changes in organizational culture or changes in therapeutic and business practices. Capacity and motivation for change. Adoption of research-based treatments require that organizations have the capacity to change. Barriers to adoption include lack of needed resources, philosophical resistance toward the research-based treatment, resistance from clientele or payers, or lack of time to plan and implement change. Research is sought to improve the organization’s capacity for change. Although workforce consensus for change may result from crisis, current organizational theory suggests that effective change results from a routine, normative practice of continuous improvement of services and products. Continuous improvement efforts might include outreach to other community providers, client focus groups, or partnerships between staff and management. Research is sought on how organizations effectively learn and adopt techniques or methods needed to effect change, such as benchmarking, formal training, attending workshops or conferences, and other approaches to identify promising clinical and business practices. Change management and follow-through. Research is sought on the processes needed for successful adoption of a new treatment after the decision to adopt has been made. These processes may include planning, implementing, and managing change, as well as monitoring to ensure that anticipated benefits are realized and that quality of services is maintained. Research is needed on the application of systematic knowledge of how to plan and manage change and how to monitor processes to insure that changes in business practices are sustained. Research on change management may include studies of the effects of improved management information systems or improved decision-making procedures on treatment performance. II. Effective Strategies to Help Non-Network Providers Adopt New Research- Based Treatments Although non-network treatment providers do not receive training or financial research incentives to implement new treatment technologies, they are under the same competitive pressures as CTN providers to improve their clinical and business practices in order to provide effective and efficient drug abuse treatment. While the research infrastructure of the CTN promotes short-term adoption of new treatment approaches, research is needed in the area of organizational change to support long-term adoption of treatment technologies found effective in the CTN. Research is encouraged to develop and test models for integrating new CTN- tested interventions into existing clinical practices, including studies on levels of theoretical and practical knowledge needed by practitioners, how to assess patient need for the new intervention, how the new treatment is staged or incorporated into an ongoing treatment regimen, how to measure program performance, outcomes, and cost-benefits for the new intervention, and how to integrate the new treatment with linked services. Areas of research interest include: - strategies to effectively transport CTN-tested treatment interventions into clinical practice, - organizational or management strategies or processes to improve transmission of knowledge, adaptation of new treatments, and their adoption into widespread clinical practice, - enhancements to technology transfer methods and mechanisms, - improvements of existing mechanisms to facilitate adoption of treatment approaches, such as research to improve the capability of Addiction Technology Transfer Centers, funded by the Substance Abuse and Mental Health Services Administration’s Center for Substance Abuse Treatment, to disseminate CTN-tested treatments beyond the network. III. Economic Research on Treatments Being Tested in the CTN Economic research on drug abuse treatment services informs decisions related to the allocation of resources and the desire to enhance efficiency and equity. Whether CTN-tested treatment interventions will be adopted by community treatment providers depends in part on whether these interventions are covered by public or private payers. Research is needed on: - Costs, including direct and indirect costs, of drug abuse services and ancillary services, as well as studies on the component unit service costs of drug abuse services to improve knowledge about full cost pricing of service delivery for CTN-tested drug abuse treatments. - Cost-benefit and cost-effectiveness analyses on innovative treatment therapies and interventions in the CTN and in non-network treatment providers. - Cost savings (or "cost-offsets") resulting from CTN-tested treatments that reduce or avert medical or social costs. - Outcome measurement and monitoring to improve the quality and management of resources. - Impact of health plan parity benefits and managed care practices on coverage of and access to CTN-tested treatments. PARTICIPATION OF CTN INVESTIGATORS Some research projects proposed under this RFA may require the participation, collaboration, cooperation, or other support by CTN investigators or community treatment provider staff or patients. Although the CTN is expected to create a research infrastructure that will support studies such as those encouraged here, some studies involving the CTN may not be feasible given the mission, goals, and timetables of the CTN cooperative studies. It is incumbent on the applicant to demonstrate that the support required of CTN participants has been obtained so that the proposed project is feasible. The use of data collected by the CTN is governed by rules established by the CTN Steering Committee, so it is especially important to demonstrate the feasibility of research proposing to use CTN-owned data. Information about the CTN, including contact information, is available at http://www.nida.nih.gov/ClinicalTrials.html. 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 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 research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report 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 subject 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 these policies. 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 of the Council 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. 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. 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 NIDA staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to the following staff by the letter of intent receipt date listed. Director, Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Blvd., Room 3158, MSC 9547 Bethesda, MD 20892-9547 Telephone: (301) 443-2755 FAX: (301) 443-0538 APPLICATION PROCEDURES 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, E-mail: GrantsInfo@nih.gov. 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 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 modifications made to the standard PHS 398 application instructions described below: PHS 398 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. 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. 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. 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. Under Personnel, list all 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. For Consortium/Contractual costs, provide an estimate of total costs (Direct plus F&A) 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. Provide an additional narrative budget justification for any variation in the number of modules requested. 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, and - List selected peer-reviewed publications, with full citations. 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. 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. 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. 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 on the face page of the application form, and the YES box must be marked. The sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. 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 Blvd., Room 3158, MSC 9547 Bethesda, MD 20892-9547 Rockville, MD 20852 (for express/courier service) 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 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 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 NIDA"s National Advisory Council. 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. 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: Are the goals and objectives of this application relevant to this RFA? 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? Has the support required of CTN participants been obtained so that the proposed project is feasible? 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 adequacy of plans to make data available to other investigators in a timely fashion. 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. Schedule: Letter of Intent: November 20, 2000 Application Receipt Date: December 19, 2000 Council Review: May 2001 Earliest Start Date: July 2001 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 strongly encouraged. The opportunity to clarify issues or questions from potential applicants is welcome. Direct inquires regarding programmatic issues to: Bennett W. Fletcher, Ph.D. Division of Epidemiology, Services, and Prevention Research National Institute on Drug Abuse 6001 Executive Boulevard, Room 4222, MSC 9565, Bethesda, MD 20892-9565 Telephone: (301) 443-4060 FAX: (301) 443-6815 Email: bfletche@nida.nih.gov Direct inquiries regarding fiscal matters to: Jack Manischewitz, Ph.D. Grants Management Branch, OPRM National Institute on Drug Abuse 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX: (301) 594-6849 Email: jmanisch@nida.nih.gov Direct inquiries regarding review issues 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: tlevitin@nida.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 Part 52 and CFR Part 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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