Full Text DA-95-004 COOPERATIVE DRUG ABUSE TREATMENT OUTCOME STUDY NIH GUIDE, Volume 24, Number 16, May 5, 1995 RFA: DA-95-004 P.T. Keywords: National Institute on Drug Abuse Letter of Intent Receipt Date: June 23, 1995 Application Receipt Date: July 21, 1995 PURPOSE The purpose of this Request for Applications (RFA) is to support a cooperative agreement to study drug abuse treatment in typical, stable programs. Investigators may propose research based on or incorporating existing data sets to which they have access. Under the cooperative agreement, the National Institute on Drug Abuse (NIDA) will also make available data collected under NIDA contracts (the "DATOS family of studies") for further collaborative analyses. Cooperative agreement investigators will also design and conduct follow-up studies of drug abuse treatment clients that were interviewed in the DATOS family of studies. HEALTHY PEOPLE 2000 The Public Health Service (PHS) 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, Cooperative Drug Abuse Treatment Outcome Study, 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) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority and women investigators are encouraged. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be a cooperative agreement (U01), an "assistance" mechanism, in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, primary responsibility, or a dominant role in the activity. Details of the responsibilities, relationships, and governance of the study to be funded under cooperative agreement(s) are discussed later in this document under the section "Terms and Conditions of Award." The total project period for applications submitted in response to the present RFA may not exceed five years. The anticipated award date is September 30, 1995. Because the nature and scope of the research proposed in response to this RFA may vary, the size of an award will also vary. Awards and level of support depend on receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the Institute, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. At this time NIDA anticipates that there will be a renewed competition after five years. If NIDA does not continue the program, awardees may submit grant applications through the usual investigator-initiated grants program. FUNDS AVAILABLE It is anticipated that approximately $1.3 million will be available to support the first year of the Cooperative Drug Abuse Treatment Outcome Study. It is anticipated that one award for the Coordinating Center will be made and two awards for Field Research Collaborative Centers will be made. The budget for the Coordinating Center is expected to be approximately one-third of the total in the first years but to increase proportionally, commensurate with follow-up fieldwork expenses, in the third through fifth years. RESEARCH OBJECTIVES Background The effectiveness of publicly-funded drug abuse treatment in treating heroin and opioid addiction was established by studies such as the Drug Abuse Reporting Program (DARP) and the Treatment Outcome Prospective Study (TOPS), which were conducted on cohorts entering treatment in 1969-73 and 1979-81, respectively. Since TOPS, patterns of drug use and the characteristics of clients presenting for drug treatment have changed, and major changes have taken place in the drug treatment system itself. These changes include the appearance of HIV/AIDS in drug abuse treatment populations, transmitted through injection drug use and drug-related sexual behavior; and the entry of new populations of drug users into treatment following the emergence of cocaine as a primary drug of abuse. At the treatment program/system level, changes include decreased levels of funding, the emergence of private third-party payors for drug abuse treatment, the significant development of a new modality (short-term inpatient care), and the evolution of existing treatment modalities related to funding changes and changes in patterns of drug use. Because of changes in treatment programs and practices, in client characteristics, and in drug use patterns, too little is currently known about the effectiveness of drug abuse treatment delivered in typical programs in the community despite a continuing need to understand what bearing these factors have on treatment outcomes. Furthermore, there are important research questions that could not be addressed in DARP or TOPS that may be examined with more recent data, such as the role of psychopathology in treatment outcomes. A broad range of important drug abuse treatment and health services research questions may be addressed through analyses of existing data, including data from investigator-initiated research and data from previous large-scale research and evaluation studies, such as TOPS. Under the cooperative agreement, NIDA will also make available three current databases it has developed under contract. These databases were created under the DATOS, DATOS-Adolescent, and CTOS research, and are described briefly below. Cooperative agreement investigators are encouraged to capitalize on NIDA's investment in these studies by using data from the DATOS family of studies to conduct intensive collaborative analyses. DATOS family of studies. In 1989, NIDA initiated a series of studies whose goals, broadly, were to investigate drug abuse treatment in typical, stable programs in order to characterize treatment as it is usually delivered and its effectiveness for current treatment populations and drug abuse patterns; to investigate the role of client and program characteristics in determining outcomes; and to investigate the relation between impairment and outcomes during and after treatment. The DATOS family of studies includes the Drug Abuse Treatment Outcome Study (DATOS), the Drug Abuse Treatment Outcome Study of Adolescents (DATOS-Adolescent), and the Cocaine Treatment Outcome Study (CTOS). Each of these studies was developed and carried out under separate NIDA contracts with the Research Triangle Institute (RTI). The DATOS studies provide rich databases with potential to address important questions in treatment outcome and health services research. Data were collected in a number of domains, including demographics, alcohol and drug use, physical and mental health, income, illegal involvement, employment, cognitive functioning, motivation and readiness, HIV/AIDS risk behavior, and treatment process and outcomes. In each study, the data sets that were acquired were deliberately designed to contain far more research potential than can be realized under the existing contract procurements. Refer to Table 1, "Points of Interview in DATOS During and After Treatment," which is available from the program staff listed under INQUIRIES. For purposes of developing an informed application, DATOS, DATOS- Adolescent, and CTOS research design and instrumentation packages are available by written request from the Services Research Branch, at the address listed under INQUIRIES. DATOS. The Drug Abuse Treatment Outcome Study is a longitudinal prospective study of adults entering drug abuse treatment programs in 1991-1993. Drug abuse treatment programs were purposely chosen to represent drug abuse treatment delivered in typical stable programs. Program-level and client-level data were obtained. Under DATOS, intake data were collected on 10,000 adults in 99 drug abuse treatment programs in 11 cities. Data were collected at 1 and 3 months during treatment and at 12 months after treatment. The study obtained data on clients in four types of treatment programs, including methadone maintenance, short-term residential (hospital inpatient, chemical dependency), long-term residential (therapeutic community), and outpatient drug-free treatment. The 12-month follow-up sample of 4,500 was drawn from 85 programs. The follow-up is stratified on treatment modality, drug pattern, impairment level, and length of time in treatment. The major goal of DATOS is to evaluate treatment effectiveness. As part of this, secondary goals are to describe current drug abuse treatment populations in terms of demographic characteristics, psychological variables, sociocultural variables, treatment history, tenure, and during-treatment behaviors; to characterize existing modalities and interventions of treatment; to determine the relation between psychological impairment and treatment outcomes; and to determine the relationship between treatment outcomes and important client, program, and treatment factors. DATOS-Adolescent. The Drug Abuse Treatment Outcome Study of Adolescents is a longitudinal prospective study of drug abuse treatment effectiveness in the adolescent population based on a sample of outpatient and residential drug abuse treatment programs for adolescents. The methodology, research design, instrumentation, and objectives of DATOS-Adolescent are designed to parallel DATOS where possible. DATOS-Adolescent began in 1991 and is still underway. Under DATOS- Adolescent, intake and follow-up data will be collected from approximately 1,500 collateral or family members and 3,000 adolescents in approximately 35 public and private drug abuse programs in 8 to 10 cities from mid-1993 through early 1995. CTOS. The Cocaine Treatment Outcome Study is an accelerated, 2-year retrospective study of 772 clients from 23 DATOS program sites in seven cities (Chicago, Miami, Minneapolis, New York, Pittsburgh, Portland, and New Orleans), based on clinical records and a 12-month follow-up interview. The follow-up interview is identical to that used in DATOS, and baseline data were obtained retrospectively (at follow-up) to supplement clinical records. The goal of the study is to rapidly acquire more knowledge about outcomes for clients admitted to treatment with a primary diagnosis of cocaine dependence. Program Objectives This cooperative study has two objectives. The first objective is to conduct studies to learn more about treatment received in typical community-based drug abuse treatment programs, particularly with regard to questions of treatment effectiveness and outcomes, as well as other questions related to health services, such as access to and utilization of treatment services, and cost-effectiveness of treatment. Studies may be carried out using data from the public domain or data from other research and evaluation studies. It is expected that databases from the DATOS family of studies will constitute significant resources in meeting this objective. The second objective is to carry out long-term follow-ups of drug abuse treatment clients in the DATOS family of studies. This includes: a 36-month follow-up of adults in DATOS to assess drug use patterns and outcomes in the three years after treatment, investigate factors predictive of relapse, and identify patterns of health service utilization over time; and a 24-month follow-up of adolescents and their family members or collaterals in DATOS- Adolescent. Program Components This study will involve the cooperation of investigators from a Coordinating Center, Field Research Collaborative Centers, and the NIDA Services Research Branch, Division of Clinical and Services Research, in conducting treatment and health services research studies. Under the cooperative agreement, it is anticipated that one Coordinating Center and two Field Research Collaborative Centers will be supported. Separate applications are being solicited for a Coordinating Center and for Field Research Collaborative Centers to participate in this collaborative study. If an institution chooses to apply for multiple awards, there should be no overlap in research and support personnel. Coordinating Center The Coordinating Center has two unique functions. The first involves coordinating cross-site cooperative study project initiatives. The second involves follow-up data collection activities. Coordination of cross-site activities The Coordinating Center will be responsible for all executive secretariat functions, including organization of Steering Committee meetings and teleconferences, developing steering committee agendas, taking minutes of sessions, photocopying and distributing materials prior to steering committee sessions, and preparation of reports from the Steering Committee to the NIDA Project Officer (who will not be a NIDA Collaborating Scientist). The meeting agenda topics may include development of research issues, planning of collaborative arrangements, planning of studies and analyses on defined topics, discussion of strategies to facilitate expeditious dissemination of cooperative agreement research findings, progress reports, and reports of scientific findings. The Coordinating Center will function as a repository for data to be analyzed under this cooperative agreement (as permitted by the data owners), including data from the DATOS family of studies. The Coordinating Center will provide documented copies of data sets used in the cooperative agreement, technical assistance, and programming support related to data management to other cooperative agreement investigators. Follow-up data collection Not only are data collected in the DATOS family of studies a valuable resource; they also represent a potential for further long-term studies of factors that influence the outcomes of individuals treated for drug abuse. Follow-up studies may permit investigation of long-term impacts of changes in drug abuse treatment access, utilization, and effectiveness; long-term outcomes for those who entered drug treatment but dropped out prior to engaging in treatment, including their prior and subsequent treatment history and investigation of spontaneous remission of drug abuse without effective treatment; research on sub-groups of particular interest, such as sub-groups defined by psychopathology, or individuals abstinent after one treatment contrasted with continuing drug users; or patterns of drug abuse, service utilization, and outcomes over time. Because of the opportunities represented by the DATOS samples and the valuable expertise that can be provided by the cooperative agreement investigators, follow-up studies of subjects in the DATOS family of studies will be carried out under the cooperative agreement. Investigators from the Coordinating Center and the Field Research Collaborative Centers will collaborate on the research design and development of instrumentation for the follow-up studies. The Coordinating Center will provide fieldwork and administrative management of the follow-up data collection efforts. In conducting the follow-ups, comparability of essential data elements with data collected under NIDA contract for the 12-month follow-ups will be maintained. However, some data elements may be deleted, or it may be desirable to augment data previously collected. The cooperative agreement investigators should be prepared to review and alter instrumentation based on analyses of data and needs of the field. The Coordinating Center will insure that procedures for collecting follow-up data are uniform so that no problems arise with comparability across sites or across interviewed samples. The Coordinating Center will link follow-up data with existing data on DATOS and DATOS-Adolescent subjects. Under contract requirements for DATOS and DATOS-Adolescent, locator information has been retained, with appropriate protection of client confidentiality, to enable long-term follow-ups of individuals in the DATOS and DATOS-Adolescent samples. DATOS follow-up. It is planned that the Coordinating Center will carry out a 36-month follow-up of individuals who were in the DATOS 12-month follow-up sample. The DATOS 12-month follow-up sample frame consists of 4,500 clients from 85 drug abuse treatment programs. Coordinating Center applicants should budget to follow up 3,500 individuals. DATOS programs are in 11 cities--Chicago, Houston, Miami, Minneapolis, New Orleans, New York, Newark, Pittsburgh, Phoenix, Portland, and San Jose. The follow-up will involve developing and field-testing the follow-up interview; hiring and training field interviewers to conduct the follow-up interview; reproducing the 36-month follow-up questionnaire; conducting data entry, editing, and analysis of data; monitoring the quality of the follow-up data; and reporting to NIDA and the Steering Committee on the progress of the follow-up. DATOS-Adolescent follow-up. DATOS-Adolescent is the first longitudinal study of adolescents treated in typical community-based programs. As such, it presents a unique opportunity to follow a cohort of adolescents into adulthood to investigate long-term drug-using behavior and health service utilization patterns of clients admitted to drug treatment at an early age. In addition to the 36-month follow-up of adults in DATOS, applicants for the Coordinating Center should anticipate conducting a 24-month follow-up study of 3,000 adolescents and 1,500 collaterals in the third and fourth years of the cooperative agreement. Field Research Collaborative Centers The Field Research Collaborative Centers will collaborate with each other, with the Coordinating Center, and with NIDA investigators on drug abuse treatment studies using existing data sets to which they have access or data from the DATOS family of studies. Field Research Collaborative Centers will also carry out analyses using follow-up data collected under the cooperative study as these data become available. Applicants for Field Research Collaborative Centers should have expertise in large-scale multi-site services research in order to identify important research issues and carry out appropriate studies. Each Field Research Collaborative Center will have a strong research focus on particular areas relevant to drug abuse treatment evaluation research and health services research areas. In making an award, consideration will be given to Field Research Collaborative Centers that are complementary rather than overlapping in their areas of interest. Areas of research emphasis for a Field Research Collaborative Center might include: o Research on the relationships between client, program, and treatment factors, and treatment effectiveness. o Research on the impact of psychopathology, cognitive functioning, physical health, and other co-morbid conditions on outcomes during and after treatment. Conceptualization and development of a multidimensional index of impairment. o Investigation of models of drug abuse treatment in current practice, based on treatment structure and process variables, conceptualization of stage of recovery/readiness for treatment, or continuity of care models. Research to update treatment typologies. o Program-level health services research, including impact of various financing and reimbursement strategies on access, utilization, and outcomes; cost effectiveness of treatment; impact of health service delivery factors on drug abuse treatment outcomes; changes in drug abuse treatment and treatment outcomes over time. All research and analyses will be reviewed and approved by the Steering Committee, and the Steering Committee may negotiate collaborative study plans after award so that individual cooperative agreement components focus on complementary, non-duplicative research studies. Field Research Collaborative Center applicants should propose studies to investigate well-conceptualized research questions. The intent of this cooperative agreement is to advance scientific knowledge about the effectiveness of drug abuse treatment as it is typically practiced by conducting analyses addressing a wide range of questions of scientific and policy relevance. While not exhaustive, the following general areas may serve as points of departure for cooperative agreement studies: o Drug use prior to, during, and after treatment. o Prevalence of multiple impairments in the population entering drug abuse treatment, and relation to outcomes. o Changes in mental health indicators during treatment. The role of psychological factors in drug abuse treatment. o Factors related to treatment retention. o Comparison of services and process in different types of treatment. o Comparison of problem areas (e.g., Addiction Severity Index problem domains) before and after treatment. o Comparative costs and benefits of drug abuse treatment, by modality. o Impact of legal involvement on treatment entry, retention, and outcomes. o Effectiveness of interventions to reduce HIV/AIDS risk behaviors during and after treatment. Collaborative analyses of follow-up data. The conceptualization of addiction as a recurrent disorder marked by cycles of drug use, abstinence, and relapse raises new questions on the design, delivery, and utilization of health services. Research is needed to examine the long-term outcomes of drug abuse treatment in sub-groups defined by gender, race/ethnicity, age, and psychological functioning. Although not an exhaustive list, follow-up research may include: o The long-term impact of changes in drug abuse treatment access, utilization, and effectiveness. o Long-term outcomes for individuals that entered drug treatment but dropped out prior to engaging in treatment, including their prior and subsequent treatment history and investigation of spontaneous remission of drug abuse without effective treatment. o Investigation of sub-groups of particular interest, such as individuals abstinent after one treatment contrasted with continuing drug users. o Patterns of drug abuse, service utilization, and outcomes over time. Comprehensive findings from the cooperative agreement studies should be widely available and accessible to maximize their benefits to the drug abuse treatment and research fields. An important element of the collaborative analyses will be to disseminate cooperative agreement research findings by participating in scientific meetings and publishing in the scientific literature. Applicants may propose collaboration with other investigators who are not cooperative agreement key staff in order to benefit from external expertise and to facilitate working with other useful data sets. Steering Committee The Steering Committee will be the primary governing board of the cooperative study and will decide all major scientific decisions. It will be composed of the Principal Investigator of the Coordinating Center, the Principal Investigators of the Field Research Collaborative Centers, and two NIDA Collaborating Scientists. Only one NIDA Collaborating Scientist will vote. The Steering Committee will create and implement study plans in three areas: (1) a plan of systematic research on treatment outcomes and health services issues in typical community-based drug abuse treatment programs, (2) 36-month follow-up data collection of DATOS subjects, and (3) 24-month follow-up data collection of DATOS-Adolescent subjects. The study plans developed by the Steering Committee may be different than any of the individual proposals; they may be based on a study proposed in one of the awardee's applications, may combine elements of studies proposed by the Coordinating Center and Field Research Collaborative Centers, or may be based on independent deliberations of the Steering Committee. In developing a research plan for treatment outcome and health services research, studies should be designed to increase knowledge of outcomes of treatment delivered in typical community-based drug abuse treatment programs. Consideration may be given to available and appropriate data resources, prioritization of research questions with regard to importance or other factors, new data that might be needed that could be obtained through cooperative agreement follow-up studies, and means for disseminating research findings to the scientific field as well as to a broader audience. At a minimum, planning the follow-up studies will involve reviewing past research procedures and protocols to identify changes that should be made and new research questions that should be addressed, as well as planning for pilot testing of the interview, hiring and training field interviewers, locating subjects, and conducting the interviews. Study plans will include the research design, data issues, analytic plans, and planned publications or reports, as well as detailed implementation procedures including staffing, resource utilization, and time lines. Plans will be periodically reviewed and evaluated by the Steering Committee. Subcommittees may be created by the Steering Committee to consider narrowly defined topics, such as methodology, data acquisition, or publication policies and procedures. Subcommittee membership will be limited to Principal Investigators or their representatives, NIDA Collaborating Scientists, and one or two technical experts. Subcommittees should be balanced so that the interests of each awardee and NIDA are fairly represented. Final approval and responsibility for topics considered by a subcommittee will reside in the Steering Committee. The Steering Committee will develop policies on data sharing, on access to data and materials, and on publication authorship. As a special task, the Steering Committee will develop a plan for the release of DATOS data collected under contract to the public domain in order to assure accessibility of DATOS research files to researchers in the drug abuse field, while also insuring insofar as possible appropriate use of data. The Steering Committee will also consider release of the Cooperative Drug Abuse Treatment Outcome Study data to the public domain. Publication policies covering all aspects of the Cooperative Drug Abuse Treatment Outcome Study will be developed by the Steering Committee. NIH policies regarding publication apply to NIDA Collaborating Scientists or other NIDA staff, and any policy regarding NIDA staff developed by the Steering Committee must be consistent with current NIH policy. The Steering Committee will develop a plan for publications, set up guidelines on authorship, and implement review procedures to maintain high scientific quality. The quality of publications resulting from the study will be the responsibility of authors; no NIDA clearances will be required except for NIDA staff who serve as coauthors (see NIDA Collaborating Scientist responsibilities). The Steering Committee will meet approximately two to three times a year, but up to five meetings may be required in the first year (usually in the Washington, DC area). Steering Committee teleconferences will be held on a monthly basis. Timetable It is envisioned that the Cooperative DATOS will be conducted over five years and will encompass several concurrent activities. The first priority will involve the establishment of the Steering Committee roles and responsibilities, described in more detail below. This activity will be completed within 3 months of award of the cooperative agreement. The second priority will be the development and implementation of the DATOS follow-up research designs. Following development of the research design and implementation plan, data collection for the 36-month follow-up study should begin in the first year of the cooperative study and be completed in the second year. In the second year of the DATOS cooperative study, designing the 24-month follow-up of the DATOS-Adolescent sample should begin. The 24-month follow-up should be carried out in the third and fourth years of the cooperative study. Concurrent with the follow-up field research, the Steering Committee will meet to develop and implement a plan of systematic research on questions relevant to drug abuse treatment and health services issues in typical community-based drug abuse treatment programs. Budget and Related Issues Applicants for the Coordinating Center must budget appropriately to conduct the follow-up data collection. Applicants should budget for 3,500 DATOS follow-up interviews, for 3,000 DATOS-Adolescent youth interviews, and for 1,500 DATOS-Adolescent collateral interviews. Urinalysis and hair analysis data should be obtained from an adequate sample of the follow-up to estimate the validity of self-report data. Follow-ups conducted by RTI averaged 10 hours per subject, including the interview itself (which averaged 90 minutes) and locating the subject. Subjects in DATOS were paid $15 per follow-up interview and $10 for urine specimens. Cooperative agreement funds may be used for expenses clearly necessary to carry out the research project being supported by the award. Expenses may include direct costs that can be specifically identified with the project and allowable indirect costs for the applicant institution. SPECIAL REQUIREMENTS To insure the success of the cooperative study, applicants must be able to interact effectively with other participating investigators. Applicants should state their willingness to follow the study plans that will be developed by the Steering Committee. Applicants for the Coordinating Center must demonstrate the availability of adequate research and office facilities to carry out proposed Coordinating Center objectives, including adequate access to the relevant drug abuse and health services literature. The Coordinating Center is expected to be a repository of reference materials that may be obtained under the cooperative agreement. Applicants for the Coordinating Center should be able to demonstrate expertise in conducting large-scale follow-up research, and in managing large data sets. Relevant support services and adequate data processing facilities must be readily accessible, and reasonable assurances of such support must be included with the proposal. Field Research Collaborative Center applicants must demonstrate the availability of adequate research facilities to carry out proposed Field Research Collaborative Center objectives. Research training costs are not allowed under this cooperative agreement. However, provision should be made for research training opportunities for graduate- and post-doctoral investigators within each Center. Applicants are encouraged to seek training support from other funding sources within and outside NIDA. The following terms and conditions will be incorporated into the award statement and provided to the Principal Investigator(s) as well as the institutional official at the time of award. Terms and Conditions These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, DHHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and other DHHS, PHS, and NIH Grant Administration policy statements. Awardee Rights and Responsibilities Awardees have primary and lead responsibilities for their component of the project as a whole, including collaboration with other awardees and with the NIDA Collaborating Scientists, as well as data collection, quality control, data analysis and interpretation, definition of objectives and approaches, and publication of research results, interpretations, and conclusions. Awardees will participate on the Steering Committee as described under Collaborative Responsibilities and on subcommittees as appropriate. Awardees will have access to data collected under these awards, subject to rules formulated by the Steering Committee, and Government rights of access consistent with current DHHS, PHS, and NIH policies. Collaborative Responsibilities Steering Committee. A Steering Committee, composed of the Principal Investigator of the Coordinating Center, the Principal Investigators of the Field Research Collaborative Centers, and the NIDA Collaborating Scientists, will be the primary governing board of the study and will have primary responsibility for identification, review, and development of research issues and plans for analytic studies; review of proposed collaborative arrangements, including arrangements between cooperative study investigators, NIDA staff not part of the agreement, supervised students, and researchers external to the cooperative agreement invited to collaborate on specific studies due to their particular expertise; monitoring of progress of ongoing data collection and analyses; reporting of scientific findings; and development of dissemination strategies for a spectrum of audiences from scientist to non-professional. Steering committee decisions will be determined by majority vote. The principal investigators from each Field Research Collaborative Center and the Coordinating Center will each have one vote. Only one of the NIDA Collaborating Scientists will vote. The chairperson, who will be someone other than a NIDA Collaborating Scientist, will be selected by the Steering Committee. Additional non-voting consultants may be appointed to the Steering Committee as needed. Subcommittees will be established by the Steering Committee, as it deems appropriate; the Collaborating Scientists will serve on subcommittees as they deem appropriate. Awardees must agree to abide by the study plans and policies developed by the Steering Committee. NIDA Collaborating Scientist responsibilities. Two NIDA Collaborating Scientists will participate in the cooperative study. NIDA Collaborating Scientists will provide access to data from DATOS, DATOS-Adolescent, and CTOS, and will facilitate collaborative studies and dissemination of DATOS-related findings of research and policy relevance. NIDA Collaborating Scientists will help to identify research questions that will have fundamental and timely significance in national policy discussions regarding the role of treatment in addressing the problem of drug abuse. NIDA Collaborating Scientists will participate in the development of instrumentation, in quality control, in development of the final study plan, and in coordination of the project. They will not participate in activities that directly involve interviewing or treatment of human subjects. NIDA Collaborating Scientists may participate, and may engage the participation of other NIDA staff, in data analysis and interpretation, and in the preparation of publications. In instances where significant involvement in the analysis of results has occurred, Collaborating Scientists and other NIDA staff may cooperate with awardees as coauthor(s) in preparing publications resulting from the research. In this regard, NIDA staff will be subject to the publication/authorship policies governing all cooperative agreement participants. In addition, publications involving NIDA staff require internal clearances and are subject to NIH publication policies. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award) between award recipients and NIDA may be brought to arbitration. An arbitration panel will be composed of three members--one selected by the Steering Committee (with the NIDA members not voting) or by the individual awardee in the event of an individual disagreement, a second member selected by NIDA, and the third member selected by the two prior selected members. This panel will make a decision within 60 days of the request. Failure to comply with the decision of the panel may result in termination of support for an awardee by NIDA. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and DHHS regulations at 45 CFR Part 16. INCLUSION OF MINORITIES AND WOMEN 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 rational and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. 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 reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by June 23, 1995, 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 to avoid conflict of interest in the review. The letter of intent is to be sent to: Director, Office of Extramural Program Review National Institute on Drug Abuse 5600 Fishers Lane, Room 10-42 Rockville, MD 20857 Telephone: (301) 443-2755 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/710-0267; and from the program administrator listed under INQUIRIES. Additional Materials to Include in the Application Any information that is required as a result of the use of the cooperative agreement mechanism, including special meetings and budgetary requirements, and adequate documentation of facilities and environment to carry out the objectives of the agreement, should be provided. Applicants should document their agreement to accept and implement study plans and procedures approved by the Steering Committee. The RFA label in the PHS 398 (rev. 9/91) 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 2a on 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: Division of Research Grants 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 also be sent to: Director, Office of Extramural Program Review National Institute on Drug Abuse 5600 Fishers Lane, Room 10-42 Rockville, MD 20857 Applications must be received by July 21, 1995. If an application is received after that date, it will be returned to the applicant without review. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG 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, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. Review Criteria Applicants are encouraged to submit and describe their own ideas about how best to meet the goals of the cooperative study and their specific objectives, and are expected to address issues identified under SPECIAL REQUIREMENTS of the RFA. The review group will assess the scientific and technical merit of the proposed study plans and related factors: o Significance and originality of the proposed research; o Appropriateness and adequacy of the proposed research approach, methodology, and plans to address special requirements; o Qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o Availability of the resources necessary to perform the research; o Appropriateness of the proposed budget and duration in relation to the proposed research; o Appropriateness of proposed methodology and demonstrated willingness to work as part of the cooperative study and with NIDA Collaborating Scientists; o Adequacy of provisions for the protection of human subjects; and o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. Coordinating Center o Adequacy of plans for conducting follow-up fieldwork; o Adequacy of plans to coordinate cross-site activities and to share data with the Field Research Collaborative Centers and the NIDA Collaborating Scientists; o Adequacy of plans to manage DATOS, follow-up, and other data, and to function as a data and information/reference repository. AWARD CRITERIA Applications recommended for further consideration by the NIDA National Advisory Council will be considered for funding based on the following factors: o Overall scientific and technical merit of the application as determined by peer review; o Significance and originality of the proposed research; o Appropriateness of budget estimates; o Compatibility of research and data analytic approaches, administrative structures, and other features to make a successful cooperative study a reasonable likelihood; o Programmatic priorities; and o Availability of funds. Letter of Intent Receipt Date: June 23, 1995 Application Receipt Date: July 21, 1995 Initial Peer Review: August 1995 Review by NIDA Advisory Council: September 1995 Anticipated Award Date: September 30, 1995 INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Frank Tims Services Research Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-30 Rockville, MD 20857 Telephone: (301) 443-4060 Email: FTIMS@AOADA.SSW.DHHS.GOV Direct inquiries regarding fiscal matters to: Gary Fleming Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 Email: GFLEMING@AOADA2.SSW.DHHS.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 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 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 routing 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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