RFA-DA-02-011: NATIONAL CRIMINAL JUSTICE DRUG ABUSE TREATMENT SERVICES RESEARCH SYSTEM

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

NATIONAL CRIMINAL JUSTICE DRUG ABUSE TREATMENT SERVICES RESEARCH SYSTEM RELEASE DATE: February 4, 2002 RFA: RFA-DA-02-011 (Reissued as RFA-DA-08-002) PARTICIPATING INSTITUTES AND CENTERS (ICs): National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) LETTER OF INTENT RECEIPT DATE: April 12, 2002 APPLICATION RECEIPT DATE: May 13, 2002 THIS REQUEST FOR APPLICATIONS (RFA) CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The NIDA invites cooperative agreement applications to participate in the National Criminal Justice Drug Abuse Treatment Research System (CJ-DATS). Awardees will conduct and participate in coordinated multisite studies to conduct rigorous scientific research with offender populations across multiple settings including jails, prisons, and in the community. The goal of this cooperative research program will be to establish and utilize a research infrastructure to develop and test research-based systems-level models that integrate public health and public safety approaches for criminal justice-involved individuals with addictive disorders. CJ-DATS research will be carried out in prisons, jails, and community-based treatment settings in collaboration with other awardees and with NIDA. The CJ-DATS will consist of a Coordinating Center and multiple Research Centers. Each Center will work in concert with other Centers and NIDA to conduct multisite and cross-regional (nationwide) criminal justice-based treatment services research. Awardees will study systems-level models integrating drug abuse treatment with the criminal justice system. Most studies to be conducted are expected to span multiple Centers, and, depending on the nature of the research, each study may have a different Research Center functioning as a "Lead Center" to coordinate other Centers in the conduct of the research. A "Coordinating Center" will provide some CJ- DATS-wide logistic and data support, as well as function as a "Lead Center" for certain studies. As a cooperative agreement, there will be substantial NIDA involvement in the management and administration of the CJ-DATS, including the determination of which studies will be implemented using components of the System. RESEARCH OBJECTIVES Background The number of individuals incarcerated in United States prisons has steadily increased since the mid-1970s. The majority of these have a drug problem significant enough to require intervention. In 1998 the Office of National Drug Control Policy estimated that 70 to 85 percent of state inmates needed treatment, but that only 13 percent received it while incarcerated. It was recently estimated that beginning in 1999, about 600,000 inmates per year began to be released back into the community, often without having received drug abuse treatment in prison or being connected to community-based drug treatment. Left untreated, drug addicted offenders often relapse to drug use and return to criminal behavior. This jeopardizes public health and public safety and leads to re-arrest and re-incarceration, which exacerbates already high burdens on the criminal justice system. Because drug abuse treatment has been shown to reduce drug use and its related criminal behavior, it has been seen as a way to intervene with drug abusers to interrupt the cycle of relapse, re-arrest, and re-incarceration. Many different approaches are being tried, including treatment as an alternative to incarceration, drug courts that blend judicial monitoring and sanctions with treatment, and drug abuse treatment in prison settings and/or treatment in community settings after release. Benefits have been found for several approaches. For example, the effectiveness of prison-based therapeutic communities followed by community- based treatment has achieved high visibility. Based on such recognized successes, new resources have been allocated to provide treatment for incarcerated drug abusers and addicts. Drug abuse treatment offered to inmates, either in jail or prison or upon re- entry, often differs from the optimal therapeutic community treatment model. In particular, the post-release continuation of therapeutic community treatment that has been shown in research to maximize good outcomes may not be fully implemented. Therapeutic community treatment is often limited in availability and capacity, and may be more expensive than some other types of treatment. The drug treatment in communities to which offenders are returned may be of uncertain quality, suitability, and availability. There may be limited or no access to medical services such as antiretroviral therapy for HIV seropositive offenders. Community-based interventions that are incongruent with in-prison treatment may negate the benefits obtained by such treatment. Many drug abuse treatment services, particularly those provided in the transition between prison and community re-entry, are of unknown effectiveness. Since comparatively little is known about either processes or outcomes of many treatment approaches, especially those other than the therapeutic community, there is an urgent need to establish what does and does not work for incarcerated drug abusers and for those who will re-enter the community. Pressure from the criminal justice system is often needed to encourage inmates or those transitioning back into the community to enter drug abuse treatment. However, the alliance between the criminal justice system and the drug abuse treatment system is often not optimal. Members of the judiciary familiar with the concept of "therapeutic jurisprudence" recognize that the criminal justice experience can have therapeutic consequences for defendants with addictive disorders if it is used as a point of departure for changing the offender"s lifestyle (Hora, Schma, Rosenthal, 1999). However, public health and public safety professionals often approach the issues of drug use and addiction from very different perspectives. While criminal justice administrators may realize the value of drug treatment in the aggregate, their primary concern is for the actions of individuals under their supervision. Drug treatment research may provide little guidance to criminal justice administrators regarding appropriate expectations for an individual"s treatment outcomes or determining whether treatment has reduced the individual"s level of risk to public safety. Criminal justice professionals need a better understanding of treatment how it works, for whom, and how to gauge progress in treatment in order to utilize it more effectively and to more fully integrate it into the criminal justice system. Developing an Integrated Systems Approach The recovery from drug addiction is often a prolonged process that only begins with abstinence from drug use. There is accumulating evidence that addiction produces persistent changes in the structure and biochemical function of the brain (McLellan, Lewis, O"Brien, Kleber, 2000). This neurophysiological damage is usually accompanied by long-lasting behavioral changes and social consequences which contribute to the observed chronicity of addictive disorders. One implication of this evolving perspective is that an approach to drug abuse treatment that corresponds more fully to the chronic nature of the addictive disorder should produce better outcomes. This concept of drug addiction and its recovery is consistent with a large body of research showing that length of treatment is an important predictor of successful outcomes. Drug abusers or addicts who are inmates or who are re-entering the community after incarceration present special problems. Most are under continuing criminal justice supervision. In addition to drug problems, many have problems in other areas, including physical and mental health, employment, housing, family and peer relationships, and gang involvement. Women, whose rates of incarceration have grown in recent years, may have special health, mental health, childcare, housing, and drug treatment needs. Community stability and cohesion may be adversely affected if significant numbers of ex-prisoners with unmet needs are returned to the community. Within the criminal justice context, a treatment model that better fits the addictive disorder should not only build on current and future knowledge about the nature of addiction and the process of recovery, but should also be integrated with the criminal justice system both to address public safety concerns and to insure a continuity of treatment that corresponds to the needs of the patient. Such an integrated model should be designed not only to incorporate the best criminal justice practices and therapeutic services but also to use the best organizational practices to deliver these. Thus, research on models to integrate drug abuse treatment and the criminal justice system might investigate how criminal justice professionals and drug abuse treatment providers can best effect change in the addict"s attitudes, perceptions, behaviors, and lifestyle. While the features of these integrated models are not predefined, it is expected that such models will recognize and anticipate the need for continuing episodes of drug treatment by combining criminal justice assessment, monitoring, and supervision over an extended period of time with appropriate drug treatment assessments and interventions, including steps to re-engage individuals in treatment as needed. The CJ-DATS is expected to forge partnerships among NIDA, drug treatment and criminal justice researchers, criminal justice professionals, drug abuse treatment practitioners, and other health and social service providers who have roles and responsibilities that are related to helping criminal justice- involved individuals return to their communities as productive, law-abiding members of society. Establishment of these partnerships is essential to assure that new models to integrate drug abuse treatment with the criminal justice system can be successfully designed and implemented. Objectives and Scope The overall goal of the National Criminal Justice and Drug Abuse Treatment Research System is to establish a research infrastructure and to develop and test models for an integrated approach to the treatment of incarcerated individuals with drug abuse or addictive disorders, including both treatment in jail or prison and treatment as part of re-entry into the community. Specific objectives include: Supporting rigorous, multisite studies that focus on integrating during- and post-incarceration drug abuse treatment system processes with criminal justice system processes for individuals with drug abuse and addictive disorders as well as co-occurring mental health disorders. Encouraging research, particularly for currently used understudied approaches, on the relative effectiveness of alternative treatment approaches for inmates in jail or prison and for ex-offenders re-entering the community. Encouraging research on the organizational processes needed to integrate effective prison- and/or community-based drug abuse treatment with criminal justice requirements. Supporting research on continuity of care models integrated with criminal justice prisoner re-entry programs for transitioning returning drug addicted offenders to their communities, including mental health services and services for other health problems such as HIV, tuberculosis, or hepatitis infections. Supporting research on how treatment effectiveness is achieved with regard to therapeutic, organizational, and managerial processes, and particularly with regard to criminal justice system processes and practices, including monitoring, supervision, and sanctions. Fostering the collaboration of treatment practitioners, criminal justice professionals, and researchers, to provide opportunities for multidirectional education and exchange of ideas, information and values between the criminal justice, treatment, and academic communities. Characteristics of the System The CJ-DATS will provide a stable infrastructure for research to improve drug abuse treatment for individuals with drug abuse or addictive disorders who are incarcerated or transitioning from jail or prison to the community. It is anticipated that one Coordinating Center will be established. (See Organization of the System, Section A.) There will be three to five regional Research Centers (Section B), and the Coordinating Center and Research Centers will constitute the CJ-DATS. The Research Centers will collaborate with the Federal government and the Coordinating Center in conducting studies under this system, serving in a "Lead Center" (Section C) role. They will also coordinate with treatment providers (Section D) and public safety participants (Section E). A CJ-DATS Steering Committee will constitute the primary operating and decision-making body of the CJ-DATS. See Section F for the composition and roles of the Steering Committee. Examples of the types of studies and questions appropriate for the CJ-DATS include: Stages of drug abuse treatment. Treatment stages can include triage, assessment, treatment in prison, post-release transition and treatment, and continuing care in the community. How are criminal justice risk assessment, monitoring, and supervision integrated with community-based drug abuse treatment for re-entering ex-offenders at each of these stages to improve adherence to treatment plans and outcomes? Types of criminal justice system/drug abuse treatment integration. What types of integration of drug abuse treatment services with the criminal justice system are best at each stage of treatment? Does involvement of community treatment providers with criminal justice staff during the in- prison treatment stage improve enrollment and engagement in community-based treatment? Levels of integration. How and under what circumstances do higher levels of drug abuse treatment/criminal justice system integration (more communication, more criminal justice involvement in the therapeutic process, more treatment provider involvement in criminal justice processes) result in better treatment engagement and adherence, better or faster progress in treatment, and better outcomes? Alternative treatment approaches. Effectiveness of extant treatment alternatives for the addicted inmate or returning offender, particularly for understudied approaches such as cognitive-behavioral models that emphasize correcting criminal thinking, faith-based approaches, and "social milieu" residential models that encompass a range of counseling and skills-building approaches. Roles of criminal justice professionals and drug abuse treatment providers. Research on strengthening criminal justice referral and linkage to treatment, health, and social services systems. Research to define roles and responsibilities of health providers and criminal justice personnel to complement and support each other in interventions for the returning prisoner. Organizational adaptation. What strategies help drug abuse treatment practitioners and criminal justice professionals adapt to improve the quality of integrated treatment? Comparison of conflict management styles (integrative, confrontation, avoidance) or improved value congruence on decision-making and problem-solving processes. Motivation. Research on how motivation and other individual attributes affect treatment engagement, participation, and outcomes. Research on relationships between criminal justice-supplied external motivation (monitoring, supervision, threat of legal sanctions) and internal motivation to change. Relation between public safety risk level and treatment. For example, does risk level affect the needed intensity of criminal justice monitoring or treatment? Is risk reduced by satisfactory engagement and progress in treatment? Research to develop reliable and valid measures of treatment performance that can be used as predictors of outcomes, and to develop performance measures that can be used by the treatment provider or others as a tool for intervening in the treatment process to improve outcomes. Optimal linkage between prison- or jail-based and community-based treatment. Research on in-prison treatment as a foundation for later community treatment. Research to improve the congruence between in-prison and post- release treatment approaches. Research on health disparities or service needs specific to women or racial/ethnic minorities. Studies to improve utilization and outcomes of medical treatment integrated with drug abuse treatment for addicted inmates or re-entering ex-offenders. Compliance with medication regimens in patients with comorbid addictive and mental or physical disorders, such as interventions to ensure antiviral medication compliance during and after incarceration in drug addicted HIV seropositive individuals, or adherence to medications for those with co- occurring mental health disorders for which effective treatments exist. Given the relationship between drug abuse and HIV infection and the need to improve the delivery of HIV treatment and prevention interventions for re- entering drug abusers, the CJ-DATS will include studies on integrating services to treat AIDS or reduce the risk of HIV transmission. All treatment programs should ensure the availability of HIV risk reduction counseling and HIV testing. Research will be conducted collaboratively involving NIDA, the Coordinating Center, and the Research Centers. The CJ-DATS structure will permit expeditious and concurrent multisite research on integrated treatment models in statistically powerful designs. The number of sites involved in specific studies will vary depending on the nature of the scientific question under study and the number and diversity of subjects required. Organization of the System A. Coordinating Center. There will be one Coordinating Center. Coordinating Center personnel should have expertise in process and outcome evaluation research on health services delivery, knowledge of drug abuse treatment, primary medical (especially HIV/AIDS) care, and mental health care in the criminal justice system context, experience in logistics, and experience working with grantees in technical assistance situations. The Coordinating Center principal investigator should be experienced in coordination of large multisite research studies. It should be noted that the Coordinating Center does not provide the primary data management and analysis capacities for all studies, each study will have a designated "Lead Center" (Section C) that will provide the primary support for studies conducted across sites. Coordinating Center responsibilities include: o To provide special expertise for research on the organizational culture, capacity and motivation for change, including organizational and economic barriers to change in treatment practices, in the criminal justice system and in the drug abuse treatment system. o To lead the CJ-DATS in development and conduct of baseline surveys of the criminal justice system to address health services questions such as access, availability, utilization, and type of treatment for drug abusers in the criminal justice system. o To collaborate with Research Centers and the Federal government in refinement of interventions and research designs, and to assist the Steering Committee in developing and implementing cooperative multisite studies. o To assist study sites with data quality control checks, including on-site training for data collection, and to assist in data management and analysis. o To facilitate cross-site data comparability, to serve as a repository for data collected under this cooperative study, and to prepare public use data sets. o To develop and maintain a CJ-DATS website to facilitate dissemination of easily accessible study progress reports and research findings to multiple audiences, including treatment practitioners and criminal justice system personnel. o To coordinate logistical functions of meetings of the CJ-DATS Steering Committee, subcommittees, and workgroups, including production and distribution of committee minutes. Funds for participant travel to meetings will not be disbursed by the Coordinating Center, applicants should make adequate provision for these funds in the budgets submitted under the present RFA. o To provide logistical and operational support for the Data and Safety Monitoring Board. o To publish results and assist in development of publications, in accordance with Steering Committee procedures to be developed. B. Research Centers. Research Centers will develop and conduct research projects in collaboration with criminal justice participants and drug abuse treatment practitioners. Criminal justice populations should represent a broad range of individuals, including juveniles, women, those with co- occurring mental disorders, HIV risk populations, and members of various racial/ethnic groups. Research Center responsibilities include: o To establish partnerships among researchers, criminal justice professionals, and treatment practitioners through contract or collaborative arrangements with one to three prisons, two to five associated drug abuse treatment programs, and the parole departments associated with the community- based treatment programs to conduct the research of the CJ-DATS. Under guidance of the CJ-DATS Steering Committee to ensure consistency across the CJ-DATS, the Research Center shall establish policies and procedures for conducting periodic reviews to examine patient accrual, data accuracy and timeliness, and compliance with study plans. o In partnership with criminal justice and treatment provider participants, to develop and coordinate research concepts and projects for submission to the Steering Committee for approval and implementation. Communication with the NIDA Scientific Collaborator and with other sites is required at all stages of study conceptualization and development. o To provide criminal justice and treatment partners with the necessary data collection infrastructure, including a data management information system, if needed, to collect intake, in-treatment, and outcome data. Plans should include assessment of relevant public safety and treatment program data. o To provide criminal justice and treatment partners with counselors, case managers, or other service delivery staff needed to conduct the research. o To provide a management and committee structure that ensures participation by treatment providers and public safety professionals in the planning and implementation of the research. o To provide training and supervision as needed for the treatment and public safety staff who are participating in the research study. o To implement studies as a Lead site, coordinating studies with other sites across the CJ-DATS, as well as to participate in studies coordinated by other Lead sites. Within its own site, each participating Research Center will have the responsibility for research coordination, data management, quality control, and training and supervision of treatment providers, either as a Lead Center or under the direction of the Lead Center. o To ensure adequate accrual of subjects from participating treatment programs to meet the requirements of each study in numbers recruited over defined time periods. o To establish and implement mechanisms for data management and analysis that ensure data collection and management procedures are: a) adequate for quality control and analysis, b) efficiently designed to encourage participation of public safety personnel and treatment providers, c) in accordance with procedures and requirements established by the Steering Committee, and d) sufficiently uniform across all participating sites. o To monitor adverse events and to report on all ongoing studies to the Data and Safety Monitoring Board in accord with policies and procedures to be determined by the Board. o To ensure that any organizations that are engaged in research, as defined by the Office for Human Research Protections (OHRP), must obtain an OHRP assurance and IRB review and approval before conducting human subjects research. Note that all research protocols involving prisoners must be reviewed and approved by an OHRP panel before it can be implemented. o To establish a mechanism for interim monitoring of progress and results to be reported at least semiannually to the CJ-DATS Steering Committee and to NIDA. o To submit annual progress reports, including treatment program reviews, to the NIDA program official. Research Center funding is contingent on progress, including collaborative contributions and satisfactory patient accrual. o To publish major findings in a timely manner, in accordance with procedures established by the CJ-DATS Steering Committee. Publication or oral presentation of work done under this agreement requires acknowledgement of NIDA support. Research Centers must agree not to report findings prior to collaborative reporting or approval by the Steering Committee. C. Lead Centers. For each research project developed and undertaken within the CJ-DATS, one Research Center will be designated as Lead Center by the Steering Committee. The Lead Center will have the additional responsibility of ensuring the participation of other sites, coordinating research across multiple sites, providing necessary training, and providing comprehensive administrative and scientific management of the research done across sites. Data from all of participating treatment programs for a given study will be forwarded by the respective participating Research Centers to the Lead Center. Lead Centers will monitor and manage the implementation of studies, reproduce and distribute research materials (such as treatment protocols, training manuals, instrumentation) and educational materials, and support operational needs such as quality assurance, data collection, resources for analysis, etc. Responsibilities also include executive secretariat functions such as organization of necessary meetings and conference calls, developing meeting agendas, taking minutes of sessions, photocopying and distributing meeting materials to the other Research Centers and NIDA, and preparation of reports to the NIDA Program Official. As noted above, in addition to OHRP assurance and IRB review, all research protocols involving prisoners must be reviewed and approved by an OHRP panel before implementation. D. Treatment Providers. Treatment providers should be established programs with experience in treating criminal justice-involved clientele. Treatment providers must be willing to participate in collaborative research. Treatment provider responsibilities include: o Agreeing to participate in research in which either its primary Research Center or another Research Center has the lead. Most studies will require controlled research designs including random assignment methods to different conditions, o Recruiting adequate numbers of patients required for specific studies, o Agreeing to provide their customary clinical care to patients participating in research studies, o Agreeing to provide experimental/standard care in accord with approved research plans, o Ensuring the availability of HIV risk reduction counseling and HIV testing, o Maintaining patient records required for each study protocol, o Collecting clinical data, including biological specimens when indicated, o Cooperating with quality control activities of the CJ-DATS and adhering to guidelines set by the Research Center, the Steering Committee, and NIDA, o Participating in the decision-making process concerning research studies to be implemented in the site with which the treatment program is associated, including design of treatment processes and, as appropriate, study designs and types of subjects to be recruited, o Agreeing not to report data prior to collaborative reporting, and o Agreeing to periodic on-site audits by representatives of its Research Center, NIDA, or a NIDA designee for compliance with regulations for IRB approval or informed consent (compliance with 45 CFR 46), compliance with research plan specifications, quality control and accuracy of data recording, and completeness of reporting of adverse events. E. Public Safety Participants. Public safety participants may include prison administrators or staff, staff who provide parole monitoring or continuing criminal justice supervision of offenders after release from incarceration, members of the judiciary who are involved with drug treatment for offenders, and others in the criminal justice community with a responsibility for criminal justice-involved drug abusers or addicts (e.g., treatment re-entry drug court professionals). Public safety participant responsibilities include: o Agreeing to participate in research in which either the primary Research Center or another Research Center has the lead. Many studies will require controlled research designs including random assignment methods to different conditions, o Providing access to criminal justice-involved individuals with drug abuse or addiction disorders, o Maintaining records required for each study protocol, o Cooperating with study plans of the CJ-DATS and adhering to guidelines set by the Research Center, the Steering Committee, and NIDA, o Participating in the decision-making process concerning research studies to be implemented in the treatment site with which the public safety organization is associated, including practical and study design aspects of integrating criminal justice requirements with treatment processes, and o Agreeing not to report data prior to collaborative reporting. F. CJ-DATS Steering Committee. The CJ-DATS Steering Committee (or, simply, Steering Committee) will constitute the primary governing body of the CJ- DATS. It will consist of the Principal Investigator of each Research Center, the PI of the Coordinating Center, and the NIDA collaborating scientist, each of whom will have one vote on the Steering Committee. This group will direct the research conducted in the CJ-DATS, develop policies and procedures for development of research plans, act upon concepts and research plans submitted by sites, determine research studies to be implemented (subject to NIDA approval), coordinate the implementation of studies across the CJ-DATS, monitor progress, guide data analysis and interpretation of results, and oversee communications within the CJ-DATS as well as with the greater scientific community and the public. The Steering Committee, by majority vote, will select a Chairperson from the group of CJ-DATS Research Center Principal Investigators. For this election, if the Steering Committee has an even number of participants and the vote is evenly split (so that there is no majority vote), the vote of the NIDA collaborating scientist will be disregarded. Federal participants may not serve as chair except to organize the first meeting and conduct the election of a permanent Chairperson. The Steering Committee will determine that other members of the Coordinating Center"s or Research Centers" teams (including treatment providers, criminal justice personnel, and/or public safety members) should attend some or all meetings as nonvoting observers or resources. The Steering Committee may also establish subcommittees and workgroups to assist it in carrying out its functions, and these groups may include members of the Centers" teams and others as the Steering Committee sees the need. The Steering Committee will establish an advisory body consisting of public safety representatives and treatment provider representatives from the Centers" research sites. This advisory body will review proposed research concepts and plans, comment upon their feasibility and practical importance, assist in the implementation of research, and carry out other activities determined by the Steering Committee. The Steering Committee will also establish training standards and procedures for treatment providers in the CJ-DATS to assure comparability and generalizability across sites. The Steering Committee will oversee development of measurement tools for use in the CJ-DATS. Core baseline and follow-up batteries will be established for both program- and patient-level data to be gathered in all treatment sites throughout the CJ-DATS. The former will include measures of program orientation, organization, structure, financing, treatment provider characteristics and processes, and related elements. The latter will include intake, outcome, and follow-up measures for all patients enrolled in studies. Measures specific to particular research plans will be subject to approval of the Steering Committee. It will also develop policies on data sharing, on access to materials and data, including making data available beyond the CJ-DATS in a timely manner, and on publication authorship. Publication policies will be written and authorship decided using procedures developed and approved by the Steering Committee. All publications, whether from a single site or multiple sites, will be submitted to the Steering Committee for review and approval. All major scientific decisions will be determined by majority vote of the Steering Committee. All participating Centers must agree to abide by the study designs and policies approved by the Steering Committee, both for studies spanning multiple sites and studies conducted within a single site. It is important to note that research to be undertaken within the CJ-DATS is not limited to research concepts contained within awardees applications, but will be determined by the Steering Committee based on input from the sites and subject to the approval of NIDA. Future research must be consistent with the scientific objectives of the RFA. The major considerations in research plan review by the Steering Committee will include: a) strength of the scientific rationale supporting the study, b) overall impact of the research, c) significance of the question being proposed, d) avoidance of unnecessary duplication with other research, e) approach, including appropriateness and feasibility of study design, f) satisfactory projected accrual rate and follow-up period, g) patient safety, h) compliance with NIH and the Federal regulatory requirements, i) adequacy of data management, and j) appropriateness of patient/participant selection, evaluation, response to intervention, and follow-up. The Steering Committee may meet up to six times during the first year, and will meet up to four times per year thereafter, usually in the Washington, D.C. area. Applicants should include budgets for travel to these Steering Committee meetings and subcommittee/workgroup meetings in their applications and should assure that adequate provisions are made to allow Principal Investigators, public safety participants, and treatment program representatives to participate fully in activities of the Steering Committee and its subcommittees/workgroups. G. Federal Participants. It is anticipated that, as the CJ-DATS develops, other Federal agencies may contribute money to NIDA to assist with funding and/or may provide NIDA with other assistance, such as facilitating access to populations or sharing expertise. NIDA will constitute a panel of Federal participants from those agencies having a role in the CJ-DATS. NIDA will use this panel to ensure that other Federal agencies are kept informed on CJ-DATS progress and findings, and the panel may be consulted for advice by the Steering Committee. The NIDA Collaborating Scientist will serve on this panel and will represent its interests to the Steering Committee. H. Data and Safety Monitoring Board (DSMB). The DSMB is an independent expert board appointed by and reporting to the Director of NIDA that will oversee and monitor the conduct of the studies to ensure the safety of participants and the validity and integrity of the data. The DSMB will also make independent assessment of whether a study will continue. One or more NIDA staff will serve as nonvoting members on the DSMB. Timetable for the Studies It is envisioned that various studies will be designed and conducted in three phases over a total of five years. Phase I will involve the establishment of the Steering Committee and development of a study plan, including planning to develop and test treatment model systems integrating continuity of care with the criminal justice system. Review of the plan by the DSMB will also occur. The developmental phase is expected to be completed in 9 to 12 months. Phase II will involve pilot testing of the data collection instruments, treatment service delivery strategies, and the research plans. Preliminary data will be analyzed and the study plans will be revised according to findings of the pilot projects. The DSMB will review the resulting study plans. The pilot testing phase is expected to be completed in 9 to 12 months. In Phase III, multisite research studies that test integrated drug abuse treatment models will be implemented at the sites according to the final study plan. Data will be collected and analyzed, and publications prepared. This phase will take three to three one-half years. MECHANISM OF SUPPORT This RFA will use NIH U01 award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is September 2002. The NIH (U01) is a cooperative agreement award mechanism in which the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the section "Cooperative Agreement Terms and Conditions of Award." It is anticipated that there will be subsequent RFAs to expand the CJ-DATS and that competing continuation applications will be invited upon expiration of the initial funding period of awards made under the present RFA, subject to the availability of funds. FUNDS AVAILABLE NIDA intends to commit approximately $3 million total costs for 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 four to six awards this year under this RFA for project periods of up to five years of support. It is anticipated that one award for the Coordinating Center will be made for approximately $500,000 (including direct and facilities and administrative costs) per year. Approximately $2.5 million per year will be distributed among three to five Research Centers to support their direct and facilities and administrative costs. 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 vary also. 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. ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic o Faith-based organizations Note: Separate applications are being solicited for Research Centers and a Coordinating Center to participate in this collaborative study. If an organization chooses to apply as a research center site and as the coordinating center, separate applications and a separate Principal Investigator for each are required, and there should be no overlap of effort in research or support personnel. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Individual with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. The Principal Investigator must commit at least 33 percent of his or her time to the CJ-DATS. SPECIAL REQUIREMENTS To promote the development of a collaborative program among award recipients, a number of issues need to be addressed in applications as discussed under Application Procedures, below. Applicants should discuss the rationale for their choice of research questions and design, should document their ability to recruit a sufficient number of participants, and should demonstrate their ability and willingness to work cooperatively with NIDA, the Coordinating Center, other Research Center awardees, public safety agencies and criminal justice professionals, and treatment providers, and to follow common research plans. 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. Cooperative Agreement Terms And Conditions of Award These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and other HHS and NIH Grant Administration policy statements. The administrative and funding instrument used for this program is a cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism) in which a substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during 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, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NIDA Collaborating Scientist. 1. Awardee Rights and Responsibilities Awardees have primary responsibilities to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their studies in collaboration with other awardees, and with assistance from the NIDA Collaborating Scientist. Awardees shall participate in the Steering Committee and abide by decisions of the Steering Committee and the Charter of Responsibilities adopted by the Steering Committee. Awardees shall develop research plans in conjunction with participating criminal justice professionals, treatment providers, and other awardees and submit them for approval by the Steering Committee. Awardees shall take lead responsibility for implementation of selected plans as determined by the Steering Committee and shall participate in additional studies that are under the leadership of other sites. Implementation of studies shall be in accord with Steering Committee policies and procedures, including policies and procedures pertaining to instrumentation, data collection, data and safety monitoring, and publication. Awardees shall conduct research in partnership with criminal justice professionals and treatment practitioners, assure quality of care, assure that research findings and adverse events are communicated to research partners and to NIDA, and assure that the study and associated treatments are conducted in accordance with established protocols. Awardee will retain custody of primary rights to their data developed under the award, subject to rules formulated by the Steering Committee, and government rights of access consistent with current DHHS, PHS, and NIH policies. 2. Federal Staff Roles and Responsibilities NIDA Collaborating Scientist. A NIDA Collaborating Scientist with expertise in research on drug abuse treatment for those who are involved with the criminal justice system will help to identify research questions that will have fundamental and timely significance for treating this population. He/she may cooperate with awardees in development of research plans and preparation of study reports. In instances where very significant involvement in the design of studies and/or analysis of results has occurred, the NIDA Collaborating Scientist may cooperate with awardees as coauthor in preparing publications of data resulting from the research. In this regard, he/she will be subject to the publication/authorship policies governing all participants. In addition, publications involving NIDA staff require internal clearances. The NIDA Collaborating Scientist will serve as a resource for specific information on NIDA"s programmatic intentions and priorities, and will help to foster collaborations between researchers, corrections administrators and practitioners, and treatment practitioners to increase the value of research to these participants. The NIDA Collaborating Scientist will be a voting member of the Steering Committee, but will not hold the position of chair. He/she will participate in the development of instrumentation, development of study plans, in quality control, and in coordination of projects, but will not participate in activities that directly involve assessment, testing, or treatment of human subjects. Other Federal staff. The CJ-DATS will enable cross-Institute and cross- agency collaboration of several types, including facilitating access to criminal justice system participants, co-funding research studies of particular interest, and providing systems-level expertise. Representatives from Federal agencies that provide resources, assistance, or expertise may be invited to join a panel constituted by NIDA. NIDA will convene meetings of this panel to ensure that these Federal agencies are kept informed on CJ-DATS progress and findings and to provide a venue for their participation in the CJ-DATS. Members of the panel may be consulted for advice by the Steering Committee. The NIDA Collaborating Scientist will serve on the Federal panel and will represent its interests on the Steering Committee. Other NIDA staff. A NIDA Program Official, who will not participate in the research, publications, or Steering Committee, will be responsible for the oversight of each cooperative agreement. The Program Official carries primary responsibility for: (1) periodic review and approval of the progress of the research plans in relation to their stated objectives, and (2) making recommendations regarding continuance of the program. The NIDA Program Official will be responsible for monitoring the conduct of the project and overseeing the Coordinating Center and the Research Centers. The Program Official will receive all required progress reports to determine that satisfactory progress is being made, and will approve the transitions to Phase II and Phase III activities based on completion of pilot studies and the outcome of review of study plans by the DSMB. This person also works collaboratively with the Grants Management Specialist to assure high quality business management of the program, including the most effective use of Federal financial assistance provided through this cooperative agreement. The Director, NIDA, will appoint an independent Data and Safety Monitoring Board which will oversee and monitor the conduct of research studies to ensure the safety of participants and the validity and integrity of the data. The DSMB will also make independent assessments of treatment effectiveness and whether a study will continue. One or more NIDA staff will serve as nonvoting members on the DSMB. Subject to Steering Committee invitation, other NIDA staff may attend and participate as non-voting resources to the Steering Committee and/or its subcommittees. 3. Collaborative Responsibilities Study Plan Development and Implementation. The study plan is a document mutually acceptable to the research site(s), the Steering Committee, and NIDA. Communication at the various stages of development is essential. The NIDA Collaborating Scientist will assist the site PIs in study plan design as appropriate by providing information regarding treatment models or organizational methods that can be tested within the CJ-DATS. NIDA will also comment on the scientific rationale, programmatic relevance, priority, design, statistical requirements, and implementation of proposed studies. Study concepts are submitted by sites to the Steering Committee. Approved concepts are developed as formal proposals by collaborating sites and submitted to the Steering Committee. Steering Committee. The Steering Committee will constitute the primary governing body of the CJ-DATS. Awardees must participate in the Steering Committee. The voting membership will consist of the Principal Investigator of each Research Center, the Principal Investigator of the Coordinating Center, and the NIDA Collaborating Scientist. The Steering Committee reviews and approves the research agenda, formulates and monitors policies and procedures guiding the research activities, and oversees communications. The Steering Committee will develop a Charter of Responsibilities subject to NIDA"s concurrence defining the roles and responsibilities for the Coordinating Center, the Research Centers, Federal participants, and other participants as described RFA-DA-02-011. All major scientific decisions are made by majority vote. The exception is in the vote for Chairperson, where a tie vote will be decided by disregarding the NIDA Staff Collaborator"s vote. Research will be determined by the Steering Committee with input from criminal justice and treatment partners, and is subject to the approval of NIDA. All research must be consistent with the scientific objectives of RFA-DA-02-011. The Steering Committee will develop policies that will guide the standard operating procedures of the CJ-DATS and that will address protocol development, protocol review and approval, study operations and standards, data acquisition and management, and analysis and publication. It will monitor progress and establish subcommittees and workgroups as needed. Awardees agree to abide by those procedures and policies. Data Management, Analysis, and Access. Data generated are the property of the awardee. However, the Coordinating Center and all Research Centers must provide NIDA with access to all data generated under this award, subject to rules specified in Certificates of Confidentiality obtained by awardees. Data must be shared upon request with the Steering Committee, subcommittees reporting to the Steering Committee, and the Data and Safety Monitoring Board. As governed by Certificates of Confidentiality, data may also be available for external monitoring if required by NIDA"s agreements with other Federal agencies. As the CJ-DATS is intended to become a national resource, sites must be prepared to share their data under provisions that safeguard the privacy and confidentiality of respondents. Thus, each proposing Research Center should include explicit indications of how they will make their data available for broad use and on what timetable. The awardee will provide for data sharing consistent with its data sharing plan, as approved by NIDA. 4. Organizational Changes Certain site organizational changes must have the prior written approval of NIDA. These include changes in key personnel and the addition or deletion of prisons, parole departments, and treatment programs. 5. Federally Mandated Regulatory Requirements Each Research Center will establish mechanisms to meet Department of Health and Human Services (DHHS)/Public Health Service (PHS) regulations regarding the protection of human subjects. Each Research Center must be able to demonstrate that each study, amendment, and informed consent document is approved by the responsible IRB prior to subject entry and at least annually thereafter, as appropriate for the degree of study risk as stipulated by 45 CFR 46. Researchers should be knowledgeable of the additional human subjects protections required for "prisoners," a term defined by the Department of Health and Human Services (DHHS) to include adults, adolescents, and children who are either confined or detained involuntarily in an institution or facility by virtue of criminal or civil statutes or commitment procedures. All investigators proposing research involving prisoners or individuals who may enter prisoner status during study involvement should read the Code of Federal Regulations, Title 45, Public Welfare, Part 46 "Protection of Human Subjects," which is available on the web at the following URL address: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. See also http://www.hhs.gov/ohrp/humansubjects/guidance/prison.htm. Pursuant to Subpart C, section 46.306, OHRP requires review and approval of research protocols prior to implementation. 6. Program Review In addition to the standard NIH requirement for submission of annual progress reports, awardees will be required to submit semiannual reports on study progress. NIDA will provide a suggested format for this purpose. The NIDA Program Official will review progress through consideration of the semiannual accrual reports, annual report, and program site visits. The inability of a Research Center to meet the performance requirements and responsibilities may result in an adjustment of funding, withholding of support, or suspension or termination of the award. 7. Study Closure NIDA may request that a study be closed for reasons including: a) insufficient accrual rate or other problems with accrual, b) poor site performance, c) patient safety, d) emergence of already conclusive study results, and e) emergence of new information that diminishes the scientific importance of the study question. NIDA will not permit expenditure of Federal funds or permit expenditure of NIDA funds after requesting closure (except to ensure patient safety for enrolled subjects). 8. Arbitration Process The arbitration procedures will be invoked only when agreement cannot be reached on programmatic decisions regarding scientific-technical issues that may arise after the award. An Arbitration Panel will be composed of three members, one person selected by the Steering Committee (with the NIDA member abstaining) or by the individual awardee in the event of an individual disagreement, one person selected by NIDA, and a third person selected by these two members. The Arbitration Panel will make a recommendation to the Director, NIDA. The special arbitration procedures described above in no way affect the awardee"s right to appeal an adverse action in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR Part 16. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Bennett 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 TEL: (301) 443-6504 FAX: (301) 443-2636 Email: bf31v@nih.gov o Direct your questions about peer review matters to: Teresa Levitin, Ph.D. Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, Maryland 20892-9547 Telephone: (301) 443-2755 FAX: (301) 443-0538 Email: tl25u@nih.gov o Direct your questions about financial or grants management matters to: Gary Fleming, J.D., M.A. Chief, Grants Management Branch National Institute on Drug Abuse 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 TEL: (301) 443-6710 Email: gf6s@nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Director Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Blvd., Room 3158, MSC 9547 Bethesda, MD 20892-9547 Phone: (301) 443-2755 SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. SUPPLEMENTAL INSTRUCTIONS Specific content must be present in the application to document the technical and scientific merit of the applicant"s plan for a Research Center or a Coordinating Center that will address the fundamental goals and collaborative nature of the CJ-DATS. The use of tables, diagrams, and organizational and flow charts is strongly encouraged and will be counted toward page limits as described below. The application should conform to the general instructions and requirements (e.g., for font size and page limits) of the PHS 398 (rev. 5/2001) with the exceptions noted below. Sections a-d should not be organized according to Specific Aims, Background and Significance, etc. as stated in the PHS 398 application kit. Replace sections a-d with the following sections numbered 1-4. The total page limit for the sum of sections 1-4 is 30. 1. Understanding of the Mission of the CJ-DATS (For Coordinating Center and Research Center Applications) This section should consist of a few pages to establish the applicant"s understanding of the CJ-DATS and to present a vision of how the applicant Center could uniquely contribute to the CJ-DATS. 2. Internal Administration and Collaborative Plans The administrative and managerial qualifications and experience of the PI must be described to provide evidence of skills in managing and coordinating research endeavors. The skills of other personnel involved in administration and management of the research should also be clear. Evidence of participation in relevant multisite studies is essential. The Principal Investigator must commit 33 percent or more effort to the CJ-DATS. Plans for communication and data management operations within the Center should be specified. Diagrams and descriptions of proposed intra-Center committee structures and decision-making procedures should be provided. Communication and coordination plans for working with involved agencies (e.g., criminal justice agencies, parole boards, treatment providers) should be given, as should be plans for developing such relationships as appropriate. The quality of partnerships among collaborating components of the Center should be addressed in detail. The plans should elaborate on infrastructure capabilities for project management, study design and development, and data systems. (For Research Centers) Plans for functioning as a "Lead Center" and as a collaborating Center should be addressed. An approach for recruiting other Centers" participation, coordinating implementation of studies across sites, providing training, and monitoring progress should be given. The application should explain how communications with other Centers and the Steering Committee would occur. Plans for receipt and management of data, for analysis, for data sharing, and dissemination should be clear. Logistic and executive secretariat issues should be addressed. (For Coordinating Center) Plans for fulfilling the consultative role of the Coordinating Center should be provided. The application should address how the Coordinating Center might collaborate with Research Centers and NIDA to refine interventions and to assist the Steering Committee in designing and implementing cooperative, multisite studies that might be led by itself or a Research Center. Plans for assisting with data quality control, training for data collection, and analysis should be given. Plans for developing and evaluating ideas for cross-site data analyses and for serving as a repository for data collected, including preparation of public use data sets, should be clear. Potential needs of other Centers and participants in the CJ-DATS should be anticipated and addressed, as should be the challenges in fulfilling those needs. This section should also include plans for addressing the logistic needs of the CJ-DATS, including coordinating meetings of the Steering Committee, subcommittee, and workgroups, as well as distributing preparatory and post- meeting documents. Plans for disseminating the results of the CJ-DATS activities to the public, providers, policy makers, researchers, and others who may be interested should be provided. The proposed content of a CJ-DATS website and structure of that website should be provided. The plans should describe innovative approaches to data sharing and for the dissemination of research findings, as well as for development of tools to promote use of research. 3. Research Capacity (For Research Centers Applications) The plans should document the availability of appropriate scientific expertise within the Research Center to design, implement, and analyze the results of studies the CJ-DATS develops, and it should describe the Research Center"s capacities and how the Research Center would interact with the Coordinating Center to accomplish CJ-DATS goals. The application should provide detailed descriptions of the programs, agencies, or institutions that will participate in the first year and include detailed descriptions of relevant program/system and offender/patient characteristics. This description is limited to two pages of text and one page for charts and tables for each discrete participating program, agency, or institution. The appendix should contain letters of agreement from the institution, agency, or program directors. The plan should provide evidence, where possible, of successful collaborations with these groups or plans for the development of successful collaborations. The program descriptions must include at least one prison or jail that will participate in the first year. Similarly, there should be a description of at least one parole department that will participate in the first year. The description of each (limited to two pages of text and one page for charts and tables as noted), should include offender characteristics, program characteristics, numbers of drug abusing or addicted individuals available for treatment, and evidence that sufficient patients of diverse racial and ethnic background could be recruited. The program descriptions must also address the treatment program infrastructure and document that at least two treatment programs will participate in the first year. There should be details on the characteristics of the program, patients, patient flow, treatment delivered, and staff structure and characteristics. This description is limited to two text pages and one page for charts and tables as above, and should document the ability to recruit and retain subjects. The plan should document the ability of the Center to deliver a variety of standard and experimental interventions, to implement system level modifications, and to study system level issues relevant to the goals of the RFA. The application should evidence anticipation of problems and challenges in conducting the research and plans for resolving them. Plans for assuring adequate staffing of research endeavors, collecting data, managing data, and analyzing it should be present. (For Coordinating Center Applications) The plans should document the availability of appropriate scientific expertise within the Coordinating Center to design, implement, and analyze the results of baseline surveys or other studies the CJ-DATS requires, and it should describe how the Coordinating Center"s capacities would interact with the Research Centers to accomplish CJ-DATS goals. Because the Coordinating Center will provide the CJ-DATS with the capacity for baseline surveys, special expertise on organizational culture and change, and cross-study meta-analyses or other studies requiring integration of data across studies, the capacity of the Center to conduct those research studies should be explained. The application should evidence anticipation of problems and challenges in conducting the research and plans for resolving them. Procedures and structures for ensuring input and collaboration with advisory groups of criminal justice providers, parole boards, and treatment agencies should be made clear. 4. Research Concepts (For Coordinating Center and Research Center Applications) Applications should not propose detailed research protocols but should provide two or three specific examples of research concepts and abbreviated plans that could be undertaken and are consistent with the goals of the RFA to take advantage of the unique capabilities of the CJ-DATS. The Research Center application should present concepts consistent with its role in the CJ-DATS, and the Coordinating Center should similarly present concepts consistent with its role. The research concepts for the proposed studies should include, as applicable, a statement on the significance of the research and how it uses the CJ-DATS resources, descriptions of research study design, interventions, outcome measures, and statistical considerations, access to subjects, procedures for data management, quality control and follow-up, procedures for monitoring and reporting adverse events, and information on human subjects protections. Each concept is limited to four pages. The concepts are included in the application to provide evidence of the applicant"s conceptualization of and approach to CJ-DATS research, and the concepts given in the application will not necessarily be implemented in the CJ-DATS. Human Subjects Human Subjects Research (PHS 398 Research Plan section E) instructions have been revised and must be addressed in the application, no specific page limits apply, but the plans must be complete and concise. The application should describe plans for human subject protections, for data safety monitoring, and for representation among patient populations. Budget The budget and accompanying justification are not part of the 30 page limit. (See below for page limits.) Applicants should include budget estimates and plans for participating in the CJ-DATS, organized around the areas of research planning, core functions, drug abuse treatment and criminal justice collaboration, and administrative and management plans. The applicant should prepare a separate budget for: 1) infrastructure to enable the Center to provide core functions (e.g., personnel, facilities, equipment, supplies, training costs, logistic support, travel, etc.), 2) research project specific costs such as research assistants, study implementation costs, staff for data collection, management, and analysis, treatment expenses related to the research (excluding costs of routine treatment), any laboratory costs, monitoring costs, publications costs, and 3) other research costs needed to support research in the CJ-DATS. As noted elsewhere in this RFA, funds for travel should be included to provide for participation in CJ-DATS related meetings. The budget should assume each site will be the Lead Center for one study and a participating center for one study. Page Limits The total length of the Research Plan, including the research concepts and administrative and management plan should not exceed 30 pages. Descriptions of participating agencies should not exceed two pages of text and one page for charts and tabular data, research concepts should not exceed four pages per concept. Literature Cited and Consortium/Contractual Arrangements sections should be provided following the 30 pages and in total should not exceed 10 pages. No specific page limits apply to the Human Subjects section, Gender, Child, and Minority inclusion sections, or data safety and monitoring plans. USING THE RFA LABEL 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 two of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH 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: Direct inquiries regarding review matters to: Teresa Levitin, Ph.D. Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, Maryland 20892-9547 Telephone: (301) 443-2755 FAX: (301) 443-0538 Email: tl25u@nih.gov APPLICATION PROCESSING Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. PEER REVIEW PROCESS 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 failing to provide required information about human subjects, data safety and monitoring, data sharing, and inclusion of gender, minorities, and children will be considered incomplete. 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: o Receive a written critique o 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 and assigned a priority score o Receive a second level review by the National Advisory Council on Drug Abuse REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to address the criteria below in order to judge the likelihood that the proposed work will have a substantial impact on the pursuit of these goals. 1. Understanding of the Mission of the CJ-DATS (Coordinating Center and Research Center Applications) How well does the application demonstrate an understanding of the scientific agenda of the CJ-DATS? How innovative is the vision the application presents for utilization of the CJ-DATS? 2a. Internal Administration and Collaborative Plans (Coordinating Center and Research Center Applications) How strong are the administrative and managerial qualifications of the PI and key staff? Is there evidence of sufficient dedication of time and other resources to the work? How clear and feasible are plans for project management, coordination and communication? How well developed are the plans for data management? Are intra-center decision making procedures specified and workable? What is the quality of the partnership with various agencies, as depicted in the administration plans? How sufficient and efficient is the infrastructure for project management, study design and development, and data systems activities? 2b. Internal Administration and Collaborative Plans (Research Centers) How well developed are the plans for functioning as a "Lead Center" and as a collaborating site? Are recruitment and implementation plans well delineated and reasonable? How well developed are the plans for cross-Center communication and communication with the Steering Committee. Are plans for data sharing and other data needs appropriate? How good are the plans for addressing logistic and executive secretariat needs? 2c. Internal Administration and Collaborative Plans (Coordinating Center) What is the quality of the plans for serving as a consultative center to the CJ-DATS? How developed are the approaches for providing consultation on design, implementation, and analysis? How well are data quality control, training, and data repository needs addressed? How well are other needs and challenges addressed? What is the quality of the plan for serving as a data repository? How feasible and developed are the logistic support and operational support plans? How well developed are the plans for including a CJ-DATS website, for disseminating findings to various groups, and for using appropriate technological resources? How strongly does the record of experience in these areas support the application? 3a. Research Capacity (Research Centers Applications) What is the quality of the scientific expertise and productivity within the Research Center, especially with respect to complex multisite studies of the criminal justice system and drug abuse? How would the Research Center interact with the Coordinating Center? What is the quality of and how appropriate are the participating agencies, especially in regard to providing sufficient patients, research support, and intellectual resources to the CJ- DATS? How well does the application document the ability of the Center to deliver a variety of standard and experimental interventions, to implement system level modifications, and to study system level issues relevant to the goals of the RFA? How well does the application evidence anticipation of problems and challenges in conducting the research and plans for resolving them? 3b. Research Capacity (Coordinating Center Applications) What is the quality of the scientific expertise within the Coordinating Center, especially with respect to complex multisite studies of the criminal justice system and drug abuse? How would the Coordinating Center interact with Research Centers to accomplish CJ-DATS goals? What is the capacity of the Coordinating Center to conduct baseline studies, organizational change studies, and other studies unique to the role of the Coordinating Center as specified in the RFA? How well specified are the procedures and structures for ensuring input and collaboration with advisory groups of criminal justice providers, parole boards, and treatment agencies? 4. Research Concepts (Coordinating Center and Research Center Applications) How well do the concepts take advantage of the unique capabilities of the CJ- DATS and the role of a Research Center or Coordinating Center (according to the type of application)? How significant are the ideas and do the plans evidence reasonable methodologies and approaches? ADDITIONAL REVIEW CRITERIA In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans (including data safety monitoring plans), animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: April 12, 2002 Application Receipt Date: May 13, 2002 Peer Review Date: July 2002 Council Review: September 2002 Earliest Anticipated Start Date: September 30, 2002 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phases I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: 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 clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a complete copy of the updated Guidelines are available at http://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: The NIH maintains a policy 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 is available at http://grants.nih.gov/grants/funding/children/children.htm. 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. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://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. HIV/AIDS COUNSELING AND TESTING POLICY FOR THE NATIONAL INSTITUTE ON DRUG ABUSE: Researchers funded by NIDA who are conducting research in community outreach settings, clinical, hospital settings, or clinical laboratories and have ongoing contact with clients at risk for HIV infection, are strongly encouraged to provide HIV risk reduction education and counseling. HIV counseling should include offering HIV testing available on-site or by referral to other HIV testing services. Persons at risk for HIV infection including injecting drug users, crack cocaine users, and sexually active drug users and their sexual partners. For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.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. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. 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. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.279, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the 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. REFERENCES Hora, P. F., Schma, W. G., Rosenthal, J. T. A. (1999). Therapeutic jurisprudence and the drug treatment court movement: Revolutionizing the criminal justice system"s response to drug abuse and crime in America. Notre Dame Law Review, 74(2), 439-537. McLellan, A. T., Lewis, D. C., O"Brien, C. P., Kleber, H. D. (2000). Drug dependence, a chronic medical illness: Implications for treatment, insurance, and outcomes evaluation. JAMA: Journal of the American Medical Association, 284(13), 1689-1695.

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