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Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov)

Components of Participating Organizations
National Institutes on Drug Abuse (NIDA) (http://www.nida.nih.gov)

Title: Criminal Justice Drug Abuse Treatment Studies 2 (CJ-DATS 2) (U01)

Announcement Type
This is a reissue of RFA-DA-02-011 which was previously released February 4, 2002.

Update: The following update relating to this announcement has been issued:

Request For Applications (RFA) Number: RFA-DA-08-002

Catalog of Federal Domestic Assistance Number(s)
93.279

Key Dates
Release Date: July 13, 2007
Letters of Intent Receipt Date(s): September 26, 2007
Application Receipt Dates(s): October 26, 2007
Peer Review Date(s): February 2008
Council Review Date(s): May 2008
Earliest Anticipated Start Date: July 1, 2008
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: October 27, 2007

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Arbitration Process
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

The National Institute on Drug Abuse (NIDA) invites cooperative agreement applications to participate as Research Centers in the second phase of the national Criminal Justice Drug Abuse Treatment Studies (CJ-DATS 2). Awardees will develop and participate in coordinated multisite studies to conduct rigorous scientific research with criminal justice agencies working with drug-involved offender populations across multiple settings including jails, prisons, and in the community. The goal of this cooperative research program is to develop and test systems-level models that integrate public health and public safety approaches for criminal justice-involved adults and adolescents with drug abuse and addictive disorders. Research undertaken in CJ-DATS 2 will provide useful knowledge about organizational processes, including processes leading to organizational change, that are involved in the successful integration of high-quality drug abuse treatment services in criminal justice settings.

CJ-DATS 2 research will be carried out in prisons, jails, reentry drug courts, and community-based treatment settings in collaboration with other awardees and with NIDA. The CJ-DATS 2 will consist of a Coordinating Center and multiple Research Centers. Each Center will work in concert with other Centers and NIDA to conduct multisite criminal justice-based treatment services research. Awardees will conduct research on implementing and sustaining improved drug abuse treatment services across a coordinated continuum of care for adolescents and adults with substance use disorders who are returning to the community after detention or incarceration.

CJ-DATS 2 research will 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 the conduct of the research. A Coordinating Center, supported under a separate contract, will provide CJ-DATS-wide logistic and data support. As a cooperative agreement, there will be substantial NIDA involvement in the management and administration of the CJ-DATS 2, including the determination of which studies will be implemented.

1. Background

In 2002 the National Institute on Drug Abuse (NIDA) established a multisite research cooperative program, the national Criminal Justice Drug Abuse Treatment Studies (CJ-DATS) under Request for Applications DA-02-011. The rationale underlying CJ-DATS was, briefly, that (1) a continuum of drug abuse treatment had been shown to be effective in reducing drug use and drug-related criminal behavior for individuals with drug problems reentering the community after incarceration; (2) existing drug treatment for criminal justice populations could be improved if it were implemented so that therapeutic services were coordinated with criminal justice assessment, monitoring, and supervision activities; and (3) research could help inform the development of treatment models integrated with the criminal justice system that both addressed public safety concerns and insured a continuity of treatment corresponding to the needs of the individual.

CJ-DATS has contributed to a significant body of research to describe existing treatment practices in the criminal justice system and to develop and test the effectiveness of specific interventions and treatment practices. In the first years of CJ-DATS, 13 studies were fielded that cover 8 study areas including: screening and referral for drug abuse, mental health, and criminal risk problems; modifying treatment programs and interventions for reentering offenders; improving engagement and retention; linking services in the community; improving coordination with criminal justice reentry processes; addressing the needs of special populations; understanding the general organizational and contextual factors in treating offenders; and understanding current treatment practices for the drug-involved offender (see Wexler & Fletcher, 2007). In addition, a large-scale survey was undertaken to provide a comprehensive examination of the nature of programs and services available to adult and adolescent drug abusers in the criminal justice system. The collaboration of treatment practitioners, criminal justice professionals, and researchers has been key to achieving these objectives.

The research to be undertaken in CJ-DATS 2 will extend previous research and create a foundation for improving the quality of treatment services for drug-involved offenders by supporting organizational and systems level studies on implementing and sustaining research-supported interventions across a continuum of care.

Implementing research-based drug abuse treatment practices in usual criminal justice practice settings often faces clinical, administrative, organizational, and policy barriers. Many research-based clinical interventions and treatment services have not been adopted for criminal justice populations and consequently few drug-involved offenders benefit from them. While various implementation barriers are often surmounted during the course of research, if the solutions are expedient rather than systemic the intervention may not be sustainable once the study ends regardless of its clinical effectiveness or cost-effectiveness.

An essential component of implementation research is organizational change. Models for organizational change are found in the quality improvement literature, in research on implementation and technology transfer, in management science literature, and in studies of interorganizational relationships and cross-agency collaboration. The processes to implement new treatment services may require changes in clinical or administrative infrastructure and practices that in some respects parallel individual behavioral change processes. Examples of organizational change that might improve treatment outcomes for drug-involved offenders include changing criteria to admit high-risk offenders to treatment, delaying facility transfers that impede program adherence, revising risk classifications that limit participation, increasing offender (and staff) incentives to participate and adhere to program requirements, and re-engineering sanctions. Organizational changes might be made to increase treatment entry and retention through each stage of a continuum of care; to improve adherence to defined practice standards; to improve the linkage between drug treatment and correctional institutions by improving information sharing; or to build an organizational infrastructure to support the sustainability of quality improvements in the delivery of treatment services to the re-entering criminal justice population.

In the medical literature, Wagner et al. (2001) have proposed a process-oriented model (the Chronic Care Model, or CCM) to adapt medical acute care service delivery systems to the needs of patients with chronic medical illnesses. Critical elements include making chronic care a key goal of the organization, ensuring that leadership is committed and visibly involved, instilling support for change and quality-improvement trials, and realigning or creating incentives (both financial and nonfinancial) for providers and patients to improve care and adhere to evidence-based guidelines. The CCM may prove useful, particularly if it were expanded to incorporate the complex issues surrounding interorganizational relationships between multiple entities including drug abuse treatment system, health and mental health care systems, and criminal justice system.

In contrasting results-focused quality improvement interventions with activity-centered improvements, Schaffer and Thomson (1992) suggest that rapid and tangible successes help create a context for supporting continuous quality improvement and organizational innovation. The results-driven quality improvement approach underpinning NIATx, the Network for the Improvement of Addiction Treatment, may offer a conceptual framework for organizational research in criminal justice settings.

2. Research Objectives

Under CJ-DATS 2, research will be conducted to develop and test models for implementing and sustaining improvements in the quality of drug abuse treatment for criminal justice populations. Three research tracks are described below; these describe areas in which the quality of treatment for drug-involved offenders can be improved by implementing existing research-based services or practices. A large body of research shows the importance of providing drug abuse treatment to the criminal justice population within a continuum of care paradigm that begins at entry into the criminal justice system and continues in the community following reentry. Thus, the underlying framework for improving treatment services is continuity of care.

Three research tracks will be undertaken in CJ-DATS 2. These clinical interventions or other treatment services in CJ-DATS 2 will be selected from those having strong evidence of effectiveness. All 3 tracks can have an adult and an adolescent component. In order to maximize statistical power and the ability to test models of implementation with cross-site variation, all Research Centers must participate in all 3 of the tracks. It is not necessary to participate in studies in both the adult and the adolescent systems provided there are sufficient sites for the planned studies. The tracks are:

(1) Developing an HIV continuum of care. Specific HIV interventions that might be undertaken include:

(2) Implementation of screening and assessment tools used in the identification of drug abuse and related behavioral or health problems and treatment planning and re-entry process. The screening and assessment tools that can be considered include:

(3) Implementation of an intervention. The interventions that can be considered are:

These tracks comprise the foundation for the study of implementation and sustainability research. That is, it is not the objective of CJ-DATS 2 studies to test the clinical efficacy or effectiveness of treatment interventions per se, outside the context of implementation research. Research on the implementation process itself focuses on the short-term, clearly defined and achievable steps toward attaining implementation and quality improvement goals. At the organizational level, the process of implementation and sustainability research may include the following:

These areas can define a process for implementation efforts that begins with strategic planning and moves through phases until the new practice or service is part of the organizational culture. Research that focuses on these organizational level processes (in contrast to individual or systemic factors) is needed so that higher-quality treatment services, practices, and processes are more likely to be sustainable over time.

It is desirable to integrate some or all of the three tracks described above into a phased research design in keeping with the continuity of care framework. The continuum of care framework might include strategies at the individual patient level, the individual practitioner level, and at the organizational level to support a continuum of high-quality treatment across correctional and community settings and between medical, mental health, drug abuse treatment, criminal justice, and other agencies as appropriate. For example, the HIV intervention study might establish and test the outcomes of a continuum of HIV care comprised of testing, counseling, HIV risk reduction interventions, a coordinated transition of services from the prison to the community, and a continuous monitoring of adherence to medications for those who are HIV positive.

Core measures of organizational structure, characteristics, and processes will be developed for use across all studies. Baseline measures are not limited to the following, but should include data on the organizational structure of participating agencies, organizational readiness to change, an assessment of treatment system needs, organizational culture and climate, treatment services and practices currently in use, information on staff competencies, the number of criminal justice-involved clients, and their relevant characteristics. Information on cost and financing of practice improvements is also needed.

Outcome measures may include distal client level outcomes (e.g., return to drug use, reincarceration, HIV risk behaviors) but, depending on the study, the primary outcome measures should include implementation measures; measures of organizational climate; organizational readiness to change; adherence to organizational and clinical processes; measures of organizational functioning such as improvements in number of clients receiving high-quality services; improved use of resources; improvements in staff turnover, expertise, training, or other capacities; changes in organizational climate and culture to adopt and improve treatment practices; or change in mission alignment of clinical and justice goals.

3. Organization of the CJ-DATS 2 Cooperative Research Program

Overview. This Request for Applications is for Research Centers (RCs). Each Research Center will work with public safety partners and treatment providers, as described below. Research Centers will work together to implement multi-site studies, with one Research Center serving as the Lead Center for a given study. As described below, the CJ-DATS 2 organization will also include a Steering Committee, a Coordinating Center (to be established under a separate contract), a Data Safety Monitoring Board, the NIDA Program Scientist and Program Official, and a panel of Federal participants.

A. Research Centers. Research Centers will develop and conduct services research focused on implementation and quality improvement projects in collaboration with criminal justice participants and drug abuse treatment practitioners.

Participating Research Centers must include at least one criminal justice agency partner as a co-Investigator. In order to make the organizational changes needed to implement sustainable treatment quality improvements, a high level of commitment is needed from the partnering criminal justice agency. For sustained change, organizational change leaders may need to ensure that the organization commits the level of effort needed for practice improvement, and that successful changes are incorporated into the organization’s ongoing business practices. The criminal justice partner co-investigator should be an individual who is an identified change leader in his or her agency. The organizational commitment of the criminal justice partner co-investigator and other criminal justice partners should be documented.

Research Centers will coordinate with treatment providers (Section D) and public safety participants (Section E). The Research Centers will collaborate with the Federal government and the Coordinating Center (Section C) in conducting studies under this cooperative research program, and may serve as a Lead Center (Section B) for some studies.

Research Center responsibilities include:

B. Lead Centers. For each of the research projects developed and undertaken within the CJ-DATS 2, 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 and monitoring 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, ensure the quality of data collected through 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, and resources for analysis. 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. Lead Centers will provide data to the Coordinating Center to maintain in the CJ-DATS 2 database.

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.

C. Coordinating Center. The Coordinating Center will be supported under a separate NIDA contract. The Coordinating Center will provide logistics, administrative support, and data management and reporting capabilities. Coordinating Center responsibilities will include:

D. Treatment Providers. Treatment providers may be associated with the criminal justice agency or re-entry court or may be a community-based treatment program that provides treatment services to criminal justice-involved individuals. Treatment providers must be willing to participate in collaborative research involving the implementation of research-based interventions for criminal justice-involved individuals. Treatment provider responsibilities include:

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:

F. CJ-DATS 2 Steering Committee. The CJ-DATS 2 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 criminal justice co-investigator from each Research Center, and the NIDA Program Scientist, each of whom will have one vote on the Steering Committee. This group will direct the research conducted in the CJ-DATS 2, develop or modify policies and procedures as needed, 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 2, monitor progress, guide data analysis and interpretation of results, and oversee communications within the CJ-DATS 2 as well as with the greater scientific community and the public.

The Steering Committee will nominate and, by majority vote, select a Chairperson. 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 program 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 may 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 may 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 oversee development of measurement tools for use in the CJ-DATS 2. Core client-level baseline and follow-up instruments have been established in CJ-DATS. Program- and system-level instruments are under development. Common core measurement batteries will be used across all CJ-DATS 2 research sites. Program- and systems-level instruments will include measures of program orientation, organization, structure, financing, and criminal justice agency and treatment provider measures. Measures specific to particular research plans will be subject to approval of the Steering Committee.

The Steering Committee is responsible for developing and implementing an ongoing oversight process to ensure the study progress and data quality in CJ-DATS 2. The details of this process must be approved by the NIDA Program Official for each study undertaken through CJ-DATS 2. The Steering Committee will review existing policies on data sharing and information management, on access to materials and data, including making data available beyond the CJ-DATS 2 in a timely manner, on human subjects, and on publication and dissemination. Following existing publication policies, 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 as approved by the Steering Committee. It is important to note that research to be undertaken within the CJ-DATS 2 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 this RFA.

Considerations in Steering Committee research plan review will include: a) significance relevant to the goals of the CJ-DATS 2 program of research; b) strength of the scientific rationale supporting the study; c) overall impact of the research; d) approach, including appropriateness and feasibility of study design; e) satisfactory projected sample size; f) adequacy of data management; g) participant safety; and h) compliance with NIH and the Federal regulatory requirements.

The Steering Committee may meet up to three times during the first year, and will meet up to two times per year thereafter, at least once per year 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. NIDA will constitute a panel of Federal participants from other Federal agencies that contribute to CJ-DATS 2. Members of this panel will keep participating Federal agencies informed on CJ-DATS 2 progress and findings, and the panel may be consulted for advice by the Steering Committee. The NIDA Program Scientist will serve on this panel and will represent its interests to the Steering Committee. The Federal participants panel will meet at least once annually to review CJ-DATS 2 progress and findings.

H. Data Safety Monitoring Board (DSMB). The DSMB is an independent expert board appointed by and reporting to the Director of the Division of Epidemiology, Services and Prevention Research, 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.

References

APA Presidential Task Force on Evidence-Based Practice (2006). Evidence-based practice in psychology. American Psychologist, 61(4), 271-285.

Schaffer, R. H., & Thomson, H. A. (1992). Successful change programs begin with results. Harvard Business Review, 70(1), 80-89.

Wagner, E. H., Austin, B. T., Davis, C., Hindmarsh, M., Schaefer, J., & Bonomi, A. (2001). Improving chronic illness care: Translating evidence into action. Health Affairs, 20(6), 64-78.

Wexler, H. K., & Fletcher, B. W. (2007). National Criminal Justice Drug Abuse Treatment Studies (CJ-DATS) overview. Prison Journal, 87(1), 1-16.

Special Considerations

HIV/AIDS Counseling and Testing Policy for the National Institute on Drug Abuse: In light of recent significant advances in rapid testing for HIV and in effective treatments for HIV, NIDA has revised its 2001 policy on HIV counseling and testing. NIDA-funded researchers are strongly encouraged to provide and/or refer research subjects to HIV risk reduction education and education about the benefits of HIV treatment, counseling and testing, referral to treatment, and other appropriate interventions to prevent acquisition and transmission of HIV. This policy applies to all NIDA funded research conducted domestically or internationally. For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-07-013.html.

National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects: The National Advisory Council on Drug Abuse (NACDA) recognizes the importance of research involving the administration of drugs with abuse potential, and dependence or addiction liability, to human subjects. Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA's Web site at

http://www.nida.nih.gov/about/organization/nacda/CouncilStatement.html.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism(s) of Support

This RFA will use the NIH U01 Cooperative Agreement 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 30, 2008.

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 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.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

The NIH U01 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, 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 VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

2. Funds Available

NIDA intends to commit approximately $5.6 million total (direct and indirect) costs for FY 2008. This level of support is dependent on the receipt of a sufficient number and diversity of applications of high scientific merit. NIDA expects to make up to eight awards this year under this RFA for project periods of up to five years of support.

Because the nature and scope of the research activities proposed in response to this RFA may vary, it is anticipated that the size of individual awards will 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.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is 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 support

The Principal Investigator must commit at least 20 percent of his or her time to the CJ-DATS.

2. Cost Sharing or Matching

Not applicable.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

Participating Research Centers must include as a co-investigator at least one criminal justice agency partner who is an identified change leader in his or her agency.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected].

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date: September 26, 2007
Application Receipt Date(s): October 26, 2007
Peer Review Date: February 2008
Council Review Date: May 2008
Earliest Anticipated Start Date: July 1, 2008

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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:

DA-08-002

Director Office of Extramural Affairs
National Institute on Drug Abuse, NIH, DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, Maryland 20892-8401
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: [email protected]

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. 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 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

DA-08-002
Director .Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD 20892-8401
Rockville, MD 20852 (for express/courier service)

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the National Institute on Drug Abuse. Incomplete and non-responsive applications will not be reviewed.

If the application is not responsive to the RFA, NIH staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

Supplementary Instructions

Specific content must be present in the application to document the technical and scientific merit of the applicant's plan for including criminal justice partners and treatment partners as part of the Research Center that will address the fundamental goals and collaborative nature of CJ-DATS 2. The use of tables, diagrams, and organizational and flow charts is strongly encouraged and will be counted toward page limits as described below.

Application Package

The application should conform to the general instructions and requirements (e.g., for font size and page limits) of the PHS 398 (rev. 09/2004) with the exceptions noted below.

Page Limits

The total length of the Research Plan, including the research concepts and administrative and management plan should not exceed 30 pages for applications for new CJ-DATS 2 Research Centers and 34 pages for competing continuation applications from existing CJ-DATS Research Centers. 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 Human Subjects section 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.

Budget

The budget and accompanying justification are not part of the specified page limits. (See below for page limits.) Applicants should include budget estimates and plans for participating in the CJ-DATS 2, organized around the areas of research planning, core functions, drug abuse treatment and criminal justice collaboration, and administrative and management plans.

The budget should be based on participation in each of the 3 research tracks described in Section I.1.2. (Research Objectives). The applicant should prepare separate budgets for each research concept and a total budget combining all 3 research tracks. The total budget should include: 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; and treatment expenses related to the research (excluding costs of routine treatment), any laboratory costs, monitoring costs, publications costs. As noted elsewhere in this RFA, funds for travel should be included to provide for participation in CJ-DATS 2 related meetings. The budget should assume each Research Center will participate in the three tracks described in Section I.2. under Research Objectives.

Specific Requirements for Applications

Sections a-d should not be organized according to Specific Aims, Background and Significance, etc. as stated in the PHS 398 application form. Existing CJ-DATS Centers should replace sections a-d with the following sections labeled A-D. The total page limit for the sum of sections A-E is 34. Applications for new CJ-DATS 2 Research Centers should replace sections a-d with the following sections labeled B-E. The total page limit for new Research Center applications is 30.

A. Progress Report Section

Applications from existing CJ-DATS Centers will provide a progress report on their contributions to the CJ-DATS. This progress report, which will also provide evidence of the Center’s unique strengths and accomplishments, should include:

B. Understanding of the Mission of the CJ-DATS

This section should consist of a few pages to establish the applicant's understanding of the CJ-DATS 2 and to present a vision of how the applicant Center could uniquely contribute to the CJ-DATS 2.

C. 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 desirable. The Principal Investigator must commit 20 percent or more effort to the CJ-DATS 2. The substantive contribution of the criminal justice co-investigator must be detailed.

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. Partnerships among collaborating components of the Center are essential to the success of CJ-DATS 2 and should be described in detail. Applicants should describe how criminal justice and treatment providers are expected to function in true partnership with the Center and CJ-DATS 2 in terms of research development, protocol design, research project implementation, and administrative support services. Applicants should anticipate potential problems and challenges that may arise in the process and propose mechanisms for collaborative resolution among Center participants. Plans should describe infrastructure capabilities for project management, study design and development, and data systems.

Plans for functioning as a Lead Center (Part II, Section I.3, Organization of the CJ-DATS 2 Cooperative Research Program part C.) and as a collaborating Research 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 collection and management of data, for analysis, for data sharing should be clear and at minimum should include: strategies for pooling data, addressing measurement issues across studies, implementing CONSORT guidelines if appropriate, ensuring that research progress and data quality are monitored across study sites, and dissemination of findings. Logistic and executive secretariat issues should be addressed.

D. Research Capacity

The plans should document the availability of appropriate scientific expertise within the Research Center to design, implement, and analyze the results of CJ-DATS 2 studies, and it should describe the Research Center's capacities and how the Research Center would interact with the Coordinating Center to accomplish CJ-DATS 2 goals.

Implementing and sustaining new HIV or treatment interventions or new screening and assessment systems requires substantial support from participating criminal justice and treatment agencies. Thus, applications should provide detailed descriptions of the programs, agencies, or institutions that are expected to participate in CJ-DATS 2 and include detailed descriptions of relevant program/system and offender/patient characteristics (e.g. organizational characteristics, program description, patient flow, staff structure and characteristics). In addition, the ability of treatment and criminal justice agencies to participate in research should be documented and should include the potential number of study participants, and plans to recruit and retain subjects in studies. This section 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 agreeing to participate in CJ-DATS 2. Letters should demonstrate an understanding of the scope of research to be undertaken through CJ-DATS 2 in the 3 research tracks in Section 2 of this RFA and the commitment to work collaboratively with other CJ-DATS 2 investigators in implementing research studies. The application should provide evidence, where possible, of successful collaborations with these groups or plans for the development of successful collaborations, either in this section or (for competing continuation applications) in the Progress Report section..

The plan should document the ability of the Center 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.

E. Research Concepts

Applications should not propose detailed research protocols but should provide research concepts, which are abbreviated examples of how each of the three research tracks outlined in Part II, Section I.2, under Research Objectives, might be approached taking advantage of the capabilities of the CJ-DATS 2. A concept should be developed for each of the 3 separate research tracks.

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 2 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 if applicable; 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 2 research. As in all research cooperatives, the concepts provided in the application will not necessarily be implemented in the CJ-DATS 2.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

The following will be considered in making funding decisions:

2. Review and Selection Process

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:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the PD/PI(s) and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the PD/PI(s) and investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

Criteria for Evaluation of Research Center Applications:

1. Understanding of the Mission of the CJ-DATS

How well does the application demonstrate an understanding of the scientific agenda of the CJ-DATS 2?

How innovative is the vision the application presents for utilization of CJ-DATS 2?

2. Internal Administration and Collaborative Plans

How strong are the administrative and managerial qualifications of the PI and key staff?

Is there evidence of involvement from the criminal justice co-Principal Investigator in the development of implementable and sustainable treatment quality improvements?

Is there evidence of sufficient dedication of time and other resources at the Research Center, Criminal Justice, and Treatment Provider levels?

How clear and feasible are plans for project management, coordination and communication?

How adequate are procedures ensuring oversight of study implementation and data quality?

How well developed are the plans for data management, including the ability to pool data across sites and resolve measurement issues?

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 strong are the applicant’s plans for collaboration and involvement of criminal justice and treatment partners in the conduct of research?

How sufficient and efficient is the infrastructure for project management, study design and development, and data systems activities?

How well developed are the plans for functioning as a "Lead Center" and as a collaborating site?

Are plans to recruit subjects and implement the research 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?

3. Research Capacity

What is the quality of the scientific expertise and productivity within the Research Center, especially with respect to complex multisite studies to improve the quality of drug abuse treatment in the criminal justice system?

What is the quality of and how appropriate are the participating agencies, especially in regard to implementing quality improvement efforts, providing sufficient subjects (staff and clients/patients), supporting research, and contributing practical and intellectual resources to the CJ-DATS 2?

How well does the application document the ability of the Center to deliver treatment services and interventions in the three specified tracks, 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?

4. Research Concepts

How well do the concepts take advantage of the unique capabilities of the CJ-DATS 2 and the role of a Research Center?

How significant are the ideas and do the plans evidence reasonable methodologies and approaches?

Do the proposed concepts have the potential to produce major improvements in the quality of treatment and services offered to drug abusers within the criminal justice system?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: 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 will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

Progress (For competing continuation applications):

Has this Coordinating Center/Research Center/ brought unique strengths or limitations to the CJ-DATS as a whole?

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

2.D. Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following 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 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement U01, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

2.A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator has 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 Project 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 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.

2.A.2. NIH Responsibilities

NIDA Project Scientist. A NIDA Project 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 significant involvement in the design of studies and/or analysis of results has occurred, the NIDA Project 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 Project 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 Project 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 2 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 2 progress and findings and to provide a venue for their participation in the CJ-DATS 2. Members of the panel may be consulted for advice by the Steering Committee. The NIDA Project Scientist will serve on the Federal panel.

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 individual Research Centers. The Program Official will receive all required progress reports to determine that satisfactory progress is being made and will work 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 Safety Monitoring Board (DSMB) 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.

2.A.3. Collaborative Responsibilities

Steering Committee. The Steering Committee constitutes the primary governing body of the CJ-DATS 2. Awardees must participate in the Steering Committee. The voting membership will consist of the Principal Investigator of each Research Center and the NIDA Program Scientist. The Steering Committee reviews and approves the research agenda, monitors policies and procedures guiding the research activities, and oversees communications. It is expected that policies and procedures developed during the initial CJ-DATS period will be usable with only minor modifications for CJ-DATS 2. Awardees agree to abide by those procedures and policies, which are posted on the CJ-DATS website (http://cjdats.org).

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 Program Scientist'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-08-002.

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 Program Scientist will contribute to study plan design as appropriate by providing information regarding treatment models or organizational methods that can be tested within the CJ-DATS 2. NIDA will also review 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.

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 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 2 is intended to be 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. In addition, CJ-DATS 2 provides a research infrastructure that can support independent research projects concerned with issues related to drug abuse treatment for criminal justice-involved individuals, and the organizational change processes needed to improve the quality of such treatment.

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 criminal justice agencies and treatment programs.

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 be familiar with OHRP guidance on prisoners as human subjects, which is available on the web at the following URL address: http://www.hhs.gov/ohrp/humansubjects/guidance/prisoner.htm. Pursuant to Title 45 of the Code of Federal Regulations, Part 46 Subpart C, Section 46.306, OHRP requires review and approval of research protocols prior to implementation.

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).

2.A.4. 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.

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. 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 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

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.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity 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:

1. Scientific/Research Contacts:

Akiva M. Liberman, Ph.D.
Services Research Branch
Division of Epidemiology, Services and Prevention Research
National Institution on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 5194, MSC 9589
Bethesda, MD 20892-9589
TEL: (301) 402-0807
FAX: (301) 443-2636
Email: [email protected]

2. Peer Review Contacts:

Teresa Levitin, Ph.D.
Director, Office of Extramural Affairs
National Institution on Drug Abuse/NIH/DHHS
6101 Executive Blvd., Room 220, MSC 8401
Bethesda, MD 20892-8401
Telephone: (301) 443-2755
Email: [email protected]

3. Financial or Grants Management Contacts:

Edith Davis
Grants Management Officer
Grants Management Branch
National Institution on Drug Abuse/NIH/DHHS
6101 Executive Blvd., Suite 270
Bethesda, MD 20892-8403
Rockville, Maryland 20852 (for express/courier service)
Telephone: (301) 443-6710
Fax: (301) 594-6847
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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 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 funding opportunity 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.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

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 "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is 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 Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

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 (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 applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002 . The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for 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 at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.

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