Department of Health and Human Services
National Institutes of Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov)
Title: Criminal Justice Drug Abuse Treatment Studies 2 (CJ-DATS 2) (U01)
This is a reissue of RFA-DA-08-002 which was previously released July 13, 2007
Update: The following update relating to this announcement has been issued:
Catalog of Federal Domestic Assistance Number(s)
Release Date: June 24, 2008
Letters of Intent Receipt Date: July 28, 2008
Application Receipt Date: August 28, 2008
Peer Review Date: November 2008
Council Review Date: January 2009
Earliest Anticipated Start Date: April 2009
Additional Information To Be Available Date (Url Activation Date): Not applicable.
Expiration Date: August 29, 2008
for E.O. 12372
Table of Contents
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, Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
D. Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information
Section V. Application Review Information
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
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
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
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 collaborative multisite studies concerning the implementation of evidence-based practices involved in the assessment and treatment of drug abuse in criminal justice contexts. The goal of this cooperative research program is to develop and test systems-level models concerning the integration of 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 involved in the successful implementation 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.
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. 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.
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 support organizational and systems level studies on implementing and sustaining research-supported interventions across a continuum of care for drug-involved offenders.
The implementation of research-based drug abuse treatment practices in 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. Several different 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 the drug abuse treatment system, health and mental health care systems, and the 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.
B. Research Objectives
Implementation Research. Under CJ-DATS 2, research will be conducted concerning the effective implementation and sustainability of improvements in the quality of drug abuse treatment for criminal justice populations. Research that focuses on 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. The objective of CJ-DATS 2 is not to test the clinical efficacy or effectiveness of treatment interventions per se, outside the context of implementation research. Rather, research on the implementation process itself focuses on the short-term, clearly defined and achievable steps toward attaining implementation and quality improvement goals.
Research on implementation and sustainability may focus on various aspects of the implementation process that may begin with strategic planning and move through phases until the new practice or service is part of the organizational culture. Implementation processes include the following:
Research Tracks. CJ-DATS 2 implementation research will be undertaken around interventions in 3 areas in which implementing existing evidence-based services or practices can improve the quality of treatment for drug-involved offenders. In each research track, CJ-DATS implementation studies will use interventions or other treatment services selected from those having strong evidence of effectiveness. All Research Centers must participate in all 3 tracks, in order to maximize statistical power cross-site variation in testing models of implementation. All 3 research tracks can have an adult and an adolescent component, but it is not necessary to participate in both the adult and the adolescent studies provided there are sufficient sites for the planned studies.
(1) 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. Screening and assessment tools that might be utilized may include: screening and assessment tools developed, tested, and demonstrating sound psychometric properties in CJ-DATS, or that have established validity and reliability in addressing drug abuse treatment needs.
(2) Implementation of an intervention. Interventions that might be utilized may include: interventions or technology supported by research according to the guidelines suggested by the APA (2006); interventions from CJ-DATS with evidence of effectiveness; approved drug abuse medications intended for a purpose other than detoxification (e.g., an opiate agonist, antagonist, or partial agonist/antagonist) but not currently in use in the criminal justice study setting; or antiretrovirals for HIV treatment.
(3) Developing an HIV continuum of care. Specific HIV interventions that might be utilized may include: Screening and counseling for HIV and other infectious diseases; HIV risk reduction interventions; Continuity of HIV antiretroviral treatment from prison or jail into the community.
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. Depending on the study, outcome measures may also include distal client-level outcomes (e.g., return to drug use, reincarceration, HIV risk behaviors).
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.
C. 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. CJ-DATS 2 Research Centers will work together to implement multi-site studies; one Research Center may serve 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 and final approval by NIDA. 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 FOA.
Considerations in the 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 four times during the first year, and will meet at least 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 may serve as nonvoting members on the DSMB.
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.
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 of Support
funding opportunity will use the NIH U01 Cooperative Agreement award mechanism.
The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project. This FOA is a one-time solicitation. The anticipated award date is April 2009.
This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see ). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.
This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) 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". It is anticipated that competing continuation applications will be invited upon expiration of the initial funding period of awards made under the present FOA, subject to the availability of funds.
2. Funds Available
The estimated amount of funds available for support of 4-6 awards as a result of this announcement is $3.5 million in FY 2009. This level of support is dependent on the receipt of a sufficient number and diversity of applications of high scientific merit. Future year amounts will depend on annual appropriations.
Because the nature
and scope of the proposed research will vary from application to application,
it is anticipated that the size and duration of each award will also vary.
Although the financial plans of the IC(s) provide support for this program,
awards pursuant to this funding opportunity are contingent upon the
availability of funds and the receipt of a sufficient number of meritorious
Direct costs are limited to $500,000 per year for a five-year period. Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.
NIH grants policies as described in the http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
The Principal Investigator must commit at least 20 percent of his or her time to the CJ-DATS. .
2. Cost Sharing or Matching
This program does not require cost sharing as defined in the current NIH Grants Policy Statement.
3. Other-Special Eligibility Criteria
Resubmissions will be accepted under this FOA.
Renewal applications will be permitted for this FOA.
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.
Applicants may submit more than one application, provided each application is scientifically distinct.
1. Address to Request Application
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) 435-0714, Email: GrantsInfo@nih.gov.
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 in item (box) 2 only of the face page of the application form and the YES box must be checked.
Foreign Organizations Non-domestic (non-U.S.) Entity)
NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600260.
Applications from foreign organizations must:
In addition, for applications from foreign organizations:
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.
Applications with Multiple PDs/PIs
When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a – 3h for all PD/PIs. NIH requires one PD/PI be designated as the “contact PD/PI” for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the “Contact PD/PI, et. al.” The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.
All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled “Multiple PD/PI Leadership Plan” must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.
Additional information is available in the PHS 398 grant application instructions.
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: July 28, 2008
Application Receipt Date: August 28, 2008
Peer Review Date: November 2008
Council Review Date: January 2009
Earliest Anticipated Start Date: April 2009
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 in Section IV.3.A.
The letter of intent
should be sent to:
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
3.B. Sending an Application to the NIH
Applications must be prepared using the forms 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)
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:
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)
3.C. Application Processing
Applications must be received on or before the application receipt date) described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute Incomplete and/or non-responsive applications will not be reviewed.
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
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 NIH Grants Policy Statement.
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 renewal award if such costs: 1) are necessary to conduct the project, and 2) 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 renewal 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/archive/grants/policy/nihgps_2003/index.htm.)
6. Other Submission Requirements and Information
Research Plan Page Limitations
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.
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.
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.
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 six 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.
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 assume participation in each of the 3 research tracks described in Research Objectives (Section II.I.1.B). 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 FOA, funds for travel should be included to provide for participation in CJ-DATS 2 related meetings.
Specific Requirements for Applications
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-E. 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 should include:
B. 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.
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. Communication and coordination plans for working with involved agencies (e.g., criminal justice agencies, parole boards, treatment providers) should be given, as well as plans for developing such relationships as appropriate. 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 capabilities and plans for intra-center decision making, project management, coordination and communication, data management, and procedures for oversight of studies.
Plans for functioning as a Research Center in the context of a cooperative research program should be described. These should include plans for cross-Center communication, communication with the Steering Committee, functioning as a Lead Center, and functioning as a collaborating Center. However, support letters from already funded CJ-DATS 2 Research Centers, or other applicants, are not considered appropriate, and will not be considered at review.
An approach should be provided for coordinating implementation of studies across sites, providing training, and monitoring progress. Plans should be provided for collecting, managing, sharing, and analyzing data, including strategies for pooling data, addressing measurement issues across studies, implementing CONSORT guidelines if appropriate, as well as plans for monitoring research progress and data quality across study sites, and disseminating findings.
C. Research Capacity
The proposal should document the scientific expertise within the Research Center with respect to implementation research to improve the implementation of evidence-based practices and overall quality of drug abuse treatment in the criminal justice system, and the expertise to design, implement, and analyze the results of CJ-DATS 2 studies.
Substantial support from participating criminal justice and treatment agencies will be necessary to implement and sustain screening and assessment systems, or HIV or treatment interventions (See Research Tracks in Section II.I.1.B). Thus, applications should describe the programs, agencies, or institutions that are expected to participate in CJ-DATS 2, including 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 this research should be documented and should include the potential number of study participants, and plans to recruit and retain subjects in 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. 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 of this FOA and the commitment to work collaboratively with other CJ-DATS 2 investigators in implementing research studies.
The application should document the ability of the Center and its partners to deliver treatment services and interventions in the three specified tracks, to implement system level modifications. Plans to recruit subjects and implement the research should be described, and the application should attempt to anticipate and address problems and challenges in conducting the research.
D. The Scientific Mission of CJ-DATS 2
This section should establish the applicant's understanding of the CJ-DATS 2 and lay out a clear conceptualization of implementation and organizational research to guide particular studies. This section should also describe how the applicant Center could uniquely contribute to the CJ-DATS 2.
E. Research Concepts
Research concepts are included in the application primarily to provide evidence of the applicant's conceptualization of and approach to CJ-DATS 2 research, and ability to contribute to the collaborative design and conduct of multi-site and multi-Center implementation research in the specific research tracks described in this FOA. The research concepts proposed should exemplify the applicant's approach to mounting theoretically meaningful implementation studies. Two research concepts should be proposed, one for each of 2 of the 3 research tracks. Each research concept is limited to six pages.
Of necessity, many research concepts proposed by successful Center applicants will not be adopted by CJ-DATS 2, due to CJ-DATS 2's collaborative structure and need for multi-site studies. Therefore, rather than propose detailed research protocols, applicants should provide abbreviated examples of how two of the three research tracks outlined in Research Objectives (Section II.I.1.B), might be approached.
For each research concept, the application should discuss how the proposed concept would contribute to our knowledge concerning implementation of evidence-based interventions for drug abusing offenders and how it would capitalize on the CJ-DATS 2 resources and structure.
Each research concept should describe the research study design, the evidence-based interventions involved, outcome measures, and general statistical approaches. Access to subjects and human subjects protections should also be discussed. Detailed research protocols are not expected, nor are detailed plans for statistical analysis.
Two research concepts should be proposed, one for each of 2 of the 3 research tracks. Each research concept is limited to six pages.
All paper PHS 398 applications must provide appendix material on CDs only, Include five identical CDs in the same package with the application. (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.Resource Sharing Plan(s)
NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance, research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and .
Specific Instructions for Foreign Applications
All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See, August 23, 2006.
Only the review criteria described below will be considered in the review process.
2. Review and Selection Process
Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the National Institute on Drug Abuse and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.
As part of the scientific peer review, all applications will:
The following will be considered in making funding decisions:
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 meritorious 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?
In the context of this FOA, significance will be evaluated, based on the entire application, and particularly regarding the application section on The Scientific Mission of CJ-DATS 2:
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?
In the context of this FOA, evaluation of the approach will be based on the entire application, and particularly the application section on Research Concepts:
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?
In the context of this FOA, evaluation of the application's innovation will be based on the entire application and primarily concern:
Because this FOA calls for research concepts concerning the implementation of evidence-based practices, those evidence-based practices will not themselves be evaluated for innovation.
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)?
In the context of this FOA, evaluation of the investigators will be based particularly on the application section on Research Capacity:
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?
In the context of this FOA, evaluation of the environment will be based particularly on the application section on Internal Administration and Collaborative Plans.
In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit
Progress (For competing continuation applications ONLY):
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 rating:
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 on Human Subjects in the PHS 398 instructions).
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 on Human Subjects in the PHS 398 instructions).
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five points described in the Vertebrate Animals section of the Research Plan will be assessed.
Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.
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.
Applications from Foreign Organizations: Whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources will be assessed.
2.C. Resource Sharing Plan(s)
When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.
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.
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/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.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.
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 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.
Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.
2. A.2. NIH Responsibilities
NIDA Project Scientist. An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. A NIDA Project Scientist 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.
NIDA Program Official. A NIDA program official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The 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.
DSMB. The NIDA Director 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.
Other NIDA staff. Subject to Steering Committee invitation, other NIDA staff may attend and participate as non-voting resources to the Steering Committee and/or its subcommittees.
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.
2.A.3. Collaborative Responsibilities (optional)
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. Each full member will have one 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 this FOA. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.
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.
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.
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
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.
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.
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.
Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually 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.
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.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
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
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 5185, MSC 9589
Bethesda, MD 20892-9589
TEL: (301) 402-0807
FAX: (301) 443-2636
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
3. Financial or Grants Management Contacts:
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
Required Federal Citations
Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.
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.
Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see
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/archive/archive/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 Requirement:
In accordance with the NIH Public Access Policy () investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award. For more information, see the Public Access webpage at .
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.
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 FOA 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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NIH Funding Opportunities and Notices
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