NATIONAL CRIMINAL JUSTICE DRUG ABUSE TREATMENT SERVICES RESEARCH SYSTEM

RELEASE DATE:  February 4, 2002

RFA:  RFA-DA-02-011 (Reissued as RFA-DA-08-002)

PARTICIPATING INSTITUTES AND CENTERS (ICs):

National Institute on Drug Abuse (NIDA)
 (http://www.nida.nih.gov)

LETTER OF INTENT RECEIPT DATE:  April 12, 2002
APPLICATION RECEIPT DATE:       May 13, 2002

THIS REQUEST FOR APPLICATIONS (RFA) CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA

The NIDA invites cooperative agreement applications to participate in the 
National Criminal Justice Drug Abuse Treatment Research System (CJ-DATS).  
Awardees will conduct and participate in coordinated multisite studies to 
conduct rigorous scientific research with offender populations across 
multiple settings including jails, prisons, and in the community.  The goal 
of this cooperative research program will be to establish and utilize a 
research infrastructure to develop and test research-based systems-level 
models that integrate public health and public safety approaches for criminal 
justice-involved individuals with addictive disorders.

CJ-DATS research will be carried out in prisons, jails, and community-based 
treatment settings in collaboration with other awardees and with NIDA.  The 
CJ-DATS will consist of a Coordinating Center and multiple Research Centers.  
Each Center will work in concert with other Centers and NIDA to conduct 
multisite and cross-regional (nationwide) criminal justice-based treatment 
services research.  Awardees will study systems-level models integrating drug 
abuse treatment with the criminal justice system.

Most studies to be conducted are expected to span multiple Centers, and, 
depending on the nature of the research, each study may have a different 
Research Center functioning as a "Lead Center" to coordinate other Centers in 
the conduct of the research.  A "Coordinating Center" will provide some CJ-
DATS-wide logistic and data support, as well as function as a "Lead Center" 
for certain studies.  As a cooperative agreement, there will be substantial 
NIDA involvement in the management and administration of the CJ-DATS, 
including the determination of which studies will be implemented using 
components of the System.

RESEARCH OBJECTIVES

Background

The number of individuals incarcerated in United States prisons has steadily 
increased since the mid-1970s.  The majority of these have a drug problem 
significant enough to require intervention.  In 1998 the Office of National 
Drug Control Policy estimated that 70 to 85 percent of state inmates needed 
treatment, but that only 13 percent received it while incarcerated.  It was 
recently estimated that beginning in 1999, about 600,000 inmates per year 
began to be released back into the community, often without having received 
drug abuse treatment in prison or being connected to community-based drug 
treatment.  Left untreated, drug addicted offenders often relapse to drug use 
and return to criminal behavior.  This jeopardizes public health and public 
safety and leads to re-arrest and re-incarceration, which exacerbates already 
high burdens on the criminal justice system.

Because drug abuse treatment has been shown to reduce drug use and its 
related criminal behavior, it has been seen as a way to intervene with drug 
abusers to interrupt the cycle of relapse, re-arrest, and re-incarceration.  
Many different approaches are being tried, including treatment as an 
alternative to incarceration, drug courts that blend judicial monitoring and 
sanctions with treatment, and drug abuse treatment in prison settings and/or 
treatment in community settings after release.

Benefits have been found for several approaches.  For example, the 
effectiveness of prison-based therapeutic communities followed by community-
based treatment has achieved high visibility.  Based on such recognized 
successes, new resources have been allocated to provide treatment for 
incarcerated drug abusers and addicts.

Drug abuse treatment offered to inmates, either in jail or prison or upon re-
entry, often differs from the optimal therapeutic community treatment model.  
In particular, the post-release continuation of therapeutic community 
treatment that has been shown in research to maximize good outcomes may not 
be fully implemented.  Therapeutic community treatment is often limited in 
availability and capacity, and may be more expensive than some other types of 
treatment.  The drug treatment in communities to which offenders are returned 
may be of uncertain quality, suitability, and availability.  There may be 
limited or no access to medical services such as antiretroviral therapy for 
HIV seropositive offenders.

Community-based interventions that are incongruent with in-prison treatment 
may negate the benefits obtained by such treatment.  Many drug abuse 
treatment services, particularly those provided in the transition between 
prison and community re-entry, are of unknown effectiveness.  Since 
comparatively little is known about either processes or outcomes of many 
treatment approaches, especially those other than the therapeutic community, 
there is an urgent need to establish what does and does not work for 
incarcerated drug abusers and for those who will re-enter the community.

Pressure from the criminal justice system is often needed to encourage 
inmates or those transitioning back into the community to enter drug abuse 
treatment.  However, the alliance between the criminal justice system and the 
drug abuse treatment system is often not optimal.  Members of the judiciary 
familiar with the concept of "therapeutic jurisprudence" recognize that the 
criminal justice experience can have therapeutic consequences for defendants 
with addictive disorders if it is used as a point of departure for changing 
the offender"s lifestyle (Hora, Schma, Rosenthal, 1999).  However, public 
health and public safety professionals often approach the issues of drug use 
and addiction from very different perspectives.  While criminal justice 
administrators may realize the value of drug treatment in the aggregate, 
their primary concern is for the actions of individuals under their 
supervision.  Drug treatment research may provide little guidance to criminal 
justice administrators regarding appropriate expectations for an individual"s 
treatment outcomes or determining whether treatment has reduced the 
individual"s level of risk to public safety.  Criminal justice professionals 
need a better understanding of treatment   how it works, for whom, and how to 
gauge progress in treatment   in order to utilize it more effectively and to 
more fully integrate it into the criminal justice system.

Developing an Integrated Systems Approach

The recovery from drug addiction is often a prolonged process that only 
begins with abstinence from drug use.  There is accumulating evidence that 
addiction produces persistent changes in the structure and biochemical 
function of the brain (McLellan, Lewis, O"Brien, Kleber, 2000).  This 
neurophysiological damage is usually accompanied by long-lasting behavioral 
changes and social consequences which contribute to the observed chronicity 
of addictive disorders.  One implication of this evolving perspective is that 
an approach to drug abuse treatment that corresponds more fully to the 
chronic nature of the addictive disorder should produce better outcomes.  
This concept of drug addiction and its recovery is consistent with a large 
body of research showing that length of treatment is an important predictor 
of successful outcomes.

Drug abusers or addicts who are inmates or who are re-entering the community 
after incarceration present special problems.  Most are under continuing 
criminal justice supervision.  In addition to drug problems, many have 
problems in other areas, including physical and mental health, employment, 
housing, family and peer relationships, and gang involvement.  Women, whose 
rates of incarceration have grown in recent years, may have special health, 
mental health, childcare, housing, and drug treatment needs.  Community 
stability and cohesion may be adversely affected if significant numbers of 
ex-prisoners with unmet needs are returned to the community.

Within the criminal justice context, a treatment model that better fits the 
addictive disorder should not only build on current and future knowledge 
about the nature of addiction and the process of recovery, but should also be 
integrated with the criminal justice system both to address public safety 
concerns and to insure a continuity of treatment that corresponds to the 
needs of the patient.  Such an integrated model should be designed not only 
to incorporate the best criminal justice practices and therapeutic services 
but also to use the best organizational practices to deliver these.

Thus, research on models to integrate drug abuse treatment and the criminal 
justice system might investigate how criminal justice professionals and drug 
abuse treatment providers can best effect change in the addict"s attitudes, 
perceptions, behaviors, and lifestyle.  While the features of these 
integrated models are not predefined, it is expected that such models will 
recognize and anticipate the need for continuing episodes of drug treatment 
by combining criminal justice assessment, monitoring, and supervision over an 
extended period of time with appropriate drug treatment assessments and 
interventions, including steps to re-engage individuals in treatment as needed.

The CJ-DATS is expected to forge partnerships among NIDA, drug treatment and 
criminal justice researchers, criminal justice professionals, drug abuse 
treatment practitioners, and other health and social service providers who 
have roles and responsibilities that are related to helping criminal justice-
involved individuals return to their communities as productive, law-abiding 
members of society.  Establishment of these partnerships is essential to 
assure that new models to integrate drug abuse treatment with the criminal 
justice system can be successfully designed and implemented.

Objectives and Scope

The overall goal of the National Criminal Justice and Drug Abuse Treatment 
Research System is to establish a research infrastructure and to develop and 
test models for an integrated approach to the treatment of incarcerated 
individuals with drug abuse or addictive disorders, including both treatment 
in jail or prison and treatment as part of re-entry into the community.  
Specific objectives include:

Supporting rigorous, multisite studies that focus on integrating during- and 
post-incarceration drug abuse treatment system processes with criminal 
justice system processes for individuals with drug abuse and addictive 
disorders as well as co-occurring mental health disorders.

Encouraging research, particularly for currently used understudied 
approaches, on the relative effectiveness of alternative treatment approaches 
for inmates in jail or prison and for ex-offenders re-entering the community.

Encouraging research on the organizational processes needed to integrate 
effective prison- and/or community-based drug abuse treatment with criminal 
justice requirements.

Supporting research on continuity of care models integrated with criminal 
justice prisoner re-entry programs for transitioning returning drug addicted 
offenders to their communities, including mental health services and services 
for other health problems such as HIV, tuberculosis, or hepatitis infections.

Supporting research on how treatment effectiveness is achieved with regard to 
therapeutic, organizational, and managerial processes, and particularly with 
regard to criminal justice system processes and practices, including 
monitoring, supervision, and sanctions.

Fostering the collaboration of treatment practitioners, criminal justice 
professionals, and researchers, to provide opportunities for multidirectional 
education and exchange of ideas, information and values between the criminal 
justice, treatment, and academic communities.

Characteristics of the System

The CJ-DATS will provide a stable infrastructure for research to improve drug 
abuse treatment for individuals with drug abuse or addictive disorders who 
are incarcerated or transitioning from jail or prison to the community.  It 
is anticipated that one Coordinating Center will be established. (See 
Organization of the System, Section A.) There will be three to five regional 
Research Centers (Section B), and the Coordinating Center and Research 
Centers will constitute the CJ-DATS. The Research Centers will collaborate 
with the Federal government and the Coordinating Center in conducting studies 
under this system, serving in a  "Lead Center" (Section C) role.  They will 
also coordinate with treatment providers (Section D) and public safety 
participants (Section E).  A CJ-DATS Steering Committee will constitute the 
primary operating and decision-making body of the CJ-DATS.  See Section F for 
the composition and roles of the Steering Committee.

Examples of the types of studies and questions appropriate for the 
CJ-DATS include:

Stages of drug abuse treatment.  Treatment stages can include triage, 
assessment, treatment in prison, post-release transition and treatment, and 
continuing care in the community.  How are criminal justice risk assessment, 
monitoring, and supervision integrated with community-based drug abuse 
treatment for re-entering ex-offenders at each of these stages to improve 
adherence to treatment plans and outcomes?

Types of criminal justice system/drug abuse treatment integration.  What 
types of integration of drug abuse treatment services with the criminal 
justice system are best at each stage of treatment?  Does involvement of 
community treatment providers with criminal justice staff during the in-
prison treatment stage improve enrollment and engagement in 
community-based treatment?

Levels of integration.  How and under what circumstances do higher levels of 
drug abuse treatment/criminal justice system integration (more communication, 
more criminal justice involvement in the therapeutic process, more treatment 
provider involvement in criminal justice processes) result in better 
treatment engagement and adherence, better or faster progress in treatment, 
and better outcomes?

Alternative treatment approaches.  Effectiveness of extant treatment 
alternatives for the addicted inmate or returning offender, particularly for 
understudied approaches such as cognitive-behavioral models that emphasize 
correcting criminal thinking, faith-based approaches, and "social milieu" 
residential models that encompass a range of counseling and 
skills-building approaches.

Roles of criminal justice professionals and drug abuse treatment providers.  
Research on strengthening criminal justice referral and linkage to treatment, 
health, and social services systems.  Research to define roles and 
responsibilities of health providers and criminal justice personnel to 
complement and support each other in interventions for the returning prisoner.

Organizational adaptation.  What strategies help drug abuse treatment 
practitioners and criminal justice professionals adapt to improve the quality 
of integrated treatment?  Comparison of conflict management styles 
(integrative, confrontation, avoidance) or improved value congruence on 
decision-making and problem-solving processes.

Motivation.  Research on how motivation and other individual attributes 
affect treatment engagement, participation, and outcomes.  Research on 
relationships between criminal justice-supplied external motivation 
(monitoring, supervision, threat of legal sanctions) and internal motivation 
to change.

Relation between public safety risk level and treatment.  For example, does 
risk level affect the needed intensity of criminal justice monitoring or 
treatment?  Is risk reduced by satisfactory engagement and progress 
in treatment?

Research to develop reliable and valid measures of treatment performance that 
can be used as predictors of outcomes, and to develop performance measures 
that can be used by the treatment provider or others as a tool for 
intervening in the treatment process to improve outcomes.

Optimal linkage between prison- or jail-based and community-based treatment.  
Research on in-prison treatment as a foundation for later community 
treatment.  Research to improve the congruence between in-prison and post-
release treatment approaches.  Research on health disparities or service 
needs specific to women or racial/ethnic minorities.

Studies to improve utilization and outcomes of medical treatment integrated 
with drug abuse treatment for addicted inmates or re-entering ex-offenders.  
Compliance with medication regimens in patients with comorbid addictive and 
mental or physical disorders, such as interventions to ensure antiviral 
medication compliance during and after incarceration in drug addicted HIV 
seropositive individuals, or adherence to medications for those with co-
occurring mental health disorders for which effective treatments exist.

Given the relationship between drug abuse and HIV infection and the need to 
improve the delivery of HIV treatment and prevention interventions for re-
entering drug abusers, the CJ-DATS will include studies on integrating 
services to treat AIDS or reduce the risk of HIV transmission.  All treatment 
programs should ensure the availability of HIV risk reduction counseling and 
HIV testing.

Research will be conducted collaboratively involving NIDA, the Coordinating 
Center, and the Research Centers.  The CJ-DATS structure will permit 
expeditious and concurrent multisite research on integrated treatment models 
in statistically powerful designs.  The number of sites involved in specific 
studies will vary depending on the nature of the scientific question under 
study and the number and diversity of subjects required.

Organization of the System

A. Coordinating Center.  There will be one Coordinating Center.  Coordinating 
Center personnel should have expertise in process and outcome evaluation 
research on health services delivery, knowledge of drug abuse treatment, 
primary medical (especially HIV/AIDS) care, and mental health care in the 
criminal justice system context, experience in logistics, and experience 
working with grantees in technical assistance situations.  The Coordinating 
Center principal investigator should be experienced in coordination of large 
multisite research studies.

It should be noted that the Coordinating Center does not provide the primary 
data management and analysis capacities for all studies, each study will have 
a designated "Lead Center" (Section C) that will provide the primary support 
for studies conducted across sites.

Coordinating Center responsibilities include:

o  To provide special expertise for research on the organizational culture, 
capacity and motivation for change, including organizational and economic 
barriers to change in treatment practices, in the criminal justice system and 
in the drug abuse treatment system.

o  To lead the CJ-DATS in development and conduct of baseline surveys of the 
criminal justice system to address health services questions such as access, 
availability, utilization, and type of treatment for drug abusers in the 
criminal justice system.

o  To collaborate with Research Centers and the Federal government in 
refinement of interventions and research designs, and to assist the Steering 
Committee in developing and implementing cooperative multisite studies.

o  To assist study sites with data quality control checks, including on-site 
training for data collection, and to assist in data management and analysis.

o  To facilitate cross-site data comparability, to serve as a repository for 
data collected under this cooperative study, and to prepare public use 
data sets.

o  To develop and maintain a CJ-DATS website to facilitate dissemination of 
easily accessible study progress reports and research findings to multiple 
audiences, including treatment practitioners and criminal justice 
system personnel.

o  To coordinate logistical functions of meetings of the CJ-DATS Steering 
Committee, subcommittees, and workgroups, including production and 
distribution of committee minutes.  Funds for participant travel to meetings 
will not be disbursed by the Coordinating Center, applicants should make 
adequate provision for these funds in the budgets submitted under the 
present RFA.

o  To provide logistical and operational support for the Data and Safety 
Monitoring Board.

o  To publish results and assist in development of publications, in 
accordance with Steering Committee procedures to be developed.

B. Research Centers.  Research Centers will develop and conduct research 
projects in collaboration with criminal justice participants and drug abuse 
treatment practitioners.  Criminal justice populations should represent a 
broad range of individuals, including juveniles, women, those with co-
occurring mental disorders, HIV risk populations, and members of various 
racial/ethnic groups.  

Research Center responsibilities include:

o  To establish partnerships among researchers, criminal justice 
professionals, and treatment practitioners through contract or collaborative 
arrangements with one to three prisons, two to five associated drug abuse 
treatment programs, and the parole departments associated with the community-
based treatment programs to conduct the research of the CJ-DATS.  Under 
guidance of the CJ-DATS Steering Committee to ensure consistency across the 
CJ-DATS, the Research Center shall establish policies and procedures for 
conducting periodic reviews to examine patient accrual, data accuracy and 
timeliness, and compliance with study plans.

o  In partnership with criminal justice and treatment provider participants, 
to develop and coordinate research concepts and projects for submission to 
the Steering Committee for approval and implementation.  Communication with 
the NIDA Scientific Collaborator and with other sites is required at all 
stages of study conceptualization and development.

o  To provide criminal justice and treatment partners with the necessary data 
collection infrastructure, including a data management information system, if 
needed, to collect intake, in-treatment, and outcome data.  Plans should 
include assessment of relevant public safety and treatment program data.

o  To provide criminal justice and treatment partners with counselors, case 
managers, or other service delivery staff needed to conduct the research.

o  To provide a management and committee structure that ensures participation 
by treatment providers and public safety professionals in the planning and 
implementation of the research.

o  To provide training and supervision as needed for the treatment and public 
safety staff who are participating in the research study.

o  To implement studies as a Lead site, coordinating studies with other sites 
across the CJ-DATS, as well as to participate in studies coordinated by other 
Lead sites.  Within its own site, each participating Research Center will 
have the responsibility for research coordination, data management, quality 
control, and training and supervision of treatment providers, either as a 
Lead Center or under the direction of the Lead Center.

o  To ensure adequate accrual of subjects from participating treatment 
programs to meet the requirements of each study in numbers recruited over 
defined time periods.

o  To establish and implement mechanisms for data management and analysis 
that ensure data collection and management procedures are: a) adequate for 
quality control and analysis, b) efficiently designed to encourage 
participation of public safety personnel and treatment providers, c) in 
accordance with procedures and requirements established by the Steering 
Committee, and d) sufficiently uniform across all participating sites.

o  To monitor adverse events and to report on all ongoing studies to the Data 
and Safety Monitoring Board in accord with policies and procedures to be 
determined by the Board.

o  To ensure that any organizations that are engaged in research, as defined 
by the Office for Human Research Protections (OHRP), must obtain an OHRP 
assurance and IRB review and approval before conducting human subjects 
research.  Note that all research protocols involving prisoners must be 
reviewed and approved by an OHRP panel before it can be implemented.

o  To establish a mechanism for interim monitoring of progress and results to 
be reported at least semiannually to the CJ-DATS Steering Committee and to NIDA.

o  To submit annual progress reports, including treatment program reviews, to 
the NIDA program official.  Research Center funding is contingent on 
progress, including collaborative contributions and satisfactory patient accrual. 

o  To publish major findings in a timely manner, in accordance with 
procedures established by the CJ-DATS Steering Committee.  Publication or 
oral presentation of work done under this agreement requires acknowledgement 
of NIDA support.  Research Centers must agree not to report findings prior to 
collaborative reporting or approval by the Steering Committee.

C. Lead Centers.  For each research project developed and undertaken within 
the CJ-DATS, one Research Center will be designated as Lead Center by the 
Steering Committee.  The Lead Center will have the additional responsibility 
of ensuring the participation of other sites, coordinating research across 
multiple sites, providing necessary training, and providing comprehensive 
administrative and scientific management of the research done across sites.  
Data from all of participating treatment programs for a given study will be 
forwarded by the respective participating Research Centers to the Lead Center.

Lead Centers will monitor and manage the implementation of studies, reproduce 
and distribute research materials (such as treatment protocols, training 
manuals, instrumentation) and educational materials, and support operational 
needs such as quality assurance, data collection, resources for analysis, 
etc.  Responsibilities also include executive secretariat functions such as 
organization of necessary meetings and conference calls, developing meeting 
agendas, taking minutes of sessions, photocopying and distributing meeting 
materials to the other Research Centers and NIDA, and preparation of reports 
to the NIDA Program Official.

As noted above, in addition to OHRP assurance and IRB review, all research 
protocols involving prisoners must be reviewed and approved by an OHRP panel 
before implementation.

D. Treatment Providers.  Treatment providers should be established programs 
with experience in treating criminal justice-involved clientele.  Treatment 
providers must be willing to participate in collaborative research.  
Treatment provider responsibilities include:

o  Agreeing to participate in research in which either its primary Research 
Center or another Research Center has the lead.  Most studies will require 
controlled research designs including random assignment methods to 
different conditions,

o  Recruiting adequate numbers of patients required for specific studies,

o  Agreeing to provide their customary clinical care to patients 
participating in research studies,

o  Agreeing to provide experimental/standard care in accord with approved 
research plans,

o  Ensuring the availability of HIV risk reduction counseling and HIV testing,

o  Maintaining patient records required for each study protocol,

o  Collecting clinical data, including biological specimens when indicated,

o  Cooperating with quality control activities of the CJ-DATS and adhering to 
guidelines set by the Research Center, the Steering Committee, and NIDA,

o  Participating in the decision-making process concerning research studies 
to be implemented in the site with which the treatment program is associated, 
including design of treatment processes and, as appropriate, study designs 
and types of subjects to be recruited,

o  Agreeing not to report data prior to collaborative reporting, and

o  Agreeing to periodic on-site audits by representatives of its Research 
Center, NIDA, or a NIDA designee for compliance with regulations for IRB 
approval or informed consent (compliance with 45 CFR 46), compliance with 
research plan specifications, quality control and accuracy of data recording, 
and completeness of reporting of adverse events.

E. Public Safety Participants.  Public safety participants may include prison 
administrators or staff, staff who provide parole monitoring or continuing 
criminal justice supervision of offenders after release from incarceration, 
members of the judiciary who are involved with drug treatment for offenders, 
and others in the criminal justice community with a responsibility for 
criminal justice-involved drug abusers or addicts (e.g., treatment re-entry 
drug court professionals).  Public safety participant responsibilities include:

o  Agreeing to participate in research in which either the primary Research 
Center or another Research Center has the lead.  Many studies will require 
controlled research designs including random assignment methods to 
different conditions,

o  Providing access to criminal justice-involved individuals with drug abuse 
or addiction disorders,

o  Maintaining records required for each study protocol,

o  Cooperating with study plans of the CJ-DATS and adhering to guidelines set 
by the Research Center, the Steering Committee, and NIDA,

o  Participating in the decision-making process concerning research studies 
to be implemented in the treatment site with which the public safety 
organization is associated, including practical and study design aspects of 
integrating criminal justice requirements with treatment processes, and

o  Agreeing not to report data prior to collaborative reporting.

F. CJ-DATS Steering Committee.  The CJ-DATS Steering Committee (or, simply, 
Steering Committee) will constitute the primary governing body of the CJ-
DATS.  It will consist of the Principal Investigator of each Research Center, 
the PI of the Coordinating Center, and the NIDA collaborating scientist, each 
of whom will have one vote on the Steering Committee.  This group will direct 
the research conducted in the CJ-DATS, develop policies and procedures for 
development of research plans, act upon concepts and research plans submitted 
by sites, determine research studies to be implemented (subject to NIDA 
approval), coordinate the implementation of studies across the CJ-DATS, 
monitor progress, guide data analysis and interpretation of results, and 
oversee communications within the CJ-DATS as well as with the greater 
scientific community and the public.

The Steering Committee, by majority vote, will select a Chairperson from the 
group of CJ-DATS Research Center Principal Investigators. For this election, 
if the Steering Committee has an even number of participants and the vote is 
evenly split (so that there is no majority vote), the vote of the NIDA 
collaborating scientist will be disregarded.  Federal participants may not 
serve as chair except to organize the first meeting and conduct the election 
of a permanent Chairperson.

The Steering Committee will determine that other members of the Coordinating 
Center"s or Research Centers" teams (including treatment providers, criminal 
justice personnel, and/or public safety members) should attend some or all 
meetings as nonvoting observers or resources.  The Steering Committee may 
also establish subcommittees and workgroups to assist it in carrying out its 
functions, and these groups may include members of the Centers" teams and 
others as the Steering Committee sees the need. The Steering Committee will 
establish an advisory body consisting of public safety representatives and 
treatment provider representatives from the Centers" research sites.  This 
advisory body will review proposed research concepts and plans, comment upon 
their feasibility and practical importance, assist in the implementation of 
research, and carry out other activities determined by the Steering Committee.

The Steering Committee will also establish training standards and procedures 
for treatment providers in the CJ-DATS to assure comparability and 
generalizability across sites.  The Steering Committee will oversee 
development of measurement tools for use in the CJ-DATS.  Core baseline and 
follow-up batteries will be established for both program- and patient-level 
data to be gathered in all treatment sites throughout the CJ-DATS.  The 
former will include measures of program orientation, organization, structure, 
financing, treatment provider characteristics and processes, and related 
elements.  The latter will include intake, outcome, and follow-up measures 
for all patients enrolled in studies.  Measures specific to particular 
research plans will be subject to approval of the Steering Committee.  It 
will also develop policies on data sharing, on access to materials and data, 
including making data available beyond the CJ-DATS in a timely manner, and on 
publication authorship.  Publication policies will be written and authorship 
decided using procedures developed and approved by the Steering Committee.  
All publications, whether from a single site or multiple sites, will be 
submitted to the Steering Committee for review and approval.

All major scientific decisions will be determined by majority vote of the 
Steering Committee.  All participating Centers must agree to abide by the 
study designs and policies approved by the Steering Committee, both for 
studies spanning multiple sites and studies conducted within a single site.  
It is important to note that research to be undertaken within the CJ-DATS is 
not limited to research concepts contained within awardees applications, but 
will be determined by the Steering Committee based on input from the sites 
and subject to the approval of NIDA.  Future research must be consistent with 
the scientific objectives of the RFA.

The major considerations in research plan review by the Steering Committee 
will include:  a) strength of the scientific rationale supporting the study, 
b) overall impact of the research, c) significance of the question being 
proposed, d) avoidance of unnecessary duplication with other research, e) 
approach, including appropriateness and feasibility of study design, f) 
satisfactory projected accrual rate and follow-up period, g) patient safety, 
h) compliance with NIH and the Federal regulatory requirements, i) adequacy 
of data management, and j) appropriateness of patient/participant selection, 
evaluation, response to intervention, and follow-up.

The Steering Committee may meet up to six times during the first year, and 
will meet up to four times per year thereafter, usually in the Washington, 
D.C. area.  Applicants should include budgets for travel to these Steering 
Committee meetings and subcommittee/workgroup meetings in their applications 
and should assure that adequate provisions are made to allow Principal 
Investigators, public safety participants, and treatment program 
representatives to participate fully in activities of the Steering Committee 
and its subcommittees/workgroups.

G. Federal Participants.  It is anticipated that, as the CJ-DATS develops, 
other Federal agencies may contribute money to NIDA to assist with funding 
and/or may provide NIDA with other assistance, such as facilitating access to 
populations or sharing expertise.  NIDA will constitute a panel of Federal 
participants from those agencies having a role in the CJ-DATS.  NIDA will use 
this panel to ensure that other Federal agencies are kept informed on CJ-DATS 
progress and findings, and the panel may be consulted for advice by the 
Steering Committee.  The NIDA Collaborating Scientist will serve on this 
panel and will represent its interests to the Steering Committee. 

H. Data and Safety Monitoring Board (DSMB).  The DSMB is an independent 
expert board appointed by and reporting to the Director of NIDA that will 
oversee and monitor the conduct of the studies to ensure the safety of 
participants and the validity and integrity of the data.  The DSMB will also 
make independent assessment of whether a study will continue.  One or more 
NIDA staff will serve as nonvoting members on the DSMB.

Timetable for the Studies

It is envisioned that various studies will be designed and conducted in three 
phases over a total of five years.

Phase I will involve the establishment of the Steering Committee and 
development of a study plan, including planning to develop and test treatment 
model systems integrating continuity of care with the criminal justice 
system.  Review of the plan by the DSMB will also occur.  The developmental 
phase is expected to be completed in 9 to 12 months.

Phase II will involve pilot testing of the data collection instruments, 
treatment service delivery strategies, and the research plans.  Preliminary 
data will be analyzed and the study plans will be revised according to 
findings of the pilot projects.  The DSMB will review the resulting study 
plans.  The pilot testing phase is expected to be completed in 9 to 12 months.  

In Phase III, multisite research studies that test integrated drug abuse 
treatment models will be implemented at the sites according to the final 
study plan.  Data will be collected and analyzed, and publications prepared.  
This phase will take three to three one-half years.

MECHANISM OF SUPPORT

This RFA will use NIH U01 award mechanism.  As an applicant you will be 
solely responsible for planning, directing, and executing the proposed 
project.  This RFA is a one-time solicitation.  Future unsolicited, 
competing-continuation applications based on this project will compete with 
all investigator-initiated applications and will be reviewed according to the 
customary peer review procedures. The anticipated award date is September 2002.

The NIH (U01) is a cooperative agreement award mechanism in which the 
Principal Investigator retains the primary responsibility and dominant role 
for planning, directing, and executing the proposed project, with NIH staff 
being substantially involved as a partner with the Principal Investigator, as 
described under the section "Cooperative Agreement Terms and Conditions of 
Award."  It is anticipated that there will be subsequent RFAs to expand the 
CJ-DATS and that competing continuation applications will be invited upon 
expiration of the initial funding period of awards made under the present 
RFA, subject to the availability of funds.  

FUNDS AVAILABLE

NIDA intends to commit approximately $3 million total costs for FY 2002.  
This level of support is dependent on the receipt of a sufficient number and 
diversity of applications of high scientific merit. NIDA expects to make four 
to six awards this year under this RFA for project periods of up to five 
years of support.  

It is anticipated that one award for the Coordinating Center will be made for 
approximately $500,000 (including direct and facilities and administrative 
costs) per year.  Approximately $2.5 million per year will be distributed 
among three to five Research Centers to support their direct and facilities 
and administrative costs.

Because the nature and scope of the research activities proposed in response 
to this RFA may vary, it is anticipated that the size of individual awards 
will vary also. Budget requests should be carefully justified and 
commensurate with the complexity of the project. Although this program is 
provided for in the financial plans of the NIDA, awards pursuant to this RFA 
are contingent upon the availability of funds for this purpose.

ELIGIBLE INSTITUTIONS

You may submit an application if your institution has any of the following 
characteristics: 
	
o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government 
o Domestic 
o Faith-based organizations

Note:  Separate applications are being solicited for Research Centers and a 
Coordinating Center to participate in this collaborative study.  If an 
organization chooses to apply as a research center site and as the 
coordinating center, separate applications and a separate Principal 
Investigator for each are required, and there should be no overlap of effort 
in research or support personnel.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Individual with the skills, knowledge, and resources necessary to carry out 
the proposed research are invited to work with their institution to develop 
an application for support.  Individuals from underrepresented racial and 
ethnic groups as well as individuals with disabilities are always encouraged 
to apply for NIH programs.

The Principal Investigator must commit at least 33 percent of his or her time 
to the CJ-DATS.

SPECIAL REQUIREMENTS

To promote the development of a collaborative program among award recipients, 
a number of issues need to be addressed in applications as discussed under 
Application Procedures, below.  Applicants should discuss the rationale for 
their choice of research questions and design, should document their ability 
to recruit a sufficient number of participants, and should demonstrate their 
ability and willingness to work cooperatively with NIDA, the Coordinating 
Center, other Research Center awardees, public safety agencies and criminal 
justice professionals, and treatment providers, and to follow common research 
plans.  The following terms and conditions will be incorporated into the 
award statement and provided to the Principal Investigator(s) as well as the 
institutional official at the time of award.

Cooperative Agreement Terms And Conditions of Award

These special Terms of Award are in addition to and not in lieu of otherwise 
applicable OMB administrative guidelines, HHS Grant Administration 
Regulations at 45 CFR Parts 74 and 92, and other HHS and NIH Grant 
Administration policy statements.

The administrative and funding instrument used for this program is a 
cooperative agreement, an "assistance" mechanism (rather than an 
"acquisition" mechanism) in which a substantial NIH scientific and/or 
programmatic involvement with the awardee is anticipated during performance 
of the activity.  Under the cooperative agreement, the NIH purpose is to 
support and/or stimulate the recipient"s activity by involvement in and 
otherwise working jointly with the award recipient in a partner role, but it 
is not to assume direction, prime responsibility, or a dominant role in the 
activity.  Consistent with this concept, the dominant role and prime 
responsibility for the activity resides with the awardee(s) for the project 
as a whole, although specific tasks and activities in carrying out the 
studies will be shared among the awardees and the NIDA Collaborating Scientist.

1.  Awardee Rights and Responsibilities 

Awardees have primary responsibilities to define objectives and approaches, 
and to plan, conduct, analyze, and publish results, interpretations, and 
conclusions of their studies in collaboration with other awardees, and with 
assistance from the NIDA Collaborating Scientist.  Awardees shall participate 
in the Steering Committee and abide by decisions of the Steering Committee 
and the Charter of Responsibilities adopted by the Steering Committee.

Awardees shall develop research plans in conjunction with participating 
criminal justice professionals, treatment providers, and other awardees and 
submit them for approval by the Steering Committee.  Awardees shall take lead 
responsibility for implementation of selected plans as determined by the 
Steering Committee and shall participate in additional studies that are under 
the leadership of other sites.  Implementation of studies shall be in accord 
with Steering Committee policies and procedures, including policies and 
procedures pertaining to instrumentation, data collection, data and safety 
monitoring, and publication.  Awardees shall conduct research in partnership 
with criminal justice professionals and treatment practitioners, assure 
quality of care, assure that research findings and adverse events are 
communicated to research partners and to NIDA, and assure that the study and 
associated treatments are conducted in accordance with established protocols.

Awardee will retain custody of primary rights to their data developed under 
the award, subject to rules formulated by the Steering Committee, and 
government rights of access consistent with current DHHS, PHS, and NIH policies.

2.  Federal Staff Roles and Responsibilities

NIDA Collaborating Scientist.  A NIDA Collaborating Scientist with expertise 
in research on drug abuse treatment for those who are involved with the 
criminal justice system will help to identify research questions that will 
have fundamental and timely significance for treating this population.  
He/she may cooperate with awardees in development of research plans and 
preparation of study reports.  In instances where very significant 
involvement in the design of studies and/or analysis of results has occurred, 
the NIDA Collaborating Scientist may cooperate with awardees as coauthor in 
preparing publications of data resulting from the research.  In this regard, 
he/she will be subject to the publication/authorship policies governing all 
participants.  In addition, publications involving NIDA staff require 
internal clearances.

The NIDA Collaborating Scientist will serve as a resource for specific 
information on NIDA"s programmatic intentions and priorities, and will help 
to foster collaborations between researchers, corrections administrators and 
practitioners, and treatment practitioners to increase the value of research 
to these participants.

The NIDA Collaborating Scientist will be a voting member of the Steering 
Committee, but will not hold the position of chair.  He/she will participate 
in the development of instrumentation, development of study plans, in quality 
control, and in coordination of projects, but will not participate in 
activities that directly involve assessment, testing, or treatment of 
human subjects.

Other Federal staff.  The CJ-DATS will enable cross-Institute and cross-
agency collaboration of several types, including facilitating access to 
criminal justice system participants, co-funding research studies of 
particular interest, and providing systems-level expertise.  Representatives 
from Federal agencies that provide resources, assistance, or expertise may be 
invited to join a panel constituted by NIDA.  NIDA will convene meetings of 
this panel to ensure that these Federal agencies are kept informed on CJ-DATS 
progress and findings and to provide a venue for their participation in the 
CJ-DATS.  Members of the panel may be consulted for advice by the Steering 
Committee.  The NIDA Collaborating Scientist will serve on the Federal panel 
and will represent its interests on the Steering Committee.

Other NIDA staff.  A NIDA Program Official, who will not participate in the 
research, publications, or Steering Committee, will be responsible for the 
oversight of each cooperative agreement.  The Program Official carries 
primary responsibility for: (1) periodic review and approval of the progress 
of the research plans in relation to their stated objectives, and (2) making 
recommendations regarding continuance of the program.  The NIDA Program 
Official will be responsible for monitoring the conduct of the project and 
overseeing the Coordinating Center and the Research Centers.  The Program 
Official will receive all required progress reports to determine that 
satisfactory progress is being made, and will approve the transitions to 
Phase II and Phase III activities based on completion of pilot studies and 
the outcome of review of study plans by the DSMB.  This person also works 
collaboratively with the Grants Management Specialist to assure high quality 
business management of the program, including the most effective use of 
Federal financial assistance provided through this cooperative agreement.

The Director, NIDA, will appoint an independent Data and Safety Monitoring 
Board which will oversee and monitor the conduct of research studies to 
ensure the safety of participants and the validity and integrity of the data.  
The DSMB will also make independent assessments of treatment effectiveness 
and whether a study will continue.  One or more NIDA staff will serve as 
nonvoting members on the DSMB.

Subject to Steering Committee invitation, other NIDA staff may attend and 
participate as non-voting resources to the Steering Committee and/or 
its subcommittees.

3.  Collaborative Responsibilities

Study Plan Development and Implementation.  The study plan is a document 
mutually acceptable to the research site(s), the Steering Committee, and 
NIDA.  Communication at the various stages of development is essential.  The 
NIDA Collaborating Scientist will assist the site PIs in study plan design as 
appropriate by providing information regarding treatment models or 
organizational methods that can be tested within the CJ-DATS.  NIDA will also 
comment on the scientific rationale, programmatic relevance, priority, 
design, statistical requirements, and implementation of proposed studies.

Study concepts are submitted by sites to the Steering Committee.  Approved 
concepts are developed as formal proposals by collaborating sites and 
submitted to the Steering Committee.

Steering Committee.  The Steering Committee will constitute the primary 
governing body of the CJ-DATS.  Awardees must participate in the Steering 
Committee.  The voting membership will consist of the Principal Investigator 
of each Research Center, the Principal Investigator of the Coordinating 
Center, and the NIDA Collaborating Scientist.  The Steering Committee reviews 
and approves the research agenda, formulates and monitors policies and 
procedures guiding the research activities, and oversees communications.  The 
Steering Committee will develop a Charter of Responsibilities subject to 
NIDA"s concurrence defining the roles and responsibilities for the 
Coordinating Center, the Research Centers, Federal participants, and other 
participants as described RFA-DA-02-011.

All major scientific decisions are made by majority vote.  The exception is 
in the vote for Chairperson, where a tie vote will be decided by disregarding 
the NIDA Staff Collaborator"s vote. Research will be determined by the 
Steering Committee with input from criminal justice and treatment partners, 
and is subject to the approval of NIDA.  All research must be consistent with 
the scientific objectives of RFA-DA-02-011.

The Steering Committee will develop policies that will guide the standard 
operating procedures of the CJ-DATS and that will address protocol 
development, protocol review and approval, study operations and standards, 
data acquisition and management, and analysis and publication.  It will 
monitor progress and establish subcommittees and workgroups as needed.  
Awardees agree to abide by those procedures and policies.

Data Management, Analysis, and Access.  Data generated are the property of 
the awardee.  However, the Coordinating Center and all Research Centers must 
provide NIDA with access to all data generated under this award, subject to 
rules specified in Certificates of Confidentiality obtained by awardees.  
Data must be shared upon request with the Steering Committee, subcommittees 
reporting to the Steering Committee, and the Data and Safety Monitoring 
Board.  As governed by Certificates of Confidentiality, data may also be 
available for external monitoring if required by NIDA"s agreements with other 
Federal agencies.

As the CJ-DATS is intended to become a national resource, sites must be 
prepared to share their data under provisions that safeguard the privacy and 
confidentiality of respondents.  Thus, each proposing Research Center should 
include explicit indications of how they will make their data available for 
broad use and on what timetable.  The awardee will provide for data sharing 
consistent with its data sharing plan, as approved by NIDA.

4.  Organizational Changes

Certain site organizational changes must have the prior written approval of 
NIDA. These include changes in key personnel and the addition or deletion of 
prisons, parole departments, and treatment programs.

5.  Federally Mandated Regulatory Requirements

Each Research Center will establish mechanisms to meet Department of Health 
and Human Services (DHHS)/Public Health Service (PHS) regulations regarding 
the protection of human subjects.  Each Research Center must be able to 
demonstrate that each study, amendment, and informed consent document is 
approved by the responsible IRB prior to subject entry and at least annually 
thereafter, as appropriate for the degree of study risk as stipulated by 45 
CFR 46.

Researchers should be knowledgeable of the additional human subjects 
protections required for "prisoners," a term defined by the Department of 
Health and Human Services (DHHS) to include adults, adolescents, and children 
who are either confined or detained involuntarily in an institution or 
facility by virtue of criminal or civil statutes or commitment procedures.

All investigators proposing research involving prisoners or individuals who 
may enter prisoner status during study involvement should read the Code of 
Federal Regulations, Title 45, Public Welfare, Part 46 "Protection of Human 
Subjects," which is available on the web at the following URL address: 
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.  See also 
http://www.hhs.gov/ohrp/humansubjects/guidance/prison.htm.  Pursuant to 
Subpart C, section 46.306, OHRP requires review and approval of research 
protocols prior to implementation.

6.  Program Review

In addition to the standard NIH requirement for submission of annual progress 
reports, awardees will be required to submit semiannual reports on study 
progress.  NIDA will provide a suggested format for this purpose.  The NIDA 
Program Official will review progress through consideration of the semiannual 
accrual reports, annual report, and program site visits.

The inability of a Research Center to meet the performance requirements and 
responsibilities may result in an adjustment of funding, withholding of 
support, or suspension or termination of the award.

7.  Study Closure

NIDA may request that a study be closed for reasons including:  a) 
insufficient accrual rate or other problems with accrual, b) poor site 
performance, c) patient safety, d) emergence of already conclusive study 
results, and e) emergence of new information that diminishes the scientific 
importance of the study question.

NIDA will not permit expenditure of Federal funds or permit expenditure of 
NIDA funds after requesting closure (except to ensure patient safety for 
enrolled subjects).

8.  Arbitration Process

The arbitration procedures will be invoked only when agreement cannot be 
reached on programmatic decisions regarding scientific-technical issues that 
may arise after the award.  An Arbitration Panel will be composed of three 
members, one person selected by the Steering Committee (with the NIDA member 
abstaining) or by the individual awardee in the event of an individual 
disagreement, one person selected by NIDA, and a third person selected by 
these two members.  The Arbitration Panel will make a recommendation to the 
Director, NIDA.

The special arbitration procedures described above in no way affect the 
awardee"s right to appeal an adverse action in accordance with PHS 
regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR Part 16.

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into three 
areas:  scientific/research, peer review, and financial or grants 
management issues:

o  Direct your questions about scientific/research issues to:

Bennett Fletcher, Ph.D.
Division of Epidemiology, Services, and Prevention Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4222, MSC 9565
Bethesda, MD  20892-9565
TEL:  (301) 443-6504
FAX:  (301) 443-2636
Email:  [email protected]

o  Direct your questions about peer review matters to:

Teresa Levitin, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, Maryland  20892-9547
Telephone:  (301) 443-2755
FAX:  (301) 443-0538
Email:  [email protected]

o Direct your questions about financial or grants management matters to: 

Gary Fleming, J.D., M.A.
Chief, Grants Management Branch
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD  20892-9541
TEL:  (301) 443-6710
Email:  [email protected]

LETTER OF INTENT

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

o  Descriptive title of the proposed research
o  Name, address, and telephone number of the Principal Investigator
o  Names of other key personnel 
o  Participating institutions
o  Number and title of this RFA 

Although a letter of intent is not required, is not binding, and does not 
enter into the review of a subsequent application, the information that it 
contains allows IC staff to estimate the potential review workload and plan 
the review.

The letter of intent is to be sent by the date listed at the beginning of 
this document.  The letter of intent should be sent to:

Director
Office of Extramural Affairs
National Institute on Drug Abuse
6001 Executive Blvd., Room 3158, MSC 9547
Bethesda, MD  20892-9547
Phone:  (301) 443-2755

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 710-0267, 
Email:  [email protected].

SUPPLEMENTAL INSTRUCTIONS

Specific content must be present in the application to document the technical 
and scientific merit of the applicant"s plan for a Research Center or a 
Coordinating Center that will address the fundamental goals and collaborative 
nature of the CJ-DATS. 

The use of tables, diagrams, and organizational and flow charts is strongly 
encouraged and will be counted toward page limits as described below.

The application should conform to the general instructions and requirements 
(e.g., for font size and page limits) of the PHS 398 (rev. 5/2001) with the 
exceptions noted below.   

Sections a-d should not be organized according to Specific Aims, Background 
and Significance, etc. as stated in the PHS 398 application kit.  Replace 
sections a-d with the following sections numbered 1-4.  The total page limit 
for the sum of sections 1-4 is 30.

1.  Understanding of the Mission of the CJ-DATS 
(For Coordinating Center and Research Center Applications)

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

2.  Internal Administration and Collaborative Plans

The administrative and managerial qualifications and experience of the PI 
must be described to provide evidence of skills in managing and coordinating 
research endeavors.  The skills of other personnel involved in administration 
and management of the research should also be clear.  Evidence of 
participation in relevant multisite studies is essential.  The Principal 
Investigator must commit 33 percent or more effort to the CJ-DATS.

Plans for communication and data management operations within the Center 
should be specified.  Diagrams and descriptions of proposed intra-Center 
committee structures and decision-making procedures should be provided.  
Communication and coordination plans for working with involved agencies 
(e.g., criminal justice agencies, parole boards, treatment providers) should 
be given, as should be plans for developing such relationships as 
appropriate.  The quality of partnerships among collaborating components of 
the Center should be addressed in detail.

The plans should elaborate on infrastructure capabilities for project 
management, study design and development, and data systems. 

(For Research Centers)

Plans for functioning as a "Lead Center" and as a collaborating Center should 
be addressed.  An approach for recruiting other Centers" participation, 
coordinating implementation of studies across sites, providing training, and 
monitoring progress should be given.  The application should explain how 
communications with other Centers and the Steering Committee would occur.  
Plans for receipt and management of data, for analysis, for data sharing, and 
dissemination should be clear.  Logistic and executive secretariat issues 
should be addressed.

(For Coordinating Center)

Plans for fulfilling the consultative role of the Coordinating Center should 
be provided.  The application should address how the Coordinating Center 
might collaborate with Research Centers and NIDA to refine interventions and 
to assist the Steering Committee in designing and implementing cooperative, 
multisite studies that might be led by itself or a Research Center.  Plans 
for assisting with data quality control, training for data collection, and 
analysis should be given.  Plans for developing and evaluating ideas for 
cross-site data analyses and for serving as a repository for data collected, 
including preparation of public use data sets, should be clear.  Potential 
needs of other Centers and participants in the CJ-DATS should be anticipated 
and addressed, as should be the challenges in fulfilling those needs. 

This section should also include plans for addressing the logistic needs of 
the CJ-DATS, including coordinating meetings of the Steering Committee, 
subcommittee, and workgroups, as well as distributing preparatory and post-
meeting documents. 

Plans for disseminating the results of the CJ-DATS activities to the public, 
providers, policy makers, researchers, and others who may be interested 
should be provided.  The proposed content of a CJ-DATS website and structure 
of that website should be provided.  The plans should describe innovative 
approaches to data sharing and for the dissemination of research findings, as 
well as for development of tools to promote use of research.

3.  Research Capacity

(For Research Centers Applications)

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

The application should provide detailed descriptions of the programs, 
agencies, or institutions that will participate in the first year and include 
detailed descriptions of relevant program/system and offender/patient 
characteristics.  This description is limited to two pages of text and one 
page for charts and tables for each discrete participating program, agency, 
or institution.  The appendix should contain letters of agreement from the 
institution, agency, or program directors.  The plan should provide evidence, 
where possible, of successful collaborations with these groups or plans for 
the development of successful collaborations.

The program descriptions must include at least one prison or jail that will 
participate in the first year.  Similarly, there should be a description of 
at least one parole department that will participate in the first year.  The 
description of each (limited to two pages of text and one page for charts and 
tables as noted), should include offender characteristics, program 
characteristics, numbers of drug abusing or addicted individuals available 
for treatment, and evidence that sufficient patients of diverse racial and 
ethnic background could be recruited.

The program descriptions must also address the treatment program 
infrastructure and document that at least two treatment programs will 
participate in the first year.  There should be details on the 
characteristics of the program, patients, patient flow, treatment delivered, 
and staff structure and characteristics.  This description is limited to two 
text pages and one page for charts and tables as above, and should document 
the ability to recruit and retain subjects.

The plan should document the ability of the Center to deliver a variety of 
standard and experimental interventions, to implement system level 
modifications, and to study system level issues relevant to the goals of the 
RFA.  The application should evidence anticipation of problems and challenges 
in conducting the research and plans for resolving them.  Plans for assuring 
adequate staffing of research endeavors, collecting data, managing data, and 
analyzing it should be present. 

(For Coordinating Center Applications)

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

Because the Coordinating Center will provide the CJ-DATS with the capacity 
for baseline surveys, special expertise on organizational culture and change, 
and cross-study meta-analyses or other studies requiring integration of data 
across studies, the capacity of the Center to conduct those research studies 
should be explained.  The application should evidence anticipation of 
problems and challenges in conducting the research and plans for resolving them.

Procedures and structures for ensuring input and collaboration with advisory 
groups of criminal justice providers, parole boards, and treatment agencies 
should be made clear.

4.  Research Concepts
(For Coordinating Center and Research Center Applications)

Applications should not propose detailed research protocols but should 
provide two or three specific examples of research concepts and abbreviated 
plans that could be undertaken and are consistent with the goals of the RFA 
to take advantage of the unique capabilities of the CJ-DATS.  The Research 
Center application should present concepts consistent with its role in the 
CJ-DATS, and the Coordinating Center should similarly present concepts 
consistent with its role.

The research concepts for the proposed studies should include, as applicable, 
a statement on the significance of the research and how it uses the CJ-DATS 
resources, descriptions of research study design, interventions, outcome 
measures, and statistical considerations, access to subjects, procedures for 
data management, quality control and follow-up, procedures for monitoring and 
reporting adverse events, and information on human subjects protections.  
Each concept is limited to four pages.

The concepts are included in the application to provide evidence of the 
applicant"s conceptualization of and approach to CJ-DATS research, and the 
concepts given in the application will not necessarily be implemented in 
the CJ-DATS.

Human Subjects

Human Subjects Research (PHS 398 Research Plan section E) instructions have 
been revised and must be addressed in the application, no specific page 
limits apply, but the plans must be complete and concise.  The application 
should describe plans for human subject protections, for data safety 
monitoring, and for representation among patient populations.

Budget

The budget and accompanying justification are not part of the 30 page limit. 
(See below for page limits.)  Applicants should include budget estimates and 
plans for participating in the CJ-DATS, organized around the areas of 
research planning, core functions, drug abuse treatment and criminal justice 
collaboration, and administrative and management plans.  

The applicant should prepare a separate budget for:  1) infrastructure to 
enable the Center to provide core functions (e.g., personnel, facilities, 
equipment, supplies, training costs, logistic support, travel, etc.), 2) 
research project specific costs such as research assistants, study 
implementation costs, staff for data collection, management, and analysis, 
treatment expenses related to the research (excluding costs of routine 
treatment), any laboratory costs, monitoring costs, publications costs, and 
3) other research costs needed to support research in the CJ-DATS.  As noted 
elsewhere in this RFA, funds for travel should be included to provide for 
participation in CJ-DATS related meetings.  The budget should assume each 
site will be the Lead Center for one study and a participating center for 
one study. 

Page Limits

The total length of the Research Plan, including the research concepts and 
administrative and management plan should not exceed 30 pages.  Descriptions 
of participating agencies should not exceed two pages of text and one page 
for charts and tabular data, research concepts should not exceed four pages 
per concept.  Literature Cited and Consortium/Contractual Arrangements 
sections should be provided following the 30 pages and in total should not 
exceed 10 pages.  No specific page limits apply to the Human Subjects 
section, Gender, Child, and Minority inclusion sections, or data safety and 
monitoring plans.

USING THE RFA LABEL

The RFA label available in the PHS 398 (rev. 5/2001) application form must be 
affixed to the bottom of the face page of the application.  Type the RFA 
number on the label.  Failure to use this label could result in delayed 
processing of the application such that it may not reach the review committee 
in time for review.  In addition, the RFA title and number must be typed on 
line two of the face page of the application form and the YES box must be 
marked. The RFA label is also available at:  
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.

SENDING AN APPLICATION TO THE NIH

Submit a signed, typewritten original of the application, including the 
Checklist, and three signed, photocopies, in one package to:

Center For Scientific Review
National Institutes Of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

At the time of submission, two additional copies of the application must be 
sent to:

Direct inquiries regarding review matters to:

Teresa Levitin, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, Maryland  20892-9547
Telephone:  (301) 443-2755
FAX:  (301) 443-0538
Email:  [email protected]

APPLICATION PROCESSING

Applications must be received by the application receipt date listed in the 
heading of this RFA.  If an application is received after that date, it will 
be returned to the applicant without review.

The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application.  The 
CSR will not accept any application that is essentially the same as one 
already reviewed.  This does not preclude the submission of substantial 
revisions of applications already reviewed, but such applications must 
include an Introduction addressing the previous critique.

PEER REVIEW PROCESS  

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by NIDA.  Incomplete and/or non-responsive applications will 
be returned to the applicant without further consideration.  Applications 
failing to provide required information about human subjects, data safety and 
monitoring, data sharing, and inclusion of gender, minorities, and children 
will be considered incomplete.

Applications that are complete and responsive to the RFA will be evaluated 
for scientific and technical merit by an appropriate peer review group 
convened by NIDA in accordance with the review criteria stated below.  As 
part of the initial merit review, all applications will:

o  Receive a written critique
o  Undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications under 
review, will be discussed and assigned a priority score
o  Receive a second level review by the National Advisory Council on Drug Abuse

REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to address the criteria below 
in order to judge the likelihood that the proposed work will have a 
substantial impact on the pursuit of these goals. 

1.  Understanding of the Mission of the CJ-DATS 
(Coordinating Center and Research Center Applications)

How well does the application demonstrate an understanding of the scientific 
agenda of the CJ-DATS?  How innovative is the vision the application presents 
for utilization of the CJ-DATS?

2a.  Internal Administration and Collaborative Plans
(Coordinating Center and Research Center Applications)

How strong are the administrative and managerial qualifications of the PI and 
key staff?  Is there evidence of sufficient dedication of time and other 
resources to the work?  How clear and feasible are plans for project 
management, coordination and communication?  How well developed are the plans 
for data management?  Are intra-center decision making procedures specified 
and workable?  What is the quality of the partnership with various agencies, 
as depicted in the administration plans?  How sufficient and efficient is the 
infrastructure for project management, study design and development, and data 
systems activities? 

2b.  Internal Administration and Collaborative Plans
(Research Centers)

How well developed are the plans for functioning as a "Lead Center" and as a 
collaborating site?  Are recruitment and implementation plans well delineated 
and reasonable?  How well developed are the plans for cross-Center 
communication and communication with the Steering Committee.  Are plans for 
data sharing and other data needs appropriate?  How good are the plans for 
addressing logistic and executive secretariat needs?

2c.  Internal Administration and Collaborative Plans
(Coordinating Center)

What is the quality of the plans for serving as a consultative center to the 
CJ-DATS?  How developed are the approaches for providing consultation on 
design, implementation, and analysis?  How well are data quality control, 
training, and data repository needs addressed?  How well are other needs and 
challenges addressed?

What is the quality of the plan for serving as a data repository?  How 
feasible and developed are the logistic support and operational support 
plans?  How well developed are the plans for including a CJ-DATS website, for 
disseminating findings to various groups, and for using appropriate 
technological resources?  How strongly does the record of experience in these 
areas support the application?

3a.  Research Capacity
(Research Centers Applications)

What is the quality of the scientific expertise and productivity within the 
Research Center, especially with respect to complex multisite studies of the 
criminal justice system and drug abuse?  How would the Research Center 
interact with the Coordinating Center?  What is the quality of and how 
appropriate are the participating agencies, especially in regard to providing 
sufficient patients, research support, and intellectual resources to the CJ-
DATS?  How well does the application document the ability of the Center to 
deliver a variety of standard and experimental interventions, to implement 
system level modifications, and to study system level issues relevant to the 
goals of the RFA?  How well does the application evidence anticipation of 
problems and challenges in conducting the research and plans for resolving them?

3b.  Research Capacity
(Coordinating Center Applications)

What is the quality of the scientific expertise within the Coordinating 
Center, especially with respect to complex multisite studies of the criminal 
justice system and drug abuse?  How would the Coordinating Center interact 
with Research Centers to accomplish CJ-DATS goals?  What is the capacity of 
the Coordinating Center to conduct baseline studies, organizational change 
studies, and other studies unique to the role of the Coordinating Center as 
specified in the RFA?   How well specified are the procedures and structures 
for ensuring input and collaboration with advisory groups of criminal justice 
providers, parole boards, and treatment agencies?

4.  Research Concepts
(Coordinating Center and Research Center Applications)

How well do the concepts take advantage of the unique capabilities of the CJ-
DATS and the role of a Research Center or Coordinating Center (according to 
the type of application)?  How significant are the ideas and do the plans 
evidence reasonable methodologies and approaches?

ADDITIONAL REVIEW CRITERIA

In addition to the above criteria, your application will also be reviewed 
with respect to the following:

o  PROTECTIONS:  The adequacy of the proposed protection for humans 
(including data safety monitoring plans), animals, or the environment, to the 
extent they may be adversely affected by the project proposed in 
the application.

o  INCLUSION:  The adequacy of plans to include subjects from both genders, 
all racial and ethnic groups (and subgroups), and children as appropriate for 
the scientific goals of the research.  Plans for the recruitment and 
retention of subjects will also be evaluated.  (See Inclusion Criteria 
included in the section on Federal Citations, below)

o  BUDGET:  The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:    April 12, 2002
Application Receipt Date:         May 13, 2002
Peer Review Date:                 July 2002
Council Review:                   September 2002
Earliest Anticipated Start Date:  September 30, 2002

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o  Scientific merit (as determined by peer review)
o  Availability of funds
o  Programmatic priorities.

REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD:  Research components 
involving Phases I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 
1998:  http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH:  It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of 
the research.  This policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43).

All investigators proposing clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), 
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.  
The amended policy incorporates: the use of an NIH definition of clinical 
research, updated racial and ethnic categories in compliance with the new OMB 
standards, clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398, and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable, and 
b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:  
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported 
by the NIH, unless there are scientific and ethical reasons not to include 
them.  This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS:  NIH 
policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT:  The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this RFA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application.  In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

HIV/AIDS COUNSELING AND TESTING POLICY FOR THE NATIONAL INSTITUTE ON DRUG 
ABUSE:  Researchers funded by NIDA who are conducting research in community 
outreach settings, clinical, hospital settings, or clinical laboratories and 
have ongoing contact with clients at risk for HIV infection, are strongly 
encouraged to provide HIV risk reduction education and counseling.  HIV 
counseling should include offering HIV testing available on-site or by 
referral to other HIV testing services.  Persons at risk for HIV infection 
including injecting drug users, crack cocaine users, and sexually active drug 
users and their sexual partners.  For more information see 
http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES:  All applications and proposals 
for NIH funding must be self-contained within specified page limitations.  
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) 
should not be used to provide information necessary to the review because 
reviewers are under no obligation to view the Internet sites.  Furthermore, 
we caution reviewers that their anonymity may be compromised when they 
directly access an Internet site.

HEALTHY PEOPLE 2010:  The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of "Healthy 
People 2010," a PHS-led national activity for setting priority areas.  This 
RFA is related to one or more of the priority areas.  Potential applicants 
may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS:  This program is described in the Catalog of 
Federal Domestic Assistance No. 93.279, and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under authorization of Sections 301 
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and 
administered under NIH grants policies described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92.

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the use of all tobacco products.  In addition, 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities (or in some cases, any portion of a facility) in which 
regular or routine education, library, day care, health care, or early 
childhood development services are provided to children.  This is consistent 
with the PHS mission to protect and advance the physical and mental health of 
the American people. 

REFERENCES

Hora, P. F., Schma, W. G., Rosenthal, J. T. A. (1999).  Therapeutic 
jurisprudence and the drug treatment court movement: Revolutionizing the 
criminal justice system"s response to drug abuse and crime in America.  Notre 
Dame Law Review, 74(2), 439-537.

McLellan, A. T., Lewis, D. C., O"Brien, C. P., Kleber, H. D. (2000).  Drug 
dependence, a chronic medical illness: Implications for treatment, insurance, 
and outcomes evaluation.  JAMA: Journal of the American Medical Association, 
284(13), 1689-1695.

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