Full Text DA-95-004

COOPERATIVE DRUG ABUSE TREATMENT OUTCOME STUDY

NIH GUIDE, Volume 24, Number 16, May 5, 1995

RFA:  DA-95-004

P.T.


Keywords: 


National Institute on Drug Abuse

Letter of Intent Receipt Date:  June 23, 1995
Application Receipt Date:  July 21, 1995

PURPOSE

The purpose of this Request for Applications (RFA) is to support a
cooperative agreement to study drug abuse treatment in typical,
stable programs.  Investigators may propose research based on or
incorporating existing data sets to which they have access.  Under
the cooperative agreement, the National Institute on Drug Abuse
(NIDA) will also make available data collected under NIDA contracts
(the "DATOS family of studies") for further collaborative analyses.
Cooperative agreement investigators will also design and conduct
follow-up studies of drug abuse treatment clients that were
interviewed in the DATOS family of studies.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This RFA,
Cooperative Drug Abuse Treatment Outcome Study, is related to the
priority area of alcohol and other drugs.  Potential applicants may
obtain a copy of "Healthy People 2000" (Full Report:  Stock No.
017-001-00474-0 or Summary Report:  Stock No. 017-001-00473-1)
through the Superintendent of Documents, Government Printing Office,
Washington, DC 20402-9325 (telephone 202-783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic for-profit and non-profit
organizations, such as universities, colleges, hospitals,
laboratories, units of State and local governments, and eligible
agencies of the Federal government.  Applications from minority and
women investigators are encouraged.

MECHANISM OF SUPPORT

The administrative and funding instrument to be used for this program
will be a cooperative agreement (U01), an "assistance" mechanism, in
which substantial NIH scientific and/or programmatic involvement with
the awardee is anticipated during the performance of the activity.
Under the cooperative agreement, the NIH purpose is to support and/or
stimulate the recipient's activity by involvement in and otherwise
working jointly with the award recipient in a partner role, but it is
not to assume direction, primary responsibility, or a dominant role
in the activity.  Details of the responsibilities, relationships, and
governance of the study to be funded under cooperative agreement(s)
are discussed later in this document under the section "Terms and
Conditions of Award."

The total project period for applications submitted in response to
the present RFA may not exceed five years.  The anticipated award
date is September 30, 1995.  Because the nature and scope of the
research proposed in response to this RFA may vary, the size of an
award will also vary.

Awards and level of support depend on receipt of a sufficient number
of applications of high scientific merit.  Although this program is
provided for in the financial plans of the Institute, awards pursuant
to this RFA are contingent upon the availability of funds for this
purpose.

At this time NIDA anticipates that there will be a renewed
competition after five years.  If NIDA does not continue the program,
awardees may submit grant applications through the usual
investigator-initiated grants program.

FUNDS AVAILABLE

It is anticipated that approximately $1.3 million will be available
to support the first year of the Cooperative Drug Abuse Treatment
Outcome Study.  It is anticipated that one award for the Coordinating
Center will be made and two awards for Field Research Collaborative
Centers will be made.  The budget for the Coordinating Center is
expected to be approximately one-third of the total in the first
years but to increase proportionally, commensurate with follow-up
fieldwork expenses, in the third through fifth years.

RESEARCH OBJECTIVES

Background

The effectiveness of publicly-funded drug abuse treatment in treating
heroin and opioid addiction was established by studies such as the
Drug Abuse Reporting Program (DARP) and the Treatment Outcome
Prospective Study (TOPS), which were conducted on cohorts entering
treatment in 1969-73 and 1979-81, respectively.  Since TOPS, patterns
of drug use and the characteristics of clients presenting for drug
treatment have changed, and major changes have taken place in the
drug treatment system itself.  These changes include the appearance
of HIV/AIDS in drug abuse treatment populations, transmitted through
injection drug use and drug-related sexual behavior; and the entry of
new populations of drug users into treatment following the emergence
of cocaine as a primary drug of abuse.  At the treatment
program/system level, changes include decreased levels of funding,
the emergence of private third-party payors for drug abuse treatment,
the significant development of a new modality (short-term inpatient
care), and the evolution of existing treatment modalities related to
funding changes and changes in patterns of drug use.

Because of changes in treatment programs and practices, in client
characteristics, and in drug use patterns, too little is currently
known about the effectiveness of drug abuse treatment delivered in
typical programs in the community despite a continuing need to
understand what bearing these factors have on treatment outcomes.
Furthermore, there are important research questions that could not be
addressed in DARP or TOPS that may be examined with more recent data,
such as the role of psychopathology in treatment outcomes.

A broad range of important drug abuse treatment and health services
research questions may be addressed through analyses of existing
data, including data from investigator-initiated research and data
from previous large-scale research and evaluation studies, such as
TOPS.  Under the cooperative agreement, NIDA will also make available
three current databases it has developed under contract.  These
databases were created under the DATOS, DATOS-Adolescent, and CTOS
research, and are described briefly below.  Cooperative agreement
investigators are encouraged to capitalize on NIDA's investment in
these studies by using data from the DATOS family of studies to
conduct intensive collaborative analyses.

DATOS family of studies.  In 1989, NIDA initiated a series of studies
whose goals, broadly, were to investigate drug abuse treatment in
typical, stable programs in order to characterize treatment as it is
usually delivered and its effectiveness for current treatment
populations and drug abuse patterns; to investigate the role of
client and program characteristics in determining outcomes; and to
investigate the relation between impairment and outcomes during and
after treatment.  The DATOS family of studies includes the Drug Abuse
Treatment Outcome Study (DATOS), the Drug Abuse Treatment Outcome
Study of Adolescents (DATOS-Adolescent), and the Cocaine Treatment
Outcome Study (CTOS).  Each of these studies was developed and
carried out under separate NIDA contracts with the Research Triangle
Institute (RTI).

The DATOS studies provide rich databases with potential to address
important questions in treatment outcome and health services
research.  Data were collected in a number of domains, including
demographics, alcohol and drug use, physical and mental health,
income, illegal involvement, employment, cognitive functioning,
motivation and readiness, HIV/AIDS risk behavior, and treatment
process and outcomes.  In each study, the data sets that were
acquired were deliberately designed to contain far more research
potential than can be realized under the existing contract
procurements.  Refer to Table 1, "Points of Interview in DATOS During
and After Treatment," which is available from the program staff
listed under INQUIRIES.

For purposes of developing an informed application, DATOS, DATOS-
Adolescent, and CTOS research design and instrumentation packages are
available by written request from the Services Research Branch, at
the address listed under INQUIRIES.

DATOS.  The Drug Abuse Treatment Outcome Study is a longitudinal
prospective study of adults entering drug abuse treatment programs in
1991-1993.  Drug abuse treatment programs were purposely chosen to
represent drug abuse treatment delivered in typical stable programs.
Program-level and client-level data were obtained.  Under DATOS,
intake data were collected on 10,000 adults in 99 drug abuse
treatment programs in 11 cities.  Data were collected at 1 and 3
months during treatment and at 12 months after treatment.  The study
obtained data on clients in four types of treatment programs,
including methadone maintenance, short-term residential (hospital
inpatient, chemical dependency), long-term residential (therapeutic
community), and outpatient drug-free treatment.  The 12-month
follow-up sample of 4,500 was drawn from 85 programs.  The follow-up
is stratified on treatment modality, drug pattern, impairment level,
and length of time in treatment.

The major goal of DATOS is to evaluate treatment effectiveness.  As
part of this, secondary goals are to describe current drug abuse
treatment populations in terms of demographic characteristics,
psychological variables, sociocultural variables, treatment history,
tenure, and during-treatment behaviors; to characterize existing
modalities and interventions of treatment; to determine the relation
between psychological impairment and treatment outcomes; and to
determine the relationship between treatment outcomes and important
client, program, and treatment factors.

DATOS-Adolescent. The Drug Abuse Treatment Outcome Study of
Adolescents is a longitudinal prospective study of drug abuse
treatment effectiveness in the adolescent population based on a
sample of outpatient and residential drug abuse treatment programs
for adolescents.  The methodology, research design, instrumentation,
and objectives of DATOS-Adolescent are designed to parallel DATOS
where possible.  DATOS-Adolescent began in 1991 and is still
underway.  Under DATOS- Adolescent, intake and follow-up data will be
collected from approximately 1,500 collateral or family members and
3,000 adolescents in approximately 35 public and private drug abuse
programs in 8 to 10 cities from mid-1993 through early 1995.

CTOS. The Cocaine Treatment Outcome Study is an accelerated, 2-year
retrospective study of 772 clients from 23 DATOS program sites in
seven cities (Chicago, Miami, Minneapolis, New York, Pittsburgh,
Portland, and New Orleans), based on clinical records and a 12-month
follow-up interview.  The follow-up interview is identical to that
used in DATOS, and baseline data were obtained retrospectively (at
follow-up) to supplement clinical records.  The goal of the study is
to rapidly acquire more knowledge about outcomes for clients admitted
to treatment with a primary diagnosis of cocaine dependence.

Program Objectives

This cooperative study has two objectives.  The first objective is to
conduct studies to learn more about treatment received in typical
community-based drug abuse treatment programs, particularly with
regard to questions of treatment effectiveness and outcomes, as well
as other questions related to health services, such as access to and
utilization of treatment services, and cost-effectiveness of
treatment.  Studies may be carried out using data from the public
domain or data from other research and evaluation studies.  It is
expected that databases from the DATOS family of studies will
constitute significant resources in meeting this objective.

The second objective is to carry out long-term follow-ups of drug
abuse treatment clients in the DATOS family of studies.  This
includes: a 36-month follow-up of adults in DATOS to assess drug use
patterns and outcomes in the three years after treatment, investigate
factors predictive of relapse, and identify patterns of health
service utilization over time; and a 24-month follow-up of
adolescents and their family members or collaterals in DATOS-
Adolescent.

Program Components

This study will involve the cooperation of investigators from a
Coordinating Center, Field Research Collaborative Centers, and the
NIDA Services Research Branch, Division of Clinical and Services
Research, in conducting treatment and health services research
studies.  Under the cooperative agreement, it is anticipated that one
Coordinating Center and two Field Research Collaborative Centers will
be supported.  Separate applications are being solicited for a
Coordinating Center and for Field Research Collaborative Centers to
participate in this collaborative study.  If an institution chooses
to apply for multiple awards, there should be no overlap in research
and support personnel.

Coordinating Center

The Coordinating Center has two unique functions.  The first involves
coordinating cross-site cooperative study project initiatives.  The
second involves follow-up data collection activities.

Coordination of cross-site activities

The Coordinating Center will be responsible for all executive
secretariat functions, including organization of Steering Committee
meetings and teleconferences, developing steering committee agendas,
taking minutes of sessions, photocopying and distributing materials
prior to steering committee sessions, and preparation of reports from
the Steering Committee to the NIDA Project Officer (who will not be a
NIDA Collaborating Scientist).  The meeting agenda topics may include
development of research issues, planning of collaborative
arrangements, planning of studies and analyses on defined topics,
discussion of strategies to facilitate expeditious dissemination of
cooperative agreement research findings, progress reports, and
reports of scientific findings.

The Coordinating Center will function as a repository for data to be
analyzed under this cooperative agreement (as permitted by the data
owners), including data from the DATOS family of studies.  The
Coordinating Center will provide documented copies of data sets used
in the cooperative agreement, technical assistance, and programming
support related to data management to other cooperative agreement
investigators.

Follow-up data collection

Not only are data collected in the DATOS family of studies a valuable
resource; they also represent a potential for further long-term
studies of factors that influence the outcomes of individuals treated
for drug abuse.  Follow-up studies may permit investigation of
long-term impacts of changes in drug abuse treatment access,
utilization, and effectiveness; long-term outcomes for those who
entered drug treatment but dropped out prior to engaging in
treatment, including their prior and subsequent treatment history and
investigation of spontaneous remission of drug abuse without
effective treatment; research on sub-groups of particular interest,
such as sub-groups defined by psychopathology, or individuals
abstinent after one treatment contrasted with continuing drug users;
or patterns of drug abuse, service utilization, and outcomes over
time.

Because of the opportunities represented by the DATOS samples and the
valuable expertise that can be provided by the cooperative agreement
investigators, follow-up studies of subjects in the DATOS family of
studies will be carried out under the cooperative agreement.
Investigators from the Coordinating Center and the Field Research
Collaborative Centers will collaborate on the research design and
development of instrumentation for the follow-up studies.

The Coordinating Center will provide fieldwork and administrative
management of the follow-up data collection efforts.  In conducting
the follow-ups, comparability of essential data elements with data
collected under NIDA contract for the 12-month follow-ups will be
maintained.  However, some data elements may be deleted, or it may be
desirable to augment data previously collected.  The cooperative
agreement investigators should be prepared to review and alter
instrumentation based on analyses of data and needs of the field.

The Coordinating Center will insure that procedures for collecting
follow-up data are uniform so that no problems arise with
comparability across sites or across interviewed samples.  The
Coordinating Center will link follow-up data with existing data on
DATOS and DATOS-Adolescent subjects.

Under contract requirements for DATOS and DATOS-Adolescent, locator
information has been retained, with appropriate protection of client
confidentiality, to enable long-term follow-ups of individuals in the
DATOS and DATOS-Adolescent samples.

DATOS follow-up.  It is planned that the Coordinating Center will
carry out a 36-month follow-up of individuals who were in the DATOS
12-month follow-up sample.  The DATOS 12-month follow-up sample frame
consists of 4,500 clients from 85 drug abuse treatment programs.
Coordinating Center applicants should budget to follow up 3,500
individuals.  DATOS programs are in 11 cities--Chicago, Houston,
Miami, Minneapolis, New Orleans, New York, Newark, Pittsburgh,
Phoenix, Portland, and San Jose.  The follow-up will involve
developing and field-testing the follow-up interview; hiring and
training field interviewers to conduct the follow-up interview;
reproducing the 36-month follow-up questionnaire; conducting data
entry, editing, and analysis of data; monitoring the quality of the
follow-up data; and reporting to NIDA and the Steering Committee on
the progress of the follow-up.

DATOS-Adolescent follow-up.  DATOS-Adolescent is the first
longitudinal study of adolescents treated in typical community-based
programs.  As such, it presents a unique opportunity to follow a
cohort of adolescents into adulthood to investigate long-term
drug-using behavior and health service utilization patterns of
clients admitted to drug treatment at an early age.  In addition to
the 36-month follow-up of adults in DATOS, applicants for the
Coordinating Center should anticipate conducting a 24-month follow-up
study of 3,000 adolescents and 1,500 collaterals in the third and
fourth years of the cooperative agreement.

Field Research Collaborative Centers

The Field Research Collaborative Centers will collaborate with each
other, with the Coordinating Center, and with NIDA investigators on
drug abuse treatment studies using existing data sets to which they
have access or data from the DATOS family of studies.  Field Research
Collaborative Centers will also carry out analyses using follow-up
data collected under the cooperative study as these data become
available.

Applicants for Field Research Collaborative Centers should have
expertise in large-scale multi-site services research in order to
identify important research issues and carry out appropriate studies.
Each Field Research Collaborative Center will have a strong research
focus on particular areas relevant to drug abuse treatment evaluation
research and health services research areas.  In making an award,
consideration will be given to Field Research Collaborative Centers
that are complementary rather than overlapping in their areas of
interest.  Areas of research emphasis for a Field Research
Collaborative Center might include:

o  Research on the relationships between client, program, and
treatment factors, and treatment effectiveness.

o  Research on the impact of psychopathology, cognitive functioning,
physical health, and other co-morbid conditions on outcomes during
and after treatment.  Conceptualization and development of a
multidimensional index of impairment.

o  Investigation of models of drug abuse treatment in current
practice, based on treatment structure and process variables,
conceptualization of stage of recovery/readiness for treatment, or
continuity of care models.  Research to update treatment typologies.

o  Program-level health services research, including impact of
various financing and reimbursement strategies on access,
utilization, and outcomes; cost effectiveness of treatment; impact of
health service delivery factors on drug abuse treatment outcomes;
changes in drug abuse treatment and treatment outcomes over time.

All research and analyses will be reviewed and approved by the
Steering Committee, and the Steering Committee may negotiate
collaborative study plans after award so that individual cooperative
agreement components focus on complementary, non-duplicative research
studies.

Field Research Collaborative Center applicants should propose studies
to investigate well-conceptualized research questions.  The intent of
this cooperative agreement is to advance scientific knowledge about
the effectiveness of drug abuse treatment as it is typically
practiced by conducting analyses addressing a wide range of questions
of scientific and policy relevance.  While not exhaustive, the
following general areas may serve as points of departure for
cooperative agreement studies:

o  Drug use prior to, during, and after treatment.

o  Prevalence of multiple impairments in the population entering drug
abuse treatment, and relation to outcomes.

o  Changes in mental health indicators during treatment.  The role of
psychological factors in drug abuse treatment.

o  Factors related to treatment retention.

o  Comparison of services and process in different types of
treatment.

o  Comparison of problem areas (e.g., Addiction Severity Index
problem domains) before and after treatment.

o  Comparative costs and benefits of drug abuse treatment, by
modality.

o  Impact of legal involvement on treatment entry, retention, and
outcomes.

o  Effectiveness of interventions to reduce HIV/AIDS risk behaviors
during and after treatment.

Collaborative analyses of follow-up data.  The conceptualization of
addiction as a recurrent disorder marked by cycles of drug use,
abstinence, and relapse raises new questions on the design, delivery,
and utilization of health services.  Research is needed to examine
the long-term outcomes of drug abuse treatment in sub-groups defined
by gender, race/ethnicity, age, and psychological functioning.
Although not an exhaustive list, follow-up research may include:

o  The long-term impact of changes in drug abuse treatment access,
utilization, and effectiveness.

o  Long-term outcomes for individuals that entered drug treatment but
dropped out prior to engaging in treatment, including their prior and
subsequent treatment history and investigation of spontaneous
remission of drug abuse without effective treatment.

o  Investigation of sub-groups of particular interest, such as
individuals abstinent after one treatment contrasted with continuing
drug users.

o  Patterns of drug abuse, service utilization, and outcomes over
time.

Comprehensive findings from the cooperative agreement studies should
be widely available and accessible to maximize their benefits to the
drug abuse treatment and research fields.  An important element of
the collaborative analyses will be to disseminate cooperative
agreement research findings by participating in scientific meetings
and publishing in the scientific literature.

Applicants may propose collaboration with other investigators who are
not cooperative agreement key staff in order to benefit from external
expertise and to facilitate working with other useful data sets.

Steering Committee

The Steering Committee will be the primary governing board of the
cooperative study and will decide all major scientific decisions.  It
will be composed of the Principal Investigator of the Coordinating
Center, the Principal Investigators of the Field Research
Collaborative Centers, and two NIDA Collaborating Scientists.  Only
one NIDA Collaborating Scientist will vote.

The Steering Committee will create and implement study plans in three
areas:  (1) a plan of systematic research on treatment outcomes and
health services issues in typical community-based drug abuse
treatment programs, (2) 36-month follow-up data collection of DATOS
subjects, and (3) 24-month follow-up data collection of
DATOS-Adolescent subjects.  The study plans developed by the Steering
Committee may be different than any of the individual proposals; they
may be based on a study proposed in one of the awardee's
applications, may combine elements of studies proposed by the
Coordinating Center and Field Research Collaborative Centers, or may
be based on independent deliberations of the Steering Committee.

In developing a research plan for treatment outcome and health
services research, studies should be designed to increase knowledge
of outcomes of treatment delivered in typical community-based drug
abuse treatment programs.  Consideration may be given to available
and appropriate data resources, prioritization of research questions
with regard to importance or other factors, new data that might be
needed that could be obtained through cooperative agreement follow-up
studies, and means for disseminating research findings to the
scientific field as well as to a broader audience.

At a minimum, planning the follow-up studies will involve reviewing
past research procedures and protocols to identify changes that
should be made and new research questions that should be addressed,
as well as planning for pilot testing of the interview, hiring and
training field interviewers, locating subjects, and conducting the
interviews.

Study plans will include the research design, data issues, analytic
plans, and planned publications or reports, as well as detailed
implementation procedures including staffing, resource utilization,
and time lines.  Plans will be periodically reviewed and evaluated by
the Steering Committee.

Subcommittees may be created by the Steering Committee to consider
narrowly defined topics, such as methodology, data acquisition, or
publication policies and procedures.  Subcommittee membership will be
limited to Principal Investigators or their representatives, NIDA
Collaborating Scientists, and one or two technical experts.
Subcommittees should be balanced so that the interests of each
awardee and NIDA are fairly represented.  Final approval and
responsibility for topics considered by a subcommittee will reside in
the Steering Committee.

The Steering Committee will develop policies on data sharing, on
access to data and materials, and on publication authorship.  As a
special task, the Steering Committee will develop a plan for the
release of DATOS data collected under contract to the public domain
in order to assure accessibility of DATOS research files to
researchers in the drug abuse field, while also insuring insofar as
possible appropriate use of data.  The Steering Committee will also
consider release of the Cooperative Drug Abuse Treatment Outcome
Study data to the public domain.

Publication policies covering all aspects of the Cooperative Drug
Abuse Treatment Outcome Study will be developed by the Steering
Committee.  NIH policies regarding publication apply to NIDA
Collaborating Scientists or other NIDA staff, and any policy
regarding NIDA staff developed by the Steering Committee must be
consistent with current NIH policy.  The Steering Committee will
develop a plan for publications, set up guidelines on authorship, and
implement review procedures to maintain high scientific quality.  The
quality of publications resulting from the study will be the
responsibility of authors; no NIDA clearances will be required except
for NIDA staff who serve as coauthors (see NIDA Collaborating
Scientist responsibilities).

The Steering Committee will meet approximately two to three times a
year, but up to five meetings may be required in the first year
(usually in the Washington, DC area).  Steering Committee
teleconferences will be held on a monthly basis.

Timetable

It is envisioned that the Cooperative DATOS will be conducted over
five years and will encompass several concurrent activities.

The first priority will involve the establishment of the Steering
Committee roles and responsibilities, described in more detail below.
This activity will be completed within 3 months of award of the
cooperative agreement.

The second priority will be the development and implementation of the
DATOS follow-up research designs.  Following development of the
research design and implementation plan, data collection for the
36-month follow-up study should begin in the first year of the
cooperative study and be completed in the second year.  In the second
year of the DATOS cooperative study, designing the 24-month follow-up
of the DATOS-Adolescent sample should begin.  The 24-month follow-up
should be carried out in the third and fourth years of the
cooperative study.

Concurrent with the follow-up field research, the Steering Committee
will meet to develop and implement a plan of systematic research on
questions relevant to drug abuse treatment and health services issues
in typical community-based drug abuse treatment programs.

Budget and Related Issues

Applicants for the Coordinating Center must budget appropriately to
conduct the follow-up data collection.  Applicants should budget for
3,500 DATOS follow-up interviews, for 3,000 DATOS-Adolescent youth
interviews, and for 1,500 DATOS-Adolescent collateral interviews.
Urinalysis and hair analysis data should be obtained from an adequate
sample of the follow-up to estimate the validity of self-report data.
Follow-ups conducted by RTI averaged 10 hours per subject, including
the interview itself (which averaged 90 minutes) and locating the
subject.  Subjects in DATOS were paid $15 per follow-up interview and
$10 for urine specimens.

Cooperative agreement funds may be used for expenses clearly
necessary to carry out the research project being supported by the
award.  Expenses may include direct costs that can be specifically
identified with the project and allowable indirect costs for the
applicant institution.

SPECIAL REQUIREMENTS

To insure the success of the cooperative study, applicants must be
able to interact effectively with other participating investigators.
Applicants should state their willingness to follow the study plans
that will be developed by the Steering Committee.

Applicants for the Coordinating Center must demonstrate the
availability of adequate research and office facilities to carry out
proposed Coordinating Center objectives, including adequate access to
the relevant drug abuse and health services literature. The
Coordinating Center is expected to be a repository of reference
materials that may be obtained under the cooperative agreement.

Applicants for the Coordinating Center should be able to demonstrate
expertise in conducting large-scale follow-up research, and in
managing large data sets.  Relevant support services and adequate
data processing facilities must be readily accessible, and reasonable
assurances of such support must be included with the proposal.

Field Research Collaborative Center applicants must demonstrate the
availability of adequate research facilities to carry out proposed
Field Research Collaborative Center objectives.

Research training costs are not allowed under this cooperative
agreement.  However, provision should be made for research training
opportunities for graduate- and post-doctoral investigators within
each Center.  Applicants are encouraged to seek training support from
other funding sources within and outside NIDA.

The following terms and conditions will be incorporated into the
award statement and provided to the Principal Investigator(s) as well
as the institutional official at the time of award.

Terms and Conditions

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

Awardee Rights and Responsibilities

Awardees have primary and lead responsibilities for their component
of the project as a whole, including collaboration with other
awardees and with the NIDA Collaborating Scientists, as well as data
collection, quality control, data analysis and interpretation,
definition of objectives and approaches, and publication of research
results, interpretations, and conclusions.

Awardees will participate on the Steering Committee as described
under Collaborative Responsibilities and on subcommittees as
appropriate.  Awardees will have access to data collected under these
awards, subject to rules formulated by the Steering Committee, and
Government rights of access consistent with current DHHS, PHS, and
NIH policies.

Collaborative Responsibilities

Steering Committee.  A Steering Committee, composed of the Principal
Investigator of the Coordinating Center, the Principal Investigators
of the Field Research Collaborative Centers, and the NIDA
Collaborating Scientists, will be the primary governing board of the
study and will have primary responsibility for identification,
review, and development of research issues and plans for analytic
studies; review of proposed collaborative arrangements, including
arrangements between cooperative study investigators, NIDA staff not
part of the agreement, supervised students, and researchers external
to the cooperative agreement invited to collaborate on specific
studies due to their particular expertise; monitoring of progress of
ongoing data collection and analyses; reporting of scientific
findings; and development of dissemination strategies for a spectrum
of audiences from scientist to non-professional.

Steering committee decisions will be determined by majority vote. The
principal investigators from each Field Research Collaborative Center
and the Coordinating Center will each have one vote.  Only one of the
NIDA Collaborating Scientists will vote.  The chairperson, who will
be someone other than a NIDA Collaborating Scientist, will be
selected by the Steering Committee.  Additional non-voting
consultants may be appointed to the Steering Committee as needed.
Subcommittees will be established by the Steering Committee, as it
deems appropriate; the Collaborating Scientists will serve on
subcommittees as they deem appropriate.  Awardees must agree to abide
by the study plans and policies developed by the Steering Committee.

NIDA Collaborating Scientist responsibilities.  Two NIDA
Collaborating Scientists will participate in the cooperative study.
NIDA Collaborating Scientists will provide access to data from DATOS,
DATOS-Adolescent, and CTOS, and will facilitate collaborative studies
and dissemination of DATOS-related findings of research and policy
relevance.  NIDA Collaborating Scientists will help to identify
research questions that will have fundamental and timely significance
in national policy discussions regarding the role of treatment in
addressing the problem of drug abuse.

NIDA Collaborating Scientists will participate in the development of
instrumentation, in quality control, in development of the final
study plan, and in coordination of the project.  They will not
participate in activities that directly involve interviewing or
treatment of human subjects.

NIDA Collaborating Scientists may participate, and may engage the
participation of other NIDA staff, in data analysis and
interpretation, and in the preparation of publications.  In instances
where significant involvement in the analysis of results has
occurred, Collaborating Scientists and other NIDA staff may cooperate
with awardees as coauthor(s) in preparing publications resulting from
the research.  In this regard, NIDA staff will be subject to the
publication/authorship policies governing all cooperative agreement
participants.  In addition, publications involving NIDA staff require
internal clearances and are subject to NIH publication policies.

Arbitration

Any disagreement that may arise on scientific/programmatic matters
(within the scope of the award) between award recipients and NIDA may
be brought to arbitration.  An arbitration panel will be composed of
three members--one selected by the Steering Committee (with the NIDA
members not voting) or by the individual awardee in the event of an
individual disagreement, a second member selected by NIDA, and the
third member selected by the two prior selected members.  This panel
will make a decision within 60 days of the request.  Failure to
comply with the decision of the panel may result in termination of
support for an awardee by NIDA.  This special arbitration procedure
in no way affects the awardee's right to appeal an adverse action
that is otherwise appealable in accordance with PHS regulations at 42
CFR Part 50, Subpart D, and DHHS regulations at 45 CFR Part 16.

INCLUSION OF MINORITIES AND WOMEN IN RESEARCH INVOLVING HUMAN
SUBJECTS

It is the policy of the NIH that women and members of minority groups
and their subpopulations must be included in all NIH supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rational and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations), which
have been in effect since 1990.  The new policy contains some
provisions that are substantially different from the 1990 policies.

All investigators proposing research involving human subjects should
read the "NIH Guidelines For Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted
in the NIH Guide for Grants and Contracts, Volume 23, Number 11,
March 18, 1994.

Investigators also may obtain copies of the policy from the program
staff listed under INQUIRIES.  Program staff may also provide
additional relevant information concerning the policy.

LETTER OF INTENT

Prospective applicants are asked to submit, by June 23, 1995, a
letter of intent that includes a descriptive title of the proposed
research, the name, address, and telephone number of the Principal
Investigator, the identities of other key personnel and participating
institutions, and the number and title of the RFA in response to
which the application may be submitted.  Although a letter of intent
is not required, is not binding, and does not enter into the review
of a subsequent application, the information that it contains allows
NIDA staff to estimate the potential review workload and to avoid
conflict of interest in the review.  The letter of intent is to be
sent to:

Director, Office of Extramural Program Review
National Institute on Drug Abuse
5600 Fishers Lane, Room 10-42
Rockville, MD  20857
Telephone:  (301) 443-2755

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these grants.  These forms are available at most
institutional offices of sponsored research; from the Office of
Grants Information, Division of Research Grants, National Institutes
of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892,
telephone 301/435-0714; and from the program administrator listed
under INQUIRIES.

Additional Materials to Include in the Application

Any information that is required as a result of the use of the
cooperative agreement mechanism, including special meetings and
budgetary requirements, and adequate documentation of facilities and
environment to carry out the objectives of the agreement, should be
provided.

Applicants should document their agreement to accept and implement
study plans and procedures approved by the Steering Committee.

The RFA label in the PHS 398 (rev. 9/91) application form must be
affixed to the bottom of the face page of the application.  Failure
to use this label could result in delayed processing of the
application such that it may not reach the review committee in time
for review.  In addition, the RFA title and number must be typed on
line 2a on the face page of the application form and the "YES" box
must be marked.

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

Division of Research Grants
National Institutes of Health
6701 Rockledge Drive, Room 1040  MSC-7710
Bethesda, MD  20892-7710*
Bethesda, MD  20817 (for express/courier service)

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

Director, Office of Extramural Program Review
National Institute on Drug Abuse
5600 Fishers Lane, Room 10-42
Rockville, MD  20857

Applications must be received by July 21, 1995.  If an application is
received after that date, it will be returned to the applicant
without review.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by DRG
and responsiveness by NIDA.  Incomplete and/or non-responsive
applications will be returned to the applicant without further
consideration.  Applications that are complete and responsive to the
RFA will be evaluated for scientific and technical merit by an
appropriate peer review group convened by NIDA in accordance with the
review criteria stated below.

As part of the initial merit review, a process (triage) may be used
by the initial review group in which applications will be determined
to be competitive or non-competitive based on their scientific merit
relative to other applications received in response to the RFA.
Applications judged to be competitive will be discussed and be
assigned a priority score.  Applications determined to be
non-competitive will be withdrawn from further consideration and the
Principal Investigator and the official signing for the applicant
organization will be notified.

Review Criteria

Applicants are encouraged to submit and describe their own ideas
about how best to meet the goals of the cooperative study and their
specific objectives, and are expected to address issues identified
under SPECIAL REQUIREMENTS of the RFA.

The review group will assess the scientific and technical merit of
the proposed study plans and related factors:

o  Significance and originality of the proposed research;

o  Appropriateness and adequacy of the proposed research approach,
methodology, and plans to address special requirements;

o  Qualifications and research experience of the Principal
Investigator and staff, particularly, but not exclusively, in the
area of the proposed research;

o  Availability of the resources necessary to perform the research;

o  Appropriateness of the proposed budget and duration in relation to
the proposed research;

o  Appropriateness of proposed methodology and demonstrated
willingness to work as part of the cooperative study and with NIDA
Collaborating Scientists;

o  Adequacy of provisions for the protection of human subjects; and

o  Adequacy of plans to include both genders and minorities and their
subgroups as appropriate for the scientific goals of the research.
Plans for the recruitment and retention of subjects will also be
evaluated.

Coordinating Center

o  Adequacy of plans for conducting follow-up fieldwork;

o  Adequacy of plans to coordinate cross-site activities and to share
data with the Field Research Collaborative Centers and the NIDA
Collaborating Scientists;

o  Adequacy of plans to manage DATOS, follow-up, and other data, and
to function as a data and information/reference repository.

AWARD CRITERIA

Applications recommended for further consideration by the NIDA
National Advisory Council will be considered for funding based on the
following factors:

o  Overall scientific and technical merit of the application as
determined by peer review;

o  Significance and originality of the proposed research;

o  Appropriateness of budget estimates;

o  Compatibility of research and data analytic approaches,
administrative structures, and other features to make a successful
cooperative study a reasonable likelihood;

o  Programmatic priorities; and

o  Availability of funds.

Letter of Intent Receipt Date:    June 23, 1995
Application Receipt Date:         July 21, 1995
Initial Peer Review:              August 1995
Review by NIDA Advisory Council:  September 1995
Anticipated Award Date:           September 30, 1995

INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to
clarify any issues or questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Dr. Frank Tims
Services Research Branch
National Institute on Drug Abuse
5600 Fishers Lane, Room 10A-30
Rockville, MD  20857
Telephone:  (301) 443-4060
Email:  FTIMS@AOADA.SSW.DHHS.GOV

Direct inquiries regarding fiscal matters to:

Gary Fleming
Grants Management Branch
National Institute on Drug Abuse
5600 Fishers Lane, Room 8A-54
Rockville, MD  20857
Telephone:  (301) 443-6710
Email:  GFLEMING@AOADA2.SSW.DHHS.GOV

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.279.  Awards are made under authorization of the
Public Health Service Act, Title IV, Part A (Public Law 78-410, as
amended by Public Law 99-158, 42 USC 241 and 285) and administered
under PHS grants policies and Federal Regulations 42 CFR 52 and 45
Parts 74 and 92.  This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review.

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

.

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