THERAPEUTIC COMMUNITY RESEARCH

Release Date:  February 2, 2001

RFA:  RFA-DA-01-015

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

Letter of Intent Receipt Date:  March 19, 2001
Application Receipt Date:       April 19, 2001

BOTH MODULAR AND NONMODULAR GRANT APPLICATIONS MAY BE SUBMITTED IN RESPONSE 
TO THIS REQUEST FOR APPLICATIONS (RFA).  FOR MODULAR GRANTS, THE "JUST-IN-
TIME" CONCEPT IS USED, AND THERE ARE DETAILED MODIFICATIONS TO STANDARD 
APPLICATION INSTRUCTIONS THAT MUST ALSO BE USED WHEN PREPARING APPLICATIONS 
IN RESPONSE TO THIS RFA.  FOR NONMODULAR APPLICATIONS (APPLICATIONS HAVING AT 
LEAST ONE YEAR'S REQUESTED DIRECT COSTS EXCEEDING $250,000), THE MODIFIED 
INSTRUCTIONS FOR MODULAR GRANTS AND JUST-IN-TIME PROCEDURES ARE NOT USED, AND 
THE TRADITIONAL PHS 398 INSTRUCTIONS SHOULD BE FOLLOWED INSTEAD.

PURPOSE

This RFA encourages new directions in behavioral treatment and services 
research in Therapeutic Communities (TCs) that provide treatment for drug 
abuse and addiction.  As scientific knowledge on the TC has evolved, research 
interest has shifted from whether the TC works, to how it works and how it 
can be improved through a better understanding of the treatment processes 
involved, through a better blending of research-based interventions with TC 
treatment practices, and through increased understanding of organizational 
and management strategies to deliver more effective and efficient treatment 
services.  This RFA encourages research aimed at improving the therapeutic 
efficacy and efficiency of TCs.  Research on therapeutic approaches that 
include behavioral treatments, alone or in combination with 
pharmacotherapies, is encouraged.  In addition, this RFA encourages studies 
on TC treatment processes; research to integrate new research-based 
interventions into TC treatment; and research on TC organizational and 
managerial processes.

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, "Therapeutic 
Community Research," 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/.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic for-profit and nonprofit 
organizations, public and private, such as universities, colleges, hospitals, 
laboratories, units of state and local governments, and eligible agencies of 
the federal government.  Racial/ethnic minority individuals, women, and 
persons with disabilities are encouraged to apply as Principal Investigators.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) research project 
grant (R01) and the exploratory/developmental grant (R21).  Applicants are 
advised to contact the National Institute on Drug Abuse (NIDA) program staff 
listed under INQUIRIES for additional information and specific application 
procedures.  Responsibility for the planning, direction, and execution of the 
proposed project will be solely that of the applicant.  The total project 
period for an application submitted in response to this RFA may not exceed 
five years.  This RFA is a one-time solicitation.  Future unsolicited 
competing continuation applications will compete with all investigator-
initiated applications and be reviewed according to the customary peer review 
procedures.  The anticipated award date is September 2001.

Because the nature and scope of the research proposed in response to this RFA 
may vary, it is anticipated that the size of the award will vary also.  
Modular budgeting procedures apply for applications up to $250,000.  See 
http://grants.nih.gov/grants/funding/modular/modular.htm for further information 
about the modular budgets.

When applying under the R21 mechanism, the applicant should obtain a copy of 
the R21 announcement, as it contains instructions for the preparation of the 
application and other useful information.  R21 grants are limited to $100,000 
in direct costs per year and to a 3 year effort.  The announcement may be 
obtained at http://www.nida.nih.gov/ResFundslist.html.

FUNDS AVAILABLE

NIDA intends to commit approximately $2.0 million in FY 2001 to fund 
approximately four to six awards in response to this RFA.  The level of 
support is dependent upon the receipt of a sufficient number of applications 
of high scientific merit.  Although the financial plans of NIDA provide 
support for this program, awards pursuant to this RFA are contingent upon the 
availability of funds and the receipt of a sufficient number of meritorious 
applications.

RESEARCH OBJECTIVES

Background

The TC for drug abuse treatment has existed for about 40 years.  It is 
generally a drug-free residential setting which provides a highly structured 
pro-social environment for the treatment of drug abuse and addiction.  It 
differs from other treatment approaches principally in its use of the 
community as the key agent of change, in which treatment staff and recovering 
clientele interact in both structured and unstructured ways to influence 
attitudes, perceptions, and behaviors associated with drug use.  The TC uses 
a staged, hierarchical model in which treatment stages are related to 
increased levels of individual and social responsibility.  Peer influence, 
mediated through a variety of group processes, is used to help residents 
learn and assimilate social norms and develop more effective social skills.  
The therapeutic approach generally focuses on changing negative patterns of 
thinking and behavior through individual and group therapy, group sessions 
with peers, and participation in a therapeutic milieu with hierarchical 
roles, privileges, and responsibilities.  Strict and explicit behavioral 
norms are emphasized and reinforced with specific contingencies (rewards and 
punishments) directed toward developing self-control and responsibility.

The TC has evolved over time to become a comprehensive treatment model 
adapted to many types of patients and offering a range of services.  As a 
result of changes in health care policy and treatment financing, TCs have 
adapted to serve a changing population of drug abusers that have a range of 
co-occurring medical and psychosocial problems.  A body of research supports 
the effectiveness of TC treatment both for general treatment populations and 
for identified sub-sets such as criminal justice-involved individuals and 
addicts with co-occurring psychiatric and drug disorders.  

This RFA encourages research to understand and describe the essential 
components and processes of TCs, research to delineate the mechanisms through 
which TCs achieve their effectiveness, and research to help the TC work 
better to treat future patients in changing health care environments.  This 
RFA encourages studies to better understand how the TC works, not whether the 
TC works.  Particularly in the era of managed care, understanding the TC’s 
organizational and therapeutic processes has become increasingly important.  
This RFA is intended to stimulate research to improve understanding of the 
therapeutic processes in TC treatment; research aimed at improving the 
therapeutic efficacy of TCs through the development, refinement and testing 
of new and improved therapeutic strategies used within TCs; research on 
organizational structures and processes and their interrelationships; and 
research to improve TC management practices and processes.  Although it is 
important to investigate how to adapt the TC model to treat new populations, 
this RFA is not intended to support such research.

Over the past decade, NIDA has implemented a major program of research on 
behavioral therapies for drug abuse and dependence.  (See PA-99-107 for a 
description of the Behavioral Therapies Development Program.)  As a result of 
this research, there has been a significant increase in the number of 
efficacious, manualized behavioral treatments that are now available for the 
treatment of drug addiction.  This RFA also seeks to stimulate research aimed 
at improving the therapeutic impact of TCs through the addition of behavioral 
treatments (e.g., cognitive-behavioral therapy; contingency management; 
motivational enhancement therapy; family therapy, etc) that have been shown 
to be efficacious in other treatment settings.  As data from a variety of 
areas of treatment research (e.g., treatment entry characteristics, retention 
predictors, relapse predictors) is beginning to show gender differences, 
investigators are urged to incorporate gender differences into their research 
design and analyses.

Applicants may propose studies to occur in existing TCs or may create 
experimental TCs based upon clearly explicated principles of the TC process.

Research Areas

Research on Therapeutic Community Treatment Processes

A better understanding of the TC treatment process is needed in order to make 
TC treatment more effective and more efficient and to enable TCs to produce 
change in systematic and predictable ways.  Treatment process research 
includes research on the core components of the TC, research on the community 
as a change agent, and research on group processes.  

o  Elements of treatment in the TC and their relationship to outcomes.  How 
do specific TC treatment elements address needs and attributes of clientele?  
What components of the TC are necessary and sufficient for attitudinal and 
behavioral change?  What value is added by individual components?

o  Variations in TC models.  What is the effect on outcomes of modifications 
to the TC model?  Can core TC elements be translated into non-residential 
treatment settings, and what are the benefits of doing so?

o  Quality and persistence of change in attitudes, perceptions, and behaviors 
derived from the community experience compared to change resulting from more 
formal or discrete services  (e.g., individual or group counseling).

o  Research on community-based learning, confrontation, games and role-
playing, and catharsis in the therapeutic community.  For example, how does 
confrontation in the TC create behavioral change, and when is confrontation 
therapeutically ineffective?

o  Research on group-level processes, including social influence 
(informational, normative, and interpersonal) in groups, groups and identity 
(individual-group connection, group membership biases), and functions of 
groups (e.g., belonging, intimacy, generativity, support, influence, 
exploration).

o  The relation of treatment stages to goals of TC treatment.  Do specific 
stages achieve  measurable treatment goals?  How are intermediate goals 
related to outcomes?  Are treatment progress and outcomes dependent upon 
successful completion of each stage?  

o  Research on threshold treatment length of stay.  What are the determinants 
of individual treatment length-of-stay thresholds?  How can length-of-stay 
thresholds for persistent change be reduced through specific therapeutic 
interventions, treatment services, or other treatment processes?   
Relationship between severity of patient problems and threshold retention, 
need for specific components of treatment, or progress through particular 
treatment stages.  

Research to Integrate New Interventions Into TC Treatment 

TCs employ a variety of behavioral change strategies.  Many TCs also 
integrate the use of medications for psychiatric disorders into treatment.  
Research is needed to understand how new theory-based and evidence-based 
treatment interventions can be effectively integrated into TC treatment 
processes.  Areas of research interest include:

o  Studies aimed at developing and testing behavioral intervention strategies 
to enhance motivation and readiness for treatment in order to improve 
retention in TCs.

o  Research that examines the potential benefits of scientifically-based and 
or empirically supported behavioral treatments when combined with standard TC 
treatment, including but not limited to the following interventions:

-  Behavioral therapies for individuals with co-occurring drug and mental 
or other health disorders.
-  Behavioral therapies that can be utilized in conjunction with 
medications, or behavioral interventions to improve compliance with 
medications regimens.
-  HIV/AIDS risk reduction interventions.
-  Behavioral therapies that address the unique needs of women, racial and 
ethnic minorities, families, children and adolescents, criminal and 
juvenile justice populations, and the homeless.

o  "Stage I" research (see NIDA PA #99-107, "Behavioral Therapies Development 
Program," at http://grants.nih.gov/grants/guide/pa-files/PA-99-107.html) on 
the development, refinement, or modification of efficacious manual-guided 
behavioral therapies for use in the TC setting.

o  "Stage III" research (see NIDA PA #99-107, "Behavioral Therapies 
Development Program," at 
http://grants.nih.gov/grants/guide/pa-files/PA-99-107.html) 
examining how to transport efficacious behavioral treatments to 
TCs.

o  Studies that examine TC therapeutic/social processes (e.g., confrontation 
within a TC) to test and understand these processes in individuals with a 
variety of characteristics, including but not limited to:

-  Personality characteristics;
-  Developmental stage:  Chronologically, cognitively, or emotionally;
-  Types or degrees of psychopathology;
-  Gender;
-  Cultural background;
-  Social/interactive styles; and
-  Social network characteristics.

o  Research on the effective use of pharmacotherapies or medications to treat 
drug, alcohol, or mental health disorders in the therapeutic community.

Research on TC Organizational and Managerial Processes

Change in the contemporary TC can be a product of internal pressures, such as 
a desire to improve treatment outcomes, or external pressures, such as 
competition or changes in treatment environment, funding, or resources.  
Research is needed to provide a better understanding of organizational 
factors and management strategies that enable TCs to improve their 
therapeutic and service delivery practices.

Organizational factors.  Structural and environmental factors can affect 
service efficiency and effectiveness.  Areas of research interest include the 
following:  

o  Structure of the TC.  Research on inter- and intra-organizational forms 
(e.g., organizational relationships, size, and complexity; staff diversity) 
related to effectiveness, efficiency, and quality of care.  Integrated, 
linked, and non-integrated service delivery models for health, mental health, 
and social services.

o  Environmental factors.  Research to understand how TC climate, 
organizational culture, and resources affect treatment entry, engagement, 
retention, satisfaction, and outcomes.  Role of the TC as part of a general 
service delivery model that includes continuing care, multiple treatment 
episodes, and mutual support/self-help groups.

o  Management and program practices.  Research to improve the adaptation and 
adoption of emerging or underutilized service delivery technologies.  
Research on program policies, guidelines, and procedures to improve the 
effectiveness and efficiency of business and therapeutic work practices.  
Studies of the ability of various management models to improve organizational 
capacity to use resources and adapt to changes in programs, systems, or 
environments.

o  Organizational development.  Research on human resources management 
practices for personnel selection, staff credentialing, training, continuing 
education, clinical supervision, and job performance incentives.  Research on 
methods to enhance staff performance quality and capabilities.  Research into 
counselor attributes and roles, including formal vs. informal aspects; 
relation to TC self-identity, culture, and climate; use of recovering staff.

Self-monitoring and quality improvement.  Self-monitoring is intended to 
insure that treatment processes conform to established treatment models or 
protocols.  Quality improvement processes are intended to systematically 
review new knowledge, new methods for treatment, and new business practices 
and to utilize or adopt those offering advantages, such as improvement in 
business efficiencies or in the quality of services.  Research is encouraged 
on topics such as the following:

o  Use of quality improvement methods in the TC.  Research on the role of 
quality monitoring and improvement, management information systems, 
internal/external evaluation, and performance indicators to improve 
treatment.

o  Research to identify practices for routine monitoring and improvement of 
quality of care, instituting a quality of care conceptual framework, 
developing and validating treatment process or performance measurement, or 
establishing practical, routine benchmarking procedures.

o  Measurement of TC in-treatment performance.   Development of in-treatment 
measures for quality monitoring and improvement, for comparisons across 
programs, for communication with treatment case or cost managers, for 
benchmarking, or for developing standards of care.  Research on the 
relationship of in-treatment performance indicators (both patient and 
program) with post-treatment measures of outcomes.

MONITORING PLAN

Applicants should be aware of NIH's recently revised policy regarding safety 
monitoring for Phase I and II clinical trials (see: 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html).  NIDA 
intends this guidance to apply to behavioral, as well as pharmaceutical, 
interventions.  The policy requires investigators to submit a general 
description of a data and safety monitoring plan as part of the research 
application.  In addition, a detailed monitoring plan must be approved by the 
Institutional Review Board and the funding Institute before the trial begins.  
Additional information may be obtained at http://www.nida.nih.gov/.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS 

It is the policy of NIH that women and members of minority groups and their 
sub-populations must be included in all NIH-supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification are 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 research involving human subjects should read the 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contracts on 
August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); 
a complete copy of the updated Guidelines is available at  
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm.  The 
revisions relate to NIH defined Phase III clinical trials and require:  a) 
all applications or proposals and/or protocols to 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) all investigators to report accrual and to conduct and report analyses 
as appropriate, by sex/gender and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH 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 was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

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

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.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.

NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE 
ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS  

The National Advisory Council on Drug Abuse recognizes the importance of 
research involving the administration of drugs to human subjects and has 
developed guidelines relevant to such research.  Potential applicants are 
encouraged to obtain and review the recommendations of the Council before 
submitting an application that will administer compounds to human subjects.  
The guidelines are available on NIDA's Home Page at http://www.nida.nih.gov/ 
under Funding or may be obtained by calling (301) 443-2755.

LETTER OF INTENT

Prospective applicants are asked to submit 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 is being 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 plan the review.

Send the letter of intent (by receipt date listed in the heading of this RFA) 
to:

Director
Office of Extramural Affairs
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD  20892-9547
Telephone:  (301) 443-2755
FAX:  (301) 443-0538

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used in 
applying for these grants.  These forms are available at most institutional 
offices of sponsored research and from the Division of Extramural Outreach 
and Information Resources, National Institutes of Health, 6701 Rockledge 
Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714,  E-mail:  
GrantsInfo@nih.gov.

The modular grant concept establishes specific modules in which direct costs 
may be requested as well as a maximum level for requested budgets. Only 
limited budgetary information is required under this approach.  The 
just-in-time concept allows applicants to submit certain information only 
when there is a possibility for an award.  It is anticipated that these 
changes will reduce the administrative burden for the applicants, reviewers, 
and Institute staff.  The research grant application form PHS 398 (rev. 4/98) 
is to be used in applying for these grants, with the modifications noted 
below.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS

BUDGET INSTRUCTIONS

Modular grant applications will request direct costs in $25,000 modules, up 
to a total direct cost request of $250,000 per year.  (Applications that 
request more than $250,000 direct costs in any year must follow the 
traditional PHS 398 application instructions.)  The total direct costs must 
be requested in accordance with the program guidelines and the modifications 
made to the standard PHS 398 application instructions described below:

PHS 398

o  FACE PAGE - Items 7a and 7b should be completed, indicating Direct Costs 
(in $25,000 increments up to a maximum of $250,000) and Total Costs [Modular 
Total Direct plus Facilities and Administrative (F&A) costs] for the initial 
budget period.  Items 8a and 8b should be completed indicating the Direct and 
Total Costs for the entire proposed period of support.

o  DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 
4 of the PHS 398.  It is not required and will not be accepted with the 
application.

o  BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the 
categorical budget table on Form Page 5 of the PHS 398.  It is not required 
and will not be accepted with the application.

o  NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative 
page (see http://grants.nih.gov/grants/funding/modular/modular.htm for sample 
pages).  At the top of the page, enter the total direct costs requested for 
each year.  This is not a Form page.

Under Personnel, list all project personnel, including their names, percent 
of effort, and roles on the project.  No individual salary information should 
be provided.  However, the applicant should use the NIH appropriation 
language salary cap and the NIH policy for graduate student compensation in 
developing the budget request.

For Consortium/Contractual costs, provide an estimate of total costs (direct 
plus facilities and administrative) for each year, each rounded to the 
nearest $1,000.  List the individuals/organizations with whom consortium or 
contractual arrangements have been made, the percent effort of all personnel, 
and their role on the project.  Indicate whether the collaborating 
institution is foreign or domestic.  The total cost for a 
consortium/contractual arrangement is included in the overall requested 
modular direct cost amount.  Include the Letter of Intent to establish a 
consortium.

Provide an additional narrative budget justification for any variation in the 
number of modules requested.

o  BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by  
reviewers in the assessment of each individual's qualifications for a 
specific role in the proposed project, as well as to evaluate the overall 
qualifications of the research team.  A biographical sketch is required for 
all personnel, following the instructions below.  No more than three pages 
may be used for each person.  A sample biographical sketch may be viewed at:  
http://grants.nih.gov/grants/funding/modular/modular.htm.

- Complete the educational block at the top of the form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on 
research projects 	  ongoing or completed during the last three years; 
and
- List selected peer-reviewed publications with full citations.

o  CHECKLIST - This page should be completed and submitted with the 
application.  If the F&A rate agreement has been established, indicate the 
type of agreement and the date.  All appropriate exclusions must be applied  
in the calculation of the F&A costs for the initial budget period and all 
future budget years.

The applicant should provide the name and phone number of the individual to 
contact concerning fiscal and administrative issues if additional information 
is necessary following the initial review.

The RFA label available in the PHS 398 (rev. 4/98) 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 in 
line 2 on the face page of the application form, and the YES box must be 
marked.

The sample RFA label available at 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to 
allow for this change.  Please note this is in pdf format.

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:

Director, Office of Extramural Affairs
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD  20892-9547
Rockville, MD  20852 (for express/courier service)

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 Research (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.

REVIEW CONSIDERATIONS

This RFA invites applications from investigators who have not typically 
conducted therapeutic community drug addiction treatment research.  For 
exploratory research, reviewers will assess innovation, creativity, and 
related factors as described below.

Upon receipt, applications will be reviewed for completeness by the CSR and 
for 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, all applications will receive a written 
critique and 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, assigned a priority score, and receive a 
second level review by the National Advisory Council on Drug Abuse.

Review Criteria

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

(1)  Significance:  Does this study address an important problem?  If the 
aims of the application are achieved, how will scientific knowledge be 
advanced?  What will be the effect of these studies on the concepts or 
methods that drive this field?  

(2)  Approach:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project?  Does the applicant acknowledge potential problem areas and consider 
alternative tactics?  

(3)  Innovation:  Does the project employ novel concepts, approaches, or 
method? Are the aims original and innovative?  Does the project challenge 
existing paradigms or develop new methodologies or technologies?  

(4)  Investigator:  Is the investigator appropriately trained and well suited 
to carry out this work?  Is the work proposed appropriate to the experience 
level of the principal investigator and other researchers (if any)?

(5)  Environment:  Does the scientific environment in which the work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements?  Is there evidence of institutional 
support?

(6) Relevance:   To what extent are the aims of the proposal relevant to the 
purpose and objectives of the RFA?

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

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

The adequacy of plans to make data available to other investigators in a 
timely fashion.

The reasonableness of the proposed budget and duration in relation to the 
proposed research.

The adequacy of the proposed protection for humans, animals, or the 
environment, to the extent they may be adversely affected by the project 
proposed in the application.

The above criteria apply to R01 applications, and there are additional 
criteria for the R21 mechanism.  When applying under the R21 mechanism, the 
applicants should obtain a copy of program announcement PA-98-004 from either 
their office of sponsored research or from the NIH Guide Web site 
(http://grants.nih.gov/grants/guide/pa-files/PA-98-004.html).  This program 
announcement contains instructions for the preparation of R21 grant 
applications.

Schedule:

Letter of Intent Receipt Date:  March 19, 2001 	
Application Receipt Date:       April 19, 2001 
Peer Review Date:               June/July 2001
Council Review:                 September 2001			
Earliest Start Date:            September 30, 2001		

AWARD CRITERIA

Award criteria that will be used to make award decisions include scientific 
merit as determined by peer review, availability of funds, and programmatic 
priorities.

INQUIRIES  

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

Direct inquiries regarding programmatic issued to:

Lisa Onken, Ph.D.
Division of Treatment Research and Development
or Bennett W. Fletcher, Ph.D.
Division of Epidemiology, Services and Prevention Research
National Institute on Drug Abuse
6001 Executive Boulevard
Bethesda, MD  20892
Telephone:  (301) 443-0107 or 443-4060, respectively
FAX:  (301) 443-8674 or (301) 443-6815, respectively
Email:  lo10n@nih.gov or  bfletche@nida.nih.gov, respectively

Direct inquiries regarding fiscal matters to:  

Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD  20892-9541
Telephone:  (301) 443-6710
FAX:  (301) 594-6849
Email:  gf6s@nih.gov

Direct inquiries regarding review issues to:  

Teresa Levitin, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD  20892-9547
Telephone:  (301) 443-2755
FAX:  (301) 443-0538
Email:  tlevitin@nida.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.279.  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 and Federal Regulations 42 CFR 52 and 45 CFR 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 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 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.


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