This Program Announcement expires on November 30, 2003, unless reissued.

COLLABORATIVE CLINICAL STUDIES IN DRUG ABUSE

Release Date:  January 2, 2001

PA NUMBER:  PAR-01-039 (see replacement PAR-04-073)

National Institute on Drug Abuse
 (http://www.nida.nih.gov)
 
THIS PROGRAM ANNOUNCEMENT (PA) USES THE "MODULAR GRANT" AND "JUST-IN-TIME" 
CONCEPTS.  IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION 
INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS 
PA.

PURPOSE

The National Institute on Drug Abuse (NIDA) seeks to increase the 
collaboration of investigators at different sites in order to address clinical 
issues in drug abuse research that require sample sizes greater than a single 
site can reasonably attain.  The expectation for the collaborative effort is 
that there will be implementation of common protocols across different sites 
in order to study patient outcomes, patient factors, provider factors, setting 
characteristics, interactions of these, or other effects where pooled samples 
are appropriate and necessary for the hypotheses under consideration.

This announcement provides guidelines for the development, review, and funding 
of Collaborative Clinical Studies in Drug Abuse (CCSDA) projects.

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 Program Announcement (PA), 
Collaborative Clinical Studies in Drug Abuse, 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 and foreign, for-profit and non-
profit 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.

The CCSDA requires more than one applicant organization, and each applicant 
organization must meet the eligibility requirements above.  Multiple campuses 
of a single institution or university system are considered separate 
organizations for the purposes of eligibility to apply.

MECHANISM OF SUPPORT

This PA will use the R01 award mechanism; no other mechanisms may be used. 
Responsibility for the planning, direction, and execution of the proposed 
project will be solely that of the applicants.  The total project period for 
an application submitted in response to this PA may not exceed 5 years.

RESEARCH OBJECTIVES

In order to draw valid conclusions from clinical studies of drug abuse and 
drug abuse-related issues, a sufficient sample size is needed.  Studies and 
analyses are sometimes limited by inadequate access to, or enrollment of, 
subjects.  Even where main hypotheses can be addressed with the sample 
available, interesting hypotheses about subpopulations (based on gender, 
ethnicity, drug use patterns, age, etc.), interaction effects, or ancillary 
questions (e.g., such as about therapist characteristics, patient matching to 
treatment, unexpected outcomes, etc.) cannot be examined because of 
limitations in the sample size.  For some questions, such as genetic studies 
or studies of relatively infrequent behaviors, the required sample size 
effectively prohibits a single site from being able to recruit sufficient 
numbers.

Collaborative clinical studies allow multiple investigators to initiate and 
submit separate applications, each with a separate PI and applicant 
institution, that propose timely recruitment of an aggregate sample sufficient 
to address clinical concerns.  By allowing multiple sites to recruit, a sample 
that otherwise could not be recruited or could not be recruited within a 
reasonable time frame can be enrolled.  CCSDA seems ideally suited to foster 
the efficiency and creativity that can be obtained through investigator-
initiated research and, at the same time, allow multiple investigators to 
coordinate a focus on a particular clinical issue relevant to drug abuse.  
Examples of possible foci for a CCSDA are:

o  Large scale trials of behavioral or psychopharmacological treatments, alone 
or in combination, focused on drug addiction and using common intervention 
protocols and cross-site analyses.  Pharmacologic treatments may include new 
or already-marketed medications.  Behavioral treatments may be intended to 
enhance medication compliance.
o  Genetic studies requiring large numbers of subjects.
o  Studies of interventions for relatively low prevalence conditions in drug 
abusing populations.
o  Clinically oriented psychometric studies that are normally hampered by low 
base rates of occurrence of the behavior of interest.
o  Clinically oriented neuroimaging studies that require multiple sites in 
order to study sufficient numbers of subjects of interest.
o  Analyses of impacts of interventions associated with gender; racial, 
ethnic, or linguistic group; sexual orientation; age; or other developmental 
variables; etc.
o  Studies of other clinical issues in drug abuse (e.g., HIV/AIDS and other 
infectious diseases) that require multiple sites to ensure a sufficiently 
large sample to answer the question posed.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS - 
UPDATED AUGUST 2, 2000

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 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.

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.

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.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev. 
4/98) and will be accepted at the standard application deadlines as indicated 
in the application kit.  Application kits are available at most institutional 
offices of sponsored research and may be obtained 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, email: GrantsInfo@nih.gov.

Separate applications must be prepared by each applicant institution.  Because 
the CCSDA is expected to address questions that were not addressable in 
previous single site studies, competing continuation applications would not be 
appropriate.  

Applicants planning to request $500,000 or more in direct costs for any year 
must contact the Institute program staff before submitting the application; 
i.e., as plans for the study are being developed.  Furthermore, the 
application must obtain agreement from the Institute staff that Institute will 
accept the application for consideration for award.  Finally, the applicant 
must identify, in a cover letter sent with the application, the staff member 
and Institute who agreed to accept assignment of the application.  This 
requirement applies to any individual CCSDA application if that application 
will exceed $500,000 in direct costs.  Also, if the overall total direct costs 
for all the CCSDA applicants in a group are $500,000 or more for any year, 
Institute staff must be contacted and agree to accept all the applications in 
that group, and the procedures noted above must be followed.  

This policy requires an applicant to obtain agreement for acceptance of both 
any such application and any such subsequent amendment.  Refer to the NIH 
Guide for Grants and Contracts, March 20, 1998 at 
http://grants.nih.gov/grants/guide/notice-files/not98-030.html.

The application must be organized in accordance with standard PHS Form 398 
instructions, with the following modifications:

Each application in a CCSDA group should be essentially identical to the 
others, with the exception of expected differences in elements such as numbers 
of available subjects, resources and environment, budgetary requirements, and 
staff.

Each application must include an overview section that is no longer than 2 
pages and constitutes the first pages of the RESEARCH PLAN section (i.e., 
immediately precedes the Specific Aims).  This overview should list the 
individual applicant organizations participating in the CCSDA and the 
Principal Investigator for each.  It should establish the need for applying as 
a CCSDA and justify the role for each applicant organization in the CCSDA.  
The investigators may also wish to identify one individual as the contact 
person for the group for the purposes of facilitating communication.  If so, 
that should be noted in the overview.

Sections A-D of the research plan should describe those aspects of the project 
that are common to all sites.  The research procedures and protocol should be 
presented in detail, along with description of the study population from which 
samples are drawn, the anticipated samples themselves, resources, plans for 
data analysis, and characteristics that support each site’s (i.e., not simply 
the applicant’s site) role in the project.  Where there are minor variations 
in plans, these should be noted in the text and then summarized in a separate 
subheading in Section D (which counts toward the 25 page limit) titled 
“ELEMENTS UNIQUE TO THIS SITE.”

The research plan should describe a feasible strategy for integration of 
research procedures, managerial and administrative responsibilities, and 
training across sites to ensure the integrity of the research effort.  The 
Principal Investigators may wish to designate a Steering Committee or other 
decision-making body.  If so, the biosketches of these individuals should be 
included.  If not, a feasible strategy for decision making must be detailed.  
Plans for ensuring access to data by all sites, analytic resources, 
publication and authorship procedures, public use of data, dissemination of 
results, and means of arbitrating disagreements should be addressed. 

Any site that contracts out elements of the research should note this as an 
element unique to the site, both in the main body of the research plan and in 
the separate section on unique elements.  The nature, purpose, and oversight 
of the contractual arrangement should be fully described.

Revised submissions of CSDAs must include an introduction to the revision that 
highlights changes in the research plan and how delays in initiating the 
project will affect the work.  This is particularly important in cases where 
some but not all of the CCSDA sites have already begun work on a project.

In accordance with NIH policy, incomplete applications will be returned to the 
applicant. Applications that are not responsive to the intent of the CCSDA 
will be returned.

All applications submitted as part of the CCSDA should be mailed together in 
one package in order to assure that they are processed as CCSDA submissions.  
All of the applications constituting the proposed CCSDA group must be 
submitted in a single package, whether or not the applications are from the 
same institution.  A cover letter must list the total number of applications 
submitted for the CCSDA group, clearly identifying each application and the 
principal investigator of each.  For each component application in the CCSDA 
group, the
original, five copies, and the appendix material must be bundled together and 
clearly identified

The title and number of the program announcement must be typed on line 2 of 
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 five 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)

APPLICATION PROCEDURES

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 the 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 key 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.

o  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.

REVIEW CONSIDERATIONS

This is a PAR .  Applications will be evaluated for scientific and technical 
merit by an appropriate scientific review group convened by NIDA in accordance 
with the standard NIH peer review procedures.  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 applications under review, will be discussed, 
assigned a priority score, and receive a second level review by the 
appropriate national advisory council or board.  Individual applications may 
receive different priority scores.

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 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)  Rationale and feasibility of the collaboration:  How well is the use of 
collaborating sites justified?  How necessary is collaboration to address the 
scientific issues?  How well does this application establish, through 
preliminary data or other means, that other sites will be able to contribute 
to the study? 

(7)  Management plans:  How well developed and reasonable are the plans for 
coordination, decision-making, quality control, and arbitration?  In 
particular, how well have other administrative and managerial issues been 
addressed with respect to:
     o  the reliability and accuracy of the main administrative site's past 
performance and the potential of the main administrative site's future 
performance in clinical trials;
     o  the experience of the Principal Investigator and other key personnel 
in conducting clinical trials;
     o  the ability of the main administrative site to manage and analyze data 
for the clinical trial; and,
     o  the appropriateness of the proposed procedures for data management, 
data storage, and analytical activities.

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

o  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 and for the 
analysis of subgroup data will also be evaluated.

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

o  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.

AWARD CRITERIA

Applications will compete for available funds with all other recommended 
applications.  The following will be considered in making funding decisions:  
Quality of the proposed project as determined by peer review, availability of 
funds, and program priority.

Funding decisions will also consider whether there are sufficient high quality 
collaborating sites  for the CCSDA project. 

INQUIRIES

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

Direct inquiries regarding programmatic issues to:

Ann  Anderson, M.D.
Division of Treatment Research and Development
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4123, MSC 9551
Bethesda, MD  20892-9551
Telephone:  (301) 443-3318
Email:  aanderson@nida.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
Email:  tl25u@nih.gov

Direct inquiries regarding fiscal matters to:

Gary Fleming, J.D., M.A.
Grants Management Branch
Office of Planning and Resource Management
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD  20892-9541
Telephone:  (301) 443-6710
Email: gf6s@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 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 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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