INTERNATIONAL RESEARCH COLLABORATION ON DRUG ADDICTION

RELEASE DATE:  November 7, 2002

PA NUMBER:  PAS-03-023 (This PA has been reissued, see PA-06-050) 

EXPIRATION DATE:  October 28, 2005, unless reissued.

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

THIS PROGRAM ANNOUNCEMENT (PA) CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA

The National Institute on Drug Abuse (NIDA) invites applications for 
international collaborative research on drug abuse and drug addiction.  NIDA 
is the single largest supporter of research on the causes, consequences, 
prevention, and treatment of drug addiction in the world, and through its 
International Program in the Office of Science Policy and Communication 
fosters international research, training, and the exchange of scientific 
information by drug abuse researchers around the globe.  While NIDA has 
supported research and research training targeting drug abuse in other 
countries in the past, given the increasing prevalence of drug abuse and 
addiction and its public health consequences, particularly the spread of 
HIV/AIDS around the world, NIDA is significantly expanding its support of 
international research on these issues.  New research will:  1) build 
knowledge for evidence-based strategies to reduce demand for illicit drugs in 
the U.S. and around the world, and 2) enhance collaborative research to take 
advantage of unique populations and resources to improve our basic 
understanding of addiction, and its prevention and treatment. 

This program will provide funding for projects conducted in whole or in part 
outside the U.S.  The research must be conducted by U.S. investigators in 
collaboration with non-U.S.-based investigators.  Either the U.S. or the non-
U.S. investigator may serve as principal investigator, but the project must 
include significant contributions of resources by each participant.  
Resources may include "in kind" contributions of personnel, access to study 
populations, laboratory and other research facilities, etc., as well as 
funding.  This is a broad call for innovative research and applications are 
encouraged in all areas of science addressing drug addiction.  Of particular 
interest are projects which take advantage of a unique set of resources or 
subject populations.  

This program is part of NIDA's effort to encourage rigorous collaborative 
international research.  Other important objectives of NIDA's program 
include: promoting an international cohort of scientists who are 
knowledgeable of NIDA's research and methods; providing professional 
development opportunities and technical consultation to the international 
drug abuse research community; and disseminating NIDA's research findings to 
international scientists and organizations.  Additional information on NIDA's 
international research program and opportunities for research and research 
training funding can be found at 
http://www.nida.nih.gov/International/INVESTHome.html.

RESEARCH OBJECTIVES

Background.

Based on estimates of the United Nations Drug Control Program (UNDCP), the 
annual global rate of illicit drug use is approximately 3.1 percent of the 
world's population, or 181 million users. Rates of illicit drug consumption 
have been increasing significantly.  Even though the UNDCP notes that drug-
reporting data is not uniform among nations and many countries lack adequate 
drug-monitoring systems, there is significant evidence that illicit drug use 
and abuse are pervasive and that the need to develop and disseminate improved 
monitoring systems as well as efficacious prevention and treatment strategies 
has become an urgent public health goal around the world.

Although cannabis is the most widely-used drug, consumed by approximately 2.5 
percent of the world's population, abuse of heroin and cocaine have far more 
serious direct health-related effects.  Of the countries that comply with 
their drug use reporting obligations under the international drug control 
treaties, 31 countries in Africa, Asia, the Americas, and Europe report 
increased abuse of heroin. In addition, the abuse of synthetic drugs, 
particularly amphetamine-type stimulants (ATS) such as "speed" and Ecstasy, 
is also widespread and increasing rapidly. Roughly 30 million people abuse 
synthetic stimulants, according to UNDCP estimates. 

The developing countries and countries experiencing rapid social and 
political change, in particular, are extremely vulnerable to the increase in 
drug abuse, which places a heavy burden on already fragile health and social 
infrastructures. In such countries, increases in illicit drug injecting pose 
significant threats for causing epidemic outbreaks of HIV and hepatitis C. 

The goal of developing efficacious strategies to monitor and reduce illicit 
drug abuse and its impact is achievable through research. Consequently, drug 
treatment and prevention research has never been as important as it is today. 
NIDA is the world's largest supporter of research on the causes, 
consequences, treatment, and prevention of drug abuse and drug addiction. 
NIDA's mission, to bring the power of science to bear on drug abuse and 
addiction, has two critical components: (1) supporting and conducting 
research across a broad range of disciplines, and (2) ensuring the effective 
dissemination and use of the results of that research to improve drug abuse 
and addiction, prevention, treatment, and policy.  In short, by supporting 
international collaborative research on drug abuse and addiction, NIDA will 
continue to generate important new information on the causes, consequences, 
prevention, and treatment of drug abuse and addiction but will also help 
address the growing problems related to illegal drug use and addiction around 
the world.

Areas of Research Focus

The program is open to researchers in all areas of NIDA-supported science, 
including basic laboratory studies, clinical studies, epidemiological 
studies, community-based studies, and services research.  The intent of this 
program is to stimulate state-of-the-science collaborative research between 
investigators from domestic U.S. institutions and researchers in other 
countries, and to rely on investigators to propose such research in order to 
maximize the potential success of this program.  Funds are being made 
available to take advantage of new opportunities to establish collaborative 
relationships with scientists conducting research or with a potential to 
conduct research in other countries as well as to support new research 
projects from established collaborators.  NIDA is also very interested in 
establishing relationships with science-funding organizations in other 
countries, and so programmatic priority funding will be given to projects 
that are collaboratively funded by an agency of the foreign country.

While this call is meant to be very broad and inclusive, the following areas 
of research are provided as illustrations of the types of research that would 
be responsive to this announcement:

o Investigations utilizing ethnographic and qualitative research 
methodologies, such as participant and nonparticipant observation, snowball 
sampling, social networking, chain referrals, informal and semi-structured 
interviewing, focus groups, and the establishment of field stations are 
encouraged because of the unique contextual findings that these methods can 
yield in the area of cross-cultural determinants, risk and protective 
factors, and health and psychosocial consequences of drug abuse;

o Research that takes advantage of particular population characteristics 
(e.g., genotype, drug use patterns, cultural sanctions) to isolate and study 
variables underlying risk for drug addiction and impact of use; 

o Research to adapt and test prevention intervention components and programs 
that have been proven to be efficacious and effective in the United States or 
other countries for replicability and effectiveness in other countries and 
cultures;   (Examples of emphases of special interest include:  the 
identification of key intervention components that impede or account for 
success in the adaptation process; culturally related barriers and 
facilitators to implementation; and process and mechanisms that increase 
potential for sustainability.)

o Studies to develop and/or evaluate new behavioral therapies and 
pharmacotherapies for the treatment of drug addiction, and to study the 
behavioral, social, cultural and/or genetic factors that may influence the 
outcome of substance abuse treatments;

o Determination of cultural and social factors that underlie treatment-
seeking behavior in different countries;

o Optimal ways to combine and deliver an expanded range of linked services 
(e.g., drug treatment, primary care, health, social, recreational, 
educational, juvenile justice) for defined populations in various cultural 
settings, and the comparative effects of these service models on long-term 
trajectories of drug use.

o Preclinical and other human or animal laboratory studies relevant to the 
study of addiction and addictive processes.

MECHANISM OF SUPPORT 

This PA will use the NIH R01 award mechanism.  As an applicant, you will be 
solely responsible for planning, directing, and executing the proposed 
project.  

This PA uses just-in-time concepts.  It also uses the modular budgeting 
format (see http://grants.nih.gov/grants/funding/modular/modular.htm).   
Specifically, if you are submitting an application with direct costs in each 
year of $250,000 or less, use the modular format.

FUNDS AVAILABLE
 
NIDA intends to commit approximately $1 million in FY 2003 to fund 3 to 4 new 
and/or competitive continuation grants in response to this PA. Because the 
nature and scope of the proposed research will vary from application to 
application, it is anticipated that the size and duration of each award will 
also vary. Although the financial plans of NIDA provide support for this 
program, awards pursuant to this PA are contingent upon the availability of 
funds and the receipt of a sufficient number of meritorious applications. 

ELIGIBLE INSTITUTIONS 

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

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

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

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into two 
areas:  scientific/research and financial or grants management issues:

o Direct your questions about scientific/research issues to:

Steven Gust, Ph.D.
Director, International Program
Office of Science Policy and Communication
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 5274, MSC 9581
Bethesda, MD  20892-0581
Telephone:  301-443-6480
Fax:  301-443-9127
Email:  sgust@mail.nih.gov

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

Gary Fleming, J.D., M.A.
Grants Management Branch
Office of Planning and Resource Management
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD  20892-9541
Telephone:  (301) 443-6710
Fax:  (301) 594-6847
E-mail:  gf6s@nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted at the standard application deadlines, which 
are available at http://grants.nih.gov/grants/dates.htm.  Application 
deadlines are also indicated in the PHS 398 application kit.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting 
up to $250,000 per year in direct costs must be submitted in a modular grant 
format.  The modular grant format simplifies the preparation of the budget in 
these applications by limiting the level of budgetary detail.  Applicants 
request direct costs in $25,000 modules.  Section C of the research grant 
application instructions for the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step 
guidance for preparing modular grants.  Additional information on modular 
grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: 
Applications requesting $500,000 or more in direct costs for any year must 
include a cover letter identifying the NIH staff member within one of NIH 
institutes or centers who has agreed to accept assignment of the application.   

Applicants requesting more than $500,000 must carry out the following steps:
   
1)   Contact the IC program staff at least 6 weeks before submitting the 
application, i.e., as you are developing plans for the study; 

2) Obtain agreement from the IC staff that the IC will accept your 
application for consideration for award; and,
  
3) Identify, in a cover letter sent with the application, the staff member 
and IC who agreed to accept assignment of the application.  

This policy applies to all investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended or revised 
version of these grant application types. Additional information on this 
policy is available in the NIH Guide for Grants and Contracts, October 19, 
2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.

SENDING AN APPLICATION TO THE NIH: 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/DHHS
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

APPLICATION PROCESSING: Applications must be received by or mailed on or 
before the receipt dates described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm.  The CSR will 
not accept any application in response to this PA 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 a substantial revision of an application already reviewed, but 
such application must include an Introduction addressing the previous 
critique.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review group 
convened in accordance with the standard NIH peer review procedures 
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific 
and technical merit.  

As part of the initial merit review, all applications will:

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

REVIEW CRITERIA

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

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The scientific review group will address and consider each of these criteria 
in assigning your application's overall score, weighting them as appropriate 
for each application.  Your 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, you 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 your study address an important problem? If the aims 
of your application are achieved, how do they advance scientific knowledge?  
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?  Do you acknowledge potential problem areas and consider alternative 
tactics?

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

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

(5) ENVIRONMENT:  Does the scientific environment in which your 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?
 
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

PROTECTIONS:  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.

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

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

AWARD CRITERIA

Applications submitted in response to a PA will compete for available funds 
with all other recommended applications.  The following will be considered in 
making funding decisions:  

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program priorities

REQUIRED FEDERAL CITATIONS 

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

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

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

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

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

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

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research 
on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).   
It is the responsibility of the applicant to provide the official NIH 
identifier(s)for the hESC line(s)to be used in the proposed research.  
Applications that do not provide this information will be returned without 
review. 

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

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 these 
recommendations of Council before submitting an application that will 
administer compounds to human subjects.  The guidelines are available on 
NIDA's Home Page at www.nida.nih.gov under the Funding, or may be obtained by 
calling (301) 443-2755.

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

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

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

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

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

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

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