IMAGING   SCIENCE TRACK AWARD FOR RESEARCH TRANSITION (I/START)

RELEASE DATE:  February 6, 2002

PA NUMBER:  PAR-02-058 (This PAR has been reissued, see PAR-06-092)

EXPIRATION DATE:  May 14, 2005

PARTICIPATING INSTITUTES AND CENTERS (ICs):

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

Application receipt date is May 14, 2002 with next receipt date of October 1, 
2002, standard receipt dates thereafter.

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 Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citation

PURPOSE OF THIS PA

The National Institute on Drug Abuse (NIDA) seeks to facilitate the entry of 
new investigators in the area of brain imaging/clinical neurobiology 
research.  This Program Announcement invites applications for the Imaging 
Science Track Award for Research Transition (I/START) program, which is a new 
program developed by NIDA to foster new investigators in areas of brain 
imaging and drug abuse research.  The application of brain imaging has become 
widespread, however, it is sometimes difficult for new investigators to 
obtain independent funding in this area.  In many research domains, junior 
investigators are given institutional support sufficient to conduct 
preliminary studies.  However, in contrast, the costs of obtaining 
preliminary data for clinical neurobiology techniques such as brain imaging 
(e.g., PET and MRI scans) often serve a prohibitive barrier to 
starting investigators.  

This award will allow for the design and collection of "proof of concept" 
brain imaging data that can then be used in the transition to more extensive 
research proposals.  The I/START program uses a brief application form and a 
rapid review process to ensure expedited funding decisions.  Funding is 
limited to direct costs for one year of up to $150,000 and is non-renewable.

RESEARCH OBJECTIVES

All areas of research dealing with the clinical neurobiology of drug abuse 
and addiction and encompassing a wide array of research studies that 
incorporate brain imaging are sought under this announcement.  Areas of 
interest that would allow preliminary data to be obtained within the I/START 
time and budget requirements include, but should not be limited to: (a) the 
neurobiology of addiction and the assessment of structural and/or functional 
alterations due to drug abuse and the addiction process, (b) neurobiological 
effects on human development/maturation due to prenatal or adolescent drug 
exposure, (c) neural mechanisms underlying cognitive processes that are 
altered by drugs of abuse, (d) neural mechanisms of cognitive or behavioral 
processes that may contribute to the initiation, progression/maintenance, or 
relapse to drug abuse/addiction, (e) neurobiological basis of individual 
differences in response to drug of abuse including differences in transition 
from drug use to addiction, (f) assessment of neurobiological changes 
resulting from pharmacological and/or behavioral treatment for drug 
abuse/addiction, (g) neurobiological and neurobehavioral factors underlying 
comorbid mental and addictive disorders, (h) characterization of interactions 
between drug abuse/addiction and HIV infection on brain, and (i) 
neurobiological processes involved in human pain and analgesia.

Research proposed under the I/START program need not be conducted in drug-
abusing populations or involve drug administration, however, the potential 
relevance to understanding drug abuse needs to be established.

MECHANISM OF SUPPORT

This PA will use the NIH Small Grant (R03) award mechanism.  For this 
specific announcement, an award may not exceed $150,000 in direct costs and 
is for a period of one year only.  The award is not renewable.  
Responsibility for the planning, direction, and execution of the proposed 
project will be solely that of the applicant.

This PA uses the just-in-time concepts.  It also uses the modular budgeting 
format (see http://grants.nih.gov/grants/funding/modular/modular.htm).

FUNDS AVAILABLE

NIDA estimates that approximately $1 million in total funds will be available 
under this PAR in FY2002.  It is expected that this program would continue in 
subsequent fiscal years at about the same funding level.

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

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to conduct 
the proposed research is invited to work with his or her 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.   

To be eligible for an I/START award, the proposed principal investigator must 
be independent of a mentor at the time of award and be at the beginning 
stages of her/his research career.  The proposed principal investigator may 
not have been supported previously as principal investigator on a National 
Institutes of Health (NIH) or federally supported research project or 
component (except a dissertation research grant or a Small Grant award/R03) 
or have received similar support from another federal agency, e.g., the 
National Science Foundation.  Previous receipt of a National Research Service 
Award Individual Fellowship and of mentored K-awards is permissible.  
Individuals in their last year of training status may apply so long as they 
will be independent investigators at the time of the I/START award.

Because this program is targeted at newly independent investigators, 
individuals who are more than five years beyond training status should 
consider other mechanisms of support.

SPECIAL REQUIREMENTS

Because this announcement targets newly independent investigators, this 
mechanism is ideal for obtaining preliminary data that could serve as the 
basis for a subsequent grant application using other mechanisms of support.  
Therefore, under this PA, inclusion of preliminary data is not a requirement 
and is not encouraged.

Resubmission of an I/START application is not permitted.  Also, the principal 
investigator on an I/START award may not be replaced.  Transfer of an I/START 
award with the principal investigator to another institution may be 
requested, as needed.  

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 three 
areas:  scientific/research, peer review, and financial or grants 
management issues.

o Direct your questions about scientific/research issues to:

Joseph Frascella, Ph.D.
Chief, Clinical Neurobiology Branch
Division of Treatment Research and Development
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4237, MSC 9551
Bethesda, MD  20892-9551
Telephone:  (301) 443-4877
Fax:  (301) 443-6814
Email:  [email protected]

o Direct your questions about peer review issues to:

Teresa Levitin, Ph.D.
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
E-mail:  [email protected]

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
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD  20892-9541
Telephone:  (301) 443-6710
FAX:  (301) 594-6847
E-mail:  [email protected]

SUBMITTING AN APPLICATION

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

Before submitting an application, investigators are strongly encouraged to 
contact the program contact listed under INQUIRIES in order to assess the 
responsiveness of their proposed project to the mission of NIDA and to the 
goals of this PA.

Sections a-d of the Research Plan must not exceed 10 pages in total.  
Appendix material may not be submitted.

APPLICATION RECEIPT DATES:  In 2002, the first receipt date will be May 14th, 
the next will be October 1, 2002, and subsequent receipt dates will follow 
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.

SENDING AN APPLICATION TO THE NIH:  Submit a signed, typewritten original of 
the application, including the checklist, and three signed photocopies in one 
package to:

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

To permit an expedited review of the applications, applicants must 
simultaneously send two additional copies of the application 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)

APPLICATION PROCESSING:  Applications must be received by or mailed before 
the receipt date of May 14, 2002, all subsequent submission dates are 
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 
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 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 reviewers 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.  

(1)  SIGNIFICANCE:  Does this preliminary study address an important problem?  
If the aims of this application were achieved, how would they be used to 
advance to the next level of a more comprehensive study?  

(2)  APPROACH:  Are the conceptual framework, design, methods, and analyses 
well integrated and appropriate to the aims of the project?  Do you 
acknowledge potential problem areas and consider alternative approaches?  A 
strong rationale, conceptual framework, and appropriate method could be 
considered sufficient for establishing the feasibility of the project, in 
lieu of preliminary data.

(3)  INNOVATION:  Does the project employ novel concepts, approaches or 
methods?  Are the aims original and innovative?  Does the project provide a 
firm basis for challenging existing paradigms?

(4)  INVESTIGATOR:  Is the investigator appropriately trained and well suited 
to carry out this work? 

(5)  ENVIRONMENT:  Does the scientific environment in which this 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.

AWARD CRITERIA

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

o Quality of the proposed project as determined by peer review
o Appropriateness to the goals of the I/START program
o Availability of funds and program priority

REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD:  Research components 
involving Phase 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.

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.

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, clinics, 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 
include 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.

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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