NEUROIMAGING TECHNOLOGY DEVELOPMENT TO ASSESS BRAIN AND BEHAVIOR IN 
PEDIATRIC POPULATIONS

Release Date:  October 26, 2001

RFA:  RFA-DA-02-001

National Institute on Drug Abuse
 (http://www.nida.nih.gov)
National Institute on Deafness and Other Communication Disorders
 (http://www.nidcd.nih.gov)
National Institute of Biomedical Imaging and Bioengineering
 (http://www.nibib.nih.gov)

Letter of Intent Receipt Date:  February 19, 2002
Application Receipt Date:       March 19, 2002

THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  MODULAR 
INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS REQUESTING 
LESS THAN $250,000 PER YEAR IN ALL YEARS. MODULAR BUDGET INSTRUCTIONS 
ARE PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE 
AT http://grants.nih.gov/grants/funding/phs398/phs398.html.

PURPOSE

The purpose of this RFA is to support studies that will address 
methodological and technical issues associated with the use of rapidly 
developing neuroimaging technology in assessing brain and behavioral 
development in child and adolescent populations, particularly those exposed 
to drugs of abuse or those with developmental or acquired communication 
disorders.  More specifically, studies are sought in two major areas:  (1) 
the neuroimaging tools themselves, the parameters they are measuring, their 
sensitivity in measuring these parameters, and problems and concerns that are 
inherent in their operation and in their use, particularly in infants, 
children and adolescents; and (2) broader issues related to the design of 
studies using specific neuroimaging techniques, including selection of 
independent and dependent variables, common threats to validity and 
reliability, and identification of the strengths and limitations of various 
components of design.

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, “Neuroimaging 
Technology Development to Assess Brain and Behavior in Pediatric 
Populations,” 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.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) 
exploratory/developmental grant (R21) award mechanism.  This mechanism for 
this RFA will support up to three years of research with a direct cost not to 
exceed $100,000 per year.  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 three 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 June 2002.  
For further information on the R21 mechanism, see 
http://grants.nih.gov/grants/guide/pa-files/PA-98-004.html.  Specific 
application instructions have been modified to reflect "MODULAR GRANT" and 
"JUST-IN-TIME" streamlining efforts that have been adopted by the NIH. 
Complete and detailed instructions and information on Modular Grant 
applications have been incorporated into the PHS 398 (rev. 5/2001).  
Additional information on Modular Grants can be found at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

FUNDS AVAILABLE 

Funds available for this initiative are $2,000,000 in FY 2002 to fund 12 to 
15 new and/or competitive continuation grants in response to this RFA.  
Because the nature and scope of the research proposed may vary, it is 
anticipated that the size of each award will also vary.  Although the 
financial plans of NIDA, NIDCD, and NIBIB 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.  At this 
time, it is not known if this RFA will be reissued.

RESEARCH OBJECTIVES

Background

With the rapid development of brain imaging technology, a new generation of 
imaging techniques has emerged that holds great promise for their ability to 
reveal structural and functional brain alterations during development in 
infants, children and adolescents.  These areas of research are of particular 
interest because of their potential in determining the neurobiological impact 
of exposure to drugs of abuse on these populations.  In addition, the 
potential exists to explicate the neurobiological bases of childhood 
communication disorders and expand our understanding of certain brain-
behavior relationships.

Included among the advanced neuroimaging techniques are positron emission 
tomography, single photon emission computed tomography, structural and 
functional magnetic resonance imaging, magnetic resonance spectroscopy, 
magnetic resonance perfusion imaging, diffusion tensor imaging, 
magnetoencephalography, and optical imaging.  Electroencephalographic and 
evoked potential recording techniques also have made considerable progress, 
especially in combination with other brain imaging modalities, and would be 
included.  In addition to the application of these technologies, development 
of new technologies or modalities that combine existing technologies are 
encouraged.

Each of these technologies used alone or in combination with others and with 
neurologic and behavioral assessments has the potential to reveal specific 
aspects of the puzzle of brain development. As the relationship between 
structural development of the postnatal central nervous system and the 
functional capacities of children from birth to adolescence gradually 
unfolds, the potential for identifying early delays in cognitive development 
and for mounting effective treatment and prevention strategies greatly 
increases.  

The rapidly expanding body of research using these sophisticated imaging 
techniques has unveiled some of the strengths and limitations inherent in the 
use of the technologies themselves.  Moreover, brain imaging studies of 
infants, children and adolescents present an additional set of unique 
technical and methodological challenges that become even more complicated 
when the research questions involve such populations as children exposed to 
drugs of abuse or those with communication disorders.  Exploration and 
resolution of these potential threats to validity and reliability, and the 
challenges they pose to research designs using brain imaging techniques, must 
be resolved before the techniques should be widely accepted and utilized as 
standard research tools.

Areas of Interest

Applications should have the potential to strengthen research on: 1) the 
neurobiological impact of exposure to drugs in pediatric populations; 2) the 
neurobiological bases of childhood communication disorders; or 3) the 
development of new technologies and the novel application of existing 
technologies to this research area. 

Research applications in these broad categories might include, but are not 
limited to:

o  Studies of both physical and statistical methods for monitoring, 
controlling and minimizing brain motion and noise artifacts, especially in 
real time
o  Development and testing of standardized protocols for acclimatizing 
subjects to imaging procedures (to minimize head movements and allow maximal 
time subject time in scanner)
o  Identification of the factors that most affect brain image quality, and 
development and testing of methods to control these variables
o  Studies using combinations of neuroimaging techniques to increase spatial 
and temporal resolution 
o  Research validating the measurement of dependent variables in brain 
imaging studies and their consistency across brain areas and between subjects
o  Studies identifying optimum equipment standards for specific neuroimaging 
modalities and the constraints these place on the availability of the 
equipment for research
o  Research focusing on the relative advantages and disadvantages of varying 
methods to increase the sensitivity of a neuroimaging technique for use in a 
pediatric population
o  Identification and testing of modifications that could be made to 
equipment or procedures to make specific brain imaging methods more adaptable 
for a pediatric population – for example, developing methods to decrease 
acquisition time in a magnet
o  Methods to determine coordinates and structural features (i.e., templates) 
of the brain during various stages in development, as well as development and 
refinement of cortical flattening methods and warping techniques
o  Studies on the developmental aspects of neurovascular coupling
o  Development of stimulus generation and appropriate neurocognitive 
(including speech and language) tasks that are amenable to study in the 
magnet and to pediatric populations
o  Determination of appropriate criteria for matching in between-group 
designs in the context of constraints imposed by the technology and the age 
of the subjects
o  Research identifying specific variables that should be controlled in the 
design of studies based on a selected brain imaging method in the pediatric 
population
o  Studies to determine the optimal experimental designs for specific 
neuroimaging methods used in pediatric populations
o  Development of mathematical or computational models for analyzing 
neuroimaging data that can be standardized for comparison across research 
sites
o  Studies that analyze neuroimaging data using different statistical 
approaches to explore for potential convergence of results
o  Research focusing on criteria for the selection and implementation of age-
appropriate cognitive tasks that will be suitable for neuroimaging studies
o  Studies that assess the value of using more than one imaging technique as 
a mechanism for cross-validation of methods

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS 

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.

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.  This policy announcement is found in the NIH Guide for Grants and 
Contracts Announcement dated June 5, 2000, at the following website:  
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.

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.

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 RFA 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.

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 all personnel 
and participating institutions; and the number and title of the RFA in 
response to which the application may be submitted.  Although a letter of 
intent is not required, is not binding, and does not enter into the review of 
a subsequent application, the information that it contains allows CSR 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
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-2755
FAX:  (301) 443-0538

APPLICATION PROCEDURES

The PHS 398 research grant application instructions and forms (rev. 5/2001) 
at http://grants.nih.gov/grants/funding/phs398/phs398.html MUST be used in 
applying for these grants.  This version of the PHS 398 is available in an 
interactive, searchable format. For further assistance contact GrantsInfo, 
Telephone 301/435-0714, Email:  GrantsInfo@nih.gov.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS

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 NIH staff.  The research grant application form PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in 
applying for these grants, with modular budget instructions provided in 
Section C of the application instructions.

The RFA label available in the PHS 398 (rev. 5/2001) 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 on 
line 2 of the face page of the application form and the YES box must be 
marked. The RFA label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.

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)

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 Review (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

Upon receipt, applications will be reviewed for completeness and 
responsiveness by the CSR and responsiveness by NIDA, NIDCD, and NIBIB.  
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 CSR 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 appropriate National Advisory Councils.

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.  Applications may 
include hypothesis-driven research as well as technology- or design-driven 
research.  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.

Further, the R21 mechanism is intended for exploratory, developmental 
research.  It is essential to consider the application in the context of the 
R21 mechanism.  The applicant must establish both the novelty and the 
potential impact of the project.  In keeping with the 
exploratory/developmental nature of the R21, preliminary data are not 
expected.  However, the application must be well-reasoned and scientifically 
sound.  Where appropriate, specific criteria by which to judge the success of 
novel approaches (including milestones that will mark progress) should be 
explicitly described.

(1)  Significance:  Does this study address an important problem?  If the 
aims of the application are achieved, how will scientific knowledge be 
advanced and how will this work expand or improve upon existing methods?  
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?  For the R21 mechanism, a strong rationale and 
conceptual framework may be 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 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?

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 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.

o  The adequacy of the proposed plan to share data, if appropriate.

Schedule

Letter of Intent Receipt Date:    February 19, 2002
Application Receipt Date:         March 19, 2002
Peer Review Date:                 June 2002
Council Review:                   September 2002
Earliest Anticipated Start Date:  September 2002

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 any issues or answer questions from potential applicants is welcome.

Direct inquiries regarding programmatic 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 9559
Bethesda, MD  20892-9559
Telephone:  (301) 443-4877
Fax:  (301) 443-6814
Email:  jf80t@nih.gov

Judith Ann Cooper, Ph.D.
Chief, Scientific Programs Branch
Division of Extramural Research
National Institute on Deafness and Other Communication Disorders/NIH
Executive Plaza South, Suite 400C
6120 Executive Boulevard, MSC 7180 
Bethesda, MD  20892-7180
Phone:  (301) 496-5061
Fax:  (301) 402-6251
Email:  jc148m@nih.gov

Joan T. Harmon, Ph.D.
Senior Advisor for Program
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Boulevard, Room 697
Bethesda, MD  20892
Phone:  (301) 594-8813
Fax:  (301) 480-3503
Email:  joan_harmon@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
Fax:  (301) 594-6847
Email:  gf6s@mail.nih.gov

Sara Stone
Chief, Grants Management Branch
National Institute on Deafness and Other Communication Disorders/NIH
Executive Plaza South, Suite 400B
6120 Executive Boulevard, MSC 7180 
Bethesda, MD  20892-7180
Phone:  (301) 402-0909
Fax:  (301) 402-1758
Email:  ss115y@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.279 (NIDA) and No. 93.173 (NIDCD).  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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