TRANSLATIONAL RESEARCH CENTERS IN BEHAVIORAL SCIENCE (TRCBS)

RELEASE DATE:  August 25, 2004

PA NUMBER:  PAR-04-151  
Update: The following update relating to this announcement has been issued: 

August 26, 2009  - See Notice NOT-MH-09-017 Second Amendment to the Notice to Discontinue 
this PAR as of September 26, 2009.

(See Notice NOT-MH-09-014 Notice to Discontinue this PAR, NIMH will no longer 
accept renewal (competing continuation) applications of center grants from this program )

(See Notice NOT-MH-06-121 Notice of Discontinuation and New Total Costs Limits)

EXPIRATION DATE:   October 23, 2006, unless reissued.

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
 (http://www.nih.gov)

COMPONENT OF PARTICIPATING ORGANIZATION:
National Institute of Mental Health (NIMH)
 (http://www.nimh.nih.gov/)

LETTER OF INTENT RECEIPT DATE:  September 22, 2004, September 22, 2005, 
                                September 22, 2006 
APPLICATION RECEIPT DATES:  November 15, 2004, October 19, 2005, 
                            October 22, 2006 

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.242

THIS PA CONTAINS THE FOLLOWING INFORMATION

o  Purpose of the PA
o  Research Objectives
o  Mechanism(s) of Support
o  Eligible Institutions
o  Individuals Eligible to Become Principal Investigators
o  Where to Send Inquiries
o  Letter of Intent
o  Submitting an Application
o  Supplementary Instructions
o  Peer Review Process
o  Review Criteria
o  Award Criteria
o  Required Federal Citations

PURPOSE OF THE PA

This PAR replaces PAR-01-027. 

The National Institute of Mental Health (NIMH) invites research grant 
applications for Translational Research Centers in Behavioral Science (TRCBS).  
The purpose of these centers is to support the translation of work from basic 
behavioral science research, and relevant integrative neuroscience research, to 
pressing issues regarding all aspects of mental disorders.  Such clinical issues 
include an understanding of the etiology and assessment of disorders; the 
assessment of functioning; development of innovative and culturally appropriate 
preventive, treatment, and rehabilitation interventions; and improvement of 
methods for the effective delivery of mental health services.  The centers are 
also intended to encourage basic behavioral scientists to seek a further 
understanding of behavioral processes through an exploration of how those 
processes are altered by mental and behavioral disorders.

These Centers are intended to support integrated research teams drawn from the 
fields of basic behavioral and social sciences, neuroscience, epidemiology, 
prevention, academic mental health, and mental health services delivery.  
Centers are to develop hypothesis-driven approaches to an important research 
question, or a focused set of research questions, using innovative designs and 
cutting-edge approaches to methodological and statistical issues.  An important 
goal of the centers is to transcend the barriers of disciplines, research 
settings, and institutions in order to harness the full range of modern 
behavioral science to the service of the nation’s critical mental health needs. 
(See the Institute of Medicine report, “Bridging Disciplines in the Brain, 
Behavioral, and Clinical Sciences,” available at 
http://books.nap.edu/catalog/9942.html.)

This Program Announcement (PA) is one of two announcements developed in response 
to a report written by the National Advisory Mental Health Council’s Behavioral 
Science Workgroup, entitled “Translating Behavioral Science into Action” 
(http://www.nimh.nih.gov/publicat/nimhtranslating.pdf).  The other 
announcement describes a range of collaborative arrangements designed to foster 
smaller-scale and developmental activities in translational research in the 
behavioral sciences (see RFA-MH-01-005 at 
http://grants.nih.gov/grants/guide/rfa-files/RFA-MH-01-005.html).

RESEARCH OBJECTIVES

Background

As enumerated in the recent Surgeon General’s report on mental health (available 
at http://www.nimh.nih.gov), mental disorders affect approximately 
15-20 percent of the U.S. population, annually.  These disorders represent a 
major cause of disability:  In a recent study of developed nations, mental 
disorders comprised four of the ten most severe causes of disability 
(depression, schizophrenia, bipolar disorder, and obsessive-compulsive 
disorder).  In the most recent estimate, the costs of treating mental illness 
were nearly $70 billion per year, with billions of dollars more in lost wages 
and other indirect costs.  In view of these pressing needs, all available 
resources must be applied toward efforts to improve the prevention, treatment 
options, and delivery of services for mental disorders.

The field of behavioral science represents a major potential resource to address 
these urgent problems.  Accordingly, NIMH has for many decades been a primary 
source of support for research in the basic behavioral sciences.  This long-term 
investment in behavioral research has resulted in the development of a large 
literature of data, theories, and methods regarding various aspects of human 
behavior.  A number of investigators have applied this body of knowledge to issues 
in mental disorders.  However, to a surprising extent, considerable areas of 
relevant and potentially valuable basic behavioral research have remained largely 
separated from academic clinical departments, schools of public health, or mental 
health services settings.  A number of problems can be identified which impede such 
translation.  These include:  growing disciplinary fragmentation; the fact that 
basic, clinical, and services researchers typically work in different venues; a 
disjunction in training between basic and clinical researchers; the incentive 
system in academic research, which typically rewards quantitative productivity in 
narrow areas; and, the frequent unavailability of clinical populations to basic 
researchers.

In 1999, the NIMH Director and the National Advisory Mental Health Council convened 
the Behavioral Science Workgroup to explore ways to increase the impact of 
behavioral science research on public mental health issues.  The Workgroup was 
comprised of experts in social, cognitive, developmental, and clinical psychology, 
psychophysiology, anthropology, sociology, public health, and biostatistics.  In 
their report, "Translating Behavioral Science into Action," they highlighted three 
priority areas of translational behavioral science research.  These included:  (1) 
Basic behavioral processes in mental illness; (2) Functional abilities in mental 
illness; and (3) Contextual influences on mental illness and its care.  Regarding 
these three areas, the Workgroup wrote:  "These priority research areas are 
critical starting points for progress in translational science because they are at 
the interface of what end-users have identified as important and what behavioral 
science researchers regard as areas of opportunity.  They offer the prospect of 
conducting exciting research, advancing scientific understanding of behavior in 
health and in illness, and improving the mental health of our Nation."

This PA represents a major NIMH effort to implement the Workgroup’s report, by 
providing for large-scale research centers with the scale and resources to overcome 
the barriers to effective translational research.  It is expected that Centers will 
include sites with multiple components drawn from basic research in behavioral 
science and relevant neuroscience, and other components comprising high-risk 
populations, clinical populations, and/or settings where mental health services are 
provided.  In addition to these fundamental components, Centers are intended to 
provide for the development of innovative advances in appropriate methodological 
and statistical techniques, and support the training of a new generation of 
research scientists schooled in the integration of basic and clinical science.

Center Characteristics

o  TRCBSs are expected to be organized around a specific and focused set of 
hypotheses, in which one or more areas of basic behavioral science are applied to 
clinical issues in mental disorders or mental health services delivery.  Centers 
will involve a multidisciplinary team of basic and clinical or services researchers 
organized to communicate across boundaries or disciplines, institutions, and 
settings.  Collaborations among different institutions are encouraged in view of 
the frequent distinctions between basic science and clinical/services settings.  
However, the TRCBS must indicate how communication will occur across institutional 
and geographic boundaries so that fully developed collaborative research 
partnerships can occur.

o  TRCBSs are expected to include components from both basic behavioral science and 
clinical or services research settings.  Each TRCBS must demonstrate the 
integration of basic and clinical work, with an organization conceived to promote 
sharing of information in both directions between the basic and clinical or 
services components.  Thus, research programs in the basic behavioral sciences 
should serve as a source of concepts and methods for clinical work; data gathered 
from clinical or high-risk populations may prompt additional research questions to 
be tested with non-clinical samples, or new methodological questions to be 
addressed.

o  The inclusion of investigators and research programs from relevant areas of 
biological science and neuroscience (e.g., psychophysiology, neuroimaging, 
neurohormonal measurements) is strongly encouraged, but not required.  The focus of 
neurobiological measures should be on their integration with concepts and data 
drawn from behavioral science.

o  A TRCBS is intended to promote innovative translational research.  A Center 
should not duplicate ongoing research, and should demonstrate how the proposed 
Center activities represent a novel synthesis of basic and clinical science.

o  The director of a TRCBS should be a distinguished senior scientist, with a 
strong record of prior research and scholarly activities.  The director should also 
demonstrate the capability to organize, lead, and administer the Center.  In 
addition to serving as the scientific head of the Center, this individual should 
also direct at least one of the individual projects, and allot a minimum time 
commitment of 30 percent effort to the Center.

o  Principal investigators of individual projects within the Center should be 
established investigators in their respective fields, with a strong record of 
basic, clinical, or services research.  Principal investigators of the projects are 
not required to have independent funding, but must demonstrate the experience and 
qualifications to provide scientific leadership of the project.

o  The clinical and/or services components of the proposed Center may include any 
aspect of relevant work.  These components are to include research with patient 
populations, that is, studies conducted with persons at high risk for mental 
disorders, diagnosed with a disorder, or with organizations that provide mental 
health services.  The TRCBS must outline clearly the ways in which the 
contributions of basic behavioral science (concepts, principles, extant 
literatures, paradigms, measures, statistical approaches, etc.) are to be applied 
to the research questions in a clinical or services setting.

o  It is expected that the basic behavioral science components of a Center will 
include active programs of experimentation, methodological or statistical 
development, or other scientific work that serves to advance the knowledge base 
being applied to the clinical applications.  That is, basic behavioral scientists 
should not serve only in a consultative role to clinical/services projects.  The 
basic research components could also address basic research questions arising from 
results with samples drawn from high-risk/clinical/services settings.

o  A TRCBS must include research apprenticeships.  These should include 
opportunities for young investigators to gain experience with the concepts, 
methods, and techniques in one or more areas of specialization.  Research 
apprenticeship opportunities should specifically address the application of basic 
research principles to clinical or services issues.  Centers should coordinate 
closely with other pre- and post-doctoral training programs at the institutions 
involved.  Special attention should be given to the recruitment and training of 
minority and/or disabled students and scientists.

o  Each TRCBS should include a program of outreach to facilitate public awareness 
of the issues involved in the research, the integration of basic and clinical or 
mental health services research, and the advances that are achieved by the Center’s 
activities.

Research Areas

The goal of the TRCBS program is to support the translation of basic behavioral 
science research to significant issues in mental disorders and mental health 
services.  Relevant areas of basic behavioral research include:  cognition, 
including learning, memory, perception, etc.; affective processes, including 
emotion, mood, and motivation; temperament and personality; social cognition; 
social and cultural influences and processes; attitudes and persuasion; 
interpersonal relationships; and fundamental biobehavioral processes such as sleep 
and eating. Basic research may include animal models as well as studies with human
populations, and may also involve theoretical and/or mathematical modeling approaches.
Relevant domains of neurobiological measurement could include psychophysiology (both
peripheral and central nervous system measures), neuroimaging, and neurohormonal
activity.  It is anticipated that activities of a TRCBS might well include work drawn
from a number of these fields, e.g., the mutual interactions of cognitive and affective
processes in mental disorders and their effect on responsiveness to treatment.

Clinical issues are expected to involve significant issues in the etiology, 
assessment, prevention, treatment, or rehabilitation of mental disorders or the 
delivery of mental health services with respect to children or adults.  Applied 
research can include the use of both qualitative and quantitative methods.  A major 
priority of the NIH is to study disparities in health across different ethnic and 
minority groups.  Accordingly, it is strongly encouraged that both basic and 
clinical studies include a broad representation of subjects with respect to gender, 
ethnicity, age, etc.; wherever possible, groups should be large enough to provide 
sufficient power for meaningful statistical tests of these group differences.

The TRCBS program is designed to foster the integration of basic behavioral 
research with mental health prevention, clinical, and services research.  In 
contrast, research that is focused only on fundamental psychological and neural 
processes likely to be involved in mental health and mental illness is not 
appropriate for the TRCBS program.  For information regarding interdisciplinary 
basic behavioral science centers, investigators should consult the following PA:  
(http://grants.nih.gov/grants/guide/pa-files/PAR-04-004.html).  Research that is 
primarily directed toward the pathophysiology of mental disorders, as opposed to 
integrative behavioral and physiological investigations, is also not appropriate 
for a TRCBS.  Investigators interested in these topics should consult the NIMH web 
site for information on the Silvio Conte Centers for the Neuroscience of Mental 
Disorders (http://grants.nih.gov/grants/guide/pa-files/PAR-02-122.html).

The following list provides some examples of broad research areas that could fit in 
the Centers program.  This list is not meant to be comprehensive, nor are the 
examples meant to be exclusive of other topics.

o  Studies of temperament, mood, emotion (including emotion dysregulation), and 
cognition, as they are mutually involved in the etiology and course of mood and 
anxiety disorders 

o  Research pertaining to factors that support the behavior of patients with 
serious mental illness in their daily functioning and therapeutic regimens (e.g., 
mechanisms of learning and memory in patients with serious mental illnesses; 
mechanisms of emotional response and emotional control in these patient groups; 
optimal characteristics of service providers; and the organization of mental health 
services in these populations)

o  Studies of processes that affect the risk, course, severity, prevention, and 
treatments for attention-deficit/hyperactivity disorder (ADHD) (e.g., models of 
normal temperament development; relation between temperament and cognitive 
development; age-appropriate models of ADHD; advances in appropriate measurement 
and diagnosis; measurement of cognitive and emotional processes in ADHD; and the 
relationship of central nervous system activity to behavioral measures across 
developmental age)

o  Research using concept and methods of basic behavioral science to identify 
specific functional deficits in mental disorders; development of targeted 
interventions for rehabilitation; and ways to organize the delivery of mental 
health services in the current health care context to provide optimal 
rehabilitation services

o  Research on new methods of conceptualizing and classifying mental disorders, as 
considered from multi-disciplinary perspectives (e.g., utility of dimensional 
approaches to such areas of psychopathology as mood disorders)

o  Research on the prevention of mental disorders and integrating basic research on 
biological, psychological, and social risk and protective processes in order to 
develop new models of preventive interventions.  Prevention may include 
interventions to (a) reduce the risk of onset, or delay onset, of mental disorders 
and behavioral dysfunction; (b) reduce the severity and course of disorder; (c) 
prevent comorbid conditions; and (d) prevent relapse, excess disability, and 
inappropriate service use.

o  Research regarding the interaction of behavioral and neurophysiological 
processes in schizophrenia such as studies of the interaction of cognitive and 
emotional processes (as measured behaviorally and neurophysiologically) involved 
with functional deficits in psychotic disorders; combined behavioral and CNS 
measures to develop an enhanced understanding of the various symptom patterns and 
their interrelationships (e.g., positive and negative symptoms, cognitive 
disorganization) in psychotic disorders; and development of behavioral techniques 
that may act through brain plasticity to ameliorate functional deficits in patients 
with schizophrenia)

o  Research programs to study the factors involved in improving mental health 
services in primary care settings (e.g., factors influencing the decision to seek 
treatment; methods of improving provider behavior to recognize, diagnose, and treat 
mental disorders; development of valid and reliable screening and other assessment 
techniques for use in primary care settings; studies of alternative providers, 
procedures, and technologies to facilitate mental health services in primary care 
settings

o  Research to develop an understanding of the behavioral and neurobiological 
deficits in autism (e.g., aspects of social and cognitive behavior as related to 
activity in specific brain regions, and development of behavioral and pharmacologic 
interventions for improvement of autistic symptoms)

Activities Supported

To provide a suitable structure for achieving the goals of the research program, a 
TRCBS may request funds for the following:

Individual Research Projects

Funds must be requested to support a number of research projects.  It is expected 
that 2 or more of the research projects will involve the basic behavioral sciences 
and/or relevant neuroscience.  (Investigators contemplating a project with only 1 
or 2 basic science components should consider a single R01 application with 
subcontracts.)  At least 1 of the research projects must involve work with patient 
populations, that is, studies conducted with persons diagnosed with a mental 
disorder, or with organizations that provide mental health services.  However, 
multiple projects in clinical or services settings are also encouraged, for 
purposes of increasing the number of patient subjects, representing different 
aspects of clinical phenomena, or increasing the diversity of patient populations 
with respect to ethnicity, gender, or age.  Each project must demonstrate the 
capability to integrate strongly with other projects of the Center.

It is anticipated that TRCBSs will request support for 1 or more “core” activities.  
These could include such functions as administration, subject recruitment, 
methodological developments (e.g., diagnosis, assessment instruments), data 
management procedures, or statistical analysis (including innovation in statistical 
methodologies as well as conducting actual statistical tests).  The TRCBS should 
clearly indicate how the cores will support the integrative, translational mission 
of the Center.  Core support may include salary costs, research resources shared 
across projects, equipment needed to conduct the research, and incidental 
alteration and renovation of facilities needed as consistent with Public Health 
Service policy.

Essential Scientific Expertise

To provide the most effective combination of scientific knowledge and skills, 
applicants may request funds to support scientists to augment or strengthen the 
skills, expertise, and capabilities of existing Center staff.  Recruitment of such 
individuals may take place after an award has been made; however, the expertise 
required, the role in Center activities, and the time to be devoted to the Center 
should be provided in the application.  It should be emphasized, however, that 
after an award is made, such individuals cannot serve as a substitute for a Project 
principal investigator.

Advisory Board

An external advisory board should serve as an important source of guidance from 
experts in the field who do not have a vested interest in the Center or in the 
research to be conducted by the Center.  Board members should include individuals 
drawn from both basic science areas and from clinical or services areas who have 
relevant experience and expertise.  Funds may be requested to support travel of 
board members for meetings in the beginning of the second year of funding, and for 
one or two additional meetings across the project period.  To avoid reducing the 
pool of potential reviewers, applicants should not identify, choose, or contact 
prospective board members before a funding decision is made.

MECHANISM OF SUPPORT

This PA will use the NIH Specialized Centers (P50) award mechanism, which provides 
support for multidisciplinary and multi-investigator approaches to the 
investigation of specific and complex research problems requiring the application 
of diverse expertise and methodologies.  As an applicant, you will be solely 
responsible for planning, directing, and executing the proposed project.

Applicants may request support for a period of up to 5 years, followed by a 
competitive renewal application for a second 5-year period.  The NIMH will not 
support individual Centers for longer than two funding periods.  Centers are 
limited to $1.5 million in direct costs in any single year, including non-competing 
continuation years.  Competitive supplements will not be considered for these 
Center grants.  It is anticipated that individual projects that are outgrowths of 
Center activity will seek independent funding through mechanisms such as research 
project grants (R01).

Since TRCBSs are defined by their integrative nature and not by departmental or
geographic boundaries, projects constituting a given Center may be based at a 
variety of institutions, representing both basic and clinical or services research.  
While the Facilities and Administrative (F&A) costs associated with all contractual 
and consortium arrangements are considered as direct costs to the applicant 
organization, for the purposes of this PA only, these will not count against the 
program direct costs cap of $1.5 million per year.  However, these costs should be 
indicated as instructed on Form PHS 398. 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html)

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 institutions/organizations
o  Foreign institutions are not eligible to apply

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

o  Direct your questions about scientific/research issues to:

Bruce N. Cuthbert, Ph.D.
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6184, MSC 9625
Bethesda, MD  20892-9625
Telephone:  (301) 443-3728
FAX:  (301) 443-4611
Email:  bcuthber@mail.nih.gov

Ann A. Hohmann, Ph.D., MPH
Division of Services and Interventions Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7135, MSC 9631
Bethesda, MD  20892-9631
Telephone:  (301) 443-4235
FAX:  (301) 443-4045
Email:  ahohmann@mail.nih.gov

Direct your questions about peer review issues to:

Michael Kozak, Ph.D.
Divisions of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6138, MSC 9606
Bethesda, MD  20892-9608
Telephone:  (301) 443-1340
FAX:  301) 443-4720
Email:  mkozak@mail.nih.gov

o  Direct inquiries regarding fiscal matters to:

Rebecca D. Claycamp, CRA
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6122, MSC 9605
Bethesda, MD  20892-9605
Rockville, MD  20852 (overnight)
Telephone:  (301) 443-2811
FAX:  (301) 443-6885
Email:  rc253d@nih.gov

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes the 
following information:

o  Descriptive title of the proposed research
o  Name, address, and telephone number of the Principal Investigator
o  Names of other key personnel
o  Participating institutions
o  Number and title of this RFA

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 IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this 
document.  The letter of intent should be sent to:

Bruce N. Cuthbert, Ph.D.
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6184, MSC 9625
Bethesda, MD 20892-9625
Telephone:  (301) 443-3728
FAX:  (301) 443-4611
Email:  bcuthber@mail.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  Applications must have a Dun and Bradstreet 
(D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier 
when applying for Federal grants or cooperative agreements.  The D&B number can be 
obtained by calling (866) 705-5711 or through the web site at 
http://www.dunandbradstreet.com/.  The D&B number should be entered on line 11 of 
the face page of the PHS 398 form.  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.

The title and number of this program announcement must be typed on line 2 of the 
face page of the application form and the YES box must be checked.

SUPPLEMENTARY INSTRUCTIONS

A major requirement for a TRCBS is the conduct of multidisciplinary research 
focused on the integration of multiple areas of basic behavioral and neuroscience, 
as they converge to address an important set of issues regarding mental disorders 
and/or the delivery of mental health services.  The application must describe the 
hypotheses to be tested and the goals of the TRCBS.  In addition, the application 
should clearly articulate the reasons a Center approach is needed for this work and 
the unique benefits that will accrue from having a Center in this research area, 
rather than addressing the research issues through other modes of support.

Using the PHS Form 398, the application should include the following components in 
the designated order.

Information for the entire Center:

o  Face Page, pertaining to the entire Center

o  Description, performance sites, and Key Personnel (Form Page 2), pertaining to 
the entire Center

o  Table of Contents (Form Page 3) for the entire application

o  Budget (Form Pages 4 and 5).  Categorical figures should be provided to describe 
the budget of the overall Center.  Since detailed budget justification will be 
provided separately for each project and core (as described below), only items for 
which justification is not provided elsewhere should be included in narrative here.

o  Biographical sketches of Key Personnel (Form Page 6).  These should be provided 
for key personnel of the entire Center, and should be arranged alphabetically based 
on the individual’s surname.

o  Other Support (Form Page 7) of key personnel for the entire Center, presented 
alphabetically by surname.

o  Resources (Form Page 8).  These should be restricted to those not described 
separately for the individual projects and cores.

o  General description of the overall Center (not to exceed 10 pages; amended 
applications should include a one-page introduction to the revision).  Provide an 
overview of the entire proposed Center, describing the Center goals and how they 
will be achieved.  Explain the contribution of each of the individual projects and 
cores to achieving the Center’s objectives, and how these components relate to each 
other.

o  Evidence of Feasibility and Preliminary Findings (for new--Type 1-- applications 
and revised Type 1 applications only; not to exceed 10 pages; for revised 
applications, provide a one-page introduction describing changes from the 
previously submitted version).  Present evidence that the research team will be 
able to work together to achieve the research goals of the Center, preliminary 
results, evidence of competence in the areas proposed, and any other information 
that speaks to feasibility.

o  Progress Report (for competing continuation--Type 2--applications and revised 
Type 2 applications only; not to exceed 3 pages for each project supported in the 
previous Center grant; for revised applications, provide a one-page introduction to 
the entire Progress Report describing changes from the previously submitted 
version).  Describe the research progress of the previously supported Center and 
the manner in which the results relate to the current application.  Describe the 
manner in which the Center mechanism provided synergy to the previously funded 
Center.

o  Operational Plan for the Overall Center (not to exceed 10 pages; for amended 
applications, provide a one-page introduction describing changes from the 
previously submitted version).  Describe the working administrative and logistical 
arrangements, as well as resource support necessary to implement the research.  
When multiple institutional sites are involved, a detailed description of the 
cooperative administrative arrangements should be included (and documented in the 
“Letters of Support” section).  Also include in this section a description of the 
manner in which an external advisory board will relate to the Center.  Prospective 
board members should not be chosen or contacted prior to a funding decision and, 
therefore, should not be named in the application.  Finally, describe the plan for 
providing access to data, research tools, and any biological material generated by 
the Center.

o  Research Career Development and Outreach Plans (not to exceed 2 pages).  
Describe how the Center will provide opportunities for junior investigators, 
including the Research Apprentice positions as well as relationships with training 
programs of participating institutions.  Also, describe plans for disseminating 
information to the public regarding the activities of the Center.

Information for each Project or Core:

Provide, in the order indicated:

o  Description, Performance Sites, and Key Personnel (Form Page 2), referring 
specifically to the project or core.

o  Budget (Form Pages 4 and 5).  Detailed budgetary information for each project or 
core, including narrative justification.

o  Resources (Form Page 8), referring specifically to the project or core.

o  Research Plan for Individual Projects (not to exceed 10 pages for any one 
project; for amended applications, provide a one-page introduction describing 
changes from the previously submitted version).  Describe the specific aims, 
background, and significance, the research questions to be addressed, and the 
hypotheses to be tested.  Address the ways in which the particular research 
question lends itself to a translational approach.  Projects should describe the 
bi-directional flows of data and research questions that are anticipated between 
basic and clinical or services research projects.  Describe the research design and 
methods in as much detail as possible, and address issues of feasibility, potential 
pitfalls, alternative approaches, and relevance to Center goals.

o  Descriptions of Individual Cores (not to exceed 8 pages for any one Core; for 
amended applications, provide a one-page introduction describing changes from the 
previously submitted version).  Describe how the core will contribute to the 
overall goals of the Center, including the facilities, resources, services, and 
professional expertise that it will provide.  Describe which projects will be 
supported by the Core and the manner in which that support will be rendered.

o  Literature Cited, compiled across all sections of the application

o  Letters of Support from Collaborating Institutions

o  Checklist

o  Personal Data on Center Director

APPLICATION RECEIPT DATES:  Applications submitted in response to this program 
announcement will be accepted at the application deadlines listed in the heading of 
this PA.  

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 $500,000 or more 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 three signed photocopies in one package 
to:

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

At the time of submission, two additional copies of the application and all copies 
of the appendix material must be sent to:

Jean Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD 20892-9609
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-3367
FAX:  (301) 443-4720
Email:  jnoronha@mail.nih.gov

APPLICATION PROCESSING:  Applications must be received on or before the application 
receipt date listed in the heading of this PAR.  If an application is received 
after that date, it will be returned to the applicant without review.

Although there is no immediate acknowledgement of the receipt of an application, 
applicants are generally notified of the review and funding assignment within 8 
weeks.

The correct standard language from the PA template should be used here. KFS
The Center for Scientific Review (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 unfunded version 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.  Appropriate scientific review groups 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.Applications will be 
evaluated for scientific and technical merit by an appropriate peer review group 
convened by NIMH in accordance with the review criteria stated below.  As part of 
the initial merit review, all applications will:

o  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 and assigned a priority score
o  Receive a written critique
o  Receive a second level review by the National Advisory Mental Health Council

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 evaluate the application in order to judge the 
likelihood that the proposed research will have a substantial impact on the pursuit 
of these goals.  The scientific review group will address and consider each of the 
following criteria in assigning the application’s overall score, weighting them as 
appropriate for each application.

o  Significance
o  Approach
o  Innovation
o  Investigator
o  Environment

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.

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?

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?

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?

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)?

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?

ADDITIONAL REVIEW CRITERIA:  In addition to the above criteria, the following items 
will be considered in the determination of scientific merit and the priority score:

Criteria for review of scientific and technical merit will include the following:

o  Intrinsic Merit:  The overall quality, scientific merit, and innovation of the 
research to be conducted; the likelihood that the Center will lead to fundamental 
advances, to new discoveries, and/or to new technological developments.  In 
addition, the research must center around a highly focused and well defined set of 
research questions.

o  Appropriateness of the Center Approach:  The need for and suitability of a 
Center approach; whether a Center approach will add significantly to what could be 
accomplished through other modes of research support.  In this respect, the 
integration and interdependence of component projects and cores is of utmost 
significance and should be described explicitly.

o  Research Competence:  The qualifications and scientific credentials of the 
Center Director and constituent project directors; these individuals should be 
regarded by their peers as leaders in, and at the forefront of, their respective 
fields.

o  Center Director Credentials:  Demonstrated ability of the Center Director to 
organize, direct, and administer the Center and, in addition, be the Principal 
Investigator on at least one of the individual projects.  It is expected that this 
individual will devote a minimum of 30 percent time to the Center grant.  The 
Director must be the scientific leader of the Center.

o  Institutional Commitment:  The nature and level of resource commitments and 
resources available from the home institution and from other participant 
institutions, and plans for interactions with the rest of the sponsoring 
institutions.

o  Appropriateness of Management Plans and Arrangements:  The feasibility and 
adequacy of the organizational and administrative plans and the mechanisms to 
evaluate the Center’s progress.

o  Quality of Plans for Research Apprenticeships:  The effectiveness of approaches 
used to attract and involve junior investigators and students who show potential 
for significant contributions to translational research and independent research 
careers.

o  Quality of linkages between the proposed Center and ongoing training programs in 
the institutional environment.

o  Outreach:  Quality of approaches used to disseminate information regarding the 
Center’s activities as they relate to public understanding of the ways in which 
basic behavioral and neurobiological sciences are harnessed to address important 
issues with regard to our understanding of the nature of mental disorders, and the 
delivery of mental health care services.

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK:  The involvement of human subjects 
and protections from research risk relating to their participation in the proposed 
research will be assessed. (See criteria included in the section on Federal 
Citations, below). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH:  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 will be 
assessed.  Plans for the recruitment and retention of subjects will also be 
evaluated. (See Inclusion Criteria in the sections on Federal Citations, below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH:  If vertebrate animals are to be 
used in the project, the five items described under Section f of the PHS 398 
research grant application instructions (rev. 5/2001) will be assessed.

ADDITIONAL REVIEW CONSIDERATIONS 

SHARING RESEARCH DATA:  Applicants requesting $500,000 or more in direct costs in 
any year of the proposed research are expected to include a data sharing plan in 
their application.  The reasonableness of the data sharing plan or the rationale 
for not sharing research data will be assessed by the reviewers.  However, 
reviewers will not factor the proposed data sharing plan into the determination of 
scientific merit or priority score.

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


AWARD CRITERIA

Applications will compete for available funds with all other recommended 
applications assigned to NIMH.  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.

The P50 grant supporting a TRCBS is not transferable to another institution.

REQUIRED FEDERAL CITATIONS

ANIMAL WELFARE PROTECTION:  Recipients of PHS support for activities involving 
live, vertebrate animals must comply with PHS Policy on Humane Care and Use of 
Laboratory Animals 
(http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as mandated 
by the Health Research Extension Act of 1985 
(http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal 
Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as 
applicable.

HUMAN SUBJECTS PROTECTION:  Federal regulations (45CFR46) require that applications 
and proposals involving human subjects must be evaluated with reference to the 
risks to the subjects, the adequacy of protection against these risks, the 
potential benefits of the research to the subjects and others, and the importance 
of the knowledge gained or to be gained. 
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

DATA AND SAFETY MONITORING PLAN:  Data and safety monitoring is required for all 
types of clinical trials, including physiologic, toxicity, and dose-finding studies 
(phase I); efficacy studies (phase II), efficacy, effectiveness and comparative 
trials (phase III).  The establishment of data and safety monitoring boards (DSMBs) 
is required for multi-site clinical trials involving interventions that entail 
potential risk to the participants.  (NIH Policy for Data and Safety Monitoring, 
NIH Guide for Grants and Contracts, June 12, 1998:  
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

SHARING RESEARCH DATA:  Investigators submitting an NIH application seeking 
$500,000 or more in direct costs in any single year are expected to include a plan 
for data sharing or state why this is not possible 
http://grants.nih.gov/grants/policy/data_sharing.  Investigators should seek 
guidance from their institutions, on issues related to institutional policies, 
local IRB rules, as well as local, state and Federal laws and regulations, 
including the Privacy Rule.  Reviewers will consider the data sharing plan but will 
not factor the plan into the determination of the scientific merit or the priority 
score.

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 "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.  

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://stemcells.nih.gov/index.asp 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, in the project description and 
elsewhere in the application as appropriate, 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.

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.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  The 
Department of Health and Human Services (DHHS) issued final modification to the 
“Standards for Privacy of Individually Identifiable Health Information”, the 
“Privacy Rule,” on August 14, 2002.  The Privacy Rule is a federal regulation under 
the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that 
governs the protection of individually identifiable health information, and is 
administered and enforced by the DHHS Office for Civil Rights (OCR).  

Decisions about applicability and implementation of the Privacy Rule reside with 
the researcher and his/her institution.  The OCR website (http://www.hhs.gov/ocr/) 
provides information on the Privacy Rule, including a complete Regulation Text and 
a set of decision tools on “Am I a covered entity?”  Information on the impact of 
the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress 
monitoring of grants, cooperative agreements, and research contracts can be found 
at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

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.healthypeople.gov/.

AUTHORITY AND REGULATIONS:  This program is described in the Catalog of Federal 
Domestic Assistance at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health Systems 
Agency review.  Awards are made under the authorization of Sections 301 and 405 of 
the Public Health Service Act as amended (42 USC 241 and 284) and under Federal 
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  All awards are subject to the 
terms and conditions, cost principles, and other considerations described in the 
NIH Grants Policy Statement.  The NIH Grants Policy Statement can be found at 
http://grants.nih.gov/grants/policy/policy.htm.

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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


H H S Department of Health
and Human Services

 
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