and Human Services (HHS)
EXPIRED
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) 710-0267, 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
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