RELEASE DATE:  February 12, 2002

PA NUMBER:  PA-02-061

EXPIRATION DATE:  February 10, 2005, unless reissued.


National Institute of Mental Health
National Institute on Drug Abuse


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


The National Institute of Mental Health (NIMH) and the National Institute on 
Drub Abuse (NIDA) seek to encourage the development of collaborative 
partnerships between scientists who study basic behavioral processes and those 
who study the etiology, diagnosis, treatment, and prevention of mental and 
behavioral disorders (including drug abuse and addiction) and the delivery of 
services to those suffering from those disorders.  NIMH and NIDA are issuing 
this Program Announcement (PA) as part of a major, long-term commitment to (a) 
encourage the systematic translation of basic behavioral theory, methods, and 
findings into research designed to reduce the burden of mental illness and 
behavioral disorders and (b) 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.  This PA was 
developed in response to a report written by the National Advisory Mental 
Health Council's Behavioral Science Workgroup, entitled "Translating 
Behavioral Science into Action,"



NIMH and NIDA have for many decades been primary sponsors of research in the 
basic behavioral sciences.  This long-term investment in behavioral research 
has resulted in the development of a large body of knowledge in such areas as 
emotion, motivation, self-concept, personality, cognition, memory, social 
cognition and influence, family processes, social networks, and sociocultural 
variations (see  However, the 
theory, methods, knowledge, and insights from the basic behavioral sciences 
have not been fully utilized in understanding pressing public health issues in 
mental health and drug abuse: the etiology and assessment of disorders; the 
development of innovative preventive and treatment interventions; and the 
effects of interventions and services for diverse types of people in disparate 
social, economic, cultural, and environmental contexts.

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:

o  Basic behavioral processes in mental illness 
o  Functional abilities in mental illness 
o  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."

The workgroup recommended that NIMH "establish and publicize translational 
behavioral science research as a priority funding area...and develop a 
coherent strategy for its systematic development."  With this current PA, NIMH 
and NIDA continue a long-term commitment to translational behavioral science 
research.  Some researchers, working singly or in small groups, have already 
accomplished significant research of this nature, to a degree that augurs the 
significant potential value of this approach.  At the current time, however, 
there is a clear need to foster a significant increase in collaborative 
efforts among basic and clinical researchers in order to realize the fullest 
potential of translational research.

This PA is designed to address the needs of investigators who have a specific 
translational research question, and sufficient pilot data to warrant an R01 
research project grant or investigator-initiated Collaborative R01.  
Investigators who are in the earlier, formative stages of the collaborative 
research process may wish to consider PAR-02-062, "Building Translational 
Research in Behavioral Science," 

General Characteristics

All applications to this PA must demonstrate that a research partnership 
between basic behavioral scientists and clinical and/or services researchers 
exists or will be developed and nurtured.  For purposes of this PA, a basic 
scientist is defined as one who has demonstrable expertise in one or more 
lines of basic research, and for whom a preponderance of his or her research 
effort (typically, 50% or more) has involved non-clinical populations, as 
measured by publications, grant support, presentations, or other scholarly 
work.  The minimum collaborative arrangement would thus involve two 
investigators, although larger groups of actual and potential collaborators 
are encouraged.  While the emphasis in this PA is on behavioral science, 
collaborations that include relevant biological measures as integrative 
components are also encouraged, particularly from disciplines such as 
behavioral neuroscience and psychophysiology in which such integration is 
implicit.  Research teams are to be conceptualized by the nature of the 
translational research goals and need not be limited by geographical or 
department boundaries.  Collaborations among different institutions are 
encouraged in view of the typical distinctions between basic sciences and 
clinical/services settings.  However, the applicants must show how 
communication will occur across these boundaries so that fully developed 
collaborative research partnerships can occur.

The primary purpose of these R01 grants is to support fully implemented 
research projects with a translational focus.  Applications submitted with a 
single principal investigator will be expected to include one or more 
additional investigators forming a collaborative team that includes basic and 
clinical/services expertise, clearly defining the roles of all investigators 
in the translational research; for investigators at multiple institutions, the 
collaborative arrangements will typically be indicated via one or more 
consortium/subcontract arrangements.  The NIMH Collaborative R01 mechanism may 
also be used for investigators at two or more institutional sites, with a 
separate principal investigator for each constituent R01 application.  R01 
research projects will have the following characteristics:

o  Translational grants must include one or more components of basic 
behavioral science.  The inclusion of relevant physiological measures, in 
addition to concepts, paradigms, and theories drawn from basic behavioral 
science, is encouraged but not required.

o  The principal investigator of a single-R01 project may be an individual 
with a primary research background in either basic or clinical/services areas. 
Submissions using the Collaborative R01 mechanism may include one or more 
separate R01 applications in each of the basic and clinical/services domains.

o  The clinical or services component of the proposed application may include 
any aspect of relevant work.  This component is to include research with 
patient populations, that is, studies conducted with persons diagnosed with 
mental disorders, including drug abuse and addiction, or with organizations 
that provide mental health or drug abuse services.  The clinical/services 
research program will reflect the contributions of basic behavioral science, 
including concepts, principles, extant literatures, paradigms, measures, 
statistical approaches, etc.; integration of comparable work from neuroscience 
is also encouraged where appropriate.  It is important to show the potential 
of the research to foster significant advances in understanding, developing 
new interventions, or providing services for the disorder(s) being investigated.

o  The clinical or services component of the proposed application must focus 
on populations in need of treatment or services for the symptoms and/or 
functional deficits associated with mental disorders and/or drug abuse.

o  The basic behavioral science component must represent a meaningful 
contribution to the overall program of research, rather than serving a limited 
consultative role.  Although not required, this component could include an 
active program of experimentation, methodological or statistical development, 
or other scientific work that is relevant to the clinical/services 
application.  These efforts might involve initial studies laying a necessary 
groundwork for projects with clinical/services populations, and/or studies to 
address basic research questions arising from results with samples drawn from 
clinical or services settings.  Basic behavioral studies typically involve 
non-clinical populations, but may also involve high-risk populations.

o  Each application must demonstrate the ability to translate and integrate 
data between basic and clinical studies.  Each component must demonstrate the 
ability to inform, and be informed by, the results of the other component(s).

Research Topics

The following are examples of broad research topics that might be the focus of 
translational research.  This list is not meant to be comprehensive, nor are 
the examples meant to be exclusive of other topics.

o  Research pertaining to the factors that maintain the engagement of patients 
with treatments for mental disorders, including drug abuse or addiction, 
whether psychosocial or pharmacologic

o  Studies of cognitive, attentional, and/or emotional processes in attention- 
deficit/hyperactivity disorder

o  Research devoted to an understanding of the nature of specific functional 
deficits in mental or drug abuse disorders (e.g., deficits in attention, 
memory, emotion-regulation, social interactions and relationships), and 
development of targeted interventions for rehabilitation and relapse prevention

o  Research regarding neurocognitive and emotional functioning related to 
severely disabling mental disorders or drug abuse, such as schizophrenia, 
bipolar illness, depression, and addiction

o  Studies of cultural factors involved in the diagnosis, prevention, 
treatment, and delivery of services in mental disorders, including drug abuse 
and addiction

o  Research regarding behavioral and neurodevelopmental factors in disorders 
characterized by impaired affiliative behavior and social functioning such as 
autism and schizophrenia

o  Studies of decision making as it affects the behavior of patients and 
providers in mental health or drug abuse services settings


This application will use the National Institutes of Health (NIH) Research 
Project Grant (R01) award mechanism.  As an applicant, you will be solely 
responsible for planning, directing, and executing the proposed project. The 
total project period for an R01 application submitted in response to this PA 
may not exceed 5 years.  Applicants must clearly specify in the application 
which mechanism is being requested. 

A translational research project (R01) may involve either a single Principal 
Investigator or a group of investigators using the Collaborative R01 
mechanism; applicants may request a project period of up to 5 years, with a 
budget determined by the work proposed.  Applicants for the Collaborative R01 
Grant are strongly encouraged to familiarize themselves with the NIMH 
announcement ( and 
direct questions to program staff listed in this announcement.

This PA uses just-in-time concepts.  It also uses the modular as well as the 
non-modular budgeting formats 
(see  Specifically, 
if you are submitting an R01 application with direct costs in each year of 
$250,000 or less, use the modular format.  Otherwise follow the instructions 
for non-modular research grant applications.


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 only
o Faith-based organizations


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.


Any research project which involves a Phase I or Phase II Clinical Trial must 
include provisions for assessment of patient eligibility and status, rigorous 
data management, quality assurance, and auditing procedures; each project is 
further required to include a Data and Safety Monitoring Plan.  See the 
Federal Citations section, below, for further information and references. 


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

o Direct your questions about scientific/research issues to:

Bruce N. Cuthbert, Ph.D. 
Adult Psychopathology and Prevention Research Branch 
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 

Lisa Onken, Ph.D. 
Behavioral Treatment Development Branch 
Division of Treatment Research and Development 
National Institute on Drug Abuse 
6001 Executive Boulevard, Room 4241, MSC 9551 
Bethesda, MD  20892-9551 
Telephone:  (301) 443-2235 
FAX:  (301) 443-6814 

Herbert Weingartner, Ph.D. 
Translational Research Branch 
Division of Neuroscience and Behavioral Research 
National Institute on Drug Abuse 
6001 Executive Boulevard, Room 4282, MSC 9555 
Bethesda, MD  20892-9555 
Telephone:  (301) 435-1321 
FAX:  (301) 594-6043 

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

Diana S. Trunnell
Grants Management Branch
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD  20892-9605
Telephone: ( 301) 443-2805
FAX:  (301) 443-6885

Gary Fleming, J.D., M.A.
Grants Management Branch
Office of Planning and Resource Management
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3119, MSC 9541
Bethesda, MD  20892-9541
Telephone:  (301) 443-6710
FAX:  (301) 594-6849


Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 710-0267, 

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

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

Applications requesting $500,000 or more in direct costs for any year must 
include a cover letter identifying the NIH staff member within one of NIH 
institutes or centers who has agreed to accept assignment of the application.   

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

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

This policy applies to all investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended or revised 
version of these grant application types. Additional information on this 
policy is available in the NIH Guide for Grants and Contracts, October 19, 
2001 at

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

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

APPLICATION PROCESSING: Applications must be received by or mailed before the 
receipt dates described at The CSR will not 
accept any application in response to this PA that is essentially the same as 
one currently pending initial review unless the applicant withdraws the 
pending application.  The CSR will not accept any application that is 
essentially the same as one already reviewed.  This does not preclude the 
submission of a substantial revision of an application already reviewed, but 
such application must include an Introduction addressing the previous critique.


Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review group 
convened in accordance with the standard NIH peer review procedures 
( will evaluate applications for scientific 
and technical merit.  

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

o Receive a written critique
o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a second level review by the appropriate national advisory council 
or board

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

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these criteria 
in assigning your application's overall score, weighting them as appropriate 
for each application.  Your application does not need to be strong in all 
categories to be judged likely to have major scientific impact and thus 
deserve a high priority score.  For example, you may propose to carry out 
important work that by its nature is not innovative but is essential to move 
a field forward.

(1) SIGNIFICANCE:  Does your study address an important problem? If the aims 
of your application are achieved, how do they advance scientific knowledge?  
What will be the effect of these studies on the concepts or methods that 
drive this field?  

(2) APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project?  Do you acknowledge potential problem areas and consider 
alternative tactics?  

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

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

(5) ENVIRONMENT:  Does the scientific environment in which your work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements?  Is there evidence of institutional support?

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

PROTECTIONS:  The adequacy of the proposed protection for humans, animals, or 
the environment, to the extent they may be adversely affected by the project 
proposed in the application.

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

DATA SHARING:  The adequacy of the proposed plan to share data, where 
relevant to the proposed work.

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


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

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


involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 

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

All investigators proposing clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 
a complete copy of the updated Guidelines are available at  
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.

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

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at

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

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

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

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

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

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance No. 93.3242 (NIMH) and 93.279 (NIDA), and is not 
subject to the intergovernmental review requirements of Executive Order 12372 
or Health Systems Agency review.  Awards are made under authorization of 
Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 
and 284) and administered under NIH grants policies described at and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92.

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

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