BASIC AND TRANSLATIONAL RESEARCH IN EMOTION

RELEASE DATE:  September 4, 2003

PA NUMBER: PA-03-169

March 2, 2006 (NOT-OD-06-046) – Effective with the June 1, 2006 
submission date, all R03, R21, R33 and R34 applications must be 
submitted through Grants.gov using the electronic SF424 (R&R) 
application.  This announcement will stay active for only the 
May 1, 2006 AIDS and AIDS-related application submission date 
for these mechanisms. The non-AIDS portion of this funding 
opportunity for these mechanisms expires on the date indicated below.  
The R01 portion of this announcement has been replaced by PA-06-380.  
Parent R03 (PA-06-180) and R21 (PA-06-181) funding opportunity 
announcements have been issued for the submission date of June 1, 2006 
and submission dates for AIDS and non-AIDS applications thereafter.  
Applications relating to R33 and R34 activities must be in response 
to NIH Institute/Center (IC)-specific announcements.

EXPIRATION DATE for R03 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R03 AIDS and AIDS-Related Applications: May 2, 2006 
EXPIRATION DATE for All R01 Applications: May 2, 2006

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATIONS

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

COMPONENTS OF PARTICIPATING ORGANIZATIONS

National Institute of Mental Health (NIMH)
 (http://www.nimh.nih.gov)
National Institute on Aging (NIA)
 (http://www.nia.nih.gov)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 (http://www.niaaa.nih.gov)
National Cancer Institute (NCI)
 (http://www.nci.nih.gov)
National Institute of Child Health and Human Development (NICHD)
 (http://www.nichd.nih.gov)
National Institute on Drug Abuse (NIDA)
 (http://www.nida.nih.gov)
National Institute of Neurological Disorders and Stroke (NINDS)
 (http://www.ninds.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.242 (NIMH), 93.866 (NIA), 
93.273 (NIAAA), 93.399(NCI), 93.865 (NICHD), 93.279 (NIDA), and 93.853 (NINDS)

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  Submitting an Application
o  Peer Review Process
o  Review Criteria
o  Award Criteria
o  Required Federal Citations

PURPOSE OF THIS PA

This Program Announcement (PA) replaces PA-00-105 and PA-00-106.

Under this PA, the National Institute of Mental Health, National Institute on 
Aging, National Institute on Alcohol Abuse and Alcoholism, National Cancer 
Institute, National Institute of Child Health and Human Development, National 
Institute on Drug Abuse, and the National Institute of Neurological Disorders 
and Stroke invite research grant applications to expand basic and translational 
research on the processes and mechanisms involved in the experience and 
expression of emotion.

RESEARCH OBJECTIVES

The study of emotion encompasses a wide range of psychological, social, 
cognitive, developmental, and biological phenomena.  Central and peripheral 
nervous system (CNS, PNS) activity in the origins, expression, regulation and 
modulation of emotion are important objects of study, as is the contribution of 
emotional and motivational systems to cognitive faculties such as perception, 
attention, learning, memory, and motor control.  The study of emotion includes 
investigations of overt behaviors (such as aggression or withdrawal), 
interpersonal relationships, communication and decision making, and the 
environmental circumstances and experiences that shape and elicit emotions.  
Emotion research can also include the study of licit and illicit psychoactive 
substances that alter mood states, and conversely, the study of how emotional 
and mood states can predispose to, or modulate the effects of, pain or alcohol 
and psychoactive substances.  This PA also encourages research on emotional 
reactions in the context of the diagnosis and treatment of cancer, and the 
study of emotion as it relates to this disease or increased risk of this 
disease, including outcomes such as social relationships, health care provider 
relationships, adherence and others.  These investigations may use human or 
other animals.

Recent years have shown the rapid expansion of concepts and methods for 
studying emotion in all of its aspects.  Outlined in this program announcement 
are current needs that stem from these advances and that constitute critical 
components of a comprehensive basic research strategy, with the ultimate aim of 
fostering mental and physical health and the understanding of human development 
and aging.  Sample research questions are provided for illustration; they are 
not intended to be exhaustive.

Basic Mechanisms of Emotion

The study of emotion may involve measurements in a number of different response 
systems (e.g., neural, physiological, behavioral).  To foster the rapid and 
orderly accumulation of knowledge, it is important that multiple system 
measurements be conducted whenever possible.  Interactions of emotion with 
cognition also constitute an important area of study.  For example, a more 
detailed understanding is needed of the interplay between emotion and cognition 
that can inform conceptualizations of disorders in which impairments of both 
emotion and cognition are apparent (e.g., schizophrenia, depression, alcohol 
and drug dependence, Alzheimer's Disease, autism), as well as provide data 
important for promoting good cognitive functioning and emotional self-
regulation. In addition, the interplay between emotion and cognition may be 
studied in the context of risk perception and decision-making, for example, as 
this interplay applies to treatment and screening among cancer patients or 
individuals at increased risk of cancer, drug abuse and other health risking 
behaviors (e.g., violence or sexual risk-taking), and in the context of 
financial and medical decision-making by older adults.  Sample research 
questions include the following:

o  What are the relationships among behavioral, physiological, and neural 
aspects of emotion?  What are the circumstances under which these various 
systems act in concert, and what is the significance of various patterns of 
desynchrony?  What is the developmental time course of these components? What 
are the biological or psychological consequences of the inhibition of one or 
more components?

o  A number of different emotion theories posit some number of discrete 
emotions.  Other theories approach the domain as two, three or more dimensions 
of emotional response.  How are these two approaches related, and can they be 
reconciled in a comprehensive theory of emotion?

o  What are the basic mechanisms by which emotions are acquired or otherwise 
shaped by the physiological and social contexts in which they occur?  What are 
the roles of parents, peers, siblings, teachers, care providers, and the media 
in socializing emotion?  How do these socialization processes interact with 
physiological and neural aspects of emotion?

o  What are the continuities across, and distinctions among, the phenomena of 
emotion, mood, temperament, emotional trait, and emotional disorder?  What 
social, psychological, environmental, and biological factors mediate or modulate 
their interrelationships?  How do these interrelationships change with age?  
How do these phenomena interact in order to contribute to psychological 
adjustment, normal psychological and biological development, treatment and 
screening adherence, and quality of life among individuals with physical or 
mental illness or those at risk for illness?

o  What are the potential mechanisms by which sensation and perception interact 
with emotion; and how do these interactions result in behavior?  In turn, how 
are interactions between sensation, perception, and emotion modulated in the 
experience of pain, in learning and memory, and in cognitive and social 
development?

o  How do attention, memory and perceived threat act to sustain or interrupt 
emotional states?  In turn, how do emotions serve to modulate or drive 
mechanisms of attention, memory, and threat perception?  

Emotional Processes in Mental Health, Substance Abuse, Developmental Disorders, 
and Physical Disease

The study of emotional processes in disorders is similar in some aspects to 
research on basic mechanisms of emotion, and different in other aspects.  
Impairments of emotion found in psychopathology and developmental disorders may 
differ in either qualitative or quantitative ways from normal emotional 
processes.  Emotional reactions may interact with the course of disease 
processes to alter the course of disorder and these influences may be subject to 
modification by alcohol or drugs of abuse.  Examples of relevant issues include 
the following:

o  What are the continuities and discontinuities between normative emotional 
processes (e.g., emotional development, expression, understanding, awareness, 
communication, resilience) and emotional processes seen in psychopathology, 
developmental disorders, health risk behaviors including alcohol or drug abuse, 
or other developmental problems (e.g., insecure attachment, aggressive 
behaviors, extreme shyness, or difficulties in social relationships)?

o  To what extent can behavioral, physiological, and neural measures of emotion 
identify individuals at risk for suicidal, violent, or self-injurious behavior, 
or alcohol/drug abuse, within the context of preventive interventions?

o  Do individual differences in emotional reactivity and regulation, including 
responses to stress or trauma, produce differential vulnerabilities to mental or 
developmental disorders, including alcohol and/or drug dependence?  Conversely, 
does alcohol/drug use or dependence produce changes in emotional reactivity?  
How do stimuli associated with alcohol or drug use become triggers of emotional 
and subjective states that may lead to relapse?

o Among cancer patients or people at increased risk for cancer, how do 
individual differences in emotional processes relate to fatigue, resumption of 
activities of daily living, adherence to treatment, cancer screening behaviors, 
family relationships, and patient-health care provider relationships? What is 
the role of emotional processes in decision making related to cancer prevention, 
detection or treatment? Do individual differences in emotional reactivity 
associated with neural, immunological, or other biological pathways influence 
cancer?

o  How can individuals be trained to best identify and regulate emotions and 
mood states that may represent a possible risk for relapse of physical or mental 
illness?  Does focusing on such emotions/moods help prevent relapse, or actually 
increase risk for relapse?

o  How do cognitive changes associated with late aging modify the expression of 
emotion and its underlying processes in older individuals?

Individual Differences

Research is suggesting that individual differences in emotional responsivity may 
mark specific vulnerabilities to mental disorder, including alcohol or drug 
dependence.  A detailed examination of these individual differences is critical 
for understanding the etiology of various disorders and for designing prevention 
efforts. In-depth study is needed of the determinants, consequences, and 
sequelae of infant temperament.  Research in adult personality variation also is 
beginning to examine individual differences in emotional responsivity, with some 
indications of connections to physiology.  Sample research questions include the 
following:

o  What are the biological (including genetic) and experiential sources of 
individual differences in emotional reactivity and regulation throughout 
development?  How do biological and experiential influences combine and interact 
in influencing outcomes?  How do these change with age?

o  How do individual differences in emotionality relate to phenomena such as 
activity level, attention, and cognitive processes?  What are the neural 
substrates of the relationships among such phenomena, and how do these 
relationships maintain or change over time?

o  Among children with developmental and learning problems or disabilities or 
childhood illness, how are individual differences in emotional processes related 
to functioning over time?  What developmental and/or learning disabilities or 
other pediatric problems interact with the development of emotional regulation 
and reactivity over time? New approaches that integrate quantitative and 
qualitative methods are needed to investigate the study of emotion and learning/
learning disabilities in order to study these interactions.

o  What are the specific emotional and behavioral differences in individuals 
with mental retardation and how do these differ from the general population? New 
techniques are needed to assess the impact of psychosocial stressors in the 
lives of people with mental retardation and developmental disabilities and to 
integrate this knowledge with diagnostic protocols, treatment strategies and 
service systems.

o  What biological, developmental, social, personality, and cognitive factors 
interact with emotion-based individual differences to contribute to 
psychopathology, health risk behaviors, drug use, and other developmental 
problems or disorders?

o  How do emotions get attached to attitudes, stereotypes, and identity?  How do 
these influence health, illness, adherence to medical regimens, and recovery?

Developmental Aspects

Data are accumulating rapidly in areas such as children's understanding and 
experience of emotions, and in emotional communications occurring between 
parents and children beginning in the earliest weeks of life.  The import of 
findings related to the development of emotions would be well served by an 
overarching theoretical framework specifying the ontogeny of emotion.  Also, 
the primary concentration to date on the early years of life needs to be 
broadened to include focused attention on early and middle childhood, 
adolescence, adulthood, and old age.  Sample research questions include the 
following: 

o  Are connections among the various  components of emotions present at birth?  
Do these change with age, particularly during periods of transition (e.g., the 
transition to school, adolescence)?  How do changes in bodily systems with age 
affect the nature and intensity of emotional responses and the 
interrelationships among these response systems?  Do some changes predispose 
toward psychopathology or drug abuse in older individuals?

o  What are the determinants, age-specific characteristics, and consequences of 
emotional attachments across the lifespan?  What are the parallels among 
attachment patterns in infancy, in childhood, in adolescence, in adulthood, in 
old age?

o  How do cognitive factors (e.g., intelligence, learning disabilities)  
influence the development of emotional processes over the lifespan?

o  What affective processes are particularly germane to coping with events in 
the family life cycle (e.g., marriage, divorce, birth, transition to parenthood, 
aging, retirement, grandparenting, dealing with death and bereavement, coping 
with substance use of family members)?

o  What are the developmental psychobiological contributions of stress and other 
environmental influences (e.g., trauma, violence) on emotional development and 
expression?

o  What is the role of emotion in brain development over the life course and 
what are the relevant mechanisms?  How might emotions affect the endocrine, 
immune and neural systems that change over the course of development and aging?  
Does prenatal exposure to alcohol or abused drugs or use of abused drugs in 
adolescence affect emotional development?  Conversely, are children with 
disorders of emotional regulation more vulnerable to becoming drug dependent? 
Does sleep deprivation affect emotion regulation, and if so, how?

Social Aspects

The quality of interpersonal relationships can be a significant source of both 
positive and negative emotions.  Further, social relationships play a 
substantial role in the modulation of emotional responses, however generated.  
Social factors thus make a critical contribution to an understanding of the 
risks for mental disorders, alcohol/drug dependence, and other developmental 
problems.  In addition to the need for further research on these interpersonal 
aspects of emotion, it is very important to examine the macro-environmental 
processes (e.g., culture, social structure, the media) that help to shape 
emotional development and adjustment.  Sample research questions include the 
following:

o  How do cultural and socialization processes influence the experience and 
expression of emotion?  How do salient social factors and contexts (e.g., child 
care and school settings, media, exposure to violence) in particular 
developmental stages shape affective development and expression?

o  What are the dynamics of emotional communications occurring within families 
and other intimate groups and how do they relate to the development, 
maintenance, or erosion of emotional bonds?  How do variations in social sharing 
of emotions lead to differences in psychopathology, therapeutic approaches, and 
potential health outcomes?  How can these variables be best modeled 
preclincally? How are these patterns altered by drug dependence?  Among cancer 
patients and their significant others, what are the short- and long-term 
consequences of patterns of emotional communication on social relationships and 
psychological adjustment?

o  How do variations in parenting style and behaviors (e.g., teaching, limit-
setting) influence the development of affect regulation in children?  How does 
child abuse or neglect (resulting from psychopathology, alcohol or drug 
addiction or other causes) influence emotional development in children?

o  How does caregiver behavior influence affect regulation in persons with 
mental disorders or drug abuse in late life, including Alzheimer's Disease?

o  How do the emotions involved with social relationships affect life in the 
community for severely disordered or disabled individuals, and how do these 
emotions interact with the characteristics of the disorder to affect its course?

o  What role does the process of social comparison play in the emotional 
response to cancer and to aging, what are some potential mechanisms explaining 
the direction of the social comparison process across individuals, and how might 
these processes be influenced by other social or non-social mechanisms?

Biological Aspects

The study of emotion provides a valuable opportunity for examination of the 
interplay between psychological, physiological, and neural processes, and 
methods are increasingly becoming available for examining the neural substrates 
of emotion.  Sample research questions include the following: 

o  What are the bi-directional influences between emotional states or emotional 
traits (e.g., temperament) and neurobiological, endocrine and immune systems?  
Among cancer patients, how might these influences on biology influence health 
status or treatment (side effects, ability to tolerate treatment)?

o  What are the neuroanatomical circuits and neurochemical processes involved in 
emotional states and emotion-based individual differences?  How do these systems 
evolve over the lifespan and how are they influenced by drugs of abuse?  To what 
extent do these neural processes overlap with those associated with 
psychopathology and substance use disorders such as alcohol or drug addiction? 

o  How can neuroimaging and large-array electrophysiological techniques best be 
used to study brain areas that are active during different emotional states and 
in pain perception?  What is the relationship of observed CNS or PNS activity to 
other responses in emotion, including alcohol/drug-induced or alcohol/drug 
withdrawal- or craving-induced changes in emotion?

o  How does the aging process, either in association with age-associated 
neurogenerative disease processes or without disease, affect the emotion-based 
networks within the brain and those that interact with the endocrine system?

Methodological Needs

Methods related to the study of emotion run the full range, from self-report and 
interview procedures, to behavioral observations and more direct assessments of 
behavior, and to measures of PNS and CNS structure and function.  Improvements 
are needed in ways that enhance the validity and efficiency of measurement 
without sacrificing richness and detail.  In research on physical illness such 
as cancer, methodology also is needed that takes into account the reports of 
others in the patient's social and medical environment, and reports that are 
sensitive to the changes in emotional responsiveness over time.  Sample needs 
include the following:

o  Most research on emotional expression concentrates on the face.  Methods also 
are needed to assess vocal, postural, and gestural components of emotional 
expression.  Further, measures of emotion need to be developed that can be 
applied across settings, cultures, cohorts, and species.

o  Techniques of computer science, neural networks, and image processing need to 
be applied to the task of producing valid and reliable judgments of facial and 
other behavioral expressions of emotion.

o  Computational models and other quantitative expressions of theories of 
emotions need to be developed.

o  Expanded and improved neuroimaging techniques are needed to examine CNS 
activity in emotional responding.  Further research is needed on the 
methodological and conceptual relationships among techniques with different 
spatial and temporal resolution.

o  Animal models need to be used to their fullest potential to examine social, 
cognitive, and biological determinants and consequences of emotion.

o  Advanced and ethically-guided human laboratory procedures for inducing 
positive and negative emotional states are needed.

MECHANISM(S) OF SUPPORT 

This PA will use the NIH Research Project Grant (R01) and Small Grant Program 
(R03) award mechanisms.  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 
five years.

The Small Grant (R03) provides two years of funding with a maximum of $50,000 
direct costs for each year.  Instructions for the R03 application can be found at 
http://grants.nih.gov/grants/guide/pa-files/PA-03-108.html.

This PA uses just-in-time concepts.  It also uses the modular budgeting format. 
(see http://grants.nih.gov/grants/funding/modular/modular.htm).  
Specifically, if you are submitting an application with direct costs in each 
year of $250,000 or less, use the modular budget format.  Otherwise follow the 
instructions for non-modular budget grant applications.  This program does not 
require cost sharing as defined in the current NIH Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.

ELIGIBLE INSTITUTIONS

You may submit (an) application(s) if your institution has any of the following 
characteristics:

o  For-profit or non-profit organizations
o  Public or private institutions, such as universities, colleges, hospitals, 
and laboratories
o  Units of State and local governments
o  Eligible agencies of the Federal government
o  Domestic or foreign institutions/organizations
o  Faith-based or community-based organizations

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 two areas:  
scientific/research and financial or grants management issues:

o  Direct your questions about scientific/research issues to:

Susan E. Brandon, Ph.D.
Affect and Biobehavioral Regulation Research Program
National Institute of Mental Health
6001 Executive Boulevard, Room 7218, MSC 9651
Bethesda, MD  20892-9651
Telephone:  (301) 443 4863
FAX:  (301) 443 9876 
Email:  Sbrandon@mail.nih.gov

Jeffrey W. Elias, Ph.D.
National Institute on Aging
7201 Wisconsin Avenue, Room 533
Bethesda, MD  20892
Telephone:  (301) 496-3136
FAX:  (301) 402-0051
Email:  Eliasj@nia.nih.gov

Ellen Witt, Ph.D.
Division of Basic Research
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 402, MSC 7003
Bethesda, MD  20892-7003
Telephone:  (301) 443-6545
FAX:  (301) 594-0673
Email:  ewitt@willco.niaaa.nih.gov

Wendy Nelson, Ph.D.
Behavioral Research Program
National Cancer Institute
6130 Executive Boulevard, Room 211, MSC 7326
Bethesda, MD  20892-7326
Telephone:  (301) 435-4590
FAX:  (301) 435-7547
Email:  nelsonw@mail.nih.gov

Margaret Feerick, Ph.D.
Child Development and Behavior Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, 4B05, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-6882
FAX:  (301) 480-0230
Email:  feerickm@mail.nih.gov 

Allison Chausmer, Ph.D.
National Institute on Drug Abuse 
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD 20892-9541
Telephone:  (301) 301-402-5088
FAX:  (301) 594-6849
Email:  achausme@nida.nih.gov

Emmeline Edwards, Ph.D.
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 2109, MSC 9521
Bethesda, MD  20892-9521
Telephone:  (301) 496-9964
FAX:  (301_ 402-2060
Email:  ee48r@nih.gov

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

Carol J. Robinson
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6118, MSC 9605
Bethesda, MD  20892-9605
Telephone:  (301) 443-3858
FAX:  (301) 443-6885
Email:  crobinso@mail.nih.gov 

Traci Lafferty
Grants Management Specialist
National Institute on Aging
7201 Wisconsin Avenue, Room 2N-212
Bethesda, MD  20892
Telephone:  (301) 496-1472
FAX:  (301) 402-3672 
Email:  Laffertt@nia.nih.gov

Judy Fox
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 504, MSC 7003
Bethesda, MD  20892-7003 
Telephone:  (301) 443-4704 
FAX:  (301) 443-3891 
Email:  jsimons@willco.niaaa.nih.gov

Crystal Wolfrey
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, Room 243, MSC 7150
Bethesda, MD  20892-7150
Telephone:  (301) 496-8634
FAX:  (301) 496-8601
Email:  wolfreyc@mail.nih.gov
 
Dianna Bailey
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A07E, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-6978
FAX:  (301) 402-0915
Email:  dn11r@nih.gov 

Gary Fleming
Grants Management
National Institute on Drug Abuse 
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD  20892-9541
Telephone:  (301) 443-6710
FAX:  (301) 594-6849
Email:  gfleming@nida.nih.gov

Aaron Kinchen
Grants Management Specialist
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 3271
Bethesda, MD  20892-9537
Telephone:  (301)496-7386
FAX:  (301) 402-0219
Email:  ak2840@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 DUNS number can be obtained by calling (866) 705-5711 or 
through the web site at http://www.dunandbradstreet.com.  The DUNS 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.

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

SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS:  Applications 
requesting up to $250,000 per year in direct costs must be submitted in a 
modular budget grant format.  The modular budget grant format simplifies the 
preparation of the budget in these applications by limiting the level of 
budgetary detail.  Applicants request direct costs in $25,000 modules.  Section 
C of the research grant application instructions for the PHS 398 (rev. 5/2001) 
at http://grants.nih.gov/grants/funding/phs398/phs398.html 
includes step-by-step guidance for preparing modular grants.  Additional 
information on modular grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

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 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 
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 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 mailed on or before the receipt 
dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm.  
The CSR will not accept any application in response to this PA that is 
essentially the same as one currently pending initial review unless the 
applicant withdraws the pending application.  The CSR will not accept any 
application that is essentially the same as one already reviewed.  This does not 
preclude the submission of a substantial revision of an unfunded version of an 
application already reviewed, but such application must include an Introduction 
addressing the previous critique.

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.

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.

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

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 written critique
o  Receive a second level review by the appropriate national advisory council 
or board

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 your 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 these criteria in assigning your application's overall 
score, weighting them as appropriate for each application.

o  Significance
o  Approach
o  Innovation
o  Investigator
o  Environment

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.

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?

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?

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?

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)?

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, the following 
items will be considered in the determination of scientific merit and the 
priority score:

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 more than $500,000 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 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

REQUIRED FEDERAL CITATIONS

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:  Starting with the October 1, 2003 receipt date, 
investigators submitting an NIH application seeking more than $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.  
This policy applies to all initial (Type 1) applications submitted for receipt 
dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS:  NIH policy 
requires education on the protection of human subject participants for all 
investigators submitting NIH proposals for research involving human subjects.  
You will find this policy announcement in the NIH Guide for Grants and Contracts 
Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

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).  Those 
who must comply with the Privacy Rule (classified under the Rule as "covered 
entities") must do so by April 14, 2003 (with the exception of small health 
plans which have an extra year to comply).

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.health.gov/healthypeople.

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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and Human Services (HHS)
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