RESEARCH ON CHILDREN EXPOSED TO VIOLENCE 

RELEASE DATE:  April 7, 2003

PA NUMBER:  PAR-03-096

EXPIRATION DATE:  June 25, 2005, unless reissued

National Institute of Child Health and Human Development (NICHD) 
 (http://www.nichd.nih.gov/)
Fogarty International Center (FIC) 
 (http://www.fic.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 (http://www.niaaa.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/)
Office of Behavioral and Social Sciences Research (OBSSR)
 (http://obssr.od.nih.gov/)
Children's Bureau, Administration on Children, Youth, and Families, 
Administration for Children and Families (CB)
 (http://www.acf.dhhs.gov/programs/cb/)
Centers for Disease Control and Prevention (CDC)
 (http://www.cdc.gov/)
Office of Special Education Programs, Department of Education (OSEP)
 (http://www.ed.gov/offices/OSERS/OSEP/)
Substance Abuse and Mental Health Services Administration (SAMSHA)
 (http://www.samhsa.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS:  93.989 (FIC), 93.273 
(NIAAA), 93.865 (NICHD), 93.279 (NIDA), 93.853 (NINDS), 93.670 (ACYF), 93.283 
(CDC), 93.230 (SAMHSA), 84.329 (OSEP-ED)

APPLICATION RECEIPT DATES:  June 25, 2003, June 25, 2004, and June 24, 2005.  

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this PA
o Research Objectives
o Mechanism of Support
o Funds Available
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

PURPOSE OF THIS PA

The above sponsoring Institutes and Agencies invite research grant 
applications in response to this Program Announcement with Set-aside (PAS) 
that will enhance our understanding of children exposed to domestic violence, 
community violence, and war/terrorism.  This PA is designed to develop new 
knowledge in these areas and in the definition, identification, epidemiology, 
prevention, etiology, effects, early intervention, and mechanisms of violence 
exposure.  This PA builds on recommendations from a recent multi-agency 
research agenda-building workshop held in Washington, DC in July 2002.  A 
complete summary of the meeting presentations and recommendations is 
available at http://www.nichd.nih.gov/crmc/cdb/cdb.htm. 

Child exposure to violence is a serious public health, justice, social 
services, and education problem.  Such exposure not only compromises the 
immediate health of children around the world, but also affects their growth 
and intellectual development, their long-term physical and mental health 
outcomes, their propensity for prosocial or antisocial behavior and substance 
abuse, their future relationships with partners and children, and their 
economic productivity as eventual wage earners.  The need for more systematic 
and multi-disciplinary research in these areas provides the impetus for this 
PA.

Although not participating in this program announcement, the National 
Institute of Mental Health (NIMH) shares an interest in this area of 
research.  For specific information on NIMH interests, see 
http://www.nimh.nih.gov/grants/nimhviotrauma.cfm. 

RESEARCH OBJECTIVES

Background

While it is difficult to make any absolute statement about the numbers of 
children exposed to violence in their homes, schools, and communities, child 
exposure to violence is an internationally recognized public health problem.  
Several surveys in the United States have indicated that some form of marital 
aggression (verbal or physical aggression) occurs in as many as 12 percent of 
American households, with severe violence occurring in between less than one 
percent and four percent of households.  These same surveys suggest that 
children under the age of 12 reside in approximately 50 percent of these 
households.  Other research indicates that children are disproportionately 
present in households where there are substantiated incidents of adult female 
assault and that young children from birth to five years are more likely to 
be present in homes where domestic violence occurs.  Research on community 
violence in the United States similarly suggests that a high number of 
children witness violence in their communities or schools.  An estimated 60 
to 90 percent of children have witnessed some form of physical violence 
(e.g., hitting, slapping, or punching) in their communities and approximately 
13 to 45 percent have witnessed some form of weapon-related violence.  
Additionally, estimates suggest that between one and 47 percent of children 
have witnessed a murder.  While few good data exist about the numbers of 
children exposed to civil strife/war/terrorism, international estimates 
suggest that in the past decade two million children have been killed in war-
related injuries, four million have been disabled, one million have been 
orphaned, and 12 million have been dislocated from their homes.

Research has suggested that child exposure to violence can take many forms 
ranging from indirect exposure (e.g., hearing about an event) to direct 
exposure (e.g., being an eyewitness to an event) and actual involvement or 
victimization (e.g., being coerced or injured).  In addition, studies have 
identified a number of characteristics of violent events, including the type 
of violence, the specific acts, severity, resolution to the violence, 
perpetrator, frequency, child age at the time of exposure, intensity, 
proximity, and duration, that appear important in understanding the effects 
of exposure to violence on individual development.    

Research has also documented the short- and long-term detrimental effects of 
exposure to violence in children, adolescents, and adults.  For the child 
witness to violence, exposure can result in immediate physical trauma (e.g., 
injuries and alterations in physiological arousal) and psychological trauma 
(e.g., post-traumatic stress symptoms) and contribute to chronic physical 
(e.g., sleep and eating disturbances, disease, and illnesses), developmental 
(disturbances or delays in social, cognitive, affective, and language 
development), neurological (e.g., changes in the central nervous system), 
emotional (e.g., depression, anxiety, and hostility) and behavioral (e.g., 
aggression and antisocial behavior, alcohol and drug abuse, dating violence, 
social withdrawal and suicide attempts) problems.  Children exposed to 
violence are vulnerable to life-long disturbances in self-esteem, trust, and 
emotion regulation, as well as difficulties in relationships with others.  
Moreover, exposure to violence can lead to a variety of educational and 
juvenile justice outcomes such as lower grades, IQ, and reading ability, and 
an increased risk for juvenile offenses and serious criminal behavior.

In communities that experience high levels of crime and violence, the effects 
may be as devastating as the effects of war or acts of terrorism.   
Frequently, children witness these acts of violence.  Research suggests that 
drug use or drug dealing often can have a direct or indirect influence on 
violent crime involving young people.  The long-term effects of these 
occurrences are unknown and remain to be studied.  

Research also is beginning to identify a number of mediating and moderating 
factors that can either ameliorate or exacerbate the consequences of violence 
exposure, such as characteristics of the child's experiences (e.g., nature, 
frequency, and severity of violence exposure, and prior history of trauma and 
violence exposure), the child's resources and vulnerabilities (e.g., 
temperament, intelligence, developmental stage, social competence, and coping 
strategies), and social support both within and outside the family.

Despite the public health significance of child exposure to violence, 
progress has been slow in developing a scientific understanding of the 
incidence, prevalence, nature, and consequences of exposure to violence and 
in measuring the efficacy of interventions to prevent or reduce the effects 
of violence exposure on child development.  In addition, research in this 
area has been hampered by a number of methodological issues and constraints 
including sampling and recruitment difficulties, ethical and reporting 
considerations, co-occurrence of multiple types of violence exposure and 
victimization experiences, and a failure to account for other family 
background or risk variables.  Since these shortcomings remain, this PAS is 
intended to encourage research on the incidence, prevalence, nature, and 
consequences of child exposure to violence, as well as on interventions 
(including social service, legal, and policy interventions) designed to 
prevent or ameliorate the short- and long-term effects of violence exposure 
on child development.

Research Goals and Topics

Studies responsive to this PAS should focus on children exposed to domestic 
violence, community or school violence, or civil strife/war/terrorism in the 
United States and, or in comparison with, other countries.  Examples of 
research areas responsive to this announcement include, but are not limited 
to, the following:   

(1) Theory-driven research on the identification, definition, classification, 
and measurement of children exposed to violence, including studies of:

o  theoretical approaches and models of defining and classifying children's 
exposure to violence and violent experiences;

o  measurement tools and instruments designed to measure characteristics of 
violent experiences and exposure to violence, children's definitions and 
perceptions of violence, or the effects of exposure to violence on children 
of different ages and developmental levels;

o  verification and modification of tools and instruments in cross-cultural 
contexts;

o  the nature of violence exposure including the range of intensity of 
violence exposure (e.g., verbal aggression through homicide); the range of 
behaviors involved (e.g., psychological control, threat of violence); the 
timing and patterning of exposure (e.g., age of onset, frequency of exposure, 
single versus multiple episodes, coincidence with important developmental 
transitions); the severity of exposure; and the child's degree of involvement 
(e.g., type of sensory input, such as directly seeing or hearing from another 
room, and the child's reaction such as attempts to intervene);

o  the co-occurrence of different types of exposure to violence (e.g., 
domestic and community); the co-occurrence of violence exposure with other 
types of violence (e.g., child abuse, sibling abuse); the co-occurrence of 
violence exposure with other risk factors (e.g., poverty, parental substance 
abuse or displacement from the home);

o  the differences between witnessing violence (domestic, community or 
school, and war/terrorism) and actual violence victimization (e.g., child 
abuse, or being the victim of gang or school violence); differences between 
exposure to war, civil strife, and terrorism;

o  community, cultural, and individual definitions and perceptions of 
violence as well as definitions of and perceptions of victims and 
perpetrators;

o  children's definitions and perceptions of violence, neighborhoods, and 
communities, as influenced by gender, age, and developmental level;

o  racial, national, ethnic, and cultural differences in defining and 
classifying violence and violence exposure.

(2) Research on the epidemiology of children exposed to violence, including 
studies of:

o  the incidence and prevalence of children exposed to domestic or community 
violence in the population; population-based surveillance systems; direct 
investigation as a means of substantiation; different reporting methods and 
how they influence estimates of incidence and prevalence; multiple reporters 
to estimate violence exposure; the reliability and validity of different 
reporters (e.g., children or parents);

o  the incidence and prevalence of exposure to school violence or violence in 
the media in the United States and, or in comparison with, other countries; 
studies of the prevalence of bullying and peer victimization in schools;

o  the level of violence exposure and drug use and their long-term 
consequences for the health status and behavior of runaway youth;  

o  the incidence and prevalence of exposure to war or terrorism in the United 
States and around the world.

(3) Research on the short- and long-term consequences of exposure to 
violence, including studies of:

o  the effects of exposure to violence on child physical, cognitive, social, 
and emotional development and socio-emotional behavior (e.g., memory and 
learning, moral development, peer relations, emotion regulation, attachment 
relationships, dating behavior, gender role attitudes, antisocial or risk-
taking behavior, drug or alcohol abuse, self-esteem, social competence, 
delinquency, and adult criminal behavior);

o  the educational and functional consequences of exposure to violence (e.g., 
need for and access to special education and related services; 
characteristics of children exposed to violence in the preschool years; 
school readiness, school adaptation, and academic achievement of children 
exposed to different types of violence; and work abilities or job 
performance);

o  the impact of exposure to violence on medical and health outcomes (e.g., 
immune system functioning or vulnerability to infections or autoimmune 
disorders);

o  the neurobiological consequences of exposure to violence (e.g., arousal, 
sympathetic and parasympathetic function, functional brain activity, 
neuroendocrine functioning, and sleep disorders) as a function of age, 
gender, and duration of exposure;

o  the neuromaturational consequences of exposure to violence (e.g., 
alterations in the time course and development of the startle inhibition, 
attentional capacity, regulation of affect, stress reactivity, control of 
motor activity, executive functions, and linguistic and cognitive 
capacities);

o  the developmental consequences of chronic exposure to low levels of 
violence (e.g., verbal conflicts or attacks among parents) or to extreme 
forms of violence (e.g., homicide or suicide); consequences of chronic versus 
acute war/terrorism situations;

o  the effects of anticipatory preparedness for war, terrorism or other 
violent situations on individual development;

o  the additive or cumulative effects of exposure to multiple types of 
violence and/or stressors (or secondary effects of violence such as loss of a 
parent), as well as the independent effects of exposure to particular types 
of violence (e.g., domestic, community, and school violence, and war and 
terrorism).

(4) Research on processes and mediators accounting for or influencing the 
effects of exposure to violence, including studies of:

o  psychosocial and psychobiological mechanisms by which exposure to violence 
results in harmful effects; the impact of violence exposure on individual 
development during infancy, childhood, adolescence or adulthood; processes of 
risk and resilience among children exposed to violence;

o  individual and social protective factors (e.g., relationships with 
teachers, family members, and other sources of social support; coping style; 
cognitions/attributions; temperament; and access to community resources or 
services), and subgroups of at-risk populations;

o  differences in the impact of exposure to violence depending on 
characteristics of the child such as age, gender, temperament, intelligence, 
family relationships or presence of disabilities;

o  the influence of family functioning on children's responses to violence 
exposure (i.e., the extent to which family cohesiveness, parental monitoring, 
and environmental influences such as neighborhood disadvantage, drug use and 
trafficking impact the behavior of children both positively and negatively);
 
o  biological, psychological, and socio-environmental mediating and 
moderating factors that affect child and adolescent responses to violence 
exposure (e.g., child cognitions/attributions, family organization and 
relationships, family interaction, relationships with extended family, 
parenting behaviors, parent coping, poverty, life stress, community 
responses, refugee or immigration status, and socioeconomic and cultural 
factors).

(5) Research on prevention and intervention programs and services for 
children exposed to violence, including studies of:

o  children's contacts with formal (e.g., healthcare, mental health, 
educational, child protection, and criminal justice) and informal (e.g., 
relatives, neighbors, and religious and community groups) systems and 
consequences of these contacts for children and families;

o  the impact and consequences of media campaigns or educational efforts 
(e.g., programs designed to increase awareness of domestic violence among key 
sentinels such as police, medical personnel or teachers) designed to increase 
awareness about different types of violence or violence exposure, or about 
the effects of violence exposure on children

o  knowledge and behaviors of health care providers or other service 
personnel that influence early detection or evaluation of children exposed to 
violence; development and validation of biomarkers, indices or classificatory 
systems that aid health providers, teachers or other community members to 
recognize children exposed to violence;

o  the effectiveness of current shelter programs and how they influence 
outcomes for children and families both in the short- and long-term, 
including indirect consequences on family functioning, socioeconomic status, 
and parenting;

o  theory-driven prevention strategies to reduce the risk for exposure to 
violence (e.g., domestic or community violence) or to prevent the harmful 
consequences of exposure to violence on children;

o  parent skills training interventions for children exposed to violence, 
including foster parents, divorced parents with children, etc.;

o  early intervention as a means of preventing initiation and progression of 
long-term health and behavioral disorders and other problems (e.g., 
aggression, substance abuse, criminal behavior, sexual health-risking 
behaviors, and sleep or immune system problems);

o  interventions tailored for use in different ethnic, social, and cultural 
groups, or different types of communities (e.g., urban versus rural, and high 
or low violence); comparisons of new interventions with existing 
interventions/services; comparisons of different types of intervention 
approaches;

o  intervention models in various social and community settings for 
ameliorating the effects of violence exposure on later development; the 
influence of setting (e.g., shelter, child care, school, clinic, foster 
care), personnel, and various levels of intervention (e.g., a single versus 
ongoing visits) on program participation and outcomes;

o  studies to establish the short- and long-term efficacy of interventions 
for different types of violence exposure including studies of "disaster 
preparedness" programs, school interventions, parent education, and family 
interventions;

o  population characteristics, societal values or intervention components 
that may affect identification, help-seeking, or access to services; barriers 
to intervention availability, delivery or effectiveness as a function of 
social group membership or factors in the setting (e.g., shelters, foster 
care, special education) in which the intervention occurs;

o  legal processes, protective services, and health and mental health 
services as the means of preventing exposure to violence or ameliorating the 
consequences of exposure to violence on children.

(6) Other topics/special issues, including studies of:

o  the effects of new legislation and policies designed to better protect or 
help victims of domestic violence and their children, including their impact 
on children and families and unintended consequences;

o  international and local gun control policies and their effects on 
community violence;

o  the effects of specific acts of terrorism (such as the attacks on 
September 11, 2001) on children, including the effects of direct versus 
indirect (e.g., through the media) exposure to such acts, the differential 
effects of varying degrees and types of exposure to such acts based upon age 
of the child, and identification of risk or protective factors that moderate 
the effects of exposure to such acts.

Types of Research Projects

Although the R01 is the mechanism of support for this PA, research projects 
not traditionally supported with this mechanism are also encouraged.  These 
may include not only large-scale research grants characteristic of more 
mature fields of study, but also exploratory, preliminary or innovative 
research projects, with sound methodology and strong rationales, that provide 
a basis for future continuing or expanded applications.  Also of interest are 
short-term projects, studies submitted by less experienced investigators, 
collaborative studies submitted by or involving investigators in a developing 
country, and feasibility studies testing methods, measures or techniques new 
to the research on children exposed to violence.

MECHANISM OF SUPPORT

This PA will use the NIH Research Project Grant (R01) award mechanism.  As an 
applicant you will be solely responsible for planning, directing, and 
executing the proposed project.

This PA uses just-in-time concepts.  It also uses the modular as well as the 
non-modular budgeting formats (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 format.  Otherwise follow the instructions for non-
modular research grant applications.

FUNDS AVAILABLE

The co-sponsors intend to commit approximately $2.75 million total costs 
[Direct plus Facilities and Administrative (F and A) costs] in FY 2004 to 
support eight to nine new and/or competing continuation grants in response to 
this PAS.  Because the nature and scope of the proposed research will vary 
from application to application, it is anticipated that the size and duration 
of each award will also vary.  Although the financial plans of the ICs 
provide support for this program, awards pursuant to this PAS are contingent 
upon the availability of funds and the receipt of a sufficient number of 
meritorious applications. 

ELIGIBLE INSTITUTIONS

You may submit an application 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  
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.   

SPECIAL REQUIREMENTS

Though reviewed by NIH, some applications will be funded in part by one or 
more of the federal partners listed at the beginning of this program 
announcement, through funds transferred to NIH.  Submission of an application 
implies willingness for NIH to share the complete file with staff from these 
other federal agencies.

It is anticipated that a successful grant application will address the 
following considerations:

Annual Meetings

Principal Investigators of grants resulting from this PAS will be asked to 
participate in annual meetings to share findings, research approaches, and 
core instruments or data elements.  Requests for funds to support attendance 
at these meetings, to be held in the Washington DC area, should be included 
as part of the application budget request.

Theoretical Framework

To the extent possible, studies should be presented within a developed or 
developing theoretical framework.  Studies should be designed to assess 
hypotheses derived from existing theory while allowing for the extension or 
modification of existing theory.
 
Definition of the Sample and Subject Selection Criteria

The samples for study must be rigorously defined to permit complete 
independent replication at another site.  Within this context, the 
ascertainment/referral sources should be described in detail, including the 
definitions and criteria employed to identify children exposed to violence.  
It is expected that not all children exposed to violence will be identified 
according to the same definitions and criteria.  Consequently, applicants 
should provide clearly documented and operationalized definitions of the 
criteria employed in the identification of children exposed to violence.  
Description of subjects as exposed to violence according to vague referral 
sources (e.g., "agency-identified" witnesses to domestic violence) is 
discouraged unless accompanied by the explicit identification criteria 
employed by the protective service agency/health care provider, etc.

In addition, all study samples should be defined, to the maximum extent 
possible, with reference to age, gender, grade level (if appropriate), race, 
ethnicity, SES, geographic region, presence of disabling/handicapping 
conditions, socio-emotional behavioral status (e.g., antisocial behavior, 
delinquency, alcohol and drug use, etc.), caretaker status (if appropriate), 
characteristics of home/family environment, and type and nature of exposure 
to violence (domestic or community violence, or war/terrorism, and 
characteristics of the exposure such as whether the exposure is direct or 
indirect, and frequency, and timing of exposure), including combinations of 
types if present.

Measurement Criteria

Given the current state of defining and measuring exposure to violence, 
studies that use multiple methods and measures are specifically needed.  
Interviews, surveys, questionnaires, observational measures, standardized 
measures, and other assessment procedures used for the identification of 
exposure to violence across physical, emotional, and academic domains must be 
described in sufficient detail to permit independent replication.  Measures 
with known reliability, validity, and appropriateness for the population 
under study should be employed when available.  If reliability and validity 
characteristics are not yet known for a particular assessment procedure, the 
application should contain specific plans for establishing these features.

Opportunities for Definition and Classification of Exposure to Violence

A critical public health task for amelioration of the harmful effects of 
violence exposure on children is the development of a set of operational 
definitions and a classification system for different types of violence 
exposure appropriate for persons of differing ages and from different 
familial and cultural contexts.  Definitional clarity and classification are 
necessary to develop prevention, early intervention, and treatment programs, 
to identify distinctions and interrelationships between types of exposure to 
violence, to ascertain the consequences of different types and levels of 
violence exposure, and to understand the relationships between different 
types of exposure and individual, familial, social, cultural, and geographic 
variables.  Applicants should consider research protocols that are capable of 
identifying well-defined subgroups that exist within the population of 
children exposed to violence.  Within this context, investigators may wish to 
cast the sampling net wide enough to ensure a representative number of 
children experiencing different types and/or levels of violence exposure.

Secondary Data

It is acceptable to propose analyses for data collected for other purposes 
that might yield insight on children exposed to violence.  In these 
instances, investigators should be specific about how violence exposure is 
operationalized, limitations of the data, and how the analyses will be 
structured.  Investigators should also be clear when such analyses are 
descriptive or designed to model a process or test a hypothesis.

Feasibility

Feasibility issues must be clearly addressed.  Plans for implementation of 
interventions should include procedures for: obtaining and maintaining the 
necessary community relations, training and supervising staff, insuring 
implementation fidelity, securing ongoing access to the subject population 
pool, recruiting a representative sample of the target population, recruiting 
minorities for the staff of the research intervention, including appropriate 
comparison groups or conditions, and monitoring subject participation over 
time.

Applicants are encouraged to document the commitment, support, cooperation, 
and nature of proposed collaboration of community agencies or other entities 
or settings outside the applicant organization whose support is essential for 
the conduct of the research.

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity 
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:  

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 

o Direct your questions about peer review issues to:  

Karen Sirocco, Ph.D.
Division of Clinical and Population Studies
Center for Scientific Review
6701 Rockledge Drive, Room 3176, MSC 7848
Bethesda, MD 20892-7848
Telephone:  (301) 435-0676
FAX:  (301) 480-3962
Email:  siroccok@mail.nih.gov 

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

Ms. Dianna Bailey
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, 8A07E, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-6978
FAX:  (301) 402-0915
Email:  dn11r@nih.gov 

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  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. 

APPLICATION RECEIPT DATES:  Applications submitted in response to this 
program announcement will be accepted on June 25, 2003, June 25, 2004, and 
June 24, 2005.  

TECHNICAL ASSISTANCE WORKSHOP:

An information/technical assistance pre-application workshop addressing the 
scientific and administrative issues associated with this initiative will be 
held in April 2003, 2004, and 2005 in Bethesda, Maryland.  The purpose of the 
workshop is to: (1) familiarize the potential applicant with established NIH 
guidelines and criteria for review, (2) discuss the areas of programmatic 
emphasis, and (3) respond to potential applicants' technical questions about 
application format, procedures, etc.  Logistic information, including time 
and location, will be posted at http://www.nichd.nih.gov/PA/PAR-03-096/
PAR-03-096.htm and may be obtained from program staff listed under 
WHERE TO SEND INQUIRIES, above.  For those who cannot attend the workshop, 
a written summary will be posted at that web site.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS:  Applications 
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 
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 six 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 received by or mailed before 
the receipt dates listed above.  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.

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

PEER REVIEW PROCESS

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 
(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 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.

REVIEW CRITERIA

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

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The scientific review group will address and consider each of these criteria 
in assigning the application's overall score, weighting them as appropriate 
for each application.  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:

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.)
 
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 CONSIDERATIONS 

DATA SHARING:  The adequacy of the proposed plan to share data.
 
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.

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD:  Research components 
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, 
1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

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 is 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.

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