THE SCIENCE AND ECOLOGY OF EARLY DEVELOPMENT (SEED)

RELEASE DATE:  June 18, 2004

PA NUMBER:  PA-04-113


December 13, 2006 - The R01 portion of this funding opportunity has been 
replaced by PA-07-149, which now uses the electronic SF424 (R&R) 
application for February 5, 2007 submission dates and beyond.

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. Other mechanisms relating to this announcement 
will continue to be accepted using paper PHS 398 applications until the stated 
expiration date below, or transition to electronic application submission. 
A replacement R03 (PA-06-345) funding opportunity announcement has been issued 
for the submission date of June 1, 2006 and submission dates for AIDS and 
non-AIDS applications thereafter.

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 R01 Non-AIDS Applications: November 2, 2006 
Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007



Department of Health and Human Services (DHHS)

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

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.865, 93.279

This Program Announcement (PA) replaces PAS-00-108, which was published in the 
NIH Guide on June 22, 2000.

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this PA
o Research Objectives
o Mechanisms of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA

This Program Announcement (PA), jointly issued by the Demographic and 
Behavioral Sciences Branch (DBSB) and the Child Development and Behavior 
Branch (CDBB) of the National Institute of Child Health and Human Development 
(NICHD) and the National Institute on Drug Abuse (NIDA), invites research 
grant applications that seek to develop a comprehensive program of research 
focused on the mechanisms through which social, economic, cultural, and 
community-level factors, and their interactions, impact the early cognitive, 
neurobiological, socio-emotional, and physical development of children. 
Understanding the influence of these mechanisms is especially important for 
understanding the impact of public policies on the development of children at 
whom (or at whose families) these policies are often specifically targeted, 
notably children living in poverty or near the federal poverty line. Arenas of 
particular relevance within public policy include childcare, early childhood 
education, welfare reform, tax, social services, and family/work policies, as 
all of these shape the life experiences of children in poverty. Thus, a goal 
is for the research to develop data that would bear directly on these arenas 
and might thereby inform policies that impact child development, whether or 
not child development is the explicit focus of those policies. This PA extends 
the Science and Ecology of Early Development (SEED) initiative.

RESEARCH OBJECTIVES

Background
 
Children's cognitive, socio-emotional, and physical development is 
unquestionably influenced by social, economic, cultural, and community-level 
factors, or the ecological context in which they grow up. However, at present, 
there is limited knowledge as to how these broader factors impact children's 
development. Research examining the link between child development and these 
factors is critical because this understanding is needed to inform policy 
development, including policies regarding childcare, welfare reform, early 
childhood education, and social services; these policies in particular have a 
large impact on poor families and their children. 
 
This program announcement is part of a larger collaborative effort among the 
following agencies:  (1) U.S. Department of Health and Human Services [NICHD, 
NIMH, NIDA, Administration on Children and Families (ACF), Office of the 
Assistant Secretary for Planning and Evaluation (ASPE), and the Centers for 
Disease Control and Prevention (CDC)], and (2) the Department of Education 
(National Center for Education Statistics and National Center for Education 
Research in the Institute of Education Sciences; Office of Special Education 
Programs).  The SEED program was launched by NICHD in 1997. In October 1998, 
the NICHD convened a planning conference for SEED that included scientists in 
developmental psychology, economics, education, evolutionary biology, 
medicine, and sociology. The purpose of this workshop was to discuss the 
issues involved in crafting a research agenda to examine ecological contextual 
factors in relation to children's development. The main themes that emerged 
included defining poverty across ethnic/cultural groups, unpacking the 
"poverty" box (i.e., focusing on mechanisms through which poverty affects 
child outcomes, developing better measures for poverty, separating out family 
characteristics that are often confounded with poverty (such as race/ethnicity 
and educational attainment), and developing theoretical models that 
incorporate the dynamic interaction between the various contexts (home, 
school, and neighborhood) in which children's developmental trajectories are 
shaped. 
 
Although there is now an expanding body of research on examining these 
ecological contextual factors in relation to children's development, there are 
still significant gaps in knowledge. These gaps are in part a reflection of 
the fact that much of this research remains discipline-specific and not well 
integrated across fields. Encouraging multidisciplinary and interdisciplinary 
research was a primary theme of the original SEED program. Thus, while much 
progress has been made in understanding the ecological context that influences 
children's development, there are still significant research questions that 
need to be answered. In general, there is a need to understand multiple 
outcomes of child development (cognitive, physical, social, and emotional) 
within the context of multiple factors (social, economic, cultural, and 
community-level), and understand how these factors interact across levels of 
family income, including those families living in poverty, at or near the 
federal poverty line, and those above the poverty line.
 
A significant body of research has accumulated regarding children's cognitive, 
social, emotional, and physical development, and therefore the process of 
children's typical development in each of these areas, is fairly well 
understood. In each area the developmental course and appropriate milestones 
are relatively well established, and deviations from a normal course of 
development can be documented. Nonetheless, although much is known about child 
development, much of this research is limited in that it has been conducted 
without examining the influence of the ecological context in which children 
grow up. Specifically, in the bioecological model developed over the past 35 
years by Bronfenbrenner and his colleagues, the mechanisms of development, 
called proximal processes, are known to be influenced by the elements of the 
child's proximal and distal environments. However, studying multiple levels of 
influence, developmental processes, and child developmental outcomes has 
proven to be a daunting task. To this end, there is a need for an 
understanding of the social, economic, cultural, and community-level factors, 
which alone and, more importantly, in combination, influence both the 
processes of development and child developmental outcomes. 

Relevant Contexts and Levels
 
The social context in which children grow up, including family structure and 
relationships and peer networks, has long been thought to influence children's 
development. For example, a large body of research documents poorer 
developmental outcomes in children growing up with single parents. Considering 
the social context in which children develop is particularly important because 
major socio-demographic changes in community and family structure and 
population composition have taken place in the last two decades. For example, 
the increase in the rate of maternal labor force participation, the parallel 
increase in the enrollment of children in non-parental care, and the rapid 
decline in the proportion of married two-parent families have created 
different challenges and opportunities for families. Today's families are 
likely to have complex and shifting family structures, highly diverse ethnic 
and linguistic backgrounds, and often have uneven education and employment. 
These issues are even more complex for poor families as, for example, the 
majority of poor children live in one-parent households and the poverty rate 
for one-parent families is higher than for two-parent households. 
 
Economic factors, such as family resources and income, parental education, 
availability of public assistance, and employment, also appear to shape the 
context in which children develop. These factors are increasingly important to 
consider in child development, as changes in welfare reform, health care, and 
child welfare have taken place in the last decade. Communities also have 
undergone drastic changes. In this era of globalization and the emergence of 
the "network society," concentrated urban poverty and related dimensions of 
economic disadvantage, such as racial and ethnic exclusion, have affected 
child development in ways that are not fully documented. Families living in 
rural communities face a different set of complex economic challenges due to 
shifts in the economy, especially farming and migrant workers. 
 
Parental drug abuse is an example of the importance of considering the joint 
effects of social and economic context. Research suggests long-term 
associations between parent drug abuse and deleterious developmental outcomes 
(e.g., insecure attachments, failure to resolve developmental tasks, 
psychological dysregulation, affiliation with deviant peers, suicide, and 
homelessness). Substance-abusing parents are likely to live in poverty and 
likely to have a chaotic lifestyle organized around drug-related activities. 
This lifestyle can put the parents and their families in dangerous situations 
and may lead to forced parent-child separations due to incarceration, drug-
related illness, or death. 
 
There are also numerous community-level issues that affect children's lives 
and development, including available neighborhood and community resources, 
neighborhood crime (such as drug-related activities), and the quality of 
schools. For example, the quality of preschool programs influences children's 
school readiness and the quality of public schools affects early academic 
outcomes across content areas. Racial segregation at the community level, 
particularly when coupled with economic disadvantage, also is likely to play 
an important role in influencing development.
 
The cultural contexts in which children develop also influence developmental 
outcomes. Ethnic and cultural beliefs and attitudes, religion and 
spirituality, and cultural norms and expectations (including those about 
family structure and roles) play a role in children's lives that is not well 
understood. In addition, there have been major shifts in the cultural context 
in which children grow up. The influence of the media in shaping cultural 
context, and its implications for child development, are poorly understood. 
Very little research has been conducted on the role of religion and family 
religious participation in child development. Increasing racial and ethnic 
diversity and income inequality in the US population add further complexity to 
the cultural environment that enfolds children growing up in the US today.
 
Public policies may impact child development, whether or not they are actually 
aimed at children. While some public policies have a direct impact on the 
child's immediate environment (e.g., legislating class size, adult-to-child 
ratios in child care, healthcare, etc.) other policies are likely to affect 
children through their impact on more distal elements of the child's world 
(e.g., policies concerning workplace leave, TANF, drug-related incarceration, 
etc.). During the 1990s, welfare reform experiments and policy shifts sought 
to reduce welfare caseloads by increasing child-support payments from non-
custodial parents and increasing employment for poor single mothers. Research 
suggests that these changes have led to higher employment rates among women 
leaving welfare dependency and stabilized the level of child-support payments, 
which otherwise would have been significantly less. Other research has 
examined the effects of these policies on children and has found, for example, 
mixed outcomes for children related to parental welfare transitions, either on 
or off welfare and into or out of paid work. Additional research has shown 
that court-awarded child support encourages increased contact between non-
resident fathers and their children. Schooling policies are another important 
context for child development. Children, particularly minority students, 
assigned to smaller classrooms perform better academically than those who in 
larger classes. In terms of social development, children are less likely to 
have racially segregated friendship networks when structured settings such as 
classrooms and extracurricular activities are integrated. However, integration 
policies at levels higher than that of the classroom or activity do not always 
have the intended effect. Racially based busing is associated with greater 
segregation, suggesting that negative family and community reaction to 
policies at the level of the school district may impact student relations and 
require that busing be accompanied by within-school integration activities.
 
Interactive Nature of Contexts and Cross-Level Interactions

Understanding the influence of these social, economic, cultural, and 
community-level factors, and their interactions, on child development is 
critical for determining effective means of improving child development 
outcomes. This is particularly critical to consider for children who are 
growing up in poverty, as these children are especially at risk for problems 
in physical health and cognitive and socio-emotional development. Poverty 
among children is associated with an array of problems, including low birth 
weight, infant mortality, contagious diseases, and childhood injury and death. 
Poor children are at risk for developmental delays in intellectual development 
and school achievement. Compared to non-poor peers, poor children tend to have 
lower average levels of school-related skills and their progress through 
school is slower and more subject to termination from dropout. Poor children 
also have relatively high rates of social, emotional, and behavioral problems, 
including anxiety, social withdrawal, aggression, and delinquency; lack of 
self-esteem and self-efficacy; and psychological distress. Nevertheless, not 
all poor children develop these problems, as many are healthy, intellectually 
productive, and socially well adjusted. This variation in outcomes suggests 
the existence of social, economic, cultural, and community-level influences 
that serve as protective or risk factors for children in poverty. 
 
In summary, there is a need to establish a body of research that examines the 
ecological contexts in which children grow up and the factors that either 
positively or negatively influence child development outcomes. While these 
issues are important for all children, they bear directly on children in 
poverty, as development and/or implementation of policies can often 
drastically change the environment in which poor children live. Research on 
these topics involves significant scientific challenges. Ecological factors 
thought to influence child development tend to be interrelated and also 
correlated strongly with individual-level characteristics of families and 
children. Correlations between parental circumstances and behaviors and child 
outcomes may reflect common biological endowments as well as social 
influences. Moving from correlation to cause and effect requires innovative 
theory and data, the development of creative study designs and methodologies, 
utilization of complex data analytic strategies, and the accumulation of 
knowledge across different approaches. However, advances in research 
methodology and data analyses, often in diverse disciplines, provide promise 
in disentangling the effects of interrelated, often hierarchically structured, 
contextual variables.
 
Objectives and Scope
 
This initiative solicits studies that focus specifically on research on the 
social, economic, cultural, and community-level factors that affect 
developmental processes and outcomes for children living in poverty, and that 
draw on current theoretical and methodological advances in social, behavioral, 
and biobehavioral research. Specifically, this initiative encourages research 
that: (1) is multidisciplinary or interdisciplinary; (2) uses existing sources 
of data and/or justifies new data collection efforts; (3) uses longitudinal, 
experimental, or comparative designs; and (4) has relevance for public policy, 
particularly in the areas of childcare, early childhood and primary/secondary 
education, welfare reform, tax reform, social services, and family/work 
policies. Populations of interest include diverse children of all ages, with a 
focus on understanding how the ecological context in which children in poverty 
grow up influences early development in the short term, or long-term 
trajectories stemming from early development. Outcomes of interest include 
cognitive, socio-emotional (e.g., temperament, behavior, character 
development, interpersonal relations), and physical development and 
trajectories. 
 
Research Priorities and Examples of Research Questions
 
The following research priorities and examples of research questions are 
offered to illuminate areas of particular interest to the NICHD and NIDA. In 
general, these institutes seek studies that are intended to identify, 
describe, and potentially inform and launch interventions based upon the 
processes underlying the relationships between poverty status and child 
outcomes.  Examples of research questions that address the objectives of this 
PA include, but are not limited to:
 
o What are the effects of welfare reform on childcare, social services, and 
family structure, and how does this have an impact on child development? 

o What are the emotional and behavioral problems and disorders experienced by 
children living in poverty? 

o How does access to health insurance impact child development and do 
different sources of insurance have different impacts?

o How do parents' relationships with each other influence child development?

o How does drug abuse by family members, particularly parents, affect 
children's developmental outcomes?

o How do parent drug use, child maltreatment, and subsequent unhealthy 
attachments between parent and child shape developmental outcomes?

o How do housing policies affect child development and/or risk for emotional 
and behavioral disorders in poor children via housing quality, quality of 
life, and residential stability? 

o In what ways do educational institutions affect peer influences that shape 
developmental, behavioral, and educational outcomes?

o How do parent drug abuse and poverty impact developmental outcomes that may 
be risk factors for later drug abuse (e.g., cognitive, emotional, and 
behavioral dysregulation, particularly conduct disorder and post-traumatic 
stress disorder)?

o How does ethnic/racial homogeneity in neighborhoods affect cultural and 
economic processes relevant to child development and does this vary by 
nativity and race/ethnicity? 

o How does family/parental stress mediate the impact of ecological factors 
(e.g., policy, crime, poverty) on child development outcomes?

o To what extent do neighborhood characteristics (cohesion, "collective 
efficacy," poverty, family composition) affect child development outcomes once 
individual family effects are taken into account? 

o How does access to public assistance funds for childcare and social services 
interact with family factors, such as employment and childcare decision-
making, and how do these forces act directly or indirectly on child 
development outcomes? 

o What qualitative aspects of parental work impact child development, and can 
community factors moderate these relationships? 

o How do religion and family religious participation affect child development, 
behavior, or health, and can they offset the negative impact of other deficits 
in the child's environment? 

o How does the context of poverty interact with biological factors in 
development, and do selected aspects of that context differentially impact 
neural and psychophysical developmental systems?

o What are the mutual influences of physical health, genetics, and nutrition 
on child outcomes and how do conditions of poverty interact with these 
factors?  How do children's age, gender, and temperament interact with 
parents' characteristics to influence parenting patterns that affect child 
development?

o What are the child characteristics (e.g., temperament) and family factors 
(e.g., sibling bonds) that put children at greater risk or protect them from 
the effects of harmful ecological factors, such as poverty combined with 
parent psychopathology and/or drug abuse?

Across these and other research questions, this PA is intended to support 
investigations that examine the processes underlying relationships between 
living in poverty and child outcomes. An understanding of the relevant 
pathways and mechanisms will lead to improvements in interventions aiming to 
reduce the risks associated with poverty and promote positive developmental 
outcomes for children in disadvantaged contexts.

MECHANISM OF SUPPORT

This PA will use the NIH Research Project Grant (R01) and Small Grant (R03) 
award mechanisms.  Please follow the guidelines for the R03 as described in 
the NIH Small Grant Program Announcement 
(http://grants.nih.gov/grants/guide/pa-files/PA-03-108.html).  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 budgeting 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 budget format.  Otherwise follow the instructions for 
non-modular budget research 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_2003/NIHGPS_Part2.htm. 
  
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 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 his/her 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

It is the intention of the SEED program to support projects that will 
accumulate information that not only furthers the scientific understanding of 
child development from an ecological perspective, but also informs public 
policy. Therefore, Principal Investigators from projects funded under the SEED 
initiative will be expected to engage in an interactive, collaborative 
process; each participating Principal Investigator will be expected to 
participate in workshops and conferences designed to further the 
research/public policy dialogue. The co-sponsors of the SEED program encourage 
the participation in these activities of junior scholars who might develop 
links with researchers to explore training opportunities. 

Annual Meeting for Investigators

Principal Investigators will be expected to attend an annual SEED 
Investigators Meeting to share findings, research approaches, and core 
instruments or data elements. Applicants should include in the application’s 
budget request, sufficient funds to support travel for the Principal 
Investigator to one two-day meeting in Washington, DC, in each of the 
requested years of support. NIH SEED investigators will interact with staff 
from SEED agencies and their contractors and grantees at these events.

WHERE TO SEND INQUIRIES

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

o Direct your questions about scientific/research issues to:  

Rosalind King, Ph.D.
Demographic and Behavioral Sciences Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, 8B07, MSC 7510
Bethesda, MD  20892-7510
Telephone: (301) 435-6986
FAX: (301) 496-0962
Email:  [email protected] 

Kyle Snow, Ph.D.
Child Development and Behavior Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B05, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 435-2307
FAX: (301) 480-0230 
Email:  [email protected]

Jessica J. Campbell, Ph.D.
Division of Epidemiology, Services, and Prevention Research 
National Institute on Drug Abuse
6001 Executive Boulevard, Suite 5174, MSC 9589
Bethesda, MD 20892-9589
Telephone:  (301) 402-1850
FAX:  (301) 480-2543
Email:  [email protected]

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

Rashawn L. Farrior
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, 8A17, MSC 7510
Bethesda, MD  20892-7510
Telephone: (301) 435-7010
FAX: (301) 402-0915
Email:  [email protected] 

Christine A. Kidd
Grants Management Branch
National Institute on Drug Abuse
6101 Executive Boulevard, Room 270, MSC 8403
Bethesda, MD  20892-8403
Telephone: (301) 435-1372
FAX: (301) 594-6849
Email:  [email protected]   
  
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) 710-0267, Email: [email protected].

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

SUPPLEMENTARY INSTRUCTIONS:  Applicants for the NIH Small Grant (R03) should 
follow the guidelines described in the NIH Small Grant Program Announcement 
(http://grants.nih.gov/grants/guide/pa-files/PA-03-108.html).    

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 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 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 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.  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 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.  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.  

o Significance
o Approach
o Innovation
o Investigator
o Environment 

The application does not need to be strong in all categories to be judged 
likely to have major scientific impact and thus deserve a high priority score.  
For example, an investigator may propose to carry out important work that by 
its nature is not innovative but is essential to move a field forward.

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

APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project?  Does the applicant acknowledge potential problem areas and consider 
alternative tactics?

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

INVESTIGATOR:  Is the investigator appropriately trained and well suited to 
carry out this work?  Is the work proposed appropriate to the experience level 
of the Principal Investigator and other researchers (if any)?

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

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

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 
(http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).  (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.)

ADDITIONAL 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).

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.  

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.

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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