This notice has expired. Check the NIH Guide for active opportunities and notices.

EXPIRED


This PA will remain active for three years, through the July 1, 2003 
application receipt date.

THE SCIENCE AND ECOLOGY OF EARLY DEVELOPMENT (SEED)

Release Date:  June 22, 2000

PA NUMBER:  PAS-00-108 (see replacement PA-04-113)

National Institute of Child Health and Human Development 
 (http://www.nichd.nih.gov) 
National Institute of Mental Health 
 (http://www.nimh.nih.gov) 

THIS PA USES THE  MODULAR GRANT  AND  JUST IN TIME  CONCEPTS. IT INCLUDES 
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED 
WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA.

PURPOSE

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 Developmental Psychopathology and Prevention Research Branch 
of the National Institute of Mental Health (NIMH), invites research grant 
applications focused on creating a science base on the development of children 
living in low-income families.  This PA falls under the Science and Ecology of 
Early Development (SEED) 2000 initiative.  SEED 2000 is designed as a 
collaborative effort among the following agencies:  U.S. Department of Health 
and Human Services [NICHD, NIMH, 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 the Department 
of Education (National Institute on Early Childhood Development and Education 
of the Office of Educational Research and Improvement, National Center for 
Education Statistics, and Office of Special Education Programs).  Its main 
focus is to establish a research agenda on the development of children in low-
income families that has scientific integrity and is highly relevant to policy 
makers.  The overarching goal of the SEED initiative is to foster research on 
the multiple contexts of development--family, child care settings, schools, 
neighborhoods, communities and broader cultural contexts-- and their impact on 
the developmental trajectories of children in low income families.

The NICHD, NIMH, and their SEED partners seek to stimulate systematic, 
multidisciplinary, and ecological research to understand the specific 
cognitive, linguistic, sociocultural, and economic factors, and the complex 
interaction among these factors, that promote or impede development of 
children in low-income families.  It is expected that the research studies 
stimulated by this initiative will contribute scientific data on the 
developmental trajectories of low-income children and have relevant 
implications for emerging public policy issues, including health disparities.

The purposes of this PA are threefold:  (1) to examine the effects of poverty, 
as it interacts with a multitude of factors, on the developmental trajectories 
of children in low-income families; (2) to identify risk and protective 
factors for physical and mental health and cognitive, linguistic, affective, 
and social development among children growing up in low-income families; and 
(3) to identify social-ecological factors that affect the development of poor 
children and that can be used to guide and inform policy, including the design 
and implementation of effective interventions.
 
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 Program Announcement (PA) is related 
to one or more of the priority areas.  Potential applicants may obtain 
 Healthy People 2010  at http://www.health.gov/healthypeople.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign for-profit and 
non-profit organizations, public and private, such as universities, colleges, 
hospitals, laboratories, units of State and local governments, and eligible 
agencies of the Federal government.  Racial/ethnic minority individuals, 
women, and persons with disabilities are encouraged to apply as Principal 
Investigators. Only new applications may be submitted in response to this 
announcement; competing continuation applications for funded projects are not 
eligible. 

MECHANISM OF SUPPORT

This PA uses the National Institutes of Health (NIH) research project grant 
(R01) and the Interactive Research Project Grant (IRPG) award mechanisms.  
Responsibility for the planning, direction, and execution of the proposed 
project will be solely that of the applicant.  The total project period for an 
application submitted in response to the PA may not exceed five years.

Use of the IRPG, consisting of theoretically and collaboratively linked 
individual research project grants, is encouraged.  For a description of the 
IRPG mechanism, please refer to:  
http://grants.nih.gov/grants/guide/pa-files/PA-96-001.html. 

Specific application instructions have been modified to reflect "MODULAR 
GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH.  
Complete and detailed instructions and information on Modular Grants can be 
found at http://grants.nih.gov/grants/funding/modular/modular.htm. 

FUNDS AVAILABLE

The NICHD intends to commit approximately $1.5 million and the NIMH intends to 
commit approximately $500,000 in total costs [direct plus Facilities and 
Administrative (F&A) costs] in FY 2001 to fund three to four new grants in 
response to this PA. SEED partner agencies may add funds to support or 
supplement projects in the program.  An applicant may request a project period 
of up to five years. Because the nature and scope of the research proposed may 
vary, it is anticipated that the size of awards also will vary.  Although this 
program is provided for in the financial plans of the NICHD and NIMH, awards 
pursuant to this PA are contingent upon the availability of funds for this 
purpose and the receipt of a sufficient number of meritorious applications.  

RESEARCH OBJECTIVES

Background

At present, the largest group of poor people living in the United States is 
children, and nearly one-fourth of poor children are under six years of age.  
Children in poverty are especially at risk for problems in physical and mental 
health, and cognitive and social 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 children, 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. Although poor children are at 
risk for problems, many are healthy, intellectually productive, and socially 
well-adjusted.     

The ecological context in which poor children develop has been significantly 
altered in the last two decades by major sociodemographic changes in community 
and family structure and population composition.  For example, the increase in 
the rate of maternal labor force participation, the parallel increase in the 
enrollment of children in non-parental care facilities, and the rapid decline 
in the proportion of two-parent families have created different challenges and 
opportunities for poor families. The majority of poor children live in one-
parent households, and the poverty rate for fatherless families is higher than 
for two-parent households.  Today’s poor families are likely to have complex 
and shifting family structures, highly diverse ethnic and linguistic 
backgrounds, and uneven education and employment.

Other factors that have drastically shaped the context in which families live 
include the recent changes in welfare reform, health care, and child welfare 
as well as the major economic expansion of 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 
understood. Violence that children experience in their own homes and 
communities or through television, movies, and interactive video games is 
increasingly common as are substance abuse, periods of homelessness, and 
serious mental illness.

Although there is an expanding body of research on the consequences on growing 
up poor for children and families, this research is, in general, discipline-
specific, not well integrated across disciplines, and reveals some gaps.  To 
address this issue, in October 1997, under the auspices of SEED, the NICHD 
convened a workshop to discuss the issues involved in crafting a research 
agenda that examines the impact of poverty on child development and health 
outcomes.  The workshop participants included distinguished scientists in 
developmental psychology, economics, education, evolutionary biology, 
medicine, and sociology.  The main goals of the workshop were to provide a 
multidisciplinary perspective on the research base on poverty and child 
development; to identify the most pressing scientific issues involving poverty 
and child development; and to offer new ideas and research questions that 
could lead us to develop a  new science  of research that is 
multidisciplinary, longitudinal, and that embraces an ecological approach to 
the study of child development. The group identified the following areas in 
which research is needed: 

1.  The nature of poverty and how to measure it

The study of poverty and its effects on children needs to consider that 
poverty is best defined along a continuum that encompasses, but exceeds, the 
official poverty threshold, from the underclass through the working class.  
Poverty is a conglomerate of conditions and events; it is not a categorical 
variable and it needs to be studied in the context of ethnicity, culture, and 
race, taking into account the variability across and within groups.

One of the fundamental issues related to estimating the effects of poverty on 
children’s outcomes is measurement.  Future research should consider the 
recommendations of the National Research Council Panel on Poverty and Family 
Assistance:  Concepts, Information and Needs, and Measurement Methods.  
However, investigators should not limit themselves to this definition and 
should consider other indices of economic well-being such as social capital, 
human capital, and economic resources.

2.  The effects of family structure, family processes, and income poverty, and 
other indices of poverty, on child outcomes

There is a compelling rationale and need for the development of a 
comprehensive program of research that can identify the full range of 
individual, social, economic, cultural, and community factors, and the 
interactions among these factors, that are directly relevant to the 
development of children in low-income families.  Such a program of research 
needs to attend to children living in fragile circumstances, including 
homeless children, children in foster care, and children living in families 
affected by chronic physical or mental health problems such as depression or 
substance abuse.  Research on these issues needs to address the multiple 
domains of development including physical and mental health, and social, 
emotional, cognitive and linguistic development.

Debates continue over the extent to which income alone makes a significant 
difference in children’s lives. Many questions remain about the relative 
contributions of economic resources and parental characteristics to children’s 
outcomes.  Research suggests that the timing of poverty has a significant 
effect on children’s outcomes and that income alone does not seem to make a 
significant difference in improving the physical health, mental health, or 
behavioral development of poor children.

3.  The mechanisms through which poverty exerts its effects

Research on poverty to date has documented an array of associations between 
poverty and child outcomes.  However, there is little understanding of the 
pathways or mechanisms--the black box-- by which poverty (income and other 
aspects of poverty) has positive or negative effects on children’s 
development.  To understand poverty’s effects on children’s outcomes, we need 
to examine how it affects their living environments, including composition, 
safety, structure, and social relationships as well as access to health care, 
child care, and other social services. We need research that advances our 
understanding of what is in the black box.

4.  The role of communities and neighborhoods in children’s development 

There is an accumulating body of research that examines neighborhood effects 
on children’s development.  If neighborhood effects on children’s outcomes 
exist, they are presumed to be constituted from social processes that involve 
collective aspects of community life.  Departing from a social capital 
perspective, research needs to explore what determines and sustains social 
support for children.  Research to date has focused on how mechanisms such as 
informal social support or social control bear on the well-being of children. 
Yet our understanding of the social mechanisms hypothesized to mediate the 
effects of neighborhood structural characteristics is still developing.  
Investigations of social mechanisms including spatial externalities, in 
conjunction with racial differences in spatial advantage and disadvantage, are 
beginning to emerge. Violence in communities, both intra-family and 
neighborhood, has a profound effect on children and families.

5.  The implications of poverty for interventions

Understanding the dynamics of poverty is essential to understanding how 
policies affect children’s development.  Family poverty and children’s 
outcomes need to be understood in their social contexts, which have changed 
dramatically.  There was a sense among workshop participants that research 
needs to focus on the factors or combination of factors that lead to change in 
children’s lives under different conditions of poverty.  The challenge for 
researchers and others is to gain insight into what is the optimal timing for 
interventions and what interventions are optimal for whom, when, and under 
what conditions.

6.  The appropriateness of existing measures of child development and the 
development of new measurement tools and methodologies 

In terms of measures, workshop participants suggested that existing 
instruments are not sufficient to predict outcomes across socioeconomic and 
cultural groups.  For example, recent research suggests that many existing 
measures of the proximal child-rearing environment (e.g., the HOME Inventory) 
may be less useful for low income families than they are for higher income 
families  and may not capture elements of parenting relevant for minority 
groups.  Consequently, there is a need to develop new measurement tools that 
can capture both commonalities and differences across ethnic and cultural 
groups.  In addition to the need for new tools for the study of poverty and 
its effects on children’s outcomes, there was a collective sense among the 
participants that research studies need to use a diverse range of research 
methodologies, including both longitudinal and ethnographic designs, and a 
combination of both qualitative and quantitative measures.

In conclusion, workshop participants noted that the field of child development 
has not fully integrated relevant socioeconomic data with children’s 
developmental trajectories.  For example, economic studies of time use have 
not traditionally been linked to studies on children’s development.  There is 
little research on how various cognitive and socio-emotional characteristics 
that influence language, memory, learning, and planning ability develop in 
impoverished environments.  Similarly, little is known about how environmental 
factors, including family and peer group contexts, and societal norms, shape 
children’s socio-emotional characteristics and, in turn, influence children’s 
engagement in cognitive tasks, or how socio-emotional development in the 
context of poverty affects various facets of cognitive development (e.g., 
language, memory, reasoning, and theory of mind).  While there are protective 
mechanisms that moderate the effects of poverty and result in better outcomes 
for some children, these are poorly understood.  Likewise, little is known 
about how ethnic and cultural variation interacts with poverty to affect 
children’s development.  Further, research on early brain development has not 
been linked to differences in the factors that mediate the effects of poverty 
on children’s development.  At a more macro level, research has paid little 
attention to the way geographical mobility due to economic needs influences 
the stability and quality of housing and schooling and, consequently, 
children’s developmental trajectories. 

In light of recent social, cultural, and economic changes that have increased 
the diversity of the U.S. population, there is a need for new theories and 
research that specifically address the development of children in poverty and 
the diverse social and cultural contexts that shape children’s developmental 
trajectories.  The intent of this initiative is to stimulate this work and to 
encourage interdisciplinary collaborations among scientists from different 
fields.

Objectives and Scope

A major goal of this research initiative is to obtain converging scientific 
evidence that ultimately can become the base for a  new science  that seeks to 
understand the diverse developmental trajectories of children in low-income 
families, how development is enhanced or impeded in low income communities, 
the effects of a complex mix of factors on development, and the optimal points 
for interventions.  

This initiative solicits studies that focus specifically on the integration of 
research on environmental, social, economic, and developmental factors that 
affect developmental processes and outcomes for children, and that draw on 
current theoretical and methodological advances in behavioral research.  
Specifically, this initiative encourages research that (1) is 
multidisciplinary; (2) uses existing sources of data and/or justifies new data 
collection efforts; (3) is or can be linked to other relevant national efforts 
across disciplines; and (4) has relevance for public policy. 

Specifically, this initiative seeks collaborative, interactive research 
projects to address these overarching research questions: 

o What are the effects of poverty on child development?

o What are the mechanisms through which poverty affects child development?

o What are the moderators (e.g., demographic, family, neighborhood, and policy 
factors) of the effects of poverty, that is, what provides for positive child 
development in the face of poverty and what compromises development?  

o What interventions are effective in preventing or mitigating the adverse 
effects of poverty on child development?  What mechanisms or moderating 
factors should they target?

o What is the role of child care, as a mechanism, moderator, or intervention, 
in child developmental trajectories?  How do family characteristics and child 
care act together to promote or impede optimal child development?

In addition to the above questions, this PA addresses two cross-cutting 
issues, namely measurement and theory.  Are current measures and theories of 
child development adequate to capture and characterize the development of 
children given the variety of family structures, community and economic 
influences, and ethnic and cultural diversity of the current U.S. population? 
 How might existing measures be modified and what new measures must be 
developed to address the complex issues in the social ecology of early 
development? The issue of measurement should extend not only to measurement of 
child development in different settings, but also measurement of poverty and 
its concomitants. Although researchers may choose to focus on measurement 
and/or theory issues alone, their work should contribute to answering one or 
more of the research questions.

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, NIMH, and 
SEED partners.  Examples of research questions that address the objectives of 
this PA include, but are not limited to:

Effects of poverty on child development

o How do children who live in impoverished conditions develop self-regulation 
and the ability to manage stress?  How do they develop values and goals?  How 
do learning, memory, and planning ability develop in different contexts such 
as the home environment, school or day care setting, and the neighborhood?
How do the relations between these different contexts promote or impede 
optimal child development?

o How do families' characteristics (e.g., household structure, relations with 
kin outside the household, parents' age, parents' education, and psychological 
resources) influence children’s development?  How do neighborhood and 
community characteristics (e.g., neighborhood cohesion, access to services, 
violence) influence families and children and shape the processes by which 
poverty affects child developmental outcomes?

o What are the mutual influences of a child’s health, genetics, nutrition, 
mental health, and personal characteristics 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? How do the interactions between parent and child 
characteristics in predicting child outcomes differ in different physical and 
social environments?  What is the role of culture in shaping how poverty 
influences children’s outcomes in different family and social contexts?

o How do early childbearing and unwanted pregnancy affect fathers' and 
mothers' parental behaviors?  How do these affect child outcomes?  How are 
these effects augmented or minimized by income, SES, and other economic 
factors?  Does extended family or community support directly or indirectly 
affect child outcomes? 

o What are the pathways to competence and healthy development for low income 
children, minority children, and children with special needs?  What factors 
promote healthy development and what factors or combinations of factors place 
children at risk for poor developmental outcomes?

o What are the emotional and behavioral problems and disorders experienced by 
children living in poverty?  What are the factors related to impoverished 
conditions that may place children at risk for future mental health problems 
and disorders? 

o How does family income in the early years affect children’s early and later 
development?  Is there variability by ethnic or cultural group?  If income 
inequality is not the primary reason for poor children’s unequal 
opportunities, how do additional resources translate into child resources? 
What are some implications for interventions?

o How do low-wage working families cope with work demands, such as irregular 
hours and shift work; with family responsibilities, including child care 
needs, training and education, responsibility for caregiving to elderly 
parents, and/or managing other family members' health needs; and with 
instability of housing and employment?  What is the effect of various coping 
strategies on child development?

o What role do fathers play in child-rearing and child care and how does their 
involvement with their children and their families relate to children’s school 
readiness?  What influence do fathers have on children at different 
developmental stages?  How does father involvement vary by cultural group?  
How is father involvement influenced by his relationship with the child’s 
mother as well as his own characteristics including economic resources, mental 
health, and parenting attitudes?  How do fathers and children create 
nurturant, positive relationships in the context of the family, neighborhood, 
and community?

o How does the community context affect poverty?  How do communities create 
environments that are safe and stimulating for children?  Why do some children 
succeed while others do not? What are the relations between the family and 
other contexts?  What are the community and family resources?  How do they 
combine to affect development?  What formulas work successfully and which lead 
to failure?

Mechanism through which poverty affects child development

o What are the pathways or mechanisms through which income, or lack thereof, 
influences children’s outcomes?  How does variation in children’s 
characteristics (e.g., health, biogenetic contribution, temperament) account 
for differences in developmental outcomes?  How do pathways vary as a function 
of children’s family, neighborhood, community, and other environmental 
characteristics? 

o What are the various mechanisms (e.g., timing of poverty, parenting in 
impoverished environments, intra-family allocation of resources, the 
contribution of fathers and other caregivers to the development of their 
children, and neighborhood influences) that transmit or buffer the effects of 
poverty?

o What are the cultural and ethnic variations in the mechanisms through which 
factors related to poverty influence children’s outcomes?

Interventions

o How do focused vs. comprehensive intervention approaches vary in terms of 
child outcomes? How do programs that target the child or the family differ 
from those that also address other aspects of the child’s environment such as 
the school, neighborhood, or community?  How do different intervention 
approaches affect children’s outcomes in different cultural and ethnic groups? 
 What are the processes by which interventions affect change in different 
cultural and ethnic groups?

o How can the development of children living in poverty be enhanced?  What are 
effective strategies for promoting healthy development?  What strategies are 
effective for fostering positive social and emotional development and its role 
in children’s school readiness?  What strategies are effective for promoting 
language and literacy development in young children?

o What are effective mental health services and interventions for children and 
their families who are experiencing poverty?  Which mental health prevention 
models are appropriate and effective for children who live in impoverished 
conditions?  Are there innovative interventions for mental health problems for 
children and families who are living in poverty?

Child care

o What type of child care arrangements do low-income parents make for their 
children?  How do quality of care and type of care interact with home factors, 
and how do these interactions affect child outcomes?  How do children in 
multiple child care arrangements fare in comparison to children in single 
child care arrangements?  How do parents balance their own needs with the 
needs of their children when choosing child care?

o What is the quality of care that is purchased by low-income families with 
the help of subsidies? How does the use of subsidies affect the quality, 
safety, and stability of care that children receive? Do parents who receive 
child care subsidies make different choices regarding the type and quality of 
care for their children than low-income parents who do not receive subsidies? 

o Given that many children experience multiple child care arrangements, as 
well as multiple caregivers, what role do secondary caregivers play in 
children’s physical, social, cognitive, and emotional development?  How do 
children who spend their time in different child care settings of different 
quality differ from those children who spend their day in more stable 
environments?  How does kinship involvement in child care vary by cultural and 
ethnic group?  How do secondary caregivers influence development at different 
developmental stages?  How do different child care arrangements and kinship 
networks interact with family, neighborhood, and community characteristics to 
affect children’s outcomes? 

Research Designs and Data Sources

The utilization of existing data is encouraged for its cost-efficiency 
whenever scientific goals can be met by its use.  There is a wide range of 
such data collected in the U.S. and available for research purposes.  Each 
data set has its particular strengths and weaknesses, which the investigator 
must understand and deal with.  Such resources include, but are not limited 
to, the Study of Income and Program Participation, Panel Study of Income 
Dynamics, and the National Longitudinal Survey of Youth.  Researchers may be 
aware of, and have access to, other data that are appropriate for answering 
the questions they wish to address.  For a description of these various 
datasets please see http://www.nichd.nih.gov/cpr/dbs/resources.htm.

New data collection is justifiable if existing data are not appropriate to the 
aims of the proposed study.  In such cases, scientific sampling procedures are 
highly desirable to ensure that sample biases do not vitiate the research 
objectives.  Prior contact with the program staff listed under INQUIRIES, 
below, is strongly encouraged for any applicant considering such an effort.  
Applicants proposing new data collection are encouraged to make their data 
available for use by other researchers and should outline plans for 
accomplishing this in the application.

Applicants proposing research that draws on social scientific approaches that 
have not been widely applied to research on poverty and child development are 
particularly encouraged to apply. Collaborations involving anthropologists, 
historians, economists, sociologists, political scientists, epidemiologists, 
and psychologists may be needed to advance theoretical and methodological 
approaches to the study of children’s developmental trajectories.  Therefore, 
applicants are encouraged to consider research designs which are innovative, 
integrative of multiple perspectives, and which utilize, as appropriate, a 
range of methods and analytic techniques. 

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.  These initiatives encourage the 
participation 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.  Applications should include in the budget 
development sufficient funds to support travel for the Principal Investigator 
to one three-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. 

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and 
their subpopulations must be included in all NIH-supported biomedical and 
behavioral research projects involving human subjects unless a clear and 
compelling rationale and justification are provided 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 research involving human subjects should read the 
 NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research,  published in the Federal Register of March 28, 1994 (FR 59 
14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 
11, March 18, 1994, and available at:
http://grants.nih.gov/grants/guide/notice-files/not94-100.html. 

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH 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 or 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," published in the NIH Guide for Grants and 
Contracts, March 6, 1998, and available at:
http://grants.nih.gov/grants/guide/notice-files/not98-024.html. 

Investigators also may obtain copies of these policies from the program staff 
listed under INQUIRIES.  Program staff also may provide additional relevant 
information concerning the policy.

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.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 
(revised 4/98) and will be accepted at the standard application deadlines as 
indicated in the application kit.  These forms are available at most 
institutional offices of sponsored research, on the Internet at 
http://grants.nih.gov/grants/funding/phs398/phs398.html, and from the Division 
of Extramural Outreach and Information Resources, National Institutes of 
Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 
301-435-0714, E-mail:  grantsinfo@nih.gov. 

Application Instructions:  Interactive Research Project Grant (IRPG) 
Applications

A description of the Interactive Research Project Grant may be found at: 
http://grants.nih.gov/grants/guide/pa-files/PA-96-001.html. 

An IRPG group consists of the coordinated submission of two or more 
applications for related research project grants (R01) that do not require 
extensive shared physical resources. Although these applications must describe 
the objectives and scientific importance of the collaboration, each project 
must be capable of being accomplished independently.  The Principal 
Investigators may be from one or more institutions.  Each application will be 
reviewed independently for scientific merit and those judged to have 
substantial merit will be considered for funding both as an independent award 
and as a component of the proposed IRPG group.

A separate application must be prepared by each participating 
institution/Principal Investigator.  It is important that all applications 
comprising the IRPG group cite this PA on line 2 of the application face page 
(see below).  

Application Instructions:   Modular Grant Applications

The modular grant concept establishes specific modules in which direct costs 
may be requested as well as a maximum level for requested budgets.  Only 
limited budgetary information is required under this approach. The just-in-
time concept allows applicants to submit certain information only when there 
is a possibility for an award. It is anticipated that these changes will 
reduce the administrative burden for the applicants, reviewers, and NIH staff. 
 The research grant application form PHS 398 (revised 4/98) is to be used in 
applying for these grants, with the modifications noted below.

Applications will request direct costs in $25,000 modules, up to a total 
direct cost request of $250,000 per year. (Applications that request more than 
$250,000 direct costs in any year must follow the traditional PHS 398 
application instructions.)  The total direct costs must be requested in a
ccordance with the program guidelines and the modifications made to the 
standard PHS 398 application instructions described below:

o  FACE PAGE:  Items 7a and 7b should be completed, indicating Direct Costs 
(in $25,000 increments up to a maximum of $250,000) and Total Costs [Modular 
Total Direct plus Facilities and Administrative (F&A) costs] for the initial 
budget period.  Items 8a and 8b should be completed indicating the Direct and 
Total Costs for the entire proposed period of support.

o  DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD:  Do not complete Form Page 4 
of the PHS 398.  It is not required and will not be accepted with the 
application.

o  BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT:  Do not complete the 
categorical budget table on Form Page 5 of the PHS 398.  It is not required 
and will not be accepted with the application.

o  NARRATIVE BUDGET JUSTIFICATION:  Prepare a Modular Grant Budget Narrative 
page.  (See http://grants.nih.gov/grants/funding/modular/modular.htm for 
sample pages.)  At the top of the page, enter the Total Direct Costs requested 
for each year.  This is not a Form Page.

Under Personnel, list key project personnel, including their names, percent of 
effort, and roles on the project.  No individual salary information should be 
provided.  However, the applicant should use the NIH appropriation language 
salary cap and the NIH policy for graduate student compensation in developing 
the budget request.

For Consortium/Contractual costs, provide an estimate of Total Costs (Direct 
plus F & A) for each year, each rounded to the nearest $1,000.  List the 
individuals/organizations with whom consortium or contractual arrangements 
have been made, the percent effort of key personnel, and the role on the 
project.  Indicate whether the collaborating institution is foreign or 
domestic.  The total cost for a consortium/contractual arrangement is included 
in the overall requested modular direct cost amount.  Include the Letter of 
Intent to establish a consortium.

Provide an additional narrative budget justification for any variation in the 
number of modules requested.

o  BIOGRAPHICAL SKETCH:  The Biographical Sketch provides information used by 
reviewers in the assessment of each individual’s qualifications for a specific 
role in the proposed project, as well as to evaluate the overall 
qualifications of the research team.  A biographical sketch is required for 
all key personnel, following the instructions below.  No more than three pages 
may be used for each person.  A sample biographical sketch may be viewed at: 
http://grants.nih.gov/grants/funding/modular/modular.htm.

- Complete the educational block at the top of the Form Page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on 
research projects ongoing or completed during the last three years;
- List selected peer-reviewed publications, with full citations.

o  CHECKLIST:  This page should be completed and submitted with the 
application.  If the F&A rate agreement has been established, indicate the 
type of agreement and the date.  All appropriate exclusions must be applied in 
the calculation of the F&A costs for the initial budget period and all future 
budget years.

o  The applicant should provide the name and telephone number of the 
individual to contact concerning fiscal and administrative issues if 
additional information is necessary following the initial review.

Submission Instructions

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

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)

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established PHS referral 
guidelines.  Applications will be evaluated for scientific and technical merit 
by an appropriate scientific review group convened in accordance with the 
standard NIH peer review procedures.  As part of the initial merit review, all 
applications will receive a written critique and undergo a process in which 
only those applications deemed to have the highest scientific merit, generally 
the top half of applications under review, will be discussed, assigned a 
priority score, and 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. Each of these 
criteria will be addressed and considered in assigning the overall score, 
weighting them as appropriate for each application. Note that 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.

(1) 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? 

(2) 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?

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

(4) 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)?

(5) 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?

In addition to the above criteria, in accordance with NIH policy, all 
applications also will be reviewed with respect to the following criteria:

 o The adequacy of plans to include both genders, minorities, and their 
subgroups as appropriate for the scientific goals of the research.  Plans for 
the recruitment and retention of subjects also will be evaluated.

o  The reasonableness of the proposed budget and duration in relation to the 
proposed research.

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

AWARD CRITERIA

Applications will compete for available funds with all other recommended 
applications. The following will be considered in making funding decisions:  
Quality of the proposed project as determined by peer review, availability of 
funds, and program priorities.

INQUIRIES

Inquiries are encouraged. The opportunity to clarify any issues or questions 
from potential applicants is welcome.

Direct inquires regarding programmatic issues to:

Natasha Cabrera, Ph.D.
Demographic and Behavioral Sciences Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B13, MSC 7510
Bethesda,  MD 20892-7510
Telephone:  301-496-1174
FAX:  301-496-0962 
E-mail:  cabreran@exchange.nih.gov 

Cheryl Boyce, Ph.D.
Developmental Psychopathology and Prevention Branch
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6200, MSC 9617
Bethesda, MD 20892-9617
Telephone:  301-443-0848
FAX:  301-480-4415
E-mail:  cboyce@nih.gov 

Direct inquiries regarding fiscal matters to:

Mr. Michael Loewe
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17, MSC 7510
Bethesda, MD  20892-7510
Telephone:  301-496-5481  
FAX:  301-402-0915
E-mail:  ml70m@nih.gov 

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance Nos. 
93.864 (Population Research), 93.865 (Research for Mothers and Children), and 
93.121 and 93.242 (NIMH).  Awards are made under authorization of Sections 301 
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and 
administered under NIH grants policies and Federal Regulations 42 CFR 52 and 
45 CFR Parts 74 and 92.  This program is not subject to the intergovernmental 
review requirements of Executive Order 12372, or to Health Systems Agency 
review.

The PHS strongly encourages all grant and contract recipients to provide a 
smoke-free workplace and promote the non-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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