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December 13, 2006 - The R01 portion of this funding opportunity has been
replaced by PA-07-149, which now uses the electronic SF424 (R&R)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: kingros@mail.nih.gov
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: snowk@mail.nih.gov
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: jcampbel@mail.nih.gov
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: farriorl@mail.nih.gov
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: ckidd@mail.nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). Applications must have a Dun and
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the
Universal Identifier when applying for Federal grants or cooperative
agreements. The DUNS number can be obtained by calling (866) 705-5711 or
through the web site at http://www.dunandbradstreet.com/. The DUNS number
should be entered on line 11 of the face page of the PHS 398 form. The PHS 398
is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an
interactive format. For further assistance contact GrantsInfo, Telephone
(301) 710-0267, Email: GrantsInfo@nih.gov.
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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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