and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
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/)
Title: The Science And Ecology Of Early Development (SEED) [R03]
Announcement Type
This is a reissue of PA-04-113,
which was previously released June 18, 2004, and now is divided into separate Funding
Opportunity Announcements (FOAs) for R03 and R01 grant mechanisms.
Update: The following update relating to this announcement has been issued:
NOTICE: Applications submitted in response to this FOA for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and SF424 (R&R) Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.
Program Announcement (PA) Number: PA-06-345
Catalog of Federal Domestic Assistance Number(s)
93.865,
93.279
Key Dates
Release/Posted
Date: April 12, 2006
Opening
Date: May 2, 2006 (Earliest date an application may be submitted to
Grants.gov)
Letters of
Intent Receipt Date(s): Not Applicable
NOTE: On time submission requires that
applications be successfully submitted to Grants.gov no later than 5:00 p.m.
local time (of the applicant institution/organization).
Application
Submission/Receipt Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
AIDS
Application Submission/Receipt Date(s): Not Applicable
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council
Review Date(s): Standard dates
apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest
Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information to Be Available Date (URL Activation Date): Not Applicable
Expiration
Date: November 2, 2007 (now January 8, 2008 per NOT-OD-07-093)
Due Dates for E.O. 12372
Not Applicable.
Additional Overview
Content
Executive Summary
This Funding Opportunity Announcement (FOA), 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.
Table of Contents
Part I
Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility
Information
1. Eligible Applicants
A. Eligible
Institutions
B. Eligible
Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and Submission
Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and
Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy
Requirements
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II
- Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
This Funding Opportunity Announcement (FOA), 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 FOA extends the
Science and Ecology of Early Development (SEED) initiative.
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 FOA is part of a larger collaborative effort among the following agencies: (1) U.S. Department of Health and Human Services [NICHD, National Institute of Mental Health (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 U.S. population add further complexity to the cultural environment that enfolds children growing up in the U.S. 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:
Across these and other research questions, this FOA 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.
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section
II. Award Information
1. Mechanism of Support
This
funding opportunity will use the NIH Small Research Grant (R03) award mechanism.
The applicant will be solely responsible for planning, directing, and executing
the proposed project.
This FOA uses just-in-time concepts. It also uses the modular budget formats (see the Modular Applications and Awards section of the NIH Grants Policy Statement). All applications submitted in response to this FOA must use the modular budget format. Specifically, since you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, Modular Budget Component, of the Application Guide).
Competing renewal (formerly competing continuation ) applications will not be accepted for the R03 grant mechanism. Small grant support may not be used for thesis or dissertation research. Up to two resubmissions (formerly revisions/amendments") of a previously reviewed small grant application may be submitted. See NOT-OD-05-046, April 29, 2005.
For specific information about the R03 programs, see: http://grants.nih.gov/grants/funding/r03.htm.
2. Funds Available
Because the nature and
scope of the proposed research will vary from application to application, it is
anticipated that the size and duration of each award will also vary. Although
the financial plans of the NIH Institutes and Centers (ICs) provide support for
this program, awards pursuant to this funding opportunity are contingent upon
the availability of funds and the receipt of a sufficient number of meritorious
applications.
A project
period of up to two years and a budget for direct costs of up to two $25,000
modules, or $50,000 per year, may be requested (i.e., a maximum of $100,000
over two years in four modules of $25,000 each). Commensurate F &A costs are
allowed.
F&A costs requested
by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004, November
2, 2004.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit an
application if your institution has any of the following characteristics:
1.B.
Eligible Individuals
Any
individual with the skills, knowledge, and resources necessary to carry out the
proposed research as the Project Directory/Principal Investigator (PD/PI) 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 support.
2. Cost Sharing or Matching
This program does not require
cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special Eligibility Criteria
Applicants may submit more than one application, provided each
application is scientifically distinct.
Section IV. Application and Submission Information
Registration and Instructions for Submission via Grants.gov
To download a SF424 (R&R) Application Package and
SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for
this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PD/PIs should work with their institutions/organizations to make sure they are registered in the NIH Commons.
Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Started
2) Organizational/Institutional Registration in the eRA Commons
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request
Application Information
Applicants
must download the SF424 (R &R) application forms and SF424 (R&R)
Application Guide for this FOA through Grants.gov/Apply.
Note: Only the forms package directly attached to a specific FOA can be
used. You will not be able to use any other SF424 (R &R) forms (e.g., sample
forms, forms from another FOA), although some of the "Attachment" files
may be useable for more than one FOA.
For further assistance contact GrantsInfo, Telephone 301-710-0267,
Email: [email protected].
Telecommunications for the hearing impaired: TTY 301-451-5936.
2.
Content and Form of Application Submission
Prepare all applications using the SF424 (R&R)
application forms and in accordance with the SF424
(R&R) Application Guide (MS Word or PDF).
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.
The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/ APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:
Required Components:
SF424
(R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research
& Related Other Project Information
Research
& Related Senior/Key Person
PHS398 Cover
Page Supplement
PHS398
Research Plan
PHS398
Checklist
PHS398 Modular
Budget
Optional Components:
PHS398
Cover Letter File
Research
& Related Subaward Budget Attachment(s) Form
Note: While both budget components are included in the SF424 (R&R) forms
package, the NIH R03 uses ONLY the PHS398 Modular Budget. (Do not use the detailed Research & Related Budget.)
Foreign
Organizations
Several special
provisions apply to applications submitted by foreign organizations:
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.
3. Submission Dates and Times
See Section IV.3.A for details.
3.A. Submission, Review and Anticipated Start Dates
Opening Date:
May 2, 2006 (Earliest date an application may be submitted to
Grants.gov)
Letters of
Intent Receipt Date(s): Not Applicable
Application
Submission/Receipt Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
AIDS
Application Submission/Receipt Date(s): Not Applicable
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council
Review Date(s): Standard dates
apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest
Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
3.A.1. Letter of Intent
A
letter of intent is not required for the funding opportunity.
3.B. Sending an
Application to the NIH
To submit an application
in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow
steps 1-4. Note: Applications must only be submitted electronically
PAPER APPLICATIONS WILL NOT BE ACCEPTED.
3.C.
Application Processing
Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the
applicant institution/organization) on the application submission/receipt
date(s). (See Section IV.3.A. for all dates.) If an
application is not submitted by the receipt date(s) and time, the application
may be delayed in the review process or not reviewed.
Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.
Upon receipt,
applications will be evaluated for completeness by the Center for Scientific
Review, NIH. Incomplete applications will not be reviewed.
There will be an
acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the
assignment of an application to a Scientific Review Group is also in the Commons.
The
NIH will not accept any application in response to this FOA that is essentially
the same as one currently pending initial merit review unless the applicant
withdraws the pending application. The NIH will not accept any application that
is essentially the same as one already reviewed. This does not preclude the
submission of an application already reviewed with substantial changes, but
such application must include an Introduction addressing the previous
critique. Note such an application is considered a "resubmission" for
the SF424 (R&R).
4. Intergovernmental Review
This
initiative is not subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants
Policy Statement.
Pre-Award Costs are
allowable. A grantee may, at its own risk and without NIH prior
approval, incur obligations and expenditures to cover costs up to 90 days
before the beginning date of the initial budget period of a new award if such
costs: are necessary to conduct the project, and would be allowable under the
grant, if awarded, without NIH prior approval. If specific expenditures would
otherwise require prior approval, the grantee must obtain NIH approval before
incurring the cost. NIH prior approval is required for any costs to be incurred
more than 90 days before the beginning date of the initial budget period of a
new award.
The incurrence of
pre-award costs in anticipation of a competing or non-competing award imposes
no obligation on NIH either to make the award or to increase the amount of the
approved budget if an award is made for less than the amount anticipated and is
inadequate to cover the pre-award costs incurred. NIH expects the grantee to be
fully aware that pre-award costs result in borrowing against future support and
that such borrowing must not impair the grantee's ability to accomplish the
project objectives in the approved time frame or in any way adversely affect
the conduct of the project. See the NIH Grants
Policy Statement.
6. Other Submission Requirements
The NIH
requires the PD/PI to fill in his/her Commons User ID in the PROFILE Project
Director/Principal Investigator section, Credential log-in field of the
Research & Related Senior/Key Person Profile component. The applicant
organization must include its DUNS number in its Organization Profile in the
eRA Commons. This DUNS number must match the DUNS number provided at CCR
registration with Grants.gov. For additional information, see Tips and Tools
for Navigating Electronic Submission on the front page of Electronic Submission of Grant
Applications.
Renewal (formerly competing continuation or Type 2 ) applications are not permitted.
All application instructions outlined in the SF424 (R&R) Application Guide (MS Word or PDF are to be followed, with the following requirements for R03 applications:
Note: While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
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, PDs/PIs from projects funded under the SEED initiative will be expected to engage in an interactive, collaborative process; each participating PD/PI 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
PDs/PIs 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 PD/PI 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.
Plan for Sharing Research Data
Applicants
requesting more than $500,000 in direct costs in any year of the proposed
research must include a plan for sharing research data in their application.
The funding organization will be responsible for monitoring the data sharing
policy (http://grants.nih.gov/grants/policy/data_sharing).
The reasonableness of
the data sharing plan or the rationale for not sharing research data may be
assessed by the reviewers. However, reviewers will not factor the proposed data
sharing plan into the determination of scientific merit or the priority score.
Sharing
Research Resources
NIH policy requires that grant awardee recipients make unique research
resources readily available for research purposes to qualified individuals
within the scientific community after publication (See the NIH Grants Policy
Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
The adequacy of the resources sharing plan and any related data sharing
plans will be considered by Program staff of the funding organization when
making recommendations about funding applications. The effectiveness of the
resource sharing will be evaluated as part of the administrative review of each Non-Competing
Grant Progress Report (PHS 2590). See Section VI.3.,
Reporting.
Section V. Application Review Information
1. Criteria
Only the review
criteria described below will be considered in the review process.
2. Review and Selection Process
Applications
submitted for this funding opportunity will be assigned to the ICs 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:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
The NIH R03 small grant is a mechanism for supporting discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding. Because the research plan is restricted to 10 pages, a small grant application will not have the same level of detail or extensive discussion found in an R01 application. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem, placing less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications, including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.
The goals of NIH-supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written comments, reviewers will be asked to comment on each of the following criteria 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.
Note that an 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 scientific health problem? If the aims of the application are
achieved, how will scientific knowledge or clinical practice be advanced? What
will be the effect of these studies on the concepts, methods, technologies,
treatments, services, or preventative interventions that drive this field?
Approach: Are the conceptual
or clinical framework, design, methods, and analyses adequately developed, well
integrated, well reasoned, and appropriate to the aims of the project? Does the
applicant acknowledge potential problem areas and consider alternative tactics?
Innovation: Is the project original
and innovative? For example: Does the project challenge existing paradigms or
clinical practice; address an innovative hypothesis or critical barrier to
progress in the field? Does the project develop or employ novel concepts,
approaches, methodologies, tools, or technologies for this area?
Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the PD/PI and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?
Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?
2.A.
Additional Review Criteria:
In addition to the
above criteria, the following items will continue to be considered in the
determination of scientific merit and the priority score:
Protection of Human Subjects from Research Risk: The involvement of human
subjects and protections from research risk relating to their participation in
the proposed research will be assessed. See item 6 of the Research Plan
component of the SF 424 (R&R).
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 item 7 of the Research Plan component of the SF 424
(R&R).
Care and Use of Vertebrate Animals in
Research: If vertebrate animals are to
be used in the project, the five items described under item 11 of the Research
Plan component of the SF 424 (R&R) will be assessed.
Biohazards: If materials or procedures are proposed that are
potentially hazardous to research personnel and/or the environment, determine
if the proposed protection is adequate.
2.B. Additional Review
Considerations
Budget
and Period of Support: The reasonableness of the proposed budget and the
appropriateness of the requested period of support in relation to the proposed
research may be assessed by the reviewers. Is the percent effort listed for the
PD/PI appropriate for the work proposed? Is each budget category realistic and
justified in terms of the aims and methods.
2.C. Sharing
Research Data
Data Sharing Plan: The reasonableness of the
data sharing plan or the rationale for not sharing research data may be
assessed by the reviewers. However, reviewers will not factor the proposed data
sharing plan into the determination of scientific merit or the priority score.
The funding organization will be responsible for monitoring the data sharing
policy. http://grants.nih.gov/grants/policy/data_sharing.
2.D. Sharing
Research Resources
NIH policy requires that grant awardee recipients make
unique research resources readily available for research purposes to qualified
individuals within the scientific community after publication (See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan for
sharing research resources addressing how unique research resources will be
shared or explain why sharing is not possible.
Program staff will be
responsible for the administrative review of the plan for sharing research
resources.
The adequacy of the resources sharing plan
will be considered by Program staff of the funding organization when making
recommendations about funding applications. Program staff may negotiate
modifications of the data and resource sharing plans with the awardee before
recommending funding of an application. The final version of the data and
resource sharing plans negotiated by both will become a condition of the award
of the grant. The effectiveness of the resource sharing will be evaluated as
part of the administrative review of each Non-Competing Grant
Progress Report (PHS 2590). See Section VI.3., Reporting.
Model Organism Sharing Plan: Reviewers are asked to assess
the sharing plan in an administrative note. The sharing plan itself should be
discussed after the application is scored. Whether a sharing plan is reasonable
can be determined by the reviewers on a case-by-case basis, taking into
consideration the organism, the timeline, the applicant's decision to
distribute the resource or deposit it in a repository, and other relevant
considerations. For the R03 mechanism, the presence or adequacy of a plan
should not enter into the scoring of the application.
3. Anticipated Announcement and Award Dates
Not Applicable.
Section VI. Award Administration Information
1.
Award Notices
After the peer review
of the application is completed, the PD/PI will be able to access his/her
Summary Statement (written critique) via the NIH eRA Commons.
If the application is under
consideration for funding, NIH will request "just-in-time"
information from the applicant. For details, applicants may refer to the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General.
A formal notification in the form of a Notice of Award (NoA) will be
provided to the applicant organization. The NoA signed by the grants management
officer is the authorizing document. Once all administrative and programmatic
issues have been resolved, the NoA will be generated via email notification
from the awarding component to the grantee business official.
Selection of an application for award is not an authorization to begin
performance. Any costs incurred before receipt of the NoA are at the
recipient's risk. These costs may be reimbursed only to the extent considered
allowable pre-award costs. See Section IV.5.,
Funding Restrictions.
2. Administrative and
National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants
Policy Statement as part of the NoA. For
these terms of award, see the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart
A: General and Part
II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions
for Specific Types of Grants, Grantees, and Activities.
3. Reporting
When
multiple years are involved, awardees will be required to submit the Non-Competing Grant
Progress Report (PHS 2590) annually and financial statements as required in
the NIH
Grants Policy Statement.
Section VII. Agency Contacts
We
encourage your inquiries concerning this funding opportunity and welcome the
opportunity to answer questions from potential applicants. Inquiries may fall
into three areas: scientific/research, peer review, and financial or grants
management issues:
1. Scientific/Research Contacts:
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]
Valerie Maholmes, Ph.D., CAS
Social and Affective Development/Child
Maltreatment and Violence
Child Development and Behavior Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, 4B05, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for
express/courier service)
Telephone: (301) 496-1514
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]
2. Peer Review Contacts:
Not Applicable.
3. Financial or Grants Management Contacts:
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]
Section VIII. Other Information
Required Federal Citations
Use of Animals in Research:
Recipients of PHS support for activities involving
live, vertebrate animals must comply with PHS Policy on Humane Care and Use of
Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects Protection:
Federal regulations (45CFR46) require that applications
and proposals involving human subjects must be evaluated with reference to the
risks to the subjects, the adequacy of protection against these risks, the
potential benefits of the research to the subjects and others, and the
importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative
trials (Phase III). Monitoring should be commensurate with risk. The
establishment of data and safety monitoring boards (DSMBs) is required for
multi-site clinical trials involving interventions that entail potential risks
to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for
Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include a
plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their
institutions on issues related to institutional policies and local IRB rules,
as well as local, State and Federal laws and regulations, including the Privacy
Rule. Reviewers will consider the data sharing plan but will not factor the
plan into the determination of scientific merit or the priority score.
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 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 funding opportunity 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.
Sharing of Model Organisms:
NIH is committed to support efforts that encourage
sharing of important research resources including the sharing of model organisms
for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the
application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.
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 (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 SF424 (R&R); 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 Clinical
Research:
The NIH maintains a policy that children (i.e.,
individuals under the age of 21) must be included in all clinical 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 (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 applications
for research involving human subjects and individuals designated as key
personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can
be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC
line(s)to be used in the proposed research. Applications that do not provide
this information will be returned without review.
NIH Public Access Policy:
NIH-funded investigators are requested to submit to
the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov)
at PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole or
in part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.
NIH is requesting that authors submit manuscripts
resulting from 1) currently funded NIH research projects or 2) previously
supported NIH research projects if they are accepted for publication on or
after May 2, 2005. The NIH Public Access Policy applies to all research grant
and career development award mechanisms, cooperative agreements, contracts,
Institutional and Individual Ruth L. Kirschstein National Research Service
Awards, as well as NIH intramural research studies. The Policy applies to
peer-reviewed, original research publications that have been supported in whole
or in part with direct costs from NIH, but it does not apply to book chapters,
editorials, reviews, or conference proceedings. Publications resulting from
non-NIH-supported research projects should not be submitted.
For more information about the Policy or the
submission process please visit the NIH Public Access Policy Web site at http://PublicAccess.nih.gov/ and
view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_manual.htm).
Standards for Privacy of Individually Identifiable
Health Information:
The Department of Health and Human Services (DHHS)
issued final modification to the "Standards for Privacy of Individually
Identifiable Health Information", the "Privacy Rule", on August
14, 2002. The Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the protection
of individually identifiable health information, and is administered and
enforced by the DHHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
Website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be
self-contained within specified page limitations. Unless otherwise specified in
an NIH solicitation, Internet addresses (URLs) should not be used to provide information
necessary to the review because reviewers are under no obligation to view the
Internet sites. Furthermore, we caution reviewers that their anonymity may be
compromised when they directly access an Internet site.
Healthy People 2010:
The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting
priority areas. This PA is related to one or more of the priority areas. Potential
applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is described in the Catalog
of Federal Domestic Assistance at http://www.cfda.gov/ and is
not subject to the intergovernmental review requirements of Executive Order
12372 or Health Systems Agency review. Awards are made under the authorization
of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241
and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.
All awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The NIH Grants Policy
Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a facility) in
which regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
Loan Repayment Programs:
NIH encourages applications for educational loan
repayment from qualified health professionals who have made a commitment to
pursue a research career involving clinical, pediatric, contraception,
infertility, and health disparities related areas. The LRP is an important
component of NIH's efforts to recruit and retain the next generation of
researchers by providing the means for developing a research career unfettered
by the burden of student loan debt. Note that an NIH grant is not required for
eligibility and concurrent career award and LRP applications are encouraged.
The periods of career award and LRP award may overlap providing the LRP
recipient with the required commitment of time and effort, as LRP awardees must
commit at least 50% of their time (at least 20 hours per week based on a 40
hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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