Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Administration for Children and Families (ACF), (http://www.acf.hhs.gov/)

Components of Participating Organizations
National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov)
Office of Planning, Research and Evaluation (OPRE/ACF), (http://www.acf.hhs.gov/programs/opre/)

Title: Interagency School Readiness Consortium (U01)

Announcement Type
This is a reissue of RFA-HD-03-003 which was previously released, January 3, 2003.

Request For Applications (RFA) Number: RFA-HD-07-008

Catalog of Federal Domestic Assistance Number(s)
93.865

Key Dates
Release Date:  August 9, 2007
Letters of Intent Receipt Date: February 27, 2008
Application Receipt Date: March 27, 2008
Peer Review Date(s): June-July, 2008
Council Review Date: October 2008
Earliest Anticipated Start Date: September 29, 2008
Additional Information to Be Available Date (Url Activation Date): Not Applicable
Expiration Date: March 28, 2008

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

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(s) 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. Address to Request Application Information
  2. Content and Form of Application Submission
  3. Submission Dates and Times
    A. Receipt and 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
    A. Cooperative Agreement Terms and Conditions of Award
      1. Principal Investigator Rights and Responsibilities
      2. NIH Responsibilities
      3. Collaborative Responsibilities
      4. Arbitration Process
  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

The NICHD invites applications from investigators willing to participate under a cooperative agreement in a multi-site Interagency School Readiness Consortium (ISRC) designed to perform experimental or quasi-experimental efficacy trials on integrative early childhood programmatic approaches that promote school readiness for children ages 3-5 who are English Language Learners (ELL) and at-risk for later school difficulties. The purpose of this solicitation is to increase our understanding of the types of integrative programmatic approaches that promote ELL child learning and development across multiple domains of early childhood competence, as well as those that address teacher and parent behaviors that promote ELL children’s development in these areas.  It is expected that projects will identify causal connections between specific programmatic approaches and specific ELL child competencies, and that the research studies and programs stimulated by this consortium will contribute scientific data that bear directly on a number of public policy issues and instructional practices as well as more broadly informing developmental science. 

The overall goal of the Consortium is to expand scientific knowledge relevant to improving school readiness outcomes for ELL children ages 3-5 who are at-risk for later school difficulties. Other critical goals are to: (1) contribute to our understanding of the ELL child learning and development across multiple domains of early childhood competence, including language and communication, emergent and early literacy, early mathematics, early science, self-regulation of behavior, emotion, and attention, social competency , cultural competency, and motivation to learn and (2) promote the development and adaptation of integrative early childhood programmatic approaches that specifically promote ELL children’s development in these domains, building upon the research of the first cohort of ISRC grantees. A key objective for the Consortium is to design, develop, and conduct multiple simultaneous efficacy trials that implement and evaluate evidence-based integrative early childhood programmatic approaches that are based on current research knowledge of early second-language acquisition and the promotion of school readiness skills in at-risk populations.  These studies must have the strong support of the pre-kindergarten programs from which their sample is drawn, and should be culturally appropriate. The primary endpoints in these studies must be associated with demonstrable improvement in important school readiness measures within the ELL population under study. The Consortium studies will involve a large number of ELL children in rigorously designed site-specific protocols with common observational and assessment measures, thus addressing  pressing research questions in ELL early childhood populations more quickly and efficiently than could individual researchers acting alone.

Research that is predominantly epidemiologic, such as observational studies, will not be reviewed and will be returned to the PI as unresponsive to the RFA. Applications that propose only to study programmatic approaches that narrowly target only the acquisition of the English language and do not evaluate effects across a broad range of school readiness outcome measures will also be considered as non-responsive and will be returned without review.  Applications on these topics can be submitted as investigator initiated applications through other NIH research award mechanisms. Federal Program staff will assist the PIs of the Interagency School Readiness Consortium (ISRC) to identify research topics of high priority, and to design, implement, and evaluate the impact of site-specific interventions using a common measurement protocol.

Background

According to the U.S. Census 2005 American Community Survey, a language other than English is spoken in 19.4% of American households. Of these households, 10.7% report speaking English “very well’, and 8.6% report speaking English “less than very well.”  The proportion of those reporting speaking English “less than very well” rises to 52.1% when the household members are foreign born, and 61.9% when they are foreign born and not U.S. citizens.  Driven by immigration patterns, increasing numbers of children are being raised in households where limited or no English is spoken.  According to analyses of the U.S. Department of Education’s Early Childhood Longitudinal Study – Birth Cohort (ECLS-B) dataset, the achievement gap between ELL children and their English speaking peers may begin as early as 24 months of age (http://www.nichd.nih.gov/about/meetings/2007/050807.cfm).  The ramifications of this trend are enormous.  Relative to English speakers, children who are English Language Learners (ELL) and from disadvantaged economic backgrounds are more likely to have lower levels of achievement throughout their academic career, including lower high school completion rates and lower rates of college attendance.

Since the War on Poverty in the 1960s, early childhood education programs have provided hope to families from low socioeconomic status backgrounds that a “head start” will help to boost their child’s school readiness skills, which will in turn increase the likelihood of their academic success.  Indeed, the findings of the 2005 Head Start Impact Study indicate that Head Start participation increases the school readiness skills of children who attend the program.  However, subgroup analyses revealed that when a child’s primary home language was Spanish, there was no impact on any of the measures of cognitive or social-emotional development.  Similar findings are reported by the Head Start Family and Child Experiences Survey (FACES) and the Head Start National Reporting System (NRS).  Given that approximately 27% of the children enrolled in Head Start programs are ELL, it is clear that existing programmatic approaches are not benefiting those who are at the highest risk for later school failure.  Although comparable data are not available for state pre-kindergarten programs, it is likely that they face a similar dilemma.   Under Part A, Subpart 1 of the No Child Left Behind Act (NCLB) of 2001, schools are now accountable for helping “limited English proficient children meet the same challenging State academic content and student academic achievement standards as all students are expected to meet.”   Meeting this goal will be difficult if ELL children do not master fundamental school readiness skills prior to entering kindergarten.

In 2000, two National Academy of Sciences (NAS) reports, Neurons to Neighborhoods and Eager to Learn, included recommendations highlighting the need to conduct more research on ELL early childhood populations, to understand both the origins of the achievement gap and how best to intervene with this population.   However, According to the 2006 Report of the National Literacy Panel on Language-Minority Children and Youth, few well-designed research studies have been conducted examining the efficacy of different approaches to enhancing the school readiness skills of ELL children ages 3-5.  With the notable exception of the Development of English Language Literacy in Spanish Speaking children (DELLSS) research consortium funded in 2000 by NICHD and ED (http://www.cal.org/delss/), few major research initiatives have targeted this population, and ELL children are often systematically excluded from early childhood surveys and research studies.  There are multiple reasons for this exclusion, including lack of equivalent measures in the child’s home language, difficulty in recruiting bilingual research staff to do parent interviews and child assessments, parental refusal to participate in research studies due to concerns over their immigration status, and difficulty in recruiting sufficient numbers of children within sub samples of the ELL population to perform meaningful analyses.  For example, a single classroom may have ELL children with different home languages.  Alternately, ELL children may speak the same home language (Spanish) but have emigrated from different geographic regions (e.g. Mexico, Cuba, Puerto Rico) and thus speak different dialects, have different cultural backgrounds, and have different immigration histories.

Somewhat paradoxically, there is an extensive developmental research literature on the acquisition of a second language, including findings regarding the cognitive costs and benefits of learning a second language in early childhood.  However, the children who were studied frequently come from more advantaged families, including higher socioeconomic status and levels of parental education.  Children from disadvantaged backgrounds who have not received rich stimulation in their home language may be overwhelmed with the “cognitive load” associated with learning a second language.  Similarly, there has been extensive research on education programs that target elementary school aged ELL children (http://www.whatworks.ed.gov/), but it is not clear if these approaches are developmentally appropriate for preschool aged ELL children.  Such studies have tended to focus on the type of instruction (i.e., home language only, English only, two-way immersion, and bilingual instruction), but less attention has been paid to how the efficacy of such approaches may vary with development.  Finally, much of the research on ELL children ages 3-5 has focused on the acquisition of English language skills, but has not addressed other critical school readiness skills and abilities such as emergent and early literacy, early mathematics and attention regulation.  While learning English will obviously benefit these children, they will continue to be at a significant disadvantage if they have not also mastered these other skills.

Given the increasing need for integrative programmatic approaches that promote school readiness for ELL children ages 3-5 who are at-risk for later school difficulties, the ineffectiveness of current programmatic approaches, and the relative dearth of comprehensive research studies examining interventions with this population, experimental or quasi-experimental efficacy trials testing innovative programmatic approaches are urgently needed to help improve the school readiness skills of ELL children.  A multi-site research consortium will facilitate high quality, collaborative research that can address many of issues that have deterred previous researchers while simultaneously building the field’s capacity to conduct research with ELL children, their families, and the pre-kindergarten programs they attend.

Scope

Originally funded to perform site-specific studies on a broad range of early childhood school readiness interventions, the Interagency School Readiness Consortium (ISRC) has transitioned to a cooperative multi-site research effort focused on performing experimental or quasi-experimental efficacy trials on integrative early childhood programmatic approaches that target a specific segment of the preschool population (ELL children) and employ common observational and assessment measures to more efficiently build research knowledge and address the major limitations of previous research efforts. Grantees will be part of a Consortium that will include Research sites and a Data Coordinating Center. The consortium is intended to strengthen and expand the infrastructure for ELL school readiness research. It will increase opportunities for scientific linkages, interaction, knowledge development and transfer, and collaborative partnerships among the research and early education communities.

This initiative calls for a broad array of interventional studies conducted by each site with their programmatic partner(s). The studies should address the learning environments provided by Head Start, State pre-kindergarten, and other early childhood programs that serve at-risk early childhood populations and are designed to increase the school readiness of children ages 3-5. Proposed interventions should emphasize the implementation of evidence-based, cost-effective, integrated programmatic approaches to promoting a broad range of school readiness skills that are empirically linked to later positive school outcomes. Applications primarily seeking funding support for the provision of preschool services will not be considered responsive to the RFA. Studies that involve partnerships with institutions that serve large numbers of ELL children (e.g., school districts) are of particular interest to the Consortium.

The Consortium will function as an affiliated group that fosters communication, innovation, and research excellence. Applications for site-specific research studies that are relevant to promoting the school readiness skills of ELL children ages 3-5 will be reviewed and funded under the Consortium. Grantees should expect to propose and participate in the collection of common core measurement protocols that will be utilized at all of the Consortium sites. It is anticipated that some site-specific measures will be retained because of their relationship with the intervention being proposed.  Grantees must be willing to work collaboratively with other Consortium members.

All research conducted under the auspices of the Consortium must be designed such that school readiness improvements in the study population are meaningful and likely to represent measurable and significantly improved academic outcomes that are sustained over time. Surrogate or intermediate outcomes must be well defined and scientifically well justified.

Priority will be given to scientific activities that have the greatest likelihood of improving school readiness skills in ELL children ages 3-5 who are at-risk for later school difficulties. All applicants must address the following basic parameters when describing their proposed study:

Types of Intervention to be Studied

This solicitation is intended to support experimental or quasi-experimental efficacy trials on integrative early childhood programmatic approaches that promote school readiness for children ages 3-5 who are English Language Learners (ELL) and at-risk for later school difficulties.  Programs are considered integrative they address children’s developmental needs in both cognitive and social-emotional domains.  Cognitive domains include, but are not limited to, language and communication, early and emergent literacy, early mathematics, and early science knowledge and skills.  Socio-emotional domains include, but are not limited to, social competency and the self-regulation of attention, behavior and emotion.  Designs for research programs should allow for the testing of causal relationships between specific program elements (independently or in combination) and child outcomes.

Applicants must include a conceptual and empirical rationale for their intervention strategy, including any published research or pilot data that support their approach.  Programs, strategies, curricular materials, training materials, parent guides and other materials must be ready for implementation early in the grant period, and must be available or developed during the grant period for sharing within the Consortium and potential outside dissemination.  Applicants should provide sufficient detail about the intervention, including its components and how these are designed to meet the specific needs and characteristics of ELL children ages 3-5 from at-risk backgrounds, as well as their teachers and parents.  Applicants should provide specific information about the types of materials and professional development or training opportunities required to implement their intervention, including the anticipated educational level of teachers and parents, required oral and reading ability in both English and the home language,  and plans for mentoring during the course of the preschool year.  Applicants should describe possible dissemination strategies for these materials to technical assistance providers, schools of education, and program providers.

Applications must include a letter of support from all preschool partner agencies, as well as documentation of previous research collaborations.  Applicants should thoroughly describe the intervention context prior to implementation, including both child and family demographic characteristics (including number and percent of ELL children per classroom and program), and program characteristics, including staff-child ratio, available ratings of classroom quality, education level of staff, number of bilingual teachers and aides, extent of current professional development and curriculum resources devoted to addressing the needs of ELL children, and outreach activities targeting the parents of ELL children.  Applicants should include information regarding local, state or federal policies that either promote or deter the implementation of the proposed intervention strategy.

Target Population

Although all Consortium studies will address the school readiness needs of ELL children ages 3-5 who are at-risk for later school difficulties, applications must address in detail the nature of their proposed sample, including whether the sample will include children who share a single home language (e.g., Spanish)  or if multiple home languages will be studied.  Likewise, applications must address the degree of heterogeneity that will be allowed within a single home language group regarding characteristics such as time since immigration, country of origin, parent’s English fluency, and income level.  If one or more of these characteristics are allowed to vary the application must provide evidence that their will be sufficient numbers of children in each subgroup to conduct meaningful analyses.

Research Design Considerations

The goal of this RFA is to determine the characteristics of integrative programs (e.g., approach, intensity, duration, content, and method of delivery) that are most effective in promoting the school readiness skills of ELL children ages 3-5 who are at-risk for later school difficulties.  As such, there is a need for scientifically rigorous studies that are sensitive to changes in child outcomes that are likely to occur as a result of the intervention, while simultaneously being able to control for random variation or variation due to factors other than those included in the designed intervention.  Therefore, only study designs that employ experimental or quasi-experimental designs will be responsive to the RFA.  If a quasi-experimental design is proposed a strong justification must be provided regarding why random assignment is not possible and steps that will taken to ensure the equivalence of the intervention and comparison groups at baseline.

For applications employing randomized designs, the application must specify at what level randomization will occur (e.g., child, teacher, school), the use of block randomization to increase the likelihood of equivalent groups at baseline, and the use of a shared control group (i.e., the use of a single control group for comparison with two or more intervention groups).  Regardless of the level of randomization, the application must include a power analysis that takes all of the above into account, especially the nesting of children within classrooms if randomization is done at the teacher level.

All applications must incorporate measures of intervention implementation and fidelity for use as a potential mediating variable in their analyses.  Applications must also specify how classroom activities, especially those that parallel the intervention, will be tracked in the control/comparison group.  Measurement of control/comparison group activities will allow for the assessment of spill-over effects, as well as identify shared practices that may account for null effects.

Depending on the age of the child at intervention, it is anticipated that children will be followed through at least kindergarten and first grade, if not longer.  As such, applications should anticipate the challenges inherent in tracking children as they disperse to different school systems, and describe their experience in conducting longitudinal research with this population.  Applications should specify any existing relationships with school districts or community agencies that have assisted the tracking efforts of previous studies. 

Measurement Considerations

For each measure proposed in the application, the following information should be specified: psychometric properties for the language of administration, age appropriateness of the measure, including the age range and relation to measures to be used for the longitudinal follow-up, and, if applicable, previous use of the measure and relevant research results.  In addition, applications must specify how the costs associated with implementing the intervention will be quantified and documented, as well as how these costs compare to those of the control/comparison group.  All costs, including training, materials, and ongoing mentoring and technical support must be tracked for both the intervention and control/comparison groups, as these data will allow for both cost-benefit analyses as well as provide an estimated cost for future dissemination of the intervention.

Once the Cooperative Agreement grant awards are made, the Consortium members will review the measurement protocols proposed by each site and will collaboratively arrive at a set of common, cross-site measures.  Common measures will maximize the potential for cross-study analyses, and improve our ability to draw conclusions about the efficacy of comparable interventions, as well as the efficacy of interventions on comparable populations.  It is anticipated that some site-specific measures will be retained because of their relationship with the intervention being proposed.

Consortium Organization

This RFA solicits applications for research sites to form a research consortium to conduct experimental or quasi-experimental efficacy trials on integrative early childhood programmatic approaches that promote the development of school readiness skills in ELL children ages 3-5 who are at-risk for later school difficulties. The grantees will form a cooperative consortium in scientific partnership with NICHD to conduct site-specific efficacy trials using a common measurement protocol.

Organizational Components

The Interagency School Readiness Consortium will consist of multiple Research Sites composed of multidisciplinary teams of collaborating scientists linked to program partners; a single Data Coordinating Center that will provide research support services and methodological and statistical expertise for the Consortium; the NICHD Project Scientist and Program Officer, and representatives from collaborating Federal Agencies. The Consortium may include additional consultants needed at specific time periods.

Steering Committee

The Steering Committee will serve as the Consortium's central point of communication; exchange of ideas; development, review and management of common measurement protocols; research and training activities; and problem resolution. The Steering Committee reviews all presentations and publications via the Publications Subcommittee and NICHD clearance mechanisms. The Steering Committee is composed of the PI of each Research Site, the PI of the Data Coordinating Center, and the NICHD Project Scientist, each of whom have one vote. NICHD will appoint a Chairperson from among the PIs for a minimum term of one year.  A representative from each collaborating Federal Agency will participate as a non-voting member.

The Steering Committee will meet twice annually in person and will participate in telephone or video conferences as needed between Steering Committee meetings. During the meetings, research progress and problems will be reviewed for each site.

Data Coordinating Center

The Consortium Data Coordinating Center has the responsibility to provide the Consortium's organizational, statistical, and technical support, including the shared funding of information technology staff and site training, and data collection assistance as appropriate. In addition, the Data Coordinating Center will financially support specialty consultations, specialty services, and other study needs. It also will be responsible for assisting the sites in developing and implementing common measurement protocols, implementing quality assurance procedures, including site monitoring; developing data management systems and databases; and developing analytic capacity. The Data Coordinating Center will be responsible for the creation and integrity of study databases, analytic capacity, and support of and attendance at all Consortium meetings.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the NIH Cooperative Research Project Grant (U01) award mechanism.

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

The NIH U01 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

2. Funds Available

NICHD intends to commit approximately $3 million dollars in total costs [direct plus Facilities and Administrative (F&A) costs] in FY 2008 to fund three to four new grants in response to this RFA.  An applicant may request a project period of up to five years and a budget for direct costs up to $500,000 per year.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each award will also vary. Although the financial plans of NICHD 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.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation see NOT-OD-05-004.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization 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 is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

Applicants may submit more than one application, provided each application is scientifically distinct.

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

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

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: February 27, 2008
Application Receipt Date: March 27, 2008
Peer Review Date(s): June-July, 2008
Council Review Date: October 2008
Earliest Anticipated Start Date: September 29, 2008

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

James A. Griffin, Ph.D.
Child Development and Behavior Branch
National Institute of Child Health and Human Development
6100 Executive Blvd. Suite 4B05
Bethesda, MD 20892-7510
(Rockville, MD 20852 for courier/non USPS service)
Telephone: (301) 435-2307
FAX: (301) 480-0230
Email: griffinj@mail.nih.gov  

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three 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 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Blvd., 5B01, MSC 7510
Bethesda, MD 20892-7510
(Rockville, MD 20852 for courier/non USPS service)
Telephone: (301) 496-1485
FAX: (301) 402-4104
Email: stretchr@mail.nih.gov   

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by NICHD. Incomplete and non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

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. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
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 or competing continuation 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 or competing continuation 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 NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

Applications for Interagency School Readiness Consortium (ISRC) must address the following:

Scientific Productivity

Applicants must demonstrate a capacity to develop and implement studies focused on promoting the school readiness skills of ELL children ages 3-5 at-risk for later school difficulties, and provide evidence of recent research productivity in one or more areas related to the scientific scope and objectives set forth in this RFA. Experience conducting experimental or quasi-experimental efficacy trials in preschool settings and evidence of scientific productivity in disseminating information about the results of such studies are essential, and must also be demonstrated.

Organizational Capability

Applicants should describe their research organization and that of the program partner(s), and include plans, information, and documentation that indicate their institutional or organizational capability to collaboratively accomplish the proposed research successfully.  Applicants should also describe how they will utilize other existing programmatic, scientific or government partnerships to enhance the productivity of the Consortium.

Applicants must demonstrate a multidisciplinary approach to the design and implementation of their proposed collaborative study. They should provide a list of available multidisciplinary scientists, administrators and teachers to act as consultants in the design and implementation of their site-specific intervention and the common measurement protocol. This team must be capable of conducting the described research, and must be familiar with the preschool services for ELL children and their parents at the program or in the community where the research will be conducted. Steps to ensure effective communication and cooperation across disciplines should be identified. Prior successful experience of the consultants with multidisciplinary multi-site research activities and implementation of research findings should be indicated.

History of Collaboration

Applicants must describe any relevant collaborative research activity undertaken with the proposed program partner(s).  Documentation of recruitment and retention rates in previous longitudinal research studies should be provided.  Evidence of successful research network or multi-site research activity also should be provided. Contributions and collaborations in areas such as measurement protocol design, study recruitment, data analysis and interpretation, and publication should be highlighted.

Evidence of Preschool Partner Support

Applicants must demonstrate the research partner's institutional commitment to and support for the proposed collaborative research study by including in their application letters of support indicating a willingness to participate in the proposed study and an understanding of how randomization to intervention and control/comparison groups will be made. Documentation from key administrative personnel at the preschool program institution should indicate support for research staff activities in their program. Examples of such support may include administrative staff assistance, equipment, supplies, access to free office space for assessments and interviews, etc. Applicants also should provide evidence of support for their research collaboration from the appropriate program funding authorities as appropriate.

Population Available for Experimental or quasi-experimental efficacy trials

Applicants must describe at-risk populations of ELL children ages 3-5 who are available to them to participate in the site-specific intervention described in the scope section. Investigators must demonstrate the ability to recruit eligible families from their sites with the aid of their program partner(s).

Awareness of Ethical and Cultural Issues in School Readiness Research

Applicants must demonstrate an awareness of and describe their experience with any ethical and cultural issues that should be considered in the design, implementation, analysis, and publication of research studies undertaken with ELL children ages 3-5 at-risk for later school difficulties. This includes issues related to framing of appropriate research questions, recruitment and retention of study populations, informed consent and other human subject considerations, design and use of research methods and instruments, the need for appropriate fidelity monitoring, data analyses and interpretation, sustainability planning, dissemination and application of findings to benefit the study populations and the broader early childhood education community. Any relationship of the study topic to national or local early childhood education policies should be clearly explained.

Capacity for Communication

Applicants should include a description of existing and anticipated technological and staff resources for the establishment and maintenance of computer-based and other communications linkages to facilitate information and research data sharing both with site program partners and with the Consortium.

Travel

It is expected that Principal Investigators and other appropriate research staff will travel to the Washington DC area at least twice per year to attend Steering Committee meetings. Requests for funds for travel to these meetings should be included in the application budget request.  All travel must be justified in detail in the application, including the purpose of any proposed staff travel.  The terms of award will specify that NICHD approval is required prior to rebudgeting funds into or out of the travel category.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

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 the priority score.

Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and 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.

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, http://grants.nih.gov/grants/funding/2590/2590.htm). 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.

The following will be considered in making funding decisions:

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NICHD in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

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 critiques, 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. Each of these criteria will be addressed and considered in assigning the 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 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?

Does the application demonstrate a sufficient breadth of understanding of existing research related to the school readiness skills of ELL children ages 3-5 at-risk for later school difficulties and awareness of the logistical, ethical and cultural issues and concerns related to the conduct of research within this population?

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?

Does the application adequately address:

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 principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Do the PI and co-investigators have adequate experience with multi-site experimental and quasi-experimental efficacy trials conducted in preschool program settings?

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 the Research Plan, Section E on Human Subjects in the PHS Form 398).

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 the Research Plan, Section E on Human Subjects in the PHS Form 398).

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

Data Sharing Plan: 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 the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

2.D. Sharing Research Resources

NIH policy expects that grant 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/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). 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.

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.

3. Anticipated Announcement and Award Dates

Applicants may learn of the outcome of the peer review of their grant applications on or after July 15, 2008.

The earliest award date for successful grant applications will be September 29, 2008.

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 or her Summary Statement (written critique) via the 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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

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 (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the 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 Also 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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement NIH U01, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

2.A.1. Principal Investigator Rights and Responsibilities

The Principal Investigators at the Research Sites will have primary responsibility for:

• Identifying priority areas for research;

• Developing and implementing research interventions and evaluation strategies;

• Presenting research concepts, plans, progress, and results to the Steering Committee;

• Projecting child enrollment for site-specific interventions during a specified time frame; continuation and level of funding will be based on actual recruitment;

• Implementing any Consortium-approved common measurement protocols, where feasible, and the recruitment of study participants, associated data collection, and study-associated quality control measures at the study sites, in collaboration with the Data Coordinating Center;

• Obtaining local IRB approval of all study interventions and common measurement protocols implemented at program partner sites and complying with local IRBs' policies and procedures;

• Complying with Consortium policies and procedures;

• Submitting abstracts and manuscripts to the Publication Subcommittee and to NICHD for clearance;

publication and dissemination of results of both independent and shared research. When data collection is completed, publication of results in collaboration with other involved Consortium sites;

• As a shared activity with the Data Coordinating Center and NICHD, collection, analysis, and interpretation of data, publication and dissemination of research results from Consortium studies;

• Participating in conference calls and attending Consortium meetings held at least twice annually in the Washington DC area;

• Working to ensure that the results of Consortium research are disseminated to technical assistance providers, program administrators and teachers;

• Submitting annual progress reports to NICHD; and

• Providing study and program site performance information.

The Data Coordinating Center

The Data Coordinating Center will provide research support services to the Consortium. These will include, but are not limited to, the creation of a common measurement protocol, the establishment and maintenance of a centralized information management system to assist the Consortium Research Sites in collecting, editing, storing analyzing, publishing, and disseminating results from their individual projects as well as from shared research. It will assist the program staff of the NICHD and other Federal Agency partners in monitoring research progress, and will work to ensure data integrity, accuracy, and accessibility among all Research Sites. It will offer technical assistance and analytical support for all sites, as needed. 

All activities of the Data Coordinating Center must be closely coordinated with the Steering Committee Chair and NICHD Project Scientist. In support of all research projects undertaken by the Consortium, the Data Coordinating Center staff will:

• Support the activities of the Steering Committee through provision of materials/documentation support, meeting planning and logistics, and conference call coordination;

• Provide advice on study design, measurement selection, data collection, data analysis, and publication development to all Consortium Research Sites;

• Assist in the preparation, design, and dissemination of measurement training manuals, data collection forms, databases, and results reporting summaries for Consortium research projects;

• Compile monthly and quarterly subject enrollment reports, meeting summaries, and other reports as needed for the Steering Committee, NICHD, other participating Federal Agencies;

• Assure maintenance of high quality databases, supervise all data collection procedures, and arrange for the most efficient transfer of study data where indicated;

• Provide training to all Research Site personnel as needed on measurement administration, data management and analysis, quality control, and quality assurance; and

• Participate in regular conference calls and attend Steering Committee meetings;

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

2.A.2. NIH Responsibilities

An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.  Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

NICHD Project Scientist

The NICHD Project Scientist will serve as the principal representative of NICHD and NIH and will have substantial programmatic and scientific involvement that is above and beyond the normal stewardship role in awards and will, in consultation with relevant NICHD program staff and representatives of the other Federal Agency partners, provide overall programmatic oversight, coordination, and assistance to the Consortium.

Specifically, the NICHD Project Scientist will:

• Facilitate communication, cooperation, and the exchange of information among Consortium members with the Data Coordinating Center;

• Participate as a voting member of the Steering Committee;

• Consult with NICHD program staff and Federal Agency partners;

• Assist the Steering Committee in the selection and approval of important research topics and the development and review of a common measurement protocol;

• Appoint the Steering Committee Chairperson from among the Research Site PIs for a term no less than one year, and approve the formation and membership of any Steering Committee subcommittees;

• Assist in the review and evaluation of each stage of the Consortium activities before subsequent stages are started, in conjunction with the Steering Committee;

• Participate in the Steering Committee and all active subcommittees;

• Oversee site participation and performance with the support of the Data Coordinating Center; and

• Participate in study design, measurement selection, data analysis, interpretation, and publication of study results.

NICHD Program Officer

Additionally, an NICHD Program Officer will be responsible for the normal scientific and traditional programmatic stewardship of the cooperative agreement award and will be named in the award notice. This role is separate from the Project Scientist and will include the following:

• Assurance of scientific merit of the site-specific interventions, including the option to withhold support to a participating institution if technical performance requirements such as enrollment targets or experimental or quasi-experimental efficacy study procedures are not implemented;

• Continuous review of all activities to ensure that the objectives are being met and that all regulatory, fiscal, and administrative matters are handled according to NIH guidelines;

• Initiation of a decision to modify or terminate a study based on the advice of the Data Coordinating Center, with the mutual consent of the Steering Committee and at the direction of the Director, NICHD; and

• Other duties required for normal program stewardship of grants for the Consortium.

Federal Agency Partners

Other Federal Agency partner research staff may participate in Steering Committee meetings as non-voting members. Specifically, Federal Agency Partner staff will, in consultation and collaboration with the NICHD Project Scientist:

• Provide scientific and programmatic assistance to the Research Sites and Data Coordinating Center;

• Share the scientific responsibility with the Project Scientist and other Steering committee Members for defining/developing the appropriate study designs and a common measurement protocol;

• Assist in overseeing Research Site and Data Coordinating Center performance; and

• Participate, as appropriate, in data analysis, interpretation, and publication of study results relevant to the research conducted by the Consortium.

2.A.3. Collaborative Responsibilities

In addition to the above specified rights, responsibilities, and involvement, the Interagency School Readiness Consortium components have collaborative responsibilities, including membership on the Steering Committee.

Steering Committee

The Steering Committee will serve as the Consortium central point of communication; exchange of ideas; development, review and management of common measurement protocols; research and training activities; and problem resolution. The Steering Committee, through the Publication Subcommittee and NICHD clearance process, reviews all presentations and publications. The Steering Committee is composed of the PI of each Research Site, the PI of the Data Coordinating Center, and the NICHD Project Scientist, each of whom have one vote. NICHD will appoint a Chairperson from among the Research Site PIs for a minimum term of one year. Representatives of other partner Federal Agencies may participate as non-voting members.

The Steering Committee will meet twice annually in person in the Washington DC area and will participate in telephone or video conferences as needed between Steering Committee meetings. During the meetings, research progress and problems will be reviewed for each site.

The Steering Committee members will:

• Agree to accept the participatory and cooperative nature of the group process and agree to collaborate with other awardees, the Data Coordinating Center, and the NIH;

• Assist in the identification of priority research issues related to the school readiness skills of ELL children ages 3-5 who are at-risk for later school difficulties;

• Approve the development of a common measurement protocol and facilitate the training, administration and coding of these measures;

• Approve the direction of joint research efforts and facilitate the conduct and monitoring of these studies;

• Adhere to all Consortium policies and procedures;

• Review site-specific research plans and provide advice on implementation strategies;

• Identify a need and propose subcommittees to undertake specific activities or to review issues, policies, or procedures of particular interest to the Consortium, subject to the approval of the NICHD Project Scientist and the Steering Committee Chairperson; and

• Agree to accept and implement policies approved by the Steering Committee.

In addition, the Consortium Steering Committee may establish policies and procedures that govern its operations, including publication. These documents may be amended and supplemented at the discretion of the NICHD and the Steering Committee.  

2.A.4. Arbitration Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

The Data Coordinating Center will compile monthly and quarterly subject enrollment reports, meeting summaries and other reports as needed for the Steering Committee, NICHD and partner Federal Agencies.

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) 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:

James A. Griffin, Ph.D.
Child Development and Behavior Branch
National Institute of Child Health and Human Development
6100 Executive Blvd., Suite 4B05
Bethesda, MD 20892-7510
(Rockville, MD 20852 for courier/non USPS service)
Telephone: (301) 435-2307
FAX: (301) 480-0230
Email: griffinj@mail.nih.gov 

2. Peer Review Contacts:
 
Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Blvd., 5B01, MSC 7510
Bethesda, MD 20892-7510
(Rockville, MD 20852 for courier/non USPS service)
Telephone: (301) 496-1485
FAX: (301) 402-4104
Email: stretchr@mail.nih.gov   

3. Financial or Grants Management Contacts:

Bryan S. Clark, MBA  
Chief Grants Management Officer
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A01C, MSC 7510 
Rockville, MD 20852
Telephone: (301) 435-6975
Fax: (301) 402-0915
Email: clarkb1@mail.nih.gov  

Section VIII. Other Information


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).

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 the 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.

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 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 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.

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. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for 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 RFA 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


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.