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Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov)

Components of Participating Organizations
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov)

Title: Eunice Kennedy Shriver NICHD Cooperative Multicenter Neonatal Research Network (U10)

Announcement Type
February 23, 2015 - This RFA has been reissued as RFA-HD-16-020.
This is a reissue of RFA-HD-04-010.

Request For Applications (RFA) Number: RFA-HD-10-003

Catalog of Federal Domestic Assistance Number(s)
93.865

Key Dates
Release Date: January 29, 2010
Letters of Intent Receipt Date: May 1, 2010
Application Receipt Date: June 1, 2010
Peer Review Date(s): October/November 2010
Council Review Date(s): January, 2011
Earliest Anticipated Start Date: April 1, 2011
Additional Information to Be Available Date (Url Activation Date): May 2010
Expiration Date: June 2, 2010

A workshop on this FOA will be held in conjunction with the Pediatric Academic Societies Meeting April 30, 2010 in Vancouver, British Columbia. The presentation will be available online ( http://www.nichd.nih.gov/RFA/HD-010-003/Workshop.htm)

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, Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
D. Application Assignment
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. Resource Sharing Plan(s)
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

Purpose

The National Institute of Child Health and Human Development (NICHD) invites applications from investigators willing to participate with the NICHD under a cooperative agreement in an ongoing multicenter clinical program designed to perform interventional and observational clinical studies in newborn infants, particularly low birth weight infants. The model of multi-site clinical centers for research is the gold standard for conducting clinical research. The objective of this program is to facilitate the advancement of neonatal care by establishing a network of academic centers that, by rigorous patient evaluation using common protocols, can study the required numbers of patients and can provide answers more rapidly that individual centers acting alone.

The infrastructure is set up for the ideal randomized double-blinded placebo controlled and management trials with the ability to follow short term (clinical effect) and long term (neurodevelopmental outcome) measures. The infrastructure is also set up for observational, longitudinal studies in the neonatal intensive care unit setting. Many randomized clinical trials involve the need for baseline information regarding disease incidence and outcome, which is available from the generic database of neonates 22-28 weeks gestational age in the current Neonatal Research Network. This initiative will foster the conduct of multicenter trials in the neonatal population.

The NICHD Program Staff will assist Principal Investigators of the Neonatal Research Network (NRN) and the Advisory Board in identifying research topics of high priority, and in designing and implementing protocols in the evaluation of optimum management in the areas targeted for research. It is anticipated that up to 18 clinical centers will be involved in the program.

Background

The primary objective of the Neonatal Research Network (NRN) is to advance the field of Neonatal-Perinatal Medicine by establishing and maintaining a network of academic centers that perform multi-center clinical protocols in a rigorous manner to investigate the safety and efficacy of treatment and management strategies to care for newborn infants, including low birth weight infants.

In an attempt to respond to the need for well-designed clinical trials in neonatal medicine, NICHD established a Neonatal Research Network in 1986. Seven university units were selected from among respondents to an RFA. The Network Steering Committee, which consists of representatives from each Clinical Center, NICHD staff, and data center staff, evaluated several controversial issues for study. It then selected certain priority areas in which to develop protocols for randomized clinical trials. Protocols on the prevention of sepsis, intraventricular hemorrhage (IVH), pulmonary hypertension, surfactant administration, and outcome and resource requirements for very low birth weight (VLBW) infants were initiated. In addition, the Network established a generic database of infants less than 1,500 grams at birth. During the second grant period of the Neonatal Research Network (1991-1996), clinical trials were initiated on the prevention or treatment of chronic lung disease, IVH, retinopathy of prematurity (ROP), and persistent pulmonary hypertension with 12 clinical centers. Studies of VLBW maturity and postnatal growth, the sequelae of the fetal drug exposure, and a standardized follow-up program also were initiated. During the third Neonatal Research Network funding period (1996 2001), IVH, retinopathy of prematurity, the treatment of persistent pulmonary hypertension, parenteral glutamine, indomethacin, erythropoietin, inhaled nitric oxide, postnatal steroids, ventilation management strategies, and outcome at follow-up were addressed with 14 clinical centers. During the fourth cycle (2001-2006), 16 clinical sites performed studies in the areas of necrotizing enterocolitis, inhaled nitric oxide, whole body cooling for asphyxia, benchmarking practices for bronchopulmonary dysplasia, phototherapy for extremely low birth weight infants, continuous positive airway pressure (CPAP) in the delivery room, candida infections, neonatal infections, pneumococcal vaccine in very low birth weight infants, and follow up of high risk infants. In the fifth cycle (2006-present), 16 clinical sites performed studies in the areas of CPAP and surfactant, oxygen saturation, early onset sepsis, candida infection, whole body cooling for hypoxic ischemic encephalopathy (HIE), amplitude integrated electroencephalogram for infants with HIE and preterm infants, school age follow up of the whole body cooling cohort of infants, pK studies of inositol, outcomes of extremely preterm infants, management of hypotension in late preterm and term infants, hypotension in extremely low birth weight (ELBW) infants, neuroimaging of ELBW infants, necrotizing enterocolitis, and follow up outcomes.

Scope

There are a number of controversial issues in neonatology that might be clarified by multicenter collaborative research. Funded Principal Investigators will cooperate with the NICHD Program Scientist in identifying research topics of high priority and in designing protocols appropriate to the evaluation of superior or even optimal management in these areas. The participating Neonatal Research Network members will be designated as Clinical Centers which will recruit, assess and treat subjects under the supervision of the respective Clinical Center Principal Investigator. The data center, which is funded under a separate FOA, will have primary responsibility for data management and analysis for Network research in collaboration with the Steering Committee.

Ongoing studies in the NRN include:

1.Inositol for prevention of retinopathy of prematurity

2.Randomized trial of surgical treatment consisting of peritoneal drainage versus laparotomy for necrotizing enterocolitis with perforation.

3.Randomized trial of cooling versus normothermia for hypoxic ischemic encephalopathy at 6-24 hours of age

4.Randomized trial of longer and deeper cooling for HIE

5.Generic Data Base (GDB)

6.Follow Up Study

The NICHD expects to enable the Network to initiate new protocols within the first two years of the next award period. The topics of these protocols will be decided cooperatively by the Steering Committee with advice from the Advisory Board. Areas of potential projects include but are not limited to:

Observational studies of areas where little or no evidence is available for clinical management (to include but not limited to infants born at the threshold of viability, nutrition, late preterm infant, infection, medical devices) or areas where there are gaps in knowledge

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 Cooperative Clinical Research U10 award mechanism award mechanism(s).

The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) 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". At this time, it is not known if this FOA will be reissued.

2. Funds Available

NICHD intends to commit approximately $5.6 million in total costs in FY2011 in response to this FOA. Up to 18 new and/or competing continuation grants are anticipated to be funded. The expected direct cost amount for individual awards is limited to up to $200,000 per year. Protocol-related expenses will be allocated to the Clinical Sites by the Data Coordinating Center during the post award period.

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 IC(s) 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.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

Organizations should have academically-oriented divisions of neonatology and a minimum of 500 admissions per year in the neonatal intensive care unit. No more than 30 percent of infants should be outborn. Large perinatal services will be given preference over combined services composed of small inborn unit(s) with a large transfer population. The need for continuous and active communication among sites dictates that only institutions in the United States are eligible to apply.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the 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

Number of Applications. Applicant organizations may submit one application only in response to this FOA.

Resubmissions. Resubmission applications are not permitted in response to this FOA.

Renewals. Renewal applications are permitted in response to this FOA.

The NICHD invites applications both from current members of the NRN Network (competing renewal applications) and from prospective members (new applications). The items under Section IV.6 must be addressed satisfactorily for an applicant to be eligible for consideration as a Network site.

Section IV. Application and Submission Information

1. Address to Request Application Information

The current 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) 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 PHS 398 application forms and in accordance with the PHS 398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html).

Applications must be prepared using the 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 in item (box) 2 only 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: May 1, 2010
Application Receipt Date: June 1, 2010
Peer Review Date(s): October/November 2010
Council Review Date: January, 2011
Earliest Anticipated Start Date: April 1, 2011

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 in Section IV.3.A.

The letter of intent should be sent to:

Rosemary D. Higgins, MD
Pregnancy and Perinatology Branch
Center for Developmental Biology and Perinatal Medicine
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH)
6100 Executive Boulevard, Room 4B03, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: 301-496-5575
Fax: 301-496-3790
Email: [email protected]

3.B. Sending an Application to the NIH

Applications must be prepared using the forms 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:

Director, Division of Scientific Review
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH)
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: 301-496-1485
Fax: 301-402-4104

3.C. Application Processing

Applications must be received on or before the application receipt date) described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute. Incomplete and/or 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 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 or renewal award if such costs: 1) are necessary to conduct the project, and 2) 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 renewal 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

In addition to the information under Section III. Eligibility Information, 3. Other-Special Eligibility Criteria, applicants must include the following in the application:

PHS398 Research Plan Component Sections

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, with the following additional requirements:

Academic Productivity

Provide evidence of research productivity by the clinical center in previous or ongoing clinical trials, especially those of a cooperative or multicenter design. Contributions in key areas of research development and design, patient recruitment, retention and study completion, data collection and analysis, and track record of publications should be included in the application.

Applicants who are current Neonatal Research Network members should describe their participation and contribution to the network in detail including patient enrollment in studies, involvement in trials and their particular contribution to the trials (principal investigator at site, trial subcommittee), standing subcommittee activities including chairmanship or vice chairmanship, and publications. New applicants must describe their recent experience and participation in randomized clinical trials. Specific roles (principal investigator, participating site, steering committee, writing committee, trial design and development) should be described for each study. Publications should be listed that resulted from participation in the studies.

Neonatology Staffing

Participants must be based at a level III/IV neonatal intensive care units that admits inborn and outborn infants. There must be at least four full time, board certified in neonatal perinatal medicine, academically oriented neonatologists. A complete description of the neonatal staff's training and qualifications in clinical care and research is required. Participation in clinical trials and clinical research should be highlighted. The principal investigator should be a practicing neonatologist and should describe his/her clinical, research, administrative and academic commitments. One neonatologist must be designated as an alternate principal investigator who is able to serve in the absence of the PI. Appropriate biographical sketches should be submitted with the application for the alternate PI and site neonatologists participating in NRN studies. Sites with neonatology staff at more than one clinical center must provide evidence of collaboration on recent trials including publications resulting from these studies.

Population Available for Clinical Trials

Applicant clinical centers must have at least 500 admissions per year. No more than 30 percent of admissions should be outborn. In order to provide peer reviewers with the specific neonatal population available for study at the clinical site(s), include information regarding admissions over the designated two-year period (2008-2009) in tabular format:

For sites with more than one clinical center, please include each site's information in a separate column. Large perinatal centers are ideal and may be given preference over multi-site arrangements. If a multi-site center has a long standing, well-documented collaboration and interaction among institutions, this should be clearly stated in the application including the investigator responsible at the collaborating site. Management plans including supervision, training, in-service, certification, data handling, quality assurance, cost effective management, and communication are required for centers with > 1 clinical site.

Eligibility and enrollment in previous clinical trials should be included in the application. Ability to recruit, retain and follow up infants in clinical trials and observational studies is critical to being an effective member of the NRN.

In addition, the patient population served by the NRN must be characterized by demographics, obstetric parameters, and payment status. Indications must be given of the proportions of various subgroups, including minorities that have been eligible and actually have been randomized in previous or current clinical trials.

In addition, centers with ongoing clinical trials should report those patients eligible for NRN studies (not competing with institutional research).

Maternal Fetal Medicine Unit

The clinical center should be located in an institution with a maternal fetal medicine service for delivery of high-risk pregnancies. Perinatologists should be active in clinical research and a history of collaboration between Neonatology and Perinatology towards excellent clinical care, database accessibility, and research productivity should be included in the application. The application should include a letter of collaboration along with a biographical sketch of a maternal fetal medicine collaborator. The application must include in tabular form the following information from 2008-2009 detailing maternal population for potential neonatal studies:

If the institution submits applications in response to both the Neonatal Research Network FOA and the Maternal Fetal Medicine Unit FOA (RFA-HD-10-008), the applicant must describe how the two research programs will be integrated.

Subspecialty Information

In the upcoming cycle of the NRN, two studies requiring specific subspecialty involvement are approved and will be underway.

The inositol for retinopathy study requires ROP final outcome information. A description of collaboration with ophthalmology to insure availability for examination and procedures for obtaining outpatient eye exams must be included in the application.

A randomized trial of laparotomy versus peritoneal drain for necrotizing enterocolitis with perforation is in progress. Applicants should detail involvement and willingness of Pediatric Surgeons and Neonatologists to participate in this ongoing randomized trial of surgical intervention in the NRN.

Follow-Up Program

An established neonatal follow-up program with experience in tracking and retaining patients must be in place at the clinical site. A minimum of 80 percent follow up rate at 18-22 months corrected gestational age is required. For infants enrolled in observational studies and clinical trials with primary or secondary outcome of 18-22 month follow-up, a follow-up rate of 90% is highly desirable. The number of clinic visits in 2008 and 2009 need to be included in the application, as well as criteria for follow-up (e.g. LBW, ELBW, neurological issue, ECMO, etc.) and post conceptual age at which the children are seen in clinic visits. A designated facility for follow up must be in place at the clinical center. Applicants should describe in detail mechanisms in place to insure compliance and assistance with neonatal follow-up including procedures for identifying infants for follow-up while in the nursery, maintaining contact with families, scheduling appointments, actions taken for missed appointments, home visit appointments including staff participating in home visits, and creative measures instituted at the site to insure excellence in follow-up rates and compliance with clinical research study protocols. There must be a follow-up investigator (can be the PI) designated in the application with an included biosketch. The follow-up portion of the clinical capabilities must include expertise in performing Bayley Developmental assessments, neurological examinations, and hearing and vision assessments. The current system of follow-up assessment including data collection, population demographics, compliance rates, schedule of follow-up visits, funding sources, policies and procedures for conducting research in the follow-up setting and appropriate specialist involvement in the follow-up program should be delineated in the application.

Currently, the NRN has two protocols with school age follow up (6-7.5 years of age). Information regarding longer term follow-up of infants enrolled in clinical trials must be provided in the application.

Perinatal Data System

An established electronic perinatal data system must be in place to collect and analyze patient information. A detailed description of variables collected, quality control, and management of the data system must be provided. An illustration of the use of the system for a recent clinical research application should be included in the application. All successful applications must provide complete, accurate and timely transmission of data to the Neonatal Research Network Data Coordinating Center. Applicants should describe their process for responses to data entry edits and queries should they be necessary.

Research Staff

A full time research staff member must be designated for the coordinator position. Additional research staff should be available, as many protocols require patient recruitment at night and on weekends. Plans for availability for staff must be included in the application. The individual staff training, experience, qualifications, and prior involvement in clinical research should be described in the application.

Intent to Participate

There must be a clearly expressed intent to participate in a cooperative manner with other NRN clinical centers, the NICHD and the data coordinating center in all aspects of research as outlined in this FOA. NRN projects are given priority at awarded clinical sites; a statement that NRN protocols will be given priority must be included in the application. The application must contain information describing the available population for the NRN trials. If there are ongoing or pending studies/trials that will limit availability of patients for NRN trials, these must be described for the review panel s consideration at the time of review. Sites are expected to participate in all trials unless they describe trials that currently conflict with ongoing network trials as part of their application for this FOA.

Steering Committee meetings are held in the Washington, DC metro area four times per year. The PI or designee is required to attend the meetings in their entirety.

Departmental and Institutional Commitment

The departmental and institutional commitments to participate in NRN research should be clearly documented with letters of support from appropriate individuals. Evidence of past support can also be cited. Support in areas of grants management, personnel management; space allocation, procurement, equipment as well as general support of the research should be described as well as evidence of past research support.

Acceptance of the Budgetary Mechanism (see also budget preparation below)

Assurance of cooperation with the policy for capitation of research costs for each individual protocol should be provided from the departmental and institutional offices of sponsored research programs. The appropriate Federal cost policies and regulations governing NIH grant programs will be applied (see NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).

Clinical Capabilities

The applicant clinical center is expected to have a full range of perinatal subspecialists, clinical capabilities and support staff, including an active research coordinator. A detailed description of the clinical attributes of the Neonatal-Perinatal Program must be provided. This should include antenatal fetal testing, intrapartum diagnosis, laboratory testing, availability of subspecialists, and perinatal pathology. Other institutional components related to the NRN must also be described. In particular, the neonatal intensive care unit(s) and ambulatory facilities for follow up care must be presented, including the established policies and procedures for conducting clinical research in these facilities. Also, the availability of an institutional pharmacy and respiratory therapy capable of supporting clinical research must be documented. A description of whether, and how, policies and procedures may have been modified to support clinical research in the past must be provided.

A clinical research coordinator must be designated for a full time position.

Capabilities for patient recruitment on nights and weekends must be outlined in the application.

Concept Proposal

To provide peer reviewers and the NICHD an idea of capabilities of investigators, a concept proposal for a project for the Neonatal Research Network submission should be described briefly (two to three pages maximum). A proposal including hypothesis, specific aim(s), background, methods, and data analysis (including a consideration of power) for potential conduct in the NRN must be provided in the application. The proposed "concept" will serve as an indicator of the applicant's ability to participate in the development and design of cooperative protocols in the network. The "concept" needs to be appropriate for the NRN in that it requires a multicenter design. The "concept" or another design on the same topic may or may not actually be performed in the network. It is anticipated that funded NRN centers will be invited to submit the "concepts" included in their application to the Steering Committee.

The "concept" should also demonstrate use of the applicant's perinatal data system to estimate numbers of available patients eligible for the protocol at the institution. In addition, the protocol should address relevant ethical issues and the appropriate inclusion of minorities as subjects.

Special Strengths of the PI or Institution

Applicants are encouraged to describe special or unique strengths that may be relevant to NRN research. This can include state-of-the art scientific capabilities such as modern imaging techniques, proteomics, genomics, micro analysis, genetics, clinical pharmacology, respiratory therapy, and so forth, which may be shared or may be available to develop and expand the scientific productivity of the NRN.

In addition, special administrative strengths or experience as well as participation in administrative aspects of clinical research (institutional review board, data safety monitoring committee, advisory board for clinical research, clinical research committees and so forth) should be highlighted. Level and support of clinical trials can be described.

Applications from institutions that have a Clinical and Translational Science Award (CTSA) funded by NIH or other funded perinatal-neonatal research centers as resources for conducting the proposed research should provide a letter of agreement that identifies the level and type of support from the PI or the CTSA program director.

Budget Preparation

The instructions for the budget requests provided with the research grant application (PHS 398) should be followed. F&A costs will be awarded in the same manner as for research project grants. Budgets will be reviewed on the basis of appropriateness for the work proposed. Allowable costs and policies governing the research grants programs of the NIH will prevail. In planning the budget section of your application, each applicant should submit the base budget estimates for all years.

The first year budget at the time of application will be limited to a BASE BUDGET with maximum allowances as follows:

The base budget direct costs are limited to $200,000 for the first year.

The Data Coordinating Center will be responsible for issuing payments for the NRN Network-approved protocol expenses. To receive reimbursements, a funded clinical site must set up an agreement with the DCC.

Participating sites will be required to accept protocol budgets for those studies underway in the Network. Clinical site researchers are encouraged to assist in the development of protocol budgets. The protocol budgets will consist of specific protocol-related allowances, capitated per subject enrolled in each study.

The clinical site Principal Investigator or designee will be required to help the DCC manage protocol costs. The PI or designee should propose estimates of recruitment efforts for each protocol to the DCC and update these at least annually.

The DCC may establish a recruitment limit. If a clinical site investigator believes that their site is able to exceed the limit then permission to do so must be obtained from the DCC.

Each NRN clinical site will be awarded base costs (as listed above) from the NICHD. For future years, the requested amount for the base award will be limited to $200,000.

The clinical sites F&A rates on the initial competitive awards will not be adjusted in future years due to changes in their negotiated rate agreements.

Total funding for clinical sites depends on the base awards and reimbursements for approved protocol-related expenses from the DCC. The overall provision of money for the NRN Network is subject to the availability of NICHD funding.

Budget Component

This FOA uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

The data sharing plan should be in accordance with current NRN Policies.

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

Review Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NICHD and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? How productive were the PI/PD and other investigators at the institution?

Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Are appropriate populations available and is there evidence of commitment to prioritize NRN studies? Does the application demonstrate willingness to work and cooperate with other NRN sites and the NICHD in a manner summarized in this FOA?

Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Are there additional administrative strengths, such as affiliations with other research units?

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Qualifications and Commitment of Key Personnel

The scientific, administrative, clinical and academic qualifications of the principal investigator and the research team at the center, as well as the qualifications of the applicant institution and the institution's population to participate fully in the Neonatal Research Network

Knowledge and experience in areas relevant to the conduct of collaborative clinical research, especially randomized clinical trials, including experience in research design, in neonatal medicine.

Commitment of staff time for the satisfactory conduct of the studies.

Experience and qualifications of team members who would be responsible for data quality and management activities.

Protocols and Procedures

Quality of the unit's participation in a randomized clinical trial (new applicants) in the recent past or Network protocols during the current grant period (current Network members).

Ability to recruit, retain and follow up infants in clinical trials and observational studies is critical to being an effective member of the NRN.

Facilities and Management

Adequacy of administrative, clinical, and data organizational management facilities as described in the requirements.

Institutional assurance to provide support to the study in such areas as fiscal administration, personnel management, space allocation, procurement, planning, and budgeting.

Scientific Review of Concept Proposal

Evaluation of the concept proposal for an interventional or observational study for potential implementation in the Neonatal Research Network in terms of the quality of proposed hypotheses, specific aim(s), background, methods, and data analysis (including a consideration of power).

Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Additional Review Considerations

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.

Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Selection Process

The following will be considered in making funding decisions:

Applications recommended by the NACHHD will be considered for award based primarily on scientific and technical merit as determined by peer review of the relevant capabilities and experience to be used in executing the responsibilities of the clinical site as well as, although to a lesser extent, the evaluation of the concept proposal, which is used to demonstrate the site’s ability to formulate appropriate and timely scientific questions applicable to the network.

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 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.

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 Notice of Award 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 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 Notice of Award. 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 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 Investigator will have the primary responsibility for:

The Data Coordinating Center is funded through a separate solicitation as a cooperative agreement (U10).

All parties will agree to accept the coordinating role of the group and the participatory and cooperative nature of the group process.

The individual members will be required to project patient enrollment for a specific protocol during a specified time frame; continuation and level of funding will be based on actual recruitment.

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

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

NICHD Project Scientist

The NICHD Project Scientist will provide technical assistance and participate as one voting member of the Steering Committee. Specifically, the NICHD Project Scientist will:

  1. Assist with the identification of important areas of study.
  2. Assist in the development of study protocols.
  3. Assist in the development and review of capitation-based budgets, including the identification of study costs and special institutional needs.
  4. Assist in the review and evaluation of each stage of the program before subsequent stages are started, in conjunction with the Steering Committee and the Advisory Board.
  5. Assistance in reporting results in the community of investigators and health care recipients.
  6. Assist in the conduct of the trials, including ongoing review of progress; possible redirection of activities to improve performance and cooperation; and frequent communication with other members of the Steering Committee.
  7. Participate on the Steering Committee and all active subcommittees.

NICHD Program Official

The NICHD will appoint a Program Official, apart from the Program Scientist, who will:

  1. Carry out 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.
  2. Have the option to withhold support to a participating institution if technical performance requirements are not met.
  3. Perform other duties required for normal program stewardship of grants.
  4. Assure the scientific merit of the trials, including the option to withhold support of a participating center if technical performance requirements such as protocol compliance, enrollment targets, or randomization of subjects are not met.

Initiate a decision to modify or terminate a study based on the advice of the data center, Data Safety and Monitoring Committee, and/or Advisory Board.

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.

2.A.3. Collaborative Responsibilities (optional)

The management of the Neonatal Research Network includes committees with the following functions:

Steering Committee

A Steering Committee will be responsible for protocol development, assisted by the Advisory Board and the Data Safety and Monitoring Committee. The Steering Committee will have primary responsibility for the conduct of protocols and the preparation of publications. The Steering Committee will be composed of all Principal Investigators, one representative from the data center, and one NICHD staff. Participating NICHD staff will include the Pregnancy and Perinatology Branch NRN Program Scientist. The NRN Program Scientist will be the only voting NICHD staff member of the Steering Committee. A member of the NICHD Grants Management Branch advises the Steering Committee on funding matters. An outside chairperson, who is not participating as a Principal Investigator, will be selected by the NICHD.

Advisory Board

The Advisory Board assists the Steering Committee in the identification and prioritization of topics for perinatal research. The advisory board is selected by the NICHD and consists of individuals with expertise in clinical trials, biostatistics, epidemiology, perinatology, and neonatology, along with the Chairperson of the Steering Committee and the NRN Program Scientist. Additional members will participate based on the need for specific expertise.

Data Safety and Monitoring Committee

A Data Safety and Monitoring Committee (DSMC) monitors the safety of ongoing clinical trials. The DSMC is established by the NICHD and reports to the Director of NICHD. The DSMC is composed of individuals with expertise in clinical trial design and conduct, perinatology, neonatology, basic science, and ethics.

In addition, the NICHD Neonatal Research Network has established policies and procedures that govern its operations, including publications. These policies and procedures can be amended by the Steering Committee and the NICHD.

Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

2.A.4. Dispute Resolution

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. A Dispute Resoultion 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 dispute resolution procedure does not alter 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

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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:

Rosemary D. Higgins, MD
Pregnancy and Perinatology Branch
Center for Developmental Biology and Perinatal Medicine
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH)
6100 Executive Boulevard, Room 4B03, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: 301-496-5575
Fax: 301-496-3790
Email: [email protected]

2. Peer Review Contacts:

Director, Division of Scientific Review
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH)
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: 301-496-1485
Fax: 301-402-4104

3. Financial or Grants Management Contacts:

Grace Poe
Grants Management Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH)
6100 Executive Boulevard, Room 8A01, MSC 7510
Bethesda, MD 20892-7510
(Rockville, MD 20852 for express/courier service, non-USPS service)
Telephone: (301) 435-7011
Fax: (301) 402-0915
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.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.

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 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.

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-09-116.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.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award. For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

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 FOA 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. 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.

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