Part I Overview Information


Department of Health and Human Services

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

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

Title: Collaborative Pediatric Critical Care Research Network (U10)

Announcement Type
This is a reissue of RFA-HD-04-004.

Update: The following update relating to this announcement has been issued:

Request for Applications (RFA) Number: RFA-HD-08-025

Catalog of Federal Domestic Assistance Number(s)
93.865

Key Dates
Release Date: August 22, 2008
Letters of Intent Receipt Date: February 28, 2009
Application Receipt Date: March 31, 2009
Peer Review Date(s): June/July 2009
Council Review Date: October 2009
Earliest Anticipated Start Date: December 1, 2009
Additional Information to Be Available Date (Url Activation Date): Not applicable
Expiration Date: April 1, 2009
 
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 and Information

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 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) invites applications from investigators interested in participating with the NICHD under a cooperative agreement (U10) to initiate/continue a multi-center program designed to investigate the safety and efficacy of treatment and management strategies to care for critically ill children, as well as address the pathophysiological bases of critical illness and injury in childhood.  This network will promote the efficient development and comparison of novel critical care treatment methods and management strategies of potential benefit for children who are critically ill and/or injured.

The purpose of this Funding Opportunity Request (FOA) is to maintain infrastructure to support the Collaborative Pediatric Critical Care Research Network (CPCCRN) in the study of these problems by establishing and maintaining the infrastructure required for a network of academic centers to perform clinical trials and pertinent descriptive and translational research for children who are critically ill. This network, by rigorous use of appropriate scientific methodology, can study the required number of patients and provide answers more rapidly than individual centers acting alone.

The NICHD Project Scientist will assist the Principal Investigators of the Clinical Sites and the Data Coordinating Center, with input from the Advisory Board, in identifying research topics of high priority and in designing and implementing protocols appropriate to the Network goals and objectives.

Competition for a Data Coordinating Center (DCC) to support the network is solicited under a companion RFA-HD-08-027 using the U01 mechanism.

Background

Several convergent developments in critical care medicine, as well as in the larger medical, scientific, and national communities, led to the decision to develop a strong collaborative infrastructure in the form of a national pediatric critical care research network. In order to address this need for children, the CPCCRN was established in 2005, following the competitions announced in RFA HD-04-014 (see: http://grants.nih.gov/grants/guide/rfa-files/RFA-HD-04-004.html).  Six clinical site centers (U10 mechanism) and a Data Coordinating Center (U01 mechanism) were funded, and the Steering Committee governance described below was used.  Studies undertaken in the first cycle included parental bereavement, functional status scale development, prevention of nosocomial sepsis in children with central lines, cortisol quantification investigations in sepsis, and critical pertussis. In addition, other innovative CPCCRN research efforts are in development. These include developmental considerations in opiod tolerance and sedation practice, the application of informatics to the mechanical ventilation of children, and a variety of other foci that will benefit special needs children.

Maintenance of this network is still crucial. The intent is to support a substantial range of research activities that reach across traditional disciplinary lines, transcending customary thinking and organizational structures in order to achieve innovative research in the care of the critically ill child. Modern critical care medicine has introduced a number of principles of management and innovative methodologies without rigorous use of the controlled observation necessary for their objective evaluation. A major problem continues to be the balance between assuring prompt implementation of new technologies, procedures, treatments, and drugs, and evaluation of their safety, efficacy, and cost/risk/benefit ratios.

Indeed, because of the urgent and complex milieu of pediatric critical care medicine, care is based on limited knowledge of new modalities not subjected to critical studies prior to introduction and use. In a critically ill child, for example, an innovative idea may be tried, which, if the child’s condition improves, may rapidly start a new trend, becoming the standard of care, expected and demanded by critically ill patients, their families, and the professionals caring for them. As a result, incorporation into the arsenal of critical care therapies may be based on limited experience, with efficacy and/or safety virtually unevaluated scientifically.  As well, the longer-term sequelae of critical illness and/or injury in childhood are not well studied, either in terms of the consequences for individual children and their families, or for the larger communities into which they are re-integrated.  Mortality has become a relatively rare outcome in US pediatric critical care services, and the correlation of critical care  treatments and strategies with morbidity, development, education and reintegration consequences for children, their families, and the larger communities of school, peer groups and participation remain understudied.

Earlier attempts to address this need by the community of pediatric critical care investigators have been productive, but the tenuous nature of unfunded infrastructure and the expanding population of children with special health care needs make the continuation of the CPCCRN even more important for US children. Recent threats of bioterrorism, utilizing infectious and chemical agents to induce critical illness in diverse organ systems, and the potential for deployment of weapons systems which induce burns and trauma, have heightened the need for adequately powered studies that evaluate the efficacy and cost/risk/benefit ratios of innovative modalities and strategies in pediatric critical illness and injury. Even though such events are rare (either occurring individually or in clusters) and unpredictable, an infrastructure to conserve and analyze data in critical illness in children is essential.  This collaborative research network is an important national resource for pediatric preparedness.

Recent discoveries across a broad range of basic science, technology and translational research have greatly expanded the options for the critically ill child. Current advances in understanding of the molecular biology underlying organ system failure offer the possibility of manipulating otherwise poorly controlled processes, including inflammation, cell and organ death, and regeneration of tissues and functional organ system capacity. Modalities of mechanical ventilation, non-invasive ventilation, circulatory support, organ transplantation, and extracorporeal life support have extended therapeutic options to children previously thought to be beyond the reach of state-of-the-art therapy.

The use of less invasive techniques in neurosurgery, general, orthopedic, reconstructive, vascular, and cardiovascular surgery, as well as the implementation of newer techniques of life  support, have brought about radical changes in mortality achievable with state of the art pediatric critical care medicine. As a result, children in higher risk groups who are critically  ill and/or injured, and those who might benefit from surgical interventions once not feasible, are benefiting from critical care in increasing number.

Often, in the present context of transdisciplinary pediatric intensive care units (PICUs), children with complex illnesses, and combinations of medical, surgical, and traumatic processes are surviving to discharge. As mortality from pediatric critical illness and injury has markedly declined, survival of children with disabling residuals of the critical pathology is increasing, and chronic medical conditions have become common. In children, it is well known that such special health care needs make the risk of subsequent critical illness greater than that for age-peers who have not sustained such illness or injury.   In certain diagnostic categories, mortality rates for children remain unacceptably high and in need of research that will contribute to improved survival:  pediatric malignancy and neurotrauma are two such categories.

This collaborative clinical research network will continue to accelerate pediatric critical care research, and lead to evaluation of promising new approaches to life support and critical decision-making in complex childhood illnesses.  The heterogeneity of critically ill children makes it difficult to accumulate a large number of comparable patients in one center. Multi-center research projects, including, but not limited to, clinical trials have the potential to reduce the number of patients needed at each clinical center, and allow subject accrual and meaningful  translational and descriptive research to be completed more rapidly. Further, common treatment protocols would reduce variables that contribute to patient outcome and allow valid comparisons between treatments.

Additionally, the Network approach will continue to increase the number of comparative trials and meaningful translational descriptive studies that are conducted by providing a framework for rapid initiation of important studies as their public health significance for children becomes apparent, through the efficient use of pooled scientific and clinical expertise and data management resources.

Scope

The CPCCRN will achieve its objectives through conducting clinical trials as well as translational and descriptive studies. Therapeutic trials may involve investigational drugs, drugs already approved but not currently labeled for use in pediatric populations, as well as diverse innovative and more traditional management strategies. Patients might be randomized between different doses, as well as modes and techniques of treatment or novel treatment versus standard therapy. It is also recognized that not all prioritized studies will be clinical trials. Pilot clinical trials and adequately powered descriptive studies are essential to the development of the database necessary to conduct successful Phase III trials.  Indeed, the unique complexity of multiple organ system failure in the young and the pathophysiology that precedes or precipitates it, is not well understood.

Some examples of research appropriate for this FOA include, but are not limited to, the following subject areas. Applicants are not limited to the subjects highlighted below, and are encouraged to submit proposals for other studies pertinent to the objectives of the FOA.  Prospective applicants are strongly encouraged to discuss their ideas with the program staff listed under Section VII. Agency Contacts.

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 U10 award mechanism.

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 the present time, it is not known whether this FOA will be re-issued.

The NICHD expects that ongoing studies will continue at the existing CPCCRN sites. New protocols may be implemented before the start of continuation.  Centers that join the Network for the first time in the next award period (beginning December 1, 2009) will participate in protocols ongoing at that time. The NICHD intends to enable the Network to initiate new protocols within the first year of the next award period.  The topics of these studies will be decided cooperatively by the CPCCRN Steering Committee (described below) with advice from the Advisory Board and NICHD.

2. Funds Available

The NICHD intends to commit approximately $2.5 million in FY 2010 to fund up to six to eight new and/or competing continuation awards in response to this FOA for Clinical Sites, in addition to 1 new or competing continuation award for the DCC, competed separately (RFA-HD-08-027). An applicant for a Clinical Site may request a project period of 5 years and a budget for direct costs associated with base costs up to $185,000 per year. Future year amounts will depend on annual appropriations. CPCCRN patient and protocol costs, and support for the support of required monitoring, Data Safety Monitoring Boards and Advisory Board meetings are administered through the DCC that supports the Network.

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:

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.

Principal Investigators for the Clinical Sites must be fully qualified pediatric intensivists located in a department or division of pediatric critical care medicine in a research-intensive setting.

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a “team science” approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application.  Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Applicants are not permitted to submit a resubmission application in response to this FOA.

Competing Renewal applications from existing CPCCRN sites will be permitted for this FOA.

Applicants may not submit more than one application in response to this FOA.

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 in item (box) 2 only of the face page of the application form and the YES box must be checked.

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs 

When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a – 3h for all PD/PIs. NIH requires one PD/PI be designated as the “contact PD/PI” for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the “Contact PD/PI, et. al.” The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled “Multiple PD/PI Leadership Plan” must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators. 

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

Additional information is available in the PHS 398 grant application instructions.

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 28, 2009
Application Receipt Date: March 31, 2009
Peer Review Date(s): June/July 2009
Council Review Date: October 2009
Earliest Anticipated Start Date: December 1, 2009

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity.

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:

Carol Nicholson, MD, MS
National Center for Medical Rehabilitation Research (NCMRR)
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH)
6100 Executive Boulevard, Room 2A03, MSC 7510
Bethesda, MD 20892 -7510 (US Postal Service Express or regular mail)
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301) 435-6843
Email: nicholca@mail.nih.gov

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:

Robert Stretch, Ph.D.
Director, Division of Scientific Review
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 5B01D, MSC 7510
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-1485
Fax: (301) 402-4104
Email: stretchr@mail.nih.gov

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 and Information

Pre-Application Workshop

An informational pre-application workshop addressing the scientific and administrative issues associated with this initiative will be held on December 3, 2008 in the Bethesda, MD area.  The purpose of this workshop is to 1) familiarize the potential applicant with established NIH guidelines and criteria for review, (2) discuss the areas of NICHD programmatic emphasis, and (3) facilitate the submission of a well-organized application.

Interested applicants should contact Dr. Carol Nicholson (see INQUIRIES) or Ms. Tammara Jenkins (jenkinst@mail.nih.gov) to request further details. Individuals planning on attending are requested to submit specific questions to Dr. Nicholson at least one week in advance of the workshop.  Attendance at the workshop is not required to submit an application in response to this announcement.

I. Organization and Governance of the Collaborative Pediatric Critical Care Research Network

The Collaborative Pediatric Critical Care Research Network will be a collaborative network of six to eight Clinical Centers, one Data Coordinating Center, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Clinical Centers will be responsible for proposing protocols that are appropriate and feasible for adoption by the Network, guiding protocol development, enrolling patients, analyzing results, and disseminating research findings. All Clinical Centers will be required to participate in a cooperative and interactive manner with one another and with the DCC. Divisions and departments of pediatric critical care medicine have the option to form a consortium and apply as a single entity for a Clinical Center award. In the case of a consortium, there will be one Principal Investigator who will serve on the Steering Committee (see below) and represent the other centers, and the maximum base award direct costs per year will be limited to $185,000.

A centralized DCC will support the activities of the Network. The functions of the DCC will include developing protocol data management aspects, devising novel comparative study designs, providing sample size calculations and statistical advice, developing data forms and protocol tools, performing data analyses, coordinating the activities of the Steering Committee, Protocol Review Committee, and Data and Safety Monitoring Board, and overall study coordination and quality assurance.

In addition, in order to hasten accrual in Network studies, at the discretion of the vote of the Steering Committee (see below), the DCC, along with NICHD and the site Principal Investigators, will have the responsibility to identify qualified and interested investigators at non-Network centers who wish to enroll patients in these studies. Arrangements for data collection and reimbursement of trial-related data collection costs at non-Network centers will be the responsibility of the DCC.

A Steering Committee will be the main governing body of the Network and will be composed of the Principal Investigators of each Clinical Center, the DCC Principal Investigator and the NICHD Project Scientist (see below).  The Chairman of the Steering Committee will not be one of the Principal Investigators, and will be appointed by NICHD, and will vote in case of ties in matters before the Steering Committee. The structure and role of the Steering Committee are described below under Cooperative Agreement Terms and Conditions of Award.

An External Advisory Board will annually attend one of the Steering Committee meetings each year, in order to assess overall progress toward Network goals and to advise NICHD and CPCCRN in prioritization of resources.  At a minimum, the advisory board will consist of a parent of a child who has survived critical illness and injury and has special health care needs and/or disability, three pediatric scientists in pediatric acute care, including at least one pediatric surgeon.  The NICHD Project Scientist (see below), the Network Steering Committee Chairman and the DCC PI will also attend the separate meeting of the advisory board annually, held in conjunction with the Steering Committee meeting.

The costs of travel to Washington DC (up to six times per year) for the Principal Investigator should be included in the application budget request. In addition, funds should be budgeted to provide for travel of the research coordinator and alternate PI to a minimum of two of the Steering Committee meetings per year. 

Data collection will be monitored in a manner consistent with NIH\NICHD Policy for Data and Safety Monitoring (http://www.nichd.nih.gov/funding/datasafety.htm).  A Data and Safety Monitoring Board (DSMB) will monitor Network studies, and will be created for each trial requiring a DSMB individually. As a part of its monitoring responsibility, the DSMB will submit recommendations to NICHD regarding the continuation of each study in its purview, and prepare a report for Principal Investigators to provide to their institutional review boards (IRBs). Funding for the functioning of the DSMB and the CPCCRN External Advisory Board will be provided through the protocol funds part of the award to the DCC.

It is anticipated that each protocol will be implemented in all of the Clinical Centers. As specific protocols are developed, support will depend on the availability of funds, and per patient (capitation) funding available. All the Clinical Site Centers must be willing to pursue this funding arrangement for each new protocol conducted. Centers that do not enroll patients in CPCCRN protocols or do not collaborate in the scientific development activities of the CPCCRN may not receive continuing support at the discretion of the Program Officer. Clinical protocols must be approved by local IRBs, and Clinical Center sites will be supported in this effort by the CPCCRN DCC.

The exact number of protocols supported in the five-year program will depend on the nature and extent of the investigations proposed by the Steering Committee. Both short-and longer-term projects will be considered for prioritization and implementation.

Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A, "Award Administration Information".

Research Plan Page Limitations

Clinical Site Applications

Scope of Activities: CPCRRN Clinical Sites

Applications may be submitted from organizations located in the United States of America. This geographic constraint is necessary because of the need for continuous close communication among members of the program, the requirement for frequent Steering Committee meetings, and the necessity of site visits for data verification and performance monitoring.  Applicants must be based in a multidisciplinary pediatric intensive care unit (or units), in an academically oriented department of pediatric critical care medicine, that admits both medical and surgical patients, and has a minimum of 1000 annual admissions to the pediatric intensive care unit, and the ability to follow children comprehensively for up to two years after discharge from intensive care.

The following items should be addressed satisfactorily for an applicant to be eligible for consideration as a Network Clinical Site.  The Research Plan section should include the following information:  (1) Description of relevant capabilities and experience to be used in executing the responsibilities of the clinical site and (2) Concept proposal.  The Concept proposal is limited to 10 pages.  Both (1) and (2) must be included within the 25 page limit for the Research Plan, as specified in the application instructions.  Applicant sites must meet the minimum requirements described below in order to be considered responsive to this FOA.

Minimum Requirements for Clinical Sites

This information should be provided in tabular format, with the following headings:  

Additional tabular summaries should be included that clearly summarize:  

(For applicants with more than one clinical site, please include each component site’s information in a clearly identified separate column.)

Larger tertiary centers are ideal and may be given preference over multi-site arrangements. If a multi-site center or consortium of centers has a long-standing and productive collaboration and interaction among institutions this should be clearly stated in the application. Eligibility information across the consortium or multi-site center, and especially enrollment information in previous trials and descriptive studies should be included.

Description of Capabilities:  Clinical Sites

Include descriptions of clinical site capabilities relevant to the following:

Concept Proposal: Clinical Site

To provide peer reviewers and the NICHD an idea of the investigators’ capabilities, a concept proposal for potential conduct in the CPCCRN should be described.  The concept proposal should describe one (and only one) study including hypothesis, specific aim(s), background, methods, data analysis (including a consideration of power, sample size and feasibility), and consideration of potential drawbacks in the study design and how to address them.  The concept proposal should estimate numbers of patients potentially eligible for the protocol at the applicant’s institution, and then extrapolate that number to a theoretical five other institutions.  For example, if the applicant’s institution would have 40 eligible subjects a year for the proposed study, the study and power calculations should be carried out for five such centers, or 200 subjects.  In addition, the protocol should address relevant ethical issues and the appropriate inclusions of minorities as subjects. 

The concept proposal is limited to a maximum of 10 pages.  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.  Randomized trials and other study designs may be considered as relevant to the research question and its significance in pediatric critical care medicine.  The concept should be appropriate for the CPCCRN in that the scientific approach and results would best be achieved in a multi-center design.  The concept proposal or another study design on the same topic may or may not actually be performed in the CPCCRN.  It is anticipated that Clinical Sites selected for awards may choose to bring their concept proposals to the CPCCRN Steering Committee for consideration.

Budget Preparation: Clinical Site Applicants

The instructions for the budget requests 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.  Allowable costs and policies governing the research grants program of the NIH will prevail. In planning the budget section of your application, each Clinical Site Applicant should submit the BASE BUDGET with maximum allowances as follows:

Because multidisciplinary collaboration at the investigator level is so critical to the success of CPCCRN, base support for investigators is provided at a level not to exceed the levels specified above. The Principal Investigator must request a minimum of 20 percent effort; it has been our experience that PI effort less than 20 percent is inadequate to meet the needs of the Network for oversight, leadership and collaboration in Network activities.  The PI is responsible for naming an alternate PI, and determining the salary support of the alternate PI and the follow-up PI, not to exceed 20 percent in total.

The base budget direct costs are limited to $185,000 for the first year.

Clinical Sites should NOT provide a budget for the concept proposal in their application.

When a Clinical Site application has been recommended by the peer review panel for further consideration, the applicant will be required to accept protocol budgets for those studies underway in the Network, and to participate in the planning of protocol budgets for studies under development in the Network. The protocol budgets will consist of specific protocol-related allowances, capitated per subject enrolled in each study at the applicant Clinical Site.  Funding from NICHD at the time of award will consist of the base budget as described above; the DCC will be responsible for issuing per protocol payments to the Clinical Sites for each study.

Participation in Studies

It is the intent of the NICHD in supporting this network that multiple trials and descriptive studies will be conducted during the five-year project period. It is anticipated that initially, one clinical trial will be selected from the studies proposed by the successful applicants; this may be continuation of the present activities of the Network.  However, a decision to fund a particular Clinical Center will not commit the Network to develop that center’s study protocol. Nevertheless, awardees must agree to actively enroll patients in at least one Network trial and/or descriptive study in the first year after the awards competed in this FOA begin. Applicants should plan that, after the first year, at least three studies will be enrolling patients each year.

Appendix Materials

All paper PHS 398 applications 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 of the Research Plan component. 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: Not Applicable

(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/.

Section V. Application Review Information


1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

Only the review criteria described below will be considered in the review process.

2. Review and Selection 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:

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.

The following will be considered in making funding decisions:

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, and weighted 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 meritorious 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?  

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? For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs?

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 PD/PI(s) and other key personnel 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 PD/PI(s) and investigative team bring complementary and integrated expertise to the project (if applicable)? 

Qualifications and commitment of key personnel: Are the scientific, administrative, clinical and academic qualifications of the Principal Investigator, the research team, and the research coordinator appropriate for the CPCCRN? Does the applicant institution reflect appropriate ethnic diversity in the CPCCRN? Do the key personnel have the knowledge and experience in areas relevant to the conduct of collaborative clinical research in pediatric critical care, including both randomized clinical trials and well designed observational studies, with experience in research design and leadership? Is the commitment of staff time satisfactory for the conduct of Network activities? Do the team members responsible for subject recruitment, enrollment, data collection and data management have the necessary qualifications?

Experience with Protocol and Procedures: Is there evidence of the quality of the Clinical Site’s participation in randomized clinical trials or seminal observational and translational studies in the recent past (for new applicants) or Network protocols during the current grant period (for current Network members)? Is there evidence of successful multidisciplinary research collaborations? Is there demonstrated willingness to work and cooperate with the other CPCCRN Centers, the DCC and the NICHD in a manner summarized in this RFA? Is there documented institutional assurance to provide support to the Network in such areas as fiscal administration, personnel management and staffing, space allocation, procurement, planning and budgeting?

Environment:  Do(es) the scientific environment(s) 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? 

Scientific Review of the concept proposal: Is an evaluation of the concept proposal (for a randomized interventional trial or an observational study that would be significant for pediatric critical care medicine) utilizing the Collaborative Pediatric Critical Care Research Network (CPCCRN) presented? Does such evaluation assess the quality of proposed hypotheses, specific aim(s), background, methods, data analysis (including a consideration of power, sample size, and feasibility), and consideration of potential drawbacks in study design and execution and how to address them?

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 rating:

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 on Human Subjects in the PHS 398 instructions).

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 on Human Subjects in the PHS 398 instructions).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five points described in the Vertebrate Animals section of the Research Plan will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: 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. Resource Sharing Plan(s)   

When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.

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 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 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

In collaboration with the other awardees and with assistance from the NICHD Project Scientist, the Principal Investigators will have primary responsibility for:

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

The individual Principal Investigators of each site will be required to project subject enrollment for specific protocols during a specified time frame; continuation and level of funding will be based on actual enrollment.

The Principal Investigator will have the primary responsibility for design and execution of CPCCRN studies, supervision of personnel, interaction with Institutional Review Boards, interaction with site grants management officials, and for collaboration and cooperation with the other Clinical Site Center PIs, the Steering Committee, NICHD, and the DCC.

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.

NICHD Project Scientist Responsibilities

An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

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

Specifically, the NICHD Project Scientist will:

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 Officer Responsibilities

2.A.3. Collaborative Responsibilities

The Steering Committee will be the main governing body of the CPCCRN and will have primary responsibility for developing research protocols by consensus, supervising the conduct of the studies, and reporting results.  The Steering Committee will consist of the Principal Investigators

(one from each Clinical Site), the Principal Investigator of the DCC, and the NICHD Project Scientist. Each full member will have one vote. An outside chairperson, who is not participating as an investigator, will be selected by the NICHD to serve as chair in conducting the agendas and meetings, and to vote in case of tie. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee. A member of the NICHD Grants Management Branch advises the Steering Committee on funding matters.  Subcommittees will be established by the Steering Committee, as deemed appropriate.  The CPCCRN 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. Awardees will be required to accept and implement the common protocols and procedures approved by the Steering Committee.

Advisory Board

The Advisory Board assists the Steering Committee in the identification and prioritization of topics for pediatric critical care research.  The Advisory Board is selected by the NICHD and consists of individuals with expertise in clinical trials, biostatistics, epidemiology, and pediatric critical care.  Additional members with may be appointed based on the need for specific expertise.  A parent of an affected child will also serve on the Advisory Board.

Policies and Procedures

In addition, the CPCCRN 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.  Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

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. The NICHD-appointed Chairperson will vote in the case of a tie vote.  All major scientific decisions will be determined by majority vote of 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

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:

Carol Nicholson, MD, MS
National Center for Medical Rehabilitation Research (NCMRR)
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH)
6100 Executive Boulevard, Room 2A03, MSC 7510
Bethesda, MD 20892 -7510 (US Postal Service Express or regular mail)
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301) 435-6843
Email: nicholca@mail.nih.gov

2. Peer Review Contacts:

Robert Stretch, Ph.D.
Director, Division of Scientific Review
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 5B01D, MSC 7510
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-1485
Fax: (301) 402-4104
Email: stretchr@mail.nih.gov

3. Financial or Grants Management Contacts:

Bryan S. Clark, M.B.A.
Chief Grant Managements Officer
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 8A01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301) 435-6975
FAX: (301) 402-0915
Email: clarkb1@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy 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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