Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Funding Opportunity Title

Collaborative Pediatric Critical Care Research Network (UG1)

Activity Code

UG1 Clinical Research Cooperative Agreements - Single Project

Announcement Type

Reissue of RFA-HD-08-025

Related Notices

  • April 10, 2014 - See Notice NOT-HD-14-013. Pre-Application Meeting/Webinar scheduled for this RFA.

Funding Opportunity Announcement (FOA) Number

RFA-HD-14-022

Companion Funding Opportunity

RFA-HD-14-020, U01 Research Project – Cooperative Agreements

Number of Applications

Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.865

Funding Opportunity Purpose

This funding opportunity announcement (FOA) invites applications from institutions proposing to serve as Clinical Sites in NICHD's multi-center Collaborative Pediatric Critical Care Research Network (CPCCRN).  The research network is designed to investigate the efficacy of treatment and management strategies to care for critically ill and injured children, as well as to better understand the pathophysiological bases of critical illness and injury in childhood.

Key Dates
Posted Date

March 20, 2014

Open Date (Earliest Submission Date)

May 2, 2014

Letter of Intent Due Date(s)

May 2, 2014

Application Due Date(s)

June 2, 2014, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June/July 2014

Advisory Council Review

October 2014

Earliest Start Date

December 1, 2014

Expiration Date

June 3, 2014

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description


Purpose

This FOA invites applications from institutions proposing to serve as Clinical Sites in NICHD's multi-center Collaborative Pediatric Critical Care Research Network (CPCCRN).  The research network is designed to investigate the efficacy of treatment and management strategies to care for critically ill and injured children, as well as to better understand the pathophysiological bases of critical illness and injury in childhood.

The purpose of this Funding Opportunity Announcement (FOA) is to maintain infrastructure to support the Collaborative Pediatric Critical Care Research Network (CPCCRN), a network of academic centers, to perform clinical trials and descriptive and translational research for children who are critically ill and/or injured.  Rigorous use of appropriate scientific methodology, deployed across the network, will achieve the numbers of patients required to provide answers more rapidly than individual Sites acting alone.

The NICHD Project Scientist will assist the  (PDs/PIs) 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-14-020 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.  The CPCCRN was established in 2005, with funding provided to six Clinical Centers (U10 mechanism) and a Data Coordinating Center (U01 mechanism), following the competitions announced in RFA-HD-04-004 and RFA-HD-04-015. The CPCCRN RFAs were reissued for a second funding cycle in 2008, funding seven Clinical Centers (U10 mechanism) and a Data Coordinating Center (U01 mechanism) via RFA-HD-08-025 and RFA-HD-08-027.

Studies undertaken by the CPCCRN to date have included parental bereavement, functional status scale development, outcome predictions in pediatric critical care, prevention of nosocomial sepsis in children with central lines, cortisol quantification investigations in sepsis, critical asthma, developmental considerations in opioid tolerance and sedation practice, the application of informatics to the mechanical ventilation of children, a core data registry project, critical pertussis, the evaluation of the quality of cardiopulmonary resuscitation (CPR) efforts in pediatric intensive care units (PICUs), and anticoagulation monitoring practices during extracorporeal life support.  In addition, other innovative CPCCRN research efforts are in development, including sepsis phenotyping and the impact of extracorporeal life support on the pharmacokinetics of certain antibiotics.  The CPCCRN also works collaboratively with multicenter clinical trials funded by the NIH, such as the NHLBI-supported Therapeutic Hypothermia After Pediatric Cardiac Arrest (THAPCA) trial, and NIGMS supported studies of the genetic pathogenesis of critical pertussis illness.

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 and injured child.  Contemporary critical care medical and surgical practice in pediatric intensive care units (PICUs) 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 consequences of critical illness and/or injury in childhood are not well studied, either 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 relationship of critical care treatments and strategies to morbidity, development, and the reintegration barriers for children, their families, and the larger communities of school and peer groups remain understudied.

Earlier attempts to address this need by the communities of pediatric critical care and surgical 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 crucial for the health of U.S. children, especially those with special needs.  Further, 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, reconstructive, vascular, and cardiovascular surgery, as well as the implementation of newer techniques of life support, have brought about radical reductions 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.

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 critical illness and injury is increasing, and chronic medical conditions have become more common in children of all ages.  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 research network will continue to accelerate pediatric critical care research, leading 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 at a single site.  Multi-site research projects, including, but not limited to, clinical trials have the potential to reduce the number of patients needed at each Clinical Site, and allow subject accrual and meaningful translational and descriptive research to be completed more rapidly.  Further, common treatment protocols have the potential to reduce the effect of variables that contribute to patient outcome, allowing for 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.

Areas of Research Interest

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 applications for other studies pertinent to the objectives of the FOA.  Prospective applicants are strongly encouraged to discuss their ideas with the Scientific/Research staff listed under Section VII. Agency Contacts.

Organization and Governance of the Collaborative Pediatric Critical Care Research Network

The Collaborative Pediatric Critical Care Research Network will be a collaborative network of up to seven Clinical Sites, one Data Coordinating Center, and the NICHD.  The DCC is supported by a separate award, described in detail in RFA-HD-14-020.  Clinical Sites 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 Sites will be required to participate in a cooperative and interactive manner with one another, the NICHD and the DCC.

A centralized DCC supports the activities of the Network.  The functions of the DCC 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 the NICHD and the Clinical Site PDs/PIs, will have the responsibility to identify qualified and interested investigators at non-Network sites who wish to enroll patients in these studies.  Arrangements for data collection and reimbursement of trial-related data collection costs at non-Network sites 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 PD/PI of each Clinical Site, the DCC PD/PI and the NICHD Project Scientist (see below).  At the discretion of the NICHD, a Network Steering Committee Chairperson may be appointed.  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 the CPCCRN in prioritization of resources.  At a minimum, the Advisory Board will consist of a parent of a child who has survived critical illness or injury, and three pediatric scientists in pediatric acute care, including at least one pediatric surgeon.  The NICHD Project Scientist (see below) and the DCC PD/PI will also attend the separate meeting of the Advisory Board annually, held in conjunction with the Steering Committee meeting.

A Data and Safety Monitoring Board (DSMB) will monitor Network interventional studies, and will be created individually for each trial requiring a DSMB.  As a part of its monitoring responsibility, the DSMB will submit recommendations regarding the continuation of each study in its purview, and prepare a report for PD(s)/PI(s) 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 administered by the DCC).

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 study may 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 Site will not commit the Network to develop that Site's study protocol.  Nevertheless, awardees must agree to actively enroll patients in at least one Clinical Network trial and/or descriptive study in the first year of the award.  Applicants should plan that, after the first year, at least three studies will be enrolling patients each year.

It is anticipated that each protocol will be implemented in all of the Clinical Sites.  As specific protocols are developed, support will depend on the availability of funds, and per patient (capitation) funding made available.  All the Clinical Sites must be willing to pursue this funding arrangement for each new protocol conducted.  Clinical Sites 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 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-long term projects will be considered for prioritization and implementation.

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New
Renewal

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NICHD intends to commit $1,800,000 in FY 2015 to fund up to seven Clinical Site awards.

Award Budget

An applicant for a Clinical Site may request a budget for direct costs up to $172,000 per year.  CPCCRN patient and protocol costs, and support for required monitoring, Data and Safety Monitoring Boards, and Advisory Board meetings are administered through the Data Coordinating Center that supports the CPCCRN.

Award Project Period

An applicant for a Clinical Site may request a project period of 5 years.

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


Eligible Organizations

Higher Education Institutions

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Applicants must be based in a multidisciplinary, research-focused 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 1,000 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.

Different (or multiple) institutions can apply as a consortium for a single Clinical Site award.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization 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.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

PD(s)/PI(s) for the Clinical Sites must be fully qualified pediatric intensivists.  For single-PD/PI applications, the PD/PI will be designated as the Clinical Site Director.   For multi-PD/PI applications, the Clinical Site Director designation will go to the Contact PD/PI. 

Because of the nature of the pediatric critical care units, the application must identify a qualified Senior/Key individual who can serve as an Alternate Clinical Site Director, able to provide Clinical Site leadership in the absence of the Clinical Site Director.  The person designated as the Alternate Clinical Site Director must be a fully qualified pediatric intensivist, or, if appropriate to the expertise and research expertise at an applicant site, a pediatric surgical researcher (general pediatric surgery, burn, trauma or neurological surgical expertise).  The Alternate Clinical Site Director may be one of the named PD(s)/PI(s) on a multiple  PI application.

2. Cost Sharing

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

3. Additional Information on Eligibility


Number of Applications

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed..

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information


1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

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.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

The letter of intent should be sent to:

Valerie Maholmes, PhD, CAS
Telephone: 301-496-1514
Fax: 301-480-0230
Email: maholmev@mail.nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed. 

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed , with the following additional instructions:

A Base Budget estimate for the Clinical Site should be included for all years. (Note:  Clinical Sites should NOT provide a budget for the "concept" proposal in their application).  The first year Base Budget will be limited to $172,000 in direct costs with allowances as follows:

After an applicant has been selected for award as part of the CPCCRN, the Clinical Site 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 protocol fund payments to the Clinical Sites for each study.

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

Each CPCCRN Clinical Site will be awarded base costs (as listed above) from the NICHD.  The Clinical Site's F&A rates on the initial competitive awards will not be increased 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 CPCCRN is subject to the availability of NICHD funding.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.  

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy:  Applicants must present satisfactory evidence for all of the following capabilities:

Applicants must provide evidence of research productivity by the Clinical Site in previous or ongoing clinical trials or descriptive studies of seminal importance in the field of pediatric critical care medicine, especially those of a cooperative or multi-center design. If a multi-site center or consortium of centers has a long standing and productive collaboration and interaction among institutions, this should be clearly described in the application.  Contributions in the key areas of research development and design, patient recruitment, retention and study completion, data collection and analysis, and track record of publications generated in collaborative activities should be included in the application.

Applicants who are current CPCCRN 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 (PD/PI at Clinical Site, trial subcommittee/working group), subcommittee activities and publications.

New applicants must describe their recent experience and participation in randomized clinical trials, preferably of a multi-center nature.  Specific roles (PD/PI, 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.

Describe the proposed staffing for the Clinical Site.  Staffing should include at least four full-time board-certified, academically oriented pediatric intensivists in a department of pediatric critical care medicine that admits both medical and surgical patients, and accepts transfers from outside facilities, including emergency departments, and pediatric inpatient services in the community setting. 

The PD/PI must be a fully qualified pediatric intensivist who is able to make a substantive, long-term commitment of effort to Network responsibilities.  His/her clinical, academic, administrative, and research time commitments, and availability for CPCCRN research and management activities, should be clearly stated in the application.

The application must identify a qualified individual to be designated as the Alternate Clinical Site Director.  This individual must be able  to act on behalf of the Clinical Site in the absence of the PD/PI, and must be able and willing to travel to the Steering Committee meetings a minimum of two meetings per year.  The Alternate Clinical Site Director may be a pediatric intensivist or, if appropriate to the expertise and research expertise at an applicant site, a pediatric surgical investigator (pediatric trauma, burn, neurological or general pediatric surgery).  The application must describe a leadership plan that includes the respective roles and responsibilities of the Clinical Site Director and the Alternate Clinical Site Director.

The application should describe additional multidisciplinary expertise available at the institution for the research undertaken in this program, including (but not limited to) the areas of pediatric critical care medicine, pediatric surgical critical care, pediatric trauma, biostatistics, bioengineering, pediatric neurology and child development, pediatric rehabilitation, informatics, immunology, pulmonology, cardiology, pharmacology, therapeutic development, and clinical trials management.  Provide an explanation of how this expertise will be coordinated by Clinical Site leadership.

The capacity to collaborate with trauma specialists and capture data relevant to pediatric critical injury is required for all applicants, and will be central in the review of the proposed Site's qualifications; no applications will be considered where the ability to consult with trauma specialists and capture pertinent trauma/injury data is not evident.

A full-time Research Coordinator who is qualified by training, background and research experience, should be clearly identified and included in the biographical sketch section of the application.  Additional research staff should be available, as many network protocols require patient recruitment at night and on weekends, so evidence of coverage will be needed to ensure maximal site participation.  The application should describe plans for training staff and managing their responsibilities and activities.

The nature of the pediatric critical care population available for clinical research must be clearly defined.  Applicant Clinical Sites must have at least 1,000 admissions per year.  No more than 30 percent of such admissions may be transfers from other facilities.  In order to provide peer reviewers with the relevant characteristics of the specific pediatric critical care population available for study at the applicant Clinical Site, include information regarding admissions over the designated two year period of January 1, 2011, to January 1, 2013.  For applicants with more than one Clinical Site, please include each Consortium Site's information in a clearly identified separate section.  If there are ongoing or pending studies/trials that will limit availability of patients for CPCCRN trials, these must be described for the review panel's consideration at the time of review.

The following information should be provided in tabular or other format:

Additional tables or summaries should be included that clearly describe:

Evidence of commitment to following children after discharge from the Pediatric Critical Care Unit (PICU) must be prominent at all CPCCRN Clinical Sites.  Data supporting the fact that at least 60% of patients discharged from the pediatric critical care service at the Clinical Site receive follow-up care at the site (or its satellite clinics) over the two years following discharge should be provided.  The NICHD goal and standard for follow-up of subjects is 80%; Clinical Sites closer to this percentage may be preferred over other applicants.  This information should be provided in tabular format, according to the diagnostic criteria above, and should be generated by a search of the Clinical Site's own database or records.  Include the percentage in each diagnostic category of children followed as outpatients in any of the Clinical Site's services, over the two years following PICU discharge.

An established electronic data system must be in place to collect and analyze patient information.  A detailed description of the 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 applicants, as a condition of the award, must provide complete, accurate and timely transmission of data to the CPCCRN Data Coordinating Center.  Applicants should describe their processes for responses to data entry edits, queries and audits.

There must be a clearly expressed intent to participate in a cooperative and collaborative manner with other CPCCRN Clinical Sites, the NICHD and the Data Coordinating Center in all aspects of research as outlined in this FOA.  Clinical 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.

The applicant Clinical Site is expected to have a full range of pediatric subspecialists, state-of-the-art facilities, clinical capabilities, and excellent support staff.  Laboratory facilities, imaging capabilities, research pharmacists, and qualified staff in nursing and respiratory therapy are essential requirements that should be documented in the application.

Applicants are encouraged to describe special or unique strengths that may be relevant to CPCCRN 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 CPCCRN.

In addition, special administrative strengths or experience, as well as participation in administrative aspects of clinical research (institutional review board, data and 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) or other funded pediatric critical care research centers must describe the type and amount of support available from those resources for conducting research at the CPCCRN Clinical Site.

To provide peer reviewers and the NICHD an idea of the investigators' capabilities to participate in the development and design of common protocols, a "concept" proposal for a project for the Collaborative Pediatric Critical Care Research Network submission should be described briefly (2-5 pages maximum).  A proposal including hypothesis, specific aim(s), background, methods, and data analysis (including a consideration of power) for potential conduct in the CPCCRN 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 CPCCN in that it requires a multi-site design.  This "concept" or another design on the same topic may or may not actually be performed in the network.  It is anticipated that funded CPCCRN Clinical Sites will be invited to submit the "concepts" included in their application to the Steering Committee.  The quality, appropriateness and scientific relevance of the research "concept" will contribute to the overall evaluation of the application, but will not be scored separately. 

Letters of Support: Strong institutional commitment must 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.

Letters from the Service or Division Chairperson of pediatric critical care medicine, and the Chief Operating or Executive Officer of the facility where the applicant is based, must be included in the application.  These letters must indicate support for the application and clearly state that appropriate clinical time commitments and schedule modifications will be made as needed to assure the applicant and Clinical Site's full participation in Network studies, as well as writing and administrative responsibilities as part of the Steering Committee.  Assurance of cooperation with the policy for capitation of research costs for each individual protocol should also be provided from the departmental and institutional offices of sponsored research programs. 

In addition to the letters of support from departmental and institutional leadership at Clinical Sites, letters supporting the research capabilities and activities of the Clinical Site should be included.  Support of research in areas of grants management, personnel management, space allocation, electronic data systems (hardware, software, maintenance and informatics technology), and procurement should be provided by letters from appropriate leaders of institutional component services.

The Chief Executive or Chief Operating Officer of the Clinical Site must provide a letter of assurance that staff resources in pharmacy, nursing, respiratory and administrative support and language translation will be available to support the activities of CPCCRN.

Applications from institutions that have a Clinical and Translational Science Award (CTSA) funded by NIH or other funded pediatric critical care 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 PD/PI or the CTSA program director.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

Appendix:  Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

Pre-Application Workshop

An informational pre-application workshop via webinar, addressing the scientific and administrative issues associated with this initiative, is anticipated.  The purpose of this webinar 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.

Applicants interested in the pre-application webinar should contact Dr. Valerie Maholmes (maholmev@mail.nih.gov) or Ms. Tammara Jenkins (tjenkins@mail.nih.gov) to request further details.  Individuals planning on participating in the webinar are requested to submit specific questions to Dr. Maholmes at least one week in advance of the workshop.  Participation in the workshop webinar is not required to submit an application in response to this announcement. Individual telephone consultation, separate from the pre-application meeting, is also available upon request for all interested applicants.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of 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 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 review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific 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(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, 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?  Are the scientific, administrative, clinical and academic qualifications of the PD/PI, the research team, and the Research Coordinator appropriate for 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?  Is there evidence of the quality of the investigators' 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)?

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?  Is there evidence that the Clinical Site will be a source of innovation in scientific design?

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 human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion 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 CPCCRN studies?  Does the application demonstrate willingness to work and cooperate with other CPCCRN Clinical Sites and the NICHD?

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?  Is there demonstrated willingness to work and cooperate with other CPCCRN Clinical Sites, the DCC and the NICHD? Is there demonstrated adequacy of administrative, clinical, and data organizational management facilities as described in the requirements?

Is there adequate institutional assurance to provide support to the study in areas of fiscal administration, personnel management, space allocation, procurement, planning, and budgeting?  Does the applicant institution have access to an ethnically diverse subject population?  Are there additional administrative strengths, such as affiliations with other research units, that strengthen the environment of the applicant Clinical Site? 

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Scientific Review of "Concept" Proposal

Does the "concept" proposal for an interventional or observational study in the CPCCRN demonstrate quality and research expertise as demonstrated by the hypotheses, specific aim(s), background, methods, and data analysis (including a consideration of power)?  Does the "concept" proposal indicate an understanding of how network infrastructure support might be used as a unique scientific opportunity?

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. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

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 on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Resubmissions

Not Applicable

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable

Select Agent 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; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the Eunice Kennedy Shriver National Institute of Child Health and Human Development in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Child Health and Human Development (NACHHD) Council. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information


1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.      

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) 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.

The PD(s)/PI(s) will have the primary responsibility for:

NIH staff 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:

Areas of Joint Responsibility include:

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 Dispute Resolution. A Dispute Resolution 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 regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
TTY: 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Valerie Maholmes, PhD, CAS
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-1514
Email: maholmev@mail.nih.gov

Peer Review Contact(s)

Sherry Dupere, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-451-3415
Email: duperes@mail.nih.gov

Financial/Grants Management Contact(s)

Bryan S. Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

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 Part 52 and 45 CFR Parts 74 and 92.


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