The purpose of this funding announcement is to invite applications to form a research network to conduct multisite clinical studies in pediatric critical care medicine. The Network will be comprised of a Data Coordinating Center (DCC) and at least seven Clinical Sites. The 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.
Deadlines:
-
Letter of Intent Due Date(s): 30 days prior to the application due date
-
Application Due Date(s): New Date August 31, 2020
RFA-HD-21-016 Expiration Date New Date September 1, 2020 per issuance of NOT-HD-20-023. (Original Expiration Date: July 31, 2020 )
The PD/PI for the PL1 application will be the PD/PI of the Data Coordinating Center. If the PL1 is submitted as a multi-PD/PI application, the DCC PD/PI should be the contact PD/PI.
Minimum Requirements for the DCC PD(s)/PI(s):
Minimal Requirements for the Clinical Sites PD(s)/PI(s):
PD(s)/PI(s) for the Clinical Sites must be board-certified pediatric critical care specialists/intensivists (MD/DO). Non-physicians holding a research doctorate (e.g. PhD) will be considered if they are able to provide descriptions of training, experience, research and publication history that affords them recognition as an academic and clinical pediatric critical care expert.
-
- · The PD(s)/PI(s) and other key personnel must have prior experience operating a DCC in multisite studies in the previous five years. Experience in planning, developing and executing pediatric studies, and the special consent and IRB procedures needed for the conduct of research in critically ill children and their families is strongly preferred.
- · The PD(s)/PI(s) must have the ability to assist in designing protocols, data collection systems, including distributed data entry, and capabilities and experience with research performance and data quality control systems.
- · The PD(s)/PI(s) should have the ability to manage and analyze data for several studies concurrently if more than one project is submitted in the application.
- · The PD(s)/PI(s) must have the ability to hold and distribute scientific protocol funds to the Clinical Sites, and to maintain accounting for such funds with regular reporting to the NICHD Program Official and Grants Management Specialist.
- · The PD(s)/PI(s) should have clinical experience in pediatrics, critical care medicine or preferably both.
Within the PL1 mechanism, Clinical Site applicants may request up to $175,000/year in direct costs for the entire project period of 5 years. Clinical Sites need not request the same amount of funding. The total budget requests for all Clinical Site applicants must not exceed $1,250,000 in direct costs per year.
The Data Coordinating Center may request a base budget up to $900,000/year in direct costs (budget must be commensurate with the proposed work) for the entire project period of 5 years. The DCC, as the responsible party for administration of protocol funds (including capitation fees) to the Clinical Sites, should request protocol funds at a minimum of $700,000/year. Protocol funds must be commensurate with the proposed work. In general, capitation costs are not subject to facilities and administration costs. The exact funds that may be requested for protocol funds will rely, in part, on the number of Clinical Sites included in the Network application and the base budgets requested, as well as the number of proposed projects.