Welcome to our Division of Neonatology Research Commitee, or FASTR (Feasibility And ScienTific Review), page! We welcome collaborations with our many internal divisions and departments, as well as external universities and industry sponsors. Some of our current and former partnerships have included bioengineering, cardiology, neurology, opthamology, and genomics.
All About FASTR
The Division of Neonatology has a robust and well-defined process for research conducted within our units and with our unique and vulnerable population(s). The FASTR Committee was established to evaluate all new clinical research studies proposed to involve UC San Diego Health and Rady Children's Hospital NICU patients and/or NICU resources. The purpose of FASTR is to perform feasibility and scientific review of all research involving the recruitment of neonatal/perinatal patients and/or use of NICU facilities. The Committee consists of neonatal/perinatal physician researchers, research nurses, respiratory therapists, research coordinators, and ad hoc expert panel members.
Both investigator initiated proposals and industry sponsored studies are reviewed through the FASTR committee prior to IRB submission and/or patient recruitment. Our goal is to establish a streamlined procedure that enhances, stimulates, and supports our researchers and the vital work they perform.
FASTR meetings occur the third Monday of every month, with a few exceptions.
How To Get Started!
If you would like to attend a meeting or have a study proposal to add to the agenda, please email NICUStudies@health.ucsd.edu or Sarah Lazar, Clinical Research Manager, directly at email@example.com. We ask that proposals are submitted at least one week prior to a committee meeting to ensure that there is appropriate time for review. We ask that proposal investigators (or a designee) present their projects at the monthly meetings either in person or via teleconference. We also request that any project involving interventional procedures or patient interaction include a Neonatologist as a co-investigator. The UCSD IRB is also aware of this requirement.
Of note, UC San Diego Jacobs Medical Center, has a separate research meeting in order to review and sign off on any research being done in the JMC unit. This research meeting takes place on the 4th Wednesday of every month, with a few exceptions. Please contact NICUStudies@health.ucsd.edu or Sarah Lazar, Clinical Research manager, directly at firstname.lastname@example.org, if you have a project that has passed the initial proposal phase and/or needs to be reviewed specifically by the team at JMC.
Retrospective chart reviews may be presented at the initial proposal phase, with a request to expedite directly to the IRB.
All submissions should start with an Initial Proposal Form request. Following the initial proposal phase, a FASTR form must be submitted. We request that all submissions approved to move to the FASTR phase also include a Research Plan (or Master Protocol if industry sponsored) and Consent Form(s) (if available). Below are the requested documents:
Initial Proposal Form (fillable Study Proposal Form - 23June2021.pdf)
FASTR Form (fillable FASTR Form - 23June2021.pdf)
Research Plan (see: https://irb.ucsd.edu/Biomedical-Forms.shtml for appropriate form(s))
Consent Form (if available)
Investigators may submit any additional documentation they feel may assist with the review. All submission documents may be emailed to NICUStudies@health.ucsd.edu or to email@example.com.
For assistance completing the Initial Proposal Form or FASTR Form or for questions regarding the committee review, please
contact a member of our core Neonatal Clinical Research Team.