The Feasibility And ScienTific Review (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.
The goals of the Neonatology Division Research Committee / FASTR are to:
Provide guidance and feedback to the PI on concept/protocol development prior to UCSD IRB submission;
Evaluate resources required to implement proposed study, including clinical and research staff effort and equipment availability;
Review study feasibility, including target population availability, recruitment goals, and anticipated timelines for completion; and
Ensure that both pre-IRB review and ongoing monitoring are performed for all projects supported by the division.
FASTR meetings occur the third Monday of every month, with a few exceptions. If you would like to attend a meeting or have a study proposal to add to the agenda, please email NICUresearch@ucsd.edu or Sarah Lazar, Clinical Research Manager, directly at firstname.lastname@example.org. We ask that proposals are submitted at least 10 days 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.
FASTR review is a multi-step process. The first step is considered the initial proposal review phase, where the committee members evaluate the general premise of the research, including overall feasibility and support from the division. Once a project has been approved at the initial proposal phase, it may move to the FASTR phase. This phase is a more in-depth look at the project, including the population being considered, resources that may be needed, etc. Prior to the FASTR phase, the investigator(s) must have approval from the medical directors of the specific units they are proposing to perform the research in.
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 NICUresearch@ucsd.edu or Sarah Lazar, Clinical Research manager, directly at email@example.com, 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, as mentioned above, 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
FASTR Form (fillable 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 NICUresearch@ucsd.edu or to firstname.lastname@example.org.
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.