The Feasibility And ScienTific Review (FASTR) Committee was established to evaluate all new clinical studies proposed for research studies involving Rady Children's Hospital-San Diego NICU and UCSD Health NICU patients. 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, a research nurse, a staff NICU nursing representative, a respiratory therapist, 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 FASTR committee 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 during the first full week of every month. 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 proposal investigators (or a designee) to present their projects at the monthly meetings either in person or via teleconference. If investigators are unable to participate, projects are reviewed based upon submitted documentation. We also request that any project involving interventional procedures or patient interaction include a Neonatologist as a co-investigator.
We request that all submissions include a FASTR submission form and research plan (or master protocol if industry sponsored). FASTR submission documentation includes the following:
FASTR Submission Form (fillable
Research Plan (UCSD IRB template)
Consent Form (if available)
Investigators may submit any additional documentation they feel may assist with the review. All submission documents may be emailed to Sarah Lazar (firstname.lastname@example.org) or Clara Law (email@example.com).
For assistance completing the FASTR Submission Form or for questions regarding the committee review, please
contact one of our NCRT research coordinators.