For Approval of COVID-19 Research
The process outlined below is for the approval of COVID-19 research studies that involve UCLA Health patients and/or health care workers and/or UCLA Health clinical research infrastructure.
UCLA Health has created an 11-member COVID-19 Scientific Prioritization and Feasibility Committee (SPFC). This committee will review studies submitted to the IRB that are COVID related that involve UCLA Health patients or health care workers and/or UCLA Health clinical research infrastructure.
The committee will be supported administratively by the CTSI Office of Clinical Research. Studies that do not require any resources from UCLA Health (as outlined below) will be quickly exempted and proceed immediately to IRB review. Please do no contact any of the committee members directly to avoid creating conflicts of interest.
To have your project or research added for review by the COVID-19 Scientific Prioritization and Feasibility Committee, fill out the following survey.
SUBMIT FOR SPFC REVIEW →
Section 1: Review Scope
For COVID studies that require UCLA Health System Resources:
- Access to the suspected and confirmed UCLA Health COVID-19 patients.
- Access to the electronic medical record chart or data of those patients.
- Access to the remnant or research biospecimen collection of those patients.
- Planning any clinical research interventional trial (drug/device) for those patients.
- COVID Population-based studies that overlap the UCLA Health population or UCLA healthcare workers.
UCLA Health will require a rapid review to assess scientific priority, operational feasibility, and data/specimen centralized coordination.
The work of this committee is critical due to:
- The increasing number of competing and overlapping studies being submitted to the IRB.
- The desire to protect the privacy of our COVID-19 patients, many of whom are UCLA employees.
- The limitation on personal protective equipment, which is prioritized for clinical care.
- Reduced operational resources during this crisis, including clinical research infrastructure.
- Limited bio-specimen availability.
Section 2: Procedure
- The IRB will flag COVID-19 trials for review at the time of submission.
- The committee will be asked to review material by email and meet ad-hoc as needed to ensure the most expedited review possible.
- The scientific review committee will review and prioritize the study assessing operational feasibility as well as population, data and biospecimen requirements.
- Recommendations will be made to the COVID-19 Clinical Research Task Force.
- Initial issues and concerns associated with the review can be escalated to Drs. Currier and Naeim who are heading the COVID-19 Clinical Research Task Force.
- Further escalation and final decision-making authority will rest with the Research COVID Oversight Committee.
General scientific review committee
- John Belperio: Chair (Pulmonary)
- Jennifer Fulcher (Infectious Disease)
- Noah Federman (CTSI)
- Paul Boutros (Cancer Center)
- Clara Lajonchere (IPH)
- Holli DeVon (Nursing)
- Chris Denny (Pediatrics/Lab)
- Moira Inkelas (Public Health)
- David Elashoff (Biostatistics)
- Joann Elmore (GIM-HSR)
- Neil Wenger (GIM-HSR, Ethics)
Clinical Trial Prioritization Subgroup
- Judith Currier
- Steve Dubinett
- Otto Yang
- Tisha Wang
- Steve Chang
- Paul Krogstad
- Arash Naeim (Operations)
- Dawn Ward (Lab)
- Eric Cheng (ISS/Data)
- Pamela Miller (Nursing/Hospital)
- Kristin Craun (IRB)
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PLEASE DO NOT CONTACT COMMITTEE MEMBERS DIRECTLY TO AVOID A PERCEPTION OR REAL CONFLICT OF INTEREST. Please contact email@example.com if you have questions.