Approval Process of COVID-19 Research
All clinical trials must be reviewed and approved by the Clinical Trial Review Committee before submission to the IRB.
The COVID-19 Clinical Trials Review Committee is charged with reviewing all proposed clinical trials at UC San Diego Health that aim to enroll participants with diagnosed or suspected COVID-19 disease to determine appropriateness and feasibility for patient populations served by UC San Diego Health.
Submission Packet for Investigators
How to submit packet and overview of the COVID-19 Clinical Trials Review Committee
ACTRI COVID-19 Research Biobank
Additional COVID-19 Resources
STEP 1: Process Overview
- Principal Investigator will prepare Submission Packet outlining their proposed study and send to Dr. Constance Benson & Karlyle Lim. Once Submission Packet is downloaded and completed, please email to Dr. Constance Benson and Karlyle Lim.
- A Primary Reviewer will be assigned from the Committee.
- The COVID-19 Clinical Trials Review Committee will convene on the 1st and 3rd Thursdays of the month to discuss submissions.
- Review Decision will be communicated back to PI.
STEP 2: Review Decisions
- Approved: Protocol moves on to IRB for review
- Approved with Contingencies: Protocol may move on to IRB once contingencies are addressed, e.g. plan for coordination of enrollment with other ongoing trials
- Deferred: Review Committee may require further explanation, information or input about specific areas of the protocol study and implementation plans identified during the review. In this situation a decision is deferred until the Review Committee receives the requisite information.
- Disapproved: Protocol cannot be implemented at UC San Diego Health
- Investigators have the option to appeal; requests for appeal and the basis for the appeal should be forwarded to Dr. Constance Benson and Karlyle Lim.
Process Map for COVID-specific clinical research
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General Criteria to Evaluation COVID-19/SARS-CoV-2 Clinical Trials for Implementation at UC San Diego Health
- Is there appropriate scientific justification for studying the intervention in question?
- Is the study design appropriate to test the hypotheses stated?
- Is the study feasible to conduct within inpatient or outpatient settings at UC San Diego Health?
- Is the funding available adequate to conduct the study?
- Are there other competing studies already underway or pending at UC San Diego Health that will impact the ability to recruit the proposed sample size and/or impact the staffing available to conduct the study?
- Do UCSD investigators play a key role in the development and implementation of the clinical trial that would be important for research objectives of UCSD Health?
- Constance A. Benson, MD – Chair
- Ezra Cohen, MD – Co-Chair
- Davey Smith, MD – Division Chief, Infectious Diseases & Global Public Health
- Atul Malhotra, MD – Division of Pulmonary/Critical Care & Sleep Medicine
- Susan Little, MD – Division of Infectious Diseases & Global Public Health
- Kimberly McConnell, PharmD – Investigational Drug Services
- Eric Mah – ACTRI (ex officio non-voting)
For additional questions regarding the COVID-19 Clinical Trials Review Committee, please contact Karlyle Lim at