Clinical Research Ramp-Up Requirements
Dear School of Medicine Faculty,

For those of you with active clinical research trials, this is a reminder of your responsibility to adhere to the COVID-19 research ramp-up process for your trials. We are currently in Phase 2, which allows for the following types of trials to be conducted:
  • Interventional treatment trials
  • Interventional supportive care, diagnostic and prevention trials
  • Time-sensitive assessments of currently enrolled participants in longitudinal observational studies
  • NEW Ancillary and correlative trials conducted in conjunction with a routine care/medically necessary visit with study personnel adhering to all required/appropriate safety measures and precautions
Any exceptional approval and processes should be reviewed and approved by the following:
  • Alpha Stem Cell Center – Dr. Daniela Bota
  • Center for Clinical Research – Dr. Daniela Bota
  • CFCCC Stern Center – Dr. Susan O’Brien
  • Institute for Memory Impairments and Neurological Disorders – Dr. David Sultzer
  • All others – department chairs (clinical research trials with department chairs as the PI or Co-I must be approved by Vice Dean of Clinical Research Dr. Daniela Bota)
Please refer to the “General Points of Consideration” outlined by the Office of Research SARS-CoV-2/COVID-19 and Research Continuity and ensure that your study teams are following the 5 points below.
  1. Perform an assessment and implement a site-specific protection plan, including a plan to monitor compliance and return to an earlier phase whenever necessary.
  2. Implement individual control measures and screenings.
  3. Implement disinfecting protocols.
  4. Implement physical distancing guidelines.
  5. Train personnel on how to limit the spread of COVID-19, including how to screen themselves for symptoms and stay at home if they have them.
Please see Research Continuity: IRB & Human Research protections Program (HRPP) for further information.

The following UCI Health and UCI resources and directives should also be reviewed, referred to, and adhered: Finally, below is additional guidance from the Centers for Disease Control and Prevention (CDC):
  • Staff and patients are encouraged to wash their hands often with soap and water for at least 20 seconds or to use hand sanitizer with at least 60% alcohol if soap and water are not available. They should use soap and water over hand sanitizer that if their hands are visibly dirty.
  • Key times for staff to clean their hands include:
    • Before and after work shifts
    • Before and after work breaks
    • After blowing their nose, coughing or sneezing
    • After using the restroom
    • Before eating or preparing food
    • After putting on, touching or removing cloth face coverings
  • Staff and patients are encouraged to avoid touching their eyes, nose and mouth with unwashed hands.
  • Staff and patients are encouraged to cover their mouth and nose with a tissue when they cough or sneeze, or use the inside of their elbow. Staff and patients should throw used tissues into no-touch trashcans and immediately wash hands with soap and water for at least 20 seconds. If soap and water are not available, they should use hand sanitizer containing at least 60% alcohol. Learn more about coughing and sneezing etiquette on the CDC website.
  • Staff and patients are encouraged to practice routine cleaning and disinfection of frequently touched objects and surfaces such as workstations, keyboards, telephones, handrails and doorknobs. Dirty surfaces can be cleaned with soap and water prior to disinfection with products that meet EPA’s criteria for use against SARS-CoV-2external icon
  • Staff and patients are encouraged to avoid using others’ phones, desks, offices or other work tools and equipment, when possible. It is recommended to clean and disinfect them before and after use.
  • Staff and patients are encouraged to practice social distancing by avoiding large gatherings and maintaining distance (at least 6 feet) from others when possible.  
Facial Coverings
Patients, faculty and providers are required to use of masks when they are in the hospital or clinic. Face coverings should be worn as feasible and are most essential in times when physical distancing is difficult. Individuals are encouraged not to touch the face covering and to wash their hands frequently.

Actively encourage sick individuals to stay home:
  • Staff and patients who have symptoms should stay home.
  • Sick staff or patients should follow CDC-recommended steps. Staff should not return to work until the criteria to discontinue home isolation are met, in consultation with healthcare providers.
  • Staff or patients who are well but who have a sick family member at home with COVID-19 should follow CDC recommended precautions.
As these requirements are continuously changing, we are relying on each of you to assure that you and your study teams are in compliance with all university and School of Medicine requirements. These requirements have been established to increase the safety of our employees. I know you share with me a deep concern for the creation and maintenance of a safe working environment and look forward to partnering together to create a safe and healthy place of work.

Thank you,

Daniela A. Bota, MD, PhD
Vice Dean for Clinical Research