IRB COVID-19 Guidance

The University of San Francisco IRB does not have a blanket recommendation or requirement about postponing or cancelling study visits, but you should minimize in-person interactions following the recommendations of the:

Centers for Disease Control: https://www.cdc.gov/coronavirus/2019-ncov/index.html

California Health Department: https://www.cdph.ca.gov/Programs/CID/DCDC/Pages/Immunization/ncov2019.aspx

Participant screening. USF IRB recommends study teams conduct a short phone or email screening for exposure to the novel coronavirus SARS-CoV-2 or symptoms of illness before any study-related visits and in-person interactions. Research participants with possible exposure or symptoms of illness should not participate in in-person interactions until after the time recommended by current public health recommendations. This screening procedure does not require IRB approval.

Appropriate screening questions might include the following, which could be modified to fit your participant population and the location of in-person interactions. Any YES answer should be considered sufficient reason to postpone in-person visits. Decisions about in-person visits should be especially conservative for people at higher risk per public health recommendations:

  • Over 60 years of age
  • Underlying health conditions including heart disease, lung disease, or diabetes
  • Weakened immune systems
  • Pregnant
  • Have you had any of the following symptoms in the past two weeks, even if they were mild? Fever — Cough — Shortness of breath
  • Have you had close contact* with a person who is under investigation for possible COVID-19?
  • In the past three weeks, have you visited a country or facility with sustained (ongoing) occurrence of COVID-19, such as: China – Iran – Italy – Japan - South Korea

In addition, researchers should:

  • Follow any guidelines or instructions from the specific facility where participant interaction would occur.
  • Consider the participant population (e.g., are they considered “high risk” for COVID-19?) and the setting in which the interaction would occur.
  • Develop possible alternatives to in-person study visits that are important for subject safety and monitoring.
  • Ensure that hand sanitizer, hand washing facilities and/or cleaning wipes are readily available for screened participants, when in-person interactions will occur.

University of San Francisco IRB is fully operational. We expect this to continue even if the University suspends operations for contagion control purposes. All IRB email will continue to be monitored with the same frequency. Researchers are strongly encouraged to use email to obtain consultations rather than in-person meetings. The IRB will likely be lightly staffed during this time, and that could change without notice to no staffing. It is strongly encouraged that you email IRBPHS@usfca.edu with questions.

 

*Close contact is defined by the CDC as (a) being within approx. 6 feet (2 meters) of a COVID-19 case for a prolonged period of time. Close contact can occur while caring for, living with, visiting, or sharing a health care waiting area or room with a COVID-19 case OR (b) having direct contact with infectious secretions of a COVID-19 case (e.g., being coughed on).