SUBJECT:

UCSD COVID-19 Human Subjects Research Guidelines

UC San Diego is committed to the health and safety of our research participants and our research clinical and administrative teams; we are committed to supporting to the fullest extent possible all research activities while mitigating risks related to COVID-19. To ensure safety of staff, research participants and research team members, all researchers performing human subject research will be required to align with the UC San Diego Health System plan to screen research participants for COVID-19 risk and implement precautions and policies. The following updated procedures apply to all human research, including clinical trials, non-trial studies, and social-behavioral-educational studies, are in effect until April 30, 2020, or as conditions change. Downloadable versions will be available at https://irb.ucsd.edu and https://research.ucsd.edu. All study personnel must be proactive in this effort. To decrease potential exposure, the research team or facility will pre-screen research participants via phone whenever feasible one day prior to their scheduled study visit and will be rescheduled if they meet the criteria regarding travel and symptoms. All research participants will also be screened upon arrival to UC San Diego research facilities and follow the UC San Diego Health System policy for a positive screen:

1. Script for Phone Screening:
http://adminrecords.ucsd.edu/Notices/2020/2020-3-13-5-Link1.pdf

2. Script for In-Person Screening: UC San Diego Health COVID-19 Care Path Resource:
http://adminrecords.ucsd.edu/Notices/2020/2020-3-13-5-Link2.pdf

3. COVID-19 UCSD Ambulatory Care In-Clinic Testing Process:
http://adminrecords.ucsd.edu/Notices/2020/2020-3-13-5-Link3.pdf

I. Research treatments requiring hospital/infusion room procedures for patients enrolled in clinical trials will continue as scheduled, while observing the precautions currently enforced for all UC San Diego Health patients.

II. Shipping of oral investigation treatments directly to research participants will be evaluated on a study by study basis.

III. Non-treatment visits will be evaluated to determine whether they can be conducted using audio or video technologies (e.g., Zoom). Large, in-person focus groups and interviewing should be postponed when possible.

IV. Clinical research participants being followed-up after completing the active treatment period will be evaluated to determine whether their visits or their study procedures (e.g., laboratory and imaging) can be rescheduled/delayed if Health System resources are limited due to COVID-19 treatments. Protocol modifications to reduce risk for staff and participants might need to be reported to the IRB. Guidance on reporting will be posted on https://irb.ucsd.edu.

V. Monitoring visits should be evaluated to determine whether they can be conducted through videoconferencing and/or rescheduled. Monitors should follow the rules enforced for patients and research subjects.

VI. UC San Diego research staff will be screened before each shift using the questions in the phone screen referenced above, and educated on Hand Hygiene and Social Distancing Interventions. Principal Investigators are responsible for ensuring this occurs.

All research support offices (e.g., Human Research Protections Program, Office of Coverage Analysis Administration, and Office of Clinical Trials Administration, Office of Contracts and Grants, and Office of Research Affairs) currently remain open.

Sandra A. Brown, PhD Vice Chancellor for Research David A. Brenner, MD Vice Chancellor for Health Sciences Gary S. Firestein, MD Associate Vice Chancellor for Clinical and Translational Research