Clarification: Screening for COVID-19 in Human Subjects Research
CPHS/OPHS would like to emphasize that their recommendation in the March 13, 2020 memo - regarding the screening of subjects for COVID-19 symptoms and/or possible travel exposure - before directly interacting with the subjects on or off campus is important but the information gleaned is not research data! Therefore, a screening process can and should be implemented without waiting CPHS/OPHS review and approval in the interest of protecting research subjects and minimizing exposure of UCB researchers. As per the memo, reporting said changes in procedures can be done by the PI via a deviation report at a later time.
Here are the regulatory references pertinent to this COVID-19 situation:
FDA: “Each IRB shall … (a) Follow written procedures for ensuring that changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except where necessary to eliminate apparent immediate hazards to the human subjects.” - 21 CFR 56.108(a)(4)
HHS: “…Ensuring prompt reporting to the IRB of proposed changes in a research activity, and for ensuring that investigators will conduct the research activity in accordance with the terms of the IRB approval until any proposed changes have been reviewed and approved by the IRB, except when necessary to eliminate apparent immediate hazards to the subject.” - 45 CFR 46.108(a)(3)(iii)
If you have any questions, please don’t hesitate to email the OPHS staff at OPHS@berkeley.edu but please do not call us as we are telecommuting!