Tuesday updates: IRB news, and Covid-19 related leave policies

Bill Maurer
Tuesday Apr 7 17:24:17 PDT 2020
    Dear all,

    A couple of information items today, including very welcome news from
    the IRB (now, who ever would expect to read that? The world really is
    upside-down!):
    
    1) The IRB will permit researchers to change study procedures to implement
    social distancing WITHOUT submitting a protocol modification. In other
    words, if you need to change how you share a study information sheet
    (electronically instead of in person), or shift a study procedure like
    in-person interviews or surveys to an online or telephone-based method,
    you do not need prior approval from the IRB. You do, however, need to
    document this change in procedure and inform the IRB at the time of your
    next modification or renewal. See here, and click on the third item down.
    
    2) In addition, this was previously announced but you may have missed
    it: UC Irvine's IRB now permits "self-determination" of Exempt
    registration status for Exempt categories 1, 2 and 3 so long as
    special/vulnerable populations are not included as research subjects,
    it is not international research, and there are no disclosable financial
    interests. The self-determination form is here and please double check
    the exceptions. Note that you are required to maintain documentation of
    Exempt status self-determination.
    
    Updates on guidance from the IRB can always be found on the Human Research
    Protections News & Announcements or by subscribing to their email list
    by sending a blank email to or-irb-hrp-join@department-lists.uci.edu
    
    It should go without saying that the shift in campus policy toward Exempt
    registration, and the special dispensation for changing study procedures
    due to social distancing, does not imply any relaxation of standards with
    respect to the protection of human subjects involved in research. As
    social and behavioral researchers we have a duty to protect research
    subjects and conduct our work in accordance with the basic ethical
    principles of beneficence, justice, and respect for persons. Don't make
    me quote the Belmont Report at you! (Oh, wait, I just did).
    
    If your project requires Expedited registration or Full Committee review,
    be aware that the IRB is prioritizing Covid-19 related projects. But the
    IRB is indeed up and running, remotely. And much of our research in the
    School qualifies for Exempt registration.
    
    All of this means that if you've been hesitating to re-start your
    research because you're worried about having to submit an e-Mod, or if
    you're thinking of setting up a new project related to the pandemic,
    or even research not related to the pandemic: Don't use the excuse of
    the IRB to hold you back!
    
    3) We also wanted again to draw your attention to the
    Covid-19 related leave policy for academic employees, here:
    https://ap.uci.edu/covid19/covid-19-guidance-academic-supervisors/. The
    policy is difficult to interpret given that we are all sheltering in
    place, and it's hard to provide guidance on how one might implement this
    policy except on a case by case basis. Please feel free to reach out to
    Natalie Cook if you would like to receive further information or to be
    put in touch with the relevant contacts in HR or the Employee Assistance
    Program. For graduate students, your main point of contact would be the
    Graduate Office in the School of Social Sciences.
    
    Looks like the rain is back! And what better activity on a rainy day
    after work than to make face masks, under the helpful supervision of
    Ginger, who is a very old cat.
    
    Bill
    

©