COVID-19 Guidance

Research Continuity for Human Subjects Research at UWM resulting from the COVID-19 Pandemic – 2020

Updated 5/29/2020

General Information

Research

COVID-19 research (new submissions) involving human subjects

  • Please submit a new study using IRBManager and email irbinfo@uwm.edu letting us know a study related to COVID-19 has been submitted and your target start date.

Amendments being made because of COVID-19 impacts

  • Please submit amendment using IRBManager and email irbinfo@uwm.edu letting us know a change is required because of COVID-19 and your target implementation date.

IRB Submissions

  • Unless there are special circumstances (COVID-19 research, urgent changes as a result of COVID-19, etc.), research submissions will be reviewed in the order of receipt.
  • In addition to urgent issues related to COVID-19 research mentioned above, IRB office staff may be required to support other research compliance functions during this time. This may result in the review of standard submissions being slower than normal. The IRB website will continue to be updated with expected times for initial review.

Ongoing Research

In-person research activities are currently NOT allowed by UWM. As restrictions are gradually lifted, the following guidance will apply to all in-person activities that are permitted to resume.

    • Research procedures should be conducted remotely, whenever possible.
    • For studies requiring in-person procedures, consider whether activities such as determining eligibility, consent discussions, etc. can be done remotely ahead of the in-person visit to minimize contact time.
    • For individuals that may be more susceptible to serious COVID-19 complications due to age, pre-existing conditions, etc., the risk of participating in the study may be unacceptably high. Consider your study population when determining whether the research should move forward, and consult with the IRB as needed.
    • Research staff must self-monitor their own health to protect research participants. If a researcher becomes ill, they should notify any participants who may have had contact with that researcher.
    • Screening related to COVID-19 symptoms should be conducted remotely prior to in-person visits, using the questions below. No amendment is necessary, but report it to the IRB at the next continuing review.
      1. In the past 14 days, have you had any of the following symptoms (without confirmation as something other than COVID-19, such as a positive flu test, chronic medical condition, etc.)? [List symptoms of COVID-19, using the most current list found at https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html]
      2. In the past 14 days, have you lived with, visited, cared for, or been in a room for a prolonged period of time with someone who is under investigation for or has tested positive for COVID-19?
    • If the answer to any question is “yes”, the visit should be rescheduled.
      1. Direct the participant to contact their physician.
      2. Document your conversation.
    • If the answer to all questions is “no”, the study visit may continue, and all screening questions should be verified again at the time of the in-person visit
  • Implement social distancing for the entire visit.
  • Disinfect space, equipment, and surfaces before and after visits.

Emergency Changes

  • If a change in study procedures is necessary to eliminate apparent hazards to a participant and there is not sufficient time to obtain IRB approval, the change may be implemented prior to IRB approval.
  • The change must be submitted through an amendment as soon as possible after implementation, but no later than 72 hours.